Theophedrine-H® (Theophedrin-N)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBelladonna Leaf Extract + Caffeine + Paracetamol + Theophylline + Phenobarbital + Cytisine + EphedrineBelladonna Leaf Extract + Caffeine + Paracetamol + Theophylline + Phenobarbital + Cytisine + Ephedrine
Dosage form: & nbspPills.
Composition:

1 the tablet contains as active ingredients 0,2 g of paracetamol (in terms of 100% anhydrous substance), 0.1 g of theophylline (in terms of 100% anhydrous substance), 0,05 g of caffeine (in terms of 100 % anhydrous substance), 0,02 g of phenobarbital (in terms of 100% anhydrous substance), 0.02 g of ephedrine hydrochloride (in terms of 100 % anhydrous substance), 0,003 g extract of belladonna thick, 0.0001 g cytisine (in terms of 100 % anhydrous substance) and Excipients: potato starch, calcium stearate, stearic acid, polyvinylpyrrolidone (povidone).

Description:

Tablets of white color with a grayish or beige shade, with impregnations, a flat-cylindrical shape with a facet and a risk.

Pharmacotherapeutic group:Bronchodilator combination.
ATX: & nbsp

R.03   Drugs for the treatment of bronchial asthma

Pharmacodynamics:

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 blood 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 exerts a moderate diuretic effect.

Due to the presence of paracetamol in the formulation, Teofedrine-H® has antipyretic and analgesic effects.

Pharmacokinetics:

Ingestion paracetamol well absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is reached within 1 h. Metabolites of paracetamol are excreted within 1-4 hours, mainly through the kidneys. The half-life of the unchanged drug from the blood plasma is about 3 hours. If the liver and / or kidney function is inadequate, as well as during an overdose, this indicator increases.

The maximum concentration of theophylline in the blood is reached 2.5 hours after taking the pill. The half-life of theophylline is 11 hours, the therapeutic concentration of theophylline in the blood is 20 μg / ml.

Atropine after oral intake by 18% is associated with blood proteins, 50 % is excreted by the kidneys unchanged.

Ephedrine is well absorbed in the digestive tract, creating and maintaining the required therapeutic level in blood plasma. Metabolised in the liver, excreted mainly in the urine.

Indications:

As an auxiliary for diseases of the respiratory system, accompanied by bronchospasm (bronchial asthma, chronic obstructive bronchitis, emphysema of the lungs).

Contraindications:

Hypersensitivity to the components included in the preparation, chronic heart failure, stenocardia, violation of the coronary circulation, heart rhythm disorders, closed angle glaucoma, prostatic hyperplasia, pregnancy and lactation period, hyperthyroidism, arterial hypertension, epilepsy and other convulsive conditions, children under 18 years of age .

Carefully:

Renal or hepatic insufficiency, diabetes mellitus, impaired urination, propensity to develop drug dependence.

Pregnancy and lactation:Contraindicated
Dosing and Administration:

The drug is taken internally as a curative and preventive agent. For relief of attacks of bronchial asthma as an auxiliary, take 2 tablets of Teofedrine-N once. If necessary, the drug is used 2-3 times a day.

The maximum daily dose is 3 tablets.

Preventively, Teofedrine-H® is taken orally 1 / 2-1 tablets once a day, after meals. 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.

Side effects:

In rare cases, allergic reactions are possible, tachycardia, heart rhythm disturbances, mental agitation, tremor, dry mouth, decreased appetite, heartburn, nausea, vomiting, headache, sleep disturbance, insomnia, increased sweating, urinary retention.

Overdose:

Signs of acute poisoning: nausea, vomiting, stomach pain, insomnia, epileptic seizures, impaired vision. Ephedrine, used in high doses, leads to increased blood glucose levels. The lethal oral dose of ephedrine is 1 g.An overdose caused by paracetamol (with the development of hepatonecrosis, increased activity of the "hepatic" transaminases and an increase in prothrombin time) appears after taking more than 10-15 g of the latter and is unlikely to be due to the presence of other active ingredients in the formulation.

Treatment: gastric lavage, artificial vomiting, symptomatic therapy.

Interaction:

Beta-blockers (propranolol), indirect anticoagulants (acenocoumarol, fenindion), carbamazepine, furosemide, cimetidine, verapamil, antibiotics (lincomycin, macrolides), fluoroquinolones (ciprofloxacin, norfloxacin), monoamine oxidase inhibitors, hormonal contraceptives, glucocorticosteroid drugs increase the concentration of theophylline in the blood and therefore 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 developing hepatotoxic effects 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 monoamine oxidase 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 drugs that depress the central nervous system. With simultaneous use with nonselective beta-adrenoblockers, the bronchodilator effect of the drug decreases.

Special instructions:

To avoid disturbance of night sleep the drug should not be taken in the evening.

With caution, the drug is used in patients with impaired liver function and / or kidney function.

To avoid toxic damage to the liver, the drug should not be combined with taking alcoholic beverages, and also to people who are prone to chronic alcohol use. It is not recommended to prescribe the drug to patients with diabetes, because ephedrine, used in doses exceeding therapeutic, increases the metabolism, thus leading to an increase in glucose in the blood.

The preparation contains strong components.

Effect on the ability to drive transp. cf. and fur: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.
Form release / dosage:
Pills.

Packaging:
10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. 1, 2 contoured cell packs together with instructions for use are placed in a pack of cardboard.
Storage conditions:
Store in a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life:
3 years. Do not use the drug beyond the expiration date.
Terms of leave from pharmacies:On prescription
Registration number:LSR-003817/08
Date of registration:19.05.2008
The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp29.12.2014
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