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All product prices are in US dollars.
US Brand Name Fosrenol
Generic Name Lanthanum Carbonate
Other Brand Name Fosbait, Lanthonate
Packing 10
Manufacturer Micro Labs Ltd, Dr.Reddy, Panacea Biotec
Form Tablet, Chewable Tablet
Strength 250mg, 500mg
Country India

  • 250mg 10 tabs $6.90
  • 500mg 10 tabs $11.90
  • 500mg 30 Chewable Tab $59.00
Available online

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  • Lanthonate, Lanthanum Carbonate

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1

Details

Introduction

Pharmacotherapeutic group are the drugs for treatment of hyperkalaemia and hype phosphatemia. It contains lanthanum carbonate hydrate. Lanthanum carbonate hydrate activity of phosphate fixation is dependent high affinity of lanthanum ions that are released from carbonate salt in the acidic environment of the stomach for food phosphate. Form insoluble lanthanum phosphate, which reduces the absorption of phosphate in the gastrointestinal tract.


Use

Lanthanum Carbonate is indicated as a fixing agent used to control phosphate hyper phosphatemia in patients with chronic renal failure undergoing continuous ambulatory hemodialysis or peritoneal dialysis (CAPD).


Side effects

The safe use of it in patients with end stage renal failure (News) maintained on hemodialysis and peritoneal dialysis was examined in three double-blind placebo-controlled short-term, three-controlled studies and three studies of long-term open long-term. These studies have provided basic safety data from a total of 1754 patients treated with lanthanum carbonate hydrate, 495 patients with more than 1 year of treatment and 130 patients with more than 2 years of treatment and being average exposure of 272.1 days (median 184.0 days, between 1 and 1123 days). Approximately 24% of all patients who participated in the NEWS clinical studies have reported drug-related effect, as determined by the investigator. No individual adverse reactions were reported more frequently than 10%. The most common side effects reported, except for hypocalcaemia, are gastrointestinal in nature; they are minimized by administering it with food and generally diminish over time with continued treatment.


Contraindication

Hypersensitivity to lanthanum carbonates hydrate or any of the excipients. Hypo phosphatemia.


storage

This medicinal product does not require any special storage conditions.


Composition

Each chewable tablet contains lanthanum carbonate hydrate corresponding to lanthanum 250 mg, 500 mg respectively. Excipients: Dextral (hydrated) Silica colloidal anhydrous Magnesium stearate.


Important Precautions

In animal studies with it, lanthanum has been shown in tissue deposition. In 105 bone biopsies taken from patients treated with it, some up to 4.5 years, an increase of lanthanum values over time. There are no clinical data on deposition of lanthanum in other human tissues. Safety data for periods over 24 months are currently limited. Risks / benefits due to long-term treatment should be considered carefully. Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with it. Patients with renal insufficiency may develop hypocalcaemia. It does not contain calcium. Therefore, serum calcium should be monitored at regular intervals for these patients and appropriate supplements given. There are no pharmacokinetic data in patients with hepatic impairment. Lanthanum is not metabolized by liver enzymes, but is most likely excreted in bile. Disease resulting in marked reduction of bile flow may be associated with the elimination of slow growing lanthanum, which may result in increased plasma levels and increased deposition of lanthanum in tissues. Therefore, caution should be exercised in treating these patients and may require monitoring of liver function. Safety and efficacy have not been established in pediatric patients, it is not recommended in children. Its treatment should be discontinued if hypo phosphatemia. Abdominal radiographs of patients taking lanthanum carbonate may have a typical radio-opacity of a contrast medium.


Dosage and administration

Lanthanum Carbonate is administered orally. Tablets should be chewed and not swallowed completely. Experience on therapy longer than two years is limitata. Riscurile / benefits due to long-term treatment for more than two years should be considered carefully. Adults, including elderly (aged> 65 years) Lanthanum Carbonate should be taken with food or immediately after meals, the daily dose divided by the number of meals. Patients should adhere to recommended diets to control phosphate and fluid intake. It is presented as chewable tablets, thus avoiding the need to ingest additional fluids. Plasma levels of phosphate should be monitored and the dose of it, titrated every 2-3 weeks until reaching an acceptable serum phosphate, with subsequent regular monitoring. Controlling serum phosphate concentration was demonstrated with doses from 750 mg per day. The maximum dose studied in clinical trials in a limited number of patients is 3750 mg. Patients who respond to treatment with lanthanum usually achieve acceptable serum phosphate at doses of 1500-3000 mg lanthanum per day. Children and adolescents Safety and efficacy have not been established in patients less than 18 years. Hepatic insufficiency The effect of hepatic impairment on the pharmacokinetics of, it has not been evaluated. Due to its mechanism of action and lack of hepatic metabolism, doses should not be altered in hepatic, but patients should be closely monitored.