POTASSIUM CHLORIDE tablet, film coated, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Preferred Pharmaceuticals Inc.

INN (mednarodno ime):

POTASSIUM CHLORIDE

Sestava:

POTASSIUM CHLORIDE 750 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Potassium chloride extended-release tablets are 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 mil

Povzetek izdelek:

Potassium chloride extended-release tablets, USP contain 600 mg, 750 mg and 1500 mg of potassium chloride (equivalent to 8 mEq, 10 mEq and 20 mEq of potassium, respectively). Potassium chloride extended-release tablets, USP are provided as extended-release, film-coated tablets. Potassium chloride extended-release 750 mg tablets (10 mEq) are ovaloid in shape, yellow in color, and are supplied and debossed as follows: NDC 68788-6771-3 NDC 68788-6771-6 NDC 68788-6771-9 Recommended Storage Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Status dovoljenje:

New Drug Application Authorized Generic

Lastnosti izdelka

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
PREFERRED PHARMACEUTICALS INC.
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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 are 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
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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 ABBVIE INC. AT
1-800-633-9110 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: 8/2020
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)
8 mEq (600 mg) oral tablets (3)
10 mEq (750 mg) oral tablets (3)
20 mEq (1500 mg) oral tablets (3)
Concomitant use with triamterene and amiloride (4, 7.1)
Gastrointestinal Adverse Reactions: Can produce ulcerative and/or
stenotic lesions of the gastrointestinal tract,
particularly when in prolonged contact with the gastroin