POTASSIUM CITRATE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Upsher-Smith Laboratories, LLC

INN (الاسم الدولي):

potassium citrate

تركيب:

potassium citrate 5 meq

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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: - In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride). - In p

ملخص المنتج:

Potassium citrate extended-release tablets 5 mEq are uncoated, tan to yellowish in color, modified ball shaped, debossed with "USL" on one side and "070" on the other, supplied in bottles as: Potassium citrate extended-release tablets 10 mEq are uncoated, tan to yellowish in color, elliptical shaped, debossed with "USL" on one side and "071" on the other, supplied in bottles as: Storage: Store in a tight container.

الوضع إذن:

New Drug Application

خصائص المنتج

POTASSIUM CITRATE- POTASSIUM CITRATE TABLET
UPSHER-SMITH LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
POTASSIUM CITRATE 5 AND 10 MEQ EXTENDED RELEASE TABLETS FOR ORAL USE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CITRATE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR POTASSIUM
CITRATE.
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Potassium citrate is a citrate salt of potassium indicated for the
management of:
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)
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.
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mEq and 10 mEq ( 3)
CONTRAINDICATIONS
Patients with hyperkalemia (or who have conditions predisposing them
to hyperkalemia). Such
conditions include chronic renal failure, uncontrolled diabetes
mellitus, acute dehydration, strenuous
physical exercise in unconditioned individuals, adrenal insufficiency,
extensive tissue breakdown ( 4)
Patients for whom there is cause for arrest or delay in tablet passage
through the gastrointestinal tract
such as those suffering from delayed gastric emptying, esophageal
compression, intestinal obstruction
or stricture ( 4)
Patients with peptic ulcer disease ( 4)
Patients with active urinary tract infection ( 4)