Alendronate (Na)

Drug #786

Alendronate (Na) is aminobisphosphonate and inhibitor of osteoclast-mediated bone resorption. Chemically Alendronate (Na) is identified as (4-Amino-1-hydroxybutylidene)-bisphosphonic acid monosodium salt trihydtare. Alendronate (Na) is prepared by chemical synthesis. Alendronate (Na) is effective to treat osteoporosis (bone thinning) by increasing bone density in post menopausal women. At the cellular level, Alendronate (Na) shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate (Na) does not interfer with osteclast recruitment or attachment, but it does inhibit osteoclast activity. While incorporated in bone matrix, Alendronate (Na) is not pharmacologically active. Thus Alendronate (Na) must be continuously administered to suppress osteoclasts on newly formed resorption surface. Alendronate (Na) is administered orally.

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Primary Characteristics

Alendronate (Na) is also known as Alendronate.

It is of Synthetic origin and belongs to Biphosphonate.

It is classified in Biphosphonate Derivative pharmacological group.

Molecular Weight: 325.1 · Solubility in Water: 1 in 25 · Solubility in Alcohol: null · Non-proprietary name: Alendronate (Na).

Pharmacokinetics

Absorption: Alendronate (Na) has an oral bioavailability is 0.4%.

Distribution: Alendronate (Na) has a volume of distribution is 0.44l/kg. plasma protein binding is about 78%.

Elimination: plasma half-life is 11.9 yrs (in bone), renal excretion is 45%.

Indications

Alendronate (Na) is primarily indicated in conditions like Osteoporosis in men, Osteoporosis prophylaxis, Pagets disease, Prevention and treatment of corticosteroid-induced osteoporosis, Treatment of osteoporosis in post menopausal women.

Alendronate (Na) is also indicated for secondary conditions like Hypercalcaemia associated with malignancy, Non-tumour induced hypercalcemia, Osteolytic tumoral bone disease.

Contraindications

Alendronate (Na) is contraindicated in conditions like Hypocalcaemia, Ulcers, Gastritis, Dysphagia, Vitamin D deficiency.

Dosage

Alendronate (Na)'s dosage details are as follows:

Dose	Single Dose	Frequency	Route	Instructions
Adult Dosage
35 – 35 mg	—	—	PO	Once weekly. Not Recommended in this Age Group
10 mg	10 mg	Every 24h	PO	Must be taken atleast 1/2hr before the first food, beverage or medication of the day with plain water only. Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate.
70 mg	70 mg	—	PO	Once weekly. For Treatment of postmenopausal osteoporosis
Paediatric Dosage (20kg)
0 – 0	—	—	—	Not Recommended in this Age Group
Neonatal Dosage (3kg)
0 – 0	—	—		Not recommended in this age group

Drug Interactions

Unknown1 interaction

3 interactions

Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Side Effects

Alendronate (Na) in overdosage may give rise to further complications which include Esophageal ulceration, Esophagus erosion, Peptic ulceration .

Alendronate (Na) is known to cause more or less tolerable side effects which are usually transient. These include Abdominal pain, Constipation , Diarrhea, Dysphagia, Gastritis, Headache, Heart burn, Nausea, Rashes , Vomiting .

Warnings / Precautions

Alendronate should be used with caution in patients with history of ulcers or any other gastrointestinal problems or difficulty in swallowing. Hypocalcemia must be corrected before initiating therapy with Alendorante, othere distrubances of mineral metabolism (such as vitamine D deficiency) should also be effectively treated. This medication should not be used by patients with more severe renal indufficiency with a creatinine clearance < 35 mL/min. No dosage adjustment is necessary for the elderly or for patients with mild to moderate renal insuffuciency with a creatinine clearance 35 to 60 mL/min. Alendronate (Na) should not be use if allergic to biphosphonates. It is also important to not smoke and to limit the amount of alcohol used as these can increase the risk of osteoporosis. This medication should not be used during pregnancy or lactation. For Prophylaxis of postmenopausal osteoporosis

Available Brands

Click on a strength to view available brands.

Single Ingredient

Caps

10 mg

Inj

70 mg

Tabs

10 mg 40 mg 5 mg 70 mg

Multi-Ingredient Combinations

Tabs

10 mg 70 mcg 70 mg 91.37 mg

Storage Conditions

Alendronate (Na) should be stored Tab.

Drug Classification

1.18.14 — Drugs affecting bone metabolism

Manufacturers

Manufacturers of Alendronate (Na) in Pakistan: