Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Papaverine Hydrochloride Injection, USP, 30 mg/mL 72516-024-25 2 mL Vial packaged in boxes of 25 72516-024-10 2 mL Vial packaged in boxes of 10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE. Manufactured for: Oryza Pharmaceuticals Inc. Coral Springs, FL 33065 Revised: January 2021; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72516-024-25 PAPAVERINE HYDROCHLORIDE INJECTION, USP 60 mg/2 mL (30 mg/mL) FOR SINGLE USE ONLY 25 X 2 mL VIALS Rx Only Each mL contains: Papaverine Hydrochloride 30 mg, Edetate Disodium 0.005% and Water for Injection q.s. pH may be adjusted with Sodium Citrate and/or Citric Acid. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT RETAIN IN CARTON UNTIL TIME OF USE. Directions For Use: See Package Insert. Manufactured for: Oryza Pharmaceuticals Inc. Coral Springs, FL 33065 Revised: January 2021 Caton-Pack of 25; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72516-024-10 PAPAVERINE HYDROCHLORIDE INJECTION, USP 60 mg/2 mL (30 mg/mL) FOR SINGLE USE ONLY 10 X 2 mL VIALS Rx Only Each mL contains: Papaverine Hydrochloride 30 mg, Edetate Disodium 0.005% and Water for Injection q.s. pH may be adjusted with Sodium Citrate and/or Citric Acid. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT RETAIN IN CARTON UNTIL TIME OF USE. Directions For Use: See Package Insert. Manufactured for: Oryza Pharmaceuticals Inc. Coral Springs, FL 33065 Revised: January 2021 Carton- Pack of 10
- HOW SUPPLIED Papaverine Hydrochloride Injection, USP, 30 mg/mL 72516-024-25 2 mL Vial packaged in boxes of 25 72516-024-10 2 mL Vial packaged in boxes of 10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE. Manufactured for: Oryza Pharmaceuticals Inc. Coral Springs, FL 33065 Revised: January 2021
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72516-024-25 PAPAVERINE HYDROCHLORIDE INJECTION, USP 60 mg/2 mL (30 mg/mL) FOR SINGLE USE ONLY 25 X 2 mL VIALS Rx Only Each mL contains: Papaverine Hydrochloride 30 mg, Edetate Disodium 0.005% and Water for Injection q.s. pH may be adjusted with Sodium Citrate and/or Citric Acid. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT RETAIN IN CARTON UNTIL TIME OF USE. Directions For Use: See Package Insert. Manufactured for: Oryza Pharmaceuticals Inc. Coral Springs, FL 33065 Revised: January 2021 Caton-Pack of 25
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72516-024-10 PAPAVERINE HYDROCHLORIDE INJECTION, USP 60 mg/2 mL (30 mg/mL) FOR SINGLE USE ONLY 10 X 2 mL VIALS Rx Only Each mL contains: Papaverine Hydrochloride 30 mg, Edetate Disodium 0.005% and Water for Injection q.s. pH may be adjusted with Sodium Citrate and/or Citric Acid. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT RETAIN IN CARTON UNTIL TIME OF USE. Directions For Use: See Package Insert. Manufactured for: Oryza Pharmaceuticals Inc. Coral Springs, FL 33065 Revised: January 2021 Carton- Pack of 10
Overview
Papaverine Hydrochloride, USP, is the hydrochloride of an alkaloid obtained from opium or prepared synthetically. It belongs to the benzylisoquinoline group of alkaloids. It does not contain a phenanthrene group as do morphine and codeine. Papaverine Hydrochloride, USP, is 6,7-dimethoxy-1- veratrylisoquinoline hydrochloride and contains, on the dried basis, not less than 98.5% of C 20 H 21 NO 4 •HCI. The molecular weight is 375.85. The structural formula is as shown. Papaverine Hydrochloride occurs as white crystals or white crystalline powder. One gram dissolves in about 30 mL of water and in 120 mL of alcohol. It is soluble in chloroform and practically insoluble in ether. Papaverine Hydrochloride Injection, USP, is a clear, colorless to pale-yellow solution. Papaverine Hydrochloride, for parenteral administration, is a smooth-muscle relaxant that is available in vials containing 30 mg/mL. Each vial also contains edetate disodium 0.005%. The 10 mL vials also contain chlorobutanol 0.5% as a preservative. pH may be adjusted with sodium citrate and/or citric acid. Structure
Indications & Usage
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 & Administration
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.
Warnings & Precautions
No warnings available yet.
Contraindications
Intravenous injection of papaverine is contraindicated in the presence of complete atrioventricular heart block. When conduction is depressed, the drug may produce transient ectopic rhythms of ventricular origin, either premature beats or paroxysmal tachycardia. Papaverine Hydrochloride is not indicated for the treatment of impotence by intracorporeal injection. The intracorporeal injection of papaverine hydrochloride has been reported to have resulted in persistent priapism requiring medical and surgical intervention.
Adverse Reactions
The following side effects have been reported: general discomfort, nausea, abdominal discomfort, anorexia, constipation or diarrhea, skin rash, malaise, vertigo, headache, intensive flushing of the face, perspiration, increase in the depth of respiration, increase in heart rate, a slight rise in blood pressure, and excessive sedation. Hepatitis, probably related to an immune mechanism, has been reported infrequently. Rarely, this has progressed to cirrhosis. To report SUSPECTED ADVERSE REACTIONS, contact Oryza Pharmaceuticals, Inc. at 1-888-296-9383 (or FDA 1-800-FDA-1088) or www.fda.gov/medwatch.
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