Cartia XT (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 (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 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 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 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.

HOW SUPPLIED

NDC: 71335-0879-1: 30 Capsules in a BOTTLE

NDC: 71335-0879-2: 90 Capsules in a BOTTLE

Diltiazem Hcl ER 180mg Capsule

Label
(click image for full-size original)
CARTIA XT
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0879(NDC:62037-598)
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
ACETYLTRIBUTYL CITRATE
AMMONIO METHACRYLATE COPOLYMER TYPE B
D&C RED NO. 28
D&C YELLOW NO. 10
ETHYLCELLULOSE (10 MPA.S)
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:2)
PROPYLENE GLYCOL
POLYSORBATE 80
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow, orange Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code Andrx;598;180;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-0879-1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:71335-0879-2 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074752 07/09/1998
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-0879), RELABEL (71335-0879)

Revised: 12/2021 Bryant Ranch Prepack

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