POTASSIUM CHLORIDE tablet, film coated, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

American Health Packaging

INN（国際名）:

POTASSIUM CHLORIDE

構図:

POTASSIUM CHLORIDE 750 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 h

製品概要:

Potassium chloride extended-release tablets, USP contain 750 mg of potassium chloride (equivalent to 10 mEq of potassium). Potassium chloride extended-release tablets, USP are provided as extended-release, film-coated tablets. Potassium chloride extended-release 10 mEq (750 mg) are ovaloid, yellow, debossed with the “a” logo on one side and “K-TAB” on the other side. Potassium chloride extended-release 10 mEq (750 mg) tablets are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-524-01 Recommended Storage Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

認証ステータス:

New Drug Application Authorized Generic

製品の特徴

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
AMERICAN HEALTH PACKAGING
----------
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
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
8 mEq (600 mg) oral tablets (3)
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 ABBVIE INC. AT
1-800-633-9110 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-inflammato