Teotard (theophylline) capsules with prolonged release 200 mg. №40

Description

Teotard (theophylline) capsules with prolonged release 200 mg. №40

Composition

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).

Dosage form

Prolonged-release capsules.

Main physical and chemical properties: the capsule body is transparent, green; capsule lid opaque, green. The capsules are filled with white granules.

Pharmacotherapeutic group

Means for systemic use in obstructive airways diseases.
ATX code R03D A04.

Pharmacological properties

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.

Indication

Chronic obstructive pulmonary disease, bronchial asthma, emphysema, central nocturnal apnea syndrome.

Contraindication

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.

• Adult and elderly patients
  The usual maintenance dose is 200 mg twice daily. In more severe cases, the dose may be increased to 400 mg 2 times a day.
• Children
  The usual dose for adolescents is 200 mg 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 in 2 doses.

Theophylline is poorly distributed in body fat, so to calculate the dose in mg / kg should take dry (excluding fat deposits) body weight.

Patients with nocturnal asthma or central nocturnal apnea syndrome may receive a single dose of Teotard at night.

Take the medicine 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, the dose should be reduced.

Doses of theophylline should be determined based on clinical effect, serum theophylline concentration 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 capsules 2 times a day, or 12 hours after the evening dose of a patient taking a single daily dose of Teotard capsules.

Children

The drug should not be used in children under 6 years of age or weighing less than 20 kg.

Overdose

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 capsules reduced accordingly.

Side effects:

• 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.