GNH USA

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.

Frequently asked questions

What is Ostenil 70 used for?+
Ostenil 70 contains alendronate sodium monohydrate, a bisphosphonate indicated for the treatment and prevention of osteoporosis, for management of Paget’s disease of bone, and for secondary osteoporosis associated with long‑term glucocorticoid therapy.
How does alendronate sodium monohydrate work?+
Alendronate binds to hydroxy‑apatite at active bone‑remodeling sites. When osteoclasts ingest the drug, it blocks farnesyl pyrophosphate synthase in the mevalonate pathway, impairing osteoclast function and inducing apoptosis, which reduces bone resorption and improves bone density.
What is the usual dose of Ostenil 70?+
The prescribed dose of alendronate is determined by the treating clinician based on the patient’s condition, renal function and risk profile. Dosage regimens are individualized and should follow the prescriber’s instructions.
Is Ostenil 70 safe during pregnancy or breastfeeding?+
Alendronate is classified as contraindicated in pregnancy and lactation because it may affect fetal bone development. Women of child‑bearing potential should use effective contraception while on therapy.
How do I order Ostenil 70 from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Ostenil 70 compare with other bisphosphonates?+
Ostenil 70 (alendronate) is an oral bisphosphonate with a well‑established efficacy profile for osteoporosis and Paget’s disease. Compared with weekly or monthly formulations of risedronate or ibandronate, alendronate is typically taken daily or weekly, offering flexibility but requiring strict administration rules to minimise gastrointestinal irritation.
How should Ostenil 70 be stored and handled?+
Store tablets at ambient temperature, below 25 °C, in the original blister pack. Protect from moisture and direct sunlight. Do not refrigerate or freeze the product.
How is Ostenil 70 administered?+
Ostenil 70 tablets are taken orally with a full glass of plain water, first thing in the morning, at least 30 minutes before any food, drink or other medication. Patients should remain upright for at least 30 minutes after ingestion to reduce oesophageal irritation.
What are the most serious risks associated with alendronate?+
Serious adverse events include osteonecrosis of the jaw, atypical femoral fractures, severe oesophagitis or ulceration, and acute hypocalcaemia. Patients should be monitored for persistent jaw pain, unexplained thigh or groin pain, and signs of gastrointestinal bleeding.
Who should not use Ostenil 70?+
Contraindications include patients with severe renal impairment (creatinine clearance <30 mL/min), active oesophageal disorders, inability to sit or stand upright for 30 minutes, known hypersensitivity to alendronate, and pregnant or breastfeeding women.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Alendronate Sodium Monohydrate
Route
Oral Use
Manufacturer
Teva Pharmaceuticals Polska Sp. Z O.O.
Origin
EU

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