Papaverine hydrochloride, C₂₀H₂₁NO₄•HCl, is a white, crystalline powder, odorless, with a slight bitter taste and is soluble in water.

Each capsule contains: papaverine hydrochloride USP 150 mg.

Chemically, it is Isoquinoline,1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-, hydrochloride. It has a molecular weight of 375.85. It has the following structural formula:

Manufactured in a special base which is designed for prolonged release. Each capsule also contains the following inactive ingredients: FD&C blue No. 1, FD&C red No. 40, gelatin, pharmaceutical glaze, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose and talc.

Last updated on RxList: 3/31/2009

For the relief of cerebral and peripheral ischemia associated with arterial spasm and myocardial ischemia complicated by arrhythmias.

One capsule every 12 hours. In difficult cases administration may be increased to one capsule every 8 hours or two capsules every 12 hours.

Papaverine Hydrochloride Sustained Release Capsules are supplied as: 150 mg brown and clear capsules, imprinted E 5156 and are available in bottles of 100, 500 and 1000.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from moisture.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for: Sandoz Inc. Princeton, NJ 08540. Manufactured by: Epic Pharma, LLC. Laurelton, NY 11413. Rev. 11/08.

Last updated on RxList: 3/31/2009

Although occurring rarely, the reported side effects of papaverine include nausea, abdominal distress, anorexia, constipation, malaise, drowsiness, vertigo, sweating, headache, diarrhea, skin rash, flushing of face, increase in heart rate and depth of respiration and slight increase in blood pressure.

No information provided.

Last updated on RxList: 3/31/2009

No information provided.

Use with caution in patients with glaucoma. Hepatic hypersensitivity has been reported with gastrointestinal symptoms, jaundice, eosinophilia and altered liver function tests. Discontinue drug if these occur.

Last updated on RxList: 3/31/2009

No information provided.

Large doses can depress atrioventricular and intraventricular conduction and thereby produce serious arrhythmias.

Last updated on RxList: 3/31/2009

The main actions of papaverine are exerted on cardiac and smooth muscle. Like quinidine, papaverine acts directly on the heart muscle to depress conduction and prolong the refractory period. Papaverine relaxes various smooth muscles. This relaxation may be prominent if spasm exists. The muscle cell is not paralyzed by papaverine and still responds to drugs and other stimuli causing contraction. The antispasmodic effect is a direct one and unrelated to muscle innervation. Papaverine is practically devoid of effects on the central nervous system.

Papaverine relaxes the smooth musculature of the large blood vessels, especially coronary, systemic peripheral and pulmonary arteries. Perhaps by its direct vasodilating action on cerebral blood vessels, papaverine increases cerebral blood flow and decreases cerebral vascular resistance in normal subjects; oxygen consumption is unaltered. These effects may explain the benefit reported from the drug in cerebral vascular encephalopathy.

The direct actions of papaverine on the heart to depress conduction and irritability and to prolong the refractory period of the myocardium provide the basis for its clinical trial in abrogating atrial and ventricular premature systoles and ominous ventricular arrhythmias. The coronary vasodilator action could be an additional factor of therapeutic value when such rhythms are secondary to insufficiency or occlusion of the coronary arteries.

In patients with acute coronary thrombosis, the occurrence of ventricular cardiac arrhythmias is serious and requires measures designed to decrease myocardial irritability. Papaverine may have advantages over quinidine used for a similar purpose, in that it may be given in an emergency by the intravenous route, does not depress myocardial contraction or cause cinchonism and produces coronary vasodilation.

Last updated on RxList: 3/31/2009

No information provided. Please refer to the PRECAUTIONS sections.

Last updated on RxList: 3/31/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PAPAVERINE - ORAL

(pap-AV-er-een)

COMMON BRAND NAME(S): Pavabid, Vasal

USES: This medication is used to increase blood flow throughout the body, including the heart and the brain. Papaverine is a vasodilator. It works by relaxing the muscles in the blood vessels.

Papaverine is also an antiarrhythmic medication that treats certain abnormal heartbeats (ventricular arrhythmias). It works by blocking the abnormal electrical activity in the heart so a normal heart beat can return. It may also help the heart beat better by increasing the blood flow to the heart.

HOW TO USE: Take this medication by mouth, usually every 8 to 12 hours or as directed by your doctor. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can destroy the long action of the drug and may increase side effects.

Dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Dizziness, drowsiness, warm/red face (flushing), sweating, headache, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. To lower your risk of serious side effects, follow your doctor's directions and keep all medical/lab appointments.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular heartbeat, vision changes (e.g., blurred/double vision).

Papaverine has rarely caused very serious liver disease. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking papaverine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problem (atrioventricular block), Parkinson's disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, irregular heartbeat, liver problems.

This drug may make you dizzy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: levodopa.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: rapid breathing, extreme drowsiness, very fast heartbeat.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.