Alostin - instructions for use, dose, side effects, contraindications

Active substanceCalcitoninCalcitonin

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Dosage form: & nbspnasal dosing spray

Composition:

Active substance: calcitonin 2200 ME (1 mg of calcitonin is equivalent to 6,000 ME).

Excipients: sodium chloride, benzalkonium chloride (50% solution), hydrochloric acid or sodium hydroxide, water for injection up to 1 ml.

Description:Transparent colorless liquid.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator

ATX: & nbsp

H.05.B.A Calcitonin preparations

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

Pharmacodynamics:

Alostin - synthetic calcitonin salmon. Calcitonin - polypeptide hormone, produced by C-cells of the thyroid gland in mammals, 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 to mammalian calcitonins, including synthetic human calcitonin), its effect is expressed to the greatest extent both in strength and in duration.

Suppressing the activity of osteoclasts due to the effect on specific receptors, and stimulating the activity of osteoblasts, 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.

In this case, a decrease below the normal level of calcium in the blood plasma is not observed. Both in animals and in humans it was shown that calcitonin has analgesic activity for pains of bone origin, which, apparently, is due to direct effects on the central nervous system.

Pharmacokinetics:

Since the radioimmunoassay methods used to date in pharmacokinetic studies are characterized by inadequate sensitivity and uncertain specificity,the pharmacokinetic parameters of salmon calcitonin, applied intranasally, are difficult to quantify. Bioavailability of salmon calcitonin, applied intranasally, is 3-5% in relation to the bioavailability of the drug used parenterally. The drug is rapidly absorbed through the nasal mucosa and its maximum concentration in the plasma is reached within the first hour. The half-life is 16-43 min. With repeated prescriptions of the drug no cumulation was observed. When the drug was used in doses exceeding the recommended dosages, its concentrations in the blood were higher (as confirmed by an increase in the area under the concentration-time curve), but the relative bioavailability did not increase.

Determining the concentration of salmon calcitonin in the blood plasma, as well as the concentrations of other polypeptide hormones, is of little value, because the therapeutic effectiveness of the drug can not be predicted from the concentration level. Thus, salmon calcitonin activity should be assessed by biochemical or clinical performance indicators.

Indications:

Treatment of postmenopausal osteoporosis;
bone pain associated with osteolysis and / or osteopenia;
Paget's disease (deforming osteitis).

Contraindications:

Hypersensitivity to synthetic salmon calcitonin, as well as to any other component of the drug, hypocalcemia.

Carefully:

Experience with the use of calcitonin in children is limited, and therefore it is not possible to give recommendations for this age group.

Pregnancy and lactation:

Since studies in women during pregnancy and breastfeeding have not been conducted, Alostin should not be used in this category of patients. Studies conducted on animals have shown that calcitonin Salmon does not have embryotoxic and teratogenic properties. It was found that in animals calcitonin Salmon does not penetrate the placental barrier.

It is not known whether the calcitonin Salmon in human milk. It was shown that the synthetic calcitonin Salmon inhibits lactation in animals, so during the period of treatment with the drug, breastfeeding is not recommended.

Dosing and Administration:

The drug is administered intranasally.

For treatment of osteoporosis a dose of 200 is recommended ME per day. In order to prevent progressive loss of bone mass, concomitantly with the use of Alostin, the administration of adequate doses of calcium and vitamin D. 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 IU can be administered at a 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. 13 In some cases, a dose of 400 IU a day, appointed in several introductions.

The duration of treatment is at least 3 months; if necessary, it can be more. The dose should be adjusted to the individual needs of the patient.

With Paget's disease, the duration of treatment with the drug 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 the discontinuation of treatment, bone metabolism disorders may occur again, in which case a new course will be required.

Use in elderly patients and selected patient groups

The extensive experience of intranasal application of salmon calcitonin in elderly patients indicates that in this age group there was no impairment 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.

Instructions on the use of nasal spray.

Before use, the vial with the drug should be stored in the refrigerator at a temperature of 2 to 8 ° C. Do not freeze.

Before using each new vial of the drug, it must be kept at room temperature.

After the first use, the vial with the drug should be stored at room temperature (not above + 25 ° C) and used within 4 weeks.

Before use, do not shake the bottle, as this can lead to the formation of bubbles in the solution and improper dosing of the preparation.

1. Remove the clean plastic dust cap and the safety clip from the nasal spray pump (Fig. 1). The safety clip prevents accidental spraying of the spray. Be careful not to press the edge of the pump at this time.

2. Hold the device is vertical (Fig. 2) between the index and middle fingers, placing them on the protruding edge of the pump, and the thumb on the bottom of the vial, press the protruding edge of the pump to the stop and release. Do this three times, which will allow the air to exit the pump. Thus, the bottle with nasal spray is ready for use.

This manipulation should be done only before the very first use of the drug to bring the device into working order.Do not refill the pump before each daily use, this will result in the consumption of the drug.

3. Tilt the head slightly forward and insert the tip of the applicator into one of the nostrils. Make sure that it is directed along one line with the nasal passage, this will ensure a more even distribution of the drug. Push the edge of the pump once (Figure 3).

After taking the drug, take a few vigorous breaths to prevent the drug from escaping. Do not exhale through the nose immediately after taking the drug.

If the doctor has prescribed two injections of the drug at a time, then the second injection is done in the second nasal passage.

Under no circumstances should you try to increase the outlet with a needle or other sharp object. Do not attempt to disassemble the dispenser. This can completely disrupt the pump. To ensure the correct dosage, store and transfer the vial with the drug in an upright position. Avoid shaking and strong temperature changes.

Side effects:

The incidence of undesirable events in the intranasal application of salmon calcitonin was assessed as follows: very often - ≥10%, often from ≥ 1% to <10%, sometimes from ≥ 0.1% to <1%.

Local side effects

Often: rhinitis (including dryness in the nasal cavity, edema and congestion in the nasal mucosa, sneezing, allergic rhinitis), nonspecific symptoms from the nose (for example, soreness, papules, exocrats, bad breath, irritation, erythema).

Often: ulcerative rhinitis, sinusitis, nasal bleeding.

These phenomena are usually poorly expressed (in 80% of cases) and require cessation of treatment in less than 5% of cases.

Systemic side effects

Often: hot flashes, dizziness, headache, nausea, diarrhea, abdominal pain, pain in the bones and muscles, pharyngitis, fatigue, perversion of taste.

Sometimes: increased blood pressure, vomiting, joint pain, cough, flu-like symptoms, edema (facial, extremities, generalized edema), visual impairment.

When using salmon calcitonin, hypersensitivity reactions are possible, such as generalized skin reactions, hot flashes, swelling (face, limbs, generalized edema), arterial hypertension, joint pain, itching. There are reports of allergic reactions, anaphylactoid-type reactions and individual cases of anaphylactic shock.

Systemic adverse effects are less common with intranasal than parenteral salmon calcitonin.

Overdose:

When parenteral application of calcitonin salmon, nausea, vomiting, hot flashes and dizziness are dose-dependent. Therefore, with an overdose of calcitonin salmon, applied intranasally, we can expect similar phenomena. However, there are reports of cases where calcitonin Salmon was applied intranasally in 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. In case of an overdose, treatment is symptomatic.

Interaction:

Alostin was not reported on drug interactions.

Special instructions:

Allergic reactions. Because the calcitonin is a polypeptide, there is the possibility of a systemic allergic reaction. It is necessary to take emergency measures in cases when such reactions can take place. If susceptibility to sensitivity of the patient to salmon calcitonin is suspected, skin tests should be performed before Alostin treatment begins.

Nasal Examination

Local (nasal) side effects are most often observed. Therefore, nasal examination should be performed prior to treatment with Alostin and at any time when nasal complaints appear. If serious ulceration of the nasal mucosa occurs (ulcers larger than 1.5 mm in diameter, penetrating deep into the mucous membrane, or accompanied by severe bleeding), the use of salmon calcitonin should be stopped intranasally. Although small ulcers heal without stopping the intranasal application of salmon calcitonin, in any case, the administration of the drug should be stopped temporarily until healing takes place.

Effect on the ability to drive transp. cf. and fur:There is no data on the effect of salmon calcitonin on the patient's ability to drive vehicles and work with mechanisms. The effect of salmon calcitonin on the central nervous system can adversely affect the ability of the patient to respond quickly. The doctor should warn the patient that in the event of any phenomena from the central nervous system, one should not drive a car or operate machinery.

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

Packaging:

For 2 ml of the drug (at least 14 doses) in a vial of colorless glass with a dosing device, with a safety clip and a plastic cap cap.

For 1 or 2 bottles together with instructions for use - in a pack of cardboard.

Storage conditions:

At a temperature of 2 to 8 ° C (in the refrigerator) in the dark place. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000088