Renagel Tablets / Film-coated
Sevelamer Hydrochloride/Carbonate
800mg
GENZYME IRELAND LIMITED
| Pack size | 180's Plastic Bottle |
|---|---|
| Dispensing mode | POM |
| Source | IRELAND |
| Agent | GULF DRUG EST. |
| Retail Price | 891.50 AED |
Indications
Renagel Tablets / Film-coated 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
Pregnancy: Not absorbed systemically following oral administration and maternal use not expected to result in fetal exposure to the drug
May decrease serum levels of fat soluble vitamins and folic acid in pregnant women; consider supplementation
Lactation: Not absorbed systemically by mother following oral administration; breastfeeding is not expected to result in exposure of child to drug
May decrease serum levels of fat soluble vitamins and folic acid in pregnant women; consider supplementation
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
Renagel 800mg Tablets / Film-coated manufactured by GENZYME IRELAND LIMITED. Its generic name is Sevelamer Hydrochloride/Carbonate. Renagel is availble in United Arab Emirates.
Farmaco UAE drug index information on Renagel Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.