DILTIAZEM HYDROCHLORIDE capsule, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

Fáanlegur frá:

Mylan Pharmaceuticals Inc.

INN (Alþjóðlegt nafn):

DILTIAZEM HYDROCHLORIDE

Samsetning:

DILTIAZEM HYDROCHLORIDE 60 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Diltiazem hydrochloride extended-release capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by X-ray on admission.

Vörulýsing:

Diltiazem Hydrochloride Extended-Release Capsules, USP (Twice-a-Day Dosage) are available containing either 60 mg diltiazem hydrochloride, USP (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride, USP (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem). The 60 mg capsules are hard-shell gelatin capsules with a coral opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 6060 in black ink on the cap and body. They are available as follows: NDC 0378-6060-01 bottles of 100 capsules The 90 mg capsules are hard-shell gelatin capsules with a coral opaque cap and ivory opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 6090 in black ink on the cap and body. They are available as follows: NDC 0378-6090-01 bottles of 100 capsules The 120 mg capsules are hard-shell gelatin capsules with a coral opaque cap and coral opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 6120 in black ink on the cap and body. They are available as follows: NDC 0378-6120-01 bottles of 100 capsules Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75077831 Revised: 11/2020 MX:DILER:R2

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker or
calcium antagonist). Chemically, diltiazem hydrochloride is (+)-5-[2-
(Dimethylamino)ethyl]-_cis_-2,3-dihydro-3-hydroxy-2-(_p_-methoxyphenyl)
-1,5-
benzothiazepin-4(5_H_)-one acetate (ester) monohydrochloride. The
chemical structure is
Diltiazem hydrochloride, USP is a white to off-white crystalline
powder with a bitter taste.
It is soluble in water, methanol, and chloroform. It has a molecular
weight of 450.98.
Each diltiazem hydrochloride extended-release capsule, USP contains
either 60 mg
diltiazem hydrochloride, USP (equivalent to 55.1 mg diltiazem), 90 mg
diltiazem
hydrochloride, USP (equivalent to 82.7 mg diltiazem), or 120 mg
diltiazem hydrochloride,
USP (equivalent to 110.3 mg diltiazem).
Inactive ingredients: diethyl phthalate, FD&C Red No. 40, gelatin,
hypromellose,
maltodextrin, methacrylic acid copolymer Type B, polyethylene glycol,
povidone, silicon
dioxide, sodium lauryl sulfate, sugar spheres (corn starch and
sucrose) and titanium
dioxide.
The 90 mg capsules also contain D&C Yellow No. 10.
In addition, the black imprinting ink contains black iron oxide, D&C
Yellow No. 10
Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum
Lake,
FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
_Meets USP Dissolution Test 4_.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem hydrochloride are believed to be
related to its ability
to inhibit the influx of calcium ions during membrane depolarization
of cardiac and
vascular smooth muscle.
MECHANISM OF ACTION
Diltiazem hydrochloride extended-release capsules produce their
antihypertensive effect
primarily by relaxation of vascular smooth muscle and the resultant
decrease in
peripheral vascular resistance. The magnitude of blood pressure
reduction is related to
the degree of hypertension;