Hyoscyamine Sulfate Elixir

Dosage Form: oral liquid
Hyoscyamine Sulfate Elixir, 0.125mg/5mL

Rx Only

Hyoscyamine Sulfate Elixir Description

Hyoscyamine Elixir (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 4% v/v alcohol for oral administration.

Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2 • H2SO4 • 2H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:

Hyoscyamine Elixir also contain as inactive ingredients: Alcohol, FD&C red #40, FD&C yellow #6, flavor, glycerin, purified water, benzoic acid, sodium citrate, sorbitol solution, and sucrose.

Hyoscyamine Sulfate Elixir - Clinical Pharmacology

Hyoscyamine Sulfate inhibits the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion.

Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions.

Hyoscyamine sulfate is absorbed totally and completely by oral administration. Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body. The half-life of hyoscyamine sulfate is 2 to 3 1/2 hours. Hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. Only traces of this drug are found in breast milk.

Hyoscyamine sulfate passes the blood brain barrier and the placental barrier.

Indications and Usage for Hyoscyamine Sulfate Elixir

Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a "drying agent" in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.

Contraindications

Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

Warnings

In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, Hyoscyamine sulfate may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.

Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.

Precautions

General

Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.

Information for Patients

Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution.

Drug Interactions

Pregnancy Category C

Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine crosses the placenta. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers

This product is excreted in human milk. This product should not be administered to a nursing mother.

Pediatric Use

This product is not recommended for use in children under six years of age. Young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of these medications' suppression of sweat gland activity.

A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of hyoscyamine sulfate; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem.

Geriatric Use

Reported clinical experience has not identified differences in safety between patients aged 65 and over 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.

This drug 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.

Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.

Antacids may interfere with the absorption of hyoscyamine sulfate. Administer Hyoscyamine Sulfate Fast Dissolving Tablets before meals; antacids after meals.

Adverse Reactions

All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.

Overdosage

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation.

Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.

Hyoscyamine Sulfate Elixir Dosage and Administration

Adults and pediatric patients 12 years of age and older

1 to 2 teaspoonfuls every four hours or as directed by health care provider. Do not exceed 12 teaspoonfuls in 24 hours.

Pediatric patients 2 to 12 years of age

1/4 to1 teaspoonful every four hours or as directed by health care provider. Do not exceed 6 teaspoonfuls in 24 hours.

The doses may be repeated every four hours or as needed. Dosage may be adjusted according to the severity of symptoms or as directed by a health care provider. Measure dosage very carefully.

How is Hyoscyamine Sulfate Elixir Supplied

Hyoscyamine Elixir (Hyoscyamine Sulfate 0.125 mg per 5 mL) is orange colored, orange flavored, and contains 4% alcohol. It is supplied in pint (473 ml) bottle.

NDC# 39328-048-16

Store at controlled room temperature 20°-25°C (68°-77°F); excursion permitted to 15°-30°C (59°-86°F). Please refer to current USP.

KEEP OUT OF REACH OF CHILDREN

Also, available as Hyoscyamine Drops as NDC# 39328-047-15

Manufactured for:

Patrin Pharma

P.O. Box 1481;

Skokie, Illinois 60076-1481;

U.S.A.

For inquiries call toll free 800-936-3088

Also available as: Hyoscyamine Oral Drops (Hyoscyamine Sulfate 0.125 mg per ml) supplied in a 15 ml bottle with a calibrated dropper; NDC# 39328-047-15

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 39328-048-16

HYOSCYAMINE

ELIXIR

Hyoscyamine Sulfate Elixir

0.125 mg per 5 mL

Each teaspoonful (5 mL)contains:

Hyoscyamine Sulfate 0.125 mg.

Contains Alcohol 4% V/V

Rx only

473 mL (1 Pint)

PATRIN PHARMA

HYOSCYAMINE  hyoscyamine sulfate  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 39328-048 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hyoscyamine Sulfate (Hyoscyamine) Hyoscyamine Sulfate 0.125 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength Glycerin   Sucrose   Sorbitol   Sodium Citrate   Orange   FD&C Red no. 40   Water   Benzoic Acid   Alcohol   FD&C Yellow no. 6   Sodium Benzoate

Product Characteristics Color ORANGE Score      Shape Size Flavor ORANGE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 39328-048-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		09/04/2011

Labeler - Patrin Pharma (806841677)

Revised: 10/2011Patrin Pharma

More Hyoscyamine Sulfate Elixir resources

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

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Zerit

Generic Name: stavudine (Oral route)

STAV-ue-deen

Oral route(Capsule;Powder for Solution)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk. Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine .

Commonly used brand name(s)

In the U.S.

• Zerit

In Canada

• Zerit Pediatrics

Available Dosage Forms:

• Capsule


• Powder for Suspension


• Powder for Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Zerit

Stavudine is used in combination with other anti-virus medicines for the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Stavudine will not cure or prevent HIV infection or AIDS. It helps to keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease.

Stavudine will not keep you or your child from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.

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

Before Using Zerit

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 stavudine in children.

Geriatric

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

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.

• Didanosine


• Doxorubicin Hydrochloride


• Hydroxyurea


• Ribavirin


• Zidovudine

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.

• Methadone

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:

• Alcohol abuse, active or history of, or


• Gallstones, active or history of, or


• Liver disease (includes hepatitis) or


• Obesity (being overweight) or


• Pancreatitis (inflammation of the pancreas), history of or


• Peripheral neuropathy (nerve disorder), history of or


• Use of other HIV medicines for a long period of time—May cause side effects to become worse.

• Diabetes—The oral liquid contains sucrose (sugar), which can make this condition worse.

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

Proper Use of stavudine

This section provides information on the proper use of a number of products that contain stavudine. It may not be specific to Zerit. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking first with your doctor.

Keep taking stavudine for the full time of treatment , even if you begin to feel better. Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor.

The capsule should be swallowed whole. Do not chew, crush or dissolve.

You may take this medicine with or without food.

Shake the oral liquid before use. Use a specially marked measuring cup or other device to measure each dose accurately.

This medicine comes with a Medication Guide and patient information leaflet. Read and follow the instructions in the guide or leaflet carefully. Talk to your doctor if you have any questions.

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 forms (capsules or oral solution):
  
  • For treatment of HIV infection:
    
    • Adults and teenagers weighing 60 kilograms (kg) or more—40 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
    
    
    • Adults and teenagers weighing up to 60 kg—30 mg every 12 hours. Your doctor may adjust your dose if needed.
    
    
    • Children weighing 30 kg or more—30 mg every 12 hours.
    
    
    • Infants and children at least 14 days old and weighing less than 30 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 milligram (mg) per kilogram (kg) of body weight every 12 hours.
    
    
    • Infants from birth to 13 days old—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.5 milligram (mg) per kilogram (kg) of body weight every 12 hours.
    
    
  
  

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.

Store the oral liquid in the refrigerator. Throw away any unused medicine after 30 days, but do not throw it in the trash. Flush it down the toilet or take it to a community take-back program when available.

Ask your doctor how to dispose of any capsules you do not use.

Precautions While Using Zerit

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

Do not take any other medicines without checking first with your doctor. To do so may increase the chance of side effects from stavudine.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your doctor.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Stop taking the medicine and call your doctor right away if you or your child have more than one of these symptoms: abdominal discomfort or cramping; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.

Stop using this medicine and check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

When you or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (e.g., pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

Avoid drinking alcohol or alcoholic beverages while taking this medicine.

Zerit 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

• Burning, numbness, tingling, or painful sensations


• chills with fever


• tingling, burning, numbness, or pain in the hands or feet


• unsteadiness or awkwardness


• weakness in the arms, hands, legs, or feet

Less common

• Cough


• difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


• joint pain


• muscle pain


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Rare

• Nausea and vomiting


• stomach pain (severe)

Incidence not known

• Abdominal or stomach discomfort or pain


• black, tarry stools


• bleeding gums


• bloating


• blood in the urine or stools


• blurred vision


• chest pain


• constipation


• darkened urine


• decreased appetite


• diarrhea


• difficulty with moving


• dry mouth


• fast, shallow breathing


• fever


• flushed, dry skin


• fruit-like breath odor


• general feeling of discomfort


• general tiredness and weakness


• increased hunger


• increased thirst


• increased urination


• indigestion


• light-colored stools


• loss of appetite


• loss of consciousness


• muscle cramping, pains, or stiffness


• painful or difficult urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red spots on the skin


• shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination


• sleepiness


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sweating


• swollen glands


• swollen joints


• troubled breathing


• troubled breathing with exertion


• unexplained weight loss


• unusual bleeding or bruising


• yellow eyes or skin

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

• Headache


• loss of appetite


• weight loss

Less common

• Difficulty with sleeping


• lack of strength or energy


• stomach pain (mild)

Incidence not known

• Gaining weight around your neck, upper back, breast, face, or waist


• sleeplessness


• unable to sleep

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: Zerit 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 Zerit resources

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

• Zerit Prescribing Information (FDA)


• Zerit Consumer Overview


• Zerit Monograph (AHFS DI)


• Zerit MedFacts Consumer Leaflet (Wolters Kluwer)


• Stavudine Professional Patient Advice (Wolters Kluwer)

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Viramune 200mg tablets

Viramune 200 mg tablets

nevirapine

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

• Keep this leaflet. You may need to read it again.


• If you have further questions, please ask your doctor or pharmacist.


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


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

In this leaflet:

• 1. What VIRAMUNE is and what it is used for


• 2. Before you take VIRAMUNE


• 3. How to take VIRAMUNE


• 4. Possible side effects


• 5. How to store VIRAMUNE


• 6. Further information

What Viramune Is And What It Is Used For

VIRAMUNE belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection.

The active ingredient of your medicine is called nevirapine. The active ingredient is the substance in this medicine that reduces the amount of viruses in the blood thus improving your medical condition.

Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working. By stopping reverse transcriptase from working, VIRAMUNE helps control HIV-1 infection.

You must take VIRAMUNE together with other antiretroviral medicines. Your doctor will recommend the best medicines for you.

Before You Take Viramune

Do not take VIRAMUNE

• if you are allergic (hypersensitive) to nevirapine or any of the other ingredients of VIRAMUNE. See Section 6 of this leaflet for a list of other ingredients (“What VIRAMUNE contains”).


• if you have taken VIRAMUNE before and had to stop the treatment because you suffered from:
  
  
  • severe skin rash
  • skin rash with other symptoms for example:
    
    
    • fever
    • blistering
    • mouth sores
    • inflammation of the eye
    • swelling of the face
    • general swelling
    • shortness of breath
    • muscle or joint pain
    • general feelings of illness
    • abdominal pain
  • hypersensitivity (allergic) reactions
  • inflammation of the liver (hepatitis)


• if you have severe liver disease


• if you have had to stop VIRAMUNE treatment in the past because of changes in your liver function


• if you are taking a medicine containing the herbal substance St John’s Wort (Hypericum perforatum). This herbal substance may stop VIRAMUNE from working properly.

Take special care with VIRAMUNE

During the first 18 weeks of treatment with VIRAMUNE it is very important that you and your doctor watch out for signs of liver or skin reactions. These can become severe and even life threatening. You are at greatest risk of such a reaction during the first 6 weeks of treatment.

If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other side effects such as

• 
  fever,
  


• 
  blistering,
  


• 
  mouth sores,
  


• 
  inflammation of the eye,
  


• 
  swelling of the face,
  


• 
  general swelling,
  


• 
  shortness of breath,
  


• 
  muscle or joint pain,
  


• 
  general feelings of illness,
  


• 
  or abdominal pain
  

YOU SHOULD DISCONTINUE TAKING VIRAMUNE AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death.

If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking VIRAMUNE.

If you experience symptoms suggesting damage of the liver, such as

• 
  loss of appetite,
  


• 
  feeling sick (nausea),
  


• 
  vomiting,
  


• 
  yellow skin (jaundice),
  


• 
  abdominal pain
  

you should discontinue taking VIRAMUNE and must contact your doctor immediately.

If you develop severe liver, skin or hypersensitivity reactions whilst taking VIRAMUNE, NEVER TAKE VIRAMUNE again without referring to your doctor. You must take the dosage of Viramune as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information in “How to take VIRAMUNE”).

The following patients are at increased risk of developing liver problems:

• women


• infected with hepatitis B or C


• abnormal liver function tests


• higher CD4 cell counts at the start of Viramune therapy (women more than 250 cells per cubic millimetre, men more than 400 cells per cubic millimetre)

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Changes of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat (see section 4 “POSSIBLE SIDE EFFECTS”).

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system and higher body mass index may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

VIRAMUNE is not a cure for HIV infection. Therefore, you may continue to develop infections and other illnesses associated with HIV infection. You should therefore remain in regular contact with your doctor. In addition, VIRAMUNE does not prevent the risk of passing on HIV to others through blood or sexual contact. Use appropriate precautions to prevent passing on HIV to other people. Please refer to your doctor.

Use in children

VIRAMUNE tablets can be taken by:

• children 16 years of age or older


• children under 16 years of age who:
  
  
  • weigh 50 kg or more
  • or have a body surface area above 1.25 square meters.

For smaller children an oral suspension liquid form is available.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Inform your doctor about all other medicines you are taking before you start taking VIRAMUNE. Your doctor might need to monitor whether your other medicines are still working and adjust doses. Carefully read the package leaflet of all other HIV medicinal products you are taking in combination with VIRAMUNE.

It is particularly important that you tell your doctor if you are taking or have recently taken:

• St John’s Wort (Hypericum perforatum, medicine to treat depression)


• rifampicin (medicine to treat tuberculosis)


• rifabutin (medicine to treat tuberculosis)


• macrolides e.g. clarithromycin (medicine to treat bacterial infections)


• fluconazole (medicine to treat fungal infections)


• ketoconazole (medicine to treat fungal infections)


• itraconazole (medicine to treat fungal infections)


• methadone (medicine used for treatment of opiate addicts)


• warfarin (medicine to reduce blood clotting)


• hormonal contraceptives (e.g. the “pill”)


• atazanavir (another medicine to treat HIV-infection)


• lopinavir/ritonavir (another medicine to treat HIV-infection)


• fosamprenavir (another medicine to treat HIV-infection)


• efavirenz (another medicine to treat HIV-infection)

Your doctor will carefully monitor the effect of VIRAMUNE and any of these medicines if you are taking them together.

If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of VIRAMUNE. This is because VIRAMUNE can be partly washed out of your blood by dialysis.

Taking VIRAMUNE with food and drink

There are no restrictions on taking VIRAMUNE with food and drink.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should stop breast-feeding if you are taking VIRAMUNE. It is in general recommended that you do not breast-feed if you have HIV infection because it is possible that your baby can become infected with HIV through your breast milk.

Driving and using machines

There are no specific studies on the ability to drive vehicles and use machinery. If you feel that your ability to drive or use machines may be affected you should not drive or use machines.

Important information about some of the ingredients of VIRAMUNE

VIRAMUNE tablet contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking VIRAMUNE.

How To Take Viramune

You should not use VIRAMUNE on its own. You must take it with at least two other antiretroviral medicines.

Your doctor will recommend the best medicines for you.

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

Only take VIRAMUNE tablets by mouth. Do not chew your tablets. You may take VIRAMUNE with or without food.

Dosage:

The dose is one 200 mg tablet per day for the first 14 days of treatment (“lead-in” period). After 14 days, the usual dose is one 200 mg tablet twice a day.

It is very important that you take only one VIRAMUNE tablet a day for the first 14 days (“lead-in” period). If you have any rash during this period, do not increase the dose but consult your doctor.

The 14-day ”lead-in” period has been shown to lower the risk of skin rash.

As VIRAMUNE must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully. These are supplied in the package leaflets for those medicines.

VIRAMUNE is also available in liquid form as an oral suspension. This is particularly suitable if:

• you have problems swallowing tablets


• or you are a child weighing less than 50 kg


• or you are a child having a body surface area less than 1.25 square metres (your doctor will work out your surface area).

You should continue to take VIRAMUNE for as long as instructed by your doctor.

As explained in ‘Take special care with VIRAMUNE’, above, your doctor will monitor you with liver tests or for undesirable effects such as rash. Depending on the outcome your doctor may decide to interrupt or stop your VIRAMUNE treatment. Your doctor might then decide to restart you on a lower dose.

If you take more VIRAMUNE than you should

Do not take more VIRAMUNE than prescribed by your doctor and described in this leaflet. There is at present little information on the effects of VIRAMUNE overdose. Consult your doctor if you have taken more VIRAMUNE than you should.

If you forget to take VIRAMUNE

Try not to miss a dose. If you notice that you have missed a dose within 8 hours, take the next dose as soon as possible. If you notice it more than 8 hours later, take the next dose at the usual time.

If you stop taking VIRAMUNE

Taking all doses at the appropriate times:

• greatly increases the effectiveness of your combination antiretroviral medicines


• reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines.

It is important that you continue taking VIRAMUNE correctly, as described above, unless your doctor instructs you to stop.

If you stop taking VIRAMUNE for more than 7 days your doctor will instruct you to start the 14 day ‘lead-in’ period (described above) once again, before returning to the twice daily dose.

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

Possible Side Effects

Like all medicines, VIRAMUNE can cause side effects, although not everybody gets them.

As mentioned in ‘Take special care with VIRAMUNE’, above, the most important side effects of VIRAMUNE are severe and life threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with VIRAMUNE. This is therefore an important period which requires close monitoring by your doctor.

If you ever observe any rash symptoms, inform your doctor immediately.

When rash occurs it is normally mild to moderate. However, in some patients a rash, which appears as a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded. Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment.

If rash occurs and you also feel sick, you must stop treatment and visit your doctor immediately.

Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:

• rash


• swelling of the face


• difficulty breathing (bronchial spasm)


• anaphylactic shock

Hypersensitivity reactions can also occur as rash with other side effects such as:

• fever


• blistering of your skin


• mouth sores


• inflammation of the eye


• swelling of the face


• general swelling


• shortness of breath


• muscle or joint pain


• a reduction in the numbers of your white blood cells (granulocytopenia)


• general feelings of illness


• severe problems with liver or kidneys (liver or kidney failure).

Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction. Such reactions can be life-threatening.

Abnormal liver functioning has been reported with the use of VIRAMUNE. This includes some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver failure, which can be both fatal.

Tell your doctor if you experience any of the following clinical symptoms of liver damage:

• loss of appetite


• feeling sick (nausea)


• vomiting


• yellow skin (jaundice)


• abdominal pain

Evaluation of the side effects is based on the following frequencies:

Very common: in at least 1 out of 10 patients treated

Common: in at least 1 out of 100 and less than 1 out 10 patients treated

Uncommon: in at least 1 out of 1000 and less than 1 out 100 patients treated

Rare: in at least 1 out of 10,000 and less than 1 out 1000 patients treated

The side effects described below have been experienced by patients given VIRAMUNE:

Very common:

• rash

Common:

• decreased numbers of white blood cells (granulocytopenia)


• allergic reactions (hypersensitivity)


• headache


• feeling sick (nausea)


• vomiting


• abdominal pain


• loose stools (diarrhoea)


• inflammation of the liver (hepatitis)


• muscle pain (myalgia)


• feeling tired (fatigue)


• fever


• abnormal liver function tests

Uncommon:

• decreased numbers of red blood cells (anaemia)


• yellow skin (jaundice)


• severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis)


• hives (urticaria)


• fluid under the skin (angioneurotic oedema)


• joint pain (arthralgia)

Rare:

• sudden and intense inflammation of the liver (fulminant hepatitis)

Not Known:

• drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms)


• allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock

Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not known at this time. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

The following events have also been reported when VIRAMUNE has been used in combination with other antiretroviral agents:

• decreased numbers of red blood cells or platelets


• inflammation of the pancreas


• decrease in or abnormal skin sensations

These events are commonly associated with other antiretroviral agents and may be expected to occur when VIRAMUNE is used in combination with other agents; however, it is unlikely that these events are due to treatment with VIRAMUNE.

Use in children

A reduction in white blood cells (granulocytopenia) can occur, which is more common in children. A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children. As with rash symptoms, please inform your doctor of any side effects.

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

How To Store Viramune

Keep out of the reach and sight of children.

Do not use VIRAMUNE after the expiry date which is stated on the carton and on the blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

Further Information

What VIRAMUNE contains

• The active substance is nevirapine. Each tablet contains 200 mg nevirapine.


• The other ingredients are:
  
  
  • microcrystalline cellulose
  • lactose monohydrate
  • povidone K25
  • sodium starch glycolate
  • colloidal silicon dioxide
  • magnesium stearate

What VIRAMUNE looks like and contents of pack

White, oval, biconvex tablets. One side is marked with the code “54 193”. The opposite side is marked with the company symbol.

VIRAMUNE tablets are supplied in blisters, with 14, 60 or 120 tablets per carton. Not all pack sizes may be marketed.

VIRAMUNE is also available as an oral suspension.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

or

Boehringer Ingelheim Ellas A.E.

5th km Paiania-Markopoulo

194 00 Koropi

Greece

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom

Boehringer Ingelheim Ltd.

Tel:+44 1344 424 600

This leaflet was last approved in 05/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu

3874/GB/IE/MT/8

PediaHist DM Drops

Pronunciation: SOO-doe-e-FED-rin/BROME-fen-IR-a-meen/DEX-troe-meth-OR-fan
Generic Name: Pseudoephedrine/Brompheniramine/Dextromethorphan
Brand Name: Resperal-DM Drops

PediaHist DM Drops are 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.

PediaHist DM Drops are a decongestant, antihistamine, and cough suppressant combination. It 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, while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use PediaHist DM Drops if:

• you are allergic to any ingredient in PediaHist DM Drops


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


• you have narrow-angle glaucoma, ulcers, severe lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD)


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


• you take sodium oxybate (GHB) or if 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 PediaHist DM Drops:

Some medical conditions may interact with PediaHist DM Drops. 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


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


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

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

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attacks may be increased


• Furazolidone, linezolid, or MAOIs (eg, phenelzine) because severe high blood pressure and fever may occur


• Barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, MAOIs (eg, phenelzine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, potassium citrate) because they may increase the risk of PediaHist DM Drops's side effects, including severe drowsiness and trouble breathing


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by PediaHist DM Drops


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by PediaHist DM Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if PediaHist DM Drops 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 PediaHist DM Drops:

Use PediaHist DM Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take PediaHist DM Drops by mouth with or without food.


• Use the dropper that comes with PediaHist DM Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of PediaHist DM Drops, 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 PediaHist DM Drops.

Important safety information:

• PediaHist DM Drops may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use PediaHist DM Drops 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 are taking PediaHist DM Drops without checking with your doctor.


• PediaHist DM Drops has pseudoephedrine, dextromethorphan, and brompheniramine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine, dextromethorphan, or brompheniramine 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.


• If you are scheduled for allergy skin testing, do not take PediaHist DM Drops for several days before the test because it may decrease your response to the skin tests.


• Tell your doctor or dentist that you take PediaHist DM Drops before you receive any medical or dental care, emergency care, or surgery.


• Use PediaHist DM Drops with caution in CHILDREN and in the ELDERLY; 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 PediaHist DM Drops while you are pregnant. It is not known if PediaHist DM Drops are found in breast milk. Do not breast-feed while taking PediaHist DM Drops.

Possible side effects of PediaHist DM Drops:

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; 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: PediaHist DM 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 PediaHist DM Drops:

Store PediaHist DM Drops 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 PediaHist DM Drops out of the reach of children and away from pets.

General information:

• If you have any questions about PediaHist DM Drops, please talk with your doctor, pharmacist, or other health care provider.


• PediaHist DM Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about PediaHist DM Drops. 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 PediaHist DM resources

• PediaHist DM Side Effects (in more detail)
• PediaHist DM Use in Pregnancy & Breastfeeding
• PediaHist DM Drug Interactions
• PediaHist DM Support Group
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Polycitra-K

Generic Name: citric acid and potassium citrate (SIT rik AS id and poe TASS ee um SIT rayt)

Brand Names: Cytra-K, Poly-Citra K Crystals, Polycitra-K

What is Polycitra-K (citric acid and potassium citrate)?

Citric acid is an alkalinizing agent that make the urine less acidic.

Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

The combination of citric acid and potassium citrate is used to treat or prevent hypokalemia (low levels of potassium in the blood). Citric acid and potassium citrate is also used to treat digitalis overdose.

Citric acid and potassium citrate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Polycitra-K (citric acid and potassium citrate)?

You should not use this medication if you have kidney failure, a urinary tract infection, uncontrolled diabetes, a peptic ulcer in your stomach, Addison's disease, severe burns or other tissue injury, if you are dehydrated, if you take certain diuretics (water pills), or if you have high levels of potassium in your blood (hyperkalemia).

You should not take citric acid and potassium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.

Avoid lying down for at least 30 minutes after you take this medication.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.

Serious side effects of citric acid and potassium citrate include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or around your mouth.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse.

What should I discuss with my healthcare provider before taking Polycitra-K (citric acid and potassium citrate)?

You should not use this medication if you are allergic to it, or if you have certain conditions. Be sure your doctor knows if you have:

• 
  

  high levels of potassium in your blood (hyperkalemia);

  
  


• 
  

  a serious heart rhythm disorder called ventricular fibrillation;

  
  


• 
  

  kidney failure with sodium loss;

  
  


• 
  

  Addison's disease (an adrenal gland disorder);

  
  


• 
  

  a large tissue injury such as a severe burn; or

  
  


• 
  

  if you are severely dehydrated.

  
  

You should not take citric acid and potassium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.

Before using citric acid and potassium citrate, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;


• 
  

  if you are taking a "potassium-sparing" diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide).

  
  


• 
  

  a urinary tract infection;

  
  


• 
  

  untreated or uncontrolled diabetes;

  
  


• 
  

  a peptic ulcer in your stomach;

  
  


• 
  

  congestive heart failure, enlarged heart, or history of heart attack;

  
  


• 
  

  other heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a blockage in your stomach or intestines; or

  
  


• 
  

  chronic diarrhea (such as ulcerative colitis, Crohn's disease).

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take citric acid and potassium citrate.

It is not known whether this medication is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether potassium 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.

How should I take Polycitra-K (citric acid and potassium citrate)?

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

Measure the 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.

The liquid form of this medication should be mixed with at least 8 ounces (one cup) of cold water or fruit juice. Drink the mixture slowly, over 5 to 10 minutes in all. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Citric acid and potassium citrate is usually taken 3 times daily after meals. Follow your doctor's instructions.

Avoid lying down for at least 30 minutes after you take this medication. Your treatment may 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 or avoid to help control your condition.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse. Store citric acid and potassium citrate at room temperature away from moisture, heat, or freezing. Keep the medication in a closed container.

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, wait until then to take the medicine and skip the missed dose. 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.

Overdose symptoms may include numbness and tingling, confusion, heavy feeling in your arms or legs, muscle weakness, limp feeling, slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking Polycitra-K (citric acid and potassium citrate)?

Avoid taking potassium supplements or using other foods or products that contain potassium without first asking your doctor. Salt substitutes or low-salt dietary products often contain potassium. If you take certain products together you may accidentally get too much potassium. Read the label of any other medicine you are using to see if it contains potassium.

You may also need to avoid eating potassium-rich foods while you are taking this medication. Foods that are high in potassium include many green leafy vegetables, squash, yams, beets, avocado, lima beans, kidney beans, pinto beans, lentils, split peas, soybeans, papaya, figs, prunes, and fish such as halibut, cod, snapper, and tuna.

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 must avoid to help control your condition.

Polycitra-K (citric acid and potassium citrate) 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. Call your doctor at once if you have any of these serious side effects:

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  severe stomach pain, ongoing diarrhea or vomiting;

  
  


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  black, bloody, or tarry stools;

  
  


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  coughing up blood;

  
  


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  fast, slow, or uneven heart rate;

  
  


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  muscle weakness, pain, or twitching;

  
  


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  numbness or tingly feeling in your hands or feet, or around your mouth;

  
  


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  confusion, anxiety, weakness, mood changes, or feeling irritable;

  
  


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  swelling in your ankles or feet; or

  
  


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  seizure (convulsions).

  
  

Less serious side effects may include:

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  mild nausea, vomiting, or upset stomach;

  
  


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  mild or occasional diarrhea; or

  
  


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  appearance of a citric acid and potassium citrate tablet in your stool.

  
  

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 Polycitra-K (citric acid and potassium citrate)?

The following drugs can interact with citric acid and potassium citrate. Tell your doctor if you are using any of these:

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  eplerenone (Inspra);

  
  


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  candesartan (Atacand), losartan (Cozaar, Hyzaar), valsartan (Diovan), or telmisartan (Micardis);

  
  


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  quinidine (Quinaglute, Quinidex, Quin-Release);

  
  


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  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or

  
  


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  any type of diuretic (water pill) such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), or torsemide (Demadex).

  
  

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

More Polycitra-K resources

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

• Polycitra-K Advanced Consumer (Micromedex) - Includes Dosage Information


• Polycitra-K Powder Pack MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Polycitra-K with other medications

• Urinary Alkalinization
• Urinary Tract Stones

Where can I get more information?

• Your pharmacist can provide more information about citric acid and potassium citrate.

See also: Polycitra-K side effects (in more detail)

Comvax

Generic Name: haemophilus b and hepatitis B vaccine (hem OFF il us B and HEP a TYE tis)

Brand Names: Comvax

What is Comvax (haemophilus b and hepatitis B vaccine)?

Haemophilus B is a type of influenza (flu) caused by bacteria.

Haemophilus B bacteria can infect the lungs or throat, and can also spread to the blood, bones, joints, brain, or spinal cord. It can cause breathing problems or meningitis, and these infections can be fatal.

Hepatitis B is a serious disease caused by virus.

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The haemophilus B and hepatitis B vaccine is used to help prevent these diseases in children.

This vaccine works by exposing your child to a small dose of the bacteria or virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Haemophilus B and hepatitis B vaccine is for use in children between the ages of 6 weeks and 15 months old.

Like any vaccine, the haemophilus B and hepatitis B vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

The haemophilus B and hepatitis B vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. Booster shots may be given at 4 months and 12 to 15 month of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with haemophilus B or hepatitis A is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

A hepatitis B vaccine will not protect you against infection with hepatitis A, C, and E, or other viruses that affect the liver. It may also not protect you from hepatitis B if you are already infected with the virus, even if you do not yet show symptoms.

Your child should not receive this vaccine if the child is allergic to baker's yeast, or if he or she has ever had a life-threatening allergic reaction to any vaccine containing haemophilus B or hepatitis B. Your child should also not receive this vaccine if the child has received cancer chemotherapy or radiation treatment in the past 3 months.

Before receiving this vaccine, tell the doctor if your child has:

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  multiple sclerosis;

  
  


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  a bleeding or blood clotting disorder such as hemophilia or easy bruising;

  
  


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  a history of epilepsy or other seizure disorder;

  
  


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  an allergy to latex rubber;

  
  


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  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

  
  


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  if the child is taking a blood thinner such as warfarin (Coumadin).

  
  

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

How is this vaccine given?

This vaccine is given as an injection (shot) into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.

The haemophilus B and hepatitis B vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. Booster shots may also be given at 4 months and 12 to 15 month of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

What happens if I a dose is missed?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

What happens if there is an overdose?

An overdose of this vaccine is unlikely to occur.

What should be avoided before or after receiving this vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after your child receives this vaccine.

This vaccine side effects

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with haemophilus B or hepatitis A is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of these serious side effects:

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  extreme drowsiness, fainting;

  
  


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  fussiness, irritability, crying for an hour or longer;

  
  


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  seizure (black-out or convulsions); or

  
  


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  high fever.

  
  

Less serious side effects include:

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  redness, pain, tenderness, swelling, or a hard lump where the shot was given;

  
  


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  diarrhea, loss of appetite, mild vomiting;

  
  


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  mild fussiness or crying;

  
  


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  joint pain, body aches; or

  
  


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  mild fever.

  
  

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 Comvax (haemophilus b and hepatitis B vaccine)?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

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  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


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  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


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  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

If your child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and there may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.

More Comvax resources

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

• Comvax Advanced Consumer (Micromedex) - Includes Dosage Information


• Comvax Vaccine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Comvax with other medications

• Haemophilus influenzae Prophylaxis
• Hepatitis B Prevention

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

See also: Comvax side effects (in more detail)