Pharmacological action Miacalcin Nasal Spray
Hormone produced by the C-cells of thyroid gland, is an antagonist of parathyroid hormone and they jointly participate in the regulation of calcium metabolism in the body.
The structure of calcitonin represented by a single chain of 32 amino acids and a ring of 7 amino acid residues at the N-terminus, the sequence of which varies in different species. Because salmon calcitonin has a high affinity receptor (compared with calcitonin mammals), its action is expressed to the greatest degree as the strength and duration.
Suppressing osteoclast activity through effects on specific receptors, salmon calcitonin significantly reduces the rate of bone turnover to normal levels in states with high rate of bone resorption such as osteoporosis.
In animals and humans have shown that Miacalcin has analgesic activity in pain bone origin, which is apparently due to a direct effect on the CNS.
Already after a single application Miacalcina spray in humans indicated a clinically relevant biological response, which shows increased urinary excretion of calcium, phosphorus and sodium (by reducing their tubular reabsorption) and decreased excretion of hydroxyproline.
In long-term (5 years) use Miacalcina achieved significant and sustainable reduction in biochemical markers of bone metabolism, such as serum C-telopeptide (sCTX) and bone alkaline phosphatase isoenzymes.
Application Miacalcin Nasal Spray leads to a statistically significant increase (1-2%), bone mineral density in the lumbar spine, which is defined already in the first year of treatment and persists up to 5 years. Miacalcin maintains mineral density in the femur.
Application Miacalcina nasal spray at a dose of 200 IU / day leads to a statistically and clinically significant reduction (36%) risk of new vertebral fractures in patients treated with Miacalcin (in combination with vitamin D and calcium), compared with a group of patients, placebo (in combination with the same drugs). In addition, the group Miacalcin been treated (in combination with vitamin D and calcium), compared with placebo (in combination with the same drugs), decreased by 35% frequency of multiple fractures of the vertebrae.
Calcitonin reduces gastric and exocrine pancreatic secretion.
Statement Miacalcin Nasal Spray
- Treatment of postmenopausal osteoporosis;
- Bone pain associated with osteolysis and / or osteopenia;
- Bone Paget’s disease (osteitis deformans);
- Neurodystrophic disease (synonyms: algodistrofiya Zudeka or atrophy) due to various etiological and predisposing factors, such as post-traumatic painful osteoporosis, reflex dystrophy, scapulohumeral syndrome, causalgia, medicinal neurotrophic disorders.
Dosing regimen Miacalcin Nasal Spray
The drug is used intranasally.
For the treatment of osteoporosis recommended dose of 200 IU / day. In order to prevent progressive bone loss at the same time using Miacalcina dosed in the form of nasal spray is recommended the appointment of adequate doses of calcium and vitamin D. Treatment should be for a long time.
When the pain in the bones associated with osteolysis and / or osteopenia, a drug prescribed daily dose of 200-400 IU Daily production capacity. The daily dose of 200 IU may be administered for 1 time. Higher doses should be separated into multiple injections. The dose should be corrected by taking into account the individual needs of the patient.
To achieve full analgesic effect may take several days. During prolonged therapy with initial daily dose is usually reduced and / or increase the interval between infusions.
When Paget’s disease drug is prescribed on a daily basis at a daily dose of 200 IU. In some cases, early treatment may be required dose of 400 IU / day, appointed a few introductions. The treatment duration is at least 3 months, if necessary, it may be more. The dose should be adjusted to the individual needs of the patient.
When Paget’s disease treatment duration Miacalcin should be from several months to several years. The treatment there is a significant decrease in alkaline phosphatase in the blood and excretion of hydroxyproline in the urine, sometimes to normal levels. However, in some cases after the initial reduction of these figures may rise again. In these cases, the physician, guided by the clinical picture, must decide whether to cancel the treatment and when it can reopen.
Through one or a few months after discontinuation of treatment of bone metabolic disorders can occur again, in this case will require a new course.
When neurodystrophic diseases is extremely important early diagnosis. Treatment should be started immediately after confirmation of diagnosis. Assign to 200 IU / day (1 Introduction) daily for 2-4 weeks. Perhaps the additional designation of 200 IU every other day for up to 6 weeks depending on the dynamics of the patient.
Side effect Miacalcin Nasal Spray
The frequency of adverse events was estimated as follows: very common -> = 10%, often – by> = 1% to = 0.1% and> = 1%.
Local: very often – rhinitis (including dryness of the nasal cavity, edema and congestion in the nasal mucosa, sneezing, allergic rhinitis), nonspecific symptoms of the nose (eg, pain, formation of papules, excoriations, odor, irritation, erythema), and often – ulcerative rhinitis, sinusitis, nosebleeds. These phenomena are usually poorly expressed (about 80% of total) and require discontinuation of treatment in less than 5% of cases.
System: often – hot flashes, dizziness, headache, nausea, diarrhea, abdominal pain, bone pain and muscle aches, sore throat, fatigue, dysgeusia, and sometimes – hypertension, vomiting, joint pain, cough, flu-like symptoms, edema ( face, extremities, generalized edema), visual disturbances.
In applying Miacalcin possible hypersensitivity reaction that can manifest generalized skin reactions, flushing, edema (face, extremities, generalized edema), increased blood pressure, joint pain, itching. There are reports of anaphylactoid reactions and the type of individual cases of anaphylactic shock.
Systemic adverse reactions are less common in the intranasal than with parenteral administration Miacalcina.
Contraindications Miacalcin Nasal Spray
- Hypersensitivity to synthetic salmon calcitonin, as well as any other component of the drug.
Pregnancy and lactation
Since the studies in women during pregnancy and lactation were not carried out, use Miacalcin in the form of a spray in these patients should not be.
Is not known whether salmon calcitonin in breast milk in humans, so the period of treatment with breast-feeding is not recommended.
In experimental studies conducted in animals have shown that Miacalcin has no embryotoxic and teratogenic properties. It was found that animals salmon calcitonin does not cross the placental barrier.
Cautions Miacalcin Nasal Spray
Because salmon calcitonin is a peptide, there is the likelihood of systemic allergic reactions. There have been reports of allergic reactions including isolated cases of anaphylactic shock that occurred in patients receiving Miacalcin in the form of spray. If you suspect a patient’s sensitivity to salmon calcitonin before treatment Miacalcin should conduct a skin test.
Long-term therapy may form antibodies to calcitonin, but clinical efficacy is usually not affected. The phenomenon of habituation, which occurs mainly in patients with Paget’s disease receiving long-term therapy may be due to saturation of binding sites, and obviously has no relation to the formation of antibodies. Therapeutic effect Miacalcin restored after an interruption in treatment.
Use in pediatrics Miacalcin Nasal Spray
Experience in applying Miacalcina in the form of metered nasal spray in children is limited, in that it is not possible to give a recommendation for this age group.
Use in elderly patients and selected groups of patients
Extensive experience with Miacalcin in the form of nasal spray dosage in elderly patients suggests that in this age group is not marked deterioration of the drug or the need to modify the dosing regimen. The same applies to patients with decreased kidney function or liver disease, although studies specifically for these groups of patients were not conducted.
Effects on ability to drive vehicles and management mechanisms
Given the possibility of dizziness, as well as increasing blood pressure during treatment with nasal spray Miacalcina, we can not exclude the possibility of negative effects of the drug on the reaction rate. Using the drug are advised to observe caution while driving and management mechanisms.
Overdose Miacalcin Nasal Spray
Symptoms: When parenteral administration Miacalcin nausea, vomiting, flushing and dizziness are dose-related nature. Therefore, in cases of overdose Miacalcin spray applied intranasally, we can expect similar phenomena. However, there are reports of cases where the Miacalcin nasal spray was applied at a dose of 1600 IU once and at a dose of 800 IU / day for three days, is not been no serious adverse events. There are reports of individual cases of overdose. In case of overdose may develop hypocalcemia with symptoms such as paresthesia, muscle twitching.
Treatment: symptomatic therapy, the development of hypocalcemia recommended the introduction of calcium gluconate.
