Fosavance 70Mg/5600 I.U Tablet

Description

Fosavance 70Mg/5600 I.U Tablet

Description : Each tablet of Fosavance contains alendronate monosodium salt trihydrate 91.37 mg which is the molar equivalent to free acid 70 mg and cholecalciferol 70 mcg or 140 mg equivalent to vitamin D 5600 IU.

Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol and practically insoluble in chloroform. Alendronate sodium is (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate, with empirical formula of C4H12NNaO7P2?3H2O. The formula weight is 325.12.

Cholecalciferol (vitamin D3) is a secosterol that is a natural precursor of the calcium-regulating hormone calcitriol (1,25-dihydroxyvitamin D3).

Cholecalciferol is a white, crystalline, odorless powder. It is practically insoluble in water, freely soluble in usual organic solvents and slightly soluble in vegetable oils. Its chemical name is (3?,5Z,7E)-9-,10-secocholesta-5,7,10(19)-trien-3-ol. The empirical formula is C27H44O and its molecular weight is 384.6.

Administration : Should be taken on an empty stomach: Take upon arising for the day, at least 1/2 hr before the 1st food, beverage (including mineral water) or medication of the day w/ a full glass of plain water only. Do not lie down for at least 1/2 hr & until after the 1st food of the day. Do not take at bedtime or before arising for the day. Swallow whole, do not suck/chew/crush.

Contraindications : Hypersensitivity. Esophageal abnormalities which delay esophageal emptying eg, stricture or achalasia; inability to stand or sit upright for at least 30 min. Hypocalcemia.

Special Precautions : Discontinue use if patient develops dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. Patients w/ active upper GI problems eg, dysphagia, esophageal diseases (Barrett’s esophagus), gastritis, duodenitis or ulcers. Correct hypocalcemia & other disorders affecting mineral metabolism prior to therapy. Patients w/ diseases associated w/ unregulated overproduction of calcitriol (eg, leukemia, lymphoma, sarcoidosis). Monitor urine & serum Ca. Discontinuation/interruption of bisphosphonate therapy should be considered based on individual benefit/risk assessment in patients requiring invasive dental surgery (eg, tooth extraction, dental implants) due to reported localized osteonecrosis of the jaw, low-energy fractures of subtrochanteric & proximal femoral shaft. Evaluate patients w/ suspected stress fractures. The optimal duration of use has not been determined. All patients on biphosphonate therapy should have the need for continued therapy reevaluated on a periodic basis. Not recommended in severe renal insufficiency (CrCl <35 mL/min). Not to be used during pregnancy & lactation. Not to be used in childn.