Tevacomb
Tevacomb: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Tevacomb
ATX code: R03AK06
Active ingredient: fluticasone (Fluticasone) + salmeterol (Salmeterol)
Manufacturer: Tsipla Ltd. (CIPLA, Ltd.) (India)
Description and photo update: 2019-09-07
Tevacomb is a combined bronchodilator drug.
Release form and composition
Dosage form - metered aerosol for inhalation: a homogeneous suspension of white color (120 doses in aluminum aerosol cans with a metering valve, an inhalation device with a protective cap and with or without a dose counter, in a cardboard box 1 can and instructions for use of Tevacomb).
Composition of 1 dose of the drug:
- active substances: fluticasone propionate - 50, 125 or 250 mcg, salmeterol (in the form of xinafoate) - 25 mcg;
- auxiliary components: lecithin, tetrafluoroethane, ethanol.
Pharmacological properties
Pharmacodynamics
Tevacomb is a combined bronchodilatory agent, the activity of which is due to the properties of two active components with different mechanisms of action.
Fluticasone is a synthetic fluorinated glucocorticosteroid (GCS) that has a pronounced antiallergic and anti-inflammatory effect. Its pharmacological action is due to the binding of target cells to glucocorticoid receptors, including epithelial cells of the respiratory tract. In terms of affinity for receptors, fluticasone exceeds dexamethasone by 18 times, budesonide is almost 3 times and beclomethasone-17-monopropionate (an active metabolite of beclomethasone dipropionate) is almost 2 times.
Fluticasone inhibits the influx of macrophages, lymphocytes, neutrophils, eosinophils and mast cells, and also reduces the production and release of inflammatory mediators and other biologically active substances (including prostaglandins, cytokines, leukotrienes and histamine) involved in the formation of allergen-specific sensitization. As a result, exudation disappears, capillary permeability and mucus secretion by mucous glands decrease, and the patency of the bronchial tree is restored.
Salmeterol is a long-acting selective β 2 -adrenergic receptor agonist. The drug increases the intracellular content of cyclic 3,5-adenosine monophosphate (cAMP), which helps to relax the smooth muscles of the bronchial wall.
The salmeterol molecule has a long side chain that binds to the outer domain of the receptor. Due to this, the drug protects against histamine-induced bronchoconstriction, and also provides longer bronchodilation (lasting at least 12 hours) compared to short-acting β 2 -adrenoreceptor agonists. Selectivity to β 2 -adrenergic receptors in salmeterol is at least 50 times greater than that of salbutamol.
Salmeterol inhibits the early and late stages of an allergic reaction. A decrease in bronchial hyperreactivity is noted after taking a single dose. Suppression of the late stage of the reaction lasts 30 hours, when the bronchodilator effect is no longer present.
The described properties of salmeterol suggest that it has an additional effect (except for bronchodilator). However, the clinical significance of this has not been fully established.
Salmeterol reduces airway resistance, prevents the development of bronchospasm, increases the vital capacity of the lungs. When used in the range of therapeutic doses, it does not affect the function of the cardiovascular system.
Pharmacokinetics
With the simultaneous use of fluticasone and salmeterol in the composition of Tevacomb, the pharmacokinetics of each of them does not change.
The main pharmacokinetic parameters of the active substances of Tevacomb:
- fluticasone: absolute bioavailability after inhalation is 5.3% of the nominal dose. The maximum plasma concentration (C max) is reached after approximately 0.33–1.15 hours. The C max of fluticasone directly depends on the size of the inhaled dose. The drug is characterized by a large volume of distribution (V d) in the equilibrium state, equal to 300 l, and a rapid clearance from plasma. It binds to plasma proteins by about 91%. Metabolized in the liver with the participation of the isoenzyme 3A4 of the cytochrome P 450 systemwith the formation of a carboxyl metabolite that does not have pharmacological activity. It is excreted in feces and urine, mainly in the form of a hydroxylated metabolite. The renal clearance of unchanged fluticasone is <0.2%, and the metabolite containing a carboxyl group is <5% of the dose. The half-life (T ½) is about 5.9 hours;
- salmeterol: after inhalation, it is absorbed by the tissues of the lungs, from where it enters the systemic circulation, without being metabolized. C max is very low (~ 200 pg / ml), observed approximately 5-10 minutes after inhalation. Plasma concentration depends on the size of the inhaled dose. Systemic absorption, which occurs mainly through the lungs, is intense at first, but gradually slows down. Salmeterol is poorly soluble in water and has a first-pass metabolism; therefore, the bioavailability of the ingested dose from the gastrointestinal tract is less than 1%.
Indications for use
- basic therapy of bronchial asthma, when it is advisable to use a combination of inhaled corticosteroids with a long-acting selective beta 2 -adrenomimetic;
- maintenance therapy for chronic obstructive pulmonary disease (COPD).
Contraindications
Absolute:
- children under 4 years of age;
- hypersensitivity to any component of the drug.
Relative (Tevacomb aerosol should be used with caution, under close medical supervision):
- fungal, viral, bacterial infections;
- active or latent pulmonary tuberculosis;
- hypothyroidism;
- thyrotoxicosis;
- diabetes;
- pheochromocytoma;
- osteoporosis;
- cataract;
- glaucoma;
- uncontrolled hypokalemia;
- idiopathic hypertrophic subaortic stenosis;
- arrhythmias;
- uncontrolled arterial hypertension;
- cardiac ischemia;
- lengthening the QT interval on the electrocardiogram (ECG);
- pregnancy and lactation.
Tevacomb, instructions for use: method and dosage
Aerosol Tevacomb is intended for inhalation use.
Recommended regimen of Tevacomb for bronchial asthma:
- adults and adolescents from 12 years old: 2 inhalation doses of the drug at a dosage of 25 μg + 50 μg, or 25 μg + 125 μg, or 25 μg + 250 μg 2 times a day;
- children 4–12 years old: 2 inhalation doses of the drug 25 mcg + 50 mcg 2 times a day.
For COPD, Tevacomb can only be used in adults. Recommended dosage regimen: 2 inhalation doses of the drug 25 mcg + 125 mcg or 25 mcg + 250 mcg 2 times a day.
Tevacomb should be administered at the lowest effective dose to control symptoms. After achieving the required therapeutic effect, it is recommended to reduce the dose or frequency of inhalations to 1 time per day. The optimal dosage is determined by the severity of the disease.
For effective treatment, Tevacomb should be taken regularly, even in the absence of clinical symptoms of bronchial asthma or COPD.
The doctor determines both the optimal dosage and the duration of therapy individually.
Rules for using the inhaler:
- Remove the protective cap and make sure the outlet tube is clean.
- Holding the inhaler in an upright position, take it between the thumb and forefinger, so that the index finger is located on the bottom of the balloon, and the thumb is on the bottom of the inhaler.
- Shake the can up and down.
- When using an inhalation device that contains a dose counter, before the first use, place it away from your face and make 2 clicks into the air. After that, the counter will display the figure "120" (the number of doses in the bottle). The inhaler is now ready for use.
- Take a deep breath through the mouth and tightly clasp the outlet tube of the inhaler with your lips.
- Take a slow deep breath, while simultaneously pressing the bottom of the balloon with your index finger to extract a dose of Tevacomb. Do not rush, inhale as slowly as possible (before the first inhalation, it is recommended to practice in front of a mirror). If the patient notices "steam" coming out of the top of the balloon or the corners of the mouth, start over from step 2.
- Remove the inhaler from the mouth and hold your breath for as long as possible (without feeling discomfort), but not less than 10 seconds.
- Exhale slowly.
- Rinse mouth with water, being careful not to swallow it.
- If you need to take another dose, you should wait 1 minute and repeat steps 2-9.
- Close the inhaler with a protective cap.
The inhalation device must be cleaned at least once a week:
- inhaler without a dose counter: remove the aluminum can, gently rinse the inhaler and protective cap with warm water. Shake off water residues and dry without using heating devices. Do not use hot water or immerse an aluminum cylinder in water;
- inhaler with a counter of doses: remove the protective cap without removing the aluminum can. Wipe the inside and outside of the inhaler and its outlet tube with a clean, dry cloth. Place the protective cap back. Do not use water to clean any part of the inhaler.
In inhalers with a counter, the number of doses in the cartridge is displayed. When 40 doses remain, the color on the counter changes from green to red. Thus, the patient is warned that the drug will soon run out. When the number "0" is displayed, the drug is no longer available, although it may appear that the bottle is not completely empty. Further use is prohibited, since the patient will not receive the required dose.
Side effects
When using Tevacomb, the development of side effects inherent in each of its active components is possible. No additional adverse reactions due to the combination of salmeterol and fluticasone were noted.
Tevacomb can cause the following violations:
- from the respiratory system: dryness of the mucous membranes of the nasal cavity, nasal congestion, nosebleeds, hoarseness, laryngitis, paradoxical bronchospasm;
- from the cardiovascular system: heart rhythm disturbances, palpitations, tachycardia, myocardial ischemia;
- from the digestive system: damage to the hard tissues of the teeth, changes in taste, hyposalivation, irritation of the mucous membranes of the oropharynx, abdominal pain, constipation, increased gas production, infections of the gastrointestinal tract, hemorrhoids;
- from the musculoskeletal system: muscle cramps, pain in joints and bones;
- from the nervous system: anxiety, sleep disorders, headaches (including migraine), behavioral disorders (including irritability and hyperreactivity), tremor;
- infections and invasions: respiratory infections, urinary tract infections, candidiasis of the oral mucosa and pharynx, other viral and bacterial infections;
- dermatological reactions: eczema, dermatoses, dermatitis, hemorrhages;
- allergic reactions: skin rashes, angioedema; in isolated cases - allergic conjunctivitis / rhinitis, respiratory symptoms (shortness of breath, bronchospasm), anaphylactic reactions, angioedema of the face and oropharynx.
Theoretically, against the background of the use of Tevacomb, it is possible to develop systemic reactions, such as a decrease in bone mineral density, growth retardation in children and adolescents, inhibition of adrenal function, Itsenko-Cushing's syndrome, glaucoma, cataracts, hyperglycemia.
Overdose
Overdose usually manifests as headache, tremors and tachycardia.
As an optimal antidote, cardioselective beta-adrenergic blockers are prescribed. However, they should be used with caution in patients with a history of bronchospasm. If Tevacomb has to be canceled due to an overdose of salmeterol, the patient should be prescribed appropriate GCS replacement therapy.
With prolonged use of Tevacomb in doses exceeding the recommended ones, there is a risk of some suppression of the function of the adrenal cortex. In connection with possible complications, control of the reserve function of the adrenal cortex is shown.
special instructions
The doctor should explain to the patient that the greatest effect of therapy is achieved only with the daily use of Tevacomb, even in cases where there are no symptoms of the disease.
Tevacomb is not intended to relieve acute attacks of bronchial asthma. For this, short-acting bronchodilators are used. The patient is advised to always have a similar drug with him in case of bronchospasm. If the need for its use increases, this indicates a worsening of the course of the disease. A sudden and increasing deterioration in the control of bronchospastic syndrome is potentially life-threatening. In this case, it is recommended to see a doctor as soon as possible.
Like other inhaled drugs, Tevacomb in some cases can cause paradoxical bronchospasm. In such a situation, it is necessary to discontinue the drug, re-evaluate the patient's condition and, if necessary, prescribe an alternative treatment.
With inhaled GCS therapy, the incidence of systemic effects is lower than with oral GCS. However, the risk cannot be completely excluded, especially when using the drug in high doses or for a long time. In this regard, it is recommended to titrate the Tevacomb dose to the minimum effective dose that can provide adequate control of the disease.
Influence on the ability to drive vehicles and complex mechanisms
Tevacomb does not affect the ability to concentrate and speed of reactions, therefore, special precautions during treatment are not required.
Application during pregnancy and lactation
Tevacomb can be used with caution during pregnancy and lactation, but only after a preliminary assessment of the balance of benefits and potential risks.
Pediatric use
The appointment of Tevacomb for children under 4 years of age is contraindicated.
With impaired renal function
The pharmacokinetics of the drug does not depend on renal function, so there is no need to adjust the Tevacomb dose in patients with functional renal impairment.
For violations of liver function
The pharmacokinetics of the drug does not depend on liver function, so there is no need to adjust the dose of Tevacomb in patients with liver dysfunction.
Use in the elderly
No dose adjustment is required for the elderly.
Drug interactions
With inhalation use of Tevacomb, plasma concentrations of fluticasone and salmeterol are low, however, the possibility of their potential interaction with other substrates or inhibitors of the CYP3A4 isoenzyme cannot be completely ruled out.
It is recommended to avoid the simultaneous use of selective and non-selective beta-blockers in patients with bronchial asthma, which is due to the risk of developing bronchospasm. If the appointment of such a combination is strictly necessary, careful monitoring is required.
With the combined use of other beta 2 -adrenoreceptor agonists, the effects of Tevacomb may be enhanced.
Analogs
Tevacomb analogs are: Duoresp Spiromax, Zenheil, Salmecort, Sabacomb, Seroflo Multichaler, Seretid, Seretid Multidisk, Symbicort Turbuhaler, Foradil combi, Foster, Formisonid-Nativ.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Do not freeze. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Tevacomb
According to reviews, Tevacomb is an effective tool that helps control the course of bronchial asthma. Separately, patients note the convenience of using the inhaler with a dose counter. Hoarseness is mentioned as a side effect.
The price of Tevacomb in pharmacies
At the moment, the drug is not available for sale, so the price of Tevacomb is unknown. The cost of the popular analogue of Seretide (for a bottle of 120 doses) is: dosage of 25 μg + 50 μg - 993-1009 rubles, 25 μg + 125 μg - 1329-1382 rubles, 25 μg + 250 μg - 1906-1990 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
