Biocal Kit
Daily Dose:
Duration:
Cheaper & Alternative Brands (150 mg+600 mg+400 IU)
Same active generic (Ibandronic Acid + Algae Calcium + Vitamin D3), same form (Tablet), exact same strength (150 mg+600 mg+400 IU)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
This kit is indicated for the treatment and prevention of osteoporosis.
Dosage & Administration
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.
Contraindications
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.
Side Effects & Adverse Reactions
Most common side effects are back pain, dyspepsia, pain in extremity, diarrhea, flatulence, constipation, headache, myalgia and upper Gl discomfort.
Warnings & Precautions
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
Pharmacology & Mechanism of Action
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.