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Musculo-Sceletal System

Londromax (Tablets)
(Alendronic Acid)



CONTENT:
Tablets. Tablet contains alendronic acid (as sodium alendronate trihydrate) 70 mg.
 
PHARMACOLOGIC PROPERTIES:
PHARMACODYNAMICS. Londromax is non-hormonal specific inhibitor of osteoclastic bone resorption. It belongs to a group of bisphosphonates and is the analogue of natural pyrophosphate. Selective action is conditioned by high affinity of bisphosphonates to the mineral bone components. Activity of osteoclasts is inhibited. It stimulates osteogenesis, restores positive balance between bone resorption and reconstitution, progressively increases bone mineral density (regulates exchange of phosphorus and calcium) and favors formation of normal bone tissue with normal histological structure.
PHARMACOKINETICS. The administration of alendronic acid before, during or immediately after the meal leads to reduction of bioavailability. During co-administration with coffee or orange juice the bioavailability of alendronate reduces by approximately 60%.
Temporarily it distributes in soft tissues and then rapidly redistributes in bone or is excreted in the urine. The mean steady-state volume of distribution is about 28 liters in humans. Concentration of alendronate in plasma following therapeutic oral doses is usually too low for analytical detection (less than 5 ng/ml). Protein binding in plasma is approximately 78%.
It is not metabolized.
It is essentially eliminated via the kidneys. The terminal half-life can be more than 10 years that is connected with the release of active ingredient from bones.
 
THERAPEUTIC INDICATIONS:
- treatment of osteoporosis in postmenopausal women to prevent fractures, including hip fractures and compression spine fractures;
- treatment of osteoporosis in men to prevent fractures.
 
CONTRAINDICATIONS:
- oesophagus diseases (stricture, achalasia);
- inability to stand or sit upright for 30 minutes after the administration of preparation;
- hypersensitivity to the components of preparation;
- patients at increased risk of aspiration;
- hypocalcaemia.
 
SIDE EFFECTS:
Londromax is well tolerated in general. Side effects are usually insignificant and dont require the therapy cessation.
From digestive system: abdominal pain, dysphagia, heartburn, oesophagitis, oesophageal ulcer or erosion, gastralgia, dyspepsia, flatulence, constipations or diarrhoea, nausea.
From central nervous system (CNS): headache, irritability.
 
DOSAGE AND ADMINISTRATION:
Rules of the preparation administration
Londromax should be taken minimum 30 min before the first food, beverage or medicinal product with plain water only. Other beverages (including mineral water), food and some medicinal products can reduce the absorption of the preparation.
To facilitate delivery to the stomach and to reduce the oesophageal irritation the tablets should be taken just after arising with a full glass of water, not chewing or resolving in mouth because of a potential for oropharyngeal ulceration. Patients should not lie down at least 30 minutes after taking the preparation. Londromax should not be taken at bedtime or before arising.
For the treatment of osteoporosis in women and men 70 mg of the preparation should be taken 1 time per week.
For elderly patients with mild or moderate renal impairment (CC=35 - 60 ml/min) no dosage adjustment is necessary.
 
PACKAGING:
 4 tablets in blister.
1 blister with the enclosed leaflet in a carton box.
 
 
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