Drug Catalog - Product Detail
TAZTIA XT 240MG CAPSULES 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 62037-0698-90 | ACTAVIS PHARMA | 90 | 240MG | CAPSULE |
PACKAGE FILES
Generic Name
DILTIAZEM HYDROCHLORIDE
Substance Name
DILTIAZEM HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA075401
Description
DESCRIPTION Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker). 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 and has a molecular weight of 450.98. Diltiazem hydrochloride extend-release capsules, USP (once-a-day dosage) contain diltiazem hydrochloride in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extend-release capsules, USP (once-a-day dosage) also contains: black iron oxide, corn starch, ethylcellulose, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose 2910, magnesium stearate, nonoxynol 100, pharmaceutical glaze, polysorbate 80, polyacrylic dispersion, povidone, propylene glycol, sucrose, talc and titanium dioxide. The 120 mg capsules also contain: D&C Red #28, FD&C Blue #1 and FD&C Red #40. The 180 mg capsules also contain: D&C Yellow #10, FD&C Blue #1 and FD&C Yellow #6. The 240 mg capsules also contain: D&C Red #28, FD&C Blue #1 and FD&C Red #40. The 300 mg capsules also contain: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6. The 360 mg capsules also contain: FD&C Blue #1. For oral administration. Meets USP requirements for dissolution test 15. Chemical Structure
How Supplied
HOW SUPPLIED TAZTIA XT ® (Diltiazem Hydrochloride Extended-Release Capsules, USP) ONCE-A-DAY-DOSAGE are available as follows: Strength Description Quantity NDC# 120 mg Pink opaque hard gelatin capsule imprinted with “ Andrx 696” and “120 mg” in black ink containing white to off-white round pellets 30’s 90’s 62037-696-30 62037-696-90 180 mg Buff opaque/light blue opaque hard gelatin capsule imprinted with “ Andrx 697” and “180 mg” in black ink containing white to off-white round pellets 30’s 90’s 62037-697-30 62037-697-90 240 mg Light blue/pink opaque hard gelatin capsule imprinted with “ Andrx 698” and “240 mg” in black ink containing white to off-white round pellets 30’s 90’s 62037-698-30 62037-698-90 300 mg Buff opaque/pink opaque hard gelatin capsule imprinted with “ Andrx 699” and “300 mg” in black ink containing white to off-white round pellets 30’s 90’s 62037-699-30 62037-699-90 360 mg Light blue opaque hard gelatin capsule imprinted with “ Andrx 700” and “360 mg” in black ink containing white to off-white round pellets 30’s 90’s 62037-700-30 62037-700-90 Storage conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in tight containers with safety closures. Brands listed are trademarks of their respective owners. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 7/2022
Indications & Usage
INDICATIONS AND USAGE Hypertension Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Chronic Stable Angina Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the treatment of chronic stable angina.
Dosage and Administration
DOSAGE AND ADMINISTRATION Hypertension: Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, usual starting doses are 120 to 240 mg once daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 120 to 540 mg once daily. Current clinical experience with 540 mg dose is limited; however, the dose may be increased to 540 mg once daily. Angina: Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 mg to 180 mg once daily. Individual patients may respond to higher doses of up to 540 mg once daily. When necessary, titration should be carried out over 7 to 14 days. Concomitant use with Other Cardiovascular Agents: 1. Sublingual Nitroglycerin (NTG): May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy. 2. Prophylactic Nitrate Therapy: Diltiazem hydrochloride may be safely coadministered with short- and long-acting nitrates. 3. Beta-blockers: (See WARNINGS and PRECAUTIONS .) 4. Antihypertensives: Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other. Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to diltiazem hydrochloride extend-release capsules (once-a-day dosage) at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may, however, be necessary and should be initiated as clinically indicated. Sprinkling the Capsule Contents on Food: Diltiazem hydrochloride extended-release capsules (once-a-day-dosage) may also be administered by carefully opening the capsule and sprinkling the capsule contents on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. Any capsule contents/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a diltiazem hydrochloride extended-release capsule (once-a-day-dosage) is not recommended.