POTASSIUM CHLORIDE capsule, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152)

זמין מ:

Padagis US LLC

INN (שם בינלאומי):

Potassium Chloride

הרכב:

Potassium Chloride 600 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 2-4% and 15-20%, respectively. Risk Su

leaflet_short:

Potassium chloride extended-release capsules contain 600 mg and 750 mg mg of potassium chloride (equivalent to 8 mEq and 10 mEq, respectively). Table 1: How Supplied Dose Color Printing Bottle Count NDC 600 mg (8 mEq) White PAD over 0180 100 0574-0180-01 750 mg (10 mEq) White PAD over 0181 90 0574-0181-90 100 0574-0181-01 500 0574-0181-05 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature ]. Dispense in tight container. Rx only

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
PADAGIS US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE
EXTENDED-RELEASE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP.
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP FOR ORAL USE
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) (2)
_Treatment of hypokalemia:_ (2)
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_Maintenance or Prophylaxis of hypokalemia:_ (2)
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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 PERRIGO AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2018
Adults: Typical doses range from 40-100 mEq/day in 2-5 divided doses;
limit doses to 40 mEq per
dose. (2.2)
Pediatric patients: 2-4 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