Theopack (Theopec)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTheophyllineTheophylline
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    ALVILS, LTD.     Russia
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  • Theophylline
    pills inwards 
    VALENTA PHARM, PAO     Russia
    • Dosage form: & nbspsustained-release tablets
    Composition:

    Composition per 1 tablet:

    Active substance: theophylline 300.0 mg;

    Excipients: polymethacrylic acid and macrogol complex

    interpolymer (composite polymer carrier, CPN) - 96.0 mg, calcium stearate - 4.0 mg.


    Description:round flat-cylindrical tablets with a risk and chamfer, white or almost white.
    Pharmacotherapeutic group:bronchodilator.
    ATX: & nbsp

    R.03.D.A.04   Theophylline

    Pharmacodynamics:

    Theophylline is a bronchodilator, a purine derivative; inhibits phosphodiesterase, increases accumulation in cAMP tissues, blocks adenosine (purine) receptors; reduces the flow of calcium ions through the channels of cell membranes, reduces the contractile activity of smooth muscles. Relaxes musculature of the bronchi, blood vessels (mainly leather kidney); has a peripheral vasodilating effect, increases renal blood flow, has a moderate diuretic effect.

    Improves the function of respiratory and intercostal muscles, stimulates the respiratory center.Normalizing the respiratory function, contributes to the saturation of blood oxygen and reduce the concentration of carbon dioxide.

    Has a stimulating effect on the heart, increases the strength and heart rate (heart rate), increases coronary blood flow and the need for myocardium in oxygen. Reduces pulmonary vascular resistance, lowers pressure in the "small" circle of blood circulation. It inhibits the aggregation of platelets.

    Delayed release of the active substance from the tablet ensures the therapeutic concentration of theophylline in the blood 3-5 h after administration and its retention for 10-12 h, so that effective theophylline concentrations in the blood during the day are maintained with the drug 2 times a day.
    Pharmacokinetics:

    After oral administration theophylline completely absorbed (bioavailability 90%). The connection with plasma proteins is about 60%. It penetrates through the histohematological barriers. Biotransformiruetsya in the liver with the formation of inactive metabolites. Excreted from the body, mainly by the kidneys, in part with breast milk.

    Indications:

    Treatment and prevention of bronchial obstructive syndrome in bronchial asthma,chronic obstructive bronchitis, pulmonary emphysema, dermato-respiratory syndrome and other diseases of the respiratory system.

    Contraindications:Hypersensitivity (including other xanthine derivatives - caffeine, pentoxifylline, theobromine), acute myocardial infarction, severe arterial hypertension or hypotension, widespread atherosclerosis of the vessels, severe cardiac rhythm disturbances (severe tachyarrhythmias, extrasystole), thyroid hyperthyroidism, peptic ulcer disease stomach and duodenum in the stage of exacerbation, gastritis with high acidity, bleeding from the gastrointestinal tract, epilepsy, increased convulsive activity, hemorrhagic ins ultras, haemorrhage in the retina of the eye, pregnancy, children under 7 years.
    Carefully:

    should be used in cases of severe angina, heart failure, hypertrophic cardiomyopathy, severe liver and kidney dysfunction, gastric and duodenal peptic ulcer (history), bleeding from the gastrointestinal tract in a recent history, prolonged hyperthermia, gastroesophageal reflux, prostatic hypertrophy.

    Pregnancy and lactation:

    Safety of use during pregnancy and lactation is not known. The drug is contraindicated during pregnancy. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Inside, after eating, squeezed with enough liquid. The tablet is not crushed, not chewed and not dissolved in water.

    The daily dose is divided into 2 doses at an interval of 12 hours.

    The average dose for adults and children over 12 years is 300 mg twice a day, at a rate of 10-15 mg / kg / day for 2 divided doses at an interval of 12 hours (300 mg 3 times a day if necessary). The average dose for children from 7 to 12 years is 150 mg twice a day (150 mg, 3 times a day if necessary).

    The optimum dose is selected individually, depending on the nature of the disease, the age and weight of the patient.

    If it is necessary to administer in large doses, the treatment is controlled by the concentration of theophylline in the blood (therapeutic concentration is within 10-15 μg / ml): at a concentration of 20-25 μg / ml, the daily dose should be reduced by 10%; 25-30 μg / ml - by 25%; above 30 mcg / ml - the daily dose is reduced by 2 times. Repeated control is carried out after 3 days.

    When stabilizing the patient's condition against the background of taking in high doses, it is necessary to carry out a control every 6-12 months.

    The duration of the drug depends on the characteristics of the course of the disease and the therapeutic effect it has.

    On average, the course of treatment can last from 2 weeks to 2 months.
    Side effects:

    From the nervous system: dizziness, headache, insomnia, agitation, anxiety, irritability, tremor.

    From the cardiovascular system: palpitations, tachycardia (including the fetus when taking a pregnant woman in the third trimester), arrhythmias, lowering blood pressure, cardialgia, an increase in the frequency of angina attacks.

    From the digestive system: gastralgia, nausea, vomiting,

    gastroesophageal reflux, heartburn, exacerbation of peptic ulcer, diarrhea, with prolonged admission - a decrease in appetite.

    Allergic reactions: skin rash, itching, fever.

    Other: pain in the chest, tachypnea, sensation of hot flashes to the face, albuminuria, hematuria, hypoglycemia, increased diuresis, increased sweating.

    Side effects decrease with a decrease in the dose of the drug.

    Overdose:

    Symptoms: decreased appetite, gastralgia, diarrhea, nausea, vomiting (including blood), gastrointestinal bleeding, tachypnea, facial skin hyperemia, tachycardia, ventricular arrhythmias, insomnia, motor agitation, anxiety, photophobia, tremor, convulsions . In severe poisoning, epileptiform seizures, hypoxia, metabolic acidosis, hyperglycemia, hypokalemia, lowering of arterial pressure, confusion, renal insufficiency with myoglobinuria may develop.

    Treatment: withdrawal of the drug, gastric lavage, the appointment of activated carbon, laxative drugs, washing the intestine with a combination of polyethylene glycol and electrolytes, forced diuresis, hemosorption, plasmasorption, hemodialysis (efficacy is not high, peritoneal dialysis is not effective), symptomatic therapy (incl. metoclopramide and ondansetron - when vomiting). If seizures occur, maintain airway patency and conduct oxygen therapy. To stop the seizure - intravenously diazepam 0.1-0.3 mg / kg (but not more than 10 mg). With severe nausea and vomiting - metoclopramide or ondansetron (intravenously).

    Interaction:

    Antibacterial, antifungal, antiviral drugs

    - Macrolides (except azithromycin), quinolone antibiotics, tetracyclines, lincomycin, ketoconazole, fluconazole, griseofulvin, pipemidinovaya acid reduce the clearance of theophylline, resulting in increased risk of adverse reactions;

    - rifampicin, isoniazid increase the clearance of theophylline, which can lead to a decrease in its effectiveness;

    - ritonavir reduces the concentration of theophylline in the blood serum;

    - Acyclovir may inhibit theophylline metabolism;

    - interferon reduces the clearance of theophylline.

    Means that affect the cardiovascular system.

    - Propranolol, ticlopidine, enalapril, verapamil, diltiazem, nifedipine, mexiletine reduce the clearance of theophylline, resulting in increased risk of adverse reactions;

    - when using adrenomimetics, the risk of developing tachyarrhythmias increases;

    - joint use with beta-blockers reduces the bronchodilator effect of theophylline and can cause bronchospasm;

    - Theophylline reduces the effectiveness of antihypertensive drugs.

    Other medicines.

    - Allopurinol, hormonal contraceptives, disulfiram, methotrexate, cimetidine, ranitidine, lansoprazole, cetirizine, pirantele, thiobendazole reduce the clearance of theophylline and increase the risk of adverse reactions to theophylline;

    - antacids can slow the absorption of theophylline;

    - when combined with corticosteroids, the risk of adverse reactions increases;

    - theophylline enhances the effect of diuretics;

    - theophylline reduces the therapeutic effect of lithium preparations, vecuronium bromide, pipecuronium bromide;

    - theophylline increases the hypoglycemic effect of glycazide;

    - phenobarbital, phenytoin, carbamazepine, sulfinpyrazone increase the clearance of theophylline;

    - theophylline can lead to heart rhythm disturbances in the application of halothane anesthesia;

    - antidiarrhoeal drugs and enterosorbents reduce the absorption of the theillin.

    Carefully theophylline prescribe concomitantly with anticoagulants.

    When vaccinated against influenza, the intensity of theophylline may increase, which may require a reduction in the dose of theophylline.

    The toxicity of theophylline increases with the simultaneous use of other xanthine drugs.

    Special instructions:

    In severe diseases of the cardiovascular system, liver, viral infections, as well as in elderly patients, the dose of the drug should be reduced. The effectiveness of the action of theophylline may decrease in smokers. Since the bronchodilator effect of Teopec develops gradually 3-6 hours after admission, the drug is not prescribed for relief of emergency conditions.

    A diet low in protein and high in carbohydrates lowers the clearance of theophylline, a diet high in protein and low in carbohydrates increases the clearance of theophylline. When taking theophylline should refrain from eating food and drinks containing caffeine, as this increases the risk of adverse reactions.

    The risk of developing adverse reactions increases significantly with an increase in serum theophylline concentration of more than 20 μg / ml (PO μmol / L). To monitor the safety of the drug, it is necessary to carry out drug monitoring.

    If bronchial asthma is well controlled and there are no side effects or factors that can change the need for a dose, the measurement of theophylline concentration is carried out at intervals of 6-12 months.

    Effect on the ability to drive transp. cf. and fur:In case of adverse reactions from the nervous system, patients are advised to refrain from controlling the car and other mechanisms, as well as to be cautious when engaging in activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Long-acting tablets, 300 mg.

    For 10 tablets in a blister of PVC film and aluminum foil with one-side coating thermolac and seal on the other side.


    For 5 blisters together with the instructions for use are placed in a pack of cardboard.
    Packaging:(10) - blisters (5) - packs of cardboard
    Storage conditions:

    In a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    5 years. Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002660
    Date of registration:16.10.2014
    The owner of the registration certificate:ALVILS, LTD. ALVILS, LTD. Russia
    Manufacturer: & nbsp
    Representation: & nbspAlvils, OOOAlvils, OOO
    Information update date: & nbsp17.09.2015
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