Avanafil 100 mg/1
Avanafil · TABLET · Camber Pharmaceuticals, Inc.
Avanafil is a tablet containing avanafil at 100 mg/1, taken oral. Manufactured by Camber Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Avanafil
- Generic Name
- Avanafil
- NDC Code (Product)
31722-441- Manufacturer
- Camber Pharmaceuticals, Inc.
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209266
- Drug Class
- Phosphodiesterase 5 Inhibitor [EPC]
- Marketing Start
- 06/14/2024
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males. Avanafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • The starting dose is 100 mg taken as early as approximately 15 minutes before sexual activity, on an as needed basis ( 2.1 ) • Take avanafil tablet no more than once a day ( 2.1 ). • Based on efficacy and/or tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity or decreased to 50 mg taken approximately 30 minutes before sexual activity. Use the lowest dose that provides benefit ( 2.1 ). • Avanafil tablet may be taken with or without food ( 2.2 ) • Do not use avanafil tablet with strong CYP3A4 inhibitors ( 2.3 ) • If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period ( 2.3 ). • In patients on stable alpha-blocker therapy, the recommended starting dose of avanafil tablet is 50 mg ( 2.3 ). 2.1 Erectile Dysfunction The recommended starting dose is 100 mg. Avanafil tablets should be taken orally as needed as early as approximately 15 minutes before sexual activity. Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken approximately …
Contraindications
4 CONTRAINDICATIONS • Administration of avanafil tablet to patients using any form of organic nitrate is contraindicated ( 4.1 ) • Hypersensitivity to any component of the avanafil tablet ( 4.2 ) • Administration with guanylate cyclase (GC) stimulators such as riociguat and vericiguat ( 4.3 ) 4.1 Nitrates Administration of avanafil tablets with any form of organic nitrates, either regularly and/or intermittently, is contraindicated. Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, avanafil has been shown to potentiate the hypotensive effects of nitrates. In a patient who has taken avanafil tablets, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 12 hours should elapse after the last dose of avanafil tablets before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications ( 4.1 ), Dosage and Administration ( 2.3 ), and Clinical Pharmacology ( 12.2 )]. 4.2 Hypersensitivity Reactions Avanafil is contraindicated in patients with a known hypersensitiv…
Drug Interactions
7 DRUG INTERACTIONS • Avanafil can potentiate the hypotensive effect of nitrates, alpha-blockers, antihypertensives, and alcohol ( 7.1 ) • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure ( 7.2 ) 7.1 Potential for Pharmacodynamic Interactions with Avanafil Nitrates Administration of avanafil to patients who are using any form of organic nitrate, is contraindicated. In a clinical pharmacology trial, avanafil was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken avanafil, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 12 hours should elapse after the last dose of avanafil before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications ( 4.1 ), Dosage and Administration ( 2.3 ), and Clinical Pharmacology ( 12.2 )]. Alpha-Blockers Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including avanafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure-l…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Avanafil was administered to 2215 men during clinical trials. In trials of avanafil for use as needed, a total of 493 patients were exposed for greater than or equal to 6 months, and 153 patients were treated for greater than or equal to 12 months. In three randomized, double-blind, placebo-controlled trials lasting up to 3 months in duration, the mean age of patients was 56.4 years (range from 23 to 88 years). 83.9% of patients were White, 13.8% were Black, 1.4% Asian, and <1% Hispanic. 41.1% were current or previous smokers. 30.6% had diabetes mellitus. The discontinuation rate due to adverse rea…
Frequently Asked Questions
What is Avanafil used for?
Avanafil contains Avanafil. It is a tablet taken oral. Consult your doctor for specific uses.
Is Avanafil a controlled substance?
Avanafil is not classified as a controlled substance by the DEA.
What is the generic name for Avanafil?
The generic name for Avanafil is Avanafil. There are no other listed brand versions of Avanafil.
What is the NDC code for Avanafil 100 mg/1?
The NDC (National Drug Code) for Avanafil 100 mg/1 is 31722-441, listed by Camber Pharmaceuticals, Inc..
Other Avanafil Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)