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, CHLORIDE ION - UNII:Q32ZN48698)

Διαθέσιμο από:

Bora Pharmaceutical Laboratories 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 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

Περίληψη προϊόντος:

Potassium chloride extended-release tablets, USP contain 750 mg and 1500 mg of potassium chloride (equivalent to 10 mEq and 20 mEq of potassium, respectively). Potassium chloride extended-release tablets is provided as extended-release film-coated tablets. Recommended Storage Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

POTASSIUM CHLORIDE EXTENDED-RELEASE- POTASSIUM CHLORIDE TABLET,
EXTENDED RELEASE
BORA PHARMACEUTICAL LABORATORIES 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 is a potassium salt
indicated for:
the treatment of hypokalemia with or without metabolic alkalosis, in
digitalis intoxication, and in
hypokalemic familial periodic paralysis ( 1)
the prevention of hypokalemia in patients who would be at particular
risk if hypokalemia were to develop
( 1)
DOSAGE AND ADMINISTRATION
Monitor serum potassium and adjust dosages accordingly. ( 2.1)
Take with meals and with a glass of water or other liquid. Swallow
tablets whole. ( 2.1)
Treatment of hypokalemia: Doses range from 40-100 mEq/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
750 mg oral tablets (10 mEq) ( 3)
1500 mg oral tablets (20 mEq) ( 3)
CONTRAINDICATIONS
Concomitant use with potassium sparing diuretics ( 4)
Known hypersensitivity to any product ingredient ( 4)
Structural, pathological, or pharmacologic cause for arrest or delay
in tablet passage through the
gastrointestinal tract ( 4)
WARNINGS AND PRECAUTIONS
Hyperkalemia: May occur in patients with impaired mechanisms for
excreting potassium ( 5.1)
Gastrointestinal lesions: Discontinue immediately if severe vomiting,
abdominal pain, distention, or
gastrointestinal bleeding occur. Do not take on an empty stomach.
(5.2)
Metabolic acidosis: Treat hypokalemia with an alkalinizing potassium
salt. (5.3)
ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, flatulence,
abdominal pain/discomfort, and
diarrhea ( 6)
TO REPORT SUSPECT