Europe — EMA
Ostenil 70 (Alendronate Sodium Monohydrate)
GNH USA supplies Ostenil 70 (Alendronate), a bisphosphonate for osteoporosis and Paget’s disease. Request a quote for global supply.
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What is Alendronate Sodium Monohydrate?
Alendronate sodium monohydrate, the active ingredient in Ostenil 70, is a bisphosphonate presented as a tablet for oral use. It treats osteoporosis and other bone‑loss conditions in post‑menopausal women and men at risk of fracture. GNH USA supplies Ostenil 70 as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
GNH USA supplies Ostenil 70 as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Alendronate Sodium Monohydrate used for?
Ostenil 70 is a bisphosphonate that acts on bone metabolism to improve skeletal strength.
- Osteoporosis: reduces the risk of vertebral and hip fractures in post‑menopausal women and men. - Paget’s disease of bone: normalises abnormal bone turnover and alleviates bone pain. - Secondary osteoporosis: helps maintain bone density in patients receiving long‑term glucocorticoid therapy.
What are the side effects of Alendronate Sodium Monohydrate?
Adverse reactions to alendronate are reported across a spectrum of frequency.
Common Side Effects: - Upper gastrointestinal irritation: dyspepsia, heartburn or abdominal discomfort. - Musculoskeletal pain: transient bone, joint or muscle aches. - Nausea or vomiting. - Constipation or diarrhoea. - Headache. - Skin rash.
Serious or Rare Side Effects: - Osteonecrosis of the jaw (ONJ): exposed necrotic bone in the maxillofacial region. - Atypical femoral fracture: low‑energy fracture of the subtrochanteric or diaphyseal femur. - Severe esophagitis or oesophageal ulceration. - Acute phase reaction: fever, myalgia and flu‑like symptoms. - Hypocalcaemia: low serum calcium levels, especially in patients with vitamin D deficiency. - Severe allergic reaction: anaphylaxis or angioedema.
What precautions apply to Alendronate Sodium Monohydrate?
Before initiating therapy, clinicians should evaluate patient history and baseline labs.
- Renal function: assess creatinine clearance; avoid in severe renal impairment. - Calcium and vitamin D status: ensure adequate supplementation to reduce hypocalcaemia risk. - Gastro‑intestinal disorders: avoid in patients with active oesophageal disease. - Concomitant medications: review for drugs that may irritate the oesophagus or affect absorption. - Pregnancy and lactation: contraindicated; advise effective contraception. - Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture and direct sunlight.
What does Alendronate Sodium Monohydrate interact with?
Alendronate may interact with several medicines that influence absorption or bone metabolism.
Major Interactions (Avoid): - Calcium‑containing antacids or supplements: taken within 30 min of alendronate reduces its absorption. - Proton pump inhibitors (e.g., omeprazole): may diminish bioavailability when used chronically. - Intravenous bisphosphonates: concurrent use increases risk of ONJ and atypical fractures.
Moderate Interactions (Monitor Closely): - Non‑steroidal anti‑inflammatory drugs (NSAIDs): may increase gastrointestinal irritation. - Corticosteroids: additive risk of bone loss and gastrointestinal side effects. - Loop diuretics: can exacerbate hypocalcaemia if calcium intake is insufficient.



