POTASSIUM CHLORIDE EXTENDED-RELEASE- potassium chloride tablet, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Dostupno od:

Vitruvias Therapeutics

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Potassium chloride extended-release tablets is 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. Potassium chloride is contraindicated in patients on triamterene or amiloride. Risk Summary There are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction 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

Proizvod sažetak:

Potassium chloride extended-release tablets, USP contain 750 mg and 1500 mg of potassium chloride (equivalent to 10 mEq and 20 mEq of potassium, respectively). Potassium chloride extended-release tablets is provided as extended-release film-coated tablets. Recommended Storage Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

POTASSIUM CHLORIDE EXTENDED-RELEASE- POTASSIUM CHLORIDE TABLET,
EXTENDED RELEASE
VITRUVIAS THERAPEUTICS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS.
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1948
INDICATIONS AND USAGE
Potassium chloride extended-release tablets is 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 dosages accordingly. (2.1)
If serum potassium concentration is less than 2.5 mEq/L, use
intravenous potassium instead of oral
supplementation (2.1)
Take with meals and with a glass of water or other liquid. Swallow
tablets whole. (2.1)
Treatment of hypokalemia: Typical dose range is 40-100 mEq per day in
divided doses. Limit doses to
20 mEq per dose. (2.2)
Prevention of hypokalemia: Typical dose is 20 mEq per day (2.2)
DOSAGE FORMS AND STRENGTHS
10 mEq (750 mg) oral tablets (3)
20 mEq (1500 mg) oral tablets (3)
CONTRAINDICATIONS
Concomitant use with triamterene and amiloride (4, 7.1)
WARNINGS AND PRECAUTIONS
Gastrointestinal Adverse Reactions: Can produce ulcerative and/or
stenotic lesions of the
gastrointestinal tract, particularly when in prolonged contact with
the gastrointestinal mucosa. 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 VITRUVIAS AT
1-844-451-5944 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Renin-angiotensin-aldosterone system inhibitors: Monitor for
hyperkalemia (7.2)
Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia