Ostalon - instructions for use, doses, side effects, contraindications

Auxiliary substances of the core: Cellulose microcrystalline 261.25 mg, silicon dioxide colloid 3.5 mg, croscarmellose sodium 1.28 mg, magnesium stearate 2.62 mg.

Shell accessories: Lustre Clearance LS 103 7 mg (microcrystalline cellulose -44%, carrageenan-18%, macrogol 8000-38%).

Description:

White, round biconvex tablets, covered with a shell, with engraving "M14" on one side.

Pharmacotherapeutic group:Bone resorption inhibitor-bisphosphonate

ATX: & nbsp

M.05.B.A.04 Alendronic acid

Pharmacodynamics:

Alendronate sodium is a bisphosphonate, synthetic analogue of pyrophosphate, binding hydroxyapatite of bone tissue. Being a non-hormonal specific inhibitor of osteoclast activity, it interferes with the resorption of bone tissue. Does not affect the formation of bone tissue. Stimulates osteogenesis, restores a positive balance between resorption and bone repair. Progressively increases the mineral density of bones (regulates phosphorus-calcium metabolism), promotes the formation of bone tissue of normal composition and structure.

Pharmacokinetics:

Absorbability after a single dose of 35 or 70 mg in the morning on an empty stomach 2 hours before breakfast is 0.64%. With a shortened interval between taking the drug and food: 0.46-0.39%. Such a decrease in absorption does not have a significant effect on the effectiveness of the drug. Simultaneous reception of coffee or orange juice reduces bioavailability by 60%.

Distribution: after ingestion, it is temporarily distributed in soft tissues, then quickly incorporated into bone tissue. The connection with plasma proteins is ~ 78%.

Metabolism: data confirming the metabolism of alendronate in human body, no.

Excretion:

Absorbed, but not embedded in the bone tissue alendronate is quickly excreted by the kidneys. The maximum saturation capacity of bone tissue in animals could not be determined by intravenous administration of a cumulative daily dose of 35 mg / kg. Despite the lack of evidence, with kidney disease, there is likely a reduction in alendronate excretion with increased accumulation in bone tissue.

Indications:

Treatment of osteoporosis in postmenopause (reducing the risk of fractures of the spinal vertebrae and the head of the hip).

Treatment of osteoporosis in men (reducing the risk of fractures of the spinal vertebrae and pelvic bones).

Contraindications:

Hypersensitivity to any of the components of the drug; abnormalities of the esophagus and other factors that impede the passage of the esophagus (achalasia, stricture, etc.); the patient's inability to remain in a vertical position, even if sitting, for 30 minutes; hypocalcemia,chronic renal failure (creatinine clearance <35 ml / min), pregnancy, lactation period, childhood, vitamin deficiency D, severe disturbances in mineral metabolism.

Carefully:

Diseases of the digestive tract in phase exacerbations (dysphagia, esophageal diseases, gastritis, duodenitis, ulcer, a serious gastrointestinal disease in the preceding 12 months, for example, peptic ulcer, gastrointestinal bleeding, surgery, except for operations on the spastic gastric gatekeeper).

Pregnancy and lactation:

Pregnancy: in the absence of the necessary clinical experience, the use of alendronate during pregnancy is contraindicated.

Breastfeeding period: there is no data on the penetration into breast milk; The intake of alendronate in the period of breastfeeding is contraindicated.

Dosing and Administration:

Recommended dose: 70 mg once a week. To ensure optimal absorption, the drug should be taken in the morning on an empty stomach, 2 hours (at least 30 minutes) before the first meal or liquid, squeezed with plain drinking water. Other beverages, including mineral water, food, a number of medicines can worsen the absorption of alendronate.

To avoid local irritation of the oral mucosa and esophagus in the morning, immediately after lifting from bed should drink at least 200 ml of plain water, then take the tablet without chewing and letting it dissolve in the mouth, within the next 30 minutes you can not take the horizontal position of the body , after this period you should take breakfast. Do not take the pill in the morning, before ascending from bed or in the evening, after going to bed.

Treatment with alendronate should be supplemented with calcium and vitamin intake D.

Elderly patients: correction of the dose is not required.

Renal insufficiency: if renal filtration> 35 ml / min, dose adjustment is not required, in more severe stages of kidney failure, prescribing the drug is not recommended because of a lack of clinical experience.

Childhood: Because of the lack of clinical data, the drug is not prescribed for children.

Side effects:

The following side effects are possible.

Often (1/100, <1/10):

From the digestive system: abdominal pain, indigestion, constipation, diarrhea, flatulence, ulcer of the esophagus, dysphagia, bloating, heartburn.

From the side of the musculoskeletal system: Ostalgia, arthralgia, myalgia.

From the nervous system: headache, irritability.

Not often (1/1000, <1/100):

Are common: itching, rashes, skin hyperemia.

From the digestive system: nausea, vomiting, gastritis, esophagitis, erosion of the esophagus, melena.

Rarely (1/10000, <1/1000):

Are common: allergic reactions (hives, angiodema, Stevens-Johnson syndrome, toxic epidermal necrolysis); transient symptoms resembling a phase of acute reaction (myalgia, weakness, poor health, rarely - high body temperature) often develop at the beginning of treatment; rash; photosensitivity; hypocalcemia (often accompanied by predisposing factors).

From the digestive system: narrowing of the esophagus, oropharyngeal ulcer, perforation of the upper gastrointestinal tract, ulcers, bleeding, however, the association with treatment is not always unambiguous.

From the sense organs: uveitis, scleritis.

Laboratory indicators: temporary, mild asymptomatic hypocalcemia and hypophosphataemia.

Overdose:

Signs of an overdose: hypocalcemia, hypophosphatemia, side reactions from the upper parts of the digestive tract (heartburn, esophagitis, gastritis, ulcer).

Specific treatment is not. It is recommended to take milk, antacids. To avoid irritation of the esophagus, do not induce vomiting, the patient should be placed in a vertical position (standing or sitting).

Interaction:

Calcium, antacids, some oral preparations, food, drinks, incl. The mineral waters affect the absorption of alendronate; medicines can be taken inside no earlier than 1 hour after taking alendronate.

Other, except for changes in absorption, interaction is unlikely.

Ranitidine increases bioavailability (clinical significance is unknown). Nonsteroidal anti-inflammatory drugs enhance the adverse effects of alendronic acid.

Special studies on drug interactions were not carried out, however, in patients with alendronate, patients taking other oral medications simultaneously participated. At the same time, they did not observe any side effects associated with the simultaneous administration of other drugs.

Special instructions:

Alendronate can cause local irritation of the mucosa of the digestive tract.The course of diseases of the upper tract can worsen during treatment with alendronate.

There are cases of adverse reactions from the esophagus (esophagitis, ulcer or erosion of the esophagus), sometimes occurring in severe form, requiring in-patient treatment, and complicated by the formation of stricture. Special attention should be paid to the fact that if the signs of esophageal irritation (dysphagia, retrosternal pain during swallowing, the appearance or deterioration of the course of heartburn) appear, the drug should be stopped and consult a doctor. The risk of esophageal injury is higher in patients who do not follow the rules of taking the drug, or continuing treatment in spite of the appearance of signs of irritation of the esophagus. It is extremely important to inform patients in a timely manner about the importance of adherence to the rules for taking the drug and to make sure that the patient understands this.

Patients should be warned that if they skip the next dose, the missed pill should be taken the next morning; in no case should you take two tablets in one day.

Treatment can begin only after the elimination of hypocalcemia, disorders of mineral and vitamin metabolism (eg, vitamin deficiency D). The use of alendronate leads to an increase in the mineral salts content in the bone tissue, the process can be accompanied by an asymptomatic change in the levels of calcium and phosphorus. Ensuring appropriate intake of calcium and vitamin D It is especially important in case of treatment of a patient with glucocorticosteroid hormones.

Treatment should be combined with a diet enriched with calcium salts.

Effect on the ability to drive transp. cf. and fur:Does not affect the ability to drive a car and perform work associated with a high risk of injury, but in the presence of adverse reactions from the body vision control of the car and working mechanisms is contraindicated until the complete disappearance of adverse reactions.

Form release / dosage:Tablets, film-coated, 70 mg.

Packaging:

4 tablets in Al/Al blister. One blister in a cardboard box with the attached instruction for use.

Storage conditions:

Store at a temperature of 15-30 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002154/07

Date of registration:11.08.2008 / 14.01.2013

Expiration Date:Unlimited

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER POLAND, Co. Ltd. Poland

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp14.06.2017

Illustrated instructions

Instructions

Ostalon® (Ostalon®)