Osteofos

Alendronate Sodium Tablets

Description
Alendronate sodium is an aminobisphosphonate 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 indicate that at the cellular level, alendronate shows preferential localisation to sites of bone resorption, specifically 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 osteoclatic bone resorption without inhibiting osteoblastic bone formation, resulting in an increase in the bone mass.

Indications
OSTEOFOS 70 is indicated for the treatment of osteoporosis in postmenopausal women.
OSTEOFOS 35 is indicated for the prevention of osteoporosis in postmenopausal women.

Dosage and Administration

Treatment of osteoporosis in postmenopausal women
The recommended dosage is 70 mg once a week.
Prevention of osteoporosis in postmenopausal women
The recommended dosage is 35 mg once a week.
OSTEOFOS 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 a full glass (200 ml) of plain water only. Waiting less than 30 minutes or taking OSTEOFOS with food, beverages ( including mineral water, coffee, orange juice) and some medications is likely to lessen the effect of OSTEOFOS by decreasing its absorption into the body. Waiting longer than 30 minutes before eating will improve the absorption of OSTEOFOS. In order to avoid esophageal irritation patients should not lie down for at least 30 minutes after ingestion of OSTEOFOS and until their first food of the day. Patients should not chew or suck
on a tablet of OSTEOFOS. Patients should be specifically instructed not to take OSTEOFOS at bedtime or before arising for the day.

Contraindications
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

Warnings and Precautions
Patients should be instructed to read the patient information leaflet carefully,
before starting therapy with OSTEOFOS. Failure to follow the instructions may increase the risk of esophageal problems (also see dosage and administration).
If patients develop symptoms suggestive of oesophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heart burn) they should stop taking OSTEOFOS and consult their physician.
General: As with other bisphosphonates, caution should be used when OSTEOFOS is given to patients with active upper gastrointestinal problems such
as dysphagia, symptomatic oesophageal 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 OSTEOFOS.
Other disturbances of mineral metabolism (such as Vit D deficiency) should be effectively treated. Presumably due to the effects of OSTEOFOS on increasing bone mineral, small asymptomatic decreases in serum calcium and phosphate may occur. Adequate calcium and vitamin D intake should be ensured to
provide for these enhanced needs.

Drug Interactions
Estrogen: Concomitant use of hormone replacement therapy and OSTEOFOS in the treatment of osteoporosis in postmenopausal women is not recommended because of lack of experience.
Calcium Supplements / Antacids: Calcium supplements and antacids and some oral medication are likely to interfere with the absorption of alendronate
sodium. Therefore patients must wait at least one-half hour after OSTEOFOS administration before taking any other drug.
NSAIDs/Aspirin: The risk of upper gastrointestinal adverse effects associated
with NSAIDs does not appear to be greater with concomitant treatment with alendronate sodium, however caution should be exercised in such cases.
Other: Although specific interaction studies were not performed, alendronate sodium 70 mg/day was used in postmenopausal osteoporosis studies with wide range of commonly prescribed drugs without evidence of clinical adverse interactions. These included antacids, anticholinergics, aspirin-containing compounds, beta-blockers, benzodiazepines, calcium channel blockers, diuretics, gastric acid secretion inhibitors, glucocorticoids, NSAIDs, sedative hypnotics, thiazides, thyroid hormones, vasoconstrictors and vasodilators.
Renal Insufficiency: Although no clinical information is available, it is likely that,
as in animals, elimination of alendronate via the kidney will be reduced in patients with impaired renal function. Therefore, greater accumulation of alendronate in bone might be expected in patients with impaired renal function. No dose adjustment is necessary in the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min).
OSTEOFOS is not recommended for patients with more severe renal insufficiency (creatinine clearance < 35 mL/min) due to lack of experience.
Hepatic Insufficiency: No dosage adjustment is necessary.
Pregnancy: There are no studies of alendronate in pregnant women. OSTEOFOS 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 OSTEOFOS is administered to nursing mothers.
Paediatric Use: Safety and efficacy of alendronate in paediatric patients have
not been established.
Use in elderly: In the clinical studies no overall difference in efficacy or safety
was observed between elderly and younger patients, but greater sensitivity of some older individuals to alendronate cannot be ruled out.

Side Effects
Side effects associated with alendronate have been mild and generally have not required discontinuation of therapy. Side effects mostly seen are, abdominal
pain, nausea, dyspepsia, diarrhoea, constipation, flatulence, acid regurgitation, esophageal ulcer, vomiting, dysphagia, abdominal distention, gastritis, musculoskeletal pain, muscle cramp, headache, dizziness and taste perversion. Rarely rash and erythema also occur. In controlled studies, mild and transient decreases in serum calcium and phosphate were observed.

Overdosage
Overdosage with alendronate would result in hypocalcemia, hypophosphatemia and upper gastrointestinal adverse effects such as stomach upset, heartburn, gastritis, oesophagitis, or ulcer. No specific information is available on treatment of overdosage with alendronate. Administration of milk or antacids to bind alendronate should be considered. Due to the risk of oesophageal
irritation, vomiting should not be induced and the patient should remain fully upright. Dialysis would not be beneficial.

Presentation
OSTEOFOS 70 Blister pack of 10 tablets
OSTEOFOS 35 Blister pack of 10 tablets