Composition Teofedrin-N
The composition of Teofedrin-N includes the following active substances: theophylline , paracetamol , phenobarbital , cytisine , caffeine , ephedrine hydrochloride , belladonna extract .
Additional ingredients: potato starch, stearic acid, calcium stearate, povidone.
Thus, the composition of Theophedrine characterizes it as a combination drug.
Pharmacodynamics and pharmacokinetics
Theophedrine-N is a combination medicine that has bronchodilator and antispasmodic properties .
The bronchodilator effect is caused by a combination of theophylline and caffeine with ephedrine and the m-anticholinergic atropine .
Phenobarbital , which is part of the drug, has a depressant effect on the nervous system.
As a result of the action of the drug, the lumen of the bronchi increases, blood pressure in the pulmonary circulation decreases, coronary vessels renal blood flow activates of heart contractions increases . The drug also acts to a moderate extent as diuretic .
In addition, the medicine has antipyretic and analgesic properties, since it contains paracetamol . It is well absorbed from the gastrointestinal tract when orally as tablets. Maximum plasma is reached after 60 minutes. Metabolites of paracetamol are excreted within 1-4 hours. This occurs primarily through the kidneys. The plasma half-life is 3 hours. This time may increase in case of renal / liver failure and drug overdose.
The maximum concentration of theophylline in the blood is observed after 150 minutes. The half-life is 11 hours.
The main active ingredient in belladonna leaf extract is atropine . It binds to blood after oral administration by 18%. About half of the dose taken is excreted unchanged through the kidneys.
Ephedrine is characterized by a good degree of absorption in the digestive tract. The required therapeutic level is maintained in plasma. Ephedrine is biotransformed in the liver. It is excreted mainly in the urine.
Contraindications
The contraindications are as follows:
- hypersensitivity to the main and additional components;
- angina pectoris;
- heart rhythm disturbances;
- prostatic hyperplasia;
- lactation;
- pregnancy;
- arterial hypertension;
- childhood;
- chronic heart failure;
- violation of coronary circulation ;
- angle-closure glaucoma;
- hyperthyroidism;
- epilepsy and other convulsive conditions .
The product should be used with caution in the following cases:
- renal and liver failure ;
- problems with urination;
- diabetes mellitus;
- tendency to develop drug dependence.
Instructions for use Teofedrin-N (Method and dosage)
The instructions for Teofedrine indicate that the medicine is administered orally . It is an auxiliary drug for preventing attacks of bronchial asthma . Single dose – 2 tablets. If necessary, take the medicine 2-3 times a day. But the maximum daily dosage should not exceed 3 tablets.
Instructions for using Teofedrin-N for preventive purposes indicate that you need to take half a tablet or one tablet per day after meals. It is advisable to do this in the morning or afternoon to avoid insomnia .
The duration of taking the tablets depends on the characteristics of the disease and the therapeutic effect of the drug.
Rules for dispensing medications
Order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities.”
Paragraph 4 of Order No. 403n regulates the form of prescription forms and drugs dispensed on them; narcotic and psychotropic drugs included in the List of Narcotic Drugs and Psychotropic Substances, the circulation of which is restricted in the Russian Federation, are dispensed according to prescriptions written on prescription forms Form N 107/u-NP and in respect of which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List II), the List (hereinafter referred to as narcotic and psychotropic drugs of List II), with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.
According to prescriptions written out on prescription forms N 148-1/у-88, the following are dispensed:
- psychotropic drugs included in the List of Psychotropic Substances, the circulation of which is limited in the Russian Federation and in respect of which certain control measures may be excluded in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List III);
— narcotic and psychotropic drugs of List II in the form of transdermal therapeutic systems;
- drugs included in the list of drugs subject to PCU, with the exception of those drugs that are dispensed in form No. 107/u-NP;
- drugs that have anabolic activity and are classified as anabolic steroids according to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization (code A14A);
- drugs specified in paragraph 5 of the “Procedure for the dispensing to individuals of medicinal products containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” (order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n);
- preparations manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in Schedule II, and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or psychotropic Schedule II medicinal product.
Other prescription drugs are dispensed on form No. 107-1/u, and are valid for two months from the date of prescription. For patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within up to one year and exceed the recommended amount of the drug for prescribing per prescription. Such a prescription must indicate the period and quantity of the drug dispensed. The prescription is returned to the buyer with notes on the date of dispensing, dosage and quantity of the drug dispensed. The next time the patient comes to the pharmacy with the same prescription, the pharmacist must take into account the notes on the previous dispensing of the drug.
The prescription remains at the pharmacy
Paragraph 14 of the Order establishes that recipes remain with the retail trade entity and are stored:
within 5 years, prescriptions for: - narcotic and psychotropic drugs of Schedule II, psychotropic drugs of List III;
within 3 years, prescriptions for: - combination drugs containing narcotic drugs or psychotropic substances included in Lists II and III of the List, manufactured in a pharmacy organization, drugs with anabolic activity, drugs subject to subject-quantitative accounting;
— medicines sold free of charge or at a discount;
within 3 months, prescriptions for: - medications in liquid dosage form containing more than 15% ethyl alcohol of the volume of finished products, other medications classified by ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives drugs (code N05C), antidepressants (code N06A) and not subject to subject-quantitative accounting.
According to paragraph 15 of the Order, prescriptions not specified in paragraph 14 of the Rules are marked with the stamp “The medicinal product is dispensed” and are returned to the person who received the medicinal product.
Prescriptions written in violation of rules 14 are registered in a journal in which the identified violations in the execution of the prescription are indicated, the last name, first name, patronymic (if any) of the medical worker who wrote the prescription, the name of the medical organization, the measures taken, are marked with the stamp “The prescription is invalid” and returned to the person who submitted the prescription. The retail trade entity informs the head of the relevant medical organization about facts of violation of the rules for filling prescriptions.
Tampering with the primary packaging of the medicinal product when dispensing it is prohibited.
Violation of the secondary (consumer) packaging of the medicinal product and dispensing of the medicinal product in the primary packaging is permitted if the amount of the medicinal product indicated in the prescription or required by the person purchasing the medicinal product (for over-the-counter dispensing) is less than the amount of the medicinal product contained in the secondary (consumer) packaging. ) packaging. In this case, when dispensing a medicinal product, the person purchasing the medicinal product is provided with instructions (a copy of the instructions) for the use of the dispensed medicinal product.
Overdose
The following symptoms of overdose are likely: manifestations of acute intoxication (nausea, pain in the stomach, epileptoid seizures , vomiting , insomnia , blurred vision). Ephedrine in high doses causes an increase in blood glucose.
The dose of ephedrine that leads to death is 1 g.
Symptoms of paracetamol appear when taking more than 10–15 g, so their development is impossible due to the presence of other active substances among the components of the drug.
As therapy, patients are prescribed gastric lavage and induce vomiting. Treatment is symptomatic.
Side effects of Teofedrine
During treatment with Teofedrine, pain in the epigastric region, vomiting, nausea, tachycardia, tremor, insomnia, and difficulty urinating may occur.
An overdose of Teofedrine may result in nystagmus, ataxia, headache, weakness, cardiac dysfunction and decreased blood pressure, seizures, increased sweating, and nervous agitation.
In case of overdose, gastric lavage is indicated. It is also necessary to carry out symptomatic therapy with constant monitoring of the basic vital functions of the body (breathing, pulse, blood pressure).
Interaction
The content of theophylline in the blood increases when taking beta-blockers , Carbamazepine , Cimetidine , antibiotics , MAO inhibitors , , indirect anticoagulants , Furosemide , Verapamil , fluoroquinolones , hormonal contraceptives . Thus, the likelihood of side effects increases.
The effect of belladonna leaf extract is reduced by the influence of m-cholinomimetics and anticholinesterase drugs.
Anticoagulants enhance the effect of paracetamol . The likelihood of developing its hepatotoxic effect increases when combined with barbiturates , Carbamazepine , Zidovudine , Phenytoin , Rifampicin and other inducers of microsomal liver enzymes .
The interaction of ephedrine and MAO inhibitors leads to severe hypertensive crises due to inhibition of the metabolism of these vasopressor substances. Ephedrine also reduces the effect of opioid analgesics and other drugs that have a depressant effect on the nervous system.
Combination with non-selective beta-blockers reduces the bronchodilator effect of Teofedrine-N.
Features of the use of Teofedrine
Theophedrine should not be taken in the evening, as it may disturb the usual state of sleep. During the period of taking the drug, it is necessary to completely avoid alcohol consumption.
This drug should be used with caution in the treatment of diabetes mellitus. Due to the activity of the drug, the level of glucose in the chemical composition of the blood increases. During the period of taking this drug, intellectual and labor activities and driving of vehicles should be limited.
The side effects of Teofedrine are enhanced when the drug is used together with beta-blockers, indirect anticoagulants, fluoroquinolones, furosemide, cimetidine, carbamazepine, verapamil, antibiotics, hormonal contraceptives, MAO inhibitors.
Paracetamol in Theophedrine can lead to intoxication of the body when used together with liver enzyme inducers and barbiturates. Ephedrine weakens the effectiveness of tranquilizers and analgesics. The bronchodilator effect of the drug is reduced when taken simultaneously with beta-blockers.
Rifampicin reduces the concentration of theophylline in the blood, and oleandomycin, ciprofloxacin and erythromycin increase it. Theophedrine reduces the therapeutic effect of doxycycline and its absorption. The use of Theophedrine in treatment in combination with lincomycin is unacceptable.
Co-administration of Teofedrine with antiepileptic and psychotropic drugs should be avoided. The effect of antihypertensive drugs, oral contraceptives and antidepressants when taken together with Theophedrine is usually reduced, and the effect of sleeping pills and diuretics may be increased.
