DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the treatment of hypertension. Diltiazem hydrochloride extended-release capsules (once-a-day dosage) may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the management of chronic stable angina. 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 mmHg systolic); (4) patients who have demonstrated hypersensitivity to the drug; and (5) patients with acute myocardial infarction and pulmonary congestion as documented by X-ray on admission.

Product summary:

Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-Day Dosage) are available containing 120 mg, 180 mg or 240 mg of diltiazem hydrochloride, USP. The 120 mg capsule is a hard-shell gelatin capsule with a pink opaque cap and pink opaque body filled with two white to off-white, round tablets with no markings. The capsule is radially printed with MYLAN over 5220 in black ink on the cap. They are available as follows: NDC 0378-5220-77 bottles of 90 capsules NDC 0378-5220-01 bottles of 100 capsules NDC 0378-5220-05 bottles of 500 capsules The 180 mg capsule is a hard-shell gelatin capsule with a lavender opaque cap and pink opaque body filled with three white to off-white, round tablets with no markings. The capsule is radially printed with MYLAN over 5280 in black ink on the cap. They are available as follows: NDC 0378-5280-77 bottles of 90 capsules NDC 0378-5280-01 bottles of 100 capsules NDC 0378-5280-05 bottles of 500 capsules The 240 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and pink opaque body filled with four white to off-white, round tablets with no markings. The capsule is radially printed with MYLAN over 5340 in black ink on both the cap and body. They are available as follows: NDC 0378-5340-77 bottles of 90 capsules NDC 0378-5340-01 bottles of 100 capsules NDC 0378-5340-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 7/2017 DILERQD:R10

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Diltiazem hydrochloride is a calcium ion 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(5H)-one acetate (ester)
monohydrochloride. Its molecular
formula is C22H26N2O4S HCl and its molecular weight is 450.99. Its
structural formula is as follows:
Diltiazem hydrochloride, USP is a white, crystalline powder or small
crystals with a bitter taste. It is
soluble in water, methanol, and chloroform.
Diltiazem hydrochloride extended-release capsules, USP (Once-a-Day
Dosage) contain multiple units
of diltiazem hydrochloride extended-release 60 mg, resulting in the
120 mg, 180 mg or 240 mg dosage
strengths allowing for the controlled release of diltiazem
hydrochloride over a 24-hour period.
In addition, each capsule contains the following inactive ingredients:
ammonium hydroxide, dibutyl
sebacate, ethylcellulose, hypromellose, magnesium stearate,
maltodextrin, microcrystalline cellulose,
oleic acid, polyethylene glycol, silica and sodium lauryl sulfate. The
empty hard-shell gelatin capsules
contain FD&C Blue No. 1, FD&C Red No. 40 Aluminum Lake, gelatin,
sodium lauryl sulfate and
titanium dioxide. In addition, the 120 mg and 180 mg empty hard-shell
gelatin capsules contain D&C
Red No. 28.
The 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.
_Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-Day
Dosage) 120 mg, 180 mg and 240_
_mg meet USP Drug Release Test 8._
CLINICAL PHARMACOLOGY
The therapeutic benefits 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 muscles.
ME