POTASSIUM CITRATE tablet, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Fáanlegur frá:

Bryant Ranch Prepack

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)] . Potassium citrate is indicated for the management of hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)] . Potassium citrate is indicated for the management of uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)] . Potassium citrate extended-release tablets are contraindicated: Animal reproduction studies have not been conducted. It is also not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate extended-release tablets should be given to a pregnant woman only if clearly needed. The normal potassium ion content of human milk is about 13 mEq/L. It is not known if potassium citrate has an effect on this content. Potassium citrate extended-release tablets should be given to a woman who is breastfeeding only if clearly needed. Safety and effectiveness in children have not been established.

Vörulýsing:

Potassium Citrate Extended-Release Tablets USP 15 mEq are off-white to yellow in color, capsule shaped, debossed with “ANI 292” and supplied in bottles of 100 tablets (NDC 63629-1967-1). Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a tight container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

POTASSIUM CITRATE- POTASSIUM CITRATE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CITRATE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS.
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Potassium Citrate Extended-Release Tablets are a citrate salt of
potassium indicated for the management
of:
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DOSAGE AND ADMINISTRATION
Objective: To restore normal urinary citrate (greater than 320 mg/day
and as close to the normal mean of
640 mg/day as possible), and to increase urinary pH to a level of 6.0
to 7.0.
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DOSAGE FORMS AND STRENGTHS
Tablets: 10 mEq and 15 mEq (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Some patients may develop minor gastrointestinal complaints such as
abdominal discomfort, vomiting,
diarrhea, loose bowel movements or nausea. These may be alleviated by
taking the dose with meals or
snacks or by reducing the dosage (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ANI PHARMACEUTICALS,
INC. AT 1-800-308-
6755 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
Renal tubular acidosis (RTA) with calcium stones (1.1)
Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2)
Uric acid lithiasis with or without calcium stones (1.3)
Severe hypocitraturia (urinary citrate < 150 mg/day): therapy should
be initiated at 60 mEq per day; a
dose of 30 mEq two times per day or 20 mEq three times per day with
meals or within 30 minutes
after meals or bedtime snack (2.2)
Mild to moderate hypocitraturia (urinary citrate >150 mg/day): therapy
should be initiated at 30 mEq
per day; a dose of 15 mEq two times per day or 10 mEq three times per
day with meals or within 30
minutes after meals or bedtime snack (2.3)
Patients with hyperkalemia (or who have conditions predisposing them
to hy