Description
Latin name
TEVANATE
Release form
Tablets.
Packing
In a blister pack of 4 tablets. In a cardboard bundle 1 blister.
Pharmacological action
Tevanate – an inhibitor of bone resorption. It belongs to the group of aminobisphosphonates – synthetic analogues of pyrophosphate that binds to hydroxyapatite, which is part of the bone tissue. Increases the mineral density of the bones of the spine and other bones of the skeleton. The mechanism of antiresorptive action is associated with suppression of osteoclast function. Promotes the formation of bone tissue with a normal histological structure.
Indications
– Treatment of postmenopausal osteoporosis.
– Osteoporosis caused by the use of corticosteroids.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and during lactation (breastfeeding).
Composition
1 tablet contains: sodium alendronate monohydrate 812 mg (equivalent to 70 mg alendronic acid).
Excipients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Dosage and administration
To ensure normal absorption of the drug and reduce the risk of adverse reactions, the recommendations for use and dosage should be strictly observed.
Tevanat appoint inside on 1 tab. 10 mg 1 time / day or 1 tab. 70 mg once a week.
Take the tablet whole with a glass of water at least 30 minutes before the first meal, drinks or other medicines. The drug is washed down only with plain water, since other drinks (including mineral water), food products and some medicines can reduce the bioavailability of alendronic acid. Do not chew or dissolve tablets.
After taking the drug, the patient should maintain an upright position (standing or sitting) for at least 30 minutes. You can not take the drug before bedtime or before the morning rise from bed.
Side effects
The frequency of adverse events is indicated in accordance with the following gradation: often ( 1/100, <1/10) infrequently ( 1/1000, <1/100) rarely ( 1/10 000, <1/1000). From the digestive system: often – pain in the stomach, dyspepsia, sour belching, nausea, constipation, diarrhea, dysphagia, flatulence, gastritis, gastric ulcer, ulceration of the mucous membrane of the esophagus infrequently – nausea, vomiting, gastritis, esophagitis, erosion rarely – esophageal stricture, ulceration of the oropharynx, perforation, ulcers, bleeding in the upper gastrointestinal tract, although a causal relationship has not been established. From the musculoskeletal system: often – bone, muscle and joint pain, muscle cramps rarely – osteonecrosis. There are reports of osteonecrosis of the jaw in patients taking bisphosphonates. Most reports relate to cancer patients, but similar cases have also been reported in patients being on therapy for osteoporosis. From the nervous system: often – headache. Dermatological reactions: infrequently – rash, itching, erythema rarely – rash with photosensitivity in some cases – severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Allergic reactions: rarely – hypersensitivity reactions, including urticaria and angioedema. From the side of the organ of vision: rarely – uveitis, scleritis, episcleritis. On the part of the body as a whole: rarely – transient symptoms similar to those in the acute phase of the disease (myalgia, malaise and rarely fever), usually at the beginning of treatment symptomatic hypocalcemia, usually associated with predisposing conditions. Overdose Symptoms: possible hypocalcemia, hypophosphatemia, diarrhea, heartburn, esophagitis, erosive and ulcerative lesions of the gastrointestinal tract. Treatment: administration of milk or antacid for alendronic acid binding. Because of the risk of esophageal irritation, no vomiting should be caused. The patient should be upright. Storage conditions Store the drug at a temperature not exceeding 30 ° C. The Expiration of is 2.5 years. Deystvuyuschee substances Alendronovaya acid pharmacy terms with prescription dosage form dosage form tablets Teva Pharmaceutical Enterprises Co., Ltd., Israel
