POTASSIUM CHLORIDE EXTENDED RELEASE- potassium chloride tablet, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Cardinal Health 107, LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so 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 in the pediatric population 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. Based on publish 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 [see Clinical Pharmacology (12.3)]. Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia [see Warnings and Precautions (5.2)] . 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.

Povzetek izdelek:

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# 750 mg (10 mEq) round Yellow “9Q3” Overbagged with 10 tablets per bag 55154-6709-0 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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

POTASSIUM CHLORIDE EXTENDED RELEASE- POTASSIUM CHLORIDE TABLET,
EXTENDED RELEASE
CARDINAL HEALTH 107, LLC
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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
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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 PADAGIS AT
1-866-634-9120 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: 2/2024
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)
Nonsteroi