Miacalcic is a drug with hypocalcemic, inhibiting bone resorption effect, affecting the phosphorus-calcium metabolism.
Release form and composition
Miacalcium is available in the following dosage forms:
- Solution for injection: colorless, transparent (in ampoules of 1 ml, 5 ampoules in a carton box);
- Nasal spray: a colorless, transparent, odorless solution (in 2 ml dispenser vials, 1 or 2 vials per carton box).
The composition of 1 ml solution includes:
- Active ingredient: synthetic salmon calcitonin - 100 IU (international units);
- Auxiliary components: sodium chloride, acetic acid, water for injection, sodium acetate trihydrate.
The composition of 1 dose nasal spray includes:
- Active ingredient: synthetic salmon calcitonin - 200 IU;
- Auxiliary components: sodium chloride, purified water, benzalkonium chloride, hydrochloric acid.
Indications for use
Miacalcium in the form of a solution for injection and nasal spray is used to treat the following diseases / conditions:
- Osteitis deformans (Pedzhet's bone disease);
- Bone pain associated with osteopenia and / or osteolysis;
- Neurodystrophic diseases (synonyms: Sudeck syndrome or algoneurodystrophy), due to various etiological and predisposing factors: medicinal neurotrophic disorders, causalgia, shoulder muscle syndrome, reflex dystrophy, post-traumatic painful osteoporosis.
An additional indication for the use of nasal spray is postmenopausal osteoporosis.
Additional indications for use of the solution for injection are:
- Acute pancreatitis (as part of a combination treatment);
- Osteoporosis: primary osteoporosis - senile osteoporosis in women and men, postmenopausal osteoporosis (early and late stages); secondary osteoporosis, in particular arising from the immobilization or treatment with glucocorticoids;
- Hypercalcemic crisis and hypercalcemia caused by immobilization, osteolysis caused by malignant tumors (myeloma, carcinoma of the kidney, lung, breast), hyperparathyroidism, vitamin D intoxication, both for the relief of emergency conditions and for the long-term treatment of chronic conditions - until the moment, for a moment, when the vitamin D is used, both for the relief of emergency conditions and for the long-term treatment of chronic conditions - until the moment, when the vitamin D is injected, and for the relief of acute conditions and for the long-term treatment of chronic conditions - until the moment, for a moment, after the symptoms, and for vitamin D, both for the relief of emergency conditions and for the long-term treatment of chronic conditions the effect of specific therapy of the underlying disease will manifest.
The use of Miacalcium is contraindicated in case of hypersensitivity to the drug components.
During pregnancy and during the breastfeeding period, the use of Miacalcium is not recommended.
Dosing and Administration
The solution is injected subcutaneously, intramuscularly or intravenously.
- Osteoporosis: daily dose - 50 or 100 IU subcutaneously or intramuscularly daily or every other day (depending on the severity of the disease). For the prevention of progressive bone loss, it is recommended to use Miacalcium in combination with adequate doses of vitamin D or calcium;
- Bone pain associated with osteolysis and / or osteopenia: daily dose - 100-200 IU daily intravenously (in saline), intramuscularly or subcutaneously, divided into several injections to achieve a satisfactory clinical effect. The dose of the solution must be adjusted depending on the patient's response to therapy. In some cases, the full analgesic effect is achieved in a few days, and therefore, with long-term therapy, the initial daily dose should be reduced and / or the interval between injections should be increased;
- Paget's disease: daily dose - 100 IU subcutaneously or intramuscularly daily or every other day. The duration of therapy is at least 3 months. The dose of the solution must be adjusted depending on the patient's response to therapy;
- Hypercalcemic crisis (emergency treatment): daily dose - 5-10 IU per 1 kg of patient's body weight in 500 ml of physiological saline intravenously for at least 6 hours. It is also possible to administer the solution intravenously in a stream, in which the daily dose should be divided into 2-4 injections during the day;
- Chronic hypercalcemia (long-term therapy): daily dose - 5-10 IU daily per 1 kg of body weight subcutaneously or intramuscularly in one or two doses. The dosage regimen is adjusted for biochemical parameters and the dynamics of the patient’s clinical condition. If the required dose of the drug is more than 2 ml, intramuscular injections are preferable and should be administered in different places;
- Neurodystrophic diseases: early diagnosis is of particular importance. Therapy should be started immediately after confirming the diagnosis. Daily dose - 100 IU intramuscularly or subcutaneously for 14-28 days. It is allowed to continue therapy with the introduction of 100 IU every other day for up to 42 days, depending on the dynamics of the patient’s condition;
- Acute pancreatitis: 300 IU intravenously (in saline) for 24 hours for a period of not more than 6 consecutive days. The solution is used as part of a combination of conservative therapy.
Miacalcium spray is used intranasally.
- Osteoporosis: daily dose - 200 IU. For the prevention of progressive bone loss, it is recommended to apply adequate doses of calcium and vitamin D simultaneously with the spray. Therapy should 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 injections. The dose is determined according to 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 injections 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 injections. The duration of therapy is from 3 months (minimum) to several years. The dose is recommended to adjust to suit the individual needs of the patient. During treatment, 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 decline, the values of these indicators may increase again. In such cases, the doctor, guided by the clinical picture, must decide on the abolition of Miacalcium and the further resumption of therapy. After discontinuation of the drug after one or several months, bone metabolism disorders may reappear. In such cases, a new course of treatment is required;
- Neurodystrophic diseases: early diagnosis is of particular importance. Therapy is important to begin 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).
During the period of Miacalcic therapy, side effects may occur on the part of some body systems.
- Nervous system: often - taste disorders, dizziness, headache;
- Sense organs: sometimes - visual disturbances;
- Cardiovascular system: often - tides; sometimes - arterial hypertension;
- The digestive system: often - diarrhea, abdominal pain, nausea; sometimes vomiting;
- Dermatological reactions: rarely - a generalized rash;
- Musculoskeletal system: often - arthralgia; sometimes - pain in the bones and muscles;
- Urinary system: rarely - polyuria;
- The body as a whole and local reactions: often - increased fatigue; sometimes - swelling of the face, generalized and peripheral edema, flu-like syndrome; rarely - itching, reactions at the injection site, chills;
- Allergic reactions: rarely - hypersensitivity reactions; very rarely - anaphylactic shock, anaphylactoid or anaphylactic reactions.
- Local reactions: very often - nonspecific symptoms of the nose (erythema, irritation, unpleasant smell, 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 - a perversion of taste, fatigue, pharyngitis, abdominal pain, bones and muscles, diarrhea, nausea, headache, dizziness, hot flashes; sometimes - visual disturbances, edema (extremities, faces, generalized edema), flu-like symptoms, cough, joint pain, vomiting, arterial hypertension.
When applying the spray Miakaltsik may experience hypersensitivity reactions, manifested by itching, pain in the joints, increased blood pressure, edema (limbs, faces, generalized edema), tides, generalized skin reactions. Anaphylactoid type reactions and individual cases of anaphylactic shock have also been reported.
Patients who take their subcutaneous injections of the solution themselves should be instructed in detail by a doctor or nurse.
Before using Miacalcik, it is necessary to visually check the condition of the ampoule and solution. Use only intact vials with a clear, colorless solution and without inclusions. After a single use of the drug, the solution remaining in the vial should be disposed of. Before subcutaneous and intramuscular administration, the solution is recommended to be heated to room temperature.
With prolonged therapy, patients can form antibodies to calcitonin, which usually does not affect the clinical efficacy of the drug. The phenomenon of escape, which occurs in most cases in patients with Paget's disease, receiving the drug for a long period, is probably due to saturation of the 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 have been reported, including isolated cases of anaphylactic shock. If you suspect hypersensitivity to calcitonin salmon prior to treatment, it is recommended to conduct skin tests using diluted sterile solution Miacaltsika.
The solution contains almost no sodium.
Experience with the use of the drug in children is limited, so it is impossible to give recommendations regarding its use in this age group.
It should be borne in mind that the side effects caused by the drug (visual disturbances, dizziness) can have a negative impact on the patient's ability to engage in potentially hazardous activities that require psychomotor speed and high concentration of attention.
With simultaneous use of calcitonin in combination with lithium preparations, plasma concentrations of the latter may decrease. Therefore, when using such combinations, it may be necessary to adjust the doses of lithium preparations.
Terms and conditions of storage
Store at a temperature of 2 to 8 ° C (not freezing) out of the reach of children.
- Solution for injection - 5 years;
- Spray nasal - 3 years.
After opening the ampoule, the solution should be used immediately (no preservatives are included).
After use, the nasal spray should be stored upright for up to 28 days at temperatures up to 25 ° C.