Acutrol C Tablet
Sevelamer Hydrochloride/Carbonate
400mg
Intas Pharmaceuticals Ltd.
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Available as:
Indications
Acutrol C Tablet is used for:
Hyperphosphataemia
Adult Dose
End-Stage Renal Disease
Hemodialysis; hyperphosphatemia
Initial dose
Serum PO4 >9 mg/dL [2.91 mmol/L]: 1600 mg PO q8hr with meals
Serum PO4 7.5-9 mg/dL [2.42-2.91 mmol/L]: 1200-1600 mg PO q8hr with meals
Serum PO4 5.5-7.5 mg/dL [1.78-2.42 mmol/L]: 800 mg PO q8hr with meals
Maintenance dose
Serum PO4 >5.5 mg/dL [>1.78 mmol/L]: Increase dose by 400-800 mg per meal
Serum PO4 3.5-5.5 mg/dL [1.13-1.78 mmol/L]: Maintain current dose
Serum PO4 <3.5 mg/dL [1.13 mmol/L] decrease by 400-800 mg per meal
Dosing considerations
Titrate dose; increase by 400-800 mg per meal at 2-week intervals; no more than 4 g
Switching From Ca-Acetate
Substitute 800 mg for 667 mg of Ca-acetate
Substitute 1600 for1334 mg of Ca-acetate
Substitute 2400 mg for 2001 mg Ca-acetate
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Should be taken with food.
Contra Indications
Hypophosphatemia or bowel obstruction.
Precautions
Patients w/ dysphagia, swallowing disorders, severe GI motility disorders, active inflammatory bowel disease or major GI tract surgery. Pregnancy and lactation. Monitoring Parameters Monitor serum levels of phosphate, Ca, Cl and bicarbonate. Vitamin supplementation due to reduction in vit D, E, K and folic acid absorption. Monitor for signs and symptoms of peritonitis in patients undergoing peritoneal dialysis.
Lactation: Not absorbed systemically; not excreted in breast milk
Pregnancy-Lactation
Interactions
May decrease absorption of ciprofloxacin, ciclosporin, mycophenolate, tacrolimus and levothyroxine. Sevelamer should be given 3 hr before or 1 hr after taking other drugs to minimise potential pharmacokinetic interaction.
Adverse Effects
Side effects of Sevelamer Hydrochloride/Carbonate :
>10%
Vomiting (22%),Nausea (20%),Diarrhea (19%),Dyspepsia (16%),Nasopharyngitis (14%),Limb pain (13%),Pruritus (13%),Arthralgia (12%),Bronchitis (11%),Dyspnea (10%),Hypertension (10%)
1-10%
Abdominal pain (9%),Constipation (8%),Flatulence (8%),Peritonitis (during peritoneal dialysis: 8%),Hypercalcemia (5-7%)
Frequency Not Defined
Back pain,Cough,Headache,Pyrexia,Upper respiratory infection,Pruritus,Rash,Intestinal perforation,Fecal impaction,Intestinal obstruction.
Mechanism of Action
Sevelamer, a polymeric compound, acts by binding to phosphate molecules in the gut, limiting its absorption and thus lowering serum phosphate levels w/o altering Ca, Al, or bicarbonate levels.
Note
Acutrol C 400mg Tablet manufactured by Intas Pharmaceuticals Ltd.. Its generic name is Sevelamer Hydrochloride/Carbonate. Acutrol C is availble in Nepal.
Farmaco Nepal drug index information on Acutrol C Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.