- Approval Id
- 32a84c672fabd561
- Drug Name
- Fosrenol Chewable Tablets 1000mg
- Product Name
- Fosrenol Chewable Tablets 1000mg
- Approval Number
- SIN13596P
- Approval Date
- 2009-01-23
- Registrant
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Licence Holder
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, CHEWABLE
- Dosage
- **DOSAGE AND ADMINISTRATION**
Patients should adhere to recommended diets in order to control phosphate and fluid intake. Tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed.
Adults, including elderly (>65 years)
For patients taking FOSRENOL for the first time, the starting dose may be determined individually based on serum phosphate concentration as indicated below:
Pre-treatment serum phosphate levelRecommended initial daily dose of FOSRENOL>1.8 and ≤2.4 mmol/L750 mg>2.4 and ≤2.9 mmol/L1500 mg>2.9 mmol/L2250 mg
FOSRENOL should be taken with or immediately after food, with the daily dose divided between meals, i.e. three times daily. Serum phosphate levels should be monitored and the dose of FOSRENOL titrated every 2–3 weeks until an acceptable serum phosphate level is reached, with regular monitoring thereafter.
Control of serum phosphate level has been demonstrated at doses from 750 mg with most patients achieving acceptable serum phosphate levels at 1500 – 3000 mg lanthanum per day.
Hepatic impairment
The effect of hepatic impairment on FOSRENOL pharmacokinetics has not been formally assessed. Due to its mechanism of action and the lack of liver metabolism, doses in hepatic impairment should not be modified, but patients should be monitored carefully (see PRECAUTIONS and PHARMACOLOGY, Pharmacokinetic Properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Children and Adolescents
The safety and efficacy of FOSRENOL has not been established in patients below the age of 18 years.
- Route Of Administration
- ORAL
- Indication Info
- **INDICATIONS**
Treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
- Contraindications
- **CONTRAINDICATIONS**
Hypersensitivity to lanthanum or any of the excipients in the product.
Hypophosphataemia.
FOSRENOL is contraindicated in patients with bowel obstruction, ileus and faecal impaction.
- Atc Code
- V03AE03
- Atc Item Name
- lanthanum carbonate
- Pharma Manufacturer Name
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Company Detail Path
- /organization/takeda-pharmaceuticals-asia-pacific-pte-ltd
