Pregnancy
Drate Tablets 70mg Contraindicated in pregnancy. Lactation. Contraindicated or not recommended. Contraindications: Renal impairment with GFR <35 mL/min. Desophageal abnormalities, stricture, achalasia or inability to remain upright for 30 min after dosing. Hypocalcaemia. Precautions: Upper GI disorders. Treat hypocalcaemia or vitamin D deficiency first. Hypoparathyroidism, calcium malabsorption. Maintain adequate calcium and vit D intake. Risk of rare osteonecrosis of the jaw, advise patients to maintain good oral hygiene. Risk of rare atypical femoral fracture; advise patients report thigh, hip, or groin pain.
Indications
Tab 10 mg: Treatment of osteoporosis in post-menopausal women to prevent fractures. Treatment of glucocorticoid induced osteoporosis and prevention of bone loss in men and women. Prevention of osteoporosis in post-menopausal women. Ow (Once Weekly) Tab 70 mg: Treatment of post-menopausal osteoporosis to reduce risk of vertebral and hip fractures Drate Tablets 70mg.
Dosage
The Drate Tablets 70mg tablet should be taken upon arising with a full glass of water, 30 min before food, drink or other oral medications. Remain upright for 30 min after dose. Tab 10 mg: Adults: Treatment of osteoporosis: 10 mg once daily. Glucocorticoid induced osteoporosis: 5 mg once daily. Post menopausal women not on oestrogen-HRT: 10 mg once daily. Prevention of post-menopausal osteoporosis: 5 mg once daily. OW (Once Weekly) Tab 70 mg: 1 tab once weekly. Children: Not recommended.
Advice to Patient
Take with a full glass of water atleast 30 minutes before the first meal of the day and remain in an upright position for atleast another 30 minutes. Do not chew or crush tablets, Swallow whole. Do not take at bedtime. Do not take with mineral water, coffee, tea, soda or juice. If you miss a dose, take the missed dose next morning and then return to normal schedule. Do not take two doses in one day. Contact prescriber if there is unrelieved abdominal upset, abdominal pain, acidity, acute headache. Limit alcohol intake and smoking. Take dietary supplements of calcium or vitamin D as recommended. Taking small, frequent meals may help to prevent or reduce flatulence, bloating, nausea, acid reflux.
Pharmacokinetics
Metabolism: None. Bioavailability: Fasting: Children =4 years and adolescents: Mean range: 0,41% to 0.56%. Adults: 0,6%, reduced up to 60% with coffee or orange juice. Half-life elimination: Exceeds 10 years. Excretion: Urine; feces (as unabsorbed drug).
Interactions
Calcium supplement, antacids, NSAID, glucocorticoids.
Adverse effects
oesophageal ulcer, abdominal pain, dyspepsia, dysphagia, abdominal distension, musculoskeletal pain, headache. Rarely, rash angioedema, oesophageal stricture, oropharyngeal ulceration, uveitis, dizziness, acid regurgitation, alopecia, gastric and duodenal ulcers, pruritus, joint swelling, asthenia, peripheral oedema Drate Tablets 70mg.
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