Chlorpheniramine/Hydrocodone/Pseudoephedrine

Pronunciation: klor-fen-EER-a-meen/hye-droe-KOE-done/sue-do-eh-FED-rin
Generic Name: Chlorpheniramine/Hydrocodone/Pseudoephedrine
Brand Name: Tussend

Chlorpheniramine/Hydrocodone/Pseudoephedrine is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Chlorpheniramine/Hydrocodone/Pseudoephedrine is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Chlorpheniramine/Hydrocodone/Pseudoephedrine if:

• you are allergic to any ingredient in Chlorpheniramine/Hydrocodone/Pseudoephedrine or any other codeine- or morphine-related medicine (eg, codeine)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Chlorpheniramine/Hydrocodone/Pseudoephedrine:

Some medical conditions may interact with Chlorpheniramine/Hydrocodone/Pseudoephedrine. 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 a fast, slow, or irregular heartbeat, heart blood vessel problems, or other heart problems


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have or recently have had any head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Chlorpheniramine/Hydrocodone/Pseudoephedrine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Chlorpheniramine/Hydrocodone/Pseudoephedrine's side effects


• Cimetidine, digoxin, droxidopa, or sodium oxybate ( GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone because it may decrease Chlorpheniramine/Hydrocodone/Pseudoephedrine's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Chlorpheniramine/Hydrocodone/Pseudoephedrine


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Chlorpheniramine/Hydrocodone/Pseudoephedrine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chlorpheniramine/Hydrocodone/Pseudoephedrine 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 Chlorpheniramine/Hydrocodone/Pseudoephedrine:

Use Chlorpheniramine/Hydrocodone/Pseudoephedrine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Chlorpheniramine/Hydrocodone/Pseudoephedrine by mouth with or without food.


• If you miss a dose of Chlorpheniramine/Hydrocodone/Pseudoephedrine, 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 Chlorpheniramine/Hydrocodone/Pseudoephedrine.

Important safety information:

• Chlorpheniramine/Hydrocodone/Pseudoephedrine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Chlorpheniramine/Hydrocodone/Pseudoephedrine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you take Chlorpheniramine/Hydrocodone/Pseudoephedrine without checking with your doctor.


• Chlorpheniramine/Hydrocodone/Pseudoephedrine has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


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


• Chlorpheniramine/Hydrocodone/Pseudoephedrine may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Chlorpheniramine/Hydrocodone/Pseudoephedrine for a few days before the tests.


• Tell your doctor or dentist that you take Chlorpheniramine/Hydrocodone/Pseudoephedrine before you receive any medical or dental care, emergency care, or surgery.


• Use Chlorpheniramine/Hydrocodone/Pseudoephedrine with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Chlorpheniramine/Hydrocodone/Pseudoephedrine in CHILDREN; they may be more sensitive to its effects.


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

When used for long periods of time or at high doses, Chlorpheniramine/Hydrocodone/Pseudoephedrine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Chlorpheniramine/Hydrocodone/Pseudoephedrine stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Chlorpheniramine/Hydrocodone/Pseudoephedrine. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Chlorpheniramine/Hydrocodone/Pseudoephedrine, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; trouble sleeping.

Possible side effects of Chlorpheniramine/Hydrocodone/Pseudoephedrine:

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; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble sleeping; vision changes.

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: Chlorpheniramine/Hydrocodone/Pseudoephedrine 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Chlorpheniramine/Hydrocodone/Pseudoephedrine:

Store Chlorpheniramine/Hydrocodone/Pseudoephedrine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpheniramine/Hydrocodone/Pseudoephedrine out of the reach of children and away from pets.

General information:

• If you have any questions about Chlorpheniramine/Hydrocodone/Pseudoephedrine, please talk with your doctor, pharmacist, or other health care provider.


• Chlorpheniramine/Hydrocodone/Pseudoephedrine is 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 Chlorpheniramine/Hydrocodone/Pseudoephedrine. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Chlorpheniramine/Hydrocodone/Pseudoephedrine resources

• Chlorpheniramine/Hydrocodone/Pseudoephedrine Side Effects (in more detail)
• Chlorpheniramine/Hydrocodone/Pseudoephedrine Use in Pregnancy & Breastfeeding
• Chlorpheniramine/Hydrocodone/Pseudoephedrine Drug Interactions
• Chlorpheniramine/Hydrocodone/Pseudoephedrine Support Group
• 4 Reviews for Chlorpheniramine/Hydrocodone/Pseudoephedrine - Add your own review/rating

• Hyphed Advanced Consumer (Micromedex) - Includes Dosage Information


• Zutripro Prescribing Information (FDA)


• Zutripro Consumer Overview

Compare Chlorpheniramine/Hydrocodone/Pseudoephedrine with other medications

• Cough and Nasal Congestion

Tri-Vitamin Drops with Iron and Fluoride

Dosage Form: oral drops
Tri-Vitamin Drops with iron & fluoride

Vitamins A, C, D, Iron and Fluoride Drops

0.25 mg per mL

Rx only

Tri-Vitamin Drops with Iron and Fluoride Description

* U.S. Recommended Daily Allowance has not been established.
		Percentage of U.S. Recommended Daily Allowance
Each 1.0 mL supplies:		Infants	Children Under 4
Vitamin A	1500 IU	100	60
Vitamin C	35 mg	100	88
Vitamin D	400 IU	100	100
Iron	10 mg	67	100
Fluoride	0.25 mg	*	*

Active Ingredient for carles prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride.

Other ingredients: Ascorbic acid, caramel color, cherry flavor, cholecalciferol, ferrous sulfate, glycerin, methylparaben, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium hydroxide, vitamin A palmitate.

Citric Acid may be used to adjust pH.

Tri-Vitamin Drops with Iron and Fluoride - Clinical Pharmacology

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Three stages of fluoride deposition in tooth enamel can be distinguished:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.


2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.


3. After eruption, the surface enamel acquires fluoride from water, supplementary fluoride and smaller amounts from saliva.

Indications and Usage for Tri-Vitamin Drops with Iron and Fluoride

Vitamins A, C, D, Iron and Fluoride Drops may be useful for infants and children whose diets are lacking in vitamins A, C, D and iron.

Vitamins A, C, D, Iron and Fluoride Drops also provide fluoride for caries prophylaxis.

Vitamins A, C, D, Iron and Fluoride Drops were developed to provide fluoride in drop form for infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride; and for children ages 3-6 years in areas where the drinking water containes 0.3 thru 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus three basic vitamins and iron.

Warnings

WARNINGS

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Precautions

The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride.

When prescribing Vitamin A, C, D, Iron and Fluoride Drops:

1. Determine the fluoride content of the drinking water.


2. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.


3. Periodically check to make sure that the child does not develop significant dental fluorosis.

Vitamins A, C, D, Iron and Fluoride Drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)

Adverse Reactions

Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010.

Tri-Vitamin Drops with Iron and Fluoride Dosage and Administration

1.0 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with cereal, fruit juice or other food. USE FULL DOSAGE.

How is Tri-Vitamin Drops with Iron and Fluoride Supplied

Vitamins A, C, D, Iron and Fluoride Drops 0.25 mg are available in 50 mL bottles with accompanying calibrated dropper.

RECOMMENDED STORAGE:

Store at room temperature, protect from light. Dispense in original container.

Manufactured By:

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

Rev. 628:05 4/09

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50383-628-50

Tri-Vitamin Drops with iron

0.25 mg

VITAMINS A, C, D IRON AND FLUORIDE

Rx Only

 

1 2/3 FL. OZ. (50 mL)

TRI-VITAMIN WITH IRON AND FLUORIDE  vitamins a, c, d, iron and fluoride  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-628 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A PALMITATE (VITAMIN A PALMITATE) VITAMIN A PALMITATE 1500 [iU]  in 1 mL ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 35 mg  in 1 mL CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL FERROUS SULFATE (IRON) IRON 10 mg  in 1 mL SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   METHYLPARABEN   POLYSORBATE 80   PROPYLENE GLYCOL   WATER   SODIUM BENZOATE   SODIUM HYDROXIDE   ANHYDROUS CITRIC ACID

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-628-50 1  In 1 CARTON contains a BOTTLE 1 50 mL In 1 BOTTLE This package is contained within the CARTON (50383-628-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		05/06/1997	03/24/2012

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE

Revised: 01/2012Hi-Tech Pharmacal Co., Inc.

Tonocard

Generic Name: tocainide (Oral route)

TOE-ka-nide

Oral route(Tablet)

Blood dyscrasias and pulmonary disorders have been reported with therapy. Some of these reactions have been fatal. Complete blood counts should be monitored during therapy. The use of tocainide as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias due the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias .

Commonly used brand name(s)

In the U.S.

• Tonocard

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiarrhythmic, Group IB

Chemical Class: Amino Amide

Uses For Tonocard

Tocainide belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm.

Tocainide produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive.

Tocainide is available only with your doctor's prescription.

Before Using Tonocard

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

Studies on this medicine have been done only in adult patients and there is no specific information comparing use of tocainide in children with use in other age groups.

Geriatric

Dizziness or lightheadedness may be more likely to occur in the elderly, who are usually more sensitive to the effects of tocainide.

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 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.

• Lidocaine


• Prilocaine

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.

• Cimetidine


• Lidocaine


• Rifampin


• Rifapentine

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.

Other Medical Problems

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

• Congestive heart failure—Tocainide may make this condition worse

• Kidney disease or


• Liver disease—Effects may be increased because of slower removal of tocainide from the body

Proper Use of Tonocard

Take tocainide exactly as directed by your doctor, even though you may feel well. Do not take more medicine than ordered.

If tocainide upsets your stomach, your doctor may advise you to take it with food or milk.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 3 doses a day, the doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

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 (tablets):
  
  • For irregular heartbeat:
    
    • Adults—At first, 400 milligrams (mg) every eight hours. Then, your doctor may increase your dose up to 600 mg three times a 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.

Precautions While Using Tonocard

It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow changes to be made in the amount of medicine you are taking, if necessary.

Your doctor may want you to carry a medical identification card or bracelet stating that you are using this medicine.

Tocainide may cause some people to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Tonocard 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 as soon as possible if any of the following side effects occur:

Less common

• Trembling or shaking

Rare

• Blisters on skin


• cough or shortness of breath


• fever or chills


• irregular heartbeats


• peeling or scaling of skin


• skin rash (severe)


• sores in mouth


• unusual bleeding or bruising

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

• Dizziness or lightheadedness


• loss of appetite


• nausea

Less common

• Blurred vision


• confusion


• headache


• nervousness


• numbness or tingling of fingers and toes


• skin rash


• sweating


• vomiting

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: Tonocard 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.

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.

More Tonocard resources

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

• Tonocard Concise Consumer Information (Cerner Multum)

Compare Tonocard with other medications

• Arrhythmia

Emla Topical

Generic Name: lidocaine and prilocaine (Topical application route)

LYE-doe-kane, PRIL-oh-kane

Commonly used brand name(s)

In the U.S.

• Emla

Available Dosage Forms:

• Cream


• Film


• Kit

Therapeutic Class: Anesthetic Combination

Chemical Class: Amino Amide

Uses For Emla

Lidocaine and prilocaine topical cream is used on the skin or in the genital area to cause numbness or loss of feeling before certain medical procedures. It is used to prevent pain caused by an injection, the drawing of blood from a vein, or minor surgeries such as removing warts. This medicine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the skin.

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

Before Using Emla

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and prilocaine topical cream in children. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Other Medical Problems

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

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency, history of or


• Heart disease or


• Heart rhythm problems or


• Infection at or near the place of application or


• Large sores, broken skin, or severe injury at the area of application—May cause side effects to become worse.

• Methemoglobinemia (blood disorder), history of—Should not use in patients with this condition.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Emla

A nurse or other trained health care professional will apply this medicine to you or your child before a medical procedure in a hospital or clinic.

You may be taught how to apply this medicine to yourself or your child at home before the medical procedure. Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if too much is used, because more of it is absorbed through the skin.

Do not apply this medicine to open wounds, burns, or broken or inflamed skin, unless directed otherwise by your doctor.

Be careful not to get any of this medicine in the eyes, because it can cause severe eye irritation. If any of the medicine does get into your eye, do not rub or wipe the eye, even if it hurts. Wash the eye with water and call your doctor right away.

Be careful not to get any of this medicine in the ears, because it can cause serious hearing problems. If any of the medicine does get into your ear, wash the ear with water and call your doctor right away.

Be careful not to get any of this medicine in the mouth. Serious unwanted effects may occur if the medicine is swallowed.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use:

• Wash your hands with soap and water before and after applying the medicine.


• Apply a thick layer of medicine to the area where numbness is needed. Do not spread the medicine on the skin.


• Cover the medicine with a special bandage called an occlusive dressing. This will keep the medicine in place. Your doctor will give you the bandage or tell you what to use.


• Seal the edges of the bandage to keep the medicine from leaking. Do not lift the bandage or disturb it. Keeping the medicine tightly covered helps it work properly.


• For babies or young children, a second covering may be used to prevent them from touching the medicine.


• Carefully watch your baby or child while the medicine is in place. Do not let them loosen or remove the bandage, touch the medicine, or put it in the mouth, eyes, nose, or ears.


• Keep the bandage in place until you or your child arrive at the hospital or clinic.


• Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.

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 topical dosage form (cream):
  
  • For preventing pain caused by medical procedures:
    
    • Adults and teenagers—Apply 1 to 2.5 grams in a thick layer to the skin area. The size of the area to be covered and the length of time the medicine is kept in place will depend on the procedure. Cover the area with a bandage. The medicine may need to stay on the skin for up to 2 hours. Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The cream is applied in a thick layer to the skin area. The size of the area to be covered and the length of time the medicine is kept in place will depend on the procedure. Cover the area with a bandage. Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.
    
    
  
  

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 Emla

It is very important that your doctor check you or your child closely for any problems or unwanted effects that may be caused by this medicine.

Do not use this medicine on a baby younger than 3 months of age unless your child's doctor tells you to. Young babies may have more unwanted effects if too much is used and absorbed through the skin. If you use this medicine on a baby younger than 3 months of age, blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of the hands, face, or mouth after you receive the medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Remove the cream and call your doctor right away if you or your child develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing.

Using too much of this medicine or using it on a large area of your skin can cause serious unwanted effects. Remove the cream and contact your doctor right away if you or your child have any of these symptoms: lightheadedness, dizziness, vision problems, an irregular or slow heartbeat, difficulty with breathing, or convulsions.

During the time that the skin feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you or your child have normal feeling in the area. Do not scratch or rub the area, and do not allow very hot or very cold objects to touch it.

Emla 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:

Rare

• Cough


• difficulty with swallowing


• large, hive-like swellings on the eyelids, face, lips, or tongue


• severe dizziness or feeling faint


• shortness of breath


• skin rash, itching, or hives


• stuffy nose


• tightness in the chest


• troubled breathing


• wheezing

Incidence not known

• Blisters on skin at application site


• blue or blue-purple color of lips, fingernails, mouth, or skin


• blurred or double vision


• convulsions


• dark urine


• dizziness or drowsiness


• fainting


• feeling hot, cold, or numb


• headache


• irregular or fast heartbeat


• muscle twitching or trembling


• nausea or vomiting


• ringing or buzzing in the ears


• shortness of breath or troubled breathing


• unusual excitement, nervousness, or restlessness


• 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

• Burning, swelling, itching, or skin rash at application site


• white or red skin at the application site

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: Emla Topical 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.

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.

More Emla Topical resources

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

Compare Emla Topical with other medications

• Anesthesia

Glycerin Lemon and Honey with Glucose and Ipecacuanha

1. Name Of The Medicinal Product

Glycerin Lemon and Honey with Glucose and Ipecacuanha

2. Qualitative And Quantitative Composition

Each 5ml of solution contains:-

Glycerol 1.36g

Ipecacuanha Liquid Extract 0.01ml

Excipients: Each 5ml contains 1.7g of Syrup (sucrose) and 280.0mg of Liquid Glucose

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

A soothing preparation for relief of the symptoms of coughs and sore throats.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Adults and children over 12 years: two 5ml spoonfuls.

May be repeated every four hours if required. Not more than 4 doses should be given in any 24 hours.

The product may be taken for up to 5 days, following which, if symptoms persist, medical advice should be sought.

4.3 Contraindications

Patients in shock, at risk of seizure, or with cardiovascular disorders.

Hypersensitivity to any of the ingredients.

Children under 12 years of age.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach and sight of children.

Not suitable for use in diabetics.

Do not give to children under 12 years

Do not exceed the stated dose

Do not take with any other cough and cold medicine

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No adverse effects are considered likely if this product is used in the above conditions, however, as with all medicines, its use should be avoided unless recommended by a doctor.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None anticipated at the recommended dosage.

4.9 Overdose

Overdose with this preparation is unlikely to occur, however, large doses of glycerin may cause thirst, headache, nausea, vomiting, diarrhoea, hyperglycaemia, dehydration, dizziness and mental confusion. Cardiac arrhythmias have been reported. Treatment should be symptomatic.

Large doses of ipecacuanha may irritate the gastrointestinal tract, and give rise to nausea, persistent bloody vomiting or bloody diarrhoea.

Mucosal erosions of the entire gastrointestinal tract have been reported. Overdosage is unlikely as a result of the emetic action of ipecacuanha, however, if emetine is absorbed in sufficient amounts it may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction. These symptoms may also be combined with dehydration due to vomiting, and may cause vasomotor collapse followed by death.

Acute overdosage of ipecacuanha should be treated with activated charcoal to delay absorption. Prolonged vomiting should be controlled by intramuscular injection of anti-emetics. Supportive measures should be taken to correct fluid and electrolyte imbalance and cardiac effects.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycerol acts as a demulcent to soothe the passage of the upper respiratory tract.

Ipecacuanha has a reflex expectorant action as a result of its irritant action on the respiratory tract.

5.2 Pharmacokinetic Properties

Glycerol is readily absorbed from the intestine and is metabolised to carbon dioxide and glycogen.

Emetine one of the major alkaloids of ipecacuanha is excreted or metabolised slowly.

5.3 Preclinical Safety Data

None known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lemon soluble essence

Syrup

Purified water

Lemon juice

Citric acid monohydrate

Honey

Liquid glucose

6.2 Incompatibilities

None stated.

6.3 Shelf Life

200ml: 24 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

200ml: glass bottle with polypropylene cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0014

9. Date Of First Authorisation/Renewal Of The Authorisation

06.04.99

10. Date Of Revision Of The Text

06.01.10

ExeClear-C

Generic Name: codeine and guaifenesin (KOE deen and gwye FEN a sin)

Brand Names: Allfen CD, Allfen CDX, Brontex, Cheracol with Codeine, Cheratussin AC, Dex-Tuss, Diabetic Tussin C, Duraganidin NR, ExeClear-C, Guaiatussin AC, Guaifen-C, Guiatuss AC, Guiatussin with Codeine, Iophen-C NR, M-Clear WC, Mar-cof CG, Mytussin AC, Robafen AC, Robitussin-AC, Tussi-Organidin NR, Tussi-Organidin-S NR, Tussiden C, Tusso-C

What is ExeClear-C (codeine and guaifenesin)?

Codeine is in a group of drugs called narcotics. It is a cough suppressant that affects the signals in the brain that trigger cough reflex.

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

The combination of codeine and guaifenesin is used to treat cough and to reduce chest congestion caused by upper respiratory infections or the common cold.

Codeine and guaifenesin will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ExeClear-C (codeine and guaifenesin)?

Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains an guaifenesin, or an expectorant. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. 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.

What should I discuss with my healthcare provider before taking ExeClear-C (codeine and guaifenesin)?

You should not take this medication if you are allergic to codeine or guaifenesin.

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

• 
  

  heart disease, heart rhythm disorder;

  
  


• 
  

  asthma, COPD, emphysema, or other breathing disorders;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a thyroid disorder;

  
  


• liver or kidney disease;


• 
  

  enlarged prostate; or

  
  


• 
  

  a history of depression, mental illness, or drug addiction;

  
  

FDA pregnancy category C. It is not known whether codeine and guaifenesin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Codeine may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Liquid forms of this medication may contain sugar or artificial sweetener (phenylalanine). Talk to your doctor before using this form of codeine and guaifenesin if you have diabetes or phenylketonuria (PKU).

How should I take ExeClear-C (codeine and guaifenesin)?

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. Cough or 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 a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take codeine and guaifenesin with food if it upsets your stomach. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

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 after 7 days of treatment, or if you also have a fever, headache, or skin rash.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using codeine and guaifenesin.

Do not stop using this medication suddenly after long-term use or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medication. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since cough medicine is taken when 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 codeine can be fatal.

Overdose symptoms may include extreme dizziness or drowsiness, nausea, vomiting, sweating, confusion, hallucinations, cold and clammy skin, blue-colored lips or fingernails, weak or limp muscles, pinpoint pupils, weak pulse, slow breathing, fainting, or seizures (convulsions).

What should I avoid while taking ExeClear-C (codeine and guaifenesin)?

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

ExeClear-C (codeine and guaifenesin) 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 any of these serious side effects:

• 
  

  severe dizziness or drowsiness;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  slow heart rate, weak pulse, fainting, weak or shallow breathing.

  
  

Less serious side effects include:

• 
  

  dizziness, drowsiness, headache;

  
  


• 
  

  warmth, redness, or tingling under your skin;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  constipation; or

  
  


• 
  

  skin rash or itching.

  
  

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 ExeClear-C (codeine and guaifenesin)?

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

Also tell your doctor if you are using any of the following drugs:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  naloxone (Narcan); or

  
  


• 
  

  naltrexone (Vivitrol).

  
  

This list is not complete and other drugs may interact with codeine and guaifenesin. 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 ExeClear-C resources

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

• ExeClear-C Prescribing Information (FDA)


• Brontex MedFacts Consumer Leaflet (Wolters Kluwer)


• Guiatuss AC Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare ExeClear-C with other medications

• Cough

Where can I get more information?

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

See also: ExeClear-C side effects (in more detail)

Niacin

Class: Antilipemic Agents, Miscellaneous
ATC Class: A11HA01
VA Class: VT103
CAS Number: 59-67-6
Brands: Advicor, Niacor, Niaspan, Nicotinex, Nico-400, Slo-Niacin

Introduction

Water-soluble, B complex vitamin.^a Prescription-only preparations are FDA-labeled for use as antilipemic agents.^a

Do not use dietary supplement preparations and prescription-only preparations interchangeably.^{178 191} (See Substitution of Different Niacin Preparations under Cautions.)

Uses for Niacin

Prevention of Cardiovascular Events

Adjunct to dietary therapy in patients with a history of MI and hypercholesterolemia to reduce the risk of recurrent nonfatal MI.¹⁶⁰

Adjunct to bile acid sequestrant therapy in patients with CHD and hypercholesterolemia to slow progression or promote regression of atherosclerosis.^{134 157 158 160}

Dyslipidemias

Adjunct to dietary therapy to decrease elevated serum total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations, and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia, including heterozygous familial hypercholesterolemia and other causes of hypercholesterolemia (e.g., polygenic hypercholesterolemia).^{107 120 121 122 124 156 160 161 163 181} Fixed combination of extended-release niacin and lovastatin (Advicor) should not be used as initial antilipemic therapy.¹⁸⁸

Adjunctive therapy in the management of severe hypertriglyceridemia in patients at risk of developing pancreatitis (typically those with serum triglyceride concentrations >2000 mg/dL and elevated concentrations of VLDL-cholesterol and fasting chylomicrons) who do not respond adequately to dietary management.^{160 161}

Also may be used in patients with triglyceride concentrations of 1000–2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis.^{160 161}

Efficacy in patients with type IV hyperlipoproteinemia and triglyceride concentrations <1000 mg/dL who exhibit type V patterns subsequent to dietary or alcoholic indiscretion not adequately studied.¹⁶⁰

Not indicated for use in patients with type I hyperlipoproteinemia who have elevated triglyceride and chylomicron concentrations but normal VLDL-cholesterol concentrations.^{160 161}

Dietary Requirements

Adequate intake of niacin needed to prevent niacin deficiency and pellagra.^a

In the US, niacin is principally obtained from fish, meat, or poultry, and niacin-enriched or niacin-fortified food (e.g., enriched and whole grain breads and bread products). Conversion of dietary tryptophan to niacin also contributes to niacin intake.

Niacin Deficiency and Pellagra

Prevention of niacin deficiency.^a

Treatment of pellagra.^a Niacinamide preferred by some clinicians due to its lack of vasodilating effects.^a

Niacin Dosage and Administration

General

• 
  

  Dietary supplements containing niacin are not FDA-labeled for prevention of cardiovascular events or management of dyslipidemias; use prescription-only preparations for these indications.¹⁹¹

  
  


• 
  

  Do not use different formulations (i.e., immediate-release, extended-release) interchangeably since pharmacokinetics (e.g., metabolism) may vary.^{160 161} (See Substitution of Different Niacin Preparations under Cautions.)

  
  


• 
  

  Minimize flushing, pruritus, and GI distress by initiating therapy at low dosages, increasing dosage gradually, and avoiding administration on an empty stomach.^{160 161 186 188} May also administer a prostaglandin-synthesis inhibitor (e.g., aspirin 325 mg, ibuprofen 200 mg) 30 minutes prior to administration of niacin to reduce flushing.^{104 105 106 107 118 124 151 160 161 186 188}

  
  

Administration

Oral Administration

Immediate-release niacin (e.g., Niacor): Administer orally with meals.¹⁶¹

Extended-release niacin (Niaspan) or extended-release niacin/lovastatin fixed combination (Advicor): Administer orally at bedtime following a low-fat snack.^{160 188} Take tablets whole; do not break, crush, or chew.^{160 188} Do not administer Advicor with grapefruit juice due to increased risk of myopathy associated with lovastatin component.¹⁸⁸

To minimize risk of flushing or pruritus, avoid administering concomitantly with alcohol or hot drinks.^{160 161 188}

Dosage

Commercially available as dietary supplements and as prescription-only preparations.^{160 161 188} Do not use these preparations interchangeably.^{190 191} (See Substitution of Different Niacin Preparations under Cautions.)

Pediatric Patients

Dietary Requirements

Recommended Daily Allowance (RDA) generally expressed in terms of niacin equivalents (NE).^a NE is calculated as follows: 1 mg of NE = 1 mg of niacin = 60 mg of tryptophan.

Oral

Recommended Dietary Allowance (RDA) is nutrient recommendation from National Academy of Sciences (NAS) for children and adults. The RDA for a given nutrient is the goal for dietary intake in individuals.

Adequate Intake (AI) is nutrient recommendation from NAS for infants ≤12 months of age; used when data are insufficient or too controversial to establish an RDA. AI set for infants ≤6 months of age is based on the observed mean niacin intake of infants fed principally human milk. AI set for infants 6–12 months of age is based on the AI for younger infants and data from adults.

Age	RDA	AI
0–6 months		2 mg of preformed niacin (0.3 mg/kg) daily
6–12 months		4 mg of NE (0.4 mg/kg) daily
1–3 years	6 mg of NE daily
4–8 years	8 mg of NE daily
9–13 years	12 mg of NE daily
14–18 years	Boys: 16 mg of NE daily

Niacin Deficiency

Pellagra

Oral

Niacin or niacinamide: 100–300 mg daily in divided doses.^a

Adults

Prevention of Cardiovascular Events

Oral

Extended-release niacin (Niaspan): Initially, 500 mg once daily at bedtime.¹⁶⁰ If response is inadequate, increase dosage by no more than 500 mg at 4-week intervals until desired effect is observed or maximum daily dosage of 2 g is reached.¹⁶⁰

Usual maintenance dosage is 1–2 g once daily at bedtime.¹⁶⁰

In patients previously treated with immediate-release preparations or in those who have discontinued extended-release niacin (Niaspan) therapy for an extended period, titrate dosage as with initial therapy.¹⁶⁰

Dyslipidemias

Oral

Immediate-release preparations: Initially, 100–500 mg 3 times daily.^b Increase dosage gradually (e.g., 300 mg daily at 4- to 7-day intervals) until desired effect is achieved.^b Usual maintenance dosage is 1.5–3 g daily given in 2 or 3 divided doses.¹⁸⁷

Initial dosage of 250 mg daily following the evening meal recommended by manufacturer of Niacor (immediate-release preparation).¹⁶¹ Increase dosage of Niacor at 4- to 7-day intervals until desired effect is achieved or dosage of 1.5–2 g daily is reached.¹⁶¹ If adequate response is not achieved after 2 months, may then increase dosage at 2- to 4-week intervals to 3 g daily (1 g 3 times daily).¹⁶¹ Manufacturer of Niacor states that higher doses (up to 6 g daily) occasionally may be required in patients with marked lipid abnormalities.¹⁶¹ Usual maintenance dosage recommended by manufacturer of Niacor is 1–2 g daily given in 2 or 3 divided doses.¹⁶¹

Extended-release niacin (Niaspan): Initially, 500 mg once daily at bedtime.¹⁶⁰ If adequate response is not achieved after 4 weeks, increase dosage by no more than 500 mg at 4-week intervals until desired effect is observed.¹⁶⁰ Usual maintenance dosage is 1–2 g once daily at bedtime.¹⁶⁰ Titrate Niaspan dosage as with initial therapy in patients previously treated with immediate-release niacin preparations or in those in whom therapy with extended-release niacin (Niaspan) has been discontinued for a prolonged period.¹⁶⁰

Extended-release niacin (Niaspan) and lovastatin combination therapy: In patients already receiving a stable dosage of lovastatin, add Niaspan (using recommended titration schedule).¹⁶⁰ In patients already receiving a stable dosage of Niaspan, add lovastatin (at initial dosage of 20 mg once daily).¹⁶⁰ Adjust dosage at 4-week intervals.¹⁶⁰

Fixed combination of extended-release niacin and lovastatin (Advicor): Use only in patients already receiving a stable dosage of Niaspan; in patients currently receiving niacin preparations other than Niaspan, discontinue current niacin therapy and switch to Niaspan.¹⁸⁸ Once a stable Niaspan dosage is reached, switch to Advicor at the same niacin-equivalent dosage as Niaspan.¹⁸⁸ In patients currently receiving a stable dosage of lovastatin, add Niaspan (using the recommended titration schedule) until a stable dosage has been reached, then switch to Advicor at the same niacin-equivalent dosage as Niaspan.¹⁸⁸ Increase Advicor dosage by no more than 500 mg (of the niacin component) at 4-week intervals.¹⁸⁸ Usual maintenance dosage ranges from 500 mg of extended-release niacin and 20 mg of lovastatin to 2 g of extended-release niacin and 40 mg of lovastatin once daily.¹⁸⁸ If Advicor therapy has been discontinued for >7 days, reinstitute at the lowest available dosage.¹⁸⁸ Because of differences in bioavailability, do not substitute 1 tablet of Advicor 1 g/40 mg for 2 tablets of Advicor 500 mg/20 mg, or vice versa.¹⁸⁸

Dietary Requirements

RDA generally expressed in terms of NE.^a NE is calculated as follows: 1 mg of NE = 1 mg of niacin = 60 mg of tryptophan.

Oral

RDA for healthy men: 16 mg of NE daily.

RDA for healthy women: 14 mg of NE daily.

RDA for pregnant women: 18 mg of NE daily. Higher dosages required in women pregnant with >1 fetus.

RDA for lactating women: 17 mg of NE daily. Higher dosages required in mothers nursing >1 infant.

Higher dosages required in patients with Hartnup disease, liver cirrhosis, carcinoid syndrome, malabsorption syndrome, or in individuals receiving long-term isoniazid therapy or undergoing hemodialysis or peritoneal dialysis.

Niacin Deficiency

Pellagra

Oral

Niacin or niacinamide: 300–500 mg daily in divided doses.^a

Hartnup Disease

Oral

Niacin: 50–200 mg daily.^a

Prescribing Limits

Adults

Prevention of Cardiovascular Events

Oral

Extended-release niacin (Niaspan): Maximum 2 g daily.¹⁶⁰

Dyslipidemias

Oral

Immediate-release preparations: Maximum 4.5 g daily;¹⁸⁷ manufacturer of Niacor states that maximum of 6 g daily generally should not be exceeded.¹⁶¹

Extended-release niacin (Niaspan): Maximum 2 g daily.¹⁶⁰ When used in combination with lovastatin, maximum 2 g of Niaspan and 40 mg of lovastatin daily.¹⁶⁰

Fixed combination of extended-release niacin and lovastatin (Advicor): Maximum 2 g of extended-release niacin and 40 mg of lovastatin daily.¹⁸⁸

Cautions for Niacin

Contraindications

• 
  

  Known hypersensitivity to niacin or any ingredient in the formulation.^{160 161 188}

  
  


• 
  

  Active liver disease or unexplained persistent elevations of serum transaminases, active peptic ulcer disease, or arterial bleeding.^{160 161 188}

  
  


• 
  

  Extended-release niacin in fixed combination with lovastatin (Advicor) contraindicated in pregnant or lactating women.¹⁸⁸

  
  

Warnings/Precautions

Warnings

Substitution of Different Niacin Preparations

Do not use dietary supplement preparations and prescription-only preparations interchangeably.^{178 191} Do not use different formulations (i.e., immediate-release, extended-release) interchangeably.^{141 160 161 178} Severe hepatic toxicity (e.g., fulminant hepatic necrosis) reported in some individuals who substituted certain sustained-release niacin preparations for immediate-release niacin at equivalent dosages.^{140 143 160 161 178 c d}

Hepatic Effects

Abnormal liver function test results^{160 161 162 163 188} (e.g., increased serum bilirubin, AST, ALT, and LDH concentrations), hypoalbuminemia, cholelithiasis, jaundice,^{160 161 162 188} hepatitis,^{181 188 e} chronic liver damage,^{160 161} and hepatic failure^{140 143 162} reported.

Perform liver function tests before initiation of therapy, every 6–12 weeks for the remainder of the first year, and periodically thereafter (e.g., semiannually).^{160 161 188}

If increased serum AST/ALT concentrations or manifestations of liver disease occur, perform second liver function evaluation to confirm findings and continue monitoring liver function until abnormalities return to normal.^{160 161 188} If increases in AST or ALT concentrations of ≥3 times the ULN persist, or if associated with nausea, fever, and/or malaise, discontinue therapy.^{160 161 188} Consider performing liver biopsy if elevations persist after discontinuance of therapy.¹⁶¹

Musculoskeletal Effects

Elevations in serum creatine kinase (CK, creatine phosphokinase, CPK),¹⁶³ myalgia,¹⁸⁸ myopathy,^{160 163 188} and rhabdomyolysis reported with niacin alone¹⁵² or in combination with other antilipemic agents (e.g., gemfibrozil,¹⁵² various statins).^{134 135 136 137 147 160}

Carefully monitor patients for signs and symptoms of muscle pain, tenderness, or weakness, especially early in the course of therapy or during upward titration.^{160 161 188} Consider periodic monitoring of serum CK and potassium concentrations in patients exhibiting such symptoms;^{160 161} no assurance that such monitoring will prevent occurrence of severe myopathy.^{160 161 188}

Fixed-combination Preparation (Advicor)

When using the fixed-combination preparation containing lovastatin, consider the cautions, precautions, and contraindications associated with lovastatin.¹⁸⁸

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, laryngeal edema, facial edema, peripheral edema, laryngismus, vesiculobullous rash) reported rarely.¹⁶⁰

Major Toxicities

Effects on Glucose Tolerance

Decreased glucose tolerance, hyperglycemia, and glycosuria reported.^{160 161 a} Closely observe patients with (or those at risk of developing) diabetes mellitus.¹⁶⁰ Monitor blood glucose concentrations periodically (especially early in the course of therapy) and adjust dosages of niacin and/or antidiabetic agents as appropriate.^{160 167 188}

Hematologic Effects

Increased PT and decreased platelet count reported.^{160 188} Use with caution in patients undergoing surgery.^{160 188} Closely monitor PT and platelet count in patients receiving niacin concomitantly with anticoagulants.¹⁶⁰

Metabolic Effects

Hyperuricemia reported; use with caution in patients predisposed to gout.^{160 161 188}

Reductions in phosphorus concentrations reported;¹⁶⁰ monitor phosphorus concentrations periodically in patients at risk for developing hypophosphatemia.^{160 188}

General Precautions

Role as Adjunct Therapy

Prior to institution of antilipemic therapy, vigorously attempt to control serum cholesterol by appropriate dietary regimens, weight reduction, exercise, and treatment of any underlying disorder that might be the cause of lipid abnormality.^{160 161}

Concomitant Illnesses

Use with caution in patients with unstable angina, AMI, or CHD, particularly when these patients also are receiving vasoactive drugs such as nitrates, calcium-channel blockers, or adrenergic-blocking agents.^{160 161 188}

Use with caution and closely observe patients with history of jaundice, hepatobiliary disease, or peptic ulcer disease.¹⁶⁰

Use with caution in patients with renal or hepatic impairment; lack of data in such patients.¹⁶⁰ (See Specific Populations under Cautions.)

Specific Populations

Pregnancy

Category C.¹⁶⁰ If used for primary hypercholesterolemia, discontinue therapy when patient becomes pregnant.^{160 161 188} If used for hypertriglyceridemia, assess benefits and risks of continued therapy.^{160 161 188}

Fixed combination of extended-release niacin and lovastatin (Advicor): Category X (due to lovastatin component).¹⁸⁸

Lactation

Distributed into milk.^{160 188} Discontinue nursing or the drug.^{160 161}

Advicor should not be used in nursing women.¹⁸⁸

Pediatric Use

Safety and efficacy not established in children or adolescents¹⁶¹ ≤16 years of age.¹⁶⁰

Extended-release niacin (Niaspan): Safety and efficacy not evaluated in patients <21 years of age.¹⁶⁰

Fixed combination of extended-release niacin and lovastatin (Advicor): Safety and efficacy not evaluated in patients <18 years of age.¹⁸⁸ Manufacturer states that use of Advicor not currently recommended in patients <18 years of age.¹⁸⁸

Geriatric Use

Extended-release niacin (Niaspan): No overall differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹⁶⁰

Fixed combination of extended-release niacin and lovastatin (Advicor): No substantial differences in safety and efficacy relative to younger adults; however, higher serum amylase concentrations observed in geriatric patients.¹⁸⁸

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease.¹⁶⁰

Renal Impairment

Use with caution.^{160 188}

Common Adverse Effects

Flushing (e.g., warmth, redness, itching and/or tingling), headache, pain, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, rhinitis, pruritus, rash.^{160 161 188}

Interactions for Niacin

Ganglionic Blocking and Vasoactive Drugs

Potentiation of hypotensive effects, resulting in postural hypotension.^{160 161 188}

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Anticoagulants, coumarin	Potential additive anticoagulant effect (increased PT and decreased platelet count reported with niacin alone or combined with lovastatin)160 188	Closely monitor PT and platelet count.160 In patients receiving fixed combination of extended-release niacin and lovastatin (Advicor), closely monitor PT upon initiation of such therapy or dosage adjustment; when stabilized, monitor PT at intervals recommended for patients receiving coumarin anticoagulants188
Antihypertensive agents (e.g., ganglionic blocking drugs, vasoactive agents)	Possible potentiation of hypotensive effects160 161 188
Aspirin	Decreased niacin metabolic clearance160 161 188	Clinical relevance not fully elucidated160 160 188
Bile acid sequestrants (cholestyramine, colestipol)	Decreased niacin bioavailability due to binding of niacin to bile acid sequestrant160 188	Administer niacin and bile acid sequestrant at least 4–6 hours apart160 188
HMG-CoA reductase inhibitors (statins)	Possible increased risk of myopathy and rhabdomyolysis when used concomitantly with niacin dosages >1 g daily;134 135 136 137 160 161 rhabdomyolysis not reported in clinical studies of up to 2 years’ duration with Niaspan-statin combination or with Advicor160 188	Carefully weigh potential benefits and risks of combined therapy; advise patients of risks if such therapy is employed160 161
Isoniazid, long-term therapy	Possible interference with conversion of dietary tryptophan to niacin. Possible increased niacin requirement
Vitamins or nutritional supplements containing large doses of niacin or nicotinamide	Potentiation of niacin adverse effects160
Tests for catecholamines	Possible false elevations in some fluorometric determinations of plasma or urinary catecholamines160
Tests for urine glucose	Possible false-positive reactions with cupric sulfate solution (Benedict’s reagent)160

Niacin Pharmacokinetics

Absorption

Bioavailability

Rapidly and extensively (60–76% of dose) absorbed following oral administration.^{160 161 166}

Peak plasma concentrations attained within 30–60 minutes or 4–5 hours following oral administration of immediate-release niacin (Niacor) or extended-release niacin (Niaspan), respectively.^{160 161 162 163 166}

Bioavailability of 1 tablet containing 1 g of extended-release niacin in fixed combination with 40 mg of lovastatin (Advicor 1 g/40 mg) differs from that of 2 tablets each containing 500 mg of extended-release niacin in fixed combination with 20 mg of lovastatin (Advicor 500 mg/20 mg).¹⁸⁸ (See Adults: Dyslipidemias under Dosage and Administration.)

Onset

Reductions in triglyceride concentrations apparent within 1–4 days.¹⁶² Reductions in LDL-cholesterol concentrations achieved within 3–5 weeks.¹⁶²

In the treatment of pellagra, redness and swelling of the tongue disappear within 24–72 hours, mental symptoms and infections of the mouth and other mucous membranes clear rapidly, and GI symptoms disappear within 24 hours.^a

Special Populations

Peak plasma concentrations following oral administration of Niaspan appear to be slightly higher in women than in men, possibly because of differences in metabolism.^{160 166}

Distribution

Extent

Distributed mainly to the liver, kidney, and adipose tissue.¹⁶⁰

Distributed into milk.¹⁶⁰

Elimination

Metabolism

Rapidly metabolized; undergoes extensive first-pass metabolism.¹⁶⁰

Converted to several metabolites, including nicotinuric acid (NUA), nicotinamide, and nicotinamide adenine dinucleotide (NAD).^{160 164 166} Nicotinamide does not appear to exert antilipemic effects;¹⁶⁰ the activity of other metabolites on lipoprotein fractions currently unknown.¹⁶⁰

Elimination Route

Niacin and metabolites are rapidly excreted in urine.^{160 161 162 163}

Immediate-release niacin (e.g., Niacor): Approximately 88% of oral dose excreted in urine as unchanged drug and inactive metabolites.¹⁶¹

Extended-release niacin (Niaspan): Approximately 60–76% of oral dose excreted in urine as unchanged drug and inactive metabolites.^{160 166}

Half-life

20–60 minutes.^{161 162 163}

Stability

Storage

Oral

Tablets

Advicor or Niaspan: 20–25°C.^{160 188}

Niacor: 15–30°C.¹⁶¹

ActionsActions

• 
  

  Niacinamide (formed from conversion of niacin) required for lipid metabolism, tissue respiration, and glycogenolysis.^a

  
  


• 
  

  At daily dosages ≥1 g, niacin decreases serum total cholesterol, LDL-cholesterol, VLDL-cholesterol, and triglyceride concentrations, and increases serum HDL-cholesterol concentrations in patients with type II, III, IV, or V hyperlipoproteinemia.^{151 160 161 162 163 165} Mechanism of antilipemic effects independent of role as vitamin.^{160 161 162} Has no effect on cholesterol synthesis or fecal excretion of fats, sterols, or bile acids.¹⁶² Refractoriness to antilipemic effects of large niacin doses reported.^b

  
  


• 
  

  Slows progression and promotes regression of coronary atherosclerotic lesions.^{160 161 129 157}

  
  


• 
  

  Causes only cutaneous vasodilation at daily dosages of 300–800 mg.^a May cause histamine release (resulting in increased gastric motility and acid secretion) and activate fibrinolytic system.^a

  
  

Advice to Patients

• 
  

  Risk of flushing; may vary in severity, last for several hours, and likely occur during sleep if niacin taken at bedtime.^{160 161} Pretreatment with aspirin or other NSAIA (e.g., taken 30 minutes prior to extended-release niacin [Niaspan] dose) may minimize flushing.^{160 161} If awakened by flushing at night, patient should get up slowly, especially if flushing is accompanied by a feeling of dizziness or fainting, or if patient is receiving antihypertensive therapy.¹⁶⁰

  
  


• 
  

  Importance of informing clinician if dizziness occurs.¹⁶⁰

  
  


• 
  

  In patients with diabetes mellitus, importance of informing clinician of changes in blood glucose values.¹⁶⁰

  
  


• 
  

  Importance of informing clinician if niacin therapy has been discontinued for an extended period of time (retitration of dosage is recommended in such cases).¹⁶⁰

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements (especially those containing niacin or nicotinamide), as well as any concomitant illnesses.¹⁶⁰

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy, advise pregnant women of risk to the fetus, and advise males to use effective contraception during therapy.

  
  


• 
  

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

  
  

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Niacin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder*
Oral	Capsules, extended-release	125 mg*
		250 mg*
		400 mg*	Nico-400	King
		500 mg*
	Elixir	50 mg/5 mL	Nicotinex (with alcohol 14%)	Fleming
	Tablets	50 mg*
		100 mg*
		250 mg*
		500 mg*	Niacor (scored)	Upsher-Smith
	Tablets, extended-release	250 mg*	Slo-Niacin	Upsher-Smith
		500 mg*	Niaspan	Kos
			Slo-Niacin	Upsher-Smith
		750 mg*	Niaspan	Kos
			Slo-Niacin	Upsher-Smith
		1000 mg	Niaspan	Kos

Niacin Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, extended-release	500 mg with Lovastatin 20 mg	Advicor (with povidone)	Kos
		750 mg with Lovastatin 20 mg	Advicor (with povidone)	Kos
		1 g with Lovastatin 20 mg	Advicor (with povidone)	Kos
		1 g with Lovastatin 40 mg	Advicor (with povidone)	Kos

Niacin and niacinamide are also commercially available in combination with other vitamins, minerals, cerebral stimulants, sedatives, antacids, amino acids, hormones, infant formulas, vasodilators, antihistamines, local anesthetics, expectorants, enzymes, and laxatives.^a For IV infusion, niacinamide is commercially available in combination with other vitamins in caloric and electrolyte solutions.^a

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Advicor 1000-20MG 24-hr Tablets (ABBOTT): 60/$257.99 or 180/$740.96

Advicor 1000-40MG 24-hr Tablets (ABBOTT): 90/$433.97 or 180/$863.95

Advicor 500-20MG 24-hr Tablets (ABBOTT): 90/$330.98 or 180/$650.97

Advicor 750-20MG 24-hr Tablets (ABBOTT): 60/$264.98 or 180/$772.93

Niacin 500MG Tablets (RUGBY): 100/$11.99 or 200/$16.96

Niaspan 1000MG Controlled-release Tablets (ABBOTT): 30/$149.99 or 90/$432.97

Niaspan 500MG Controlled-release Tablets (ABBOTT): 30/$87.99 or 90/$240.97

Niaspan 750MG Controlled-release Tablets (ABBOTT): 30/$119.99 or 90/$332.98

Slo-Niacin 500MG Controlled-release Tablets (UPSHER-SMITH): 100/$25.99 or 200/$41.97

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.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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43. Sugerman AA, Clark CG. Jaundice following administration of niacin. JAMA. 1974; 228:202. [IDIS 39830] [PubMed 4406053]

47. Kohn RM, Montes M. Hepatic fibrosis following long acting nicotinic acid therapy: a case report. Am J Med Sci. 1969; 258:94-9. [PubMed 5805238]

80. Einstein N, Baker A, Galper J et al. Jaundice due to nicotinic acid therapy. Am J Dig Dis. 1975; 20:282-6. [PubMed 1124751]

100. Nicolar prescribing information. In: Huff BB, ed. Physicians’ desk reference. 42nd ed. Oradell, NJ: Medical Economics Company Inc; 1988:1804-5.

101. Kaijser L, Eklund B, Olsson AG et al. Dissociation of the effects of nicotinic acid on vasodilation and lipolysis by a prostaglandin synthesis inhibitor, indomethacin, in man. Med Biol. 1979; 57:114-7. [PubMed 376964]

102. Olsson AG, Carlson LA, Anggard E et al. Prostacyclin production augmented in the short term by nicotinic acid. Lancet. 1983; 2:565-6. [IDIS 175457] [PubMed 6136711]

103. Andersson RGG, Gunnar A, Brattsand R et al. Studies on the mechanism of flush induced by nicotinic acid. Acta Pharmacol Toxicol (Copenh). 1977; 41:1-10. [PubMed 197786]

104. Brown MS, Goldstein JL. Drugs used in the treatment of hyperlipoproteinemias. In: Gilman AG, Goodman LS, Rall TW et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan Publishing Company; 1985:827-45.

105. Hunnighake DB. Pharmacologic therapy for the hyperlipidemic patient. Am J Med. 1983; 74(Suppl 5A):19-22. [IDIS 171222] [PubMed 6846378]

106. Anon. Lipid-lowering drugs. Med Lett Drugs Ther. 1985; 27:74-6. [PubMed 3860714]

107. American Heart Association Committee to Design a Dietary Treatment of Hyperlipoproteinemia. Recommendations for treatment of hyperlipidemia in adults: a joint statement of the Nutrition Committee and the Council on Arteriosclerosis. Circulation. 1984; 69:1065-90A. [PubMed 6713610]

108. National Institutes of Health Office of Medical Applications of Research. Consensus conference: treatment of hypertriglyceridemia. JAMA. 1984; 251:1196-200. [PubMed 6582287]

109. American Medical Association Council on Scientific Affairs. Dietary and pharmacologic therapy for the lipid risk factors. JAMA. 1983; 250:1873-9. [IDIS 176576] [PubMed 6620484]

110. Kuo PT. Hyperlipoproteinemia and atherosclerosis: dietary intervention. Am J Med. 1983; 74(Suppl 5A):15-8. [PubMed 6846377]

111. National Institutes of Health Office of Medical Applications of Research. Consensus conference: lowering blood cholesterol to prevent heart disease. JAMA. 1985; 25:2080-6.

112. Rahimtoola SH. Cholesterol and coronary heart disease: a perspective. JAMA. 1985; 253:2094-5. [PubMed 3974101]

113. The Coronary Drug Project Research Group. Gallbladder disease as a side effect of drugs influencing lipid metabolism: experience in the Coronary Drug Project. N Engl J Med. 1977; 296:1185-90. [IDIS 71278] [PubMed 323705]

114. Glueck CJ. Nonpharmacologic and pharmacologic alteration of high-density lipoprotein cholesterol: therapeutic approaches to prevention of atherosclerosis. Am Heart J. 1985; 110:1107-15. [IDIS 208439] [PubMed 2865887]

115. The Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA. 1975; 231:360-81. [IDIS 49334] [PubMed 1088963]

116. Canner PL. Mortality in Coronary Drug Project patients during a nine-year post-treatment period. J Am Coll Cardiol. 1985; 5:442.

117. Knopp RH, Ginsberg J, Albers JJ et al. Contrasting effects of unmodified and time-release forms of niacin on lipoproteins in hyperlipidemic subjects: clues to mechanism of action of niacin. Metab Clin Exp. 1985; 34:642-50. [PubMed 3925290]

118. Hoeg JM, Gregg RE, Brewer HB. An approach to the management of hyperlipoproteinemia. JAMA. 1986; 255:512-21. [IDIS 209539] [PubMed 3510334]

119. Hoeg JM, Maher MB, Bou E et al. Normalization of plasma lipoprotein concentrations in patients with type II hyperlipoproteinemia by combined use of neomycin. Circulation. 1984; 70:1004-11. [IDIS 193212] [Pu