STAXYN- vardenafil hydrochloride tablet, orally disintegrating

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Physicians Total Care, Inc.

DCI (Dénomination commune internationale):

VARDENAFIL HYDROCHLORIDE

Composition:

VARDENAFIL 10 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. Pregnancy Category B: STAXYN is not indicated for use in women. There are no studies of STAXYN use in pregnant women. No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the maxim

Descriptif du produit:

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 or as a 40 tablet bulk pack. 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.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

STAXYN - VARDENAFIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING
PHYSICIANS TOTAL CARE, INC.
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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
INDICATIONS AND USAGE
STAXYN is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of erectile dysfunction. (1)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
STAXYN 10 mg: White, round, orally disintegrating tablets (not scored)
(3)
CONTRAINDICATIONS
Administration with nitrates and nitric oxide donors (2.4, 4.1)
WARNINGS AND PRECAUTIONS
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 seek immediate medical
assistance. (5.3)
Effects on the Eye: Patients should stop use of STAXYN, and seek
medical attention in the event of sudden loss of
vision in one or both eyes. Discuss with patients the increased risk
of non-arteritic anterior ischemic optic neuropathy
(NAION) in individuals who have already experienced NAION. (5.4, 6.2)
Sudden Hearing Loss: Patients should stop STAXYN and seek medical
attention in the event of sudden decrease or
loss in hearing. (