POTASSIUM CHLORIDE capsule, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Solco Healthcare LLC

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

Potassium chloride extended-release capsules, USP, contain 600 mg and 750 mg of potassium chloride (equivalent to 8 mEq and 10 mEq, respectively). Table 1: How Supplied Dose Color Printing NDC#: 43547-xxx-xx Bottle Count 100 500 600 mg (8 mEq) white plain - body 552-10 - P532 - cap 750 mg (10 mEq) light blue plain - body 553-10 553-50 P533 - cap Store at 20o to 25o C (68o to 77o F); excursions are permitted to 15o to 30o C (59o to 86o F) [See USP Controlled Room Temperature.] Dispense in tight, light-resistant container as defined in the USP. Rx only

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
SOLCO HEALTHCARE 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 SOLCO HEALTHCARE US,
LLC AT 1-866-257-
2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2021
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 triamt