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Products » » Human medicines
|Composition||Each tablet contains alendronate 70 mg.|
|Indications||1- Osteoporosis in post-menopausal women which is confirmed by the finding of low bone density.
2- Prevention of osteoporosis in women of early menopause, or thin body built women or family history of osteoporosis.
3- Paget’s disease of bone: treatment in patients with Paget’s disease of bone having alkaline phosphatase (at least two times the upper normal limit) or those at risk of complications from their disease.
|Mode of action||Animal studies have indicated the following mode of action: at the cellular level, alendronate shows a preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts normally adhere to the bone surface which in turn leads to increase bone mass. Alendronate inhibits the activity of osteoclasts.
Studies in mice indicates the localization of radioactive alendronate on the bone showed about 10 times higher uptake on osteoclasts. Alendronate should be administered continuously to inhibit the osteoclasts on the newly formed resorption surface.
|Contra-indications||1- Abnormalities of the esophagus which delays esophagus emptying.
2- Inability to stand or sit upright for at least 30 minutes.
3- Hypersensitivity to any component of this drug.
|Side effects||Abdominal pain – nausea – dyspepsia – constipation or diarrhea – flatulence – vomiting – esophageal ulcer – rarely skin rashes.|
|Warnings||1- Observing the esophagus and pharynx especially in those who don’t take medicaments regularly.
2- Gastritis, duodenal ulcers, esophagus and pharynx diseases.
3- Renal insufficiency.
4- Impairment calcium and mineral metabolism that should be treated previously.
5- Should not take any other medicament at the same time, at least 30 minutes after taking SINAMAX.
6- Alendronate has not been studied in pregnant and nursing women.
7- There is no evidence that Sinamax affects the ability to drive or use machines.
|Drug interactions||1- Intravenous ranitidine was shown to double the bioavailability of oral Sinamax.
2- Products containing calcium or antacids will interfere with absorption of Sinamax, it decreases the bioavailability of the drug.
3- Aspirin: clinical studies have shown that gastrointestinal adverse reactions increased in patients receiving concomitant therapy with doses of Sinamax greater than 10 mg / day and aspirin-containing compounds.
|Dosage & administration||One tablet (70 mg) per week, to be swallowed with full glass of water without chewing or dissolving in the mouth (avoid mineral water), not to be taken before bedtime, also do not lie down. It is preferable to be taken at rising of the day or 30 minutes before lunch time without having any food or drink during this period.|
|Over-dosage||Hypo-calcemia, hypophatemia gastrointestinal adverse events such as gastritis or gastric ulcers.|
|Package||One blister contains 10 blue tabs.|