TIAZAC Capsule, ectended release (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US LLC

Λέξεις κλειδιά

0187-2612 0187-2613 0187-2614 0187-2615 0187-2616 0187-2617

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1. Description

Tiazac (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3(acetyloxy) ...

2. 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 ...

3. Indications and Usage

Hypertension Tiazac is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Chronic Stable Angina Tiazac is indicated for the treatment ...

4. Contraindications

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 ...

5. Warnings

1. Cardiac Conduction: Diltiazem hydrochloride prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect ...

6.1. General

Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameters of renal and hepatic function ...

6.4. Drug Interactions

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at oral dosage levels of up to 100 mg/kg/day and a 21-month study in mice at oral dosage levels of up to 30 mg/kg/day showed no evidence of carcinogenicity. There was also no mutagenic ...

6.7. Pregnancy

Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from 4 to 6 times (depending on species) the upper limit of the optimum dosage range in clinical trials ...

6.9. Nursing Mothers

Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of Tiazac is deemed essential, an alternative method of infant feeding should ...

6.10. Pediatric Use

Safety and effectiveness in children have not been established.

6.11. Geriatric Use

Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

Serious adverse reactions have been rare in studies with Tiazac, as well as with other diltiazem formulations. It should be recognized that patients with impaired ventricular function and cardiac conduction ...

9. Overdosage

The oral LD50s in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD50s in these species were 60 and 38 mg/kg, respectively. The ...

10. 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 ...

11. How Supplied

Tiazac (diltiazem hydrochloride) Extended-Release Capsules, USP Strength Description Quantity NDC# 120 mg #3 lavender/lavender capsuleimprinted: Tiazac 120 3090 0187-2612-300187-2612-90 180 mg ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.