Each tablet contains : Sodium Alendronate trihydrate equivalent to Alendronic acid 10 mg or 70 mg.
Alendrotab (Sodium Alendronate trihydrate) is a bisphosphonate that inhibits osteoclastic bone reabsorption with no direct effect on bone formation and the BMD is increased , the bone formed during treatment with Alendronate is of normal quality. Protein binding is about 78% ,Alendronate do not appear to be metabolized .The elimination half - life is estimated to exceed 10 years.
Alendrotab is used for :
- Treatment and prevention of osteoporosis in postmenopausal women.
- To increase bone mass in men with osteoporosis.
- Treatment of glucocorticoid-induced osteoporosis in men and women.
- Treatment of paget's disease of bone.
- Patient should take the tablet at morning after getting up and at least 30 minutes before taking the first food, beverage (including mineral water) ,medicinal products ( including calcium supplements or antacids) or doing activities of the day because Alendronate is effective only if taken on empty stomach.
- Patient should swallow the tablet whole with a full glass of plain water (not less than 200 ml) , not to be crushed , chewed or dissolved in the mouth .
- Patient should not lie down , just stay fully upright (sitting, standing or walking) for at least 30 minutes after taking the drug .
- Patient should not take the tablet before going to bed.
- Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
- Patients should be advised to do exercise.
- For dose 70 mg tablet ,the patients should choose one day of the week that fits schedule and should take the tablet each week on the same day that has chosen.
* In case of missing the dose :
- For Alendrotab 10 mg once daily tablet: if patient missed a dose of 10 mg tablet, should take it in the next morning of the day and continue to take the tablet daily as usual. It should not be taken two tablets on the same day.
- For Alendrotab 70 mg once weekly tablet: if patient missed a dose of 70 mg tablet, should take it in the next morning of the day and return to take the tablet on the chosen day as originally scheduled . It should not be taken two tablets on the same day.
- Treatment of osteoporosis in postmenopausal women : 70 mg once weekly or 10 mg once daily.
- To increase bone mass in men with osteoporosis : 70 mg once weekly or 10 mg once daily .
- Prevention of osteoporosis in postmenopausal women : 35 mg (half 70 mg tablet) once weekly or 5 mg (half 10 mg tablet) once daily.
- Treatment of glucocorticoid-induced osteoporosis in men and women : The recommended dosage is
5 mg (half 10 mg tablet) once daily except for postmenopausal women not receiving estrogen for whom
the recommended dosage is 10mg once daily.
- Paget's disease of bone : 40 mg (4 tablets of 10 mg)once a day for six months.
- No dosage adjustment is necessary for the elderly patients.
- Use in renal impairment : No dosage adjustment is necessary for patients with GFR greater than 35 ml / min.
RESTRICTIONS ON USE :
- Hypersensitivity to Alendronate .
- Patients with problems in the esophagus such as narrowing or difficulty in swallowing .
- Inability to stand or sit upright for at least 30 minutes.
- Patients with Hypocalcaemia.
- Patients with severe renal impairment when GFR is less than 35 ml/min.
- Pregnant, lactating women or children below 18 years of age.
- Caution should be taken in patients with swallowing or digestive problems.
- If difficulty or pain upon swallowing , chest pain or heartburn has developed after taking Alendrotab, the patient should stop taking the drug and consult the doctor.
- Caution should be taken in patients with poor dental health, gum disease or patient who do not receive routine dental care .
- Caution should be taken in patients with cancer or undergoing chemotherapy or radiotherapy.
- Caution should be taken in patients who are taking corticosteroids such as dexamethasone or prednisone.
- Patients should be advised to stop smoking as it may increase the risk of broken bones .
- It is recommended to do periodic examinations such as dental check-ups during treatment with Alendrotab and tests for bone density and blood calcium level.
Effect on the ability to drive vehicles or use machines
Alendrotab may cause blurred vision ,dizziness , bone, muscle or joints pain that may affect on the ability to drive or use machines.
Use in Pregnancy & Lactation
Alendrotab should not be used during pregnancy and lactation.
DRUG INTERACTIONS :
- Concomitant therapy of Alendronate with calcium supplements or antacids will interfere with absorption of Alendronate.
- Concomitant therapy of Alendronate with aspirin or other NSAIDs can increase the upper gastrointestinal adverse events.
ADVERSE EFFECTS :
As other medicines not all patients get adverse effects and not all of these adverse effects may occur. The common effect is abdominal pain, some patients may get bone, muscle or joints pain, heartburn, difficulty in swallowing, bloating of the stomach, headache, dizziness, constipation or diarrhea. The less frequent effects are nausea, vomiting, blurred vision, rash and altered sense of taste. Rarely, allergic reaction (swelling of the face, lips, tongue and/ or throat that may cause difficulty in breathing or swallowing) are also reported .
Symptoms : hypocalcaemia , gastritis, esophagitis, heartburn, ulcer may result from overdosage.
Treatment : the patient should drink a full glass of milk or take antacids and immediately go to a hospital, he should not laying down or induce vomiting.
STORAGE INSTRUCTIONS :
Store below 30°C, in a dry place.
Alendrotab 10 mg : Blister of 30 tablets and hospital packs of different sizes.
Alendrotab 70 mg : Blister of 4 tablets and hospital packs of different sizes.