Composition, form of production and packaging
Tablets of white color with a grayish or beige shade, with impregnations, a flat-cylindrical shape, with a facet and a risk.
dense extract of belladonna 3 mg
caffeine 50 mg
paracetamol 200 mg
theophylline 100 mg
phenobarbital 20 mg
cytisine 100 Ојg
ephedrine hydrochloride 20 mg
[PRING] calcium stearate, potato starch, polyvinylpyrrolidone (povidone), stearic acid.
10 pieces. - Packings contour mesh (1) - packs cardboard.
10 pieces. - packings contour mesh (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
The combined preparation has a bronchodilator and spasmolytic effect.
The bronchodilator effect of the drug is due to a combination of methylxanthine derivatives (theophylline, caffeine) with sympathomimetic ephedrine and m-cholinolytic atropine, which is the main active start of the belladonna extract.
Phenobarbital eliminates the excitation of the central nervous system.
The drug increases the clearance of the bronchi, dilates the vessels of the lungs and lowers the pressure in a small circle of circulation, stimulates the respiratory center, dilates the coronary vessels and increases the frequency and strength of the heart contractions, increases renal blood flow and has a moderate diuretic effect.Due to the presence of paracetamol in the formulation, Teofedrine-HВ® has antipyretic and analgesic effects.
After oral administration, paracetamol is well absorbed from the digestive tract. C max in blood plasma is achieved within 1 h. Metabolites of paracetamol are excreted for 1-4 h, mainly with urine. T 1/2 of the unchanged drug from the blood plasma for about 3 hours. If the liver and / or kidney function is inadequate, as well as during an overdose, this indicator increases.
C max theophylline in the blood is reached 2.5 hours after taking the pill. T 1/2 theophylline 11 hours, the therapeutic concentration of theophylline in the blood is 20 Ојg / ml.
Atropine after ingestion by 18% is associated with blood proteins, 50% is excreted in the urine by the kidneys unchanged.
Ephedrine is well absorbed from the digestive tract, creating and maintaining the necessary therapeutic level in the blood plasma. Metabolised in the liver, excreted mainly in the urine.
As an auxiliary for diseases of the respiratory system, accompanied by bronchospasm, including:
- bronchial asthma;
- chronic obstructive bronchitis;
- emphysema of the lungs.
The drug is taken orally.
For relief of attacks of bronchial asthma as an adjuvant taken once for 2 tab. Theofedrine-N. If necessary, the drug is used 2-3 times / day. The maximum daily dose is 3 tablets.
For the prevention of Teofedrine-H В® taken internally by 1 / 2-1 tab. 1 time / day after a meal.
To avoid disturbance of night sleep the drug is taken in the morning or in the afternoon. Duration of the drug depends on the nature, characteristics of the course of the disease and the therapeutic effect.
From the side of the cardiovascular system: in isolated cases - tachycardia, violations of the heart rhythm.
From the side of the central nervous system: in isolated cases - mental agitation, tremor, headache, sleep disturbance, insomnia.
On the part of the digestive system: in isolated cases - decreased appetite, heartburn, nausea, vomiting.
Other: in isolated cases - dry mouth, increased sweating, urinary retention, allergic reactions.
- Chronic heart failure;
- angina pectoris;
- violation of the coronary circulation;
- heart rhythm disturbances;
- an angle-closure glaucoma;
- hyperplasia of the prostate;
- arterial hypertension;
- epilepsy and other convulsive conditions;
- lactation period;
- children's age till 18 years;
- Hypersensitivity to the components included in the preparation.
With caution apply the drug in renal or hepatic insufficiency, diabetes mellitus, urinary disorders, propensity to develop drug dependence.
PREGNANCY AND LACTATION
Contraindicated use of the drug during pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution apply the drug in case of liver failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution apply the drug for kidney failure.
APPLICATION FOR CHILDREN
Contraindicated: children under 18 years.
To avoid disturbance of night sleep the drug should not be taken in the evening.
In order to avoid toxic damage to the liver, the drug should not be combined with the intake of alcoholic beverages, as well as to people who are prone to regular use of alcohol.
It is not recommended to prescribe the drug to patients with diabetes mellitus, since ephedrine, used in doses exceeding therapeutic, increases the metabolism, thus leading to an increase in blood glucose levels.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. The preparation contains strong components.
Symptoms of acute poisoning: nausea, vomiting, stomach pain, insomnia, epileptic seizures, impaired vision.
Ephedrine, used in high doses, leads to an increase in the level of glucose in the blood. The lethal oral dose of ephedrine is 1 g.
An overdose caused by paracetamol (with the development of hepatonecrosis, an increase in the activity of hepatic transaminases and an increase in prothrombin time) is manifested after intake of more than 10-15 g of the latter and is hardly possible due to the presence of other active ingredients in the formulation.
Treatment: gastric lavage, artificial vomiting, symptomatic therapy.
Beta-blockers (propranolol), indirect anticoagulants (acenocumarol, phenindione), carbamazepine, furosemide, cimetidine, verapamil, antibiotics (lincomycin, macrolides), fluoroquinolones (ciprofloxacin, norfloxacin), MAO inhibitors, hormonal contraceptives, GCS increase the concentration of theophylline in the blood and so may increase the risk of developing its side effects.
Extract krasavki weakens the effect of m-holinomimetikov and anticholinesterase funds.
Paracetamol increases the effect of anticoagulants. The risk of hepatotoxic action of paracetamol increases with the simultaneous administration of barbiturates, phenytoin, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes.
With the combined use of ephedrine with MAO inhibitors, severe hypertensive crises may occur due to the suppression of the metabolism of these vasopressor substances. Ephedrine weakens the effect of opioid analgesics and other agents that depress the central nervous system. With simultaneous use with nonselective beta-adrenoblockers, the bronchodilator effect of the drug decreases.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List of potent substances.
The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 В° C. Shelf life - 2 years.