POTASSIUM CHLORIDE capsule, coated, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Cardinal Health 107, LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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).   Table 1: How Supplied Dose Color Printing NDC 750 mg (equivalent to 10 mEq of potassium) opaque blue "R52" - body Carton of 100 tablets (10 tablets per blister pack x 10 blister packs) NDC 0904-6930-61 750 mg (equivalent to 10 mEq of potassium) opaque blue "LU" - cap 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  

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, COATED, EXTENDED
RELEASE
CARDINAL HEALTH 107, LLC
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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_:
•
•
_Maintenance or Prophylaxis of hypokalemia_:
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
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
•
•
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)
Adults: Typical dose is 20 mEq per day (2.2)
Pediatric patients: Typical dose is 1 mEq/kg/day.(2.3)
Extended-release capsules: 600 mg (8mEq) and 750 mg (10 mEq)
Concomitant use with triamterene and amiloride.(4)
Gastrointestinal Irritation: Take with meals (5.1)
Triamter