Papaverine Hydrochloride 30 mg/mL
Papaverine Hydrochloride · INJECTION · Nexus Pharmaceuticals, LLC
Papaverine Hydrochloride is a injection containing papaverine hydrochloride at 30 mg/mL, taken intramuscular. Manufactured by Nexus Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Papaverine Hydrochloride
- Generic Name
- Papaverine Hydrochloride
- NDC Code (Product)
14789-121- Manufacturer
- Nexus Pharmaceuticals, LLC
- Strength
- 30 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Marketing Start
- 06/28/2021
Recall History
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Vitae Enim Vitae Scientific, Inc.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND 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
DOSAGE AND 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.
Contraindications
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
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.
Frequently Asked Questions
What is Papaverine Hydrochloride used for?
Papaverine Hydrochloride contains Papaverine Hydrochloride. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Papaverine Hydrochloride a controlled substance?
Papaverine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Papaverine Hydrochloride?
The generic name for Papaverine Hydrochloride is Papaverine Hydrochloride. There are 1 other brand versions of Papaverine Hydrochloride.
What is the NDC code for Papaverine Hydrochloride 30 mg/mL?
The NDC (National Drug Code) for Papaverine Hydrochloride 30 mg/mL is 14789-121, listed by Nexus Pharmaceuticals, LLC.