Renosev 800

Sevelamer Hydrochloride/Carbonate is used to treat increased phosphate level in the blood. It is used in patients who are on dialysis due to severe kidney disease. It inhibits the absorption of phosphate from the intestine and lower the phosphate levels in the blood. Sevelamer Hydrochloride/Carbonate should be taken with food. Take it in the dose and duration as advised by your doctor. Take it regularly and at a fixed time each day to get maximum benefit of the medicine. Using of Sevelamer Hydrochloride/Carbonate may cause side effects such as nausea, vomiting, abdominal pain, constipation and diarrhea. You may also develop low levels of calcium, folic acid and vitamins A, D, E and K in your blood. Take necessary supplements as advised by your doctor. Sevelamer Hydrochloride/Carbonate inhibits the absorption of phosphate from the intestine and lower the phosphate levels in the blood.

• High phosphate levels in blood

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.

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

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Sevelamer Hydrochloride/Carbonate is to be taken with food.

If you miss a dose of Sevelamer Hydrochloride/Carbonate, skip it and continue with your normal schedule. Do not double the dose.

Common: • Nausea • Vomiting • Upper abdominal pain • Flatulence • Constipation • Diarrhea

[CONSULT YOUR DOCTOR] It is not known whether Sevelamer Hydrochloride/Carbonate alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react. Sevelamer Hydrochloride/Carbonate is used to control blood phosphate level in patients that are on dialysis treatment. You must take it with food and stick to the diet prescribed by your doctor. You may develop low levels of calcium, folic acid, and vitamins A,D,E, and K in your blood. Your doctor may prescribe supplements, if necessary. Avoid taking any other medicine 1 hour before or 3 hours after taking Sevelamer Hydrochloride/Carbonate. Inform your doctor if you have nausea, vomiting, constipation, pain in the abdomen, or if you have undergone any major stomach surgery.

Hypophosphatemia or bowel obstruction.

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.

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Sevelamer Hydrochloride/Carbonate. Please consult your doctor.

[CONSULT YOUR DOCTOR] Sevelamer Hydrochloride/Carbonate may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[SAFE IF PRESCRIBED] Sevelamer Hydrochloride/Carbonate is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.

[SAFE IF PRESCRIBED] Sevelamer Hydrochloride/Carbonate is safe to use in patients with kidney disease. No dose adjustment of Sevelamer Hydrochloride/Carbonate is recommended. However, regular monitoring of calcium levels is advisable in these patients. [SAFE IF PRESCRIBED] Sevelamer Hydrochloride/Carbonate is probably safe to use in patients with liver disease. Limited data available suggests that dose adjustment of Sevelamer Hydrochloride/Carbonate may not be needed in these patients. Please consult your doctor.

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