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Alendronate

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Overview

What is Alendronate?

Alendronate sodium is a 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.

Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is CHNNaOP∙3HO and its formula weight is 325.12. The structural formula is:

Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.

Alendronate sodium tablets, USP for oral administration contain 6.53, 13.06, 45.69 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35 and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.



What does Alendronate look like?



What are the available doses of Alendronate?

Tablets: 5 mg, 10 mg, 35 mg and 70 mg ()

What should I talk to my health care provider before I take Alendronate?

How should I use Alendronate?

Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets, USP increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).

The recommended dosage is:


What interacts with Alendronate?

Sorry No Records found


What are the warnings of Alendronate?

Sorry No Records found


What are the precautions of Alendronate?

Sorry No Records found


What are the side effects of Alendronate?

Sorry No records found


What should I look out for while using Alendronate?

Alendronate sodium is contraindicated in patients with the following conditions:


What might happen if I take too much Alendronate?

Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m) and 966 mg/kg (2898 mg/m), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m).

No specific information is available on the treatment of overdosage with alendronate sodium. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.

Dialysis would not be beneficial.


How should I store and handle Alendronate?

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Product: 50090-2587NDC: 50090-2587-0 4 TABLET in a BLISTER PACK NDC: 50090-2587-1 4 TABLET in a BLISTER PACK Product: 50090-2587NDC: 50090-2587-0 4 TABLET in a BLISTER PACK NDC: 50090-2587-1 4 TABLET in a BLISTER PACK Product: 50090-2587NDC: 50090-2587-0 4 TABLET in a BLISTER PACK NDC: 50090-2587-1 4 TABLET in a BLISTER PACK