Teotard 40s 200 mg capsules retard

The instruction for medical use

of TEOTARD medicine

the Trade name
of TEOTARD

the International unlicensed


name Theophylline Dosage Form
of the Capsule with the prolonged release of 200 mg or 350 mg

Ingredients:
One capsule contains
active agent – theophylline of anhydrous 200 mg or 350 mg,
excipients: povidone, talc, copolymer of ammonia of methacrylate, silicon dioxide colloidal, dibutyl phthalate,
structure of a cover of the capsule: the titan dioxide, dye quinolinic yellow, an azoruby, dye crimson, dye patent blue, diamond black, marked hydroxybenzoate, spent on drink hydroxybenzoate, gelatin.

The description
of the Capsule, filled with granules of white color. A capsule body – transparent dark green color, a capsule cover – opaque dark green color.

Pharmacotherapeutic group
Drugs for treatment of bronchial asthma. Other drugs for treatment of bronchial asthma for system use. Xanthine derivatives.
The code of automatic telephone exchange



the Pharmacological

Pharmacokinetics Later properties of oral administration Teotard is almost completely soaked up by R03DA04. The slowed-down release of active ingredient from retard-capsules of the drug Teotard provides maintenance of uniform level of theophylline in blood serum within 12 hours. Broncholitic action of Teotard develops gradually therefore drug is not appointed for stopping of medical emergencies. After one-time reception of 350 mg of drug, within 6.3-8.8 hours the maximum concentration in plasma which makes 4.4 tsg/ml is reached it. Therapeutic concentration is reached in several days and it makes 8-20 tsg/ml. Teotard is metabolized generally by means of microsomal enzymes of a liver.
The pharmacodynamics
Teotard represents pure anhydrous theophylline (derivative xanthine) in the form of granules. Theophylline belongs to phosphodiesterase inhibitors, increases accumulation in fabrics ts-AMF that reduces sokratitelny activity of smooth muscles. Drug possesses the significant broncholitic action, prevents or eliminates bronchial obstruction. Improvement of function of lungs allows to increase supply of arterial blood with oxygen that leads to decrease in concentration of CO2.
Teotard has promoting effect on a respiratory center, reduces pulmonary vascular resistance, lowers pressure in a small circle of blood circulation, improves mukotsiliarny clearance, possesses positive inotropic and chronotropic action on heart. Drug stimulates a diuresis. Expands blood vessels (mainly vessels of a brain, skin and kidneys), utnetat aggregation of thrombocytes.

Indications
- treatment and prevention of a reversible bronkhoobstruktion in
bronchial asthma, chronic obstructive bronchitis, emphysema
of lungs
- pulmonary hypertensia at a chronic pulmonary heart
- night disturbances of breath of the central genesis.

The route of administration and doses
of the Capsule of drug cannot be opened or chewed.
The dosage of drug is individual. To inadmissibly exceed a daily dose of 15 mg/kg at adults, children have 20 mg/kg. For selection of a dose of drug it is necessary to define concentration of theophylline in blood serum. As a rule, concentration of theophylline in blood serum from 10 to 15 tsg/ml provides therapeutic action at minimal risk of development of side effects. If concentration exceeds 20 tsg/ml, then the dose of drug should be reduced. During the first three days it is necessary to accept on one retard-capsule of drug each 12 hours. For the third day it is necessary to estimate efficiency of therapy and tolerance of drug. At insufficient efficiency the dose can be increased. In case of undesirable by-effects the dose should be reduced.
Teotard of 200 mg is appointed to children whose body weight exceeds 20 kg, as well as the adult with low body weight. Teotard of 350 mg is appointed to adults and children whose body weight exceeds 40 kg. Morning and evening doses of drug can be various depending on time of emergence of attacks of the complicated breath, from a clinical picture of a disease and efficiency of therapy.

Side effects
the Frequency of emergence of by-effects increases with a uvelichenima of concentration of drug in blood serum
- pain in a stomach, nausea, vomiting, diarrhea
- a headache, insomnia, a tremor, irritability,
- disturbance of a warm rhythm, tachycardia,
a lowering of arterial pressure, increase of attacks of stenocardia
- strengthening of a diuresis, a hyperglycemia, a hypopotassemia
- skin rash,

naggers Protivopokazaniya
- hypersensitivity
- epilepsy
- an acute myocardial infarction, acute disorders of a rhythm (tachyarrhythmia) - a peptic ulcer of a stomach and duodenum in
an aggravation stage
- children's age up to 3 years

Medicinal interactions
Theophylline do not apply to theophylline together with other derivatives xanthine. In a combination with phenobarbital, dipheninum, rifampicin, an isoniazid, carbamazepine, Sulfinpyrazonum, Phenytoinum the decrease in efficiency of theophylline is observed that increase in the applied drug doses can demand. At simultaneous use with antibiotics of group of macroleads, lincomycin, Allopyrinolum, Cimetidinum, izoprenaliny, oral contraceptives, epoksatsiny and at vaccination against flu the intensity of action can increase that can demand a theophylline dose decline. Drug suppresses therapeutic effects of lithium carbonate and beta blockers. Theophylline exponentiates effect of diuretics due to increase in glomerular filtration and reduction of a kanaptsevy reabsorption. With care theophylline is appointed along with anticoagulants.

Special instructions
Drug is not recommended to be used in the profound arterial hypertension, widespread atherosclerosis of vessels. With care it is necessary to apply in heavy stenocardia, heart failure, serious violations of a warm rhythm, hypertrophic cardiomyopathy, a hyperthyroidism, the profound abnormal liver functions and kidneys.
In a serious illness of a cardiovascular system, a liver, viral infections and also at patients of advanced age the dose of drug should be reduced. To persons, at whom theophylline is exposed to fast metabolism (persons of young age, smokers), one-time administration of drug in day will be insufficient.
Pregnancy and a lactation
the Drug should be taken only when the expected advantage for mother exceeds risk for a fruit, it is impossible to accept at the end of pregnancy as it can stop reduction of a uterus. It is allocated with breast milk, in case of emergence in the child of signs of sensitivity or insomnia it is necessary to consult with the doctor.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug can have negative impact on psychomotor reactions therefore it is recommended to be careful at control of vehicles and work with potentially dangerous mechanisms.

Overdose
Symptoms: tremor of hands, nausea, vomiting, diarrhea, psychomotor excitement, disturbance of a warm rhythm, lowering of arterial pressure, muscular spasms.
Treatment: symptomatic treatment. Gastric lavage, intake of activated carbon.

A form of release and packing
On 10 capsules in the blister. 4 blisters in cardboard packing together with the instruction for use.




To Store storage conditions at a temperature up to 25 °C, in the place protected from light and moisture. To store out of children's reach!

A period of storage
of 5 years
Drug should not be used after the expiry date specified on packing.

Prescription status
According to the prescription

the Producer
KRK, of, the place, Slovenia
in cooperation with Astellas Pharm GmbH, Germany Is new