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Wednesday, July 25, 2012

Invega

Generic Name: paliperidone (Oral route)

pal-ee-PER-i-done

Oral route(Tablet, Extended Release)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared with placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Paliperidone is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s)

In the U.S.

Invega

Available Dosage Forms:

Tablet, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Uses For Invega

Paliperidone is used to treat the symptoms of psychotic disorders, such as schizophrenia. It may be used alone or together with other medicines to treat patients with schizoaffective disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.

This medicine is available only with your doctor's prescription.

Before Using Invega

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of paliperidone in children with schizophrenia younger than 12 years of age and in children with schizoaffective disorder in children younger than 18 years of age. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paliperidone in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving paliperidone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride

Dronedarone

Mesoridazine

Metoclopramide

Pimozide

Sparfloxacin

Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide

Ajmaline

Alfuzosin

Amiodarone

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Asenapine

Azimilide

Azithromycin

Bretylium

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Dasatinib

Desipramine

Disopyramide

Dofetilide

Dolasetron

Droperidol

Erythromycin

Flecainide

Fluconazole

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Hydromorphone

Hydroquinidine

Ibutilide

Iloperidone

Imipramine

Lapatinib

Levofloxacin

Lopinavir

Lumefantrine

Mefloquine

Methadone

Moxifloxacin

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Pazopanib

Perflutren Lipid Microsphere

Pirmenol

Posaconazole

Prajmaline

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Salmeterol

Saquinavir

Sematilide

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sunitinib

Tedisamil

Telavancin

Telithromycin

Terfenadine

Tetrabenazine

Toremifene

Trazodone

Trifluoperazine

Trimipramine

Vandetanib

Vardenafil

Vemurafenib

Voriconazole

Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Paroxetine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Invega

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine may be taken with or without food.

Swallow the extended-release tablet whole with a liquid (water or juice). Do not crush, break, or chew it.

Part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and is nothing to worry about.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release tablets):
- For schizophrenia:
  - Adults—6 milligrams (mg) once a day, every morning. Some patients may need 3 mg per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 12 mg per day.
  - Teenagers 12 to 17 years of age weighing 51 kg (112 lbs) or more—3 mg once a day, every morning. Your doctor may increase your dose if needed. However, the dose is usually not more than 12 mg per day.
  - Teenagers 12 to 17 years of age weighing less than 51 kg (112 lbs)—3 mg once a day, every morning. Your doctor may increase your dose if needed. However, the dose is usually not more than 6 mg per day.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For schizoaffective disorder:
  - Adults—6 milligrams (mg) once a day, every morning. Some patients may need 3 mg per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 12 mg per day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Invega

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Stop taking this medicine and check with your doctor right away if you your child have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you your child have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

For diabetic patients: This medicine may affect your blood sugar levels. Check with your doctor right away if you your child have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests or if you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Paliperidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that require you to be alert, well-coordinated, or able to think or see well.

Paliperidone may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines including other narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you your child are using this medicine.

This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you your child are too hot and cannot cool down.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you your child are using this medicine.

If your or your child's symptoms do not improve or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Invega Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficulty with speaking

drooling

fast, pounding, or irregular heartbeat or pulse

increase in body movements

loss of balance control

muscle trembling, jerking, or stiffness

restlessness

shuffling walk

stiffness of the limbs

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

Less common

Chest pain

cold sweats

confusion

cough

difficulty with swallowing

dizziness

excessive muscle tone

fainting

inability to move the eyes

increased blinking or spasms of the eyelid

increased blood pressure

loss of balance control

mask-like face

muscle tension or tightness

pain in the arms or legs

slow heartbeat

slowed movements

slurred speech

sticking out tongue when not meaning to

tic-like (jerky) movements of the head, face, mouth, and neck

trembling and shaking of the fingers and hands

tremors

trouble with breathing, speaking, or swallowing

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual facial expressions

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Absent, missed, or irregular menstrual periods

difficulty having a bowel movement (stool)

fear or nervousness

headache

inability to sit still

nausea

need to keep moving

sleepiness or unusual drowsiness

stopping of menstrual bleeding

vomiting

weight gain

Less common

Acid or sour stomach

back pain

belching

blurred vision

changes in appetite

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fever

heartburn

indigestion

lack or loss of strength

muscle aches

sore throat

stomach discomfort, upset, or pain

stuffy or runny nose

swelling of the breasts or breast soreness in both females and males

swollen tongue

unexpected or excess milk flow from breasts

upper abdominal or stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Invega side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Invega resources

Invega Side Effects (in more detail)
Invega Use in Pregnancy & Breastfeeding
Drug Images
Invega Drug Interactions
Invega Support Group
15 Reviews for Invega - Add your own review/rating

Invega Prescribing Information (FDA)

Invega Consumer Overview

Invega Monograph (AHFS DI)

Invega Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Paliperidone Professional Patient Advice (Wolters Kluwer)

Invega Sustenna Prescribing Information (FDA)

Invega Sustenna MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Invega with other medications

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Schizophrenia

Sunday, July 22, 2012

Zyrtec Chewable Tablets

Pronunciation: se-TIR-i-zeen
Generic Name: Cetirizine
Brand Name: Zyrtec

Zyrtec Chewable Tablets are used for:

Preventing or treating symptoms of hay fever and other upper respiratory allergies such as stuffy nose, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. It is also used for preventing or treating chronic hives. It may also be used for other conditions as determined by your doctor.

Zyrtec Chewable Tablets are an antihistamine. It works by blocking the action of histamine, which reduces the symptoms of an allergic reaction.

Do NOT use Zyrtec Chewable Tablets if:

you are allergic to any ingredient in Zyrtec Chewable Tablets or to hydroxyzine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zyrtec Chewable Tablets:

Some medical conditions may interact with Zyrtec Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have kidney or liver problems, or you are receiving dialysis

Some MEDICINES MAY INTERACT with Zyrtec Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Theophylline because it may increase the risk of Zyrtec Chewable Tablets's side effects

How to use Zyrtec Chewable Tablets:

Use Zyrtec Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Zyrtec Chewable Tablets by mouth with or without food.

Chew thoroughly before swallowing.

If you miss a dose of Zyrtec Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zyrtec Chewable Tablets.

Important safety information:

Zyrtec Chewable Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Zyrtec Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Zyrtec Chewable Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Zyrtec Chewable Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Zyrtec Chewable Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Zyrtec Chewable Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Zyrtec Chewable Tablets for a few days before the tests.

Use Zyrtec Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Zyrtec Chewable Tablets in CHILDREN; they may be more sensitive to its effects, especially stomach pain and trouble sleeping.

Zyrtec Chewable Tablets should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is not known if Zyrtec Chewable Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zyrtec Chewable Tablets while you are pregnant. Zyrtec Chewable Tablets are found in breast milk. Do not breast-feed while taking Zyrtec Chewable Tablets.

Possible side effects of Zyrtec Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth; stomach pain (in children); tiredness; trouble sleeping (in children).

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; fainting; fast or irregular heartbeat; mental or mood changes; persistent fatigue; seizures; severe dizziness; unusual bruising or bleeding; yellowing of eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zyrtec side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include irritability; restlessness; severe drowsiness.

Proper storage of Zyrtec Chewable Tablets:

Store Zyrtec Chewable Tablets between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zyrtec Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Zyrtec Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.

Zyrtec Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zyrtec Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Zyrtec resources

Zyrtec Side Effects (in more detail)
Zyrtec Dosage
Zyrtec Use in Pregnancy & Breastfeeding
Drug Images
Zyrtec Drug Interactions
Zyrtec Support Group
53 Reviews for Zyrtec - Add your own review/rating

Compare Zyrtec with other medications

Hay Fever
Urticaria

Friday, July 20, 2012

Imipramine Hydrochloride 25mg / 5ml Oral Solution

Imipramine Hydrochloride 25mg/5ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine

Keep this leaflet. You may need to read it again

If you have any further questions, ask your doctor or your pharmacist

This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1. What Imipramine Hydrochloride Oral Solution is and what it is used for

2. Before you take Imipramine Hydrochloride Oral Solution

3. How to take Imipramine Hydrochloride Oral Solution

4. Possible side effects

5. How to store Imipramine Hydrochloride Oral Solution

6. Further Information

What Imipramine Hydrochloride Oral Solution is and what it is used for

Imipramine Hydrochloride Oral Solution contains the active ingredient imipramine. This belongs to a class of medicines called tricyclic antidepressants and is used to treat:

the symptoms of depression

night-time bed-wetting in children.

Before you take Imipramine Hydrochloride Oral Solution

Do not take Imipramine Hydrochloride Oral Solution if you:

are allergic (hypersensitive) to imipramine or any other tricyclic antidepressant, or to any of the other ingredients of Imipramine Hydrochloride Oral Solution (see Section 6, and end of Section 2)

have serious heart or liver disease

have narrow angle glaucoma (increased pressure in the eye)

have difficulty in passing water

suffer from mania

have had a heart attack in the past 3 months

are taking (now or recently) any other medicines for depression (particularly monoamine oxidase inhibitors [MAOIs] such as moclobemide within the last 3 weeks).

Children under 6 years old should not take this medicine.

Take special care with Imipramine Hydrochloride Oral Solution:

Before you take this medicine tell your doctor if you have:

epilepsy (fits) or brain damage

severe kidney disease

a history of low blood pressure

a tumour of the adrenal gland (called phaeochromocytoma or neuroblastoma)

an overactive thyroid

constipation, especially if you are elderly or bedridden

an intolerance to some sugars

a withdrawal from alcohol or any anticonvulsive drugs

electroconvulsive therapy (ECT) treatment and are taking Imipramine Hydrochloride Oral Solution – you will be carefully supervised.

If you think that any of the above apply to you then tell your doctor before taking Imipramine Hydrochloride Oral Solution.

While you are taking Imipramine Hydrochloride Oral Solution:

you will need routine tests (blood, heart and liver tests) from time to time. These will be carried out by your doctor

you will be closely monitored as improvement may not occur for the first 2 – 4 weeks of treatment

if you already suffer from a panic disorder, you may experience an increase in your feeling of anxiety when you start treatment with Imipramine Hydrochloride Oral Solution. This is usually worse in the first few days and should go away in the first 2 weeks

have regular dental check-ups as long term treatment may increase the risk of tooth decay

if you need an operation tell your doctor that you are taking the solution

contact lens wearers may notice reduced production of tears

if you have suicidal thoughts or want to harm yourself tell your doctor immediately; it may be necessary to reduce or stop the dose. Always speak to your doctor first in order to avoid possible side effects.

Children taking Imipramine Hydrochloride Oral Solution may have behavioural changes.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following medicines, because they may interact with Imipramine Hydrochloride Oral Solution:

medications for depression called MAOIs (monoamine oxidase inhibitors) such as moclobemide – see Section “Do not take Imipramine Hydrochloride Oral Solution”

medication for depression called SSRIs (Selective serotonin reuptake inhibitors) such as fluoxetine and fluvoxamine

a medication used to treat depression and to help stop smoking called amfebutamone

medications for high blood pressure such as guanethidine, betanidine, reserpine, clonidine or alpha-methyldopa

medication for irregular heartbeat such as those containing quinidine

medication for colds, sinus problems, containing decongestants such as ephedrine, phenylephrine or phenylpropanolamine

antihistamines for hay fever or allergies

isoprenaline used to treat asthma

oral contraceptives or oestrogens (e.g. hormone replacement therapy [HRT])

cimetidine (an anti-ulcer drug)

methylphenidate (used to treat behavioural disorders in children)

disulfiram or alprazolam (for alcohol abuse)

barbiturates, tranquillizers (such as phenothiazines, thioridazine or benzodiazepines), general or local anaesthetics

treatments for Parkinson’s disease such as biperiden

medication to treat epilepsy such as carbamazepine or phenytoin

antifungal medication such as terbinafine

noradrenaline, mainly used to treat low blood pressure in emergencies

nicotine found in cigarettes or in medications used to help stop smoking

blood-thinning tablets (anticoagulants) e.g. warfarin.

Taking Imipramine Hydrochloride Oral Solution with food and drink

DO NOT DRINK alcohol while you are taking this medicine.

Pregnancy and Breast-feeding

Ask your doctor for advice before taking any medicine.

Treatment with Imipramine Hydrochloride Oral Solution should be avoided during pregnancy unless your doctor considers it necessary.

If you are breastfeeding, you may be advised to stop taking Imipramine Hydrochloride Oral Solution gradually, or to stop breastfeeding, because imipramine passes into breast milk.

Driving and using machines

You may feel dizzy or sleepy or have blurred vision when you take this medicine.

DO NOT drive or operate machinery without advice from your doctor or pharmacist.

Important information about some of the other ingredients of Imipramine Hydrochloride Oral Solution

Sorbitol – 1.5g per 5ml spoonful. This may have a mild laxative effect. Also, tell your doctor if you have an hereditary intolerance to some sugars

Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) – may cause allergic reactions (possibly delayed).

How to take Imipramine Hydrochloride Oral Solution

Always take Imipramine Hydrochloride Oral Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Depression:

Adults: At first, one 5ml spoonful (25mg) one to three times a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 6 to 8 spoonfuls (150-200mg) a day unless you are in hospital.

Elderly: Your doctor may prescribe lower doses of Imipramine Hydrochloride Oral Solution, particularly when you first start taking this medicine.

Night-time Bed-wetting

Children over 6 years: 1 to 3 spoonfuls (25mg-75mg) a day at bedtime depending on the age and weight of the child.

Treatment with Imipramine Hydrochloride Oral Solution must be checked after 3 months.

Keep taking your medicine until your doctor tells you to stop. Do not stop suddenly because you do not feel any better – the solution may take up to 4 weeks to work.

If you take more Imipramine Hydrochloride Oral Solution than you should

If you (or a child) accidentally take too much Imipramine Hydrochloride Oral Solution, tell your doctor at once or contact your hospital casualty department. Overdosage in children is serious and could be potentially fatal.

If you forget to take Imipramine Hydrochloride Oral Solution

It is important to take your medicine at the right times. If you forget to take a dose, take the next dose at the usual time

DO NOT take a double dose to make up for the forgotten dose.

If you stop taking Imipramine Hydrochloride Oral Solution

Keep taking your medicine until your doctor tells you to stop. Do not stop suddenly because you do not feel any better. If you need to stop treatment, your doctor will tell you how to reduce the dose gradually. This is to help prevent unwanted effects such as headache, sickness, stomach upset, diarrhoea, sleeplessness, nervousness and anxiety.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Imipramine Hydrochloride Oral Solution can cause side effects, although not everybody gets them.

Allergic reactions – skin rash or itching, swelling of the face, lips, tongue or throat, or difficultly in breathing may be signs of an allergic reaction. If this happens, STOP taking Imipramine Hydrochloride Oral Solution and seek medical advice.

The most common side effects are:

dry mouth

blurred vision

headache

hot flushes, sweating

constipation

trembling

weight gain

fast heartbeat

light headedness (especially when getting up from lying or sitting position).

The above effects are often mild and may disappear during treatment. If they are severe or last for more than a few days, tell your doctor.

You are unlikely to experience any of the following side effects but if you do – see your doctor as soon as possible.

drowsiness, tiredness

dizziness

restlessness, anxiety

nausea (feeling sick)

any yellowing of your skin or the whites of your eyes

sore throat or fever

glaucoma (increased pressure in the eye)

difficulty in passing water

hair loss

swelling of the breasts and discharge of milk

dilation of the pupils

increased sensitivity to sunlight

sexual difficulties

ringing in the ears

mood changes, aggression

activation of psychotic symptoms

vomiting, loss of appetite, weight loss

paralytic ileus (no bowel movement)

diarrhoea

stomach pain

any general swelling

tingling or numbness

poor blood circulation which makes the toes and fingers numb and pale

skin rash or itching

darkening of skin

loss of balance

muscle weakness or stiffness, muscle spasm

difficulty in controlling movements

changes to the electrical waves in your brain

difficulty in speaking

inflammation of the lungs which causes breathlessness, cough and raised temperature

feeling your heartbeat or irregular heartbeat

heart failure

red or brownish spots on skin

fits, confusion or delirium

sleep disturbances or difficulty in sleeping

raised blood pressure

low blood pressure

hallucinations

change in blood sugar levels

a condition called ‘syndrome of inappropriate anti-diuretic hormone secretion’ which will cause a lowering of salt in your body

severe reduction in number of white blood cells which makes infections more likely

reduction in blood platelets, which increases risk of bleeding or bruising

other blood disorders

raised levels of enzymes in your liver

inflammation of the mouth or sores on the tongue.

If any of the side effects gets serious, or if you notice any other side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

How to store Imipramine Hydrochloride Oral Solution

Keep out of the reach and sight of children

Keep the medicine in a cool place (below 25°C).

Keep the bottle tightly closed and in its carton when not in use.

Do not use for more than 1 month after first opening.

Do not use Imipramine Hydrochloride Oral Solution after the expiry date which is stated on the carton as {EXP MM/YYYY}.

The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Imipramine Hydrochloride Oral Solution contains

The active ingredient is imipramine. Each 5ml contains 25mg imipramine hydrochloride.

The other ingredients are betacyclodextrin (E459), sorbitol (E420), saccharin sodium (E954), hydroxyethylcellulose, propylene glycol (E1520), banana flavour, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and water (see end of section 2 “Important information about some of the other ingredients” for further information on sorbitol and benzoates).

What Imipramine Hydrochloride Oral Solution looks like and contents of the pack

Imipramine Hydrochloride Oral Solution is a clear, colourless, banana-flavoured solution.

It comes in bottles of 150ml.

Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

Manufacturer

Dales Pharmaceuticals (Trading division of Dechra Ltd)

Snaygill Industrial Estate

Keighley Road

Skipton

North Yorkshire

BD23 2RW

This leaflet was last approved in August 2009.

P0470

F675

Thursday, July 19, 2012

Prevacid Delayed-Release Capsules

Pronunciation: lan-SOE-pra-zole
Generic Name: Lansoprazole
Brand Name: Prevacid

Prevacid Delayed-Release Capsules are used for:

Preventing or treating certain types of ulcers. It is also used to treat symptoms of gastroesophageal reflux disease (GERD) (eg, heartburn) and irritation of the esophagus. It is also used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Prevacid Delayed-Release Capsules are a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

Do NOT use Prevacid Delayed-Release Capsules if:

you are allergic to any ingredient in Prevacid Delayed-Release Capsules

you are taking an HIV protease inhibitor (eg, atazanavir)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prevacid Delayed-Release Capsules:

Some medical conditions may interact with Prevacid Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have low blood potassium or magnesium levels, liver problems, or stomach or bowel cancer

if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Prevacid Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased

Clarithromycin or voriconazole because they may increase the risk of Prevacid Delayed-Release Capsules's side effects

Anticoagulants (eg, warfarin), digoxin, or tacrolimus because the risk of their side effects may be increased by Prevacid Delayed-Release Capsules

Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Prevacid Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prevacid Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prevacid Delayed-Release Capsules:

Use Prevacid Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prevacid Delayed-Release Capsules by mouth on an empty stomach before eating.

Swallow Prevacid Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over 1 tablespoon (15 mL) of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears. Swallow the mixture right away. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.

You may also open the capsule and sprinkle the contents into 2 oz (60 mL) apple juice, orange juice, or tomato juice. Mix briefly, then swallow at once. Do not chew or crush the granules. Do not store the mixture for use at a later time. After you take your dose, rinse the glass with at least 4 oz (120 mL) of juice and swallow to be sure you have received all of the medicine.

Do NOT mix Prevacid Delayed-Release Capsules with other foods or liquids.

You may take antacids while you are using Prevacid Delayed-Release Capsules if you are directed to do so by your doctor.

If you are also taking an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before taking Prevacid Delayed-Release Capsules.

If you also take sucralfate, take Prevacid Delayed-Release Capsules at least 30 minutes before taking sucralfate.

Continue to take Prevacid Delayed-Release Capsules even if you feel well. Do not miss any doses.

If you miss a dose of Prevacid Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prevacid Delayed-Release Capsules.

Important safety information:

Prevacid Delayed-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Prevacid Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds; or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.

Prevacid Delayed-Release Capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Prevacid Delayed-Release Capsules in high doses, for long periods of time, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information.

Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Prevacid Delayed-Release Capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).

Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Prevacid Delayed-Release Capsules.

Prevacid Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prevacid Delayed-Release Capsules.

Prevacid Delayed-Release Capsules should be used with caution in Asian patients; the risk of side effects may be increased in these patients.

Use Prevacid Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.

Prevacid Delayed-Release Capsules should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prevacid Delayed-Release Capsules while you are pregnant. It is not known if Prevacid Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Prevacid Delayed-Release Capsules.

Possible side effects of Prevacid Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; unusual bruising or bleeding; unusual tiredness; vision changes.

See also: Prevacid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prevacid Delayed-Release Capsules:

Store Prevacid Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prevacid Delayed-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Prevacid Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

Prevacid Delayed-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prevacid Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Prevacid resources

Prevacid Side Effects (in more detail)
Prevacid Dosage
Prevacid Use in Pregnancy & Breastfeeding
Drug Images
Prevacid Drug Interactions
Prevacid Support Group
26 Reviews for Prevacid - Add your own review/rating

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Tuesday, July 17, 2012

Mapap Rapid Tabs

Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)

Brand Names: Acetaminophen Quickmelt, Actamin, Adprin B, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Children's Tylenol Meltaway, Ed-APAP, Elixsure Fever/Pain, Genebs, Infants Tylenol Concentrated Drops, Leader 8 Hour Pain Reliever, Little Fevers, Little Fevers Children's Fever/Pain Reliever, Mapap, Mapap Arthritis Pain, Mapap Extra Strength Rapid Burst, Mapap Infant Drops, Mapap Infants', Mapap Meltaway, Mapap Rapid Release Gelcaps, Mapap Rapid Tabs, Medi-Tabs, Q-Pap, Q-Pap Extra Strength, Silapap Childrens, Silapap Infants, St. Joseph Aspirin-Free, Tactinal, Tempra, Tempra Quicklets, Triaminic Fever & Pain, Triaminic Infant Drops, Tycolene, Tylenol, Tylenol Arthritis Caplet, Tylenol Arthritis Gelcap, Tylenol Caplet, Tylenol Caplet Extra Strength, Tylenol Childrens, Tylenol Cool Caplet Extra Strength, Tylenol Extra Strength, Tylenol Extra Strength Cool Caplet, Tylenol Extra Strength EZ, Tylenol Gelcap Extra Strength, Tylenol Geltab Extra Strength, Tylenol Infant's Drops, Tylenol Junior Meltaway, Tylenol Rapid Release Gelcap, Tylenol Sore Throat Daytime, Vitapap

What is acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Acetaminophen may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Know the amount of acetaminophen in the specific product you are taking.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking acetaminophen?

You should not take acetaminophen if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen if you have:

liver disease; or

a history of alcoholism.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. It is not known whether acetaminophen will harm an unborn baby. Before taking acetaminophen, tell your doctor if you are pregnant. Acetaminophen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label. Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking acetaminophen and call your doctor if:

you still have a fever after 3 days of use;

you still have pain after 7 days of use (or 5 days if treating a child);

you have a skin rash, ongoing headache, or any redness or swelling; or

if your symptoms get worse, or if you have any new symptoms.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.

Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking acetaminophen?

Acetaminophen side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have a serious side effect such as:

nausea, upper stomach pain, itching, loss of appetite;

dark urine, clay-colored stools; or

jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen?

Ask a doctor or pharmacist if it is safe for you to use acetaminophen if you are also using any of the following drugs:

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

birth control pills or hormone replacement therapy;

blood pressure medication;

cancer medications;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medications;

medicines to treat psychiatric disorders;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medications.

This list is not complete and there may be other drugs that can interact with acetaminophen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Mapap Rapid Tabs resources

Mapap Rapid Tabs Side Effects (in more detail)
Mapap Rapid Tabs Use in Pregnancy & Breastfeeding
Mapap Rapid Tabs Drug Interactions
Mapap Rapid Tabs Support Group
0 Reviews for Mapap Rapid Tabs - Add your own review/rating

acetaminophen Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Acetaminophen MedFacts Consumer Leaflet (Wolters Kluwer)

Acetaminophen Monograph (AHFS DI)

Acetazolamide Monograph (AHFS DI)

Apra Advanced Consumer (Micromedex) - Includes Dosage Information

Apraclonidine Hydrochloride Monograph (AHFS DI)

Genapap Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Mapap Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

Ofirmev Consumer Overview

Ofirmev Injection MedFacts Consumer Leaflet (Wolters Kluwer)

Ofirmev Prescribing Information (FDA)

Paracetamol Consumer Overview

Tempra 1 Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Tylenol Consumer Overview

Tylenol MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Mapap Rapid Tabs with other medications

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Where can I get more information?

Your pharmacist can provide more information about acetaminophen.

See also: Mapap Rapid Tabs side effects (in more detail)

Fondaparinux Sodium

Class: Direct Factor Xa Inhibitors
Chemical Name: MethylO - 2 - deoxy - 6 - O - sulfo - 2 - (sulfoamino) - α - d - glucopyranosyl - (1→4) - O - β - d - glucopyranuronosyl - (1→4) - O - 2 - deoxy - 3,6 - di - O - sulfo - 2 - (sulfoamino) - α - d - glucopyranosyl - (1→4) - O - 2 - O - sulfo - α - l - idopyranuronosyl - (1→4) - 2 - deoxy - 6 - O - sulfo - 2 - (sulfoamino) - α - d - glucopyranoside decasodium salt
Molecular Formula: C₃₁H₄₃N₃Na₁₀O₄₉S₈
CAS Number: 114870-03-0
Brands: Arixtra

Spinal/Epidural Hematoma Risk

Epidural or spinal hematomas and neurologic injury, including long-term or permanent paralysis, associated with concurrent use of fondaparinux, low molecular weight heparins, or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture.¹ ⁷ ¹⁶ ¹⁹

Risk increased by use of indwelling epidural catheters or by concomitant use of drugs affecting hemostasis (e.g., NSAIAs, platelet inhibitors, other anticoagulants).¹ ⁷ ¹⁹

Risk also increased by history of traumatic or repeated epidural or spinal puncture or history of spinal deformity or spinal surgery.¹ ³ ⁴ ⁷ ¹⁹

Monitor frequently for signs and symptoms of neurologic impairment and treat urgently if neurologic compromise noted.¹ ⁷ ¹⁹

Consider potential benefits versus risks of spinal or epidural anesthesia or spinal puncture in patients receiving or being considered for thromboprophylaxis with anticoagulants.¹ ⁷ ¹⁹ (See Neurologic Effects under Cautions and also see Interactions.)

Introduction

Anticoagulant; a synthetic activated factor X_a inhibitor.

Uses for Fondaparinux Sodium

Thromboprophylaxis in Hip-Fracture, Hip-Replacement, or Knee-Replacement Surgery

Prevention of postoperative DVT and PE in patients undergoing hip-fracture, hip-replacement, or knee-replacement surgery.¹ ² ³ ⁴ ⁵ ⁶ ¹⁰ ¹⁹ The American College of Chest Physicians (ACCP) recommends fondaparinux, a low molecular weight heparin, or warfarin as first-line prophylaxis in such patients.¹⁹

Used for extended prophylaxis (i.e., approximately 3 weeks beyond the perioperative period) in patients undergoing hip-fracture surgery.¹ ¹⁸ ACCP recommends extended prophylaxis (e.g., up to 35 days) in patients undergoing total hip-replacement, total knee-replacement, or hip-fracture surgery who have ongoing risk factors for venous thromboembolism (e.g., history of venous thromboembolism, obesity, delayed mobilization, advanced age, cancer).¹⁹

Thromboprophylaxis in General Surgery

Prophylaxis of postoperative DVT and PE in patients undergoing general (e.g., abdominal) surgery who are at risk for thromboembolic complications, including those undergoing major surgical procedures or those undergoing general surgery with multiple risk factors for thromboembolism (e.g., history of previous venous thromboembolism, cancer, obesity, hypercoagulable state).¹ ¹⁹ ²⁶

ACCP recommends a low molecular weight or unfractionated heparin or fondaparinux and/or intermittent pneumatic compression or graduated compression stockings for prevention of postoperative venous thromboembolism in patients at moderate or higher risk undergoing major general surgery, including abdominal, gynecologic†, and urologic surgery†, depending on the type of surgery and the risk for thromboembolism and bleeding.¹⁹

ACCP also recommends fondaparinux as an alternative to low molecular weight heparin or low-dose unfractionated heparin for thromboprophylaxis in patients undergoing extensive gynecologic surgery for malignancy, major open urologic procedures, inpatient bariatric surgery, or major thoracic surgery.¹⁹ Fondaparinux also recommended as an option for thromboprophylaxis in patients undergoing major vascular surgery, laparoscopic surgery, or gynecologic surgery who have additional risk factors for thromboembolism.¹⁹

Thromboprophylaxis in Selected Medical Conditions

ACCP recommends fondaparinux, low-dose unfractionated heparin, or low molecular weight heparin in acutely ill medical patients with heart failure, severe lung disease, or those confined to bedrest who have one or more additional risk factors (e.g., previous venous thromboembolism, sepsis, acute neurologic disease, inflammatory bowel disease).¹⁹

Treatment of DVT and PE

Used in conjunction with warfarin for treatment of DVT.¹ ²⁰ ²²

Used in conjunction with warfarin for treatment of PE, when initial therapy is given in the hospital.¹ ²¹ ²² However, ACCP states that IV unfractionated heparin is preferred in patients experiencing massive PE; IV unfractionated heparin also preferred if there is concern about sub-Q absorption or in patients in whom thrombolytic therapy is being considered.²²

ST-Segment Elevation MI

Has been used as an adjunct to thrombolysis in a limited number of patients with acute ST-segment elevation MI†.²⁵ ²⁹ ³² The American College of Cardiology and American Heart Association (ACC/AHA) and ACCP recommend use of fondaparinux (given as an initial IV injection followed by daily sub-Q injections) in the management of such patients, except in those undergoing primary PCI.²⁹ ³² ³³

Unstable Angina and Non-ST-Segment Elevation MI

Has been used as an alternative to unfractionated heparin or a low molecular weight heparin in the management of non-ST-segment elevation acute coronary syndromes† (unstable angina or non-ST-segment elevation MI)†.²⁸

ACCP recommends fondaparinux over enoxaparin in patients with non-ST-segment elevation acute coronary syndrome† undergoing early conservative or delayed invasive management.²⁸ ACC/AHA state that fondaparinux, unfractionated heparin, and enoxaparin are all acceptable options in patients with non-ST-segment elevation acute coronary syndrome being managed conservatively, but fondaparinux is preferred in patients with an increased risk of bleeding.³⁶

ACCP recommends unfractionated heparin and a GP IIb/IIIa-receptor inhibitor over fondaparinux in patients undergoing early invasive management.²⁸

Thrombosis Associated with Heparin-induced Thrombocytopenia

May be effective in the management of heparin-induced thrombocytopenia† (HIT).²⁷ However, ACCP states that other direct thrombin inhibitors such as lepirudin and argatroban are preferred as an alternative to unfractionated heparin in patients with confirmed or strongly suspected HIT†.²⁷

Fondaparinux Sodium Dosage and Administration

General

Evaluate the possibility of an underlying bleeding disorder before initiation of treatment.¹⁶ Since coagulation parameters are insensitive for monitoring fondaparinux activity, routine monitoring of such parameters is not required.¹ ¹⁶

Administration

Administer by sub-Q injection; do not give IM.¹

Has been administered by direct IV injection† initially in the treatment of acute ST-segment elevation MI† or non-ST-segment elevation acute coronary syndromes†.²⁸ ²⁹

Patients should be sitting or supine during administration.¹⁶

Increased risk of major bleeding if administered <6 hours after surgery.¹

Sub-Q Administration

Administer by sub-Q injection into fatty tissue, alternating injection sites daily (e.g., between the left and right anterolateral or posterolateral abdominal wall).¹ ¹⁶

Insert the entire length of the needle into a skin fold created by the thumb and forefinger; hold the skin fold, and push the plunger of the syringe the full length of the syringe barrel.¹ ¹⁶ Release the plunger, and the needle automatically withdraws from the skin and retracts into the security sleeve.¹ ¹⁶

Dosage

Dosages for fondaparinux sodium and regular (unfractionated) heparin, heparinoids, or low molecular weight heparins cannot be used interchangeably on a unit-for-unit (or mg-for-mg) basis.¹ Differs from regular (unfractionated) heparin, heparinoids, or low molecular weight heparins in the manufacturing process, anti-factor Xa and antithrombin activity, and dosage.¹ ¹⁰

The activity of fondaparinux sodium is measured based on plasma drug concentrations quantified by anti-Factor Xa activity using fondaparinux as the calibrator.¹

Dosage of fondaparinux sodium is expressed in terms of the salt.¹

Adults

Hip-Fracture, Hip-Replacement, or Knee-Replacement Surgery

Prophylaxis of DVT and PE

Sub-Q

Patients weighing ≥50 kg: 2.5 mg once daily.¹ ¹⁹ Manufacturer recommends that initial dose be given no earlier than 6–8 hours after surgery, provided hemostasis has been established.¹ ACCP states that initial dose may be given either 6–8 hours after surgery or the next day following major orthopedic procedures.¹⁹ Avoid use in patients weighing <50 kg.¹ (See Contraindications.)

Usual duration of therapy is 5–9 days,¹ ³ ⁴ ⁵ ⁶ ⁷ although up to 11 days has been studied in clinical trials of orthopedic surgery.¹ ¹⁶

Extended prophylaxis: Recommended for up to 24 additional days (i.e., after perioperative prophylaxis) in patients who have undergone hip-fracture or hip-replacement surgery; prophylaxis for up to a total of 32 days (including perioperative and extended prophylaxis) has been administered in clinical trials.¹ ¹⁸ ACCP states that extended prophylaxis (e.g., up to 35 days) should be considered in patients undergoing total hip-replacement, total knee-replacement, or hip-fracture surgery who have ongoing risk factors for venous thromboembolism (e.g., history of venous thromboembolism, obesity, delayed mobilization, advanced age, cancer).¹⁹

General Surgery

Prophylaxis of DVT and PE in Abdominal Surgery

Sub-Q

Patients weighing ≥50 kg: 2.5 mg once daily, with the initial dose given 6–8 hours after surgery, provided hemostasis has been established.¹ ¹⁹ ²⁶ Avoid use in patients weighing <50 kg.¹ (See Contraindications.)

Usual duration of therapy is 5–9 days, although up to 10 days has been studied.¹

DVT and PE

Treatment

Sub-Q

Patients weighing <50 kg: 5 mg once daily.¹

Patients weighing 50–100 kg: 7.5 mg once daily.¹

Patients weighing >100 kg: 10 mg once daily.¹

Usual duration of therapy is 5–9 days, although up to 26 days of treatment has been used.¹

Initiate concurrent warfarin as soon as possible,¹ usually within 72 hours of fondaparinux injection;¹ ²⁰ however, ACCP recommends initiating warfarin simultaneously on the first day of fondaparinux treatment.²²

Continue fondaparinux and warfarin for ≥5 days and until an adequate response to warfarin is achieved (i.e., a stable INR of 2–3);¹ ACCP recommends continuing concomitant therapy for ≥5 days and until INR of 2–3 has been maintained for ≥24 hours.¹ ²²

ST-Segment Elevation MI†

IV, then Sub-Q

Initially, 2.5 mg as a single dose by direct IV injection, followed by 2.5 mg sub-Q once daily for the duration of hospitalization or up to 8 days.²⁹ ³²

Special Populations

Hepatic Impairment

No dosage adjustment required in patients with mild to moderate hepatic impairment.¹ Pharmacokinetics not evaluated in patients with severe hepatic impairment.¹ (See Hepatic Impairment under Cautions.)

Renal Impairment

Contraindicated in patients with severe renal impairment (Cl_cr <30 mL/minute or S_cr ≥3); increased risk for major bleeding episodes.¹ ³² Exercise caution in patients with other degrees of renal impairment.¹

Low Body Weight

Use with caution and decrease dosage to 5 mg once daily for the treatment of DVT or PE in patients weighing <50 kg.¹ Contraindicated for prophylaxis of DVT or PE in patients with body weight <50 kg undergoing hip-fracture, hip-replacement, knee-replacement, or abdominal surgery; increased incidence of major bleeding.¹

Geriatric Patients

No specific dosage recommendations; however, careful attention to dosage directions recommended.¹ (See Specific Populations under Cautions.)

Cautions for Fondaparinux Sodium

Contraindications

Patients with severe renal impairment (Cl_cr <30 mL/minute or S_cr ≥3).¹ ³²

Prophylactic use in patients undergoing hip-fracture, hip-replacement, knee-replacement, or abdominal surgery who weigh <50 kg.¹

Active major bleeding, bacterial endocarditis, or thrombocytopenia associated with a positive in vitro test for antiplatelet antibody (heparin-induced thrombocytopenia) in the presence of the drug.¹ ³ ⁴ ¹⁰ ¹⁶

Warnings/Precautions

Warnings

Neurologic Effects

Epidural or spinal hematomas and neurologic injury, including long-term or permanent paralysis, associated with concurrent use of fondaparinux and neuraxial (spinal/epidural) anesthesia or spinal puncture procedures.¹ ⁷ ¹⁶ (See Boxed Warning.) Frequent monitoring for signs of neurologic impairment recommended.¹ ⁷ Some experts suggest that anticoagulant prophylaxis with fondaparinux be avoided in patients receiving epidural analgesia.³ ⁴ ⁷ ¹⁹

Hematologic Effects

Use with extreme caution in patients with an increased risk of hemorrhage (e.g., congenital or acquired bleeding disorders; active ulceration and angiodysplastic GI disease; hemorrhagic stroke; uncontrolled arterial hypertension; diabetic retinopathy; recent brain, spinal, or ophthalmic surgery).¹ ³ ⁴ Use with caution in the treatment of DVT or PE in patients who weigh <50 kg.¹ Use with caution in patients with moderate renal insufficiency (Cl_cr 30–50 mL/minute).¹

Periodic routine blood counts, including platelet counts, and tests for occult blood in stool recommended.¹

Avoid concomitant use of drugs that increase risk of bleeding unless essential for management of underlying condition (e.g., concomitant use of vitamin K antagonists for treatment of venous thromboembolism).¹ Closely monitor for signs and symptoms of bleeding.¹

Do not administer earlier than 6–8 hours after surgery because of increased risk of major bleeding.¹

Moderate thrombocytopenia (platelet counts of 50,000–100,000/mm³) and severe thrombocytopenia (platelet counts <50,000/mm³) reported.¹ Fondaparinux unlikely to cause HIT;² ¹¹ ¹² ¹³ however, isolated cases of thrombocytopenia with thrombosis resembling HIT reported during postmarketing experience.¹ Manufacturer recommends monitoring thrombocytopenia of any degree closely and discontinuing fondaparinux if platelet counts fall below 100,000/mm³.¹ However, ACCP states that routine platelet count monitoring is not necessary due to the low frequency of HIT.²⁷

Patients with Prosthetic Heart Valves

Cases of valve thrombosis resulting in death and/or requiring surgical intervention reported with low molecular weight heparin (e.g., enoxaparin) therapy in patients with prosthetic heart valves; some cases included pregnant women, and maternal and/or fetal deaths have been reported.¹⁵ Manufacturer states that fondaparinux has not been studied in patients with prosthetic heart valves and that no information is available on safety of the drug in such patients.¹⁶

Sensitivity Reactions

Latex Sensitivity

Some packaging components (e.g., needle covers) contain natural latex proteins in the form of dry natural rubber (latex), which may cause allergic-type reactions (including life-threatening hypersensitivity reactions) in susceptible individuals.¹ ²⁴ ³⁰ ³¹ The needle cover of the diluent syringe should not be handled by individuals sensitive to latex.¹ ²⁴ ³⁰ ³¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ Use caution.¹

Pediatric Use

Safety and efficacy not established in children <17 years of age.¹ ¹⁶

Geriatric Use

Use with caution.¹ No substantial differences in efficacy relative to younger adults.¹ ¹⁶ Possible increased major bleeding or other serious adverse effects in patients ≥75 years of age compared with younger adults.¹ ¹⁶ Substantially eliminated by kidneys; assess renal function periodically since geriatric patients are more likely to have decreased renal function.¹ Careful attention to dosage directions and concomitant therapy (particularly platelet-aggregation inhibitors) is advised.¹

Hepatic Impairment

Following a single 7.5 mg dose in patients with moderate hepatic impairment, response (i.e., aPTT, PT/INR, and antithrombin III) similar to that in patients with normal hepatic function.¹ Pharmacokinetics not studied in patients with severe hepatic impairment.¹

Increased risk of hemorrhage; closely monitor for signs and symptoms of bleeding.¹ (See Hematologic Effects under Cautions.)

Renal Impairment

Use with caution in those with moderate renal impairment (Cl_cr 30–50 mL/minute); increased risk of hemorrhage.¹ ¹⁶ Contraindicated in patients with severe renal impairment (Cl_cr <30 mL/minute or S_cr ≥3).¹ ¹⁶ ³² Assess renal function periodically (e.g., serum creatinine determinations).¹ Discontinue immediately in patients who develop severe renal impairment during therapy.¹

Common Adverse Effects

Patients undergoing hip-fracture, hip- or knee-replacement surgery: Anemia, fever, nausea, edema, constipation, rash, vomiting, insomnia, increased wound drainage, hypokalemia, urinary tract infection, dizziness, purpura, hypotension, confusion, bullous eruption, urinary retention, hematoma, major bleeding, diarrhea, dyspepsia, postoperative hemorrhage, headache.¹ ¹⁶

Patients undergoing abdominal surgery: Postoperative wound infection, postoperative hemorrhage, fever, surgical site reaction, anemia, hypertension, pneumonia, vomiting.¹

Venous thromboembolism: Constipation, headache, insomnia, fever, nausea, urinary tract infection, coughing.¹

Interactions for Fondaparinux Sodium

Weak inhibitor of CYP2A6, 1A2, 2C9, 2C19, 2D6, 3A4, and 3E1 in vitro.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely.¹

Protein-bound Drugs

Pharmacokinetic interaction unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Anticoagulants, oral	Increased risk of bleeding¹	Discontinue oral anticoagulants prior to initiation of fondaparinux¹ If coadministration is essential, monitor patients closely¹
Digoxin	Pharmacokinetic/pharmacodynamic interaction unlikely¹ ¹⁶
NSAIAs	Pharmacodynamic interaction unlikely¹	Discontinue NSAIAs prior to initiation of fondaparinux¹ If coadministration is essential, monitor patients closely
Platelet-aggregation inhibitors	Increased risk of bleeding¹	Discontinue platelet-aggregation inhibitors prior to initiation of fondaparinux¹ If coadministration is essential, monitor patients closely¹

Fondaparinux Sodium Pharmacokinetics

Absorption

Bioavailability

Sub-Q: Absolute bioavailability 100%.¹ ¹⁰ ^b

Duration

Anticoagulant effects may persist for 2–4 days following discontinuance of therapy in patients with normal renal function (i.e., ≥3–5 half-lives).¹

Special Populations

In patients with renal impairment, anticoagulant effects may persist for >2–4 days following discontinuance of therapy.¹

Distribution

Extent

In healthy adults, distributes mainly in blood and only to a minor extent in extravascular fluid.¹ Distributed into milk in rats; not known whether distributed into human milk.¹

Plasma Protein Binding

In vitro, 94% bound to antithrombin III.¹

Elimination

Metabolism

Most of dose not metabolized.¹

Elimination Route

Eliminated unchanged in urine in individuals with normal renal function.¹ ^b

Half-life

17–21 hours.¹

Special Populations

In patients with renal impairment, the total clearance is reduced by 25, 40, and 55% in patients with mild, moderate, and severe renal impairment, respectively, compared with those with normal renal function.¹

In geriatric patients >75 years of age, total clearance is approximately 25% lower compared with patients <65 years of age.¹

In dialysis-dependent patients, approximately 20% of the drug is removed by hemodialysis.¹

In patients weighing <50 kg, total clearance is reduced by approximately 30%.¹

Stability

Storage

Parenteral

Solution for Injection

25°C (may be exposed to 15–30°C).¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Do not mix with other injections or infusions.¹

Actions

Anticoagulation results from rapid inhibition of factor Xa by antithrombin III bound to fondaparinux (about 300-fold greater than innate activity).¹ ² ⁴ ⁹ ¹⁰ Neutralization of coagulation factor Xa inhibits the conversion of prothrombin to thrombin and subsequent thrombus formation.¹ ² ⁴ ⁹ ¹⁰ Unable to lyse established thrombi.¹⁶

Binds selectively to antithrombin III; unable to inactivate thrombin.¹ ² ⁴ ⁸ ⁹ ¹⁶ At the recommended dosage, fibrinolytic activity not affected.¹

Platelet function or global clotting function tests (e.g., PT, bleeding time, aPTT) generally not affected when administered at the recommended dosage.¹ ¹⁰ ¹⁶

Advice to Patients

Importance of initiating self-administration only if a clinician determines that the such administration is appropriate and that medical follow-up is available as necessary.¹ Importance of appropriate training in injection technique.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Fondaparinux Sodium
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	2.5 mg/0.5 mL	Arixtra (available as a 0.5-mL, disposable prefilled syringe)	GlaxoSmithKline
		5 mg/0.4 mL	Arixtra (available as a 0.4-mL, disposable prefilled syringe)	GlaxoSmithKline
		7.5 mg/0.6 mL	Arixtra (available as a 0.6-mL, disposable prefilled syringe)	GlaxoSmithKline
		10 mg/0.8 mL	Arixtra (available as a 0.8-mL, disposable prefilled syringe)	GlaxoSmithKline

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. GlaxoSmithKline. Arixtra (fondaparinux sodium) injection prescribing information. Research Triangle Park, NC: 2010 Mar.

2. Turpie AGG, Gallus AS, Hoek JA, for the Pentasaccharide Investigators. A synthetic pentasaccharide for the prevention of deep-vein thrombosis after total hip replacement. N Engl J Med. 2001; 344:619-25. [IDIS 459860] [PubMed 11228275]

3. Eriksson BI, Bauer KA, Lassen MR et al. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip- fracture surgery. N Engl J Med. 2001; 345:1298-304. [IDIS 471305] [PubMed 11794148]

4. Bauer KA, Eriksson BI, Lassen MR et al. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med. 2001; 345:1305-10. [IDIS 471306] [PubMed 11794149]

5. Lassen MR, Bauer KA, Eriksson BI et al. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: A randomized double-blind comparison.Lancet 2002; 359:715-20.

6. Turpie GG, Bauer KA, Eriksson BI et al.. Postoperative enoxaparin for prevention of venous thromboembolism after elective hip-replacement surgery: A randomized double-blind trial. Lancet 2002; 359:1721-6. [IDIS 481278] [PubMed 12049860]

7. Geerts WH, Heit JA, Clagett GP et al. Prevention of venous thrombembolism. Chest. 2001; 119 (Suppl):133S-75S.

8. Hirsh J, Warkentin TE, Shaughnessy SG et al. Heparin and low- molecular-weigh heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest. 2001; 119:64S-94s. [IDIS 459443] [PubMed 11157643]

9. Weitz J, Hirsh J. New anticoagulant drugs. Chest. 2001; 119:95S- 107s. [IDIS 459444] [PubMed 11157644]

10. Bauer KA. Fondaparinux sodium: a selective inhibitor of factor Xa. Am J Health-Syst Pharm. 2001; 58 (Suppl.2):S14-7. [IDIS 472189] [PubMed 11715834]

11. Rosenberg RD. Redesigning heparin. N Engl J Med. 2001; 344:673-4. Editorial. [IDIS 459863] [PubMed 11228284]

12. Ahmad S, Jeske WP, Walenga JM et al. Synthetic pentasaccharides do not cause platelet activation by antiheparin-platelet factor 4 antibodies. Clin Appl Thromb Hemost. 1999; 5:259-66. [PubMed 10726024]

13. Amiral J, Lormeau JC, Marfaing-Koka A et al. Absence of cross- reactivity of SR90107A/ORG31540 pentasaccharide with antibodies to heparin-PF4 complexes developed in heparin-induced thrombocytopenia. Blood Coagul Fibrinolysis. 1997; 8:114-7. [PubMed 9518042]

14. Hull R, Pineo G. A synthetic pentasaccharide for the prevention of deep- vein thrombosis. N Engl J Med. 2001; 345:291. Letter. [IDIS 467250] [PubMed 11474672]

15. Aventis. Lovenox (enoxaparin sodium) injection prescribing information. Bridgewater, NJ; 2001 Jul.

16. Organon Sanofi-Synthelabo, West Orange, NJ: Personal communication.

17. Bounameaux, H, Perneger T. Fondaparinux: A new synthetic pentasaccharide for thrombosis prevention. Lancet.2002; 359:1710-1.

18. Eriksson BI, Lassen MR. Duration of prophylaxis against venous thromboembolism with fondaparinux after hip fracture surgery: a multicenter, randomized, placebo-controlled, double-blind study. Arch Intern Med. 2003; 163:1337-42. [IDIS 499798] [PubMed 12796070]

19. Geerts WH, Bergqvist D, Pineo GF et al. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008; 133(Suppl.):381S-453S. [IDIS 523840] [PubMed 15383478]

20. Buller HR, Davidson BL, Decousus H et al. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med. 2004; 140:867-73. [IDIS 516440] [PubMed 15172900]

21. Buller HR, Davidson BL, Decousus H et al. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med. 2003; 349:1695-702. [IDIS 505897] [PubMed 14585937]

22. Kearon C, Kahn SR, Agnelli G et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008:133 (Suppl.):454S-545S.

23. Organon Sanofi-Synthelabo. Arixtra (fondaparinux sodium) injection prescribing information. West Orange, NJ: 2001 Dec.

24. Food and Drug Administration. Natural rubber-containing medical devices; user labeling. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1997; 62:51021-30.

25. Antman EM, Anbe DT, Armstrong PW et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction-executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1999 guidelines for the management of patients with acute myocardial infarction). J Am Coll Cardiol. 2004; 44(3):671-719. [PubMed 15358045]

26. Agnelli G, Bergvist D, Cohen AT et al. Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. Br J Surg. 2005; 92:1212-20. [PubMed 16175516]

27. Warkentin TE, Greinacher A, Koster A et al. Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008; 133:340S-80S [PubMed 18574270]

28. Harrington RA, Becker RC, Cannon CP et al. Antithrombotic therapy for non ST-segment elevation acute coronary syndromes: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008:133:670S-707S.

29. Goodman SG, Menon V, Cannon CP et al. Acute ST-segment elevation myocardial infarction: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008; 133:708S-75S [PubMed 18574277]

30. Food and Drug Administration. Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1998; 63:50660-704.

31. Food and Drug Administration. Latex-containing devices; user labeling. 21 CFR Part 801. Proposed rule. (Docket No. 96N-0119) Fed Regist. 1996; 61:32617-21.

32. Antman EM, Anbe DT, Armstrong PW et al. 2007 Focused Update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Group to Review New Evidence and Update the ACC/AHA 2004 Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction). J Am Coll Cardiol. 2008; 51:210–47.

33. King SB III, Smith SC Jr, Hirschfeld JW Jr et al. 2007 Focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: American College of Cardiology/American Heart Association Task Force on Practice Guidelines, 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention. JACC. 2008; 51:172-209. [PubMed 18191745]

34. Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators, Yusuf S, Mehta SR et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006; 354:1464-76. [PubMed 16537663]

35. Mehta SR, Granger CB, Eikelboom JW et al. Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial. J Am Coll Cardiol. 2007; 50:1742-51. [PubMed 17964037]

36. Anderson JL, Adams CD, Antman EM et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007; 50:e1-e157. [PubMed 17692738]

b. Donat F, Duret JP, Santoni A et al. The pharmacokinetics of fondaparinux sodium in healthy volunteers. Clin Pharmacokinet. 2002; 41 Suppl 2:1-9. [PubMed 12383039]

More Fondaparinux Sodium resources

Fondaparinux Sodium Side Effects (in more detail)
Fondaparinux Sodium Use in Pregnancy & Breastfeeding
Fondaparinux Sodium Drug Interactions
Fondaparinux Sodium Support Group
3 Reviews for Fondaparinux Sodium - Add your own review/rating

Arixtra Prescribing Information (FDA)

Arixtra Concise Consumer Information (Cerner Multum)

Arixtra Advanced Consumer (Micromedex) - Includes Dosage Information

Arixtra MedFacts Consumer Leaflet (Wolters Kluwer)

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Deep Vein Thrombosis
Deep Vein Thrombosis Prophylaxis after Abdominal Surgery
Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery
Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery
Deep Vein Thrombosis, Prophylaxis
Pulmonary Embolism

Wednesday, July 25, 2012

Invega

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Before Using Invega

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

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Interactions with Food/Tobacco/Alcohol

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Missed Dose

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Sunday, July 22, 2012

Zyrtec Chewable Tablets

Zyrtec Chewable Tablets are used for:

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Friday, July 20, 2012

Imipramine Hydrochloride 25mg / 5ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine

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What Imipramine Hydrochloride Oral Solution is and what it is used for

Before you take Imipramine Hydrochloride Oral Solution

Do not take Imipramine Hydrochloride Oral Solution if you:

Take special care with Imipramine Hydrochloride Oral Solution:

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Taking other medicines

Taking Imipramine Hydrochloride Oral Solution with food and drink

Pregnancy and Breast-feeding

Driving and using machines

Important information about some of the other ingredients of Imipramine Hydrochloride Oral Solution

How to take Imipramine Hydrochloride Oral Solution

Depression:

Night-time Bed-wetting

If you take more Imipramine Hydrochloride Oral Solution than you should

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What Imipramine Hydrochloride Oral Solution contains

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Thursday, July 19, 2012

Prevacid Delayed-Release Capsules

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Tuesday, July 17, 2012

Mapap Rapid Tabs

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