POTASSIUM CHLORIDE tablet, film coated, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Zydus Pharmaceuticals USA Inc

INN (International Name):

POTASSIUM CHLORIDE

Sammensætning:

POTASSIUM CHLORIDE 750 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 milk is about 13 mEq per liter. Since potassium from oral supplements such as potassium chloride extended-release tablets 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. Safety and effectiveness of potassium chloride extended-release tablets in children have not been established. Clinical studies of potassium chloride extended-release tablets 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. Doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. 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. 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 NSAIDs, 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.

Produkt oversigt:

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. Recommended Storage Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Autorisation status:

New Drug Application Authorized Generic

Produktets egenskaber

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
ZYDUS PHARMACEUTICALS USA INC
----------
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-inflam