Alendronate + Cholecalciferol

Indications & Dose:

Treatment of postmenopausal osteoporosis in women at risk of vitamin D deficiency

• BY MOUTH

Adult (female): 1 tablet once weekly.

Contraindications:

Abnormalities of the esophagus which delay esophageal emptying such as stricture orachalasia. Inability to stand or sit upright for at least 30 minutes. Hypersensitivity to any component of this product. Hypocalcemia 

Side Effects:

Body as a whole : Headache, dizziness

Gastrointestinal : Abdominal pain, nausea, dyspepsia, constipation, diarrhea, flatulence, regurgitation, esophageal ulcer, vomiting, dysphagia, abdominal distension, gastritis.

Musculoskeletal : Musculoskeletal pain \

Miscellaneous : Taste perversion, skin rash, facial swelling.

Cautions:

Precautions:

If any esophageal reaction occurs, the patients should be instructed to discontinue the drug. Caution should be used when the drug is given to patients with active upper gastrointestinal problems such as dysphagia. esophageal diseases, gastritis, duodenitis or ulcer.

Interaction:

If taken at the same time it is likely that calcium supplements, antacids, and other oral medications will interfere with absorption. Therefore, patients must wait at least one-half hour after taking drug before taking any other oral medication.

No other drug interaction of clinical significance are anticipated.

Concomitant use of HRT and alendronate sodium was assessed in two clinical studies of one or two years’ duration in postmenopausal osteoporotic women. Combined use of alendronate sodium and HRT resulted in greater increases in bone mass,together with greater decreases in bone turnover, than seen with either treatment alone. In these studies, the safety and tolerability profile of the combination was consistent with those of the individual treatments.

In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving daily therapy with dosages of alendronate sodium greater than 10mg and aspirincontaining products. However, this was not observed in studies with alendronate sodium once weekly 70mg.

The drugs that impair the absorption and metabolism of cholecalciferol are bile acids, olestra & mineral oils. Anti-convulsants, cimetidine and thiazides increase the catabolism of cholecalciferol.

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: