Diltiazem Hydrochloride
Diltiazem Hydrochloride Extended-Release Capsules, USP[Sun Pharma Global FZE]
FULL PRESCRIBING INFORMATION: CONTENTS*
- DILTIAZEM HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- DILTIAZEM HYDROCHLORIDE INDICATIONS AND USAGE
- DILTIAZEM HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DILTIAZEM HYDROCHLORIDE ADVERSE REACTIONS
- OVERDOSAGE
- DILTIAZEM HYDROCHLORIDE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 120 MG
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 180 MG
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 240 MG
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 300 MG
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 360 MG
FULL PRESCRIBING INFORMATION
DILTIAZEM HYDROCHLORIDE DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanisms of Action
Hypertension:
Angina:
Hemodynamic and Electrophysiologic Effects:
WARNINGS
Pharmacodynamics
Hypertension:
Angina:
Pharmacokinetics and Metabolism:
In vitroin vitro
Diltiazem Hydrochloride Extended-Release Capsules:max
maxmin
DILTIAZEM HYDROCHLORIDE INDICATIONS AND USAGE
Hypertension:
Chronic Stable Angina:
DILTIAZEM HYDROCHLORIDE CONTRAINDICATIONS
WARNINGS
1. Cardiac Conduction:
2. Congestive Heart Failure:
3. Hypotension:
4. Acute Hepatic Injury:PRECAUTIONS
PRECAUTIONS
General
ADVERSE REACTIONS
Drug Interactions
WARNINGSWARNINGS
Anesthetics:
Benzodiazepines: maxe.g.,
Beta-Blockers:In vitroWARNINGS
Buspirone:max½max
Carbamazepine:
Cimetidine:
Clonidine:
Cyclosporine:
Digitalis:WARNINGS
Quinidine:(0→∞)½oral
Rifampin:
Statins:
maxmax
Carcinogenesis, Mutagenesis, Impairment of Fertility
in vitro in vivoin vitro
Pregnancy
Nursing Mothers
Pediatric Use
Geriatric Use
DILTIAZEM HYDROCHLORIDE ADVERSE REACTIONS
| Placebo | Diltiazem | ||
|---|---|---|---|
| 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 |
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) |
| Placebo | Diltiazem | ||
|---|---|---|---|
| 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) |
Cardiovascular:
Nervous System:
Gastrointestinal: WARNINGS, Acute Hepatic Injury
Dermatological:
Other:
OVERDOSAGE
Bradycardia:
High-Degree AV Block:
Cardiac Failure:
Hypotension:
DILTIAZEM HYDROCHLORIDE DOSAGE AND ADMINISTRATION
Hypertension:
Angina:
Concomitant use with Other Cardiovascular Agents:
- Sublingual Nitroglycerin (NTG): May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy.
- Prophylactic Nitrate Therapy: Diltiazem hydrochloride may be safely coadministered with short- and long-acting nitrates.
- Beta-blockers: (see WARNINGS and PRECAUTIONS.)
- 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.
Sprinkling the Capsule Contents on Food
HOW SUPPLIED
| Strength |
Description |
Quantity |
NDC# |
| 120 mg |
#2 purple colored cap and body with “669” imprinted in black ink on cap and body, containing white to off white pellets |
30's CRC |
47335-669-83 |
| 90's CRC |
47335-669-81 |
||
| 90's NCRC |
47335-669-19 |
||
| 500's NCRC |
47335-669-13 |
||
| 1000's NCRC |
47335-669-18 |
||
| 180 mg |
#1 green colored cap and white colored body with “670” imprinted in black ink on cap and body, containing white to off white pellets |
30's CRC |
47335-670-83 |
| 90's CRC |
47335-670-81 |
||
| 90's NCRC |
47335-670-19 |
||
| 500's NCRC |
47335-670-13 |
||
| 1000's NCRC |
47335-670-18 |
||
| 240 mg |
#0 purple colored cap and green colored body with “671” imprinted in black ink on cap and body, containing white to off white pellets |
30's CRC |
47335-671-83 |
| 90's CRC |
47335-671-81 |
||
| 90's NCRC |
47335-671-19 |
||
| 500's NCRC |
47335-671-13 |
||
| 1000's NCRC |
47335-671-18 |
||
| 300 mg |
#00 purple colored cap and white colored body with “672” imprinted in black ink on cap and body, containing white to off white pellets |
30's CRC |
47335-672-83 |
| 90's CRC |
47335-672-81 |
||
| 90's NCRC |
47335-672-19 |
||
| 500's NCRC |
47335-672-13 |
||
| 1000's NCRC |
47335-672-18 |
||
| 360 mg |
#00 green colored cap and body with “673” imprinted in black ink on cap and body, containing white to off white pellets |
30's CRC |
47335-673-83 |
| 90's CRC |
47335-673-81 |
||
| 90's NCRC |
47335-673-19 |
||
| 500's NCRC |
47335-673-13 |
||
| 1000's NCRC |
47335-673-18 |
Caraco Pharmaceutical Laboratories, Ltd.
Sun Pharmaceutical Ind. Ltd.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 120 MG
NDC 47335-669-83
Diltiazem Hydrochloride Extended-Release Capsules, USP
(Once-a-Day Dosage)
120 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 180 MG
NDC 47335-670-83
Diltiazem Hydrochloride Extended-Release Capsules, USP
(Once-a-Day Dosage)
180 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 240 MG
NDC 47335-671-83
Diltiazem Hydrochloride Extended-Release Capsules, USP
(Once-a-Day Dosage)
240 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 300 MG
NDC 47335-672-83
Diltiazem Hydrochloride Extended-Release Capsules, USP
(Once-a-Day Dosage)
300 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 360 MG
NDC 47335-673-83
Diltiazem Hydrochloride Extended-Release Capsules, USP
(Once-a-Day Dosage)
360 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
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Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
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Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
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Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
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Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
