TIADYLT ER 120 mg/1

diltiazem hydrochloride · CAPSULE, EXTENDED RELEASE · Zydus Pharmaceuticals (USA) Inc.

No Recall HistoryCurrently in Shortage

Plain English

TIADYLT ER is a capsule, extended release containing diltiazem hydrochloride at 120 mg/1, taken oral. Manufactured by Zydus Pharmaceuticals (USA) Inc..

Key Facts

Brand Name: TIADYLT ER
Generic Name: diltiazem hydrochloride
NDC Code (Product): 68382-745
Manufacturer: Zydus Pharmaceuticals (USA) Inc.
Strength: 120 mg/1
Dosage Form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: ANDA206641
Marketing Start: 11/08/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea1,256 reports

pain1,147 reports

fatigue1,079 reports

fall1,031 reports

arthralgia858 reports

diarrhoea851 reports

headache847 reports

dizziness833 reports

hypotension822 reports

pruritus804 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Hypertension: Tiadylt ® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Chronic Stable Angina: Tiadylt ® ER capsules are indicated for the treatment of chronic stable angina.

Dosage & 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 …

Warnings

WARNINGS 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 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. 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 preexi…

Contraindications

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 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.

Drug Interactions

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 and/or conduction (see WARNINGS ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with Tiadylt (see WARNINGS ). Diltiazem is both a substrate and an inhibitor of the Pg-p and cytochrome P450 3A4 enzyme system which may affect exposure to diltiazem and concomitant drugs metabolized by those pathways. Patients with renal and/or hepatic impairment may be particularly at risk of exposure changes. Anesthetics: The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium channel blockers should be titrated carefully. Benzodiazepines: Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4-fold and the C max by 2-fold, compared to placebo. The elimination half-life of midazolam a…

Adverse Reactions

ADVERSE REACTIONS Serious adverse reactions have been rare in studies with Tiadylt, as well as with other diltiazem formulations. It should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. A total of 256 hypertensives were treated for between 4 and 8 weeks; a total of 207 patients with chronic stable angina were treated for 3 weeks with doses of Tiadylt ranging from 120 to 540 mg once daily. Two patients experienced first-degree AV block at the 540 mg dose. The following table presents the most common adverse reactions, whether or not drug-related, reported in placebo-controlled trials in patients receiving Tiadylt up to 360 mg and up to 540 mg with rates in placebo patients shown for comparison. MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED HYPERTENSION TRIALS Adverse events occurring in treated patients at 2% or more than placebo-treated patients. Placebo Tiadylt Adverse Events (COSTART Term) n=57 # pts (%) Up to 360 mg n=149 # pts (%) 480 to 540 mg n=48 # pts (%) edema, peripheral 1 (2) 8 (5) 7 (15) dizziness 4 (7) 6 (4) 2 (4) vasodilation 1 (2) 5 (3) 1 (2) dyspepsia…

Frequently Asked Questions

What is TIADYLT ER used for?

TIADYLT ER contains diltiazem hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is TIADYLT ER a controlled substance?

TIADYLT ER is not classified as a controlled substance by the DEA.

What is the generic name for TIADYLT ER?

The generic name for TIADYLT ER is diltiazem hydrochloride. There are 12 other brand versions of diltiazem hydrochloride.

What is the NDC code for TIADYLT ER 120 mg/1?

The NDC (National Drug Code) for TIADYLT ER 120 mg/1 is 68382-745, listed by Zydus Pharmaceuticals (USA) Inc..

Product NDC

68382-745

Package NDC

68382-745-01

Other Diltiazem Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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