Miakaltsik - instructions for use, doses, side effects, contraindications

Active substanceCalcitoninCalcitonin

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Dosage form: & nbspnasal dosing spray

Composition:

1 ml of nasal spray contains:

active substance: synthetic salmon calcitonin 2200 ME;

Excipients: benzalkonium chloride 0.0001 g, sodium chloride 0.0085 g, hydrochloric acid 25% to pH 3.7 ± 0.1, water purified to 1 ml.

Description:A clear, colorless, odorless solution.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator

ATX: & nbsp

H.05.B.A Calcitonin preparations

H.05.B.A.01 Salmon calcitonin synthetic

Pharmacodynamics:

The hormone produced by C-cells of the 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 per N-the end, the sequence of which is not the same for different species. Because the calcitonin Salmon has a higher affinity for receptors (compared with mammalian calcitonins), its effect is expressed to the greatest extent by force,both in terms of duration and duration.

Suppressing the activity of osteoclasts due to action on specific receptors, calcitonin salmon significantly reduces the rate of bone tissue exchange to normal levels in conditions with an increased rate of resorption, for example, in osteoporosis.

Both in animals and in humans it was shown that Miakaltsik has analgesic activity in bone pains, which, apparently, is due to a direct effect on the central nervous system.

Already after a single application of Miakaltsik nasal spray, a clinically significant biological response is observed in man, which is manifested by increased urinary excretion of calcium, phosphorus and sodium (due to a decrease in tubular reabsorption) and a decrease in hydroxyproline excretion. With prolonged (for 5 years) use of Mycatalc, a significant and persistent decrease in the level of biochemical markers of bone exchange, such as serum C-telopeptides (sCTX) and bone isoenzymes of alkaline phosphatase.

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

The use of Miakaltsik nasal spray at a dose of 200 ME per day leads to a clinically significant decrease (by 36%) of the risk of developing new vertebral fractures in the group of patients who received Miakaltsik (in combination with vitamin preparations D and calcium), compared with the group of patients who received placebo (in combination with the same drugs). In addition, in the group of patients treated with Miakaltsikom (in combination with vitamin preparations D and calcium), compared with the group of patients 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:

Bioavailability of Miakaltsik applied intranasally is 3-5% by relative to the bioavailability of the drug used parenterally. Miakaltsik quickly absorbed through the nasal mucosa and its maximum concentration in the plasma is reached during the first hour (an average of about 10 minutes). The half-life is about 20 minutes.At repeated appointments of a preparation of a cumulation it is not noted. When using the drug in doses, exceeding the recommended ones, tothe concentration of blood in the blood was higher (as evidenced by an increase in the area under the concentration-time curve, (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, is of little value, because by level

concentrations can not predict the therapeutic efficacy of the drug. Thus, the activity of Myoccalcic should be assessed by clinical efficacy.

Salmon calcitonin does not penetrate the human placental barrier.

Indications:

- Treatment of postmenopausal osteoporosis.

- Bone pain associated with osteolysis and / or osteopenia.

- Paget's disease (deforming osteitis).

- Neurodystrophic diseases (synonyms: algoneurodystrophy, Zudeck's atrophy), caused by various etiological and predisposing factors, such as posttraumatic painful osteoporosis, reflex degeneration, humerus syndrome, causalgia, drug neurotrophic disorders.

Contraindications:

Hypersensitivity to synthetic salmon calcitonin or a component of the drug.

Pregnancy and lactation:In experimental studies, Miakaltsik did not exert embryotoxic and teratogenic effects and did not penetrate the placental barrier. However, there are no clinical data on the safety of Miakaltsik during pregnancy. In this regard, the drug should not be used in women during pregnancy. It is not known whether the calcitonin salmon in breast milk in humans, so during the period of therapy and the drug is recommended to abandon breastfeeding.

Dosing and Administration:

The drug should be administered intranasally.

Introduction of a nasal spray Myoclocal should be performed alternately in one or both nasal passages.

For treatment of osteoporosis the recommended dose is 200 IU per day. In order to prevent progressive loss of bone mass at the same time with the use of Miakaltsik nasal spray, the administration of adequate doses of calcium and vitamin D is recommended. Treatment should be carried out for a long time.

Bone pain associated with osteolysis and / or osteopenia. The daily dose is 200-400 IU daily. A daily dose of 200 ME can be administered in 1 time. Higher doses should be divided into several injections. The dose should be adjusted to the individual needs of the patient.

To achieve a complete analgesic effect, it may take several days. In long-term therapy, the initial daily dose is usually reduced and / or the interval between administrations is increased.

Paget's disease. The drug is prescribed daily in a daily dose of 200 ME. In some cases, a dose of 400 administered in several administrations may be required at the start of treatment. Duration of treatment at least 3 months; at need it may be more. The dose should be adjusted to the individual needs of the patient.

Note. With Paget's disease, the duration of treatment with Myoclactic should be from several months to several years. Against the backdrop of treatment there is a significant decrease in the concentration of alkaline phosphatase in the blood and excretion of hydroxyproline in the urine, sometimes to normal values. However, in some cases, after the initial decline, the values of these indicators may again rise.In these cases, the doctor, guided by the clinical picture, must decide whether treatment should be revoked and when it can be resumed.

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

Neurodystrophic diseases. It is extremely important to make an early diagnosis. Treatment should be started immediately after confirmation of the diagnosis. Assign 200 IU / day (per single administration) daily for 2-4 weeks. Additional administration of 200 IU every other day for up to 6 weeks is possible depending on the dynamics of the patient's condition.

Use in children

The experience of using Miakaltsik nasal spray in children is limited, so it is not possible to give recommendations for this age group.

Use in elderly patients and selected patient groups

The extensive experience of using Miacalcic nasal spray in elderly patients indicates that in this age group there was no worsening of drug tolerance or the need to change the dosage regimen.The same applies to patients with impaired renal or hepatic function, although studies specifically for these groups of patients have not been conducted.

Side effects:

There have been reported adverse effects such as nausea, vomiting, dizziness, minor "tides" of blood to the face, accompanied by a feeling of warmth, arthralgia. Nausea, vomiting, dizziness and "hot flashes" depend on the dose and are more likely to occur with intravenous than with intramuscular or subcutaneous injections. Against the background of the drug Miakaltsik^® possibly the development of polyuria and chills, which usually disappear on their own, and only in some cases require a temporary reduction in the dose of the drug.

The incidence of adverse events possibly associated with the use of the drug is estimated as follows: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1 000, <1/100); rarely (≥ 1/10 000, <1/1 000), including individual messages.

Immune system disorders: rarely hypersensitivity; rarely - Anaphylactic or anaphylactoid reactions, anaphylactic shock, bronchospasm, angioedema (edema of the tongue and pharynx);

Disorders from the nervous system: often - headache, dizziness, flavors (including metallic taste in the mouth);

Disorders from the side of the organ of vision: infrequently - visual disturbances.

Vascular disorders: often - "tides"; infrequently - Increased blood pressure;

Disturbances from the respiratory system, chest, mediastinum: very rarely - soreness in the nasal cavity, congestion, edema in the nasal mucosa, sneezing, rhinitis, dryness in the nasal cavity, allergic rhinitis, erythema of the nasal mucosa, irritation of the mucous membrane of the nasal cavity, unpleasant odor from the nasal cavity, the formation of excoriations in the nasal cavity; often - nosebleeds, sinusitis, ulcerative rhinitis, pharyngitis; infrequently - cough;

Disorders from the digestive system: often - nausea, abdominal pain, diarrhea; infrequently - vomiting;

Disturbances from the skin and subcutaneous tissues: rarely generalized rash.

Disturbances from musculoskeletal and connective tissue: often - arthralgia; infrequently - pain in the bones and muscles;

Disorders from the kidneys and urinary tract: rarely - polyuria.

Metabolic disorders and eating disorders: rarely - Transient hypocalcemia (usually in patients with severe bone remodeling, for example, in young patients and patients with Ledgeg disease, 4-6 hours after the administration of the drug, more often asymptomatic).

General disorders and disorders at the site of administration: often - increased fatigue; infrequently - flu-like syndrome, facial edema, peripheral and generalized edema, rarely - chills, reactions at the injection site, itching.

Laboratory data: rarely - the appearance of neutralizing antibodies to calcitonin (usually not associated with a clinical decline in the effectiveness of the drug, but their detection in a small number of patients who were on prolonged therapy with the drug was associated with a decrease in response to therapy, not due to an increase in the frequency of allergic reactions).

Side effects data from clinical practice and literature sources (frequency not known): disorders of the nervous system: tremor.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

With parenteral use of Mycalfic, nausea, vomiting, hot flashes and dizziness are dose-dependent. Therefore, with an overdose of Miakaltsik applied intranasally, we can expect similar phenomena. However, there are reports of cases when Miakaltsik nasal spray was applied at a dose of up to 1600 ME once and at a dose of 800 ME per day for 3 days, with no serious adverse events noted. There are reports of individual cases of overdose. Treatment is symptomatic.

In case of an overdose, hypocalcemia may develop with symptoms such as paresthesia, muscle twitching. Treatment: administration of calcium gluconate.

Interaction:

When calcitonin is used together with lithium preparations, a decrease in the plasma concentration of lithium is possible. Thus, with the simultaneous appointment of Miakaltsik and lithium preparations, it may be necessary to adjust the dose of the latter.

Special instructions:

Because the calcitonin Salmon is a peptide, there is a possibility of occurrence of systemic reactions. There are reports of allergic reactions, including some cases of anaphylactic shock, which occurred in patients who received Miakaltsik nasal spray.If susceptibility to sensitivity of the patient to salmon calcitonin is suspected, then skin tests should be performed prior to treatment with Myocalcicum.

Note. With prolonged therapy, the formation of antibodies to calcitonin is possible, but this is not generally affected by clinical efficacy. The phenomenon of addiction, which is observed mainly in patients with Paget's disease receiving long-term therapy, may be a consequence of the saturation of binding sites and obviously has nothing to do with the formation of antibodies. The therapeutic effect of Miakaltsik is restored after a break in treatment.

Effect on the ability to drive transp. cf. and fur:The influence of Miakaltsik on the ability to drive vehicles and work with mechanisms has not been studied. Some of the side effects of the drug, such as dizziness and visual disturbances, can adversely affect the ability to drive and perform potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.

Form release / dosage:Spray nasal 200 IU / dose.

Packaging:

Spray nasal 200 IU / dose 2 ml in a bottle of colorless glass.One or two vials with a screw-on dispensing dispenser together with instructions for use in a cardboard bundle.

Storage conditions:

Before use, store in the refrigerator at 2-8 ° C. Do not freeze.

After the beginning of use, store at a temperature below 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.

Keep out of the reach of children.

List B.

Shelf life:

3 years.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013245 / 01

Date of registration:17.05.2010

Expiration Date:Unlimited

The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland

Manufacturer: & nbsp

NOVARTIS PHARMA, S.A.S. France

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp12.05.2018

Illustrated instructions

Instructions

Myacalcic® (Miacalcic®)