Stendra
INDICATIONS
STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
DOSAGE AND ADMINISTRATION
Erectile Dysfunction
The recommended starting dose is 100 mg. STENDRA should be taken orally as needed approximately 30 minutes before sexual activity. Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg. The lowest dose that provides benefit should be used. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.
Use with Food
STENDRA may be taken with or without food.
Concomitant Medications
Nitrates
Concomitant use of nitrates in any form is contraindicated [see CONTRAINDICATIONS].
Alpha-Blockers
If STENDRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with STENDRA, and STENDRA should be initiated at the 50 mg dose [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
CYP3A4 Inhibitors
- For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use STENDRA [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
- For patients taking concomitant moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
HOW SUPPLIED
Dosage Forms And Strengths
STENDRA (avanafil) is supplied as oval, pale yellow tablets containing 50 mg, 100 mg, or 200 mg avanafil debossed with dosage strength
Storage And Handling
STENDRA (avanafil) is supplied as oval, pale yellow tablets containing 50 mg, 100 mg, or 200 mg avanafil debossed with dosage strengths.
| 50 mg | 100 mg | 200 mg | |
| Bottle of 30 | NDC 62541-301-30 | NDC 62541-302-30 | NDC 62541-303-30 |
| Bottle of 100 | NDC 62541-301-01 | NDC 62541-302-01 | NDC 62541-303-01 |
Recommended Storage: Store at 20-25°C (68-77°F); excursions permitted to 30°C (86°F) [see USP Controlled Room Temperature].
Protect from light [see USP Controlled Room Temperature].
Manufactured for Vivus, Inc., Mountain View, CA 94040, Manufactured in Osaka Japan. Issued: October/2012
Last reviewed on RxList: 11/19/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Stendra Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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