Drug Catalog - Product Detail
DILTIAZEM ER CP 60MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-6060-01 | MYLAN | 100 | 60MG | CAPSULE |
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Description
DESCRIPTION Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)-ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is: C 22 H 26 N 2 0 4 S•HCl 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 450.99. Each extended-release capsule, for oral administration, contains 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: Diethyl phthalate, gelatin, hypromellose, maltodextrin, methacrylic acid copolymer Type B, pharmaceutical glaze, polyethylene glycol, povidone, propylene glycol, silicon dioxide, sodium lauryl sulfate, sugar spheres (25/30 mesh), synthetic black iron oxide, titanium dioxide, FD&C Red #40, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake. In addition, the 90 mg product contains D&C Yellow #10 coloring agent. Diltiazem Hydrochloride Extended-release Capsules, USP (Twice-a-Day Dosage) 60 mg, 90 mg, and 120 mg meet USP Drug Release Test 4 . MM1
How Supplied
HOW SUPPLIED Diltiazem Hydrochloride Capsules Extended-release Capsules, USP (Twice-a-Day Dosage) are available containing 60 mg, 90 mg and 120 mg of diltiazem hydrochloride, USP. The 60 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6060 in black ink on both the cap and the body. They are available as follows: NDC 0378-6060-01 bottles of 100 capsules The 90 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and an ivory opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6090 in black ink on both the cap and the body. They are available as follows: NDC 0378-6090-01 bottles of 100 capsules The 120 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6120 in black ink on both the cap and the body. They are available as follows: NDC 0378-6120-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP for 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 REVISED JUNE 2006 DILER:R5
Indications & Usage
INDICATIONS & USAGE Diltiazem Hydrochloride Extended-release Capsules, USP (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.
Dosage and Administration
DOSAGE & ADMINISTRATION Dosages must be adjusted to each patient's needs, starting with 60 to 120 mg twice daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. Although individual patients may respond to lower doses, the usual optimum dosage range in clinical trials was 240 to 360 mg/day. Diltiazem hydrochloride extended-release capsules have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules or the concomitant antihypertensives may need to be adjusted when adding one to the other. See WARNINGS and PRECAUTIONS regarding use with beta-blockers.