Universal reference book for medicines
Product name: TEVACOMB (TEVACOMB)

Active substance: fluticasone, salmeterol

Type: Anti-inflammatory and bronchodilator drug

Manufacturer: CIPLA (India)
Composition, form of production and packaging
Aerosol for inhalation dosed
as a homogeneous suspension of white color.

1 dose

salmeterol (in the form of xinafoate) 25 μg

fluticasone propionate 50 μg

[PRING] ethanol - 1.56 mg, lecithin - 0.00001725 mg, tetrafluoroethane - 76.354 mg.

120 doses - aerosolized aluminum cylinders with a dosing valve, equipped with an inhalation device with a protective cap (1) - packs of cardboard.

120 doses - aerosolized aluminum cylinders with a dosing valve, equipped with an inhalation device with a dose counter and a protective cap (1) - packs of cardboard.

Aerosol for inhalation dosed as a homogeneous suspension of white color.

1 dose

salmeterol (in the form of xinafoate) 25 μg

fluticasone propionate 125 μg

[PRING] ethanol - 1.56 mg, lecithin - 0.000032 mg, tetrafluoroethane - 76.279 mg.

120 doses - aerosolized aluminum cylinders with a dosing valve, equipped with an inhalation device with a protective cap (1) - packs of cardboard.

120 doses - aerosolized aluminum cylinders with a dosing valve, equipped with an inhalation device with a dose counter and a protective cap (1) - packs of cardboard.

Aerosol for inhalation dosed as a homogeneous suspension of white color.

1 dose

salmeterol (in the form of xinafoate) 25 μg

fluticasone propionate 250 μg

[PRING] ethanol - 1.56 mg, lecithin - 0.00005726 mg, tetrafluoroethane - 76.154 mg.

120 doses - aerosolized aluminum cylinders with a dosing valve, equipped with an inhalation device with a protective cap (1) - packs of cardboard.

120 doses - aerosolized aluminum cylinders with a dosing valve, equipped with an inhalation device with a dose counter and a protective cap (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Combined bronchodilator preparation, which consists of two active components: fluticasone (synthetic fluorinated GCS) and salmeterol (selective agonist? 2-adrenoreceptors of long-acting), which have different mechanisms of action.

Fluticasone has a pronounced anti-inflammatory and anti-allergic activity.
The pharmacological action of fluticasone is due to the ability to bind to the glucocorticoid receptors of target cells, incl. epithelial cells of the respiratory tract. In terms of affinity for receptors, fluticasone is 18 times dexamethasone, almost 2 times beclomethasone-17-monopropionate, the active metabolite of beclomethasone dipropionate, and almost 3 times of 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 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 receptor's outer domain, so that salmeterol provides protection against histamine-induced bronchoconstriction and longer bronchodilation (lasting at least 12 hours) compared with agonists?
2- adrenoreceptors of short action. Salmeterol is at least 50 times more selective to? 2 - adrenoreceptors 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 described properties indicate that salmeterol in addition to the bronchodilator effect has an additional effect, the clinical significance of which has not been finally established.

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.
C max of salmeterol in plasma is extremely low (about 200 pg / ml), reached 5-10 min after administration of the drug. The concentration of salmeterol in plasma correlates with the dose of the inhaled drug. Systemic absorption of fluticasone occurs predominantly through the lungs, with absorption first occurring more intensively, but then slowing 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 of the gastrointestinal tract is less than 1%.
Fluticasone

Suction and distribution

Absolute bioavailability of fluticasone in the application of salmeterol / fluticasone is 5.3% of the nominal dose.
C max in the blood plasma is achieved after about 0.33-1.5 hours. There is a direct relationship between the amount of the inhaled dose and the concentration of fluticasone in the blood plasma.
The distribution of fluticasone is characterized by a rapid clearance from the plasma, a large V d in the equilibrium state (300 L) and a final T 1/2 of about 5.9 h. The binding to plasma proteins is approximately 91%.

Metabolism and excretion

Fluticasone undergoes biotransformation in the liver with the participation of the 3A4 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

- as a basic therapy of bronchial asthma, when it is advisable to use a combination of selective beta 2 -adrenomimetics long-acting with inhaled glucocorticosteroids;

- as a supporting therapy for COPD.

DOSING MODE

Intended for inhalation.

In bronchial asthma, adults and adolescents over 12 years old receive Tevacomb 25 μg / 50 μg or 25 μg / 125 μg or 25 μg / 250 μg prescribe
2 inhalation doses 2 times / day. Children from 4 to 12 years old prescribe a drug Tevacomb 25 μg / 50 μg for 2 inhalation doses 2 times / day.
When
COPD is prescribed for adults drug Tevacomb 25 μg / 125 μg or 25 μg / 250 μg for 2 inhalation doses 2 times / 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 / day, it is advisable to reduce the dose to a minimally effective dose or to switch to a smaller dose, the frequency of application is 1 time / 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.
In elderly patients and in patients with liver or kidney pathology, dose adjustment is not required.

Terms of use of the inhaler

The drug Tevacombe 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.
It is necessary to 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 cylinder.
2. Shake the aluminum cylinder up and down.

If the inhalation device contains a dose counter, then before using for the first time, place the inhaler 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 bottle. The inhaler is now ready for use.
3. Make a deep exhalation through the mouth and tightly clamp the outlet tube of the inhalation device.

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 Tevacomb, continue to slowly inhale.
5. Then remove the inhalation device from the mouth and hold your breath for 10 seconds or at a time that does not cause 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 oral mucosa.

7. If you need to enter more than one dose of the drug, you need to wait 1 minute and repeat all the steps from step 2 to step 6.

8. Then close the inhalation device with a protective cap.

Steps 3 and 4 should not be in a hurry.
At the time of release, it is important to inhale as slowly as possible. Before use, you can practice around the mirror. If you notice "steam" coming out of the top of the can or from the corners of the mouth, you need to 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 protective cap to remove residual 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 clean with a 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 of the parts of the inhaler!

Information on 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 a new inhaler is needed.
It may seem that the balloon is not completely empty, but with its further use, the patient will not receive the correct amount of the drug.
SIDE EFFECT

Since Tevacomb contains salmeterol and fluticasone, side reactions that are characteristic of each component separately should be expected.
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, incl.
migraine, sleep disorders, tremor, behavioral disorders, including hyperreactivity and irritability, anxiety.
Allergic reactions: rash and angioedema;
in isolated 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 digestive system: irritation of the mucous membranes of the oropharynx, change in taste sensations, hyposalivation, gastrointestinal infections, damage to hard tissues of the teeth, abdominal pains, increased gas formation, constipation, hemorrhoids.

Dermatological reactions: hemorrhages, eczema, dermatitis and dermatosis.

From the musculoskeletal system: muscle cramps, pain in the bones and joints.

Infections and invasions: Candidiasis of the oral and pharyngeal mucosa, urinary tract infections, respiratory infections, other bacterial and viral infections.

As with the use of other inhaled medications, the development of paradoxical bronchospasm may occur with the use of Tevacombe.
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 to develop systemic reactions that include the Itenko-Cushing syndrome, suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density, cataracts, glaucoma, hyperglycaemia.

CONTRAINDICATIONS

- Children's age up to 4 years;

- Hypersensitivity to salmeterol, fluticasone and other components of the drug.

With caution should prescribe the drug for tuberculosis, fungal, viral or bacterial infections, pheochromocytoma, thyrotoxicosis, hypothyroidism, diabetes mellitus, uncontrolled hypokalemia, uncontrolled arterial hypertension, arrhythmia, ischemic heart disease, QT interval prolongation on the ECG, idiopathic hypertrophic subaortal stenosis, cataract, glaucoma, osteoporosis, during pregnancy and 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.

APPLICATION FOR FUNCTIONS OF THE LIVER

There is no need for dose adjustment in patients with kidney pathology.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

There is no need for dose adjustment in patients with liver pathology.

APPLICATION FOR CHILDREN

Contraindicated: children under 4 years.

APPLICATION IN ELDERLY PATIENTS

There is no need for dose adjustment in elderly patients .

SPECIAL INSTRUCTIONS

Patients should be informed that for the best effect, Tevacombe should be used daily even in the absence of symptoms.

Tevacombe is not a drug for relieving 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 used dose of Tevacomb provides adequate control of the disease.
Like other inhaled preparations containing GCS, Tevacomb 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.
Impact on the ability to drive vehicles and manage mechanisms

There is no need for special precautions for persons driving a car or complicated equipment.

OVERDOSE

Symptoms: tremor, headache, tachycardia.

Treatment: as optimal antidotes apply cardioselective blockers of beta-adrenoreceptors, which should be used with caution in the treatment of patients with bronchospasm in the anamnesis.
If treatment with Tevacomb should be discontinued due to an overdose? 2 -agonist, which is part 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.
DRUG 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 Tevacombe with? -adrenoconverters is only permissible if there are strong indications.
Combined use with other agents containing beta 2 -adrenoceptor agonists can lead to increased effects.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Do not freeze. Shelf life - 3 years.
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