TIAZAC EXTENDED RELEASE

TIAZAC EXTENDED RELEASE is an FDA-registered drug product whose active ingredient is DILTIAZEM HYDROCHLORIDE. It is labelled by Bausch Health US, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0187-2612, application NDA020401, label effective 20260807. It is one of 31 FDA drug label records sharing the active ingredient DILTIAZEM HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DILTIAZEM HYDROCHLORIDE are most often described in connection with: tiazac indicated, chronic stable, usage hypertension, alone combination, antihypertensive medications. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 of chronic stable angina.

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 Tiazac capsules 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: Tiazac (diltiazem hydrochloride) Extended-Release Capsules 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 Tiazac (diltiazem hydrochloride) Extended-Release Capsule is not recommended.

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.

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 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 hydrochloride 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 hydrochloride 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 hydrochloride is uncertain in some cases but probable in some (see PRECAUTIONS ).

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 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 Tiazac 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 Tiazac 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 Tiazac Adverse Events (COSTART Term) n=57 # pts (%) Up to 360 mg n=149 # pts (%) 480 - 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 0 (0) 7 (5) 0 (0) pharyngitis 2 (4) 3 (2) 3 (6) rash 0 (0) 3 (2) 0 (0) infection 2 (4) 2 (1) 3 (6) diarrhea 0 (0) 2 (1) 1 (2) palpitations 0 (0) 2 (1) 1 (2) nervousness 0 (0) 3 (2) 0 (0) MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED ANGINA TRIALS Adverse events occurring in treated patients at 2% or more than placebo-treated patients. Placebo Tiazac Adverse Events (COSTART Term) n=50 # pts (%) Up to 360 mg n=158 # pts (%) 540 mg n=49 # pts (%) headache 1 (2) 13 (8) 4 (8) edema, peripheral 1 (2) 3 (2) 5 (10) pain 1 (2) 10 (6) 3 (6) dizziness 0 (0) 5 (3) 5 (10) asthenia 0 (0) 1 (1) 2 (4) dyspepsia 0 (0) 2 (1) 3 (6) dyspnea 0 (0) 1 (1) 3 (6) bronchitis 0 (0) 1 (1) 2 (4) AV block 0 (0) 0 (0) 2 (4) infection 0 (0) 2 (1) 1 (2) flu syndrome 0 (0) 0 (0) 1 (2) cough increase 0 (0) 2 (1) 1 (2) extrasystoles 0 (0) 0 (0) 1 (2) gout 0 (0) 2 (1) 1 (2) myalgia 0 (0) 0 (0) 1 (2) impotence 0 (0) 0 (0) 1 (2) conjunctivitis 0 (0) 0 (0) 1 (2) rash 0 (0) 2 (1) 1 (2) abdominal enlargement 0 (0) 0 (0) 1 (2) In addition, the following events have been reported infrequently (less than 2%) in clinical trials with other diltiazem products: Cardiovascular: Angina, arrhythmia, AV block (second- or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles. Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor. Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase ( see WARNINGS, Acute Hepatic Injury ), nausea, thirst, vomiting, weight increase. Dermatological: Petechiae, photosensitivity, pruritus. Other: Albuminuria, allergic reaction, amblyopia, asthenia, CPK increase, crystalluria, dyspnea, edema, epistaxis, eye irritation, headache, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, neck rigidity, nocturia, osteoarticular pain, pain, polyuria, rhinitis, sexual difficulties, gynecomastia. In addition, the following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride: acute generalized exanthematous pustulosis, alopecia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), leukopenia, purpura, retinopathy, and thrombocytopenia. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and diltiazem hydrochloride therapy is yet to be established. To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 31 drug label records with DILTIAZEM HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is TIAZAC EXTENDED RELEASE used for?
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 of chronic stable angina.

Who makes TIAZAC EXTENDED RELEASE?
Bausch Health US, LLC is the labeler of record for TIAZAC EXTENDED RELEASE. 31 FDA label records share the active ingredient DILTIAZEM HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does TIAZAC EXTENDED RELEASE come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is TIAZAC EXTENDED RELEASE prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DILTIAZEM HYDROCHLORIDE?
Yes. 31 FDA drug label records list DILTIAZEM HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has TIAZAC EXTENDED RELEASE been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.