Universal reference book for medicines
Product name: OSTEREPAR ® (OSTEREPAR)

Active substance: alendronic acid

Type: Inhibitor of bone resorption in osteoporosis

Manufacturer: Pharmaceutical Works POLPHARMA (Poland)
Composition, form of production and packaging
Tablets are
white, oblong, biconvex.

1 tab.

alendronate sodium trihydrate 91.37 mg,

which corresponds to the content of alendronic acid 70 mg

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide colloidal anhydrous.

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

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Inhibitor of bone resorption.
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 of 70 mg in the morning on an empty stomach 2 hours before breakfast, 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 bioavailability by 60%.
Distribution

After oral administration, it is temporarily distributed in soft tissues, then quickly distributed 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 the bone tissue alendronate is quickly excreted by the kidneys.
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 postmenopausal osteoporosis with the aim of preventing vertebral and hip fractures.

DOSING MODE

The drug is taken orally.
The recommended dose is 70 mg once a week. To ensure optimal absorption, the drug should be taken in the morning on an empty stomach, for 2 hours (at least 30 minutes) before the first meal or liquid, squeezed with plain drinking water. Other drinks, incl. mineral waters, food, a number of medicines can worsen the absorption of alendronate.
In order 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 the intake of calcium and vitamin D.

Older patients do not need a dose adjustment.

With CK> 35 ml / min dose adjustment is not required.
With renal failure with a <35 ml / min KK, the drug should not be prescribed because of a lack of clinical experience.
SIDE EFFECT

On the part of the digestive system: often (1/100, <1/10) - abdominal pain, indigestion, constipation, diarrhea, flatulence, ulcer of the esophagus, dysphagia, bloating, heartburn;
infrequently (1/1000, <1/1000) - 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, but the connection with treatment is not always unambiguous.
From the musculoskeletal system: often (1/100, <1/10) - Ostalgia, arthralgia, myalgia.

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

On the part of the skin: infrequently (1/1000, <1/1000) - itching, rash, skin hyperemia;
rarely (1/10 000, <1/1000) - photosensitivity.
Allergic reactions: rarely (1/10 000, <1/1000) - urticaria, angioedema, 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.
From the side of metabolism: rarely (1/10 000, <1/1000) - hypocalcemia (often accompanied by predisposing factors).

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

Laboratory indicators: rarely (1/10 000, <1/1000) - temporary, mildly expressed asymptomatic hypocalcemia and hypophosphatemia.

CONTRAINDICATIONS

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

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

- hypocalcemia;

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

- Pregnancy;

- the period of lactation (breastfeeding);

- childhood;

- deficiency of vitamin D;

- severe disturbances in mineral metabolism;

- Hypersensitivity to the components of the drug.

Caution should be applied to the preparation with diseases of the digestive tract in the phase of exacerbation (dysphagia, esophagus, gastritis, duodenitis, ulcer, serious gastrointestinal disease in the previous 12 months, for example, peptic ulcer, gastrointestinal bleeding, surgery, except for spastic surgery the gatekeeper of the stomach).

PREGNANCY AND LACTATION

In the absence of the necessary clinical experience, the use of the drug Osterepar ® during pregnancy is contraindicated.

There are no data on the penetration of alendronate into breast milk.
Taking Osteverpar ® during breastfeeding is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER

At a glomerular filtration rate> 35 ml / min, dose adjustment is not required.
With renal failure with a glomerular filtration rate <35 ml / min, the drug should not be prescribed because of a lack of clinical experience.
APPLICATION FOR CHILDREN

Child age: due to the lack of clinical data, the drug is not prescribed to children.

SPECIAL INSTRUCTIONS

Alendronate can cause local irritation of the mucosa of the digestive tract.
The course of diseases of the upper parts of the digestive tract may 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 continue treatment despite the appearance of signs of irritation of the esophagus. It is extremely important to inform patients in a timely manner about the importance of compliance with the rules for taking the drug and make sure that the patient understands this.
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 the case of treatment of a patient with SCS.
Treatment should be combined with a diet enriched with calcium salts.

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 2 tablets in one day.
Use in Pediatrics

Due to the lack of clinical data, the drug is not prescribed to children.

Impact on the ability to drive vehicles and manage mechanisms

The drug does not affect the ability to drive vehicles and perform work associated with a high risk of injury, but in the presence of adverse reactions from the view organ, the management of transport and working mechanisms is 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 take a vertical position (standing or sitting).
DRUG INTERACTION

Calcium, antacids, some oral preparations, food, drinks, incl.
The mineral waters affect the absorption of alendronate. Drugs can be taken inside no earlier than 1 hour after taking alendronate.
Other types of interaction, except for changes in absorption, are unlikely.

Ranitidine increases the bioavailability of alendronate (clinical significance is unknown).

NSAIDs enhance the adverse effects of alendronic acid.

Special studies on drug interactions were not conducted, however, in studies with alendronate, patients taking other oral medications simultaneously participated.
At the same time, they had no adverse reactions 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, dry, protected from light at a temperature below 25 ° C.
Shelf life - 2 years.
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