Tsibutol Cyclocaps - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Cibutol cyclocaps is a selective beta2-adrenoreceptor agonist.
In therapeutic doses, he acts on beta2-adrenoreceptors of smooth muscles of the bronchi, exerting a pronounced bronchodilator effect, preventing and arresting bronchoconstriction, reducing resistance in the airways, increasing the vital capacity of the lungs. Prevents the release of histamine, a slowly reacting substance from mast cells and neutrophil chemotaxis factors. Has a slight positive chrono-and inotropic effect on the myocardium. Causes the expansion of the coronary arteries, practically does not reduce blood pressure. It has a tocolytic effect: it lowers the tone and contractile activity of the myometrium.The action of the drug begins 5 minutes after inhalation and lasts for 4-6 hours.

Pharmacokinetics:After inhalation, 10 to 20% of the dose falls into the respiratory tract. The rest is retained in the device or settles in the oropharynx and then swallowed. Part of the dose that remains in the airway is absorbed by the lung tissue, without being metabolized in the lungs, and enters the bloodstream. If it enters the systemic circulation, it can be metabolized in the liver and excreted predominantly (70%) with urine in unchanged form or in the form of phenolic sulfate. The half-life is between 2.7 and 5.5 hours.
Part of the dose received by the gastro-intestinal tract, absorbed and undergoes extensive metabolism during the first pass through the liver, turning in the phenolic sulfate. The unchanged drug and conjugate are excreted mainly in the urine. Most of the dose of salbutamol administered intravenously, orally, or inflationally, is withdrawn within 74 hours. The degree of binding of salbutamol with plasma proteins is 8%.

Indications:Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive bronchitis, emphysema.

Contraindications:- hypersensitivity to any component of the drug,
- tachyarrhythmia,
- myocarditis,
- heart diseases, aortic stenosis,
- Decompensated diabetes mellitus,
- hyperthyroidism,
- glaucoma,
- Children under 12 years of age (for 400 μg capsules),
- Children under 2 years (for capsules of 200 mcg).
Inhalation drugs salbutamol is not used in the management of preterm labor. Salamol should not be used with threatening abortion.

Pregnancy and lactation:Pregnant women are prescribed a drug only in cases where the expected benefit to the mother exceeds any possible risk to the fetus. Salbutamol, probably penetrates into breast milk, so it is not recommended for breastfeeding women to take it, unless the expected benefit to the mother exceeds any possible risk to the child. It is not known whether any adverse effects on the newborn child salbutamol, present in breast milk.

Dosing and Administration:Cibutol Cyclocapsules are intended for inhalations only with the aid of the Cyclochaler inhaler.
Adults and children over 12 years of age:
With the development of an attack of bronchial asthma, the recommended (one-time initial) dose is 200 μg (1 inhalation).
To prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical exertion, it is recommended to make one inhalation of 200 micrograms every 10-15 minutes before the proposed exposure.
With prolonged therapy Cibutolum Cyclocaps is prescribed in a dose of 200 mcg (1 inhalation) up to 4 times a day.
Supportive therapy for chronic obstructive pulmonary diseases: it is recommended to inhale 400 μg of Cibutol Cyclocaps (2 capsules of 200 μg or 1 capsule of 400 μg) 3-4 times a day.
Children older than 2 years:
When developing an attack of bronchial asthma, as well as to prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical exertion, the recommended dose is 200 μg (1 inhalation) to 3-4 times a day.
Admission of cibutol should be performed in the presence of adults. The attached Cyclochaler inhaler can be used provided that the child uses it correctly.
Mode of application
The drug is taken with the help of an inhaler - cyclohaler. The patient needs to be trained in the proper use of the inhaler.
1. With the cyclochalker inhaler, remove the protective cover
2.The inhaler should be in the upright position with the buttons down.
Holding the inhaler in the base, open it by turning the throat in the direction of the indicated arrow
1- neck
2- The base of the inhaler
3- perforating push buttons
3. Remove the capsule from the blister cell just before use.
4. Place the capsule in the capsular chamber.
5. Check whether the capsule is fully seated in the capsule chamber. If necessary, correct the capsule in the chamber.
6. Close the inhaler by turning the throat to its original position until the inhaler is fully closed.
7. The inhaler is again brought upright in a vertical position.
The thumbtacks hold the thumb and forefinger. Once press the buttons simultaneously with two fingers, carrying out a rapid and strong pressure.
8. Completely exhale the air (not through the inhaler) and bring the inhaler into a horizontal position.
9. Slightly tilting the head back, insert the mouth of the inhaler completely into the mouth with your teeth, placing the neck on the tongue. Tightly tighten the lips around the neck. Produce a quick, uniform deep breath.With a good performance, the inhaler produces a rattling sound, which is due to the rotation of the capsule in the inhaler chamber as the powder is released.
10. The inhaler is taken out of the mouth. Hold the breath for 5-10 seconds, so that the drug enters the lungs and produces a slow exhalation. Open the inhaler and check to see if the capsule is completely empty. If the powder is partially left to repeat the operation (see paragraph 8)
11. After the end of inhalation rinse your mouth with water, not swallowing. Then open the inhaler and remove the empty capsule. The inhaler is again covered with a protective cap.
12. The inhaler should be kept clean and dry in a special case.
13. The inhaler is cleaned once a week. Open the inhaler as fully as possible by turning the throat in the direction indicated in Fig. arrow. Detach the neck from the base. Rinse the neck with warm water. The inhaler should be completely dry before use. The capsule chamber can be cleaned with an applied brush. Press the buttons several times so that the perforation pins can also be cleaned. Do not use water to clean the base and / or perforation pins.
The patient should be aware that the gelatin capsule can break in very rare cases and small pieces of gelatin can enter the mouth or throat after inhalation. The patient should be aware that gelatin is harmless to the body and easily swallowed. The probability of breaking the capsule will be minimal, if we restrict it to a single piercing.

Side effects:Cibutocaps Cyclocaps can cause a slight tremor of skeletal muscles, which is usually most pronounced in the hands and is a typical side effect of all beta2-adrenergic receptor agonists. In some cases, patients have headache, peripheral vascular enlargement, and a slight compensatory increase in heart rate. Very rarely develop hypersensitivity reactions (including angioedema, hives, bronchospasm, arterial hypotension and collapse), muscle cramps, tachycardia, nausea, vomiting.
Inhalation drugs can cause a paradoxical bronchospasm. Paradoxical bronchospasm should be immediately stopped with the help of another dosage form of salbutamol or another high-speed inhaled bronchodilator.In the case of paradoxical bronchospasm, the use of Cibutocyl Cyclocaps should be discontinued immediately, the patient's condition assessed, the necessary examination should be performed and, if necessary, another therapy should be prescribed.
Inhalation preparations can cause irritation of the mucous membrane of the oral cavity and pharynx.
Therapy with beta2-adrenoreceptor agonists sometimes causes hypokalemia, which can be a serious danger to the patient.
Like other beta2-adrenergic receptor agonists, Cibutaps Cyclocaps may occasionally cause excitation and increased motor activity in children.
Some patients may develop cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole).

Overdose:In case of an overdose of salbutamol, the best antidotes are cardioselective beta-blockers. However, beta-adrenoreceptor blockers should be used with caution in patients with bronchospasm in the anamnesis. The use of large doses of salbutamol can cause hypokalemia, so if you suspect an overdose, you should monitor the potassium level in the serum.

Interaction:It is not recommended to simultaneously use Cibutol Cyclocaps and non-selective beta-adrenergic blockers, such as propranolol.
Cibutocaps Cyclocaps is contraindicated in patients who receive monoamine oxidase inhibitors.
Hypokalemia can be exacerbated by simultaneous use of Cibutol Cyclocaps and derivatives of xanthine, glucocorticosteroids, diuretics.

Special instructions:In patients with a severe or unstable course of bronchial asthma, the use of bronchodilators should not be the primary or only method of therapy.
If the effect of the usual dose of Cibutol Cyclocaps becomes less effective or less prolonged (the drug should last no longer than 3 hours), the patient should consult a doctor. The increased need for the use of inhaled beta2-adrenoceptor agonists with short duration of action to control the symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, the treatment plan of the patient should be reviewed and the question of prescribing or increasing the dose of inhaled or systemic glucocorticoid steroids should be considered.
Therapy with beta2-adrenoreceptor agonists can lead to hypokalemia. Particular caution should be exercised in the treatment of severe attacks of bronchial asthma, because in these cases, hypokalemia can be exacerbated by the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, and also due to hypoxia. In such situations, it is necessary to monitor the potassium level in the blood serum.

Effect on the ability to drive transp. cf. and fur:Data on the effects of salbutamol on the ability to drive vehicles and work with mechanisms are not available. It is necessary to take into account the risk of side effects when driving vehicles and working with mechanisms.

Form release / dosage:Capsules for inhalation.

Packaging:30 capsules in blisters in a cardboard box.
120 capsules in blisters in a cardboard box.
30 capsules in blisters in a cardboard box with an inhaler Cyclochaler in a cardboard bundle. Cyclochaler can be in plastic case or plastic bag.
120 capsules in blisters in a cardboard bundle with an inhaler Cyclochaler in a cardboard bundle. Cyclochaler can be in plastic case or plastic bag.

Storage conditions:Store at 15-25 ° C in a dry place protected from light and out of the reach of children.

Shelf life:3 years. Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N014241 / 01-2002

Date of registration:13.10.2008

Expiration Date:Unlimited

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

PHARMACHEMIE, B.V. Netherlands

Information update date: & nbsp2016-09-15

Illustrated instructions

Instructions

Cibutocaps Cibutocaps (Cybutol Cyclocaps)