TAZTIA XT- diltiazem hydrochloride capsule, extended release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Actavis Pharma, Inc.

Designación común internacional (DCI):

DILTIAZEM HYDROCHLORIDE

Composición:

DILTIAZEM HYDROCHLORIDE 120 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the treatment of chronic stable angina. Diltiazem is contraindicated in: - Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker - Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker - Patients with severe hypotension (less than 90 mm Hg systolic) - Patients who have demonstrated hypersensitivity to the drug - Patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Resumen del producto:

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

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TAZTIA XT- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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TAZTIA XT
(DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP)
ONCE-A-DAY-DOSAGE
RX ONLY
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.
®
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem hydrochloride are believed to be
related to its ability
to inhibit the cellular influx of calcium ions during membrane
depolarization of cardiac
and vascular smooth muscle.
MECHANISMS OF ACTION
HYPERTENSION: Diltiazem produ