Ризендрос®

General characteristics. Structure:

Active agent: ризедронат sodium of 35 mg.
Excipients:
Kernel - cellulose microcrystallic, кросповидон, magnesium stearate.
Film cover - a gipromelloza 2910/5, talc, a macrogoal 6000, titanium dioxide, dye ferrous oxide red (Е 172), dye ferrous oxide yellow (Е 172).

Description: Biconvex round tablets of orange color, film coated.

Pharmacological properties:

Means for treatment of osteoporosis, concerns to group of bisfosfonat, regulates phosphorus-calcium exchange, reduces a bone resorption of calcium, stimulates bone formation.

Pharmacodynamics. Inhibitor of a bone resorption. Rizedronovy acid contacts a hydroxyapatite at the cellular level and suppresses function of osteoclasts, reduces a bone resorption. Time of achievement of the maximum therapeutic effect - 3-6 months, duration of therapeutic action - 12 months.

Pharmacokinetics. Absorption of drug after intake rather bystry, also makes about 1 hour. Average bioavailability of drug - 0,63%, decreases at meal. Communication with proteins of plasma - 24%. Distribution volume - 6,3 l/kg. There are no data confirming system metabolism of rizedronovy acid. About a half of the absorbed dose is removed with urine within 24 hours. The average renal clearance makes 105 ml/min. and the average general clearance makes 122 ml/min. The renal clearance does not depend on concentration of drug, there is a linear dependence between renal clearance and clearance of creatinine. Not absorbed rizedronovy acid is removed with excrements in not changed form.

Indications to use:

• Treatment of the established post-menopausal osteoporosis.

Route of administration and doses:

The recommended dose for adults: 35 mg once a week. The pill needs to be taken in the same day of the week. Absorption of rizedronovy acid depends on meal therefore for ensuring adequate absorption patients have to accept РИЗЕНДРОС® not less than in 30 minutes before the first meal, other medicine or drink (other than water).
Patients need to explain that if they missed reception of a dose, then it is necessary to accept drug that day when they remembered it. Then the patient should return to reception of one tablet once a week in day of standard practice. It is not necessary to take two pill in the same day.
The pill should be taken entirely and not to chew, standing better and to wash down with usual water (> 120 ml). After reception of a tablet patients should not lay down within 30 minutes.
During treatment observance of an adequate diet with the sufficient content of calcium and vitamin D is recommended. If necessary perhaps additional purpose of drugs of calcium and vitamin D.

Features of use:

Before therapy by drug it is necessary to adjust a hypocalcemia, and also other pathology exerting impact on bone and mineral metabolism (for example, dysfunctions of epithelial bodies, deficit of vitamin D). At insufficient receipt with food of calcium and vitamin D their additional reception is necessary.
Use of a number of bisfosfonat is followed by an esophagitis and cankers of a gullet. Therefore patients have to observe strictly instructions for dosing (see the section "Route of Administration and Doses").
Patients who are not able to be within 30 minutes in vertical position after administration of drug and also to patients with dysfunction of a gullet in the anamnesis (such as stricture or akhlaziya) rizedronovy acid need to apply with extra care because of limited clinical experience of use it at such patients.
The doctor appointing treatment is obliged to emphasize importance of observance of instructions on the dosing mode at such patients.

Side effects:

From the alimentary system: often - dyspepsia, nausea, a gastralgia, abdominal pains, a lock, diarrhea; sometimes - an esophagitis, ulcers of a gullet and a stomach, gastritis, colitis dysphagy, an eructation, a duodenitis, a glossitis, a gullet stricture, disturbance of indicators of function of a liver.
From a nervous system: headache, dizziness, adynamy, increased fatigue, spasms of gastrocnemius muscles, myasthenia.
From skeletal and muscular system: skeletal and muscular pain, spasms of gastrocnemius muscles.
From sense bodys: an acute iritis (a sclera hyperemia, eye pain), an amblyopia, an illegibility of visual perception, dryness of a mucous membrane of eyes, a ring in ears.
Allergic reactions: skin rash.
Others: ostealgia, arthralgia, bronchitis (cough), sinusitis, stethalgia, peripheral hypostases, insignificant passing hypocalcemia and hypophosphatemia.

Interaction with other medicines:

The medicines containing polyvalent cations, such as calcium, magnesium, iron and aluminum can reduce drug absorption. There are no clinically significant interactions with non-steroidal anti-inflammatory drugs (in that number with acetylsalicylic acid), blockers of H2-histamine receptors, inhibitors of the protonew pump, antiacid medicines, blockers of slow calcium channels, beta adrenoblockers, thiazide diuretics, glucocorticosteroids, anticoagulants, anticonvulsant medicines, cardiac glycosides.
Let's combine with hormonal replaceable medicines.

Contraindications:

• Hypersensitivity to drug components;
• Hypocalcemia;
• Heavy renal failure (clearance of creatinine less than 30 ml/min.);
• Pregnancy and period of breastfeeding (lactation);
• Children's age up to 18 years.
With care at erosive cankers of a mucous membrane of digestive tract (including in the anamnesis), at patients with dysfunction of a gullet in the anamnesis (such as stricture or akhlaziya).

Overdose:

Symptoms (are potentially possible): hypocalcemia.
Treatment: milk reception, purpose of the antacids containing magnesium, calcium or aluminum.
At considerable overdose for removal of not absorbed drug it is recommended to carry out a gastric lavage.

Storage conditions:

Does not demand special storage conditions. To store in the place, unavailable to children. Period of validity 2 years. Not to use after expiry date.

Issue conditions:

According to the recipe

Packaging:

Tablets film coated 35 mg. On 2 or 4 tablets in the blister from OPA/A1/PVC/A1. On 1 blister (on 2 tablets), on 1, 2 or 3 blisters (on 4 tablets) in a cardboard pack together with the application instruction.