POTASSIUM CHLORIDE capsule, 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:

Major Pharmaceuticals

INN (International Nazwa):

POTASSIUM CHLORIDE

Skład:

POTASSIUM CHLORIDE 750 mg

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%, respectivel

Podsumowanie produktu:

Potassium Chloride Extended-release Capsules USP, 10 mEq are dark blue opaque capsules, imprinted with Andrx logo on the cap and 560 on the body, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in Cartons of 100 capsules (10 capsules each blister pack x 10) NDC 0904-6068-61 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.                                                                                                                     

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
MAJOR PHARMACEUTICALS
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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 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:_
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_Maintenance or Prophylaxis of hypokalemia:_
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, flatulence,
abdominal pain/discomfort, and diarrhea. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACTAVIS AT
1-800-272-5525 OR FDA AT 1-800-FDA-1088
OR HTTP://WWW.FDA.GOV/ FOR VOLUNTARY REPORTING OF ADVERSE REACTIONS.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2019
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 (1