Forosa
Forosa: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Forosa
ATX code: M05BA04
Active ingredient: alendronic acid (alendronic acid)
Manufacturer: Lek (Slovenia)
Description and photo update: 2018-23-10
Prices in pharmacies: from 437 rubles.
Buy
Forosa is a bone resorption inhibitor, a drug for the treatment of osteoporosis.
Release form and composition
Forosa is produced in the form of film-coated tablets: round, white, biconvex, engraved on one side "ALN 70" (4 or 2 pcs. In blisters, in a cardboard box 6, 4, 3, 2 or 1 blister) …
1 tablet contains:
- active substance: alendronate sodium trihydrate - 91.35 mg, which is equivalent to 70 mg of alendronic acid;
- auxiliary components: croscarmellose sodium, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silicon dioxide;
- casing: Luster Clear LC 103 - macrogol 8000, carrageenan, microcrystalline cellulose.
Pharmacological properties
Pharmacodynamics
Forosa is a non-hormonal drug that stimulates osteogenesis. Its mechanism of action is aimed at suppressing the activity of osteoclasts as a result of specific inhibition of osteoclastic bone resorption. Promotes a positive balance between bone resorption and bone repair.
Regulates calcium-phosphorus metabolism, increasing bone mineral density. The action of the drug stimulates the formation of a normal histological structure in bone tissue.
Pharmacokinetics
The bioavailability of alendronate when taken orally at a dose of 70 mg on an empty stomach (in the morning 2 hours before breakfast) in women is 0.64%, in men - 0.59%. If a meal is started 1 hour after taking the pill, then the absorption of alendronate will decrease to 0.46%, after 0.5 hours - to 0.39%.
When using the drug less than 0.5 hours before the first meal or drink, during or during the first 2 hours after a meal, the clinical efficacy of alendronate is negligible or absent.
Drinking coffee or orange juice at the same time reduces the bioavailability of the drug by about 60%. In blood plasma, the concentration of the drug is less than 5 ng / ml.
When administered intravenously (iv), alendronate enters the soft tissues for a while, then redistributes to the bones or excreted in the urine. In equilibrium, the volume of distribution averages 28 liters, excluding bone tissue.
The binding of alendronate to plasma proteins is approximately 78%.
The metabolic process of alendronate in the body has not been established.
Within 72 hours after intravenous administration of alendronate, about 50% of the dose is excreted through the kidneys, and a small part of the dose through the intestines. Against the background of a single intravenous injection of 10 mg alendronate, the renal clearance rate is 71 ml / min, systemic clearance is up to 200 ml / min. The concentration of the drug in the blood plasma 6 hours after intravenous administration is 5% of the initial.
Indications for use
- osteoporosis caused by prolonged use of glucocorticosteroids (GCS);
- osteoporosis in postmenopausal women, including to reduce the risk of hip fractures and compression fractures of the spine;
- osteoporosis in men - to prevent fractures.
Contraindications
- pathologies of the esophagus, causing a slowdown in the movement of food along it, including stricture and achalasia of the esophagus;
- hypocalcemia;
- inability of the patient to be in a standing or sitting position for 0.5 hour;
- severe renal failure with creatinine clearance (CC) less than 35 ml / min;
- period of pregnancy;
- breast-feeding;
- severe disorders of mineral metabolism;
- childhood;
- individual intolerance to the components of the drug.
Caution should be exercised when prescribing Forosa to patients with hypovitaminosis D or such diseases of the gastrointestinal tract (GIT) as gastritis, exacerbation of peptic ulcer disease, dysphagia, active gastrointestinal bleeding, duodenitis, if a history of surgery is indicated in the upper gastrointestinal tract.
Instructions for use Forosa: method and dosage
Forosa tablets are taken orally, swallowing whole (cannot be chewed!) And washed down with plain water in a volume of 200 ml.
The drug should be taken in the morning, preferably 2 hours, but no later than 0.5 hours before the first intake of any drink, food or other drug. After taking the pill, the patient should not take a horizontal position for 0.5 hour.
The use of Forosa is contraindicated in bed until the morning rise or before bedtime.
Recommended dosage: 1 pc. Once a week.
With moderate impairment of renal function (CC is more than 35 ml / min) and for elderly patients, dose adjustment for Forosa is not required.
Side effects
- from the musculoskeletal system: pain in muscles, joints and bones; rarely - osteonecrosis of the jaw;
- from the nervous system: increased irritability, headache;
- from the digestive system: flatulence, abdominal pain, constipation or diarrhea, nausea, stomach dystonia, vomiting, heartburn, dysphagia, esophagitis, melena, ulceration of the mucous membrane (mouth, pharynx, esophagus, stomach, duodenum);
- allergic reactions: hypersensitivity reactions, including urticaria, hyperemia, angioedema;
- on the part of the organ of vision: scleritis, uveitis;
- others: asymptomatic transient hypocalcemia, hypophosphatemia, photosensitization.
Overdose
Symptoms: heartburn, abdominal pain, dysphagia, dyspeptic disorders, gastritis, esophagitis. Development of hypocalcemia and hypophosphatemia is possible.
Treatment: the appointment of symptomatic therapy. The patient must be in an upright position. To bind alendronate, intake of milk and antacids is indicated. Vomiting should not be induced due to possible damage to the esophagus.
special instructions
The tablets should be taken with only plain water, since other drinks (mineral water, tea, coffee or fruit juices) impair the absorption of alendronate.
The use of Forosa at bedtime or in the supine position is not recommended due to the increased risk of developing esophagitis.
It is possible to start treatment with the drug only after correction of metabolic disorders (including vitamin D deficiency) and hypocalcemia. An increase in bone mineral density during therapy with alendronate can cause a slight decrease in serum calcium and phosphate levels (clinically asymptomatic), especially with the concomitant use of corticosteroids, which reduce calcium absorption. Therefore, it is required to ensure that a sufficient amount of calcium and vitamin D is supplied to the body.
The patient should be informed that if he accidentally misses the next dose of the drug on the set day of the week, it (1 tablet) must be taken in the morning of the next day. Further, the use of the drug should be continued according to the previously established therapy regimen. Do not allow taking 2 tablets in one day!
When prescribing Forosa, the doctor must explain to the patient the rules for taking the drug in detail and make sure that he understands them. The patient should be aware of the increased risk of side effects from the esophagus if the instructions are not followed. Symptoms of esophageal irritation include heartburn (onset or worsening), chest pain, and dysphagia. Since it is possible to develop severe disorders of the esophagus while continuing to take alendronic acid after the onset of these symptoms of irritation of the esophagus, when you feel their first signs, you should consult a doctor.
Against the background of the use of other bisphosphonates, osteonecrosis of the jaw has been observed in rare cases. Risk factors for osteonecrosis of the jaw include an established diagnosis of cancer, concomitant use of corticosteroids, concomitant radiation therapy, chemotherapy, anemia, coagulopathy, gum disease, and infections. Most often, osteonecrosis of the jaw is noted with intravenous administration of bisphosphonates. The manifestation of symptoms of osteonecrosis of the jaw can intensify dental surgery during the period of use of bisphosphonates.
Since it has not been precisely established whether the risk of osteonecrosis of the jaw decreases with the abolition of bisphosphonates, the decision to prescribe Forosa should be made after a careful assessment of the risk-benefit ratio of therapy for each patient individually.
Long-term use of alendronic acid can cause a low-energy (fatigue) fracture of the proximal femoral shaft. It can appear both after a minor injury, or in its absence. This should be considered when hip pain occurs, often accompanied by outward signs of stress fractures long before a complete hip fracture.
Long-term femoral shaft fractures in a patient taking bisphosphonates require an examination of the contralateral femur because low-energy fractures of the proximal femoral shaft are often bilateral. Cancellation of bisphosphonates in this category of patients is recommended after an individual assessment of the condition and comparison of the potential risk and expected benefit from therapy.
Application during pregnancy and lactation
The use of Forosa is contraindicated during gestation and breastfeeding.
Pediatric use
According to the instructions, Forozu cannot be prescribed to patients in childhood, since the safety and clinical efficacy of the drug has not been established.
With impaired renal function
The use of Forosa is contraindicated in case of severe renal dysfunction (CC less than 35 ml / min).
With a moderate degree of renal dysfunction (CC more than 35 ml / min), treatment should be carried out at the usual dose.
Use in the elderly
No dose adjustment is required for elderly patients.
Drug interactions
With the simultaneous use of Forosa:
- antacids and calcium supplements, including dietary supplements, impair the absorption of alendronate;
- nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid, can increase the side effects of alendronic acid from the gastrointestinal tract.
It is recommended to take other medicines only 30 minutes after taking the drug. This will avoid the development of clinically significant interactions of alendronate with commonly used drugs.
Analogs
Forosa analogues are: Tevabon, Tevanat, Alenthal, Alendronat, Fosamax, Osterapar, Ostalon.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, protected from moisture and light.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Foroz
Few reviews of Forosa indicate the effectiveness of tablets in the treatment of osteoporosis. The action of the drug contributes to a significant increase in the structural density of bones. Some patients who have suffered from pain for several years and have undergone therapy with other means, after taking the drug, felt an immediate reduction in pain.
Forosa price in pharmacies
The price of Forosa is approximately 1,433 rubles for a package containing 12 tablets, 604 rubles for a package containing 4 tablets.
Forosa: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Forosa 70 mg film-coated tablets 4 pcs. 437 r Buy |
|
Forosa 70 mg film-coated tablets 8 pcs. 450 RUB Buy |
|
Forosa tablets p.p. 70mg 4 Pcs. RUB 524 Buy |
|
Forosa tablets p.p. 70mg 8 pcs. 758 RUB Buy |
|
Forosa 70 mg film-coated tablets 12 pcs. 850 RUB Buy |
|
Forosa tablets p.p. 70mg 12 Pcs. 1278 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
