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Renafos

Renafos

sevelamer

Manufacturer:

Fahrenheit Synthon
Concise Prescribing Info
Contents
Sevelamer carbonate
Indications/Uses
Control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis or w/ CKD not on dialysis w/ serum P ≥1.78 mmol/L. Used w/in the context of a multiple therapeutic approach that includes Ca supplement, 1,25-dihydroxy vit D3 or 1 of its analogues to control renal bone disease development.
Dosage/Direction for Use
Recommended starting dose: 2.4 g or 4.8 g daily based on serum P levels taken 3 times daily. Total daily dose over 3 meals daily: Patient w/ serum P level >2.42 mmol/L (>7.5 mg/dL) 4.8 g; 1.78-2.42 mmol/L (5.5-7.5 mg/dL) 2.4 g. Titration & maintenance: Titrate dose every 2-4 wk until acceptable serum P level is reached, w/ regular monitoring thereafter. Continuous treatment based on the need to control serum P levels & w/ expected ave daily dose of approx 6 g daily.
Administration
Should be taken with food: Swallow whole, do not crush/chew/break tab.
Contraindications
Hypersensitivity. Hypophosphataemia, bowel obstruction.
Special Precautions
Not recommended in adults w/ CKD not on dialysis w/ serum P <1.78 mmol/L. 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 GI tract surgery. Carefully monitor & re-evaluate patients who develop severe constipation or other severe GIT symptoms. Patients w/ CKD who develop low levels of fat-soluble vit A, D, E & K; hypo- or hypercalcaemia; metabolic acidosis. Regularly assess serum vit A, D, E, & K status in patients not taking supplemental vit. Additional fat-soluble vit & folic acid monitoring in patients undergoing peritoneal dialysis. Possible folate deficiency during long term use. Monitor serum Ca levels at regular intervals; bicarbonate levels. Closely monitor patients on peritoneal dialysis & ensure correct use of appropriate aseptic technique w/ prompt recognition & management of signs & symptoms associated w/ peritonitis; w/ hypothyroidism & recommended to administer w/ levothyroxine. Long-term chronic treatment. Not indicated for control of hyperparathyroidism. 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. Concomitant use w/ levothyroxine; anti-arrhythmics & anti-seizure medicinal products. Administer other medicinal products at least 1 hr before or 3 hr after treatment as it may affect bioavailability.
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
Renafos FC tab 800 mg
Packing/Price
1 × 30's
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