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Corvelam

Corvelam

sevelamer

Manufacturer:

Pharose

Distributor:

Corbridge
Concise Prescribing Info
Contents
Sevelamer carbonate
Indications/Uses
Control of hyperphosphatemia in adult patients receiving hemo- or peritoneal dialysis, or in adult patients w/ CKD not on dialysis w/ serum P >1.78 mmol/L.
Dosage/Direction for Use
Patient w/ serum P level >2.42 mmol/L (>7.5 mg/dL) Total daily dose: 4.8 g to be taken over 3 meals daily, 1.78-2.24 mmol/L (5.5-7.5 mg/dL) Total daily dose: 2.4 g to be taken over 3 meals daily. Patient previously on phosphate binders Give on a g for g basis w/ monitoring of serum P levels to ensure optimal daily doses.
Administration
Should be taken with food: Swallow intact, do not chew/crush/break.
Contraindications
Hypersensitivity. Hypophosphatemia. Bowel obstruction.
Special Precautions
Not recommended in adult patients w/ CKD not on dialysis w/ serum P <1.78 mmol/L. Not indicated for control of hyperparathyroidism. Safety & efficacy have not been established in patients w/ dysphagia, swallowing disorders, severe GI motility disorders (including untreated or severe gastroparesis, retention of gastric contents & abnormal or irregular bowel motion), active inflammatory bowel disease, major GIT surgery. Patients w/ CKD may develop low levels of fat-soluble vit A, D, E & K. Insufficient data to exclude possibility of folate deficiency during long term treatment. Potential absorption & accumulation during long-term chronic treatment cannot be excluded. Monitor constipated patients during treatment & re-evaluate treatment in patients who develop severe constipation or other severe GI symptoms. Monitor serum Ca levels regularly in patients w/ CKD & give elemental Ca as supplement if required; serum bicarbonate levels in patients w/ CKD; for any signs & symptoms associated w/ peritonitis in patients on peritoneal dialysis; TSH levels in concomitant use w/ levothyroxine. Caution in concomitant use w/ antiarrhythmics & anti-seizure medicinal products. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. No data on effect on fertility in humans. Pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Nausea, vomiting, upper abdominal pain, constipation. Diarrhea, dyspepsia, flatulence, abdominal pain.
Drug Interactions
Decreased bioavailability of ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil & tacrolimus in transplant patients. Very rare cases of increased phosphate levels w/ PPIs. May affect bioavailability of other medicinal products.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.
Presentation/Packing
Form
Corvelam FC tab 800 mg
Packing/Price
100's
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