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

Active substanceCalcitoninCalcitonin

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Dosage form: & nbspnasal dosing spray

Composition:

1 dose of spray contains

Active substance

Calcitonin 200 ME

Excipients

Benzalkonium chloride 9.0 μg

Sodium chloride 81.0 μg

Hydrochloric acid concentrated to pH 3,7±0,1

Water for injection up to 90 μl

Description:Transparent colorless liquid without foreign inclusions.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator

ATX: & nbsp

H.05.B.A Calcitonin preparations

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

Pharmacodynamics:

Calcitonin - a 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. Calcitonin Salmon has a higher affinity for receptors (compared to mammalian calcitonins), its effect is expressed to the greatest extent both in strength and in duration.

Salmon calcitonin suppresses the activity of osteoclasts by affecting specific receptors, significantly reduces the rate of bone exchange to a normal level at conditions with an increased rate of resorption (with osteoporosis).

Calcitonin has analgesic activity for bone pain, which is caused by direct action on the central nervous system.

Already after a single application of the drug, a clinically significant response is observed, which is manifested by an increase in urinary excretion of calcium, phosphorus and sodium (due to a decrease in tubular reabsorption) and a decrease in hydroxyproline excretion.

According to known data, with prolonged use of calcitonin, a significant and persistent decrease in the level of biochemical markers of bone metabolism, such as serum C-telopeptides (sCTX) and bone isoenzymes of alkaline phosphatase.

The use of the drug leads to a statistically significant increase in bone mineral density in the lumbar vertebrae, which is determined as early as the first year of treatment and persists up to 5 years; ensures the maintenance of mineral density in the femur.

The use of the drug in a dose of 200 ME a day in combination with vitamin preparations D and calcium leads to a statistically and clinically significant reduction in the risk of developing new vertebral fractures and reducing the incidence of multiple vertebral fractures.

Calcitonin reduces gastric secretion and exocrine pancreatic function.

Pharmacokinetics:

Suction. The drug is quickly absorbed through the nasal mucosa, its maximum concentration in the plasma is reached during the first hour (on average about 10 minutes). Bioavailability is 3-5%. When using the drug in doses exceeding the recommended dose, it increases AUC, while the bioavailability does not increase.

Determining the concentration of salmon calcitonin in plasma, as well as the concentrations of other polypeptide hormones, is of little value, since the level of concentration can not predict therapeutic effectiveness preparation.The activity of the drug is assessed by clinical indices effectiveness.

Salmon calcitonin does not penetrate the placental barrier.

Metabolism. The half-life is about 20 minutes. With repeated use of drugs based on calcitonin cumulation is not noted.

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) of different etiology, caused by various predisposing factors, incl. such as post-traumatic osteoporosis, reflex degeneration, humerus syndrome, causalgia, drug-induced neurotrophic disorders.

Contraindications:

Hypersensitivity to synthetic salmon calcitonin or any other component of the drug.

The drug is not recommended for use in children under the age of 18 due to lack of data on efficacy and safety.

Carefully:

Pregnancy and lactation:

Calcitonin does not have embryotoxic and teratogenic effects, does not penetrate the placental barrier.

There are no clinical data on the safety of the drug during pregnancy. In this regard, the drug should not be used in women during pregnancy.

During the period of therapy with the drug, it is recommended to abandon breastfeeding, since it is not known whether calcitonin salmon in breast milk.

Dosing and Administration:

The drug is administered intranasally.

It is recommended that the nasal spray be injected alternately: then into one or the other nasal passage.

For the treatment of osteoporosis: 200 is recommended ME per day.

In order to prevent progressive loss of bone mass at the same time with the use of nasal spray, the appointment of adequate doses of calcium and vitamin D. Treatment should be carried out for a long time.

For pain in bones associated with osteolysis and / or osteopenia: daily dose of the drug is 200 - 400 ME daily. The daily dose of 200 ME, can be entered for 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.

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

Paget's disease: daily dose of 200 ME. In some cases, at the beginning of treatment, a dose of 400 ME day, appointed in several introductions.

With Paget's disease the duration of treatment 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. In some cases, after the initial decrease in the value of these indicators, it is possible again to raise them. 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.

Neurodegenerative diseases: daily dose of 200 ME, daily for 2-4 weeks. Possible additional assignment of 200 ME every other day for 6 weeks, depending on the dynamics of the patient's condition.

Use in elderly patients and selected patient groups

According to known data, elderly patients and patients with a decrease in kidney or liver function do not need to change the dosage regimen of the drug.

Application rules

- Never shake the bottle, as this can lead to the formation of air bubbles inside the vial and, as a result, to incorrect dosing of the drug.

- First use: remove the protective cap, then, holding the device with one or two hands strictly vertically, push the piston three times, which will allow air to exit the tube. Possible spattering of the solution is provided and does not affect the subsequent number of doses.

- Subsequent use: remove the protective cap. Slightly tilt the head forward and insert the tip into the nasal passage. To more evenly distribute the solution, the tip should be aligned with the nose stroke. Push the plunger once.Remove the tip from the nose and take a few vigorous breaths to prevent the drug from escaping. Do not clean the nose immediately after applying the drug. If two injections are prescribed at one time, then the second injection should be done in the other nasal passage.

Gently wipe the tip with a clean dry cloth, be sure to put on the protective cap.

Side effects:

It has been reported about such undesirable effects as nausea, vomiting, dizziness, minor flushes of blood to the face, arthralgia.

Perhaps 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); sometimes (≥ 1/1 000, <1/100); rarely (≥ 1/10 000, <1/1000), including individual message.

Disorders from the immune system: rarely - hypersensitivity; rarely - anaphylactic or anaphylactoid reactions, anaphylactic shock.

From the side of the nervous system: headache, dizziness, taste disorders.

From the senses: sometimes - visual disturbances.

From the side of the cardiovascular system: often - tides; sometimes - arterial hypertension.

From the respiratory system: very often - soreness in the nasal cavity, congestion, mucosal edema of the nose, sneezing, rhinitis, dryness in the nasal cavity, allergic rhinitis, erythema of the nasal mucosa, irritation, unpleasant odor, the formation of excoriations in the nasal cavity; often - nosebleeds, sinusitis, ulcerative rhinitis, pharyngitis; sometimes - cough.

From the digestive system: often - nausea, abdominal pain, diarrhea; sometimes - vomiting.

From the skin: rarely - generalized rash.

From the side of the musculoskeletal system: often - arthralgia; sometimes - pain in the bones and muscles.

From the urinary system: rarely - polyuria.

General disorders and disorders at the site of administration: increased fatigue; sometimes - flu-like syndrome, facial swelling, peripheral and generalized edema, rarely - chills; reaction at the site of the drug - itching.

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, inform the doctor about it.

Overdose:

In case of an overdose it is possible to expect - nausea, vomiting, hot flashes and dizziness. There are reports of the use of calcitonin 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. 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:

With the simultaneous administration of calcitonin and lithium preparations, it may be necessary to adjust the dose of the latter, since it is possible to reduce the plasma concentration of lithium.

Special instructions:

Calcitonin salmon is a peptide, therefore there is a possibility of occurrence of systemic allergic reactions. There are reports of allergic reactions, including individual cases of anaphylactic shock, which occurred in patients who received calcitonin in the form of a nasal spray.

If susceptibility to sensitivity of the patient to salmon calcitonin is suspected, consult a physician before starting treatment with the drug.

With prolonged therapy, the formation of antibodies to calcitonin is possible, but this is not generally affected by clinical efficacy.

In patients with Paget's disease who are receiving long-term therapy, the phenomenon of addiction can be a consequence of saturation of binding sites and obviously has nothing to do with the formation of antibodies. The therapeutic effect of the drug is restored after a break in treatment.

Effect on the ability to drive transp. cf. and fur:

Currently, data on the possible impact of Veprenes the ability to drive a car and control the mechanisms is missing. Nevertheless, given that the use of the drug can lead to the development of side effects such as dizziness, fatigue and visual disturbances, it is recommended to use caution when driving a car or working with mechanisms.

Form release / dosage:

Spray nasal dosed with 200 IU / dose.

Packaging:

By 2.0 ml (14 doses) of the drug in vials of colorless glass with a screw-on dispensing dispenser.

For 1 or 2 bottles, along with the instructions for use are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-000017

Date of registration:26.10.2010

Expiration Date:26.10.2015

Date of cancellation:2015-10-12

The owner of the registration certificate:NATIVA, LLC NATIVA, LLC Russia

Manufacturer: & nbsp

NATIVA, LLC Russia

Information update date: & nbsp26.01.2017

Illustrated instructions

Instructions

Vepren® (Veprena®)