Tevacomb (Tevacomb)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSalmeterol + FluticasoneSalmeterol + Fluticasone
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    • Dosage form: & nbsp
    Aerosol for inhalation dosed.

    Composition:
    On a single dose
    Active substances: salmeterol (in the form of salmeterol xinafoate) - 0.025 mg / 0.025 mg / 0.025 mg;
    fluticasone propionate - 0.050 mg / 0.125 mg / 0.250 mg.
    Excipients: Ethanol 1.560 mg / 1.560 mg / 1.560 mg, lecithin 0.00001725 mg / 0.000032 mg / 0.00005726 mg, tetrafluoroethane 76,354 mg / 76.279 mg / 76.154 mg.

    Description:A white homogeneous suspension in a liquefied propellant placed in an aerosol can under pressure.
    Pharmacotherapeutic group:Bronchodilator (beta2-adrenomimetic selective + glucocorticosteroid local).
    ATX: & nbsp

    R.03.A.K   Sympathomimetics in combination with corticosteroids or other drugs, excluding anticholinergic drugs

    R.03.A.K.06   Salmeterol and fluticasone

    Pharmacodynamics:
    TEVAKOMB is a combined medicinal product, which includes two active components: fluticasone and salmeterol. These drugs belong to different classes (synthetic fluorinated glucocorticoid and selective agonist beta2-adrenoreceptors of long-acting) and have different mechanisms of action.
    Fluticasone - a synthetic glucocorticosteroid for topical application, which has a pronounced anti-inflammatory and anti-allergic activity. The pharmacological action of fluticasone is due to the ability to bind to glucocorticoid receptors of target cells, including epithelial cells of the respiratory tract. By the degree of affinity for the receptors fluticasone exceeds 18 times dexamethasone, almost doubled beclomethasone-17-monopropionate, the active metabolite of beclomethasone dipropionate, and almost threefold budesonide. Fluticasone inhibits the influx of mast cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the production and release of inflammatory mediators and other biologically active substances (including histamine, prostaglandins, leukotrienes and cytokines) involved in the formation of allergen-specific sensitization.As a result, the permeability of capillaries decreases, exudation disappears, the secretion of mucus by the mucous glands decreases, and the patency of the bronchial tree is restored.
    Salmeterol is a selective long-acting beta2-adrenergic receptor agonist. Salmeterol increases the intracellular content of cyclic 3,5-adenosine monophosphate (cAMP), which leads to relaxation of the smooth muscles of the bronchi wall.
    The salmeterol molecule has a long side chain that binds to the outer domain of the receptor, salmeterol provides protection against histamine-induced bronchoconstriction and prolonged bronchodilation (duration of at least 12 hours) in comparison with beta2-adrenoreceptor agonists of short action. Salmeterol at least 50 times more selective for beta2-adrenergic receptors than salbutamol.
    Suppresses early and late stage of allergic reaction; after the introduction of a single dose, the hyperreactivity of the bronchi decreases, suppression of the late stage lasts 30 hours, when the bronchodilating effect is no longer present.
    The properties described indicate that salmeterol in addition to bronchodilator effect has an additional effect, the clinical significance of which has not been determined.
    Salmeterol prevents the formation of bronchospasm, reduces the resistance of the airways, increases the vital capacity of the lungs. In therapeutic doses, it has no effect on the cardiovascular system.
    Pharmacokinetics:
    When combined inhalation administration fluticasone and salmeterol do not affect the pharmacokinetics of each other.

    Salmeterol is absorbed by the lung tissue and, without being metabolized in the lungs, enters the systemic circulation. The maximum concentration of salmeterol in the plasma is extremely low (about 200 pg / ml), reached 5-10 minutes after the administration of the drug. The concentration of salmeterol in plasma correlates with the dose of the inhaled drug. System Absorption fluticasone occurs predominantly through the lungs, and at first the absorption occurs more intensively, but then slows down. Part of the inhalation dose can be swallowed; due to the low solubility of the drug in water and due to its pre-systemic metabolism, the bioavailability from the gastrointestinal tract is less than 1%.
    Absolute bioavailability fluticasone when using salmeterol / fluticasone is 5.3% of the nominal dose. The maximum concentration in the blood plasma is reached after approximately 0.33-1.5 hours. There is a direct relationship between the magnitude of the inhaled dose and the concentration of fluticasone in the blood plasma. The distribution of fluticasone is characterized by rapid clearance from the plasma, a large volume of distribution in the equilibrium state (300 L) and a final half-life (T1 / 2) of about 5.9 hours. Binding to plasma proteins is approximately 91%.
    Fluticasone undergoes biotransformation in the liver with the participation of the CYP3A4 isoenzyme of the cytochrome P450 system to form an inactive carboxyl metabolite. It is excreted by the intestine and urine, mainly in the form of hydroxylated metabolite. The renal clearance of unchanged fluticasone is less than 0.2%, the renal clearance of a metabolite containing a carboxyl group is less than 5% of the dose.
    Indications:The drug TEVAKOMB is shown as a basic therapy of bronchial asthma, when it is advisable to use a combination of beta2-adrenomimetic selective long-acting with inhalationglucocorticosteroid, as well as for maintenance therapy for chronic obstructive pulmonary disease (COPD).
    Contraindications:
    Hypersensitivity to salmeterol, fluticasone and other components of the drug; children's age up to 4 years.
    Carefully:Precautions: tuberculosis, fungal, viral or bacterial infections, pheochromocytoma, hyperthyroidism, hypothyroidism, diabetes mellitus, uncontrolled hypokalemia, uncontrolled hypertension, arrhythmia, coronary heart disease, lengthening QT interval on the electrocardiogram, idiopathic hypertrophic subaortic stenosis, cataract, glaucoma, osteoporosis , pregnancy, lactation
    Pregnancy and lactation:Pregnant and lactating women can prescribe the drug only if the intended benefit to the mother exceeds the potential risk to the fetus or child.
    Dosing and Administration:
    The drug TEVAKOMB is intended for inhalation.
    Bronchial asthma
    Adults and adolescents over 12 years of age:
    The drug TEVAKOMB 25 mcg / 50 mcg: 2 inhalation doses 2 times a day. The drug TEVAKOMB 25 mcg / 125 mcg: 2 inhalation doses 2 times a day.The drug TEVAKOMB 25 mcg / 250 mcg: 2 inhalation doses 2 times a day.
    Children from 4 to 12 years:
    The drug TEVAKOMB 25 mcg / 50 mcg: 2 inhalation doses 2 times a day.

    Chronic obstructive pulmonary disease (COPD)
    The drug TEVAKOMB 25 mcg / 125 mcg: 2 inhalation doses 2 times a day. The drug TEVAKOMB 25 mcg / 250 mcg: 2 inhalation doses 2 times a day. The drug is prescribed in a minimally effective dose, providing control of the symptoms of the disease. When the effect is achieved by applying the drug 2 times a day, it is advisable to reduce the dose to the minimum effective dose or to switch to a lower dosage, the frequency of application is 1 time per day. The amount of fluticasone in the chosen form should correspond to the severity of the disease.
    To obtain the optimal effect, the drug is used regularly, even in the absence of symptoms of bronchial asthma and COPD. The doctor determines the course of treatment and the dose of the drug individually.
    There is no need for dose adjustment in elderly patients and in patients with liver or kidney pathology.

    Terms of use of the inhaler:
    The drug TEVAKOMB is placed in an aluminum cylinder with a metering valve, equipped with an inhalation device with a protective cap. The inhalation device may comprise a dose counter.
    1. Remove the protective cap from the inhalation device and make sure that the outlet tube of the inhalation device is clean. Keep the inhalation device between the index and thumb in an upright position, with the thumb on the bottom of the inhalation device and the index finger on the bottom of the aluminum canister.
    2. Shake the aluminum cylinder up and down.
    (If your inhalation device contains a dose counter, before using it for the first time, place it away from your face and make 2 clicks into the air to release 2 doses.) The dose counter will show the number "120": the number of doses in the balloon. The inhaler is ready for future use.)
    3. Take a deep breath through your mouth. Tighten the outlet tube of the inhalation device tightly.
    4. Take a slow and deep breath. At the moment of inspiration, press the index finger on the bottom of the aluminum cylinder, releasing the dose of the drug TEVAKOMB, continue to slowly inhale.
    5. Remove the inhalation device from the mouth and hold your breath for 10 seconds or at a time that will not cause you any discomfort. Slowly exhale.
    6. After inhalation, rinse your mouth with water, trying not to swallow the aerosol that was ingested during the inhalation on the mucous membrane of the mouth.
    7. If more than one dose is required, wait 1 minute and repeat all steps from step 2 to step 6.
    8. Close the inhalation device with a protective cap.
    In steps 3 and 4, do not rush. At the time of release, it is important to inhale as slowly as possible. Before use, practice around the mirror. If you notice "steam" coming from the top of the can or from the corners of the mouth, then start again from step 2.

    Cleaning the inhaler
    The inhalation device should be cleaned at least once a week. Inhalation device without a dose counter.
    Remove the aluminum can from the inhalation device. Gently rinse the inhalation device and protective cap with warm water. Do not use hot water! Shake the inhalation device and the protective cap to remove the remaining water and dry them without using heating devices. Do not let the aluminum cylinder into the water!
    Inhalation device with a dose counter.
    Remove the protective cap from the inhalation device, but do not remove the aluminum canister from it! Wipe with a clean dry cloth inside and outside the inhalation device and its outlet tube. Replace the protective cap.
    Warning: Do not wash or rinse in water any part of the inhaler!
    Information about the dosage counter.
    The dose counter shows the number of doses in the bottle. During the use of the inhaler, the numbers on the counter decrease, and the counter shows the remaining number of doses in the cylinder. When there are 40 doses left in the bottle, the color on the meter changes from green to red. This shows that there are not many doses left in the bottle and you need to think about a new inhaler.
    When the dose counter shows the figure "0", it means that there is no more medicine in the bottle and you need a new inhaler. It may seem that the balloon is not completely empty, but with its further use, you will not get the correct amount of the drug.
    Side effects:
    Because TEVCOMB contains salmeterol and fluticasone, we should expect the development of adverse reactions, characteristic of each component separately. Additional side effects with simultaneous use of the two components of the drug are not noted.
    From the cardiovascular system: tachycardia, palpitation, heart rhythm disturbances, myocardial ischemia.
    From the nervous system: headaches, including migraine, sleep disorders, tremor, behavioral disorders, including hyperreactivity and irritability, anxiety.
    From the immune system: hypersensitivity reactions, including rash and angioedema, in single cases angioedema and edema of the face, development of respiratory symptoms - dyspnea and bronchospasm and, extremely rarely, anaphylactic reactions, allergic rhinitis and conjunctivitis. On the part of the respiratory system: nosebleeds, nasal congestion, dry mucous membranes of the nasal cavity, laryngitis, hoarseness of the voice. On the part of the gastrointestinal tract: irritation of the mucous membranes of the oropharynx, changes in taste, hypo-salivation, gastrointestinal tract infections, damage to hard tissues of the teeth, abdominal pains, increased gas formation, constipation, hemorrhoids.
    From the skin: hemorrhages, eczema, dermatitis and dermatosis.
    From the musculoskeletal system: cramps in the muscles, pain in the bones and joints.
    Infections and infestations: Candidiasis of the oral and pharyngeal mucosa, urinary tract infections, respiratory infections, other bacterial and viral infections.
    As with the use of other inhalants, against the background of the use of the drug TEVAKOMB possible development of paradoxical bronchospasm. In this case, immediately stop the use of the drug, assess the patient's condition and, if necessary, prescribe an alternative therapy.
    It is theoretically possible development of systemic reactions, including Cushing's syndrome, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, hyperglycemia.
    Overdose:
    In case of an overdose of the drug TEVAKOMB, tremors, headache, and tachycardia are possible. As best antidotes used cardioselective beta-adrenergic receptors, which should be used with caution during treatment of bronchospasm in patients with a history. If the drug treatment TEVACOMB should be discontinued due to an overdose of the beta2 agonist included in the
    the composition of the drug should be assigned to the patient appropriate replacement therapy GCS.
    With prolonged use of the drug in doses exceeding the recommended, it is possible some oppression of the function of the adrenal cortex. Given the possible complications, it is recommended to monitor the reserve function of the adrenal cortex.
    Interaction:
    Under normal conditions, low concentrations of salmeterol and fluticasone in blood plasma are achieved after inhalation, however, potential interaction with other substrates or inhibitors of the CYP3A4 isoenzyme can not be ruled out.
    It should avoid the use of nonselective and selective beta-blockers in patients with bronchial asthma because of the risk of developing bronchospasm. The use of the drug TEVAKOMB together with beta-blockers is permissible only if there are strict indications.
    Combined use with other agents containing beta2-adrenergic receptor agonists may lead to increased effects.
    Special instructions:
    Patients should be informed that for the best effect, the drug TEVAKOMB must be used daily even in the absence of symptoms.
    The drug TEVAKOMB is not a drug for relief of asthma attacks. For relief of attacks, short-acting bronchodilators are used. It should be recommended to the patient to always have a drug to stop bronchospasm. The increased demand for short-acting bronchodilators indicates a worsening of the course of the disease. The sudden and increasing deterioration in the control of bronchospasm syndrome poses a potential threat to life. In this situation, you need to see a doctor, because The dose of TEVAKOMB does not provide adequate control of the disease.
    Like other inhaled preparations containing GCS, the drug TEVAKOMB should be used with caution in patients with active or latent pulmonary tuberculosis, expressed cardiovascular diseases, including heart rhythm disturbances, hypokalemia, thyrotoxicosis.
    Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses; it should be noted, however, that the likelihood of such symptoms is much lower than when treated with oral GCS.Possible systemic effects include suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density, cataract and glaucoma. Given the above, the dose of inhaled GCS should be titrated to a minimum, which ensures the maintenance of effective control.
    Effect on the ability to drive transp. cf. and fur:There is no need for special precautions for persons driving a car or complicated equipment.
    Form release / dosage:
    Aerosol for inhalation dosed 25 + 50 μg / dose, 25 + 125 μg / dose, 25 + 250 μg / dose.
    Packaging:
    For 120 doses in an aluminum canister with a metering valve, equipped with an inhalation device with a protective cap.
    Or 120 doses per aluminum canister with dosing valve, equipped with an inhalation device with a dose counter and a protective cap.
    1 bottle with instructions for use in a cardboard box.
    To control the first opening, each bundle can be wrapped in a transparent polyethylene film with a tear tape.
    Storage conditions:
    At a temperature of no higher than 30 ° C. Do not freeze. Keep out of the reach of children!

    Shelf life:
    3 years.
    Do not use after the expiry date printed on the package!

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008795/10
    Date of registration:26.08.2010
    The owner of the registration certificate:Cipla Ltd.Cipla Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp17.08.2015
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