Fosrenol Lanthanum Carbonate Chewable Tablets

1. Indications and Usage
Hyperphosphatemia in Chronic Kidney Disease (CKD):
Treatment of hyperphosphatemia in adult patients with End-Stage Renal Disease (ESRD) on dialysis.
Note: Also indicated for CKD patients not on dialysis with serum phosphorus ≥ 5.5 mg/dL (≥ 1.78 mmol/L).
2. Dosage and Administration
Route of Administration:
Oral administration.
Recommended Dosage:
Initial Dose: 750 mg (1 tablet) three times daily with meals.
Titration: Dosage should be adjusted every 2–3 weeks based on serum phosphorus levels.
Maintenance Dose: Typically 1500 mg to 3000 mg per day, divided into three doses.
Maximum Dose: 3750 mg per day.
Critical Administration Instructions:
Chew Thoroughly: These are Chewable Tablets. They MUST be chewed completely before swallowing. Do not swallow whole.
With Food: Must be taken with meals or immediately after eating to effectively bind dietary phosphorus.
3. Mechanism of Action
Polymeric Phosphate Binder:
Lanthanum Carbonate is a rare earth metal salt that contains no calcium or aluminum.
Gastric Acid-Dependent Binding:
In the acidic environment of the stomach, lanthanum ions (La³⁺) are released from the carbonate base.
Therapeutic Result: Lanthanum binds with high affinity to dietary phosphate in the gastrointestinal tract to form insoluble lanthanum phosphate complexes. These complexes are not absorbed and are excreted in the feces, thereby reducing serum phosphorus levels.
4. Safety and Warnings
Gastrointestinal Obstruction/Perforation:
Severe gastrointestinal adverse events, including obstruction and perforation, have been reported.
Action: Use with caution in patients with severe gastrointestinal motility disorders or recent GI surgery. Ensure patients chew the tablets thoroughly.
Long-Term Accumulation:
Lanthanum can accumulate in the body over long-term use (primarily in bone), although clinical significance is not fully established.
Electrolyte Imbalances:
Can cause hypocalcemia (low calcium) and hypophosphatemia. Monitor serum calcium and phosphorus levels regularly.
Contraindications:
Hypophosphatemia.
Bowel obstruction.
5.Adverse Reactions
Most Common:
Nausea, vomiting, diarrhea, abdominal pain, dyspepsia, constipation, and headache.
6.Drug Interactions
Absorption Interference:
May reduce the absorption of concomitantly administered oral medications.
Action: Administer other oral drugs at least 2 hours before or 4 hours after Lanthanum Carbonate.
Specific Drugs:
Fluoroquinolones: Significantly reduces bioavailability of ciprofloxacin.
Thyroid Hormones: May reduce absorption of levothyroxine.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Lanthanum Carbonate Hydrate.
Appearance: White to off-white, film-coated chewable tablets (e.g., 500 mg, 750 mg).
Packaging: Bottles or Blister packs.
Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Protect from moisture.