Chronic obstructive seizure of a leg, bronchial asthma, emphysema legen, central apnea syndrome. Achievements for systemic stasis in obstructive ganglions of dichal grooms.
active substance: theophylline;
1 prolonged-release capsule contains 200 mg of theophylline;
Excipients: povidone, colloidal anhydrous silica, triethyl citrate, ammonium methacrylate copolymer (type A), ammonium methacrylate copolymer (type B), talc.
capsule shell: gelatin, titanium dioxide (E 171), indigotine (E 132), quinoline yellow (E 104).
Main physical and chemical properties: the capsule body is transparent, green; capsule cap opaque, green. The capsules are filled with white granules.
Theophylline has antispasmodic and anti-inflammatory effects, as well as hemodynamic and extrapulmonary effects.
By relaxing the smooth muscles of the bronchi, theophylline increases the flow of air through the bronchi and thus improves breathing. Because theophylline improves bronchial mucus transport by increasing mucus and surfactant secretion, it improves ciliary epithelial clearance. The anti-inflammatory effect of theophylline is to inhibit the proliferation of T lymphocytes, inhibit the secretion of cytokines (eg, interleukin-2, tumor necrosis factor), the activity of eosinophils, macrophages and tissue basophils). These effects reduce inflammation of the bronchial mucosa.
Theophylline also affects the smooth muscles of the coronary arteries, blood vessels of the muscles and kidneys, relaxes the muscles of the uterus, cardioesophageal sphincter and bile ducts. Theophylline helps to increase the ejection fraction of blood from the right ventricle, improve heart function, reduce resistance in the pulmonary blood vessels and reduce pulmonary hypertension. Theophylline stimulates the respiratory center, increases the contraction of the diaphragm and respiratory muscles, increases diuresis, increases the secretion of catecholamines from the adrenal glands.
Chronic obstructive pulmonary disease, bronchial asthma, emphysema, central nocturnal apnea syndrome.
Hypersensitivity to any component of the drug, as well as to xanthine drugs (eg, caffeine, theobromine, pentoxifylline), acute heart failure, angina, uncompensated chronic heart failure, acute myocardial infarction, acute cardiac arrhythmias (acute and cardiac arrhythmias) , extrasystole, severe hypertension, severe hypotension, widespread atherosclerosis, pulmonary edema, hemorrhagic stroke, epilepsy, convulsive readiness, hyperthyroidism, uncontrolled hypothyroidism, thyrotoxicosis, hemorrhage, hepatic dysfunction, severe disorders gastric and duodenal ulcers (in the acute stage), gastroesophageal reflux, porphyria, sepsis, use in children simultaneously with ephedrine.
Method of application and dosage
The dose is set by the doctor individually depending on age, body weight and metabolic characteristics.
Usually the dose for adults and children weighing more than 40 kg is 350 mg of theophylline 2 times a day.
The usual dose for adolescents and adults of very lean physique is 200 mg of theophylline 2 times a day.
The usual dose for children over 6 years of age weighing more than 20 kg is 10-15 mg / kg / day, if possible – in 2 doses.
Patients with nocturnal asthma or central nocturnal apnea syndrome can take a single dose of Teotard at night.
Take the drug after meals with plenty of water. Swallow the capsules whole without chewing.
The effectiveness of treatment and tolerability of theophylline should be determined on day 3 of treatment. If the effectiveness of treatment is satisfactory, continue with the prescribed dose, otherwise the dose should be increased. If side effects occur, reduce the dose.
Doses of theophylline should be determined based on the clinical effect, the concentration of theophylline in the serum and possible side effects.
Therapeutic serum concentrations of theophylline are determined in the laboratory. The exact values of theophylline concentration can be obtained by taking blood for analysis 4 hours after the morning dose of a patient taking Teotard 2 times a day, or 12 hours after the evening dose of a patient taking a single daily dose of Teotard.
The drug should not be used in children under 6 years of age or weighing less than 20 kg.
Overdose is observed if the concentration of theophylline in the serum exceeds 110 μmol / l. Severe symptoms may develop 12 hours after an overdose of a sustained-release drug.
Clinical signs of overdose include tremor of the hands (tremor), nausea, epigastric pain, hematemesis, vomiting, diarrhea, pancreatitis, delirium, agitation, anxiety, dementia, toxic psychosis, increased limb reflexes, muscular hypertension, metabolic hypertension, arterial hypertension, arterial hypertension hypokalemia, hypomagnesemia, hypophosphatemia, hypercalcemia, hyperglycemia, rhabdomyolysis, respiratory alkalosis, hyperventilation, acute renal failure, dehydration. Other manifestations of adverse reactions may be exacerbated. In particularly severe cases – cardiac arrhythmias (tachyarrhythmias), ectopic rhythm, a sharp drop in blood pressure, muscle cramps and may even develop coma. Tachyarrhythmias and convulsions may occur suddenly without the warning signs typical of a minor overdose (eg, nausea and vomiting). In most cases, it is sufficient to reduce the dose or temporarily discontinue the drug Teotard.
After taking an excessive number of capsules, hypotension, anxiety, tremor, delirium, convulsions and dangerous heart rhythm disorders may occur. In such cases, the serum concentration of theophylline should be determined immediately and the dose of Teotard reduced accordingly.
The use of activated charcoal and gastric lavage in case of taking too high a dose for 1-2 hours. Repeated use of activated charcoal may increase the excretion of theophylline. You can use osmotic laxatives. In severe cases, the excretion of theophylline can be accelerated by hemosorption or hemodialysis. Serum potassium levels should be determined immediately, and blood levels monitored until hypokalaemia is resolved. Excessive potassium should be avoided due to the possibility of severe hyperkalaemia during rehabilitation. With low serum potassium, magnesium levels should be determined as soon as possible. Renal and cardiac function (ECG) should be monitored.
In the treatment of ventricular arrhythmias, the use of antiarrhythmic drugs that have anticonvulsant effects, such as lidocaine, should be avoided due to the risk of seizures or exacerbations.
If a severe overdose is suspected, plasma theophylline levels should be monitored until the level returns to normal. Antiemetics such as metoclopramide or ondansetron should be used to relieve vomiting.
At tachycardia with adequate cardiac output it is better not to apply treatment. In severe cases, β-blockers may be used for patients who do not suffer from bronchial asthma. Intravenous use of diazepam and elimination of hypokalemia as causes are indicated for seizure control.
Adverse reactions are usually observed at plasma concentrations of theophylline> 20 μg / ml. Side effects are reduced by reducing the dose of the drug.
At the beginning of treatment, mild and mostly temporary side effects may occur:
- From the immune system: allergic reactions (rash, itching), hypersensitivity reactions, including angioneurotic edema, anaphylactic reactions, bronchospasm.
- From the psyche: increased excitability, irritability, dizziness, insomnia.
- From the nervous system: headache.
- From the heart: rapid heartbeat or an unpleasant sensation of palpitations (palpitations).
- From the gastrointestinal tract: abdominal pain, heartburn, nausea, vomiting, diarrhea, stimulation of gastric acid secretion.
If the concentration of theophylline in the serum exceeds therapeutic levels (in hypersensitive patients even earlier), the following side effects may occur:
- From the psyche: delirium.
- From the nervous system: sleep disturbances, trembling hands (tremor), irritability, anxiety, restlessness, agitation, confusion, delirium, convulsions.
- From the heart: cardiac arrhythmia (tachyarrhythmia), chest pain, tachycardia, cardialgia, increased frequency of angina attacks, extrasystole (ventricular, supraventricular), heart failure.
- From vessels: sharp decrease in arterial pressure.
- From the gastrointestinal tract: repeated vomiting, increased gastroesophageal reflux at night (due to decreased tone in the lower esophageal sphincter), with prolonged use – decreased appetite / anorexia, exacerbation of peptic ulcer disease.
- From the skin and subcutaneous tissue: exfoliative dermatitis, urticaria.
- From the musculoskeletal and connective tissues: rhabdomyolysis, muscle spasms.
- From the urinary system: increased diuresis, urinary retention.
- General disorders: fever, metabolic acidosis, fever and facial flushing, sweating, weakness, shortness of breath.
- Studies: hypokalemia and / or hyperkalemia, hyperglycemia and hyperuricemia, hypercalcemia, acid-base imbalance.
Store at a temperature not exceeding 30 ° C. Keep out of reach of children.