Biocal Kit Tablet

This kit is indicated for the treatment and prevention of osteoporosis.

Each kit contains-

• Ibandronic Acid Tablet: Each coated tablet contains Ibandronate Sodium Monohydrate Ph. Eur. equivalent to 150 mg Ibandronic Acid.
• Calcium (Algae Source) + Vitamin D3 Tablets: Each coated tablet contains Calcium Carbonate USP (Algae Source) equivalent to 600 mg elemental Calcium & Colecalciferol Concentrate BP equivalent to 400 IU Vitamin D3.

Ibandronic Acid: Ibandronic Acid (Ibandronate Sodium Monohydrate) is a nitrogen-containing bisphosphonate that inhibits osteoclast mediated bone resorption. The action of ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

Calcium (Algae Source) and Vitamin D3: Calcium from algae source is a plant based algae which is hand harvested, sun dried, then milled into a powder. The algae plant draws Calcium and 12 other essential bone supporting minerals from seawater. The pharmacokinetic profiles of Calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed in the gastro-intestinal tract while the remainder reverts to insoluble calcium carbonate and calcium stearate, and is excreted in the feces. Vitamin D3 aids in the absorption of calcium from Gl tract and helps to maintain calcium balance in the body.

Day 1 to Day 10: Take one Calcium & Vitamin D3 tablet daily after meal.

Day 11: Take one Ibandronic Acid tablet with a full glass of plain water 1 hour before the breakfast in empty stomach. After taking Ibandronic Acid tablet, patient can usually sit or walk around but must not lie down or take any food or liquid (except plain water) for 1 hour.

Day 11 to Day 30: Take one Calcium & Vitamin D3 tablet daily after meal.

Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established.

Ibandronic Acid: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with absorption of ibandronic acid. Because aspirin, NSAIDs and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with ibandronic acid.

Calcium (Algae Source) and Vitamin D3: Biocal Kit has possible interaction with digoxin, antacids containing calcium, aluminium or magnesium, other calcium supplements and calcitriol. Oral calcium can reduce the absorption of tetracycline, doxycycline, aminocycline or oxytetracycline. Thiazide diuretics reduce the renal excretion of calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of vitamin D.

Drug interaction with food and others: Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of calcium. Calcium supplements, antacids and some oral medications may interfere with absorption of ibandronate.

This kit is contraindicated in patients with known hypersensitivity to ibandronic acid or calcium or vitamin D3 or any other components of this product.

Ibandronic Acid: It is contraindicated in patients with-

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
• Inability to stand or sit upright for at least 60 minutes
• Hypocalcaemia.

Calcium & Vitamin D3: The combination is contraindicated in patients with-

• Hypercalcaemia
• Hyperparathyroidism
• Hypercalciuria
• Nephrolithiasis
• Severe renal insufficiency
• Concomitant digoxin therapy
• Renal calculi
• Zollinger-Ellison syndrome.

Most common side effects are back pain, dyspepsia, pain in extremity, diarrhea, flatulence, constipation, headache, myalgia and upper Gl discomfort.

There are no data with ibandronic acid use in pregnant women to inform any drug associated risks. This kit is not indicated for use in women of reproductive potential. There is no information on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant or the effects of ibandronate on milk production. This kit should not be used during lactation.

Ibandronic Acid-

• Caution should be used when ibandronic acid is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).
• Hypocalcemia and other disturbances of bone and mineral metabolism should be treated before starting ibandronic acid therapy.
• Discontinue ibandronic acid if any patient develop severe bone, joint and muscle pain.
• If any Patient develops osteonecrosis of the jaw, discontinuation of bisphosphonate therapy should be considered.
• Any patient presenting with thigh or groin pain should be evaluated to rule out an incomplete femur fracture and interruption of bisphosphonate therapy should be considered.
• Ibandronic acid is not recommended for use in patients with severe renal impairment (creatinine clearance of <30 ml/min).

Calcium & Vitamin D3-

• Patients with mild to moderate renal failure or mild hypercalciuria should be periodically checked for plasma calcium levels and urinary calcium excretion.
• Calcium should be used cautiously in patients with pre-existing heart disease, sarcoidosis, kidney stones and kidney diseases.
• When hypercalcemia occurs, discontinuing of the drug should be considered.
• Patients with a history of stone formation should increase their fluid intake.
• Doses of calcium and iron should be separated by several hours

No specific information is available on the treatment of overdose with ibandronic acid. Oral overdose of ibandronic acid may result in hypocalcaemia, hypophosphatemia and upper gastrointestinal adverse events such as upset stomach, dyspepsia, esophagitis, gastritis or ulcer. Milk or antacids should be given to bind ibandronic acid. Symptoms of calcium and vitamin D3 combination overdose include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, unconsciousness, diarrhea, weakness, headache, constipation, dizziness or irritability. Treatment includes cessation of therapy and adequate rehydration.

Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.