POTASSIUM CHLORIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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%, respectiv

Product summary:

Potassium chloride extended-release capsules USP, 8 mEq are white opaque capsules, imprinted with Andrx logo on the cap and 559 on the body, each containing 600 mg microencapsulated potassium chloride (equivalent to 8 mEq K) in bottles of 100 (NDC 62037-559-01) and bottles of 500 (NDC 62037-559-05). 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 bottles of 90 (NDC 62037-560-90), bottles of 100 (NDC 62037-560-01), bottles of 500 (NDC 62037-560-05) and bottles of 1000 (NDC 62037-560-10). 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.                                                                                                                     

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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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 USE
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:_
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 TEVA AT 1-888-838-2872
OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Triamterene and amiloride: Concomitant use is contraindicated (7.1)
Renin-angiotensin