Miacaltsik - Instructions For Use, Reviews, Price, Spray, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Miacaltsik

Miacaltsik: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Miacalcic

ATX code: H05BA01

Active ingredient: calcitonin (calcitonin)

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

Description and photo updated: 28.08.

Miacalcic is a drug that affects calcium-phosphorus 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 1 ml ampoules, 5 ampoules in a cardboard box);
• Nasal spray: colorless, transparent, odorless (in vials (bottles) of 2 ml (14 doses), 1 or 2 bottles in a cardboard box).

Each pack also contains instructions for using Miacaltsik.

The composition of 1 ml 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 of nasal spray includes:

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

* 1 IU corresponds to approximately 0.2 μg 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 is not the same in different species. Salmon calcitonin has a higher affinity for receptors (in comparison with mammalian calcitonins), therefore its effect is most pronounced in terms of 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 metabolism 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, in all likelihood, is associated with a direct effect on the central nervous system.

After a single application 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 prolonged (over 5 years) use of Miacalcic, a significant and persistent decrease in the level of biochemical markers of bone metabolism is achieved - bone isozymes 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 already during the first year of treatment and lasts up to 5 years. Thanks to the use of Miacalcic, the maintenance of the mineral density in the femur is ensured.

With therapy in a daily dose of 200 IU, there is 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 and vitamin D preparations), in comparison with the group of patients who received placebo (in combination with the same drugs). Also, during combined treatment, there is a 35% decrease in the frequency of multiple vertebral fractures.

Calcitonin helps to 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, C _max (maximum concentration of the substance) in plasma is reached within 60 minutes. When used intranasally, the bioavailability is from 3 to 5% in relation to the bioavailability of the drug, which is administered parenterally. When using Miacaltsik in doses exceeding the recommended ones, the concentration of the active substance in the blood is higher, but the relative bioavailability does not increase.

Determination of the plasma concentration of salmon calcitonin is of little value, since it is impossible to predict the therapeutic efficacy of the drug by the value of this indicator. Thus, it is necessary to evaluate the activity of the Miacalcic spray according to clinical performance indicators.

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

T _1/2 (half-life) ranges from 16 to 43 minutes. With repeated appointments of Miacalcic, the accumulation of the active substance is not noted.

Injection

The bioavailability of salmon calcitonin after intramuscular or subcutaneous administration is approximately 70%.

Time to reach C _max in plasma is 60 minutes. Apparent V _d (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, unchanged - only 2% of them. T _1/2 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, Zudeck's atrophy) caused by various predisposing and etiological factors, including drug neurotrophic disorders, post-traumatic painful osteoporosis, reflex dystrophy, causalgia, shoulder-scapular syndrome;
• Deforming osteitis (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, carcinoma of the lungs, breast, kidneys), immobilization, hyperparathyroidism, vitamin D intoxication (for relief of emergency conditions and long-term therapy of chronic hypercalcemia - until then 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 (concurrently with other drugs).

Contraindications

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

Due to the lack of the necessary data, pregnant women should not use the drug. It is recommended that breastfeeding be interrupted during lactation.

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.

Miacaltsik, instructions for use: method and dosage

Injection

Miacalcic solution is administered subcutaneously, intramuscularly and intravenously.

The dosage regimen is determined by the indications:

• Osteoporosis: subcutaneously or intramuscularly; the daily dose is 50 or 100 IU, daily or every other day (determined by the severity of the disease). For the prevention of progressive bone loss, together with Miacalcic, it is recommended to prescribe adequate doses of vitamin D and calcium;
• Bone pain associated with osteopenia and / or osteolysis: intravenously, drip (in saline), subcutaneously or intramuscularly; daily dose - 100-200 ME in several injections, daily. The therapy is carried out until a satisfactory clinical effect is achieved. Dose adjustment is possible taking into account the patient's response to therapy. It may take several days to achieve full analgesic effect. With prolonged treatment, the initial daily dose is usually reduced and / or the interval between injections is increased;
• Paget's disease: subcutaneously or intramuscularly; the daily dose is 100 ME, daily or every other day. The duration of the course is at least 3 months, if necessary, longer therapy is possible. Dose adjustments are sometimes made based on the patient's response to treatment;
• Hypercalcemic crisis (emergency treatment): intravenous drip for at least 6 hours; the daily dose is 5-10 IU / kg in 500 ml of saline. Intravenous jet slow administration is also possible, in this case the daily dose is divided into 2-4 injections;
• Chronic hypercalcemia (long-term therapy): subcutaneously or intramuscularly; the daily dose is 5-10 IU / kg, once or in 2 administrations. The scheme for using Miacaltsik needs to be adjusted taking into account the dynamics of biochemical parameters and the clinical condition of the patient. If the daily dose is more than 2 ml, intramuscular administration of the drug is preferable, the solution must be injected into different places;
• Neurodystrophic diseases: subcutaneously or intramuscularly; daily dose - 100 ME, course duration - 2-4 weeks. Depending on the dynamics of the patient's condition in the future, Miacalcic can be administered every other day at the same dose for no more than 1.5 months. It is recommended to start therapy immediately after confirming the diagnosis;
• Acute pancreatitis (along with other drugs): intravenous drip; daily dose - 300 ME (in physiological solution), daily for no more than 6 days.

Nasal spray

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

The dosage regimen is determined by the indications:

• Osteoporosis: daily dose - 200 ME. For the prevention of progressive bone loss, the use of adequate doses of vitamin D and calcium is recommended concurrently with therapy. As a rule, the treatment is long;
• Bone pain associated with osteopenia and / or osteolysis: daily dose of 200-400 IU, in 1 (200 IU) or several injections (higher doses), daily. It is possible to adjust the scheme of using Miacalcic, taking into account the individual needs of the patient. With prolonged therapy, it is possible to reduce the dose or increase the interval between injections of the drug;
• Paget's disease; daily dose - 200 IU, sometimes it is possible to increase up to 400 IU (in several injections), 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 scheme of 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 the excretion of hydroxyproline in the urine, in some cases - to normal values. Sometimes the values of these indicators may rise again after the initial decrease. The question of canceling or continuing therapy is decided by the doctor individually. If, one or several months after the end of therapy, disorders of bone metabolism occur again, a second course may be required;
• Neurodystrophic diseases: the initial daily dose is 200 IU (in one administration), daily for 2-4 weeks. If necessary, in the future, Miacalcic is used every other day in the same dose for no more than 6 weeks (depending on the dynamics of the patient's condition). Therapy should be started immediately after the diagnosis is confirmed.

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 air bubbles may form inside the solution, which can lead to incorrect dosing.

At the first use, the bottle must be kept strictly upright. To squeeze air out of the tube, press the piston 3 times. After that, the color of the dose counter window will change from red to green, which means that the device is ready for operation. After each use, the figure in the dose counter window changes. The vial contains 14 doses, due to the provided remainder of the solution, it is possible to receive 2 more additional doses.

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

To prevent the solution from flowing out, several vigorous nasal breaths should be taken after spraying. It is not recommended to clear the nose immediately after the introduction of Miacalcic. When 2 doses are prescribed, they are administered into different nasal passages.

Do not try to enlarge the opening of the sprayer with a needle or other sharp objects, as this may cause 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 actions as dizziness, vomiting, nausea, arthralgia, minor 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 decrease in the dose of Miacalcic.

The incidence of side effects, possibly associated with therapy, is assessed as follows (≥1 / 10 - very often; ≥1 / 100, <1/10 - often; ≥1 / 1000, <1/100 - sometimes; ≥1 / 10,000, <1/1000, including isolated messages - rarely):

• 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 impairment;
• The organism as a whole and local reactions: often - increased fatigue; sometimes - facial edema, flu-like syndrome, generalized and peripheral edema; rarely - reactions at the injection site, chills, itching.

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

Overdose

There are no reports of any serious side effects due to an overdose of Miacalcic.

The main symptoms are:

• injection solution: nausea, vomiting, dizziness, hot flashes, hypocalcemia may develop (manifested in the form of paresthesias, muscle twitching);
• nasal spray: disorders similar to those arising from parenteral administration. There are reports of cases when Miacalcic was applied once at a dose of up to 1600 IU and for three days at a daily dose of 800 IU, while no serious adverse events developed.

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

special instructions

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

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

Salmon calcitonin belongs to peptides, therefore, there is a possibility of developing systemic allergic reactions. If you suspect an increased sensitivity of the patient to the active substance, skin tests should be performed using a diluted sterile solution of Miacaltsik before starting therapy.

The injectable solution contains practically no sodium (less than 23 mg).

Influence on the ability to drive vehicles and complex mechanisms

During therapy, it is necessary to take into account the possibility of the development of some side effects of Miacaltsik (visual disturbances, dizziness), which negatively affect the ability to drive and perform potentially hazardous types of work that require increased concentration of attention and quick psychomotor reactions.

Application during pregnancy and lactation

Miacalcic is not prescribed during pregnancy / lactation.

Pediatric use

Patients under 18 years of age are not prescribed Miacalcic.

Drug interactions

When using Miacaltsik 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

Analogues of Miacaltsik are: Alostin, Veprina, Osteover, Calcitrin.

Terms and conditions of storage

Keep out of reach of children at 2-8 ° C, do not freeze.

Shelf life:

• Nasal spray - 3 years;
• Injection solution - 5 years.

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

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Miacalcik

Reviews about Miacaltsik are different. In many cases, patients were satisfied with the effectiveness and tolerability of the drug. It is often prescribed as part of a comprehensive treatment. Other users report the development of side effects, manifested mainly in the form of facial flushing, nausea. Also, when using an injection solution, they indicate pronounced local reactions at the injection site.

The price of Miacalcic in pharmacies

The approximate price for Miacalcic in the form of an injection solution (5 ampoules) is 1032–1111 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!