Strometta granules d / prig.susp. 2d, no. 28

It is taken internally. The recommended dose is 2 g 1 time / day. Apply for a long time.

Granules for the preparation of a suspension for oral administration from white to light yellow; powder from white to light yellow color is allowed.

1 pack. strontium ranelate octahydrate 2.561 g,

which corresponds to the content of strontium ranelate 2 g

Excipients: aspartame - 0.02 g, maltodextrin - 0.4 g, mannitol - up to 4 g.

Hypersensitivity to strontium ranelate.

pharmachologic effect

A drug that affects bone metabolism. In vitro studies have shown that strontium ranelate stimulates bone formation in the structure of bone tissue, and also stimulates the replication of osteoblast precursors and collagen synthesis in bone cell culture; reduces bone resorption by suppressing the differentiation of osteoclasts, as well as their resorptive activity.

As a result, the metabolism in the bone tissue is rebuilt in the direction of bone formation.

The ingress of strontium into the bone tissue occurs mainly due to adsorption on the surface of the bone crystal; strontium only to a small extent replaces the calcium in the apatite crystal in the newly formed bone. Strontium ranelate does not alter the characteristics of bone tissue. The combined effects of strontium distribution in bone tissue and increased x-ray absorption of strontium compared to calcium lead to an increase in bone mineral density (BMD), which is measured by two-photon X-ray absorptiometry.

For strontium ranelate, the secondary effect, in relation to the main pharmacological properties, is a slight decrease in serum concentrations of calcium and parathyroid hormone, as well as an increase in the concentration of phosphorus in the blood and the total activity of alkaline phosphatase, which is not accompanied by any adverse clinical consequences.

Pharmacokinetics

After oral administration in a single dose of 2 g, Cmax in blood plasma is achieved after 3-5 hours. The absolute bioavailability of strontium is 25% (range 19-27%). Taking strontium ranelate together with calcium and food reduces the bioavailability of strontium by about 60-70% compared to bioavailability when taken 3 hours after meals. The equilibrium state is achieved after 2 weeks of therapy. Vd is about 1 l / kg. The binding of strontium to human plasma proteins is low and amounts to 25%, while strontium is characterized by a high affinity for bone tissue. Measurements of strontium concentrations in iliac biopsy in patients who received strontium ranelate at a dose of 2 g / day for a long time (up to 60 months) show that strontium concentrations in bone tissue can reach a plateau after about 3 years of therapy.There are no data on the elimination of strontium from bone tissue after discontinuation of therapy. Strontium is not metabolized in the human body. Strontium ranelate does not inhibit cytochrome P450 isozymes.

Excretion of strontium depends on time and dose. The effective T1 / 2 of strontium is approximately 60 hours. Strontium is excreted by the kidneys and through the intestines. Plasma clearance of strontium is about 12 ml / min, renal clearance is about 7 ml / min. Absorbed ranelic acid is rapidly and unchanged excreted by the kidneys.

Side effect

From the side of the central nervous system: often - headache; after 4 years of treatment, often - impaired consciousness, memory loss, convulsions.

From the digestive system: often - nausea, diarrhea, loose stools; frequency not established - vomiting, abdominal pain, irritation of the oral mucosa, including stomatitis and / or ulceration of the mucous membrane.

Dermatological reactions: often - dermatitis, eczema.

Allergic reactions: skin rash, itching, urticaria, angioedema, Stevens-Johnson syndrome, DRESS syndrome (including eosinophilia, rash, hepatitis, adenopathy, interstitial nephropathy, interstitial pneumonia).

From the musculoskeletal system: myalgia, muscle spasms, bone pain, arthralgia, pain in the extremities, transient acute rises in the CPK level 3 times higher than VGN.

From the side of the cardiovascular system: after 4 years of treatment rarely - venous thromboembolism.

Application during pregnancy and lactation

Strontium ranelate is intended only for the treatment of postmenopausal women.

Not recommended during pregnancy and lactation (breastfeeding). There are no clinical data on the effects of strontium ranelate during pregnancy.

Strontium is excreted in breast milk.

Application for impaired renal function

It is not recommended to use strontium ranelate in patients with CC <30 ml / min due to the lack of data on the safety of use in severe renal failure.

Application in children

The efficacy and safety of strontium ranelate in children and adolescents has not been studied, therefore the use in this category of patients is not recommended.

special instructions

It is not recommended to use strontium ranelate in patients with CC <30 ml / min due to the lack of data on the safety of use in severe renal failure.

The results of clinical studies indicate that treatment with strontium ranelate is accompanied by an increase in the annual incidence of venous thromboembolism (VTE), including pulmonary embolism. The reason for this phenomenon has not yet been established. When treating patients at risk of VTE or patients with a possible increased risk of VTE, special attention should be paid to the specific signs and symptoms of VTE, as well as adequate prevention of this complication.

During the period of treatment, it is necessary to additionally prescribe calcium and vitamin D in cases when the content of these substances in food does not correspond to the accepted norm.

Strontium influences the results of colorimetric methods for assessing calcium levels in blood and urine. Therefore, methods such as inductively coupled plasma atomic emission spectrometry or atomic absorption spectrometry should be used to more accurately estimate blood and urine calcium concentrations.

The efficacy and safety of strontium ranelate in children and adolescents has not been studied, therefore the use in this category of patients is not recommended.

Drug interactions

Food products, in particular milk and dairy products, as well as medicines containing calcium, can reduce the bioavailability of strontium ranelate by about 60-70% (an interval of at least 2 hours should be observed between taking strontium ranelate and these foods and medicines).

The use of aluminum and magnesium hydroxides, both 2 hours before taking strontium ranelate, and simultaneously with it, causes a slight decrease in the absorption of strontium ranelate (AUC decreases by 20-25%), while when taking an antacid drug 2 hours after taking strontium ranelate, the level of absorption is practically unchanged.

Since molecular complexes containing divalent cations interact at the gastrointestinal tract level with antibiotics of the tetracycline and quinolone series, the simultaneous use of strontium ranelate and these drugs leads to a decrease in the absorption of strontium ranelate (simultaneous administration is not recommended). In order to prevent such an interaction, when prescribing antibiotics from the group of tetracyclines or quinolones, treatment with strontium ranelate should be suspended.