ALENOST Tablet

For the treatment of osteoporosis.

Dosage and Administration

The recommended dosage is 10mg once a day. This tablet must be taken the first thing on arising for the day at least 30 minutes before the first food, beverage, or medication of the day with full glass (200mL) or plain water only. Waiting less than 30 minutes or taking this tablet with food, beverages (including mineral water, coffee, orange juice) and some medications are likely to lessen the effect of this medicine by decreasing it’s absorption into the body. Waiting longer than 30 minutes before eating will improve the absorption of this medicine. In order to avoid esophageal irritation patients should not lie down for at least 30 minutes after ingestion of this tablet and until their first food of the day. Patients should not chew or suck on a tablet. Patients should be specially instructed not to take this tablet at bedtime or before arising for the day.

Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia

Inability to stand or sit upright for at least 30 minutes

Hypersensitivity to any of the components of this product

Hypocalcemia

Side effects mostly seen are abdominal pain, nausea, dyspepsia, diarrhoea, constipation, flatulence, acid regurgitation, esophageal ulcer, vomiting dysphagia, abdominal distention, gastritis, musculoskeletal pain and muscle cramp, headache, dizziness, taste perversion. Rarely rash and erythema may also occur. In controlled studies, mild and transient decreases in serum calcium and phosphate were observed.

See the package insert about the details below:

Estrogen

Calcium Supplements/Antacids

NSAIDs

Other: antacids, anticholinergics, aspirin containing compounds, beta-blockers, benzodiazepines, calcium channel blockers, diuretics, gastric acid secretion inhibitors, glucocorticoids, NSADs, sedative hypnotics, thiazides, thyroid hormones, vasoconstrictors and vasodilators.

Pregnancy

There are no studies of alendronate in pregnant women. This medicine should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and foetus.

Lactation

It is not known whether alendronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this medicine is administered to nursing mothers.

See the package insert about the details.

- Pediatric use

Patients should be instructed to read the patient information leaflet carefully, before starting therapy with ALENOST 70. Failure to follow the instructions may increase the risk of esophageal problems (also see dosage and administration).

If patients develop symptoms suggestive of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking this medicine and consult their physician.

General: As with other bisphosphonates, caution should be used when this medicine is given to patients with active upper gastrointestinal problems such as dysphagia, symptomatic esophageal diseases, gastritis, duodenitis or ulcers. Causes of osteoporosis other than estrogen deficiency and aging should be considered.

Hypocalcemia must be corrected before initiating the therapy with this medicine. Other disturbances of mineral metabolism (such as Vit.D deficiency) should be effectively treated. Presumably due to the effects of this medicine on increasing bone mineral, small asymptomatic decreases in serum calcium and phosphate may occur. Adequate calcium and vitamin intake should be ensured to provide for these enhanced needs.

See the package insert about the details below:

- Renal Insufficiency

- Hepatic Insufficiency

- Use in elderly

- Use in men

Alendronate Sodium is an amino bisphosphonate that acts as a specific inhibitor of osteoclast mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Animal studies indicated that at the cellular level, alendronate shows preferential localization to sites of bone resorption, specially under osteoclasts. Alendronate does not interfere with the osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Animal studies indicate that alendronate reduces bone turnover. Thus, alendronate inhibits osteoclastic bone resorption without inhibiting osteoblastic bone formation, resulting in an increase in the bone mass.