Alen D Tablet
Alendronic Acid + Vitamin D3
70 mg + 2800 IU
Advanced Medical Optics UppsalaAB, Sweden
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| Retail Price | 25.17 AED |
Indications
Alen D Tablet is used for:
Osteoporosis in postmenopausal women, Osteoporosis in men to increase bone mass
Adult Dose
Treatment of osteoporosis in postmenopausal women:
One tablet once weekly.
Treatment to increase bone mass in men with osteoporosis:
One tablet once weekly.
Child Dose
Renal Dose
Dosing in renal insufficiency:
No dosage adjustment is necessary for patients with mild-to-moderate renal insufficiency
(creatinine clearance 35 to 60 mL/min).
CrCl (ml/min)
<35 Not recommended.
Administration
Tablets should be swallowed whole with plenty of water while sitting or standing; to be taken on an empty stomach at least 30 minutes before breakfast (or another oral medicine); the patient should stand or sit upright for at least 30 minutes after taking the tablet.
Contra Indications
Abnormalities of the esophagus which delay emptying such as stricture or achalasia
Inability to stand/sit upright for at least 30 minutes
Hypocalcemia
Hypersensitivity to any component of this product
Precautions
Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur.
Hypocalcemia can worsen and must be corrected prior to use.
Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop.
Osteonecrosis of the Jaw has been reported.
Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out an incomplete femoral fracture.
Monitoring Parameters
Monitor renal function and serum calcium, phosphate and magnesium.
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
Calcium supplements/antacids or oral medications containing multivalent cations interfere with the absorption of alendronate.
Use caution when co-prescribing aspirin/nonsteroidal antiinflammatory drugs that may worsen gastrointestinal irritation.
Some drugs may impair the absorption or increase the catabolism of cholecalciferol (vitamin D 3). Additional vitamin D supplementation should be considered.
Adverse 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.
Mechanism of Action
Bisphosphonate; binds to hydroxyapatite crystals in bone and inhibits osteoclast-mediated bone resorption; decreases mineral release and collagen or matrix breakdown in bone.
The principal action of 1,25-dihydroxyvitamin D 3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation, and bone resorption.
Note
Alen D 70 mg + 2800 IU Tablet manufactured by Advanced Medical Optics UppsalaAB, Sweden. Its generic name is Alendronic Acid + Vitamin D3. Alen D is availble in Bangladesh.
Farmaco BD drug index information on Alen D Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.