- Approval Id
- 35766857a21d539c
- Drug Name
- FOSACORD 70 TABLET 70 MG
- Product Name
- FOSACORD 70 TABLET 70 MG
- Approval Number
- SIN16511P
- Approval Date
- 2022-06-10
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **v. Dosage and Administration:**
Alendronate Sodium must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of Alendronate Sodium (see drug interactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Alendronate Sodium should only be swallowed upon arising for the day with a full glass of water and patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate Sodium should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences (see precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate Sodium is not recommended for patients with more severe renal insufficiency (creatinine clearance < 35 mL/min) due to lack of experience.
_Treatment of osteoporosis in postmenopausal women and in men:_
The recommended dosage is one 70 mg tablet once weekly.
**vi. Method of administration**
Alendronate Sodium must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only.
- Route Of Administration
- ORAL
- Indication Info
- **iv. Therapeutic Indication:**
Alendronate Sodium is indicated for the treatment of osteoporosis in postmenopausal women.
For the treatment of osteoporosis, Alendronate Sodium reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
Alendronate Sodium is indicated for the treatment of osteoporosis in men.
The optimal duration of use of bisphosphonates for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
- Contraindications
- **vii. 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 component of this product.
- Hypocalcemia (see Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Atc Code
- M05BA04
- Atc Item Name
- alendronic acid
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
- Company Detail Path
- /organization/7b2062edde9ff0f1/accord-healthcare-private-limited
