POTASSIUM CHLORIDE capsule, coated, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Sẵn có từ:

Lupin Pharmaceuticals, Inc.

INN (Tên quốc tế):

POTASSIUM CHLORIDE

Thành phần:

POTASSIUM CHLORIDE 10 meq

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.   Potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene.   Risk Summary There are no human data related to use of potassium chloride extended-release capsules during pregnancy and animal reproductive studies have not been conducted.  Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm.   The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respecti

Tóm tắt sản phẩm:

Potassium chloride Extended-Release Capsules USP contain 600 mg and 750 mg of potassium chloride (equivalent to 8 mEq and 10 mEq of potassium, respectively).   Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature] . Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure. Rx only  

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, COATED, EXTENDED
RELEASE
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES
POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES FOR ORAL
ADMINISTRATION
INITIAL U.S. APPROVAL: 1948
INDICATIONS AND USAGE
Potassium chloride extended-release capsules, USP contain potassium
chloride, a potassium salt
indicated for the treatment and prophylaxis of hypokalemia with or
without metabolic alkalosis, in patients
for whom dietary management with potassium-rich foods or diuretic dose
reduction is insufficient.(1)
DOSAGE AND ADMINISTRATION
Monitor serum potassium and adjust dosage accordingly (2.1)
If serum potassium concentration is <2.5 mEq/L, use intravenous
potassium instead of oral
supplementation.(2.1)
_Treatment of hypokalemia_:
Adults: Typical doses range from 40 to 100 mEq/day in 2 to 5 divided
doses; limit doses to 40 mEq per
dose.(2.2)
Pediatric patients: 2 to 4 mEq/kg/day in divided doses not to exceed 1
mEq/kg as a single dose or 20
mEq, whichever is lower; if deficits are severe or ongoing losses are
great, consider intravenous
therapy.(2.3)
_Maintenance or Prophylaxis of hypokalemia_:
Adults: Typical dose is 20 mEq per day (2.2)
Pediatric patients: Typical dose is 1 mEq/kg/day.(2.3)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 600 mg (8mEq) and 750 mg (10 mEq)
CONTRAINDICATIONS
Concomitant use with triamterene and amiloride.(4)
WARNINGS AND PRECAUTIONS
Gastrointestinal Irritation: Take with meals (5.1)
ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, flatulence,
abdominal pain/discomfort, and
diarrhea.(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS,
INC. AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Triamterene and amiloride: Concomitant us