POTASSIUM CHLORIDE EXTENDED RELEASE- potassium chloride tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 and 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

Περίληψη προϊόντος:

Potassium chloride extended-release tablets (potassium chloride, USP) contains 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq and 10 mEq respectively. Potassium chloride extended-release tablets is provided as extended release tablets. Table 1: How Supplied Dose Shape Color Debossment Count NDC# 600 mg (8 mEq) round Light blue “1G5” 100 0574-0274-01 500 0574-0274-05 750 mg (10 mEq) round Yellow “9Q3” 100 0574-0275-01 500 0574-0275-05 Carton of 100 (10x10 blisters) 0574-0275-11 Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature.]. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

POTASSIUM CHLORIDE EXTENDED RELEASE- POTASSIUM CHLORIDE TABLET,
EXTENDED RELEASE
REMEDYREPACK 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, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR POTASSIUM CHLORIDE
EXTENDED-RELEASE TABLETS, USP.
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 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 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 without crushing, chewing or sucking.
(2.1)
Treatment of hypokalemia: Doses range from 40-100 mEq/day in divided
doses. Limit doses to 40 mEq per dose. (2.2)
Prevention of hypokalemia: Typical dose is 20 mEq per day. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) (3)
CONTRAINDICATIONS
Concomitant use with triamterene and amiloride (4)
WARNINGS AND PRECAUTIONS
Gastrointestinal Irritation: Take with meals (5.1) (5)
ADVERSE REACTIONS
The most common adverse reactions are nausea, vomiting, flatulence,
abdominal pain/discomfort and diarrhea. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO AT
1-866-634-9120 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Triamterene and amiloride: Concomitant use is contraindicated (7.1)
Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia
(7.2)
Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia (7.3)
USE IN SPECIFIC POPULATIONS
Cirrhosis: Initiate therapy at the low end of the dosing