Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
McKesson Corporation dba SKY Packaging
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE 120 mg
ORAL
PRESCRIPTION DRUG
Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm. 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.
Product: 63739-283 Product: 63739-284 NDC: 63739-284-10 10 CAPSULE, EXTENDED RELEASE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-285 NDC: 63739-285-10 10 CAPSULE, EXTENDED RELEASE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE NDC: 63739-285-04 30 CAPSULE, EXTENDED RELEASE in a BLISTER PACK / 10 in a BOX
Abbreviated New Drug Application
DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE MCKESSON CORPORATION DBA SKY PACKAGING ---------- DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (ONCE-A-DAY DOSAGE) 40-8791 Revised — June 2011 RX ONLY DESCRIPTION Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5_H_)one,3-(acetyloxy)- 5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-_cis_-. 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. Diltiazem hydrochloride, USP is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Each diltiazem extended-release capsule, for oral administration, contains the following inactive ingredients: 120 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate 180 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate 240 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate 300 mg— ammonio methacrylate c Lestu allt skjalið