VARDENAFIL HYDROCHLORIDE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Bryant Ranch Prepack

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Administration of vardenafil hydrochloride tablets 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 vardenafil hydrochloride tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil hydrochloride tablets for the safe administration of nitrates or nitric oxide donors has not been determined. Do not use vardenafil hydrochloride tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil hydrochloride tablets may potentiate the hypotensive effects of GC stimulators. Risk Summary Vardenafil hydrochloride is not indicated for use in females. There are no data with the use of vardenafil hydrochloride 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 vardenafil during organogenesis at exposures for unbound vardenafil and its major metabolite at approximately 100 and 29 times, respectively, the maximum recommended human dose (MRHD) of 20 mg based on AUC (see Data) . Data Animal Data 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 MRHD of 20 mg. In the rat pre- and postnatal development study, the NOAEL (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day. Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk. The number of living pups born to rats exposed pre- and postnatally was reduced at 60 mg/kg/day. Based on the results of the pre- and postnatal study, the developmental NOAEL is less than 1 mg/kg/day. Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. Risk Summary Vardenafil hydrochloride is not indicated for use in females. There is no information on the presence of vardenafil and its major metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. Vardenafil is present in rat milk of lactating rats (see Data) . Data Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma. Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours. Vardenafil hydrochloride is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population. Elderly males 65 years of age and older have higher vardenafil plasma concentrations than younger males (18 to 45 years), mean Cmax and AUC were 34% and 52% higher, respectively. Phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of vardenafil 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients. However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg vardenafil should be considered in patients ≥65 years of age [see Clinical Pharmacology (12.3)] . Dosage adjustment is necessary in patients with moderate hepatic impairment. Do not use vardenafil hydrochloride in patients with severe hepatic impairment (Child-Pugh C). Vardenafil has not been evaluated in this patient population. A starting dose of 5 mg is recommended in patients with moderate hepatic impairment (Child-Pugh B) and the maximum dose should not exceed 10 mg. In volunteers with moderate hepatic impairment, the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects [see Warnings and Precautions (5.8) and Dosage and Administration (2.3)] . In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects. No dosage adjustment is necessary in patients with mild hepatic impairment. Do not use vardenafil hydrochloride in patients on renal dialysis as vardenafil has not been evaluated in such patients. No dosage adjustment is necessary in patients with creatinine clearance (CLcr ) of 30 to 80 mL/min. In male volunteers with CLcr = 50 to 80 mL/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with CLcr > 80 mL/min. In male volunteers with CLcr = 30 to 50 mL/min or CLcr < 30 mL/min, the AUC of vardenafil was 20 to 30% higher compared to that observed in a control group with CLcr > 80 mL/min [see Dosage and Administration (2.3) and Warnings and Precautions (5.9)] .

Termék összefoglaló:

Vardenafil hydrochloride tablets are available as follows: 20 mg – tan, film-coated, round, standard convex tablets, debossed with “TV” on one side of the tablet and with “7V” on the other side, NDC: 71335-9688-1: 30 Tablets in a BOTTLE Recommended Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

VARDENAFIL HYDROCHLORIDE- VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VARDENAFIL
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
VARDENAFIL HYDROCHLORIDE TABLETS.
VARDENAFIL HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 3/2023
INDICATIONS AND USAGE
Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5)
inhibitor indicated for the treatment
of erectile dysfunction. (1)
DOSAGE AND ADMINISTRATION
Vardenafil hydrochloride tablets are taken as needed: For most
patients, the starting dose is 10 mg, up
to once daily. Increase to 20 mg or decrease to 5 mg based on
efficacy/tolerability. (2.1)
A starting dose of vardenafil hydrochloride tablets, 5 mg should be
considered in patients ≥65 years of
age. (2.3)
Vardenafil hydrochloride tablets are taken orally, approximately 60
minutes before sexual activity. (2.1)
The maximum recommended dosing frequency is one tablet per day. (2.1)
Vardenafil hydrochloride tablets may be taken with or without food.
(2.2)
If taking strong or moderate inhibitors of CYP3A4, the dose of
vardenafil hydrochloride tablets should be
adjusted as follows (2.4, 5.2, 7.2):
Ritonavir: No more than 2.5 mg in a 72-hour period
Cobicistat: No more than 2.5 mg in a 72-hour period
Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily,
itraconazole 400 mg daily,
clarithromycin: No more than 2.5 mg in a 24-hour period
Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No
more than 5 mg in a 24-
hour period.
In patients on stable alpha-blocker therapy the recommended starting
dose of vardenafil hydrochloride
tablets is 5 mg (2.4, 5.6)
The recommended starting dose of vardenafil hydrochloride tablets is 5
mg in patients with moderate
hepatic impairment (Child-Pugh B). The maximum dose in patients with
moderate hepatic impairment
should not