STAXYN Tablet, orally disintegrating (2012)

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Physicians Total Care, Inc.

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1. Indications and Usage

STAXYN is indicated for the treatment of erectile dysfunction.

2. Dosage and Administration

2.1 General STAXYN is available in 10 mg orally disintegrating tablets. STAXYN is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). STAXYN provides higher systemic exposure compared ...

3. Dosage Forms and Strengths

STAXYN is available in 10 mg white, round, orally disintegrating tablets (not scored), no debossing.

4. Contraindications

4.1 Nitrates Administration of STAXYN with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)]. Consistent with the ...

5. Warnings and Precautions

The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment. Before prescribing STAXYN, it ...

6. Adverse Reactions

The following serious adverse reactions with the use of STAXYN (vardenafil) are discussed elsewhere in the labeling: Cardiovascular effects [see Contraindications (4.1) and Warnings and Precautions ...

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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation. Because these reactions are reported voluntarily from a population of ...

7. Drug Interactions

The drug interaction studies described below were conducted using vardenafil film-coated tablets. 7.1 Potential for Pharmacodynamic Interactions with STAXYN Nitrates Concomitant use of STAXYN and nitrates ...

8.1. Pregnancy

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 ...

8.3. Nursing Mothers

STAXYN is not indicated for use in women. It is not known if vardenafil is excreted in human breast milk. Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold ...

8.4. Pediatric Use

STAXYN is not indicated for use in pediatric patients. Safety and efficacy in children has not been established.

8.5. Geriatric Use

Vardenafil AUC and Cmax in elderly patients (65 years or older) taking STAXYN were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below. No overall differences ...

8.6. Hepatic Impairment

Do not use STAXYN in patients with moderate or severe hepatic impairment. In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil (film-coated ...

8.7. Renal Impairment

Do not use STAXYN in patients on renal dialysis. In volunteers with mild renal impairment (CLcr=50–80 mL/min), the pharmacokinetics of vardenafil 20 mg film-coated tablets were similar to those observed ...

10. Overdosage

The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the film–coated tablets administered to eight healthy male volunteers. The majority of these subjects experienced ...

11. Description

STAXYN is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific PDE5. Vardenafil ...

12.1. Mechanism of Action

Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve ...

12.2. Pharmacodynamics

The pharmacodynamic studies described below were conducted using vardenafil film-coated tablets. Effects on Blood Pressure In a clinical pharmacology study of patients with erectile dysfunction, single ...

12.3. Pharmacokinetics

The pharmacokinetics of vardenafil and its M1 metabolite from STAXYN have been evaluated in healthy male volunteers (18–50 years) and in young (18–45 years) and elderly (≥65 years) erectile dysfunction ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite ...

14. Clinical Studies

The efficacy and safety of STAXYN were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials (studies 1 and 2). STAXYN was dosed without regard to meals on an as-needed ...

16.1. How Supplied

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 ...

16.2. Storage and Handling

Recommended Storage 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 ...

17. Patient Counseling Information

See FDA-Approved Patient Labeling 17.1 Use with Other Formulations of Vardenafil Physicians should inform patients that STAXYN is not interchangeable with vardenafil film-coated tablets (LEVITRA) as it ...