Universal reference book for medicines
Product name: OSTEOLAT

Active substance: strontium ranelate

Type: A drug that affects the metabolism of bone tissue, used in osteoporosis

Producer: FP Obolenskoye (Russia) manufactured by EvoPharm (Russia)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
An agent that affects the metabolism of bone tissue.
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 the synthesis of collagen 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 strontium enters the bone tissue, mainly due to adsorption on the surface of the bone crystal, strontium only to a small extent replaces calcium in the apatite crystal in the newly formed bone.
Ranelate strontium does not change the characteristics of bone tissue. Combined effects of distribution of strontium in bone tissue and increased absorption of strontium as compared to calcium, according to X-ray, lead to an increase in bone mineral density (BMD), which is measured by two-photon X-ray absorptiometry.
For strontium ranelate secondary effect, in relation to the main pharmacological properties, is a slight decrease in serum calcium and parathyroid hormone concentrations, as well as an increase in the concentration of phosphorus in the blood and the overall activity of AP, which is not accompanied by any adverse clinical consequences.

PHARMACOKINETICS
After ingestion in a single dose of 2 grams of C max in blood plasma is achieved after 3-5 hours. The absolute bioavailability of strontium is 25% (range 19-27%).
The intake of strontium ranelate along with calcium and food reduces the bioavailability of strontium by about 60-70% compared to bioavailability when taken 3 hours after a meal. The equilibrium state is achieved after 2 weeks of therapy. V d is about 1 l / kg. The binding of strontium to human plasma proteins is low and is 25%, with strontium characterized by a high affinity for bone tissue. Measurements of strontium concentrations with 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 the strontium concentrations in the bone tissue can reach plateaus in about 3 years of therapy. There is no data on elimination of strontium from bone tissue after discontinuation of therapy. Strontium is not metabolized in the human body. The strontium ranelate does not suppress the isoenzymes of the cytochrome P450 system.
The excretion of strontium is time and dose dependent.
Effective T 1/2 strontium is approximately 60 hours. Strontium is excreted by the kidneys and through the intestine. The plasma clearance of strontium is about 12 ml / min, the renal clearance is about 7 ml / min. Absorbed woundelic acid is rapidly and unchanged in the form of kidneys.
INDICATIONS
Osteoporosis in women in the postmenopausal period (in order to reduce the risk of vertebral and hip fractures).

DOSING MODE
Is taken internally.
The recommended dose is 2 g 1 time / day. Applied for a long time.
SIDE EFFECT
From the side of the central nervous system: often - a headache;
after 4 years of treatment, often - impaired consciousness, memory loss, seizures.
From the side of 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 mucosa.
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).

On the part of the musculoskeletal system: myalgia, muscle spasms, bone pain, arthralgia, pain in the extremities, transient acute elevations of the level of CK 3 times higher than VGN.

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

CONTRAINDICATIONS
Hypersensitivity to strontium ranelate.

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

It is not recommended for pregnancy and lactation (breastfeeding).
There are no clinical data on the effects of strontium ranelate in pregnancy.
Strontium is excreted in breast milk.

APPLICATION FOR FUNCTIONS OF THE LIVER
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 FOR CHILDREN
The efficacy and safety of strontium ranelate in children and adolescents have not been studied, so use in this category of patients is not recommended.

SPECIAL INSTRUCTIONS
It is not recommended to use strontium ranelate in patients with QC <30 ml / min due to the lack of safety data for patients with 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 is not currently fixed. In the treatment of patients at risk of VTE or patients with a possible increase in the risk of VTE, special attention should be paid to the specific signs and symptoms of VTE, and adequate prevention of this complication.
During the 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 affects the results of colorimetric methods of estimating the calcium content in blood and urine.
In this connection, methods such as atomic emission spectrometry with inductively coupled plasma or atomic absorption spectrometry should be used to more accurately estimate calcium concentrations in blood and urine.
The efficacy and safety of strontium ranelate in children and adolescents have not been studied, so use in this category of patients is not recommended.

DRUG INTERACTION
Food products, in particular milk and dairy products, as well as calcium-containing medicinal products, can reduce the bioavailability of strontium ranelate by about 60-70% (between intervals of strontium ranelate and specified foods and drugs, the interval should be at least 2 hours).

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

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