Belladonna Leaf Extract + Caffeine + Paracetamol + Theophylline + Phenobarbital + Cytisine + Ephedrine - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Included in the formulation

Theophedrine-H®

pills inwards

MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia

Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

VED

ONLS

АТХ:

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, the drug has antipyretic and analgesic effects.

Pharmacokinetics:

After oral administration paracetamol well absorbed from gastrointestinal tract. Maximum concentration in blood plasma is achieved within 1 hour. Metabolites of paracetamol are excreted within 1-4 hours, mainly with urine. PThe half-elimination period (half-life) 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.

Maximum concentration theophylline in the blood is achieved 2.5 hours after taking the pill. PThe half-elimination period (half-life) theophylline 11 hours, the therapeutic concentration of theophylline in the blood is 20 μg / ml.

Atropine after ingestion by 18% is associated with blood proteins, 50% is excreted in the urine by the kidneys in unchanged form.

Ephedrine well absorbed from the gastrointestinal tract, creating and maintaining the necessary therapeutic level in the blood plasma. Metabolised in the liver, excreted mainly in the urine.

Indications:

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

ICD-10

X.J40-J47.J42 Chronic bronchitis, unspecified

X.J40-J47.J43 Emphysema

X.J40-J47.J45 Asthma

Contraindications:

Chronic heart failure; angina pectoris; violation of the coronary circulation; heart rhythm disturbances; angle-closure glaucoma; hyperplasia of the prostate; hyperthyroidism; arterial hypertension; epilepsy and other convulsive conditions; pregnancy; lactation period; children's age till 18 years; Hypersensitivity to the components included in the preparation.

Carefully:

FROM caution apply the drug in renal or hepatic insufficiency, diabetes, urinary disorders, propensity to develop drug dependence.

Pregnancy and lactation:

Contraindications to the use of the drug during pregnancy and lactation.

Dosing and Administration:

The drug is taken orally.

For relief of attacks of bronchial asthma as an adjuvant taken once for 2 tablets of the drug. If necessary, the drug is used 2-3 times a day. The maximum daily dose is 3 tablets.

AT prevention a drug Take inside 1 / 2-1 tablets 1 time per 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:

From the cardiovascular system: in isolated cases - tachycardia, heart rhythm disturbances.

From the central nervous system: in isolated cases - mental agitation, tremor, headache, sleep disturbance, insomnia.

From the digestive system: in isolated cases - decreased appetite, heartburn, nausea, vomiting.

Other: in isolated cases - dry mouth, increased sweating, urinary retention, allergic reactions.

Overdose:

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) appears after taking more than 10-15 g of the latter and is unlikely to be due to the presence in the formulation of other activecomponents.

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, glucocorticosteroids increase the concentration of theophylline in the blood and therefore may increase the risk of 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 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.

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, because 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.

Instructions

Belladonna Leaf Extract + Caffeine + Paracetamol + Theophylline + Phenobarbital + Cytisine + Ephedrine (Extractum foliorum Belladonna + + Coffeinum + Paracetamolum + Theophyllinum + Phenobarbitalum + Cytisinum + Ephedrinum)