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:

TWi Pharmaceuticals, Inc.

Taoyuan City, 32063, Taiwan

Revised: 09/18

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.