POTASSIUM CITRATE EXTENDED RELEASE- potassium citrate tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

REMEDYREPACK INC.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 predisposing 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 patients in 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, or those taking anticholinergic medication. • In patients with peptic ulcer disease because of its ulcerogenic potential. • In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium citrate extended–release tablets to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from potassium citrate therapy might promote further bacterial growth. • In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia. 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 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 should be given to a woman who is breastfeeding only if clearly needed. Safety and effectiveness in children have not been established.

Toote kokkuvõte:

Potassium citrate extended-release tablets USP 10 mEq are uncoated, pale yellow colored, caplet shaped, bi-Convex, debossed with 'S407' on one side and plain on the other side, supplied in NDC: 70518-1221-00 PACKAGING: 100 in 1 BOTTLE PLASTIC Storage: Store in a tight container at 20°–25°C (68°–77°F), Excursions permitted between 15° and 30°C (59° and 86°F) [See USP controlled room temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

POTASSIUM CITRATE EXTENDED RELEASE- POTASSIUM CITRATE TABLET
REMEDYREPACK INC.
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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 is a citrate salt of potassium indicated for the
management of: (1)
• Renal tubular acidosis (RTA) with calcium stones (1.1) (1)
• Hypocitraturic calcium oxalate nephrolithiasis of any etiology
(1.2) (1)
• Uric acid lithiasis with or without calcium stones (1.3) (1)
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. (2)
• 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) (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) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mEq (3) (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) (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) (4