STAXYN- vardenafil hydrochloride tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VARDENAFIL HYDROCHLORIDE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)

Available from:

GlaxoSmithKline LLC

INN (International Name):

VARDENAFIL HYDROCHLORIDE

Composition:

VARDENAFIL 11.85 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

STAXYN® is indicated for the treatment of erectile dysfunction. Administration of STAXYN with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)] . Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including STAXYN, may potentiate the hypotensive effects of nitrates. A suitable time interval following STAXYN dosing for the safe administration of nitrates or nitric oxide donors has not been determined. Do not use STAXYN in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including STAXYN may potentiate the hypotensive effects of GC stimulators. STAXYN is not indicated for use in females. There are no data with the use of STAXYN in pregnant women to inform any drug-associated risks. In animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of vardenafi

Product summary:

STAXYN (vardenafil HCl) are white, round orally disintegrating tablets with no debossing. STAXYN orally disintegrating tablets are packaged into foil blisterpacks and supplied as a 4 tablet unit. Package Strength NDC Code 1 blister card containing 4 tablets 10 mg 0173-0822-04 In addition to the active ingredient, vardenafil, each tablet contains aspartame, peppermint flavor, magnesium stearate, and Pharmaburst™ B2 (crospovidone, mannitol, silica colloidal hydrated, and sorbitol). Store STAXYN at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. STAXYN is dispensed in blisterpacks. The patient should be advised to examine the blisterpack before use and not use if blisters are torn, broken, or missing.

Authorization status:

New Drug Application

Summary of Product characteristics

STAXYN- VARDENAFIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STAXYN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR STAXYN.
STAXYN (VARDENAFIL HYDROCHLORIDE) ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
ADVERSE REACTIONS REPORTED BY ≥ 2% OF PATIENTS TREATED WITH STAXYN:
HEADACHE, FLUSHING, NASAL CONGESTION,
DYSPEPSIA, DIZZINESS, BACK PAIN. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAYERHEALTHCARE
PHARMACEUTICALS AT 1-888-84-BAYER
(1-888-842-2937) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Warnings and Precautions, Effects on the Eye (5.4) 8/2017
STAXYN is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of erectile dysfunction. (1)
STAXYN is not interchangeable with vardenafil 10 mg film-coated
tablets (LEVITRA). STAXYN provides higher
systemic exposure compared to vardenafil 10 mg film-coated tablets
(LEVITRA). (2.1)
STAXYN is taken as needed, orally, approximately 60 minutes before
sexual activity. (2.1)
The maximum recommended dosing frequency is one tablet per day. (2.1)
STAXYN should be placed on the tongue where it will disintegrate. It
should be taken without liquid. (2.1)
STAXYN may be taken with or without food. (2.2)
STAXYN 10 mg: White, round, orally disintegrating tablets (not scored)
(3)
Administration with nitrates and nitric oxide donors (2.4, 4.1)
Cardiovascular Effects: Patients should not use STAXYN if sex is
inadvisable due to cardiovascular status. (5.1)
Potent and Moderate CYP3A4 Inhibitors: Do not use STAXYN in patients
taking potent or moderate CYP3A4
inhibitors. (5.2, 7.2)
Risk of Priapism: In the event that an erection lasts more than 4
hours, the patient should