POTASSIUM CHLORIDE tablet, film coated, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Mylan Pharmaceuticals Inc.

INN (שם בינלאומי):

POTASSIUM CHLORIDE

הרכב:

POTASSIUM CHLORIDE 8 meq

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 and amiloride. 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. The normal potassium ion content of human milk is about 13 mEq per lit

leaflet_short:

Potassium Chloride Extended-Release Tablets, USP are available containing 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq, respectively). The 8 mEq (600 mg) tablets are light brown, film-coated, round, unscored tablets debossed with M on one side of the tablet and PC2 on the other side. They are available as follows: NDC 0378-4560-77 bottles of 90 tablets NDC 0378-4560-05 bottles of 500 tablets The 10 mEq (750 mg) tablets are peach, film-coated, round, unscored tablets debossed with M on one side of the tablet and PC1 on the other side. They are available as follows: NDC 0378-4561-77 bottles of 90 tablets NDC 0378-4561-05 bottles of 500 tablets 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 as defined in the USP using a child-resistant closure.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
MYLAN 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
Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) 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: 4/2020
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)
Gastrointestinal Irritation: Take with meals (5.1)
The most common adverse reactions are nausea, vomiting, flatulence,
abdominal pain/discomfort and diarrhea. (6)
Triamterene and amiloride: Concomitant use is contraindicated (7.1)
Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia
(7.2)
Nonsteroid