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Taztia XT 180 Mg Caps 90 By Actavis Pharma

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Taztia XT 180 Mg Caps 90 By Actavis Pharma

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Taztia XT 180 Mg Caps 90 By Actavis Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10048262/RXD3481983/RXA456790
Size : 90
Selling UoM : EA
NDC: 62037-0697-90
UPC Barcode : 362037697906
Supplier: 0050000679 ACTAVIS PHARMA INC/GENERIC
Supplier Material : 069790
Generic Code : 024537 DILTIAZEM HCL ORAL CAPSULE ER 180 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic

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Product Description.:

Andrx 697, 180 mg
capsule , blue off-white , oblong oblong
Andrx underlined
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Diltiazem hydrochloride 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. Its molecular formula is C22H26N2O4S?HCl. Diltiazem Hydrochloride Extended- Release Capsules USP (Once-a-Day Dosage) for oral administration, contain diltiazem hydrochloride in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg.

Diltiazem Hydrochloride Extended-release Capsules USP (Once-a-Day Dosage) also contain: 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.

INDICATIONS AND USAGE

Hypertension

Diltiazem Hydrochloride Extended-Release Capsules USP (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 USP (Once-a-Day Dosage) are indicated for chronic stable angina.

CONTRAINDICATIONS

Diltiazem 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 severe 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.

WARNINGS

1. Cardiac Conduction

Diltiazem prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (13 of 3007 patients or 0.43%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem.

2. Congestive Heart Failure

Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction 24% ? 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt). Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. Experience with the use of diltiazem in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.

3. Hypotension

Decreases in blood pressure associated with diltiazem therapy may occasionally result in symptomatic hypotension.

4. Acute Hepatic Injury

Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, and SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem is uncertain in some cases, but probable in some

PRECAUTIONS

General

Diltiazem 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 should be monitored at regular intervals. The drug should be used with caution in patients with impaired renal or hepatic function. In suba