Papaverine

Papaverine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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Overview

Papaverine is a phosphodiesterase inhibitor that is FDA approved for the treatment of vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral vascular disease,peripheral and pulmonary embolism. Common adverse reactions include general discomfort, nausea, abdominal discomfort, anorexia, skin rash, malaise, vertigo and headache..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Papaverine is recommended in various conditions accompanied by spasm of smooth muscle, such as vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral vascular disease in which there is a vasospastic element, or certain cerebral angiospastic states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic.
• Dosage

• Papaverine Hydrochloride may be administered intravenously or intramuscularly. The intravenous route is recommended when an immediate effect is desired, but the drug must be injected slowly over the course of 1 or 2 minutes to avoid uncomfortable or alarming side effects.

• Parenteral administration of papaverine hydrochloride in doses of 1 to 4 mL is repeated every 3 hours as indicated. In the treatment of cardiac extrasystoles, 2 doses may be given 10 minutes apart.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Papaverine in adult patients.

Non–Guideline-Supported Use

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• Initial, 30 mg INTRACAVERNOSAL over 1 to 2 min; may increase to 60 mg according to response
• Combination therapy, 30 mg papaverine / 0.5 to 1 mg phentolamine INTRACAVERNOSAL

• Do not use more than 3 times weekly or 2 days in succession

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Papaverine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in children have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Papaverine in pediatric patients.

Non–Guideline-Supported Use

Arterial catheter occlusion; Prophylaxis

• In pediatric patients aged 3 weeks to 18 years

• Infusion of an arterial catheter solution containing papaverine 60 milligrams/500 milliliter (mL), and heparin 1 unit/mL, in normal or half-normal saline when the catheter remained in place for more than 4 days.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Papaverine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Papaverine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Papaverine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Papaverine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Papaverine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Papaverine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Papaverine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Papaverine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Papaverine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Papaverine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Papaverine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Papaverine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Papaverine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Papaverine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Papaverine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Papaverine in the drug label.

Pharmacology

There is limited information regarding Papaverine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Papaverine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Papaverine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Papaverine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Papaverine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Papaverine in the drug label.

How Supplied

Storage

There is limited information regarding Papaverine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Papaverine in the drug label.

Precautions with Alcohol

• Alcohol-Papaverine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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