Calcitonin is a regulator of calcium-phosphorus metabolism; a drug that has hypocalcemic, analgesic and bone resorption inhibitory effects.
Release form and composition
Calcitonin Dosage Forms:
- Solution for injection 50 IU and 100 IU - in 1 ml ampoules, 100 IU and 400 IU - in 2 ml bottles;
- Dosed nasal spray 200 IU / 1 dose - in vials containing 14 and 28 doses.
The active component of the drug is a substance of the same name, which is a polypeptide hormone consisting of 32 amino acid residues, obtained from salmon or a synthetic method, which is an analogue of the hormone produced by parafollicular thyroid cells and similar cells of the thymus and parathyroid glands of man.
Indications for use
- Systemic diseases with skeletal remodeling (aseptic necrosis of the femoral head, Paget's disease, spontaneous bone resorption, osteogenesis imperfecta);
- Osteoporosis (parathyroid, postmenopausal, steroid, senile, etc.);
- Osteomyelitis (radiation and traumatic);
- Bone pain associated with osteopenia and / or osteolysis;
- Traumatic damage to the bones, characterized by a complicated course of the repair process (including delayed adhesion of fractures);
- Zonal pathological bone remodeling in athletes;
- Syudec syndrome (pain due to limb injury, accompanied by osteoporosis, prolonged trophic and vasomotor disturbances);
- Prevention of bone disorders as a result of prolonged immobilization;
- Bone metastases;
- Periodontal disease;
- Hypercalcemia of various origins (including idiopathic in newborns);
- Familial hyperphosphatemia;
- Fibrous dysplasia;
- Hypervitaminosis D;
- Acute pancreatitis (as part of combination therapy).
- Breastfeeding period;
- Hypersensitivity to the drug.
Nasal spray should be used with caution in patients with chronic rhinitis.
Dosing and Administration
Calcitonin solution is intended for subcutaneous, intramuscular and intravenous administration.
In / in the drug is administered, as a rule, in emergency severe conditions (hypercalcemic crises). The daily dose is calculated based on the weight of the patient - at the rate of 5-10 IU per kg of body weight. Immediately before use, it is diluted in 500 ml of isotonic NaCl solution, injected slowly drip (for 6 hours). The daily dose is divided into 2-4 injection.
In chronic conditions, Calcitonin is administered intramuscularly or subcutaneously in a similar dose, but 1-2 times.
In all cases, the treatment is carried out under the control of biochemical parameters and the clinical response of the patient, if necessary, adjust the dose.
In the form of a spray, the drug is administered intranasally. The daily dose can vary from 100 IU to 400 IU (in several injections).
The duration of treatment in each case is determined individually, depending on the type of disease, the patient's condition and the effectiveness of the therapy. The main course, as a rule, lasts 2-4 weeks, then the dose is reduced and the treatment is continued for another 6 weeks.
Regardless of the method of use, the following side effects may occur: hot flashes to the face, unpleasant taste in the mouth, edema (extremities, faces, generalized edema), arthralgia, increased blood pressure, local and generalized allergic reactions, including anaphylactic shock (one case of fatal anaphylaxis).
When parenteral use, in addition, the following are possible: hyperemia and tenderness at the injection site, abdominal pain, loss of appetite, diarrhea, gastralgia, nausea, vomiting, headache, dizziness, fatigue, pharyngitis, myalgia, taste perversion, visual disturbances, pain in eyes, flu-like symptoms, cough, polyuria, itchy earlobes, skin rash, nocturia, sensation of heat, swelling of the feet.
When intranasal use can also occur: rhinitis, sinusitis, sneezing, nosebleeds, papules in the nasal cavity, dryness and / or swelling, erosion of the nasal mucosa.
More than 3% of patients with postmenopausal osteoporosis who used Calcitonin in the form of a nasal spray had the following adverse effects: rhinitis, nasal bleeding, symptoms from the nose (dryness and formation of crusts in the nasal cavity, itching, irritation, redness, erythema, soreness, compaction, pallor of mucous membranes, infections, formation of bleeding wounds, discomfort and pain around the nose), arthralgia, back pain, headache.
With an overdose of calcitonin, signs of hypocalcemia appear (including muscle twitching, paresthesia). With subcutaneous administration of the drug, only nausea and vomiting occurred. Data on the long-term use of high doses of calcitonin are not enough to assess the degree of its toxicity.
With intranasal administration, overdose cases are unknown. There are reports of a single dose of up to 1600 IU and daily use of a daily dose of 800 IU for 3 consecutive days, no serious side effects have been noted.
Treatment of symptomatic overdose, parenteral administration of calcium gluconate is indicated.
With extreme caution parenteral drug should be administered to patients prone to allergies, since there are reports of several cases of serious allergic reactions and one fatal outcome. In addition, with the first administration of Calcitonin (and in some cases with several injections), hypocalcemia may develop. Given this, in the office where the injections are carried out, emergency means should be provided, including calcium gluconate for parenteral administration. It is important to differentiate allergic reactions from hypotension and generalized hot flashes.
Before prescribing Calcitonin, a skin test is performed to the patient, especially if a hypersensitivity is suspected, and the concentration of calcium in the blood is determined. With a low calcium content (less than less than 10 mg%) or a pronounced skin reaction (swelling, erythema), treatment is not carried out. In the case of hot flushes and increased blood pressure, they take a 2-3-day break and repeat the test, if the reactions are repeated, the therapy is not performed.
In chronic diseases characterized by increased metabolism in the bone tissue (including Paget's disease), calcitonin leads to a significant decrease in the level of alkaline phosphorus in serum and a decrease in the release of hydroxyproline in the urine. Particularly pronounced decline in these indicators, reflecting the positive effect of treatment (reduction of osteogenesis and bone resorption), observed after 6-24 months of therapy. It is necessary to monitor the level of alkaline phosphatase and the daily excretion of hydroxyproline in the urine before starting to use Calcitonin, regularly for the first 3 months of treatment and then every 3-6 months.
With prolonged treatment in all patients it is necessary to periodically examine the urine sediment. In patients with hypercalcemia, in addition, the level of calcium in the blood should be systematically monitored.
In order to prevent progressive loss of bone mass in the treatment of osteoporosis, it is necessary to ensure adequate intake of vitamin D and calcium.
Prior to the appointment of a nasal spray and periodically during its use, it is necessary to examine the nasal mucosa, nasal conchas, septum and blood vessels of the nasal mucosa. If there are pronounced ulcerations (more than 1.5 mm in diameter) or ulcerations that penetrate the mucous membrane or are accompanied by severe bleeding, treatment should be stopped. Small ulcers often heal without discontinuing the drug, yet it is recommended to temporarily stop therapy until they heal.
During the treatment with Calcitonin, caution is recommended when driving a vehicle or performing potentially dangerous work.
Studies to assess the interaction of calcitonin with other drugs have not been conducted. No interaction has been reported.
In the treatment of hypercalcemia, the simultaneous use of calcium-containing drugs and / or vitamin D can counteract the effect of calcitonin. When treating other diseases, calcium supplements can be taken 4 hours after Calcitonin.
Terms and conditions of storage
Store in a sealed package in a dark place at a temperature not higher than 2-4 ºC.
Shelf life - 3 years.