Diltiazem Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Diltiazem Hydrochloride

Sun Pharma Global FZE

Diltiazem Hydrochloride Extended-Release Capsules, USP[Sun Pharma Global FZE]


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DILTIAZEM HYDROCHLORIDE DESCRIPTION



Diltiazem Hydrochloride





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



MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED HYPERTENSION TRIALSAdverse events occurring in treated patients at 2% or more than placebo-treated patients.
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)

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED ANGINA TRIALSAdverse events occurring in treated patients at 2% or more than placebo-treated patients.
  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.
Diltiazem Hydrochloride

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.
Diltiazem Hydrochloride

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.
Diltiazem Hydrochloride

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.
Diltiazem Hydrochloride

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 Hydrochloride

Diltiazem Hydrochloride

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-669
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE DILTIAZEM 120 mg

Inactive Ingredients

Ingredient Name Strength
Hypromellose 2910 (5 Mpa.s)
talc
ETHYLCELLULOSES
TRIETHYL CITRATE
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 3

Product Characteristics

Color Size Imprint Code Shape
PURPLE 18 mm 669;669 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-669-83 30 in 1 BOTTLE
2 NDC:47335-669-81 90 in 1 BOTTLE
3 NDC:47335-669-19 90 in 1 BOTTLE
4 NDC:47335-669-13 500 in 1 BOTTLE
5 NDC:47335-669-18 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090421 2010-11-15


Diltiazem Hydrochloride

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-670
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE DILTIAZEM 180 mg

Inactive Ingredients

Ingredient Name Strength
Hypromellose 2910 (5 Mpa.s)
talc
ETHYLCELLULOSES
TRIETHYL CITRATE
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C GREEN NO. 3
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
WHITE 19 mm 670;670 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-670-83 30 in 1 BOTTLE
2 NDC:47335-670-81 90 in 1 BOTTLE
3 NDC:47335-670-19 90 in 1 BOTTLE
4 NDC:47335-670-13 500 in 1 BOTTLE
5 NDC:47335-670-18 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090421 2010-11-15


Diltiazem Hydrochloride

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-671
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE DILTIAZEM 240 mg

Inactive Ingredients

Ingredient Name Strength
Hypromellose 2910 (5 Mpa.s)
talc
ETHYLCELLULOSES
TRIETHYL CITRATE
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 3
FD&C GREEN NO. 3
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
GREEN 21 mm 671;671 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-671-83 30 in 1 BOTTLE
2 NDC:47335-671-81 90 in 1 BOTTLE
3 NDC:47335-671-19 90 in 1 BOTTLE
4 NDC:47335-671-13 500 in 1 BOTTLE
5 NDC:47335-671-18 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090421 2010-11-15


Diltiazem Hydrochloride

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-672
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE DILTIAZEM 300 mg

Inactive Ingredients

Ingredient Name Strength
Hypromellose 2910 (5 Mpa.s)
talc
ETHYLCELLULOSES
TRIETHYL CITRATE
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 3

Product Characteristics

Color Size Imprint Code Shape
WHITE 24 mm 672;672 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-672-83 30 in 1 BOTTLE
2 NDC:47335-672-81 90 in 1 BOTTLE
3 NDC:47335-672-19 90 in 1 BOTTLE
4 NDC:47335-672-13 500 in 1 BOTTLE
5 NDC:47335-672-18 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090421 2010-11-15


Diltiazem Hydrochloride

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-673
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE DILTIAZEM 360 mg

Inactive Ingredients

Ingredient Name Strength
Hypromellose 2910 (5 Mpa.s)
talc
ETHYLCELLULOSES
TRIETHYL CITRATE
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C GREEN NO. 3
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
GREEN 24 mm 673;673 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-673-83 30 in 1 BOTTLE
2 NDC:47335-673-81 90 in 1 BOTTLE
3 NDC:47335-673-19 90 in 1 BOTTLE
4 NDC:47335-673-13 500 in 1 BOTTLE
5 NDC:47335-673-18 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090421 2010-11-15


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Be sure to consult your doctor before taking any medication!
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