home All hormones Miacalcic - instructions for use. A drug from the group of non-steroidal anti-inflammatory drugs Miacalcic

Miacalcic - instructions for use. A drug from the group of non-steroidal anti-inflammatory drugs Miacalcic

pharmachologic effect

Hormone produced by C cells thyroid gland, is an antagonist of parathyroid hormone and, together with it, participates in the regulation of calcium metabolism in the body.

The structure of all calcitonins is represented by one chain of 32 amino acids and a ring of 7 amino acid residues at the N-terminus, the sequence of which is different in different types. Since salmon calcitonin has a higher affinity for receptors (compared to mammalian calcitonins), its effect is most pronounced in both strength and duration.

By suppressing the activity of osteoclasts due to its effect on specific receptors, salmon calcitonin significantly reduces the metabolic rate bone tissue before normal level in conditions with increased speed resorption, for example in osteoporosis.

In both animals and humans, Miacalcic has been shown to have analgesic activity for pain of bone origin, which appears to be due to a direct effect on the central nervous system.

Already after a single use of Miacalcic, a person experiences a clinically significant biological response, which is manifested by an increase in urinary excretion of calcium, phosphorus and sodium (due to a decrease in their tubular reabsorption) and a decrease in the excretion of hydroxyproline.

With long-term (5 years) use of Miacalcic, a significant and persistent decrease in the level of biochemical markers of bone metabolism, such as serum C-telopeptides (sCTX) and bone isoenzymes, is achieved alkaline phosphatase.

The use of Miacalcic leads to statistically significant increase(by 1-2%) bone mineral density in the lumbar vertebrae, which is determined already in the first year of treatment and persists for up to 5 years. Miacalcic ensures the maintenance of mineral density in the femur.

The use of Miacalcic at a dose of 200 IU/day leads to statistically and clinically significant reduction(by 36%) the risk of developing new vertebral fractures in the group of patients receiving Miacalcic (in combination with vitamin D and calcium preparations), compared with the group of patients receiving placebo (in combination with the same drugs). In addition, in the group treated with Miacalc (in combination with vitamin D and calcium preparations), compared with the group receiving placebo (in combination with the same drugs), there was a 35% decrease in the incidence of multiple vertebral fractures.

Calcitonin reduces gastric and exocrine pancreatic secretion.

Pharmacokinetics

Since radioimmunoassay methods used to date in pharmacokinetic studies are characterized by inadequate sensitivity and uncertain specificity, the pharmacokinetic parameters of salmon calcitonin administered intranasally are difficult to quantify.

Suction

Salmon calcitonin is rapidly absorbed through the nasal mucosa and its Cmax in plasma is reached within the first hour. Bioavailability for intranasal use is 3-5% relative to the bioavailability of the drug used parenterally. When using the drug in doses exceeding the recommended concentrations active substance in the blood were higher (which was confirmed by an increase in AUC), but the relative bioavailability did not increase.

Determining the concentration of salmon calcitonin in plasma, as well as the concentrations of other polypeptide hormones, seems to be of little value, since the level of concentrations cannot predict the therapeutic effectiveness of the drug. Thus, the activity of Miacalcic spray should be assessed by clinical indicators efficiency.

Distribution

Salmon calcitonin does not cross the placental barrier in humans.

It is unknown whether salmon calcitonin penetrates into breast milk in humans.

Removal

T 1/2 is 16-43 min. With repeated prescriptions of the drug, no accumulation of the active substance was observed.

Indications

- treatment of postmenopausal osteoporosis;

- bone pain associated with osteolysis and/or osteopenia;

— bone disease Paget's (osteitis deformans);

- neurodystrophic diseases (synonyms: algodystrophy or Sudeck atrophy), caused by various etiological and predisposing factors, such as post-traumatic painful osteoporosis, reflex dystrophy, glenohumeral syndrome, causalgia, drug-induced neurotrophic disorders.

Dosage regimen

The drug is used intranasally.

For treatment of osteoporosis A dose of 200 IU/day is recommended. In order to prevent progressive bone loss, it is recommended to prescribe adequate doses of calcium and vitamin D simultaneously with the use of Miacalcic in the form of a dosed nasal spray. Treatment should be carried out over a long period of time.

At bone pain associated with osteolysis and/or osteopenia, the drug is prescribed daily at a daily dose of 200-400 IU. A daily dose of 200 IU can be administered at a time. More high doses should be divided into several administrations. The dose should be adjusted to suit the individual needs of the patient.

It may take several days to achieve the full analgesic effect. When carrying out long-term therapy, the initial daily dose is usually reduced and/or the interval between administrations is increased.

At Paget's disease the drug is prescribed daily daily dose 200 IU. In some cases, at the beginning of treatment, a dose of 400 IU/day may be required, given in several doses. The duration of treatment is at least 3 months; if necessary it can be larger. The dose should be adjusted to suit the individual needs of the patient.

In Paget's disease, the duration of treatment with Miacalc should range from several months to several years. During treatment, there is a significant decrease in the concentration of alkaline phosphatase in the blood and hydroxyproline excretion in the urine, sometimes up to normal values. However, in some cases, after an initial decrease, the values of these indicators may increase again. In these cases, the doctor, guided by clinical picture, must decide whether treatment should be discontinued and when it can be restarted.

One or several months after discontinuation of treatment, bone metabolism disorders may recur; in this case, a new course will be required.

At neurodystrophic diseases Early diagnosis is extremely important. Treatment should begin immediately after confirmation of the diagnosis. Prescribe 200 IU/day (in 1 administration) daily for 2-4 weeks. An additional dose of 200 IU is possible every other day for up to 6 weeks, depending on the dynamics of the patient’s condition.

Side effect

The incidence of adverse events was assessed as follows: very often - ≥10%, often - from ≥1% to<10%, иногда – от ≥0.1% до ≥1%.

Local: very often - rhinitis (including dryness in the nasal cavity, swelling and congestion in the nasal mucosa, sneezing, allergic rhinitis), nonspecific nasal symptoms (for example, soreness, formation of papules, excoriations, unpleasant odor, irritation, erythema); often - ulcerative rhinitis, sinusitis, nosebleeds. These phenomena are usually mild (about 80% of all reports) and require discontinuation of treatment in less than 5% of cases.

System: often - hot flashes, dizziness, headache, nausea, diarrhea, abdominal pain, pain in bones and muscles, pharyngitis, fatigue, perversion of taste; sometimes - arterial hypertension, vomiting, joint pain, cough, flu-like symptoms, edema (of the face, limbs, generalized edema), visual disturbances.

When using Miacalc, hypersensitivity reactions are possible, which can manifest as generalized skin reactions, hot flashes, swelling (of the face, limbs, generalized swelling), increased blood pressure, joint pain, itching. There have been reports of anaphylactoid-type reactions and isolated cases of anaphylactic shock.

Systemic adverse events are less common with intranasal than with parenteral use of Miacalcic.

Contraindications for use

- hypersensitivity to synthetic salmon calcitonin, as well as any other component of the drug.

Use during pregnancy and breastfeeding

Since studies have not been conducted in women during pregnancy and lactation, Miacalcic should not be used in this category of patients.

It is not known whether salmon calcitonin passes into breast milk in humans, therefore breastfeeding is not recommended during treatment with the drug.

IN experimental studies conducted in animals, it was shown that Miacalcic does not have embryotoxic and teratogenic properties. It was found that in animals, salmon calcitonin does not penetrate the placental barrier.

Use in children

Contraindicated in children (nasal aerosol).

Overdose

Symptoms: with parenteral use of Miacalcic, nausea, vomiting, hot flashes and dizziness are dose-dependent. Therefore, with an overdose of Miacalcic nasal spray, similar phenomena can be expected. However, there are case reports where Miacalcic nasal spray was used at a dose of up to 1600 IU once and at a dose of 800 IU/day for three days, and no serious adverse events were observed. There are reports of isolated cases of overdose. In case of overdose, hypocalcemia may develop with symptoms such as paresthesia and muscle twitching.

Treatment: Symptomatic therapy is carried out; if hypocalcemia develops, the administration of calcium gluconate is recommended.

Drug interactions

No cases of drug interactions with Miacalcic have been reported.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

List B. Before use, the drug should be stored in the refrigerator at a temperature of 2° to 8°C; do not freeze. Shelf life - 3 years. After starting use, the drug should be stored at a temperature not exceeding 25°C for no more than 4 weeks (do not store in the refrigerator). To ensure proper spraying, the bottle must be stored in an upright position. The drug should not be used after the expiration date.

Use for liver dysfunction

There was no deterioration in tolerability of the drug or the need to change the dosage regimen in patients with decreased liver function, although studies specifically for these groups of patients have not been conducted.

Use for renal impairment

There was no deterioration in tolerability of the drug or the need to change the dosage regimen in patients with decreased renal function, although studies specifically for these groups of patients have not been conducted.

Use in elderly patients

Extensive experience with the use of Miacalcic injection solution in elderly patients indicates that in this age group there was no deterioration in tolerability of the drug or the need to change the dosage regimen. .

special instructions

Since salmon calcitonin is a peptide, there is a potential for systemic allergic reactions. There are reports of allergic reactions, including isolated cases of anaphylactic shock, that occurred in patients receiving Miacalcic. If a patient is suspected of hypersensitivity to salmon calcitonin, skin tests should be performed before starting treatment with Miacalcic.

With long-term therapy, the formation of antibodies to calcitonins is possible, but this, as a rule, does not affect the clinical effectiveness. The habituation phenomenon, which is observed mainly in patients with Paget's disease receiving long-term therapy, may be a consequence of saturation of binding sites and is apparently not related to the formation of antibodies. The therapeutic effect of Miacalcic is restored after a break in treatment.

Use in pediatrics

Experience with the use of Miacalcic in children is limited, and therefore it is not possible to make recommendations for this age group.

Use in elderly patients and certain patient groups

Extensive experience with the use of Miacalcic in elderly patients indicates that in this age group there was no deterioration in tolerability of the drug or the need to change the dosage regimen. The same applies to patients with decreased kidney or liver function, although studies have not been conducted specifically for these groups of patients.

Impact on the ability to drive vehicles and operate machinery

Considering the possibility of dizziness, as well as an increase in blood pressure during the use of Miacalcic, the possibility of a negative effect of the drug on the rate of reactions cannot be excluded. When using the drug, it is recommended to be careful when driving a car and operating machinery.

Miacalcic is a drug with a hypocalcemic, bone resorption-inhibiting effect that affects phosphorus-calcium metabolism.

Release form and composition

Miacalcic is produced in the following dosage forms:

Solution for injection: colorless, transparent (in ampoules of 1 ml, 5 ampoules in a cardboard box);
Nasal spray: colorless, transparent, odorless solution (in bottles with a 2 ml dispenser, 1 or 2 bottles in a cardboard box).

The composition of 1 ml solution includes:

Active substance: synthetic salmon calcitonin – 100 IU (international units);
Auxiliary components: sodium chloride, acetic acid, water for injection, sodium acetate trihydrate.

The composition of 1 dose of nasal spray includes:

Active substance: synthetic salmon calcitonin – 200 IU;
Auxiliary components: sodium chloride, purified water, benzalkonium chloride, hydrochloric acid.

Indications for use

Miacalcic in the form of injection solution and nasal spray is used to treat the following diseases/conditions:

Osteitis deformans (Paget's disease of bone);
Bone pain associated with osteopenia and/or osteolysis;
Neurodystrophic diseases (synonyms: Sudeck syndrome or algoneurodystrophy), caused by various etiological and predisposing factors: drug-induced neurotrophic disorders, causalgia, glenohumeral syndrome, reflex dystrophy, post-traumatic painful osteoporosis.

An additional indication for the use of nasal spray is postmenopausal osteoporosis.

Additional indications for the use of the injection solution are:

Acute pancreatitis (as part of combination treatment);
Osteoporosis: primary osteoporosis – senile osteoporosis in women and men, postmenopausal osteoporosis (early and late stages); secondary osteoporosis, in particular resulting from immobilization or treatment with glucocorticoids;
Hypercalcemic crisis and hypercalcemia caused by immobilization, osteolysis caused by malignant tumors (myeloma, carcinoma of the kidneys, lungs, breast), hyperparathyroidism, vitamin D intoxication, both for the relief of emergency conditions and for long-term treatment of chronic conditions - until the the effect of specific therapy for the underlying disease will appear.

Contraindications

The use of Miacalcic is contraindicated in case of hypersensitivity to the components of the drug.

During pregnancy and during breastfeeding, the use of Miacalcic is not recommended.

Directions for use and dosage

The solution is administered subcutaneously, intramuscularly or intravenously.

Dosage regimen:

Miacalcic spray is used intranasally.

Dosage regimen:

Osteoporosis: daily dose – 200 IU. To prevent progressive bone loss, it is recommended to use adequate doses of calcium and vitamin D simultaneously with the spray. Therapy must be carried out over a long period;
Bone pain associated with osteolysis and/or osteopenia: 200-400 IU per day. A dose of 200 IU can be administered 1 time; higher doses should be divided into several administrations. The dose is determined taking into account the individual needs of the patient. In some cases, the full analgesic effect is achieved after several days of use of the drug, and therefore, with long-term therapy, the initial daily dose should be reduced and/or the interval between doses should be increased;
Paget's disease: daily dose – 200 IU; at the beginning of therapy, in some cases a dose of 400 IU per day may be required, which should be divided into several administrations. Duration of therapy – from 3 months (minimum) to several years. It is recommended to adjust the dose based on the individual needs of the patient. During the treatment period, there is a significant decrease in the excretion of hydroxyproline in the urine and the concentration of alkaline phosphatase in the blood (sometimes to normal values). However, in some cases, after an initial decrease, the values of these indicators may increase again. In such cases, the doctor, guided by the clinical picture, must make a decision regarding discontinuation of Miacalc and further resumption of therapy. After discontinuation of the drug, disorders of bone metabolism may reappear after one or several months. In such cases, a new course of treatment is required;
Neurodystrophic diseases: early diagnosis is of particular importance. It is important to start therapy immediately after confirmation. The dosage of Miacalcic is 200 IU (1 administration) every other day for a period not exceeding 42 days (depending on the dynamics of the patient’s condition).

Side effects

During Miacalc therapy, side effects from certain body systems may occur.

Injection:

Nervous system: often – taste disturbances, dizziness, headache;
Sense organs: sometimes – visual disturbances;
Cardiovascular system: often – hot flashes; sometimes – arterial hypertension;
Digestive system: often – diarrhea, abdominal pain, nausea; sometimes - vomiting;
Dermatological reactions: rarely - generalized rash;
Musculoskeletal system: often – arthralgia; sometimes – pain in bones and muscles;
Urinary system: rarely – polyuria;
The body as a whole and local reactions: often - increased fatigue; sometimes – facial swelling, generalized and peripheral edema, influenza-like syndrome; rarely – itching, reactions at the injection site, chills;
Allergic reactions: rarely – hypersensitivity reactions; very rarely - anaphylactic shock, anaphylactoid or anaphylactic reactions.

Nasal spray:

Local reactions: very often - nonspecific nasal symptoms (erythema, irritation, unpleasant odor, formation of excoriations, papules, soreness), rhinitis (including allergic rhinitis, sneezing, swelling and congestion in the nasal mucosa, dryness in the nasal cavity); often – nosebleeds, sinusitis, ulcerative rhinitis;
Systemic reactions: often - taste perversion, fatigue, pharyngitis, pain in the abdomen, bones and muscles, diarrhea, nausea, headache, dizziness, hot flashes; sometimes – visual disturbances, edema (of the limbs, face, generalized edema), flu-like symptoms, cough, joint pain, vomiting, arterial hypertension.

When using Miacalcic spray, hypersensitivity reactions may occur, manifested by itching, joint pain, increased blood pressure, edema (of the limbs, face, generalized edema), hot flashes, and generalized skin reactions. Anaphylactoid-type reactions and isolated cases of anaphylactic shock have also been reported.

special instructions

Patients who make subcutaneous injections of the solution themselves should be instructed in detail by a doctor or nurse.

Before using Miacalcic, it is necessary to visually check the condition of the ampoule and solution. Only undamaged ampoules containing a clear, colorless solution free of foreign matter should be used. After a single use of the drug, the solution remaining in the ampoule should be discarded. Before subcutaneous and intramuscular administration, it is recommended to warm the solution to room temperature.

With long-term therapy, patients may develop antibodies to calcitonin, which usually does not affect the clinical effectiveness of the drug. The escape phenomenon that occurs in most cases in patients suffering from Paget's disease receiving the drug for a long period is probably due to saturation of binding sites rather than the formation of antibodies. The therapeutic effect of the drug is restored after a break in treatment.

Due to the fact that salmon calcitonin is a peptide, systemic allergic reactions may occur. Allergic reactions, including isolated cases of anaphylactic shock, have been reported. If hypersensitivity to salmon calcitonin is suspected, before starting therapy, it is recommended to conduct skin tests using a diluted sterile solution of Miacalcic.

The solution contains virtually no sodium.

Experience with the use of the drug in children is limited, so it is impossible to make recommendations regarding its use in this age group.

It should be taken into account that the side effects caused by the drug (visual disturbances, dizziness) may have a negative impact on the patient’s ability to engage in potentially hazardous activities that require rapid psychomotor reactions and high concentration.

Drug interactions

With simultaneous use of calcitonin in combination with lithium preparations, plasma concentrations of the latter may decrease. In this regard, when using such combinations, dose adjustment of lithium preparations may be required.

Terms and conditions of storage

Store at a temperature of 2 to 8 ° C (do not freeze) out of the reach of children.

Best before date:

Solution for injection – 5 years;
Nasal spray – 3 years.

After opening the ampoule, the solution should be used immediately (it does not contain preservatives).

After starting use, the nasal spray should be stored in an upright position for up to 28 days at temperatures up to 25 °C.

Found an error in the text? Select it and press Ctrl + Enter.

Miacalcic: instructions for use and reviews

Latin name: Miacalcic

ATX code: H05BA01

Active substance: calcitonin

Manufacturer: Novartis Pharma Stein AG (Switzerland), Novartis Pharma (France), Delpharm Yuning S.A.S. (France)

Updating the description and photo: 23.06.2018

Miacalcic is a drug that affects phosphorus-calcium metabolism and is used in the treatment of osteoporosis.

Release form and composition

Miacalcic is available in two dosage forms:

Solution for injection: colorless, transparent (in ampoules of 1 ml, 5 ampoules in a cardboard box);
Nasal spray: colorless, transparent, odorless (in bottles (bottles) of 2 ml (14 doses), 1 or 2 bottles in a cardboard box).

Each pack also contains instructions for using Miacalcic.

The composition of 1 ml of solution for injection includes:

Active ingredient: synthetic salmon calcitonin – 100 ME* (international units);
Auxiliary components: acetic acid, sodium acetate trihydrate, sodium chloride, water for injection.

The composition of 1 ml nasal spray includes:

Active ingredient: synthetic salmon calcitonin – 200 ME*;
Auxiliary components: benzalkonium chloride, sodium chloride, hydrochloric acid, purified water.

*1 ME corresponds to approximately 0.2 mcg of active ingredient.

Pharmacological properties

Pharmacodynamics

Calcitonin, the active substance of Miacalcic, is a hormone produced by C-cells of the thyroid gland, an antagonist of parathyroid hormone, and at the same time takes part in the regulation of calcium metabolism in the body.

The structure of all calcitonins is a chain of 32 amino acids and a ring of seven amino acid residues at the N-terminus; their sequence varies from species to species. Salmon calcitonin has a higher affinity for receptors (compared to mammalian calcitonins), so its effect is most pronounced in duration and strength.

Due to the effect on specific receptors, the activity of osteoclasts is suppressed, due to which salmon calcitonin significantly reduces the rate of bone tissue turnover to a normal level against the background of conditions with an increased rate of resorption, in particular in osteoporosis.

It has been established that Miacalcic has analgesic activity for pain of bone origin, which is most likely associated with a direct effect on the central nervous system.

Already after a single use of Miacalcic, a clinically significant biological response is observed, which manifests itself in the form of an increase in the excretion of phosphorus, sodium and calcium in the urine (due to a decrease in their tubular reabsorption) and a decrease in the excretion of hydroxyproline.

In the case of long-term (over 5 years) use of Miacalcic, a significant and persistent decrease in the level of biochemical markers of bone metabolism is achieved - bone isoenzymes of alkaline phosphatase and serum C-telopeptides (sCTX).

As a result of therapy, there is a statistically significant increase (by 1–2%) in bone mineral density in the lumbar vertebrae, which is determined within the first year of treatment and persists for up to 5 years. Thanks to the use of Miacalc, mineral density in the femur is maintained.

When treated with a daily dose of 200 IU, there was a statistically and clinically significant decrease (by 36%) in the likelihood of new vertebral fractures in the group of patients who received Miacalcic (in combination with calcium supplements and vitamin D), compared with the group of patients who received placebo ( in combination with the same drugs). Also, when carrying out combined treatment, there is a reduction in the incidence of multiple vertebral fractures by 35%.

Calcitonin helps reduce gastric and exocrine pancreatic secretion.

Pharmacokinetics

Nasal spray

The pharmacokinetic parameters of intranasally administered salmon calcitonin are difficult to quantify.

The substance is absorbed through the nasal mucosa quickly, Cmax (maximum concentration of the substance) in plasma is achieved within 60 minutes. When administered intranasally, the bioavailability ranges from 3 to 5% relative to the bioavailability of the drug administered parenterally. When using Miacalcic in doses exceeding the recommended ones, the concentrations of the active substance in the blood are higher, but the relative bioavailability does not increase.

Determining the plasma concentration of salmon calcitonin is of little value, since it is impossible to predict the therapeutic effectiveness of the drug based on the value of this indicator. Thus, the activity of Miacalcic spray should be assessed based on clinical indicators of effectiveness.

Salmon calcitonin does not penetrate the placental barrier. There is no information confirming/refusing the penetration of the substance into breast milk.

T1/2 (half-life) ranges from 16 to 43 minutes. With repeated prescriptions of Miacalcic, accumulation of the active substance is not observed.

Injection

The bioavailability of salmon calcitonin when administered intramuscularly or subcutaneously is approximately 70%.

The time to reach Cmax in plasma is 60 minutes. Apparent Vd (volume of distribution) – 0.15–0.3 l/kg. Binds to plasma proteins at a level of 30–40%.

Up to 95% of calcitonin and its metabolites are excreted in the urine, only 2% of them unchanged. T1/2 is approximately 1 hour or 1–1.5 hours for intramuscular and subcutaneous administration, respectively.

Indications for use

Bone pain associated with osteopenia and/or osteolysis;
Neurodystrophic diseases (manifested in the form of algoneurodystrophy, Sudeck atrophy), caused by various predisposing and etiological factors, including drug-induced neurotrophic disorders, post-traumatic painful osteoporosis, reflex dystrophy, causalgia, glenohumeral syndrome;
Osteitis deformans (Paget's disease);
Postmenopausal osteoporosis (early and late stages).

Additionally, Miacalcic injection solution is prescribed for the treatment of the following diseases/conditions:

Hypercalcemic crisis and hypercalcemia caused by such factors as: osteolysis caused by malignant tumors (myeloma, lung, breast, kidney carcinoma), immobilization, hyperparathyroidism, vitamin D intoxication (for relief of emergency conditions and long-term therapy of chronic hypercalcemia - until until the effect of specific treatment of the underlying disease appears);
Primary osteoporosis: senile osteoporosis in men and women;
Secondary osteoporosis associated with glucocorticoid therapy or immobilization;
Acute pancreatitis (simultaneously with other drugs).

Contraindications

A contraindication to the use of Miacalcic is hypersensitivity to the components of the drug.

Due to the lack of necessary data, pregnant women should not use the drug. During lactation it is recommended to interrupt breastfeeding.

Miacalcic in any dosage form is not prescribed to children due to the lack of sufficient data on the safety and effectiveness of its use in this age group.

Miacalcic, instructions for use: method and dosage

Injection

Miacalcic solution is administered subcutaneously, intramuscularly and intravenously.

Nasal spray

Miacalcic spray is used intranasally, preferably alternately in one and the other nasal passage.

The dosage regimen is determined by the indications:

Osteoporosis: daily dose – 200 IU. To prevent progressive bone loss, the use of adequate doses of vitamin D and calcium is recommended simultaneously with therapy. As a rule, treatment is long-term;
Bone pain associated with osteopenia and/or osteolysis: daily dose of 200-400 IU, in 1 (200 IU) or several administrations (higher doses), daily. It is possible to adjust the regimen for using Miacalcic, taking into account the individual needs of the patient. With long-term therapy, it is possible to reduce the dose or increase the interval between drug administrations;
Paget's disease; daily dose – 200 IU, sometimes it is possible to increase to 400 IU (in several administrations), daily. The duration of therapy is at least 3 months (if necessary, it can be increased to several years). It is possible to adjust the regimen for using Miacalcic, taking into account the individual needs of the patient. During therapy, there may be a significant decrease in the concentration of alkaline phosphatase in the blood and hydroxyproline excretion in the urine, in some cases to normal values. Sometimes the values of these indicators after an initial decrease may increase again. The question of canceling or continuing therapy is decided by the doctor individually. If, one or several months after the end of therapy, bone metabolism disorders occur again, a repeat course may be required;
Neurodystrophic diseases: initial daily dose – 200 IU (in one administration), daily for 2-4 weeks. If necessary, Miacalcic is used in the future every other day at the same dose for no more than 6 weeks (depending on the dynamics of the patient’s condition). Therapy should begin immediately after confirmation of the diagnosis.

Elderly patients and patients with reduced renal or liver function should not adjust the dosage regimen of Miacalcic in any dosage form.

The nasal spray bottle should never be shaken, as this may cause air bubbles to form inside the solution, which may result in incorrect dosing.

When using for the first time, the bottle must be kept strictly in an upright position. To squeeze air out of the tube, press the plunger 3 times. After this, the color of the dose counter window will change from red to green, which means the device is ready for operation. After each use, the number in the dose counter window changes. The bottle contains 14 doses, thanks to the provided remainder of the solution, it is possible to obtain 2 additional doses.

When using the spray, the tip of the bottle should be positioned in line with the nasal passage. This will ensure a more uniform distribution of the drug.

To prevent the solution from leaking out, after spraying you should take several vigorous breaths through your nose. It is not recommended to clear your nose immediately after administering Miacalcic. When prescribing 2 doses, they are administered into different nasal passages.

Do not try to enlarge the nozzle opening with a needle or other sharp objects, as this may lead to malfunction of the dispensing device.

Side effects

During the use of all dosage forms of Miacalcic, there were reports of the development of such undesirable effects as dizziness, vomiting, nausea, arthralgia, slight flushing of the face, accompanied by a feeling of warmth. Dyspeptic disorders, hot flashes and dizziness depend on the dose used; with intravenous administration of the drug they develop more often than with subcutaneous or intramuscular administration. Also, during therapy, polyuria and chills may occur, which, as a rule, go away on their own and only in some cases require a temporary reduction in the dose of Miacalcic.

The incidence of side effects possibly related to therapy is assessed as follows (≥1/10 - very common; ≥1/100,<1/10 – часто; ≥1/1000, <1/100 – иногда; ≥1/10 000, <1/1000, включая отдельные сообщения – редко):

Nervous system: often – dizziness, headache;
Cardiovascular system: often – hot flashes; sometimes – arterial hypertension;
Immune system: rarely – hypersensitivity; very rarely - anaphylactic shock, anaphylactoid or anaphylactic reactions;
Gastrointestinal tract: often – dyspeptic disorders (in the form of abdominal pain, nausea, diarrhea); sometimes - vomiting;
Urinary system: rarely – polyuria;
Musculoskeletal system and connective tissue: often – arthralgia; sometimes – pain in muscles and bones;
Skin and subcutaneous tissue: rarely – generalized rash;
Sense organs: often – taste disturbances; sometimes – visual disturbances;
The body as a whole and local reactions: often - increased fatigue; sometimes – facial swelling, flu-like syndrome, generalized and peripheral edema; rarely - reactions at the injection site, chills, itching.

When using Miacalcic nasal spray, respiratory tract disorders may additionally develop: very often - unpleasant odor, congestion, pain in the nasal cavity, swelling of the nasal mucosa, rhinitis, sneezing, dryness in the nasal cavity, erythema of the nasal mucosa, allergic rhinitis, irritation, formation of excoriations in the nasal cavity; often – sinusitis, nosebleeds, pharyngitis, ulcerative rhinitis; sometimes - cough.

Overdose

There are no reports of any serious side effects caused by an overdose of Miacalcic.

Main symptoms:

injection solution: nausea, vomiting, dizziness, hot flashes, possible development of hypocalcemia (manifested in the form of paresthesia, muscle twitching);
nasal spray: disturbances similar to those occurring with parenteral administration. There are reports of cases where Miacalcic was used once at a dose of up to 1600 IU and for three days at a daily dose of 800 IU, and no serious adverse events developed.

Therapy: symptomatic; in case of hypocalcemia, administration of calcium gluconate is recommended.

special instructions

The ampoule with the injection solution must not be damaged, the solution must be colorless, transparent, without foreign inclusions. The solution in the ampoule that is not used after a single use must be disposed of. Before intramuscular and subcutaneous administration, the Miacalc solution must be warmed to room temperature.

With prolonged therapy, patients may develop antibodies to calcitonin, which, as a rule, does not affect the clinical effectiveness. Most often, the “escape” phenomenon is observed in Paget’s disease; after a break in therapy, the therapeutic effect is usually restored.

Salmon calcitonin is a peptide, so there is a possibility of developing systemic allergic reactions. If the patient is suspected of hypersensitivity to the active substance, before starting therapy, skin tests should be performed using a diluted sterile solution of Miacalcic.

The injection solution contains virtually no sodium (less than 23 mg).

Impact on the ability to drive vehicles and complex mechanisms

During therapy, it is necessary to take into account the possibility of developing some side effects of Miacalcic (visual disturbances, dizziness), which negatively affect the ability to drive a car and perform potentially dangerous types of work that require increased concentration and rapid psychomotor reactions.

Use during pregnancy and lactation

Miacalcic is not prescribed during pregnancy/lactation.

Use in childhood

Miacalcic is not prescribed to patients under 18 years of age.

Drug interactions

When using Miacalcic simultaneously with lithium preparations, a decrease in the plasma concentration of lithium is possible, which may lead to the need to adjust the doses of these drugs.

Analogs

Analogs of Miacalcic are: Alostin, Veprena, Osteover, Calcitrin.

Terms and conditions of storage

Store out of the reach of children at a temperature of 2-8°C, do not freeze.

Best before date:

Nasal spray – 3 years;
Injection solution – 5 years.

After opening the bottle of nasal spray, the drug can be used for 4 weeks provided it is stored at room temperature, avoiding sudden temperature changes.

"Miacalcic" is a drug from the group of non-steroidal anti-inflammatory drugs (NSAIDs), which helps fight various bone diseases, as well as stabilizing calcium-phosphorus metabolism. It is produced by the Swiss group of companies Novartis Pharma AG and is supplied to pharmacies in the form of a nasal spray and solution for injection.

Forms of release of the drug

In both forms of release, the drug looks like a clear liquid that has neither color nor odor.

The main component of the drug is synthetic salmon calcitonin. One injection ampoule contains 100 IU, and 1 ml of nasal spray contains 2200 IU.

As for the excipients, their content in the drug is as follows:

In the pharmacy, "Miacalcic" is supplied in 2-ml bottles with a dosing device and in 1-ml ampoules, which are placed in cardboard packages.

Storage conditions

Before use, the drug should be stored in a dry place, out of reach of children, at a temperature of 2-8 °C. However, it is not allowed to freeze “Miakaltsik”. It is strictly forbidden to store ampoules open (since they contain no preservatives). After starting use, the spray retains its healing properties for up to 4 weeks, but only if it is stored in a dark place (not a refrigerator) at a temperature of up to 25 ° C, constantly in an upright position.

Shelf life of the drug in unopened form:

For Miacalcic ampoules – 5 years;
For spray – 3 years.

Indications for use

Initially, the instructions for use of the spray and injection solution “Miacalcic” indicated that this drug is suitable for combating primary and secondary osteoporosis. However, in connection with studies carried out by the European Agency for the Evaluation of Medicines (which will be discussed below), this point has undergone significant adjustments, and today the drug "Miacalcic" is recommended only for those patients who suffer from:

Sudden and significant loss of bone mass caused by immobilization;
Paget's disease (but only if it is impossible to use alternative treatment methods);
Hypercalcemia caused by oncological diseases.

In other cases (when long-term use of Miacalcic spray is expected), the risks associated with the use of the drug outweigh the benefits of its use. Therefore, in order not to cause irreparable harm to the patient’s health, the doctor must select an alternative treatment method.

"Miacalcic": instructions for use and dosage

Since significant side effects have been identified with the Miacalcic nasal spray, the duration of treatment and the daily dose of the drug are calculated for each case individually (based on the needs of the patient and his response to the drug).

As for the solution in ampoules, it can be used both for subcutaneous and intramuscular injections, and for intravenous infusions. However, this is only true in cases where it involves taking a relatively small dose of the drug, and not a bolus administration. Moreover, the dosage and duration of taking the drug directly depend on the indications for its use. So:

Whatever the reasons prompt you to take Miacalcic, taking the drug should be limited both in terms of treatment time and in dosage to the minimum effective values.

To minimize the side effects of Miacalcic on the body, take the prescribed injections in different places.

Contraindications for use

"Miacalcic" belongs to the pharmacotherapeutic group of regulators of calcium-phosphorus metabolism (ATX code H05BA01), and therefore is not recommended:

Children, since the experience of using the drug in this age group has practically not been studied;
Girls who are pregnant or just planning a pregnancy, as well as nursing mothers, since there is no clinical data regarding the safety of using Miacalcic during this period;
Patients with individual intolerance or allergic reaction to any of the components of the drug;
People who are engaged in potentially hazardous activities, operate vehicles or operate machinery that require increased attention and speed of response (side effects of the drug include dizziness, vision problems and general weakness, which can slow down psychomotor reactions).

Side effects

In the original version of the instructions for use of “Miacalcic” the following list of negative reactions of the body to taking the drug was given:

CNS	Respiratory system	Digestive system	The immune system	The cardiovascular system	Other
Drowsiness	Pain in the nasal cavity	Nausea and vomiting	Anaphylactic shock	Arterial hypertension	Atralgia
Dizziness	Swelling of the nasal mucosa	Stomach ache	Anaphylactoid reactions	Tides	Muscle pain
Headache	Sneezing	Diarrhea	Hypersensitivity	Sudden changes in blood pressure	Bone pain
Taste disturbances	Rhinitis, incl. allergic and ulcerative		Facial swelling		Polyuria
Increased fatigue	Dryness and erythema of the nasal mucosa		Generalized rash		Visual impairment
Unreasonable chills	Excoriation in the nasal cavity		Peripheral edema
	Sinusitis		Flu-like syndrome
	Nose bleed		Generalized edema
	Unpleasant smell		Allergic itching at the injection site
	Pharyngitis
	Cough

However, in 2012, the Federal Service for Surveillance in Healthcare published open letter No. 04I-876/12. It indicated that the European Agency for the Evaluation of Medicines conducted clinical trials of this drug, during which a connection was identified between long-term use of Miacalcic and the appearance of malignant tumors in patients. Thus, according to studies, in those patients who took calcitonin as part of the experiment, the incidence of malignant neoplasms increased by 0.7% (when using an injection solution) and 2.4% (when using a nasal spray), while in those who took a placebo at the same time, the indicators remained unchanged.

Based on these data, the Committee for Medicinal Products for Human Use (CHMP) decided to remove from the list of indications for use those diseases for which the risks of treatment with calcitonin are higher than the benefits (for example, postmenopausal osteoporosis). And the list of side effects of Miacalcic was supplemented by the risk of malignant neoplasms.

The presented list of side effects does not fully reflect the picture of what is happening. It indicates only the main and most common manifestations, while in practice there are much more negative consequences.

Therefore, if after starting to take Miacalcic your condition worsens (without objective reasons), you should immediately stop the course of treatment and contact your attending physician.

Additional Information

In those patients who have been treated with Miacalc for a long time, the production of antibodies to calcitonin can often be observed.

Although this usually does not affect clinical indicators, those suffering from Paget's disease should take a break from treatment if such an “addiction syndrome” occurs.

When resuming the course after some time (at the discretion of the attending physician), the therapeutic effect will be enhanced at first, which will allow it to be taken in smaller doses.

"Miakaltsik": price and analogues

The cost of "Miacalcic" in the form of ampoules today starts from 1085 rubles, in the form of a spray - from 1200 rubles. However, after the publication of research data from the European Medicines Evaluation Agency, it has become much more difficult to find this drug in Russian pharmacies. And doctors themselves try not to take unnecessary risks by prescribing potentially dangerous medications to patients. Therefore, if this drug helps you, take note of the following analogues:

No specialized studies have been conducted on the above drugs. However, those that contain calcitonin may pose the same potential danger as Miacalcic. Therefore, if this drug causes you concern, ask your doctor to replace it with one in which the main element is not calcitonin, but some other substance.

Drug interactions

A full-scale study of the consequences of using calcitonin with other drugs has not been conducted. However, in the course of basic clinical studies, it was found that the combined use of Miacalcic and lithium-containing drugs leads to a noticeable decrease in lithium in the blood plasma. Therefore, if you have to combine these medications, be sure to ask your doctor to adjust the dosage of the medications.

Overdose of "Miacalcic"

The drug goes on sale in special ampoules and bottles, so the possibility of an overdose when using it is negligible. However, it will not be superfluous to have this information at hand. So:

Symptoms of overdose include nausea and vomiting, general weakness and dizziness, parasthesia and muscle twitching;
During treatment, they resort to symptomatic therapy, as well as the administration of calcium gluconate (the latter only by qualified medical personnel).

"Miacalcic": reviews of doctors and people who have already taken this drug

Alexander, 39 years old, orthopedic traumatologist“Over the 8 years of my practice, I have used Miacalcic quite actively. In patients suffering from osteoporosis, improvement was observed literally from the very first weeks after starting treatment. Several thousand people have already passed through my office, and none of them developed any tumors after starting the course (except for those who had a hereditary predisposition or other factors contributing to the development of the disease). Therefore, if we talk about the effectiveness of Miacalcic, then I personally rate it quite highly. However, since this drug now has equivalent analogues, so as not to take risks, I often prescribe them. And for those who were once heavily on Miacaltic, I advise you to get checked, since cancer is no joke.”

Anastasia, 29 years old, professional photographer“During filming, I constantly use both hands, so when one of them was broken, I had to take a break from work. Naturally, clients don’t like to wait, so I tried to get back on track as quickly as possible. And then, as luck would have it, it turned out that I had begun to experience a sharp loss of bone mass, since my hand was immobile most of the time. On the advice of the doctor, I injected Miacalcic for 2 weeks. The process at first noticeably slowed down, then completely came to a standstill. When my friend found out that I was taking this drug, she told me that it would cause some tumors to develop and that you could even get cancer. Of course, I immediately underwent examination, but everything seemed to work out. And therefore, although the drug helped me, I still won’t recommend it. I don’t even understand why these dangerous drugs are prescribed and not even warned about the possible consequences.”

Veniamin, 63 years old, pensioner“At my age, joint problems are already a given. For a long time I believed that it was pointless to fight them (since in place of one cured sore another immediately appears). But a doctor once prescribed Miacalcic, and I completely changed my mind. During the two and a half weeks that I received the injections, my health became much better, and the pain in the joints practically did not remind me of myself. Therefore, after the first use, I periodically repeated the treatment, although the drug was not cheap. But recently it has become almost impossible to find Miacalcic in pharmacies. A pharmacist I know said that this is due to the fact that it allegedly provokes the development of some dangerous diseases. For young people this is possible and relevant. But what should we do with old people? We don’t have long to live anyway, and finding an equally effective replacement (which would also be inexpensive) is not easy. At least I haven’t been able to do this over the past 3 years.”

Lyudmila, 55 years old, deputy head of department“Despite my age, I always felt great. Therefore, when, out of the blue, I started having pain in my legs, it was an unpleasant surprise for me. The doctor said I had Paget's disease, a disease that causes bones to become brittle and deformed. And that if I do nothing, then soon my legs will begin to bend, and maybe it will even lead to fractures. The problem was aggravated by the fact that I was overweight, and then the disease began to progress quite actively. The doctor prescribed me Miacalcic in ampoules, which I was injected with for 2 months. The pain in my legs disappeared almost immediately, but these injections alone were not enough for a complete cure. I had to have surgery. At that time, I did not know that the drug posed a health threat. If I could rewind time back, I wouldn’t take it now. It did not bring any particular benefit, and among conventional painkillers there are much cheaper and safer analogues.”

Daniil, 33 years old, builder“In recent months, my mother often complained that her legs began to hurt. I took him to a rheumatologist, it turned out that it was osteoporosis. The doctor prescribed Miacalcic injections, which she regularly took throughout the course of treatment. We somehow didn’t notice a miraculous healing (and for that kind of money we were waiting for it), so we didn’t go to this doctor anymore. However, after 2 months, the mother discovered an unknown lump in the chest area. What this is, we have not yet figured out. I don’t know if Miacalcic had this effect, or if it was just a coincidence, but I categorically do not recommend injecting this remedy! And I generally advise doctors who prescribe it to older people to change their profession!”

If you have any questions regarding the price of Miacalcic, reviews about it, instructions for use or other aspects, ask them in the comments. Our specialists will definitely help, and this information may also be useful to other site guests.

Many diseases are associated with improper calcium metabolism in the body. These are, for example, abnormalities in the development of bone tissue, acute pancreatitis. Miacalcic will help regulate disturbed metabolism.

Description, pharmacokinetics

The main active ingredient of Miacalcica is synthetic salmon calcitonin.. It affects the regulation of calcium metabolism in the body.

The drug is available with a doctor's prescription.

Mycalcic is absorbed quite quickly into the nasal mucosa, the result of application is achieved within one hour. If the drug is used in doses that exceed the required amount, then the active substance is concentrated more highly in the blood, but the bioavailability remains unchanged.

Calcitonin does not reach the human placenta.

Cumulation of the active substance was not observed with repeated use of the drug.

Pharmacological action

The hormone, which is produced by the cells of the thyroid gland, is an antagonist of parathyroid hormone. With their help, calcium in the body regulates its metabolism.

The calcitonin chain consists of 32 amino acids and a ring of 7 amino acid residues; they have different sequences of different types. And the action of salmon calcitonin here is expressed in the highest degree of duration and strength.

Salmon calcitotin is good at reducing bone turnover to a slow pace. Mycalcic has an analgesic effect on the central nervous system.

After the first use in humans channel reabsorption decreases and hydroxyproline excretion. If the drug is taken for a long time, a significant decrease in the rate of biochemical markers of bone metabolism is noticed. Calcitanin leads to a decrease in gastric and exocrine pancreatic secretion. It proves effectiveness of Mycalcic in the fight against acute pancreatitis.

Release form, composition, price

Miacalcic is available in two forms:

Nasal spray 280 IU, 14 doses of 2 ml.

Compound: synthetic salmon calcitonin, benzalkonium chloride, sodium chloride, hydrochloric acid, water. Price – 2000-2300 rubles.

Solution for injections (injections) 100IU, 5 ampoules of 1 ml.

Compound: synthetic salmon calcitonin, acetic acid, sodium acetate trihydrate, sodium chloride, water. Price – 220-250 rubles.

Storage conditions and periods

Store the medicine of group B in the refrigerator at 2 – 8 degrees, do not lower the temperature. If the ampoule has been opened, its contents must be used immediately, because the solution is without preservatives. Keep out of the reach of children.

If lithium preparations are taken simultaneously with Miacalc, the plasma concentration of lithium may decrease. No negative effects were observed when taking other drugs.

Store the spray at a temperature not exceeding 25 degrees for no more than a month.

Allowed store the medicine for no more than 3 years.

Indications for use

Miacalcic is used in cases of:

postmenopausal osteoporosis;
bone pain;
Paget's bone disease;
treatment of neurodystrophic diseases arising due to etiological and predisposing factors;
prevention of bone loss;
treatment of hypercalcemia.

Contraindications, side effects

Based on the results of long-term use of the drug, few contraindications and undesirable effects were noticed:

In case of hypersensitivity to synthetic salmon calcitonin, or to one of the other components of the drug.
When taking this drug, you may experience nausea, vomiting, slight dizziness, flushing of the face, and a feeling of internal warmth.

Overdose

An overdose of this drug causes:

vomiting;
nausea;
dizziness;
blood flushes.

More serious symptoms were not noticed.

Special instructions, instructions

Below are some features of the use of the drug that are most often of interest to consumers:

for renal and hepatic dysfunction

No special studies have been carried out on this issue, but not a single case of a negative effect of the drug on the body with this dysfunction has been noted.

during pregnancy and breastfeeding

A study was conducted which showed that this the drug does not have embryotoxic or teratogenic effects and does not penetrate the placenta. But there are no clinical data on the safety of taking the drug during pregnancy and lactation, so during this period you should protect yourself from taking Miacalcic.

in old age

Miacalcic injections do not have preservatives, so the opened ampoule should be used immediately

No special studies have been conducted on this issue, but many years of experience in using this drug suggests that there is no need to change the regimen or dosage of the drug, because no deterioration in tolerability was found.

Analogues

Miacalcic has analogues:

Alostin 1 dose is equal to 200 IU, 14 doses of 2 ml, spray nasal, price - 1800-2000 rubles
Veprena 1 dose is equal to 20 IU, 14 doses of 2 ml, spray nasal, price - 1600-1800 rubles