$5.10
Manufacturer: Bulgaria
Chronic obstructive pulmonary disease, bronchial asthma, pulmonary emphysema, central sleep apnea syndrome.
Description
Teotard (theophylline) tablets with prolonged release 300 mg. №50
Composition
active substance: theophylline
1 prolonged-release tablet contains 300 mg of theophylline;
Excipients: methacrylate copolymer dispersion, polyacrylate dispersion, microcrystalline cellulose, talc, magnesium stearate.
Dosage form
Prolonged-release tablets.
Main physical and chemical properties: round tablets of the correct shape, 10 mm in diameter with a chamfer and a notch on one side, white.
Pharmacotherapeutic group
Other drugs for systemic use in obstructive airways diseases. Xanthini.
ATX code R03D A04.
Pharmacological properties
Theophylline’s mechanism of action includes:
- inhibition of the enzyme phosphodiesterase, causing an increase in cAMP levels;
- antagonism towards adenosine receptors;
- inhibition of intracellular calcium release;
- stimulating the release of catecholamines;
- anti-inflammatory effect, which is achieved by inhibiting the activity of T-lymphocytes, eosinophils and neutrophils.
Teotard tablets has two distinct effects on the airways in patients with reversible obstructive disease: relaxes smooth muscle (bronchodilation) and inhibits airway response to stimulation (non-bronchodilating anti-inflammatory prophylactic effect).
Indications
Symptomatic treatment and prevention of bronchial asthma, chronic bronchitis and pulmonary emphysema.
Contraindications
Hypersensitivity to theophylline, other xanthine derivatives (caffeine, pentoxifylline, theobromine) or to any of the excipients; epilepsy; glaucoma; porphyria; the simultaneous use of theophylline and ephedrine in children; acute period of myocardial infarction, acute cardiac arrhythmias (acute tachyarrhythmia), severe arterial hypertension, hyperthyroidism, gastric ulcer and duodenal ulcer in the acute stage, severe liver dysfunction.
Application during pregnancy or lactation
Pregnancy. Theophylline crosses the placental barrier. There are no adequate data from well-controlled studies of pregnant women. It is not recommended to prescribe the drug during pregnancy because its safety has not been proven.
The use of the drug during pregnancy is possible only if there are strict medical indications, careful calculation of the dose and monitoring the condition of the mother and fetus, since theophylline at the end of pregnancy can inhibit uterine contraction.
Lactation. Theophylline passes into breast milk and may cause increased irritability in the newborn. Its use by nursing mothers is allowed only if the intended benefit to the mother outweighs the risk to the newborn.
Method of administration and dosage
The drug Teotard tablets is administered orally 30-60 minutes before meals or 2 hours after meals, drinking plenty of fluids. The 300 mg tablet can be divided in half, but should not be crushed, chewed or dissolved in water. In some cases, to reduce the irritating effect on the gastric mucosa, the drug should be taken during or immediately after a meal.
The dosage regimen is set individually depending on the age, body weight of the patient and the peculiarities of metabolism.
Adults and children over 12 years of age weighing more than 45 kg.
The initial daily dose is 300 mg divided into 2 doses (with an interval of 12 hours). After 3 days, in the absence of serious side effects, the dose can be increased to 600 mg per day, also divided into 2 doses (1 tablet of 300 mg 2 times a day).
Dose escalation is possible only with good tolerability.
Children
The drug Teotard tablets should not be used to treat children under 12 years of age.
Overdose
Severe intoxication may be caused by doses above 3 g in adults (40 mg / kg in children). The lethal dose may be at least 4.5 g in adults (60 mg / kg in children), but it is usually higher.
Symptoms: Severe symptoms may develop 12 hours after an overdose of sustained release dosage forms.
Digestive symptoms: nausea, vomiting (often severe), diarrhea, epigastric pain and haematemesis. If abdominal pain persists, it may be pancreatitis.
Neurological symptoms: anxiety, tremor, muscular hypertension, increased limb reflexes and convulsions, delirium. Coma can develop in very severe cases.
Symptoms of the cardiovascular system: sinus tachycardia is a common reaction, ectopic rhythm, supraventricular and ventricular tachycardia, a sharp decrease in blood pressure, hypotension.
Symptoms of metabolic disorders: hypokalaemia (due to the transition of potassium from plasma to cells), which can develop rapidly and in severe form. Hyperglycaemia, hypomagnesaemia, metabolic acidosis and rhabdomyolysis may occur.
Side effects:
- Adverse reactions are usually observed with plasma theophylline concentrations> 20 μg / ml. In most cases, they disappear with the use of lower doses.
- Based on the long-term use of theophylline, the following side effects are described, presented by systemic organ classes:
- From the immune system: hypersensitivity, anaphylactic and anaphylactoid reactions.
- From the side of metabolism and nutrition: hyperuricemia, hypokalemia and / or hypercalcemia, hyperglycemia, metabolic acidosis, rhabdomyolysis.
- Mental disorders: agitation, insomnia, especially in children; anxiety, delirium.
- From the nervous system: headache, tremors, confusion, convulsions, irritability, dizziness, sleep disturbances.
- From the gastrointestinal tract: abdominal pain, stomach irritation, gastroesophageal reflux, nausea, vomiting, anorexia, occasional diarrhea, stimulation of gastric acid secretion.
- From the heart: palpitation, arrhythmia, tachycardia.
- From the side of the vessels: lowering blood pressure.
- From the side of the kidneys and urinary tract: increased urine output, especially in children, urinary retention in elderly men.
- Skin and subcutaneous tissue disorders: itching, rash, urticaria, exfoliative dermatitis.
- General disorders: fever, fever, weakness.
The observed adverse reactions in most cases depend on the dose and can be avoided through accurate calculation and individualization of the dosage.
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