Ostel-D
Generic Name
Alendronate Sodium + Cholecalciferol (Vitamin D3)
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
ostel d 70 mg tablet | ৳ 30.20 | ৳ 241.60 |
Description
Overview of the medicine
Ostel-D 70 mg Tablet is a combination medication containing Alendronate Sodium, a bisphosphonate, and Cholecalciferol (Vitamin D3), a form of Vitamin D. It is primarily used to treat and prevent osteoporosis in postmenopausal women and men, as well as glucocorticoid-induced osteoporosis, by increasing bone mineral density and reducing the risk of fractures.
Uses & Indications
Dosage
Adults
One tablet (Alendronate 70 mg / Cholecalciferol 5600 IU) once weekly. The tablet should be taken with a full glass of plain water upon awakening, at least 30 minutes before the first food, beverage, or other medication of the day. The patient should remain upright (sitting or standing) for at least 30 minutes after taking the tablet.
Elderly
No dosage adjustment is required for elderly patients with normal renal function.
Renal_impairment
Not recommended for patients with creatinine clearance less than 35 mL/min.
How to Take
Take orally with plain water only, immediately upon rising for the day, at least 30 minutes before the first food, drink, or medication. Remain upright for at least 30 minutes and until after the first food of the day. Do not lie down. Do not chew or suck the tablet.
Mechanism of Action
Alendronate inhibits osteoclast-mediated bone resorption by binding to hydroxyapatite crystals in bone, thereby preventing bone breakdown. Cholecalciferol (Vitamin D3) is essential for calcium and phosphate absorption and metabolism, maintaining normal serum calcium and phosphate concentrations, and supporting bone mineralization.
Pharmacokinetics
Onset
Alendronate: Bone mineral density increases within 3 months. Cholecalciferol: Gradual, effects on vitamin D levels within days to weeks.
Excretion
Alendronate: Primarily excreted unchanged in urine. Cholecalciferol: Excreted in bile and feces.
Half life
Alendronate: Long half-life in bone (estimated >10 years). Cholecalciferol: Initial half-life ~24 hours, active metabolites have longer half-lives.
Absorption
Alendronate: Poorly absorbed (bioavailability <1%). Cholecalciferol: Well absorbed from the small intestine, primarily through lymphatic channels.
Metabolism
Alendronate: Not metabolized. Cholecalciferol: Metabolized in the liver to 25-hydroxyvitamin D [25(OH)D] and then in the kidneys to the active form 1,25-dihydroxyvitamin D [1,25(OH)2D].
Side Effects
Contraindications
- Abnormalities of the esophagus (e.g., stricture or achalasia) which delay esophageal emptying.
- Inability to stand or sit upright for at least 30 minutes.
- Hypocalcemia (must be corrected before initiating therapy).
- Hypersensitivity to any component of the product.
- Severe renal impairment (creatinine clearance <35 mL/min).
Drug Interactions
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
Concurrent use may increase the risk of upper gastrointestinal adverse events.
Calcium supplements, antacids, or other oral medications
Should not be taken within 30 minutes of Alendronate/Cholecalciferol due to interference with absorption.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Alendronate overdose may include hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events (e.g., upset stomach, heartburn, esophagitis, gastritis, ulcer). Treatment includes milk or antacids to bind Alendronate, and medical support for symptoms. Overdose of Vitamin D can lead to hypercalcemia; symptoms include nausea, vomiting, polyuria, polydipsia, and weakness.
Pregnancy & Lactation
Not recommended during pregnancy due to potential fetal harm (Alendronate). Caution advised during lactation; consult a physician.
Side Effects
Contraindications
- Abnormalities of the esophagus (e.g., stricture or achalasia) which delay esophageal emptying.
- Inability to stand or sit upright for at least 30 minutes.
- Hypocalcemia (must be corrected before initiating therapy).
- Hypersensitivity to any component of the product.
- Severe renal impairment (creatinine clearance <35 mL/min).
Drug Interactions
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
Concurrent use may increase the risk of upper gastrointestinal adverse events.
Calcium supplements, antacids, or other oral medications
Should not be taken within 30 minutes of Alendronate/Cholecalciferol due to interference with absorption.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Alendronate overdose may include hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events (e.g., upset stomach, heartburn, esophagitis, gastritis, ulcer). Treatment includes milk or antacids to bind Alendronate, and medical support for symptoms. Overdose of Vitamin D can lead to hypercalcemia; symptoms include nausea, vomiting, polyuria, polydipsia, and weakness.
Pregnancy & Lactation
Not recommended during pregnancy due to potential fetal harm (Alendronate). Caution advised during lactation; consult a physician.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, check specific packaging.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Off-patent (Generic available)
Clinical Trials
Extensive clinical trials have demonstrated Alendronate's efficacy in reducing fracture risk and increasing bone mineral density in osteoporosis patients. Cholecalciferol supplementation is standard for Vitamin D deficiency.
Lab Monitoring
- Serum calcium and phosphate levels (especially before initiating therapy and if hypocalcemia is suspected).
- 25-hydroxyvitamin D levels.
- Renal function (creatinine clearance).
Doctor Notes
- Emphasize strict adherence to administration instructions to minimize esophageal irritation.
- Assess calcium and Vitamin D status before and during therapy. Correct hypocalcemia prior to initiation.
- Periodically re-evaluate the need for continued bisphosphonate therapy, especially after 3-5 years.
Patient Guidelines
- Take the tablet first thing in the morning with a full glass of plain water, at least 30 minutes before any food, drink, or other medications.
- Remain upright (sitting or standing) for at least 30 minutes after taking the tablet.
- Do not lie down until after your first meal of the day.
- Do not chew or suck the tablet.
- Ensure adequate calcium and Vitamin D intake through diet or supplements, as advised by your doctor.
Missed Dose Advice
If a dose is missed, take one tablet on the morning after it is remembered. Do not take two tablets on the same day. Resume the usual weekly schedule on the originally appointed day.
Driving Precautions
Generally, it does not affect the ability to drive or operate machinery. However, if you experience dizziness or other side effects, use caution.
Lifestyle Advice
- Regular weight-bearing exercise (e.g., walking) is beneficial for bone health.
- Avoid smoking and excessive alcohol consumption, as these can negatively impact bone density.
- Maintain a balanced diet rich in calcium and Vitamin D.
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