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:

Proficient Rx LP

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 750 mg of potassium chloride (equivalent to 10 mEq. Potassium chloride extended-release tablets is provided as extended release tablets. Table 1: How Supplied Dose Shape Color Debossment Count NDC# 750 mg (10 mEq) round Yellow “9Q3” 90 71205-996-90 100 71205-996-00 180 71205-996-78 270 71205-996-65 360 71205-996-97 500 71205-996-55 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
PROFICIENT RX LP
----------
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
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) (3)
CONTRAINDICATIONS
•
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
•
•
•
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2022
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)
Concomitant use with triamterene and amiloride (4)
Triamterene and amiloride: Concomitant use is contraindicated (7.1)
Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia
(7.2)
Nonsteroidal anti-infla