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:

Bryant Ranch Prepack

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 2-4% and 15-20%, respectively. Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition from birth to 18 years. Clinical studies of potassium chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently [see Clinical Pharmacology (12.3)]. Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors or nonsteroidal anti-inflammatory drugs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions (7.2, 7.3)] . The serum potassium level should be monitored frequently. Renal function should be assessed periodically.

Podsumowanie produktu:

Potassium chloride extended-release capsules, USP, 8 mEq contain 600 mg of potassium chloride (equivalent to 8 mEq). NDC: 63629-1077-1: 90 Capsules in a BOTTLE NDC: 63629-1077-2: 360 Capsules in a BOTTLE Store at 20° to 25°C (68°-77°F); excursions are permitted to 15° to 30°C (59°-86°F) [see USP Controlled Room Temperature.] Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
BRYANT RANCH PREPACK
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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 40-100 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)
_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, CONTACTTHE MANUFACTURER ADARE
AT 1-877-731-
5116,OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Triamterene and amiloride: Concomitant use is contraindicated (7.1)
Renin-ang