CARTIA XT 300 mg/1
diltiazem hydrochloride · CAPSULE, EXTENDED RELEASE · DirectRx
CARTIA XT is a capsule, extended release containing diltiazem hydrochloride at 300 mg/1, taken oral. Manufactured by DirectRx.
Key Facts
- Brand Name
- CARTIA XT
- Generic Name
- diltiazem hydrochloride
- NDC Code (Product)
72189-344- Manufacturer
- DirectRx
- Strength
- 300 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA074752
- Marketing Start
- 04/06/2022
Recall History
Actavis Laboratories, FL, Inc.
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Teva Pharmaceuticals USA
Labelling: Incorrect Exp. Date
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 management of chronic stable angina and angina due to coronary artery spasm.
Dosage & Administration
DOSAGE AND ADMINISTRATION Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules (once-a-day dosage) at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules (once-a-day dosage) may be needed in some patients. Monitor patients closely. Subsequent titration to higher or lower doses may be necessary. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose. Hypertension: Adjust dosage to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, schedule dosage adjustments accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up…
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 3290 patients or 0.40%). 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 (see ADVERSE REACTIONS ). 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 reporte…
Contraindications
CONTRAINDICATIONS Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are 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 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.
Drug Interactions
Drug Interactions Because of the potential for additive effects, slow titration is 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 diltiazem hydrochloride extended-release capsules (once-a-day dosage) (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, titrate anesthetics and calcium blockers slowly. 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 elimina…
Adverse Reactions
ADVERSE REACTIONS Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsule (once-a-day dosage) up to 360 mg with rates in placebo patients shown for comparison. Diltiazem Hydrochloride Extended-release Capsule (once-a-day dosage) Placebo-Controlled Angina and Hypertension Trials Combined Adverse Reactions Diltiazem Hydrochloride Extended-release Capsule (once-a-day dosage) (n=607) Placebo (n=301) Headache 5.4% 5.0% Dizziness 3.0% 3.0% Bradycardia 3.3% 1.3% AV Block First Degree 3.3% 0.0% Edema 2.6% 1.3% Asthenia 1.8% 1.7% In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials: Cardiovascular: Congestive heart failure, palpitations, syncope, ventricular extrasystoles. Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia,…
Frequently Asked Questions
What is CARTIA XT used for?
CARTIA XT contains diltiazem hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is CARTIA XT a controlled substance?
CARTIA XT is not classified as a controlled substance by the DEA.
What is the generic name for CARTIA XT?
The generic name for CARTIA XT is diltiazem hydrochloride. There are 12 other brand versions of diltiazem hydrochloride.
What is the NDC code for CARTIA XT 300 mg/1?
The NDC (National Drug Code) for CARTIA XT 300 mg/1 is 72189-344, listed by DirectRx.
Other Diltiazem Brands
See all →- Diltiazem hydrochloride120 mg/172578-202
- Diltiazem Hydrochloride60 mg/10615-8033
- Diltiazem Hydrochloride240 mg/10904-7219
- DILTIAZEM HYDROCHLORIDE120 mg/116714-523
- Diltiazem Hydrochloride240 mg/116729-305
- Diltiazem Hydrochloride120 mg/124979-026
- Cardizem CD120 mg/10187-0795
- Cardizem LA360 mg/10187-2049
- TIAZAC EXTENDED RELEASE180 mg/10187-2613
- Diltiazem Hydrochloride120 mg/146708-725
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)