VERAPAMIL HYDROCHLORIDE capsule, extended release

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)

Հասանելի է:

Physicians Total Care, Inc.

INN (Միջազգային անվանումը):

VERAPAMIL HYDROCHLORIDE

Կազմը:

VERAPAMIL HYDROCHLORIDE 100 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Verapamil hydrochloride extended-release capsules (PM) for oral use are indicated for the management of essential hypertension. Verapamil is contraindicated in: - Severe left ventricular dysfunction [see Warnings and Precautions (5.1)] . - Hypotension (less than 90 mm Hg systolic pressure) or cardiogenic shock. - Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). - Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). - Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g.,  Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) [see Warnings and Precautions (5.4)]. Reproduction studies have been performed in rabbits and rats at oral doses up to 1.9 (15 mg/kg/day) and 7.5 (60 mg/kg/day) times the human oral daily dose, respectively, and have revealed no evidence of teratogenicity. In the rat, however, this multiple of the human dose was embryocidal and retarded fetal growth and devel

Ապրանքի ամփոփագիր:

Verapamil Hydrochloride Extended-Release Capsules (PM) are available containing 100 mg, 200 mg or 300 mg of verapamil hydrochloride, USP. The 100 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a white opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6201 in black ink on both the cap and the body. They are available as follows:   NDC 54868-2211-0  bottles of 30 capsules The 200 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a light orange opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6202 in black ink on both the cap and the body. They are available as follows:   NDC 54868-6124-0  bottles of 10 capsules   NDC 54868-6124-1  bottles of 30 capsules The 300 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a red opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6203 in black ink on both the cap and the body. They are available as follows:   NDC 54868-5841-0  bottles of 20 capsules   NDC 54868-5841-2  bottles of 30 capsules   NDC 54868-5841-1  bottles of 60 capsules Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

VERAPAMIL HYDROCHLORIDE - VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES (PM) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR VERAPAMIL HYDROCHLORIDE EXTENDED-
RELEASE CAPSULES (PM).
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (PM) (CONTROLLED
ONSET) FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Verapamil hydrochloride is a calcium channel blocker indicated for the
management of essential hypertension. (1)
DOSAGE AND ADMINISTRATION
Do not crush or chew capsule contents; swallow capsule whole or
sprinkle entire contents onto applesauce. (2.2, 17)
Usual dosage: 200 mg once daily at bedtime; if inadequate response,
titrate upward to 300 mg, then 400 mg once daily
at bedtime. (2.1)
Initial dose of 100 mg once daily at bedtime in patients with renal or
hepatic impairment, elderly or low-weight patients.
(2.1)
DOSAGE FORMS AND STRENGTHS
• Extended-release capsules controlled-onset: 100 mg, 200 mg, 300
mg. (3)
CONTRAINDICATIONS
Severe left ventricular dysfunction. (4)
Hypotension (< 90 mm Hg systolic pressure) or cardiogenic shock. (4)
Sick sinus syndrome (except in patients with pacemaker). (4)
2nd- or 3rd-degree AV block (except in patients with pacemaker). (4)
Atrial flutter or atrial fibrillation and an accessory bypass tract.
(4)
WARNINGS AND PRECAUTIONS
Congestive heart failure or pulmonary edema may develop. (5.1)
Hypotension/dizziness may occur. (5.2)
Elevated transaminases have occurred; monitor liver function. (5.3)
Ventricular fibrillation has occurred in patients with atrial flutter
or atrial fibrillation and an accessory bypass tract. (5.4)
Reduce dose or discontinue therapy if marked first-degree AV block or
progression to second- or third-degree AV
block occurs. (5.5)
Sinus bradycardia, pulmonary edema, severe hypotension, second-degree
AV block, sinus arrest and death occurr