Diltiazem Hydrochloride (Page 4 of 4)

DOSAGE AND ADMINISTRATION

Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules, USP (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 mg 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 mg to 360 mg once daily. Individual patients may respond to higher doses of up to 480 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 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.

Concomitant Use with Other Cardiovascular Agents:

Sublingual NTG: May be taken as required to abort acute anginal attacks during diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) therapy.

Prophylactic Nitrate Therapy: Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) may be safely coadministered with short- and long-acting nitrates.

Beta-blockers: (See WARNINGS and PRECAUTIONS .)

Antihypertensives: Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) or the concomitant antihypertensives may need to be adjusted when adding one to the other.

HOW SUPPLIED

Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-Day Dosage)
Strength Quantity NDC Number Description
120 mg 30 bottle 24979-026-06 Light turquoise blue opaque cap and light turquoise blue opaque body, imprinted T026 and 120 in black ink on the cap and the body respectively
90 bottle 24979-026-07
500 bottle 24979-026-02
180 mg 30 bottle 24979-027-06 Light blue opaque cap and light turquoise blue opaque body, imprinted T027 and 180 in black ink on the cap and the body respectively
90 bottle 24979-027-07
500 bottle 24979-027-02
240 mg 30 bottle 24979-028-06 Light blue opaque cap and light blue opaque body, imprinted T028 and 240 in black ink on the cap and the body respectively
90 bottle 24979-028-07
500 bottle 24979-028-02
300 mg 30 bottle 24979-029-06 Light blue opaque cap and grey opaque body, imprinted T029 and 300 in black ink on the cap and the body respectively
90 bottle 24979-029-07
500 bottle 24979-029-02
360 mg 90 bottle 24979-030-07 Light blue opaque cap and white opaque body, imprinted T030 and 360 in black ink on the cap and the body respectively

Storage Conditions: Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.

Manufactured for:

TWi Pharmaceuticals USA, Inc.

Paramus, NJ 07652

Manufactured by:

75fbd7b2-figure-02

TWi Pharmaceuticals, Inc.

Taoyuan City, 32063, Taiwan

Revised: 09/18

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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75fbd7b2-figure-04
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75fbd7b2-figure-05
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75fbd7b2-figure-06
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75fbd7b2-figure-07
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DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-026
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
SUCROSE
STARCH, CORN
AMMONIO METHACRYLATE COPOLYMER TYPE B
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10
PROPYLENE GLYCOL
SHELLAC
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color BLUE (light turquoise blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code T026;120
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-026-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24979-026-07 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:24979-026-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205231 10/01/2018
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-027
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 180 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
SUCROSE
STARCH, CORN
AMMONIO METHACRYLATE COPOLYMER TYPE B
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10
PROPYLENE GLYCOL
SHELLAC
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color BLUE (light blue) , BLUE (light turquoise blue) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code T027;180
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-027-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24979-027-07 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:24979-027-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205231 10/01/2018
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-028
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 240 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
SUCROSE
STARCH, CORN
AMMONIO METHACRYLATE COPOLYMER TYPE B
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10
PROPYLENE GLYCOL
SHELLAC
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color BLUE (light blue) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code T028;240
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-028-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24979-028-07 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:24979-028-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205231 10/01/2018
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-029
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
SUCROSE
STARCH, CORN
AMMONIO METHACRYLATE COPOLYMER TYPE B
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10
PROPYLENE GLYCOL
SHELLAC
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color gray, blue (light blue) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code T029;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-029-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:24979-029-07 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:24979-029-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205231 10/01/2018
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-030
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 360 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
SUCROSE
STARCH, CORN
AMMONIO METHACRYLATE COPOLYMER TYPE B
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10
PROPYLENE GLYCOL
SHELLAC
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color WHITE, BLUE (light blue) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code T030;360
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-030-07 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205231 10/01/2018
Labeler — TWi Pharmaceuticals, Inc. (658402052)
Registrant — TWi Pharmaceuticals, Inc. (658402052)
Establishment
Name Address ID/FEI Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 MANUFACTURE (24979-026), MANUFACTURE (24979-027), MANUFACTURE (24979-028), MANUFACTURE (24979-029), MANUFACTURE (24979-030), ANALYSIS (24979-026), ANALYSIS (24979-027), ANALYSIS (24979-028), ANALYSIS (24979-029), ANALYSIS (24979-030)
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging 143213275 PACK (24979-026), PACK (24979-027), PACK (24979-028), PACK (24979-029), PACK (24979-030)

Revised: 09/2018 TWi Pharmaceuticals, Inc.

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