Universal reference book for medicines
Product name: Ostalon ® (OSTALON)

Active substance: alendronic acid

Type: Inhibitor of bone resorption in osteoporosis

Manufacturer: GEDEON RICHTER (Hungary) manufactured by GRODZISK PHARMACEUTICAL WORKS POLFA (Poland)
Composition, form of production and packaging
The tablets covered with a cover of
white color, round, biconcave, with engraving "M14" on one side.

1 tab.

alendronate sodium trihydrate 91.35 mg,

which corresponds to the content of alendronic acid 70 mg

Excipients: microcrystalline cellulose, silicon dioxide colloid, croscarmellose sodium, magnesium stearate.

The composition of the shell: Lusterre Clearant LS 103 (microcrystalline cellulose, carrageenan, macrogol 8000)

4 things.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Inhibitor of bone resorption in osteoporosis.
Alendronate sodium is a bisphosphonate, a synthetic analogue of pyrophosphate, which binds the 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

Suction

After a single dose, in the morning on an empty stomach (2 hours before breakfast) at a dose of 35 mg or 70 mg, the absorption 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 intake of coffee or orange juice reduces the bioavailability of alendronate sodium by 60%.
Distribution

After ingestion, alendronate sodium is temporarily distributed into soft tissues, then quickly incorporated into bone tissue.
Binding to plasma proteins - 78%.
Metabolism

There are no data confirming the metabolism of alendronate in the human body.

Excretion

Absorbed, but not embedded in bone tissue, alendronate sodium is quickly excreted in the urine.
The maximum saturating capacity of bone tissue in animals could not be established with iv 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 (reduction of risk of fractures of the spinal vertebrae, head of the hip);

- Treatment of osteoporosis in men (reduced risk of fractures of the spinal vertebrae, pelvic bones);

- Osteoporosis caused by prolonged use of GCS.

DOSING MODE

The drug should be taken at 70 mg once a week.
To ensure optimal absorption Absolon ® should be taken in the morning on an empty stomach for 2 hours (at least 30 minutes) before the first meal or liquid, drinking down with plain drinking water. Other beverages (including mineral water), food, a number of medicines may impair 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 have 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 the use of calcium and vitamin D.

In elderly patients, dose adjustment is not required.

With CK> 35 ml / min , dose adjustment is not required, with severe renal failure to prescribe the drug is not recommended because of a lack of clinical experience.

SIDE EFFECT

From the digestive system: often (? 1/100, <1/10) - abdominal pain, indigestion, constipation, diarrhea, flatulence, ulcer of the esophagus, dysphagia, bloating, heartburn;
sometimes (? 1/1000, <1/100) - nausea, vomiting, gastritis, esophagitis, erosion of the esophagus, melena; rarely (? 1/10 000, <1/1000) - narrowing of the esophagus, oropharyngeal ulcer, perforation of the upper gastrointestinal tract, ulcer, bleeding (connection with treatment is not always unambiguous).
From the musculoskeletal system: often (? 1/100, <1/10) - Ostalgia, arthralgia, myalgia.

From the side of the central nervous system: often (? 1/100, <1/10) - headache, irritability.

From the sense organs: rarely (? 1/10 000, <1/1000) - uveitis, scleritis.

Dermatological reactions: sometimes (? 1/1000, <1/100) - itching, skin hyperemia, rash;
rarely (1/10 000, <1/1000) - photosensitivity.
From the side of metabolism: rarely (? 1/10 000, <1/1000) - hypocalcemia (often accompanied by predisposing factors), hypophosphatemia.

Allergic reactions: rarely (? 1/10 000, <1/1000) - urticaria, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Other: rarely (? 1/10 000, <1/1000) - transient symptoms resembling a phase of acute reaction (myalgia, weakness, poor health, rarely - high body temperature), most often develop at the beginning of treatment.

CONTRAINDICATIONS

- abnormalities of the esophagus and other factors that complicate the passage of the esophagus (including achalasia, stricture);

- hypocalcemia;

- chronic renal failure (CK <35 ml / min);

- deficiency of vitamin D;

- severe disturbances in mineral metabolism;

- the patient's inability to remain in a vertical position, even if sitting, for 30 minutes;

- Pregnancy;

- the period of lactation (breastfeeding);

- childhood;

- Hypersensitivity to the components of the drug.

Caution should be used when
Gastrointestinal diseases in the phase of exacerbation (dysphagia, esophagus, gastritis, duodenitis, ulcer, in the previous 12 months - peptic ulcer, gastrointestinal bleeding, surgical intervention, except for operations on the spastic gastric gatekeeper).
PREGNANCY AND LACTATION

The use of Ostalon during pregnancy and during breastfeeding is contraindicated.

APPLICATION FOR FUNCTIONS OF THE LIVER

The use of the drug in chronic renal failure (CC <35 ml / min) is contraindicated.

APPLICATION FOR CHILDREN

Contraindicated in childhood.

APPLICATION IN ELDERLY PATIENTS

In elderly patients, dose adjustment is not required.

SPECIAL INSTRUCTIONS

Alendronate can cause local irritation of the gastrointestinal mucosa.
The course of upper GI diseases may worsen during treatment with Ostalon.
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 patients that if the signs of esophageal irritation (dysphagia, retrosternal pain during swallowing, the appearance or deterioration of the course of heartburn attacks) 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 the drug, or continue treatment despite the appearance of signs of irritation of the esophagus.
It is necessary to warn the patient that in case of missing the next dose of the drug, the missed tablet should be taken the next morning.
In no case should you take 2 tablets in one day.
Treatment can begin only after the elimination of hypocalcemia, violations of mineral and vitamin metabolism (eg, vitamin D deficiency).
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 is especially important in case of simultaneous treatment of the patient with SCS.
Treatment should be combined with a diet enriched with calcium salts.

Impact on the ability to drive vehicles and manage mechanisms

The drug does not affect the ability to drive and perform work associated with a high risk of injury, but in the presence of adverse reactions from the body of vision, driving and working mechanisms are contraindicated until the complete disappearance of adverse reactions.

OVERDOSE

Symptoms: hypocalcemia, hypophosphatemia, side reactions from the upper gastrointestinal tract (heartburn, esophagitis, gastritis, ulcer).

Treatment: there is no specific treatment, it is recommended to take milk, antacids.
To avoid irritation of the esophagus, do not induce vomiting, the patient should be given a vertical position (standing or sitting).
DRUG INTERACTION

Calcium, antacids, some preparations for ingestion, food, drinks (including mineral water) affect the absorption of alendronate - drugs can be taken orally no earlier than 1 hour after Ostalon's administration.

Other, except for the change in absorption, the interaction is unlikely.

Ranitidine increases bioavailability (clinical significance is unknown).

NSAIDs enhance the adverse effects of alendronic acid.

Special studies of drug interaction were not conducted, however, in studies with alendronate, patients who received other drugs were taking part.
At the same time, there was no side effect associated with simultaneous administration of other drugs.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of 15 ° to 30 ° C.
Shelf life - 2 years.
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