Theotard
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Teotard is a bronchodilating drug with a moderately pronounced diuretic effect, which helps to relax the muscles of the bronchi and blood vessels, improves the function of the intercostal and respiratory muscles and has a stimulating effect on the activity of the heart and the respiratory center.
Release form and composition
The dosage form of Teotard's release - capsules of prolonged action: hard gelatinous, size No. 2 or No. 1 (200 or 350 mg, respectively); body - dark green, transparent; cover - dark green, opaque; the capsules contain white pellets (10 pcs. in blisters, 3 or 4 packages in a cardboard box).
Composition of 1 capsule:
- active substance: theophylline - 200 or 350 mg;
- auxiliary components: talc, dibutyl phthalate, anhydrous colloidal silicon dioxide, povidone, ammonium methacrylate copolymer type B, ammonium methacrylate copolymer type A;
- shell: gelatin, titanium dioxide (E171), quinoline yellow dye (E104), indigo carmine dye (E132).
Indications for use
- broncho-obstructive syndrome of any genesis, including bronchial asthma, chronic obstructive bronchitis and chronic obstructive pulmonary disease;
- sleep apnea (nocturnal breathing disorders of the central genesis);
- cor pulmonale, pulmonary hypertension.
Contraindications
Absolute:
- arterial hypo- or hypertension in severe course;
- acute myocardial infarction;
- hemorrhagic stroke;
- severe arrhythmias;
- retinal hemorrhage;
- epilepsy;
- peptic ulcer of the stomach and duodenum in the acute stage, gastritis with high acidity, bleeding from the gastrointestinal tract;
- age up to 6 (200 mg capsules) or up to 12 years (350 mg capsules);
- individual intolerance to the components of the drug, including hypersensitivity to other xanthine derivatives (pentoxifylline, caffeine, theobromine).
Relative (the appointment of Theotard requires caution in the presence of the following diseases / conditions):
- uncontrolled hypothyroidism or thyrotoxicosis;
- common vascular atherosclerosis;
- porphyria;
- increased convulsive readiness;
- impaired hepatic / renal function in severe course;
- unstable angina (severe coronary insufficiency);
- chronic heart failure;
- bleeding from the gastrointestinal tract, transferred recently;
- hypertrophic obstructive cardiomyopathy;
- frequent ventricular premature beats;
- gastroesophageal reflux;
- hypertrophy of the prostate;
- prolonged hyperthermia;
- burdened history of gastric ulcer and duodenal ulcer;
- pregnancy and lactation period (Teotard is prescribed to pregnant women only after assessing the ratio of the expected benefit to the possible risk; if possible, it is recommended to control the serum concentration of theophylline more often and adjust the dose; in the third trimester of pregnancy, the use of the drug is not recommended, since therapy can lead to a decrease in uterine contractility. women are advised to strengthen control of the condition of the newborn; in cases of sleep disturbances and irritability, it is recommended to consult a specialist);
- children and elderly (from 60 years old) age.
Method of administration and dosage
Teotard is taken orally with a sufficient amount of liquid, without chewing or opening the capsules, after eating.
The doctor determines the dosage regimen individually based on the nature of the disease, the weight and age of the patient, as well as the serum concentration of theophylline in the blood. In most cases, to ensure a therapeutic effect, it should be in the range of 0.01–0.015 mg / ml, while maintaining a minimal likelihood of adverse reactions. This indicator should be monitored every 6–12 months of therapy, if the serum theophylline concentration in the blood is more than 0.02 mg / ml, the dose is reduced.
Do not exceed the maximum daily dose:
- adults: 15 mg / kg in 2 divided doses with a 12-hour break;
- children: 20 mg / kg.
The first 3 days of therapy are taken every 12 hours, 1 capsule (200 or 350 mg), after evaluating the efficacy / tolerance ratio, it is possible to increase the dose to the maximum or decrease it.
The size of a single dose for administration in the morning and in the evening is set depending on the time of onset of attacks of shortness of breath, the effectiveness of treatment and the clinical picture of the disease.
Criteria for choosing the dosage form of Theotard (capsules of 200 or 350 mg):
- 200 mg: children weighing from 20 kg, adults with low body weight;
- 350 mg: adults and children weighing 40 kg.
Average maintenance dose for adults weighing 60 kg: 2 times a day, 1 capsule 350 mg.
Features of the appointment of therapy for adults:
- non-smoking patients weighing over 60 kg: the initial dose is 350 mg once a day in the evening; in the future, the dose is increased to 2 capsules of 350 mg in 1 dose in the evening;
- smoking patients and patients with increased metabolism: the initial dose is 350 mg once a day; in the future, the dose is increased to 3 capsules (350 mg in the morning and 700 mg in the evening);
- patients with reduced clearance: initial dose - once a day, 200 mg; after 2 days, the dose is increased to a maintenance dose - 400 mg once a day in the evening; with a body weight of up to 60 kg, the dose is left at the initial level.
The average frequency of taking the drug for children 6-12 years old (single dose - 1 capsule of 200 mg):
- 6–8 years old with a body weight of 20–30 kg: 2 times a day;
- 8–12 years old with a body weight of 30–40 kg: 3 times a day.
Children 12-16 years old with a weight of 40-60 kg Teotard is prescribed in capsules of 350 mg with a frequency of administration 2-3 times a day (daily dose - 700-1400 mg).
The full effect of the drug appears 3-4 days after the start of the course.
Side effects
- digestive system: gastroesophageal reflux, exacerbation of peptic ulcer disease, heartburn, abdominal pain, nausea, diarrhea, vomiting; with a long course - decreased appetite;
- cardiovascular system: lowering blood pressure, cardialgia, palpitations, tachycardia (including in the fetus, if a woman takes Teotard in the third trimester of pregnancy), an increase in the frequency of angina attacks, arrhythmias;
- central and peripheral nervous system: insomnia, vertigo, agitation, tremor, anxiety, irritability, dizziness, headache;
- laboratory parameters: hematuria, albuminuria, hypercalcemia and / or hypokalemia, hyperuricemia and hyperglycemia;
- allergic reactions: itching, skin rash, fever;
- others: increased urine output, chest pain, tachypnea, increased sweating, sensation of hot flushes on the face.
Adverse reactions are usually dose-dependent in nature, the frequency of their occurrence increases with a serum theophylline concentration in the blood of more than 0.02 mg / ml.
special instructions
It is recommended to take the drug to patients with a fast metabolism (young patients, smoking patients) 2 times a day.
Theotard in reduced doses is prescribed in the presence of the following diseases / conditions: combined use with certain drugs, viral infections (especially influenza), fever, pneumonia, thyroid hyperfunction, heart and liver failure (especially liver cirrhosis), old age.
During therapy, some laboratory results may change, namely, an increase in the content of fatty acids and the level of catecholamines in the urine.
Drinking alcohol or large amounts of foods / drinks containing methylxanthines, including tonic drinks, coffee, cocoa, tea, chocolate, Coca-Cola and similar drinks, is not recommended, since in this case, the potentiation of the stimulating effect of theophylline on the central nervous system is observed.
Drug interactions
With the combined use of Teotard with some drugs / substances, the following effects may develop:
- other xanthine derivatives: development of interaction (the combination is not used);
- enterosorbents and drugs with antidiarrheal action: decreased absorption of theophylline;
- glucocorticosteroids, mineralocorticosteroids, general anesthetics, drugs that excite the central nervous system: an increase in the likelihood of adverse reactions, including hypokalemia, hypernatremia, ventricular arrhythmias, neurotoxicity;
- lithium carbonate, beta-blockers, adenosine: suppression of their therapeutic effects;
- antibiotics of the macrolide group, lincomycin, allopurinol, cimetidine, fluoroquinolones, disulfiram, phenylbutazone, fluvoxamine, imipenem, paracetamol, probenecid, ranitidine, tacrine, thiabendazole, recombinant interferon alfa, methotrexate, propenedene, mexilephene-containing contraceptives, phenobarbital, pentobarbital, magnesium hydroxide, moracizin, ritonavir or sulfinpyrazone, rifampicin, isoniazid, carbamazepine, primidone, sulfinpyrazone, aminoglutethimide, phenytoin, enoxacin, viloxazine, consummation, as well as an increase in the intensity of vaccination against its action by 30-60%;
- blockers of alpha-adrenergic receptors, thiazide diuretics, furosemide: an increase in the likelihood of hypokalemia;
- beta-adrenostimulants, reserpine, diuretics: potentiation of their action (due to a decrease in tubular reabsorption and an increase in glomerular filtration).
Theotard can be taken simultaneously with antispasmodics.
Terms and conditions of storage
Store in a dark and dry place at temperatures up to 25 ° C. Keep out of the reach of children.
The shelf life is 5 years.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!