SJ & G Fazal Elahi

Drate Plus D Tablets

Drate Plus D Tablets

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SPECIFICATION

Requires Prescription (YES/NO)

Yes

Generics

Alendronate Sodium , Cholecalciferol

Used For

Osteoporosis

How it works

At the cellular level, alendronate 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 does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. Cholecalciferol (vitamin D3) is formed in the skin under influence of UV rays and metabolized in two hydroxylation steps at first in the liver and then in the kidney tissue into the biological active metabolite 1,25-dihydroxy-cholecalciferol. 1,25-dihydroxy-cholecalciferol is involved fundamentally in the regulation of the calcium and phosphate balance together with parathyroid hormone and calcitonin.

USAGE AND SAFETY

Dosage

Alendronate Sodium , Cholecalciferol

Side Effects

Body as a Whole: Common: Hypersensitivity reactions including urticaria, transient symptoms of myalgia and malaise. Rare: Angioedema, fever, symptomatic hypocalcemia. Gastrointestinal: Common: Esophagitis, esophageal erosions, esophageal ulcers. Rare: Esophageal stricture or perforation and oropharyngeal ulceration. Gastric or duodenal ulcers, some severe and with complications, have also been reported. Skin: Common: Rash (occasionally with photosensitivity), pruritis. Rare: Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Special Senses: Rare: Uveitis, scleritis.

Drug Interactions

Estrogen/Hormone Replacement Therapy (HRT) , Calcium Supplements/Antacids , Aspirin , Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

Indication

It is used in the treatment of post-menopausal osteoporosis to reduce risk of vertebral and hip fractures .

When not to Use

Hypersensitivity to any component of this product . Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes . Hypocalcemia.

PRECAUTIONS

Precaution

Ensuring adequate calcium absorption and vitamin D intake is especially important in patients with Paget’s disease of bone and in patients receiving glucocorticoids as small asymptomatic decreases in serum calcium and phosphate may occur with the treatment of alendronate.

WARNINGS

Warning 1

Causes of osteoporosis other than estrogen deficiency, aging and glucocorticoid use should be considered.

Warning 2

Physicians should be alert to symptoms signaling a possible esophageal reaction including dysphasia, odynophagia, retrosternal pain or new/worsening heartburn. Patients should be instructed to discontinue alendronate.

Warning 3

Alendronate is not recommended for patients with severe renal insufficiency (creatinine clearance ).

ADDITIONAL INFORMATION

Pregnancy category

Always consult your physician before using any medicine.

Storage (YES/NO)

Store this medicine at room temperature, away from direct light and heat.

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