Alendronate - Instructions For Use, Indications, Doses, Analogues

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Alendronate - Instructions For Use, Indications, Doses, Analogues
Alendronate - Instructions For Use, Indications, Doses, Analogues

Video: Alendronate - Instructions For Use, Indications, Doses, Analogues

Video: Alendronate - Instructions For Use, Indications, Doses, Analogues
Video: FDA Urges Caution Over Long-Term Use of Bone-Density-Building Drugs 2024, November
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Alendronate

Instructions for use:

  1. 1. Release form and composition
  2. 2. Indications for use
  3. 3. Contraindications
  4. 4. Method of application and dosage
  5. 5. Side effects
  6. 6. Special instructions
  7. 7. Drug interactions
  8. 8. Analogs
  9. 9. Terms and conditions of storage
  10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 283 rub.

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Alendronate tablets
Alendronate tablets

Alendronate is a biophosphonate, a non-hormonal inhibitor of osteoclastic bone resorption, stimulates osteogenesis, suppresses osteoclasts, increases bone mineral density, and promotes the formation of bone tissue with a normal histological structure.

Release form and composition

Dosage form - tablets: round, flat-cylindrical, 10 mg - with a chamfer, 70 mg - with a dividing line and a chamfer, almost white or white, with slight marbling (10 mg - 10 pcs. In a blister strip, in a cardboard box 1 or 3 packs; 70 mg - 4 pcs. in a blister, in a cardboard box 1, 2 or 3 packs; 10 pcs. in a blister, in a cardboard box 1 pack).

1 tablet of Alendronate contains:

  • Active ingredient: sodium alendronate (in terms of alendronic acid) - 10 mg or 70 mg;
  • Auxiliary components: lactose monohydrate, potato starch, colloidal silicon dioxide, calcium stearate, povidone (low molecular weight polyvinylpyrrolidone).

Indications for use

  • Paget's disease;
  • Osteoporosis in postmenopausal women (for the prevention of bone fractures, including the spine and proximal thigh);
  • Osteoporosis in men.

Contraindications

  • Pathology of the esophagus, delaying the processes of its emptying (including achalasia, strictures);
  • Hypocalcemia;
  • Inability to sit or stand upright for 30 minutes or more;
  • Lactose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency;
  • Chronic renal failure, with creatinine clearance (CC) less than 35 ml / min;
  • The period of pregnancy and breastfeeding;
  • Children and adolescents up to 18 years old;
  • Hypersensitivity to drug components.

It is recommended to prescribe the drug with caution to patients during an exacerbation of diseases of the gastrointestinal tract (GIT): gastritis, dysphagia, duodenitis, esophagitis, gastric ulcer and duodenal ulcer; with severe pathologies of the gastrointestinal tract, such as gastrointestinal bleeding, peptic ulcer, surgery on the upper gastrointestinal tract (except pyloroplasty), transferred within the previous 12 months; with a predisposition to hypocalcemia (calcium malabsorption, hypothyroidism); with oncological diseases, vitamin D deficiency and other disorders of mineral metabolism; with the simultaneous use of corticosteroids and other drugs, chemotherapy and / or radiation therapy; with poor oral hygiene (including dental diseases, periodontitis), coagulopathy, anemia, concomitant infectious and other pathologies.

Method of administration and dosage

The tablets are taken orally, swallowing whole, preferably 2 hours before, but later than 0.5 hours before the first intake of water, food or other medications. Drink with plain water only, as tea, mineral water, orange juice or coffee will reduce absorption.

The use of Alendronate should be accompanied by the intake of vitamin D and calcium in a dose that meets the daily requirement.

The optimal duration of bisphosphonate therapy has not been established. It is determined by a doctor on a regular basis, especially in patients after use for five years or more.

Recommended dosage:

  • Postmenopausal osteoporosis in women, and osteoporosis in men: 70 mg once a week or 10 mg once a day;
  • Paget's disease: 40 mg once a day, a course of therapy for six months.

For elderly patients, patients with functional impairment of the liver and / or mild to moderate renal failure (CC 35-60 ml / min), dose adjustment is not required.

If you miss the next dose of the drug on the set day (when taken once a week), the pill should be taken in the morning of the next day, provided that it will not be taking two tablets at the same time. Then continue the application according to the established scheme.

Side effects

In general, the use of Alendronate is well tolerated, the severity of side effects is usually mild and does not require discontinuation of the drug.

Adverse drug effects with a frequency of development in more than 1% of patients established during clinical trials:

  • Digestive system: nausea, abdominal pain, constipation, diarrhea, sour belching, dyspepsia, dysphagia, esophageal ulcer, gastritis, flatulence, stomach ulcer, melena;
  • Nervous system: headache;
  • Musculoskeletal system: bone pain, muscle cramps, myalgia, joint pain.

Side effects recorded in wide clinical practice:

  • Nervous system: dizziness, impaired taste, systemic dizziness;
  • Digestive system: nausea, vomiting, erosion or ulcer of the esophagus, perforation, gastritis, melena, esophageal stricture, oropharyngeal ulcer, esophagitis; rarely - peptic ulcer of the stomach and duodenum (the connection with the drug is not confirmed), osteonecrosis of the jaw (local), more often associated with a previous local infection (including osteomyelitis) and / or tooth extraction;
  • Metabolism: hypocalcemia; rarely - peripheral edema;
  • Musculoskeletal system: myalgia, joint and / or bone pain; rarely - severe forms of joint swelling, hip fractures;
  • Allergic reactions: urticaria, rarely - angioedema;
  • Sense organs: rarely - scleritis, uveitis, episcleritis;
  • Dermatological reactions: skin itching, rash, alopecia, photosensitivity; rarely - erythema, toxic epidermal necrolysis, Stevens-Johnson syndrome and other severe skin reactions;
  • Others: asthenia, malaise, myalgia; rarely - fever (are transient, appear at the beginning of therapy).

special instructions

When prescribing Alendronate, the doctor must inform the patient in detail about the rules for taking the pills and the consequences of not following the recommendations.

To reduce the irritating effect on the esophagus, the pill must be taken immediately after waking up in the morning, washed down with a full glass of water and not take a horizontal position for 0.5 hour after taking it (risk of developing esophagitis).

The patient should pay special attention to signs of unwanted reactions from the esophagus. If you experience heartburn, chest pain, dysphagia or pain when swallowing, stop taking the drug and consult a doctor.

Due to the positive effect of the drug on bone mineral density, slight asymptomatic decreases in serum levels of calcium and phosphate concentration may be observed. This is of particular importance for patients on glucocorticosteroid therapy, since calcium absorption in them may be reduced.

Risk factors for the development of osteonecrosis of the jaw include: concomitant therapy (chemotherapy, radiation therapy, corticosteroid drugs), diagnosed cancer, gum disease, anemia, infections, coagulopathy.

Surgical dental manipulations can enhance the manifestations of osteonecrosis of the jaw.

The decision on the appropriateness of using the drug must be made after assessing the ratio of the expected benefit from therapy and the possible risk for each patient individually.

The effect of alendronic acid on the patient's ability to drive vehicles and mechanisms has not been established.

Drug interactions

When used simultaneously with drugs for oral administration, including antacids and calcium-containing drugs, the absorption of alendronic acid may be reduced, so these combinations should not be allowed. If concomitant therapy is needed, the interval between taking Alendronate and other drugs should be 0.5 hours or more.

The side effects of alendronic acid on the gastrointestinal tract can be enhanced by its combination with acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Combined therapy with estrogen preparations (observing the interval between doses) does not cause a change in their action and the development of side effects.

The bioavailability of alendronic acid is not affected by oral administration of prednisolone.

Analogs

Alendronat's analogues are: Alendon, Alendros, Lindron, Lindromax, Osterepar, Rekostin, Tevanat, Fosalen, Fosamax, Forosa.

Terms and conditions of storage

Store in a dark place at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Alendronate: prices in online pharmacies

Drug name

Price

Pharmacy

Alendronate 70 mg tablets 4 pcs.

283 r

Buy

Alendronate 70 mg tablets 4 pcs.

RUB 300

Buy

Alendronate 70 mg tablets 4 pcs.

309 r

Buy

Alendronate 70mg tablets 4 pcs.

RUB 318

Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!

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