Alendronic Acid + Vitamin D3
Indications
Alendronic Acid + Vitamin D3 is used for:
Osteopetrosis, postmenopausal osteoporosis, Paget's disease of bone
Adult Dose
Treatment of osteoporosis in postmenopausal women: One tablet once weekly.
Treatment to increase bonemass in men with osteoporosis: One tablet once weekly.
Hepatic Impairment No dosage adjustment needed.
Child Dose
Renal Dose
Dosing in elderly and renal insufficiency: No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min).
CrCl (ml/min)
<35 Not recommended.
Administration
Contra Indications
Hypocalcaemia; oesophageal abnormalities and factors which delay oesophageal emptying; severe renal impairment; hypersensitivity; inability to stand or sit upright for <30 min. Pregnancy, lactation.
Precautions
Upper GI disorders (discontinue if symptoms worsen); history of ulcers, active GI bleeding. Correct vitamin D and calcium deficiency before starting therapy. To be taken half an hr before breakfast and remain upright for at least 30 minutes after admin. Not recommended for use in patients with CrCl <35 ml/min.
Pregnancy-Lactation
Alendronic Acid
Pregnancy
Available data on use in pregnant women insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes; discontinue when pregnancy recognized.
Lactation
Not known whether drug present in human breast mild, affects milk production or has effects on infants
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential effects on breastfed child from drug or underlying maternal condition
Vitamin D3
Pregnancy
There are no adequate and well-controlled studies in pregnant women
Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Animal studies
Calcifediol has been shown to be teratogenic in rabbits when given in doses 8-16 times the human dose of 60 mcg/day, based on body surface area
Lactation
Limited data suggest calcifediol is poorly excreted in human milk; caution if administered to a breastfeeding female
Interactions
Concomitant iron, calcium supplements and antacids hinder alendronate absorption. Concomitant aspirin or NSAIDs may increase the incidence of adverse GI effects.
Side Effects
Side effects of Alendronic Acid + Vitamin D3 :
The most common side-effect is digestive reactions. These reactions include irritation, inflammation, or ulcers of the esophagus, which may sometimes bleed. This may occur especially if patients do not drink a full glass of water or if they lie down in less than 30 minutes or before their first food of the day.
Less common side-effects are nausea, vomiting, a full or bloated feeling in the stomach, constipation, diarrhea, black or bloody stools, gas, headache, a changed sense of taste, and bone, muscle, or joint pain.
Mode of Action
Alendronic acid reduces bone resorption by inhibiting the action of osteoclasts.