methylprednisolone

meth-il-pred-NIS-oh-lone

Commonly used brand name(s)

In the U.S.

• Medrol


• Methylpred-DP

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For methylprednisolone

Methylprednisolone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, eye or vision problems, lupus, skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Methylprednisolone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

methylprednisolone is available only with your doctor's prescription.

Before Using methylprednisolone

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 methylprednisolone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methylprednisolone 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

No information is available on the relationship of age to the effects of methylprednisolone in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of methylprednisolone in geriatric patients.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 methylprednisolone, 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 methylprednisolone 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.

• Rotavirus Vaccine, Live

Using methylprednisolone 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.

• Aldesleukin


• Bupropion


• Fluindione


• Quetiapine


• Telaprevir

Using methylprednisolone 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.

• Acenocoumarol


• Alatrofloxacin


• Alcuronium


• Aprepitant


• Aspirin


• Atracurium


• Balofloxacin


• Carbamazepine


• Cinoxacin


• Ciprofloxacin


• Clarithromycin


• Clinafloxacin


• Cyclosporine


• Dalfopristin


• Diltiazem


• Enoxacin


• Erythromycin


• Fleroxacin


• Fluindione


• Flumequine


• Fosphenytoin


• Gallamine


• Gemifloxacin


• Grepafloxacin


• Hexafluorenium


• Itraconazole


• Ketoconazole


• Levofloxacin


• Licorice


• Lomefloxacin


• Metocurine


• Mibefradil


• Moxifloxacin


• Nefazodone


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Phenobarbital


• Primidone


• Prulifloxacin


• Quinupristin


• Rifampin


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Troleandomycin


• Trovafloxacin Mesylate


• Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of methylprednisolone. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts or


• Congestive heart failure or


• Cushing's syndrome (adrenal gland problem) or


• Diabetes or


• Eye infection or


• Glaucoma or


• Hyperglycemia (high blood sugar) or


• Hypertension (high blood pressure) or


• Infection (e.g., bacterial, virus, or fungus) or


• Mood changes, including depression or


• Myasthenia gravis (severe muscle weakness) or


• Osteoporosis (weak bones) or


• Peptic ulcer, active or history of or


• Personality changes or


• Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or


• Tuberculosis, inactive—Use with caution. May make these conditions worse.

• Fungal infections—Should not be used in patients with this condition.

Proper Use of methylprednisolone

Take methylprednisolone 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 for unwanted effects.

If you use methylprednisolone for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

Dosing

The dose of methylprednisolone 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 methylprednisolone. 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 (tablets):
  
  • Dose depends on medical condition:
    
    • Adults—At first, 4 to 48 milligrams (mg) per day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of methylprednisolone, 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 methylprednisolone

If you will be taking methylprednisolone for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by methylprednisolone. Blood or urine tests may be needed to check for unwanted effects.

Using methylprednisolone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using methylprednisolone, tell your doctor right away.

If you are using methylprednisolone for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of methylprednisolone might need to be changed for a short time while you have extra stress.

Using too much of methylprednisolone or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using methylprednisolone: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

methylprednisolone may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

While you are being treated with methylprednisolone, do not have any immunizations (vaccines) without your doctor's approval. Methylprednisolone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

methylprednisolone may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while taking methylprednisolone.

methylprednisolone might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using methylprednisolone, tell the doctor if you think your child is not growing properly.

Make sure any doctor or dentist who treats you knows that you are using methylprednisolone. methylprednisolone may affect the results of certain skin tests.

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.

methylprednisolone 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

• Aggression


• agitation


• anxiety


• blurred vision


• decrease in the amount of urine


• dizziness


• fast, slow, pounding, or irregular heartbeat or pulse


• headache


• irritability


• mental depression


• mood changes


• nervousness


• noisy, rattling breathing


• numbness or tingling in the arms or legs


• pounding in the ears


• shortness of breath


• swelling of the fingers, hands, feet, or lower legs


• trouble thinking, speaking, or walking


• troubled breathing at rest


• weight gain

Incidence not known

• Abdominal cramping and/or burning (severe)


• abdominal pain


• backache


• bloody, black, or tarry stools


• cough or hoarseness


• darkening of skin


• decrease in height


• decreased vision


• diarrhea


• dry mouth


• eye pain


• eye tearing


• facial hair growth in females


• fainting


• fatigue


• fever or chills


• flushed, dry skin


• fractures


• fruit-like breath odor


• full or round face, neck, or trunk


• heartburn and/or indigestion (severe and continuous)


• increased hunger


• increased thirst


• increased urination


• loss of appetite


• loss of sexual desire or ability


• lower back or side pain


• menstrual irregularities


• muscle pain or tenderness


• muscle wasting or weakness


• nausea


• pain in back, ribs, arms, or legs


• painful or difficult urination


• skin rash


• sleeplessness


• sweating


• trouble healing


• trouble sleeping


• unexplained weight loss


• unusual tiredness or weakness


• vision changes


• vomiting


• vomiting of material that looks like coffee grounds

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

• Increased appetite

Incidence not known

• Abnormal fat deposits on the face, neck, and trunk


• acne


• dry scalp


• lightening of normal skin color


• red face


• reddish purple lines on the arms, face, legs, trunk, or groin


• swelling of the stomach area


• thinning of the scalp hair

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.

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The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Cepacol Extra Strength Cherry Sugar Free

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Cepacol Extra Strength Cherry Sugar Free (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

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

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

What is the most important information I should know about Cepacol Extra Strength Cherry Sugar Free (benzocaine topical)?

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

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Cepacol Extra Strength Cherry Sugar Free (benzocaine topical)?

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

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

• 
  

  asthma, bronchitis, emphysema, or other breathing disorder;

  
  


• 
  

  heart disease;

  
  


• 
  

  a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Cepacol Extra Strength Cherry Sugar Free (benzocaine topical)?

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

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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 benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Cepacol Extra Strength Cherry Sugar Free (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Cepacol Extra Strength Cherry Sugar Free (benzocaine topical) side effects

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• 
  

  headache, tired feeling, confusion;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  feeling light-headed or short of breath; and

  
  


• 
  

  pale, blue, or gray appearance of your skin, lips, or fingernails.

  
  

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 using benzocaine topical and call your doctor at once if you have any of these other serious side effects:

• 
  

  headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

  
  


• 
  

  severe burning, stinging, or sensitivity where the medicine is applied;

  
  


• 
  

  swelling, warmth, or redness; or

  
  


• 
  

  oozing, blistering, or any signs of infection.

  
  

Less serious side effects may include:

• 
  

  mild stinging, burning, or itching where the medicine is applied;

  
  


• 
  

  skin tenderness or redness; or

  
  


• 
  

  dry white flakes where the medicine was applied.

  
  

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 Cepacol Extra Strength Cherry Sugar Free (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. 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 Cepacol Extra Strength Cherry Sugar Free resources

• Cepacol Extra Strength Cherry Sugar Free Side Effects (in more detail)
• Cepacol Extra Strength Cherry Sugar Free Use in Pregnancy & Breastfeeding
• 0 Reviews for Cepacol Extra Strength Sugar Free - Add your own review/rating

• Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information


• Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information


• Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Cepacol Extra Strength Cherry Sugar Free with other medications

• Oral and Dental Conditions
• Tonsillitis/Pharyngitis

Where can I get more information?

• Your pharmacist can provide more information about benzocaine topical.

See also: Cepacol Extra Strength Sugar Free side effects (in more detail)

Venomous Spider Bite Medications

There are currently no drugs listed for "Venomous Spider Bite".

Drug List:

Trental

Generic Name: pentoxifylline

Dosage Form: tablet, film coated
Trental®

(pentoxifylline)

Tablets, 400 mg

Trental Description

Trental® (pentoxifylline) tablets for oral administration contain 400 mg of the active drug and the following inactive ingredients: FD&C Red No. 3, hypromellose USP, magnesium stearate NF, polyethylene glycol NF, povidone USP, talc USP, titanium dioxide USP, and hydroxyethyl cellulose USP in an extended-release formulation. Trental is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3,7-dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The CAS Registry Number is 6493-05-6.

The chemical structure is:

Trental - Clinical Pharmacology

Mode of Action

Pentoxifylline and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of pentoxifylline and the sequence of events leading to clinical improvement are still to be defined. Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation. Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of pentoxifylline in patients with peripheral arterial disease.

Pharmacokinetics and Metabolism

After oral administration in aqueous solution pentoxifylline is almost completely absorbed. It undergoes a first-pass effect and the various metabolites appear in plasma very soon after dosing. Peak plasma levels of the parent compound and its metabolites are reached within 1 hour. The major metabolites are Metabolite l (1-[5-hydroxyhexyl]-3,7-dimethylxanthine) and Metabolite V (1-[3-carboxypropyl]-3,7-dimethylxanthine), and plasma levels of these metabolites are 5 and 8 times greater, respectively, than pentoxifylline.

Following oral administration of aqueous solutions containing 100 to 400 mg of pentoxifylline, the pharmacokinetics of the parent compound and Metabolite l are dose-related and not proportional (non-linear), with half-life and area under the blood-level time curve (AUC) increasing with dose. The elimination kinetics of Metabolite V are not dose-dependent. The apparent plasma half-life of pentoxifylline varies from 0.4 to 0.8 hours and the apparent plasma half-lives of its metabolites vary from 1 to 1.6 hours. There is no evidence of accumulation or enzyme induction (Cytochrome P450) following multiple oral doses.

Excretion is almost totally urinary; the main biotransformation product is Metabolite V. Essentially no parent drug is found in the urine. Despite large variations in plasma levels of parent compound and its metabolites, the urinary recovery of Metabolite V is consistent and shows dose proportionality. Less than 4% of the administered dose is recovered in feces. Food intake shortly before dosing delays absorption of an immediate-release dosage form but does not affect total absorption. The pharmacokinetics and metabolism of Trental have not been studied in patients with renal and/or hepatic dysfunction. The pentoxifylline AUC was increased and elimination rate decreased in an older population (60–68 years, n=6) compared to younger individuals (22–30 years, n=6) (see PRECAUTIONS, Geriatric Use).

After administration of the 400 mg extended-release Trental tablet, plasma levels of the parent compound and its metabolites reach their maximum within 2 to 4 hours and remain constant over an extended period of time. Coadministration of Trental tablets with meals resulted in an increase in mean Cmax and AUC by about 28% and 13% for pentoxifylline, respectively. Cmax for Metabolite 1 also increased by about 20%. The extended release of pentoxifylline from the tablet eliminates peaks and troughs in plasma levels for improved gastrointestinal tolerance.

Indications and Usage for Trental

Trental is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Trental can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.

Contraindications

Trental should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.

Precautions

General

Patients with chronic occlusive arterial disease of the limbs frequently show other manifestations of arteriosclerotic disease. Trental has been used safely for treatment of peripheral arterial disease in patients with concurrent coronary artery and cerebrovascular diseases, but there have been occasional reports of angina, hypotension, and arrhythmia. Controlled trials do not show that Trental causes such adverse effects more often than placebo, but, as it is a methylxanthine derivative, it is possible some individuals will experience such responses. Patients on Warfarin should have more frequent monitoring of prothrombin times, while patients with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration, cerebral and/or retinal bleeding) should have periodic examinations for bleeding including, hematocrit and/or hemoglobin.

Drug Interactions

Although a causal relationship has not been established, there have been reports of bleeding and/or prolonged prothrombin time in patients treated with Trental with and without anticoagulants or platelet aggregation inhibitors. Patients on Warfarin should have more frequent monitoring of prothrombin times, while patients with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration) should have periodic examinations for bleeding including hematocrit and/or hemoglobin. Concomitant administration of Trental and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Such patients should be closely monitored for signs of toxicity and have their theophylline dosage adjusted as necessary. Trental has been used concurrently with antihypertensive drugs, beta blockers, digitalis, diuretics, antidiabetic agents, and antiarrhythmics, without observed problems. Small decreases in blood pressure have been observed in some patients treated with Trental; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy. If indicated, dosage of the antihypertensive agents should be reduced.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies of the carcinogenic potential of pentoxifylline were conducted in mice and rats by dietary administration of the drug at doses up to 450 mg/kg (approximately 19 times the maximum recommended human daily dose (MRHD) in both species when based on body weight; 1.5 times the MRHD in the mouse and 3.3 times the MRHD in the rat when based on body surface area). In mice, the drug was administered for 18 months, whereas in rats, the drug was administered for 18 months followed by an additional 6 months without drug exposure. In the rat study, there was a statistically significant increase in benign mammary fibroadenomas in females of the 450 mg/kg group. The relevance of this finding to human use is uncertain. Pentoxifylline was devoid of mutagenic activity in various strains of Salmonella (Ames test) and in cultured mammalian cells (unscheduled DNA synthesis test) when tested in the presence and absence of metabolic activation. It was also negative in the in vivo mouse micronucleus test.

Pregnancy

Category C. Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD. No evidence of fetal malformation was observed. Increased resorption was seen in rats of the 576 mg/kg group. There are no adequate and well controlled studies in pregnant women. Trental (pentoxifylline) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Pentoxifylline and its metabolites are excreted in human milk. Because of the potential for tumorigenicity shown for pentoxifylline in rats, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Trental did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

The active metabolite is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Clinical trials were conducted using either extended-release Trental tablets for up to 60 weeks or immediate-release Trental capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200–400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release Trental tablets, immediate-release Trental capsules, or the corresponding placebos. The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S.

The table indicates that in the tablet studies few patients discontinued because of adverse effects.

INCIDENCE (%) OF SIDE EFFECTS

	Extended-Release Tablets		Immediate-Release Capsules
	Commercially Available		Used only for Controlled Clinical Trials
	Trental	Placebo	Trental	Placebo
(Numbers of Patients at Risk)	(321)	(128)	(177)	(138)
Discontinued for Side Effect	3.1	0	9.6	7.2
CARDIOVASCULAR SYSTEM
Angina/Chest Pain	0.3	-	1.1	2.2
Arrhythmia/Palpitation	-	-	1.7	0.7
Flushing	-	-	2.3	0.7
DIGESTIVE SYSTEM
Abdominal Discomfort	-	-	4.0	1.4
Belching/Flatus/Bloating	0.6	-	9.0	3.6
Diarrhea	-	-	3.4	2.9
Dyspepsia	2.8	4.7	9.6	2.9
Nausea	2.2	0.8	28.8	8.7
Vomiting	1.2	-	4.5	0.7
NERVOUS SYSTEM
Agitation/Nervousness	-	-	1.7	0.7
Dizziness	1.9	3.1	11.9	4.3
Drowsiness	-	-	1.1	5.8
Headache	1.2	1.6	6.2	5.8
Insomnia	-	-	2.3	2.2
Tremor	0.3	0.8	-	-
Blurred Vision	-	-	2.3	1.4

Trental has been marketed in Europe and elsewhere since 1972. In addition to the above symptoms, the following have been reported spontaneously since marketing or occurred in other clinical trials with an incidence of less than 1%; the causal relationship was uncertain:

    

Cardiovascular - dyspnea, edema, hypotension.

    

Digestive - anorexia, cholecystitis, constipation, dry mouth/thirst.

    

Nervous - anxiety, confusion, depression, seizures, aseptic meningitis.

    

Respiratory - epistaxis, flu-like symptoms, laryngitis, nasal congestion.

    

Skin and Appendages - brittle fingernails, pruritus, rash, urticaria, angioedema.

    

Special Senses - blurred vision, conjunctivitis, earache, scotoma.

    

Miscellaneous - bad taste, excessive salivation, leukopenia, malaise, sore throat/swollen neck glands, weight change.

A few rare events have been reported spontaneously worldwide since marketing in 1972. Although they occurred under circumstances in which a causal relationship with pentoxifylline could not be established, they are listed to serve as information for physicians. Cardiovascular — angina, arrhythmia, tachycardia, anaphylactoid reactions. Digestive — hepatitis, jaundice, increased liver enzymes; and Hemic and Lymphatic — decreased serum fibrinogen, pancytopenia, aplastic anemia, leukemia, purpura, thrombocytopenia.

Overdosage

Overdosage with Trental has been reported in pediatric patients and adults. Symptoms appear to be dose related. A report from a poison control center on 44 patients taking overdoses of enteric-coated pentoxifylline tablets noted that symptoms usually occurred 4–5 hours after ingestion and lasted about 12 hours. The highest amount ingested was 80 mg/kg; flushing, hypotension, convulsions, somnolence, loss of consciousness, fever, and agitation occurred. All patients recovered. In addition to symptomatic treatment and gastric lavage, special attention must be given to supporting respiration, maintaining systemic blood pressure, and controlling convulsions. Activated charcoal has been used to absorb pentoxifylline in patients who have overdosed.

Trental Dosage and Administration

The usual dosage of Trental in extended-release tablet form is one tablet (400 mg) three times a day with meals.

While the effect of Trental may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.

Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Trental should be discontinued.

How is Trental Supplied

Trental (pentoxifylline) is available for oral administration as 400-mg pink film-coated oblong tablets imprinted Trental; supplied in bottles of 100 (NDC 0039-0078-10).

Store between 59 and 86° F (15 and 30° C).

Dispense in well-closed, light-resistant containers.

Rev. October 2007

US Patents 3,737,433 & 4,189,469

US Patent 3,737,433 patent term has been extended.

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

©2007 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - Label

NDC 0039-0078-10

Trental®

pentoxifylline

Tablets

400mg

100 Tablets

sanofi aventis

Trental  pentoxifylline  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0039-0078 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pentoxifylline (pentoxifylline) pentoxifylline 400 mg

Inactive Ingredients Ingredient Name Strength FD&C Red No. 3   hypromellose   magnesium stearate   polyethylene glycol   povidone   talc   titanium dioxide   hydroxyethyl cellulose (2000 CPS AT 1%)

Product Characteristics Color PINK Score no score Shape OVAL (capsule-shaped) Size 17mm Flavor Imprint Code Trental Contains

Packaging # NDC Package Description Multilevel Packaging 1 0039-0078-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018631	08/30/1984

Labeler - Sanofi-Aventis U.S. LLC (824676584)

Establishment
Name	Address	ID/FEI	Operations
Patheon Pharmaceuticals Inc.		005286822	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
sanofi-aventis Canada Inc.		251046934	MANUFACTURE

Revised: 03/2010Sanofi-Aventis U.S. LLC

More Trental resources

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

• Trental Concise Consumer Information (Cerner Multum)


• Trental MedFacts Consumer Leaflet (Wolters Kluwer)


• Trental Advanced Consumer (Micromedex) - Includes Dosage Information


• Pentoxifylline Professional Patient Advice (Wolters Kluwer)


• Pentoxifylline Monograph (AHFS DI)

Compare Trental with other medications

• Intermittent Claudication

Zotex GPX

Generic Name: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)

Brand Names: Aldex G, Aquatab D, Crantex, D-Phen 1000, D-Tab, Deconex, Deconsal II, Deconsal Pediatric, Despec, Donatussin Drops, Duomax, Duraphen 1000, Duraphen II, Duratuss, Dynex LA, ExeTuss, Extendryl G, Fenesin PE IR, Genexa LA, Gentex LA, Gilphex TR, Guaiphen-D 1200, Guaiphen-D 600, Guaiphen-PD, Guiadex PD, Guiatex PE, J-Max, Liquibid D-R, Liquibid-D, Liquibid-PD, Lusonex, Maxiphen, Medent-PE, MontePhen, Mucinex Children's Cold, Mucus Relief Sinus, Mydex, Nariz, Nasex, Nescon-PD, Nexphen PD, Norel EX, PE-Guai, Pendex, Prolex D, Refenesen PE, Reluri, Rescon-GG, Respa-PE, Robitussin Head & Chest Congestion, Simuc, Simuc-GP, Sina-12X, Sinupan, SINUvent PE, Sitrex PD, Sudafed PE Non-Drying Sinus, Sudex, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec, Xedec II, Xpect-PE, Zotex GPX

What is Zotex GPX (guaifenesin and phenylephrine)?

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

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.

Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Zotex GPX (guaifenesin and phenylephrine)?

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

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

What should I discuss with my healthcare provider before taking Zotex GPX (guaifenesin and phenylephrine)?

You should not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use guaifenesin and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use guaifenesin and phenylephrine before the MAO inhibitor has cleared from your body.

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

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  circulation problems;

  
  


• 
  

  glaucoma;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  enlarged prostate or problems with urination.

  
  

It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor's advice if you are pregnant. This medication passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Zotex GPX (guaifenesin and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

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

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold medicine 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.

Overdose symptoms may include nausea, vomiting, numbness or tingly feeling, dizziness, and feeling restless or nervous.

What should I avoid while taking Zotex GPX (guaifenesin and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Zotex GPX (guaifenesin and phenylephrine) 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 using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  vomiting, upset stomach;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling excited or restless (especially in children);

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  headache; or

  
  


• 
  

  dizziness.

  
  

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 Zotex GPX (guaifenesin and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with guaifenesin and phenylephrine. 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 Zotex GPX resources

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

• Crantex Prescribing Information (FDA)


• Despec Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex LA Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Gentex LA Sustained-Release Tablets (12 Hour) MedFacts Consumer Leaflet (Wolters Kluwer)


• Guiatex PE Prescribing Information (FDA)


• Lusonex Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rescon-GG Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Sina-12X Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Zotex GPX with other medications

• Cough and Nasal Congestion
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and phenylephrine.

See also: Zotex GPX side effects (in more detail)

Chlorphenamine Elixir BP

1. Name Of The Medicinal Product

Chlorphenamine Elixir BP

Rhino-Syrup Allergy

Pollenase Allergy Syrup

Lloyds Pharmacy Allergy Relief Syrup

2. Qualitative And Quantitative Composition

Each 5ml contains Chlorphenamine Maleate BP 2.0mg

3. Pharmaceutical Form

Sugar free syrup in bottles of 150ml

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms caused by allergic conditions such as hayfever, allergic rhinitis, perennial rhinitis, vasomotor rhinitis, urticaria and skin rashes, angioneurotic oedema, drug and serum reactions, food allergy, insect bites etc, which are responsive to antihistamines.

4.2 Posology And Method Of Administration

Adults and children over 12 years:		2 spoonfuls (10ml) every 4-6 hours. Daily maximum should be 24mg i.e. 60ml.
Elderly:		As for adults. Elderly patients are more likely to experience confusional psychosis and other neurological anticholinergic side effects.
Children:	Up to1 year	Not Recommended
	1-2year	½ spoonful (2.5ml) twice a day
	2-5 years	½ spoonful (2.5ml) every 4 – 6 hours. Daily maximum should be 6mg i.e.15ml.
	6-12 years	1 spoonful (5ml) every 4 –6 hours. Daily maximum should be 12mg i.e. 30ml.

4.3 Contraindications

Chlorphenamine is contraindicated in patients who are hypersensitive to antihistamines or any other ingredients in the syrup.

Chlorphenamine is contraindicated in patients who have had treatment with Monoamine Oxidase Inhibitors (MAOI's) within the last 14 days as the anticholinergic properties of chlorphenamine are intensified by MAOI's.

4.4 Special Warnings And Precautions For Use

Chlorphenamine produces anticholinergic effects such as drowsiness, dizziness, blurred vision and psychomotor impairment. This may cause serious problems when the patient is driving or using machinery.

Due to the anticholinergic effect of the drug caution is advised in patients who have epilepsy, raised intra-ocular pressure including glaucoma, prostatic hypertrophy, severe hypertension or cardiovascular disease, bronchitis, bronchiectasis and asthma, hepatic disease and thyrotoxicosis. The neurological anticholinergic effects are more likely in the elderly and children.

The effects of alcohol are likely to be increased.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcoholic drinks and certain other central nervous system depressants such as anxiolytics or hypnotics can potentiate the sedative effects of chlorphenamine.

Phenytoin metabolism is inhibited by chlorphenamine and this can cause phenytoin toxicity.

The anticholinergic effects of chlorphenamine are intensified by the use of other anticholinergic drugs such as atropine, tricyclic antidepressants and MAOI's (see contraindications).

4.6 Pregnancy And Lactation

Safety in pregnancy has not been established. The use of chlorphenamine in pregnancy should be assessed and only used when the possible benefits outweigh the possible risks to the foetus. Effects on the neonate have been seen when chlorphenamine is used in the third trimester of pregnancy.

There may be some inhibition of lactation by chlorphenamine and some of the drug may be secreted into the breast milk. Therefore the risk to the mother and child should be assessed against the possible benefits of using chlorphenamine when breast feeding.

4.7 Effects On Ability To Drive And Use Machines

As with all antihistamines, dizziness and drowsiness may occur. Extreme caution should be advised when driving or operating machinery.

4.8 Undesirable Effects

Undesirable effects include sedation, which varies from slight drowsiness to deep sleep.

There have been occasional reports of the following: lassitude, inability to concentrate, blurred vision, hepatitis including jaundice, urinary retention, headaches, dry mouth, dizziness, palpitations, tachycardia, arrhythmias, hypotension, chest tightness, thickening of the bronchial secretions, haemolytic anaemia and other blood dyscrasias, tinnitus, depression, irritability, nightmares, twitching, muscular weakness and incoordination.

Gastrointestinal disturbances have been reported occasionally including, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain and anorexia.

Allergic reactions have been observed and include exfoliative dermatitis, photosensitivity and urticaria.

Paradoxical excitation in children and confusional psychosis in the elderly can occur.

4.9 Overdose

The estimated lethal dose of Chlorphenamine Maleate is 25-50mg per kg bodyweight. Symptoms of overdose include sedation, paradoxical stimulation of the CNS, toxic psychosis, seizures, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.

Treatment should include gastric lavage for massive overdosage or induced emesis using syrup of Ipecacuanha. Following this activated charcoal and cathartics may be administered to minimise absorption.

Symptomatic and supportive measures should be given, with particular attention paid to the cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. Hypotension and arrhythmias should be treated vigorously. If convulsions occur sedate with intramuscular paraldehyde, or i.v. diazepam or phenytoin Haemoperfusion may be used in severe cases.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chlorphenamine is a potent H₁– blocking drug. It antagonises the pharmacological actions of histamine released by antigen-antibody reaction in allergic diseases, thus providing symptomatic relief.

Chlorphenamine alone is less effective when pollen counts are high, allergen exposure is prolonged and nasal congestion has become prominent.

5.2 Pharmacokinetic Properties

Chlorphenamine Elixir is an immediate release liquid containing the well established active ingredient Chlorphenamine Maleate.

Chlorphenamine maleate is absorbed relatively slowly from the gastrointestinal tract and peak plasma concentrations occur between 2.5 and 6 hours after oral administration. It is reported that only 25 to 50% of an oral dose is absorbed as it appears that chlorphenamine undergoes considerable first pass metabolism. Metabolites include desmethyl- and didesmethylchlorphenamine. Chlorphenamine distributes widely in the body and penetrates into the CNS. In the circulation, about 70% of chlorphenamine is bound to plasma proteins.

Excretion of unchanged drug and metabolites is mainly via the urine and is dependent on urinary pH and flow rate. The elimination half-life is widely variable and has been reported to range from 2 to 43 hours. However, the duration of action is only 4-6 hours which is shorter than might be predicted.

It is reported that in children, absorption is faster and more extensive, and there is a quicker clearance with a shorter half-life.

5.3 Preclinical Safety Data

None provided.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maltitol Solution USP

Citric Acid Monohydrate Ph. Eur

Sodium Citrate Ph. Eur

Sodium Benzoate Ph. Eur

Carmellose Sodium Ph. Eur

Strawberry Flavour C9987

Purified Water Ph. Eur

6.2 Incompatibilities

None Stated

6.3 Shelf Life

The shelf-life of this product is 36 months

6.4 Special Precautions For Storage

Store below 25°C. Protected from light

6.5 Nature And Contents Of Container

Amber glass or PET bottles with HDPE, EPE wadded, tamper evident child resistant closure.

6.6 Special Precautions For Disposal And Other Handling

None Stated

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Sandoz Ltd

Woolmer Way

Bordon

Hampshire GU35 9QE

United Kingdom

8. Marketing Authorisation Number(S)

PL 4416/0368

9. Date Of First Authorisation/Renewal Of The Authorisation

7^th March 2000

10. Date Of Revision Of The Text

July 2004

levocetirizine

Generic Name: levocetirizine (LEE voe se TIR a zeen)

Brand names: Xyzal, LEVRIX, XYZALL

What is levocetirizine?

Levocetirizine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Levocetirizine is used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 6 months old. It is also used to treat symptoms of seasonal allergies in adults and children who are at least 2 years old.

Levocetirizine is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.

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

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

You should not use this medication if you are allergic to levocetirizine or cetirizine (Zyrtec). Do not take levocetirizine if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take levocetirizine.

Before taking levocetirizine, tell your doctor if you have liver disease, kidney disease, or gallbladder problems.

It is very important not to give a child more than the prescribed dose of this medication. A child's body absorbs twice as much of the same dose size of levocetirizine as an adult's body. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of levocetirizine. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by levocetirizine. Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

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

You should not use this medication if you are allergic to levocetirizine or cetirizine (Zyrtec). Do not take levocetirizine if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take levocetirizine.

To make sure you can safely take levocetirizine, tell your doctor if you have any of these other conditions:

• 
  

  liver disease;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  gallbladder problems.

  
  

FDA pregnancy category B. Levocetirizine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Levocetirizine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking levocetirizine. Do not give this medication to a child younger than 6 months old.

How should I take levocetirizine?

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

It is very important not to give a child more than the prescribed dose of this medication. A child's body absorbs twice as much of the same dose size of levocetirizine as an adult's body.

Taking more of this medication will not make it more effective, and may cause severe drowsiness.

You may take this medication with or without food. Levocetirizine is usually taken once per day, in the evening.

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

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever. Store at room temperature away from moisture and heat.

See also: Levocetirizine dosage (in more detail)

What happens if I miss a dose?

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.

Overdose symptoms may include feeling restless or agitated, and then feeling drowsy.

What should I avoid while taking levocetirizine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of levocetirizine.

Levocetirizine 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 using levocetirizine and call your doctor at once if you have a serious side effect such as:

• 
  

  feeling like you might pass out;

  
  


• 
  

  nosebleed (especially in a child);

  
  


• 
  

  pain or fullness in your ear, hearing problems;

  
  


• 
  

  depression, agitation, aggression, hallucinations;

  
  


• 
  

  numbness or tingling around your lips or mouth;

  
  


• 
  

  jaundice (yellowing of your skin or eyes);

  
  


• 
  

  dark-colored urine, foul-smelling stools; or

  
  


• 
  

  fever, stomach pain, loss of appetite.

  
  

Less serious side effects may include:

• 
  

  drowsiness, weakness;

  
  


• 
  

  tired feeling;

  
  


• 
  

  stuffy nose, sinus pain, sore throat, cough;

  
  


• 
  

  vomiting, diarrhea, constipation;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  weight gain.

  
  

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.

Levocetirizine Dosing Information

Usual Adult Dose for Allergic Rhinitis:

Seasonal and perennial allergic rhinitis and chronic idiopathic urticaria;
5 mg orally once daily in the evening

Usual Adult Dose for Urticaria:

Seasonal and perennial allergic rhinitis and chronic idiopathic urticaria;
5 mg orally once daily in the evening

Usual Pediatric Dose for Allergic Rhinitis:

Seasonal allergic rhinitis:
12 years or older: 5 mg orally once daily in the evening
6 to 11 years old: 2.5 mg orally once daily in the evening
2 to 5 years old: 1.25 mg orally once daily in the evening

Perennial allergic rhinitis and chronic idiopathic urticaria:
12 years or older: 5 mg orally once daily in the evening
6 to 11 years old: 2.5 mg orally once daily in the evening
6 months to 5 years old: 1.25 mg orally once daily in the evening

Usual Pediatric Dose for Urticaria:

Seasonal allergic rhinitis:
12 years or older: 5 mg orally once daily in the evening
6 to 11 years old: 2.5 mg orally once daily in the evening
2 to 5 years old: 1.25 mg orally once daily in the evening

Perennial allergic rhinitis and chronic idiopathic urticaria:
12 years or older: 5 mg orally once daily in the evening
6 to 11 years old: 2.5 mg orally once daily in the evening
6 months to 5 years old: 1.25 mg orally once daily in the evening

What other drugs will affect levocetirizine?

Before using levocetirizine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by levocetirizine.

Tell your doctor about all other medicines you use, especially:

• 
  

  ritonavir (Norvir, Kaletra); or

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl).

  
  

This list is not complete and other drugs may interact with levocetirizine. 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 levocetirizine resources

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

• levocetirizine Advanced Consumer (Micromedex) - Includes Dosage Information


• Levocetirizine Prescribing Information (FDA)


• Levocetirizine MedFacts Consumer Leaflet (Wolters Kluwer)


• Levocetirizine Dihydrochloride Monograph (AHFS DI)


• Xyzal Prescribing Information (FDA)


• Xyzal Consumer Overview

Compare levocetirizine with other medications

• Allergies
• Hay Fever
• Urticaria

Where can I get more information?

• Your pharmacist can provide more information about levocetirizine.

See also: levocetirizine side effects (in more detail)

Hemocyte-F

Generic Name: ferrous fumarate and folic acid (FER us FUE ma rate and FOE lik AS id)

Brand Names: Ed Cyte F, Ferrocite F, Hematinic with Folic Acid, Hemocyte-F, Ircon-FA

What is Hemocyte-F (ferrous fumarate and folic acid)?

Ferrous fumarate is a type of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Folic acid helps your body produce and maintain new cells, and also helps prevent changes to DNA that may lead to cancer.

Ferrous fumarate and folic acid is used to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body).

Ferrous fumarate and folic acid may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Hemocyte-F (ferrous fumarate and folic acid)?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have iron overload syndrome, hemolytic anemia (a lack of red blood cells), porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system), thalassemia (a genetic disorder of red blood cells), if you are an alcoholic, or if you receive regular blood transfusions.

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of iron can be fatal, especially in a young child.

Symptoms of a ferrous fumarate and folic acid overdose may include nausea, severe stomach pain, bloody diarrhea, coughing up blood or vomit that looks like coffee grounds, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).

Take ferrous fumarate and folic acid on an empty stomach, at least 1 hour before or 2 hours after a meal. Avoid taking antacids or antibiotics within 2 hours before or after taking ferrous fumarate and folic acid.

Ferrous fumarate and folic acid is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat to make sure you get enough iron and folic acid from both your diet and your medication.

What should I discuss with my health care provider before taking Hemocyte-F (ferrous fumarate and folic acid)?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  iron overload syndrome;

  
  


• 
  

  hemolytic anemia (a lack of red blood cells);

  
  


• 
  

  porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  
  


• 
  

  thalassemia (a genetic disorder of red blood cells);

  
  


• 
  

  if you are an alcoholic; or

  
  


• 
  

  if you receive regular blood transfusions.

  
  

If you have any of these conditions, you may not be able to use ferrous fumarate and folic acid, or you may need a dose adjustment or special tests during treatment.

It is not known whether this medication could be harmful to an unborn baby. Tell your doctor if you become pregnant during treatment. It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give ferrous fumarate and folic acid to a child younger than 12 years old.

How should I take Hemocyte-F (ferrous fumarate and folic acid)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Take ferrous fumarate and folic acid on an empty stomach, at least 1 hour before or 2 hours after a meal.

Ferrous fumarate and folic acid is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat to make sure you get enough iron and folic acid from both your diet and your medication.

Store this medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of iron can be fatal, especially in a young child.

Overdose symptoms may include nausea, severe stomach pain, bloody diarrhea, coughing up blood or vomit that looks like coffee grounds, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).

What should I avoid while taking Hemocyte-F (ferrous fumarate and folic acid)?

Do not take any vitamin or mineral supplements that your doctor has not prescribed or recommended.

Avoid taking an antibiotic medicine within 2 hours before or after you take ferrous fumarate and folic acid. This is especially important if you are taking an antibiotic such as ciprofloxacin (Cipro), demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), norfloxacin (Noroxin), ofloxacin (Floxin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Certain foods can also make it harder for your body to absorb ferrous fumarate. Avoid taking this medication within 1 hour before or 2 hours after eating fish, meat, liver, and whole grain or "fortified" breads or cereals.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb ferrous fumarate.

Hemocyte-F (ferrous fumarate and folic acid) 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 using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  sore throat, trouble swallowing;

  
  


• 
  

  severe stomach pain; or

  
  


• 
  

  blood in your stools.

  
  

Less serious side effects may include:

• 
  

  diarrhea;

  
  


• 
  

  constipation;

  
  


• 
  

  nausea, vomiting, heartburn;

  
  


• 
  

  leg pain; or

  
  


• 
  

  darkened skin or urine color.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hemocyte-F (ferrous fumarate and folic acid)?

Before using ferrous fumarate and folic acid, tell your doctor if you use any of the following drugs:

• 
  

  acetohydroxamic acid (Lithostat);

  
  


• 
  

  etidronate (Didronel); or

  
  


• 
  

  levodopa (Larodopa, Lodosyn);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  penicillamine (Cuprimine, Depen);

  
  


• 
  

  phenytoin (Dilantin); or

  
  


• 
  

  dimercaprol (an injection used to treat poisoning by arsenic, lead, or mercury).

  
  

This list is not complete and there may be other drugs that can interact with ferrous fumarate and folic acid. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Hemocyte-F resources

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

• Hemocyte-F MedFacts Consumer Leaflet (Wolters Kluwer)


• ED Cyte F MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Hemocyte-F with other medications

• Anemia Associated with Iron Deficiency
• Iron Deficiency Anemia

Where can I get more information?

• Your pharmacist can provide more information about ferrous fumarate and folic acid.

See also: Hemocyte-F side effects (in more detail)