Prolonged theophylline preparations. Theophylline and possible contraindications are used. heartburn, nausea, vomiting, epigastric pain, diarrhea, gastroesophageal

01.09.2020 Complications

Theophylline (Theophyllinum Lat.) - Pyrin derivative, alkaloid, adenosinergic agent, known as the CNS stimulator with antispasmodic, bronchodular, anti-asthma, cardiotonic and pronounced diuretic properties.

This derivative of Pyrin is produced in a well-packed container that protects the main active substance - theophylline - from the direct effect of light.

Forms of issue of theophylline:

  • pills oral theophylline anhydrous - (100 mg, 200 mg); depot (200 mg, 300 mg); retard (100 mg, 250 mg);
  • powder in capsules - (50 mg, 75 mg, 100 mg, 125 mg, 200 mg, 300 mg);
  • rectal candles 0.2 g;
  • syrup (elixir) (15 ml - 80 mg).

Tablets Theophylline

The theophylline tablets of anhydrous (flat-cylindrical with fistal) are covered with soluble shell, and can be released without it. Packs in blisters (cellular packaging) and plastic container jars.

Active substance in one tablet - from 100 to 300 mg.

"Depot" and "Retard" - not the name of the tablets! This is a pressed form of theophylline powder, containing the main drug substance theophylline. The stomach dissolves in the stomach, allowing the medicine to enter the body gradually, dosage is a prolonged form of drug production. Depono (lat.) - postpone, Retardo (lat.) - slow down.

This form is most attractive for the patient, since it provides a stable concentration of the medicinal substance in the body, facilitates the load on the gastrointestinal tract and significantly reduces the negative consequences if the drug was not adopted on time or they forgot about it at all.

Capsule and powder form of the drug

Inspection capsules of anhydrous theophylline - a drug of modified action, that is, combining the speed of the offensive therapeutic effect and the duration of exposure.

Theophylline powder is packed in a solid gelatin shell, having 3 colors, for simplicity of determining the amount of medicinal substance. So:

  • white-pink capsule (white or colorless housing and pink cover) - 100 mg;
  • white-blue capsule - 200 mg;
  • capsule No. 1 White-green - 300 mg.

Suppositories Theophylline

Rectal candles Theophylline - suppositories contain theophylline 0.2 g, the rest is the fat basis in which the drug is spread evenly.

Such bases melt under the action of body temperature, providing maximum availability of a medicinal substance through a mucous membrane, having the ability to easily move from a solid state into a liquid, bypassing the "masking" state.

Theophylline suppositories are least toxic, almost not cause allergies, dissolve within an hour. One package contains 10 per rectum-candles with theophylline.

Syrup

Teophyllin syrup

Theophylline in the form of elixir is often called "syrup". Elixir Theophyllinum has a trade name - Theophylline Ki. Generic (international) Name Complicated - Theophylline / Potassium iodine (Teophyllin-potassium Iodide). It is called syrup because of the large sugar content in orange solution and a pleasant orange-citrus taste and smell for children.

This elixir has a significant advantage among other forms of the production of theophylline - it is available for the use of kids from 1 year, when as other forms - not earlier than 6 or 12 years.

Pharmacological effects of theophylline drugs

Since the drug Theophylline is alkaloid, its largest content in the leaves of tea and grain coffee. It is known that the effect of this substance is the expansion of the coronary vessels of the heart, relaxation of the muscles of the bronchi, the excitation of the nervous system and a diuretic action.

Nowadays, such a derivative of Pyrin and Xanthina receive synthetically, which made theophylline available for everyone.

The use of alkaloids in medicine:

  • Improving coronary blood circulation with angina and chronic coronary failure.
  • For stagnation Cardiac and renal blood circulation - edema.



Theophylline, in combination with other drugs, perfectly copes with all these tasks. For example, strengthens the alignment of edema in combination with cardiac means. The effect is obtained higher than from theobromine (cocoa bean alkaloid). And in a pair with applied to treatment bronchial asthma with bronchospasms.

Strengthening MCC (Mukicillary clearance) due to the stabilization of the membrane of the fat cells, theophylline affects:

  • on the functions of respiratory and interrogrocal muscles, increasing the reductions of the diaphragm;
  • stimulating the respiratory center - normalizes breathing, reinforces the release of adrenaline adrenaline.

This contributes to the saturation of blood oxygen and other organs, reduces the concentration of carbon dioxide and increases the ventilation of the lungs.

In turn, such an action has a positive-stimulating effect on the heart, increasing the strength and frequency of heart abbreviations, ensuring the flow of oxygen into myocardium.

Effect of application:

  • decreases tone blood vessels brain, kidneys (diuretic effect) and skin;
  • the resistance of pulmonary vessels is reduced;
  • reduced the contractile activity of the smooth muscles of the bronchi;
  • reduced pressure in a small circulation circle;
  • improves the apparent function of the left and right heart ventricles.




Theophylline is used as a primary preparation (with broncho-prestructive syndrome), and as an aid with other diseases (swelling syndrome of renal genesis).

Indications for the use of theophylline

The main directions of application of tablets, capsules and candles 1,3-dimethylksanthin (chemical name of theophylline):







Indications for the use of Teofillin Ki elixir for children under 3 years: Category PBX - bronchhalytic and (musolitic, bronchodiators).

In the packaging of the drug of any form of release placed instructions, with detailed description the drug itself and recommendations for its use, other helpful informationwhich is important to explore, before starting treatment.

Method of application and dosage of the drug

Theophylline is released from pharmacies for a doctor's prescription.

This is associated with an individual for each patient approach in calculating the dose and confidence of the doctor, after passing certain analyzes, in the tolerant of tolerance of the drug.

Generally accepted doses of theophyllinum are as follows:

  • the initial dose should not exceed 400 mg of 1,3-dimethylksanthin per day;
  • the dosage can smoothly increase by 25% for 3 days;
  • when the therapeutic effect is achieved (4-5 days), it is desirable to stop increasing.

Stop or continue using the doctor must decide.

Dosage of theophylline in blood plasma, which should not be exceeded by mg / kg per day:

  • from 20 to 25 kg - 24 mg / kg;
  • from 24 to 32 kg - 20 mg / kg;
  • from 50 to 70 kg - 18 mg / kg;
  • from 70 - 13 mg / kg.

Intolerance to the derivatives of Pyrin, stroke, heart attack, hemorrhage (including ulcerative disease), atherosclerosis coronary arteries, Pregnancy and lactation.

Side effects medication

Most often observed:

  • violation of consciousness and vision;
  • anxiety;
  • convulsions;
  • attacks of angina, arrhythmia, tachycardia;
  • sore throat;
  • atonia;
  • allergic reactions.






Analogs and trade names of the drug:

  • Afonilaum;
  • Sphophyllin retard;
  • Teobiolong;
  • Theodil;
  • Ventax;
  • Uni-dy
  • Unilla;
  • Diffum;
  • Sphophylline;
  • Retrail.

Theophylline has a number of generics - so usually referred to the medications for which the official term of the patent (patent protection) is exposed.

Generics are famous for lower price compared to patent preparations, but the price of theophylline is without that low (about 200-300 rubles per pack).

Instructions for medical application

drug

Teophylline

Tradename

Teophylline

International non-proprietary title

Dosage form

Prolonged Release Capsules 350 mg

Structure

One capsule contains

active substance- Theophylline Pellet 500.0 mg

(equivalent to theophylline 350.0 mg),

excipients:talc,

the composition of gelatin capsules: Gelatin, titanium dioxide (E 171).

Description

Solid gelatin capsules: housing and white lid. Size capsule №0. Content capsules - white or almost white pellets.

Pharmaco.therapeuti.chery group

Preparations for the treatment of obstructive diseases respiratory tract.

Other preparations for the treatment of obstructive respiratory diseases for system use. Xanthines. Teophylline

ATH code R03DA04

Pharmacological properties

Pharmacokinetics

When taking inside theophylline quickly and completely absorbed from the gastrointestinal tract.

The maximum concentration in the blood plasma after taking the drug is reached after 4-8 hours. Theophylline bioavailability is approximately 90%. Plasma proteins binding - 60%, in patients with liver diseases - 20-40%. Theophylline moderately penetrates the tissue, the distribution volume is about 0.5 l / kg.

Well penetrates through the hematostephalic barrier, placenta and in breast milk.

The duration of preservation of the therapeutic concentration in the blood after a disposable drug reception ranges from 4 to 5 hours.

Theophylline is metabolized in the liver with the participation of microsomal enzymes. In the process of metabolism, 1,3-dimethyl ocheric acid, 1-methylmoic acid and 3-methylxanthine are formed. These metabolites are displayed with urine. In unchanged form, 10% of theophylline is removed in adults.

The half-life averages 6-12 hours.

Theophylline clearance decreases in elderly people, patients with impaired liver function, heart failure.

Pharmacodynamics

The mechanism of the drug is to block the phosphodiesterase enzyme, which leads to an increased accumulation of CAMF, blocking adenosine receptors, stimulating the synthesis of endogenous catecholamines, inhibition of intracellular calcium release, which leads to a decrease in the contractile activity of the smooth muscles.

Relaxes the muscles of the bronchi, blood vessels (mainly of the vessels of the brain, leather and kidney); It has a peripheral vasodilant action, increases the renal blood flow, has a moderately pronounced diuretic effect.

Theophylline, expanding the pulmonary vessels, reduces the pressure in a small circle of blood circulation (reduces transient hypertension in a small circle of blood circulation during an attack of bronchial asthma), improves the pump function of the right and left ventricles of the heart.

Stabilizes the membrane of the fat cells, inhibits the release of inflammation mediators, increases mukiciliary clearance.

It has a stimulating effect on the respiratory center, which leads to increased ventilation of the lungs due to an increase in the contractile ability of intercostal muscles and diaphragms.

Indications for use

- Broncho-constructive syndrome with bronchial asthma, chronic obstructive bronchitis, lung emphysema

- Lung hypertension in chronic pulmonary heart

Method of application and dose

The drug is used inward, drinking sufficient liquid.

Capsules should be swallowed entirely without opening and not chewing.

The dosing mode is set by an individually attending physician.

The initial daily dose for adults and children over 12 years old with a body weight of more than 45 kgit is 350 mg (1 capsule 1 time per day). The daily dose can be increased 3 days to 700 mg (1 capsule 2 times a day) with good tolerability of the drug. The maximum daily dose should not exceed 13 mg / kg.

In patients with body weight less than 45 kg The daily dose of the drug is 10 mg / kg.

To select the dose of the drug, it is necessary to determine the concentration of theophylline in the blood serum. As a rule, the concentration of theophylline in serum from 10 to 15 μg / ml provides a therapeutic effect with minimal risk of side effects. If the concentration exceeds 20 μg / ml, then the dose of the drug should be reduced.

The effect of the drug is fully manifested in 3-4 days after the start of treatment.

Side effects

- heartburn, nausea, vomiting, epigastric pain, diarrhea, gastroesophageal

reflux, aggravation of ulcer of the stomach and 12-rosis

patients suffering from this pathology

- Headache, dizziness, excitement, insomnia, anxiety, irritability

- tremor hands, cramps

- sinus tachycardia, arrhythmias, arterial hypotension

- Pain in the chest, an increase in the frequency of angina attacks in patients with coronary heart disease

  • increase diurea (especially in children)
  • hypokalemia, hypoglycemia
  • allergic reactions, skin rash, itching, hyperthermia

Contraindications

  • hypersensitivity to theophylline and other xanthine derivatives or other components of the drug
  • joint admission with Ephedrine in children
  • porphyry
  • epilepsy and others facial states
  • myocardial infarction in acute and subacute period, violations heart Rhythm
  • hemorrhagic stroke, hemorrhage in the retina
  • pronounced arterial hyper- and hypotension
  • ulcerative disease of the stomach and 12-rosewood in the stage of exacerbation
  • pregnancy and lactation period
  • childhood up to 12 years old

Medicinal interactions

Theophylline potentials the bronchyolitic effect of beta 2 -adrenomimetics, which allows the use of the latter in smaller doses.

Theophylline increases lithium and pyridoxine clearance with joint appointment, so their effectiveness is reduced at a constant concentration of the drug in the blood plasma.

The concentration of theophylline in the blood may decrease with simultaneous use with phenobarbital, rifampicin, carbamazepine, sulfintizon, phenytino, ritonavir, prison, hormone grass, as well as smoking people.

Plasma concentrations of theophylline can be reduced by simultaneously receiving the Hypericum.

The concentration of theophylline in the blood may increase by simultaneously use with antibiotics from a group of macrolides, allopurinol, beta-adrenobloclars, cimetidine, hormonal oral contraceptives, isoprenaline, lincomycin, ciprofloxacin, orefloxacin, otoniazem, verapamil, furosemide, isoniazide, fluconazole, mexylenetic, conpaphenon, disulfiram , interferon alpha, corticosteroids.

With simultaneous reception with Ketamine, a decline in the convulsive threshold is possible, the doxapprame is an increased stimulation of the CNS, with beta-adrenobloclars - a decrease in the armored effect.

Theophylline can potentiate hypokalemia, due to the action of β 2 -adrenoreceptor stimulants, corticosteroids and diuretics.

The drug should not be applied together with drugs containing xanthine derivatives (caffeine, theobromin, pentoxifillin), fluvoxamine.

special instructions

This dosage form is not intended to buy urgent states.

The treatment is carried out with periodic control of the concentration of theophylline in the blood.

Theophylline should be used with caution in patients with severe coronary insufficiency (angina) common atherosclerosis of the vessels, due to the possible increase in the seizures of angina, the appearance of cardialgies, chronic heart failure, hepatic and / or renal insufficiency, chronic alcoholism, ulcerative stomach disease and duodenal gut (Perhaps the exacerbation), gastritis with increased acidity, hyperthyroidism (due to the possibility of cumulation), hyperthermia, prostate hypertrophy, obstruction urinary tract Due to the possibility of urine delay.

The half-life of theophylline may increase in older people and patients with heart failure, impaired liver function or viral infection. Toxic cumulation can develop, and therefore it is necessary to reduce the dose in elderly patients.

Application in pediatrics

Pregnancy and lactation period

Teophylline penetrates the placental barrier, stands out from breast milk.

During pregnancy teophylline apply only if the estimated benefit for the mother exceeds possible risk For fetal.

If it is necessary to prescribe a drug during lactation, it is recommended to stop breastfeeding.

Features of the influence of the medicinal product on the ability to control the vehicle or potentially hazardous mechanisms

Care should be taken when managing vehicles and working with potentially dangerous mechanisms, taking into account the possibility of dizziness.

Overdose

Symptoms:nausea, vomiting, pain in the epigastria, anxiety, tremor hands, cramps, psychomotor arousal, sinus tachycardia, religious and ventricular extrasystole, decline arterial pressure, hypokalemia, hyperglycemia, hypomagnation, metabolic acidosis, Rabbomioliz, renal failure with myoglobinuria.

Treatment: Cancellation of the drug, washing the stomach, receiving activated carbon, laxatives, elimination of electrolyte imbalance, symptomatic therapy (with vomiting - metoclopramide, ondansetron, to relieve seizures - intravenous diazepams 0.1-0.3 mg / kg).

Release form and packaging

10 capsules in the contour cellular packaging of polyvinyl chloride or imported, and aluminum or imported foil.

On 4 contour cellular packaging, together with the approved medical application instructions in public and Russian, are placed in a pack of cardboard for consumer packaging or chrome-erzats.

Information is allowed from the instructions for medical use in the state and Russian languages \u200b\u200bto be applied to the pack.

Putchs are placed in boxes from cardboard boxes or corrugated.

Storage conditions

Store in a dry, protected from light at a temperature not higher than 25ºС.

Keep out of the reach of children!

Storage term

Do not apply the drug after the expiration date.

Conditions of vacation from pharmacies

On prescription

Manufacturer

JSC "Himfarm", Republic of Kazakhstan,

g. Shymkent, ul. Rashidova, b / n, t / f: 560882

Owner of the registration certificate

JSC "Himfarm", Republic of Kazakhstan

Address of the organization hosting on the territory of the Republic of Kazakhstan consultations from consumers for product quality (product)

JSC "Himfarm", Shymkent, Republic of Kazakhstan,

ul. Rashidova, b / n, t / f: 560882

Telephone number 7252 (561342)

Fax number 7252 (561342)

E-mail address [Email Protected]

| Theophyllinum

Analogs (generics, synonyms)

Bronchofillin, Derkast, Teofil, Aqualin, Asmafil, Lanofillain, Optifflin, Oralfillin, Theoliks, Teofen, Aufillin, Unicontin, Teoek, Neophyllin

Recipe (international)

RP: Theophyllini 0.2
D.T.D: №50 TAB
S: Inside after eating 1 tablet 2 times a day.

Recipe (Russia)

Recipentar Blank - 107-1 /

Active substance

Theophyllinum)

pharmachologic effect

Phosphodiesterase inhibitor, purine derivative. Increases the accumulation in tissues of the CAMF, blocks adenosine (purine) receptors; Reduces the flow of calcium ions through cells of cell membranes, reduces the contractile activity of smooth muscles. Relaxes the muscles of the bronchi, blood vessels (mainly vessels of brain, leather and kidney); It has a peripheral vasodilant action, increases the renal blood flow, has a moderately pronounced diuretic effect.

Stabilizes the membrane of the fat cells, inhibits the release of allergic reaction mediators. Increases mukiciliary clearance, stimulates the diaphragm reduction, improves the function of respiratory and intercostal muscles, stimulates the respiratory center. Normalizing the respiratory function contributes to the saturation of blood oxygen and a decrease in carbon dioxide concentration; Stimulates breathing centers. Enhances the ventilation of the lungs in hypokalemia conditions.

It has a stimulating effect on the activity of the heart, increases the strength of heart abbreviations and heart rate, increases the coronary blood flow and the need of myocardium in oxygen. Reduces the tone of blood vessels (mainly brain vessels, skin and kidney). Reduces pulmonary vascular resistance, lowers pressure in a small circulation circle.

Increases renal blood flow, has a moderate diuretic effect. Expands extrahepatic gallways. Through platelet aggregation (suppresses platelet activation factor and PGE2?), Increases the stability of erythrocytes to deformation (improves the rheological properties of blood), reduces thrombosis and normalizes microcirculation.

Mode of application

For adults: Install individually.
The initial dose is an average of 400 mg / day. Under the condition of good tolerability, the dose can be increased by approximately 25% of the starting every 2-3 days before the optimal achievement therapeutic effect.

Maximum doseswhich can be used without control of the concentration of theophylline in the blood plasma: aged 16 and older - 13 mg / kg / day or 900 mg / day.

If symptoms appear when applying in these doses toxic action Or the need to further increase the dose (due to an insufficient therapeutic effect), it is recommended to control the concentration of theophylline in the blood plasma.
Optimal therapeutic concentrations of theophylline - 10-20 μg / ml.
At lower concentrations, the therapeutic effect is expressed weakly, at large - there is no significant strengthening of therapeutic action, while significantly increases the risk of developing side effects.
The reception frequency depends on dosage form.
For kids: Maximum doses:
children aged 3-9 years - 24 mg / kg / day, 9-12 years - 20 mg / kg / day, 12-16 years - 18 mg / kg / day; the patients

Indications

Broncho-constructive syndrome of various origin: bronchial asthma (the drug of choice for asthma of physical stress and as an additional means with other forms of bronchial asthma)
- COPD (chronic obstructive bronchitis, lung emphysema).
- Lung hypertension
- lonantic Heart
- Entry of kidney genes syndrome (as part of combined therapy), night apnea.

Contraindications

Epilepsy, ulcerative ulcer of the stomach and duodenum in the exacerbation phase
- gastritis with increased acidity, recent bleeding from the gastrointestinal tract
- severe arterial hyper- or hypotension
- Heavy tachyrhythmia
- Hemorrhagic stroke
- hemorrhage in retina eye
- children's age (up to 3 years, for prolonged oral forms - up to 12 years)
- increased sensitivity to theophylline and to other xanthine derivatives (caffeine, pentoxyphylin, theobromine).

Side effects

From the CNS: dizziness, headache, insomnia, excitement, anxiety, irritability, tremor.

From side of cardio-vascular system: heartbeat, tachycardia (including fetal when taking in the third trimester), arrhythmias, decreased blood pressure, cardialgia, increasing the frequency of angina attacks.

From side digestive system: gastralgy, nausea, vomiting, gastroesophageal reflux, heartburn, aggravation peptic disease, diarrhea, during long-term reception - decreased appetite.

Allergic reactions: Skin rash, itching, fever.

Others: Breast pain, tachipne, feeling of tides to face, Albuminuria, hematuria, hypoglycemia, strengthening diuresis, increased sweating.
Side effects decrease with dose reduction.

Form release

Tab. Prolongir. Actions 100 mg: 20, 30 or 50 pcs.
Release form, composition and packaging\u003e Tablets of prolonged action 1 tab.
theophylline 100 mg
10 pieces. - Packaging cell contour (5) - packs cardboard.
10 pieces. - Packaging cell contour (2) - packs cardboard.
10 pieces. - Packaging cell contour (3) - packs cardboard.
20 pcs. - Polymeric banks (1) - packs cardboard.
30 pcs. - Polymeric banks (1) - packs cardboard.
50 pcs. - Polymeric banks (1) - packs cardboard.

ATTENTION!

Information on the page you will be viewed exclusively for informational purposes and does not promote self-treatment. The resource is intended to familiarize health officers with additional information about certain medicines, thereby increasing their level of professionalism. The use of the drug "" necessarily provides for advice with a specialist, as well as its recommendations for the method of application and dosage of the medicine you have chosen.

Theophylline (Table Prolongung.200 mg N50) Russia Valentine Pharmaceuticals OJSC

LSR-001948 / 09.NNN Theophylline &
Trade name Teophylline
Rosurur LSR-001948/09
Registration date 03/13/2009.
Date of cancellation
Manufacturer Valen Pharmaceutical OJSC - Russia

Packaging:
No. P / n Packaging ND EAN
1 Tablets of prolonged action 100 mg 10 pcs., Packaging Cell Contour (5) - Putters Cardboard FSP 42-0055-0128-06 4602193003613
2 tablets of prolonged action 200 mg 10 pcs., Packaging cell contour (5) - packs cardboard FSP 42-0055-0128-06 4602193003620
3 tablets of prolonged action 300 mg 10 pcs., Packaging cell contour (5) - packs cardboard FSP 42-0055-0128-06 4602193003637

Description active substance (INN) Theophylline.

Pharmacology : pharmachologic effect - spasmodic, bright, anti-asthma, vasodilator, cardiotonic, diuretic. Binds adenosine receptors.

Indications : Bronchial asthma, asthmatic status, obstructive bronchitis, lung emphysema, apnea in newborns (auxiliary).

Contraindications : Hypersensitivity, incl. And to others. Ksanthin derivative (caffeine, pentoxifillalin, theobromine), hemorrhagic stroke, hemorrhage in the retina eye, acute myocardial infarction, pronounced atherosclerosis of coronary arteries, bleeding in a recent history, pregnancy, breastfeeding (for the treatment stop).

Side effects : Anxiety, violation of consciousness, convulsions, vision disorders, scotch, attacks of angina, arrhythmia, tachycardia, hypotension, laryngitis, throat, influenza-like syndrome, nasal congestion, xerostomy, anorexia, nausea, vomiting, heartburn, exacerbation of cholecystitis, cholestatic hepatitis, increase Concentrations of hepatic enzymes (AST, Alt, alkaline phosphatase, LDH), intestinal atony, leukopenia, hypoofibrinegenemia, pancytopenia, thrombocytopenia, allergic reactions.

Interaction : Cimetidine, allopurinol, cyclosporin A, macrolide antibiotics, oral contraceptives, anti-hygospose serum, low protein and high-carbohydrate diet - reduce Cl and increase the risk of developing side effects.

Phenobarbital, phenytoin, xanthines, smoking - accelerate biotransformation (induced microsomal liver enzymes). Beta-adrenoblocators reduce bronchhalytic activity. Adsorbents, enveloping agents, antacids, oxidizers slow down and reduce Cmax, and leaning substances are raised. Strengthens the effects of diuretics, reduces - NSAIDs (from the group of derivatives of pyrazolone), beta-adrenoblockers, probilecid.

Overdose : Symptoms: Astemation, confusion of consciousness, convulsions, tachycardia, arrhythmia, hypotension, nausea, diarrhea, vomiting with blood impurity, hyperglycemia, hypokalemia, metabolic acidosis.

Treatment: Purpose of activated carbon, intestinal irrigation combination of polyethylene glycol and salts; with pronounced nausea and vomiting - metoclopramide or ondansetron (in / c), salads - benzodiazepines, phenobarbital (or sodium thiopental) and peripheral muscle relaxants; If necessary, hemoperfusion.

Method of application and dose : Inside, after eating adults (irregular forms) - 0.1-0.2 g 2-4 times a day. Higher singular I. daily dose Inside and rectally consist of 0.4 and 1.2 g, respectively. Children: from 2 to 4 years - 0.01-0.04 g, 5-6 years - 0.04-0.06 g, 7-9 years - 0.05-0.075 years, 10-14 years - 0, 05-0.1 g at the reception.

Precautions : Retree treatment treatment is produced in periodic control of the concentration of the drug in the blood (should not exceed 20 μg / ml).

I Capsule with a modified release of 100 mg comprises: theophyllin anhydrous 100 mg excipients: neutral micropellets (sucrose and starch corn), whitening shellac, talc, gelatin, azorubin (E122).
1 Capsule with modified release 200 mg comprises: Theophyllin anhydrous 200 mg,
Auxiliary substances: Neutral micropellets (sucrose and starch corn), bleached shellac, talc, gelatin, indigocarmin (E132). .,
1 Capsule with modified release of 300 mg comprises: Theophyllin anhydrous 300 mg,
Auxiliary substances: neutral micropellets (sucrose and starch corn), bleached shellac, talc, gelatin, quinoline yellow (E104), patented blue V (E131).

Description

Capsules 100 mg
Solid gelatin capsules No. 3 consisting of a colorless case and a lid of pink color.
Capsules 200 mg
Solid gelatin capsules No. 2 consisting of a colorless case and a lid of a dark blue color.
Capsules 300 mg
Solid gelatin capsules No. 1 consisting of a colorless case and a lid of green.

Indications for use

Theophile SR® is used as a bronchitator for symptomatic treatment and prevention of bronchial asthma attacks, reversible bronchospasm when chronic bronchitis and bronchial asthma
- the relationship and prevention of attacks of difficult breathing in patients with chronic obstructive diseases of the lungs;

Contraindications

Age up to 6 years;
-the sensitivity to the components of the drug;
-epilepsy;
Sump of the stomach and duodenum in the extension phase

Pregnancy and lactation period

The purpose of theophylline preparations during pregnancy should be considered only in the absence of safe alternative methods of treatment. Theophyllin penetrates the placenta, the safety of its use during pregnancy is not installed.
Theophylline stands out with breast milk and should not be assigned to nursing mothers.

Method of application and dose

Doses of the drug are installed individually. Since theophylline is not distributed in adipose tissue, then the dose of the drug is calculated on the basis of the ideal body weight. Recommended doses are as follows.
Adults: 200-300 mg 2 times a day.
Children over 6 years old: 100-200 mg 2 times a day.

Age

Dose

6-9 years old

24 mg / kg / day

9-12 years old

20 mg / kg / day

12-16 years old

18 mg / kg / day

Over 16 years old

13 mg / kg / day or 900 mg / day

Capsules should be taken entirely, not chewing, drinking sufficient liquid.
The total dose should usually not exceed 24 mg / kg of body weight
For children and 13 mg / kg for adults. It is impossible to guarantee bioequivalence between various drugscontaining theophylline. If the patient once selected an effective dose, then he should not be replaced by theophil to another drug containing xanthines without re-selection of an effective dose and clinical observation.

Side effect"Type \u003d" Checkbox "\u003e

Side effect

Side effects are closely related to the serum concentrations of theophylline, so they are rare when receiving slow-release preparations. The following side effects noted:
Gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea.
Central nervous system: Headache, irritation, fatigue, insomnia, reflex hyperoportability, muscular twitching, clonic and tonic generalized cramps.
Cardiovascular system: fluttering, tachycardia, extrasystolia, tides, hypotension, circulatory collapse, ventricular arrhythmia.
Respiratory system: Tahipne.
Urinary System: Diurea Potentation Other: Alopecia, Hypertriglyceridemia, Rash.

Overdose

Symptoms and symptoms, headache, nausea, vomiting, fatigue, hypotension, tachycardia, arrhythmia (usually sufficiently valuable tachyarhythmia) are possible.
Treatment: Empty stomach washing or causing vomiting. Purpose of activated carbon. During the development of convulsion, the patient is injected with diazepams 0.1 - 0.3 mg / kg to 10 mg.
For adult dose, more than 3 g may have serious consequences (40 mg / kg for children). The deadly dose for adults can be only 4.5 g (60 mg / kg in a child), but, as a rule, above.
Symptoms
ATTENTION: Serious signs can develop within 12 hours after overdose.
From the digestion: nausea, vomiting (often heavy forms),
Difficult pain
Metabolic functions: hypokalemia due to the transition of potassium from
Plasma in cells is a common phenomenon, can develop quickly and is heavy
character. Also possible hyperglycemia, hypomagnation, metabolic
Acidosis and rhabdomiolysis.
Treatment:
With a significant overdose within 1 -2 hours, activated carbon should be done or washing the stomach. .
After the re-dose of activated carbon can increase the removal of theophylline from the body. Urgently measure the concentration of potassium in the blood plasma, often repeat the measurements for the correction of hypokalemia.
ATTENTION! For large doses of potassium during the recovery period, serious hypercalemia may develop. If the concentration of potassium in plasma is low, the magnesium concentration should be immediately measured.
In the treatment of ventricular arrhythmia, antiarrhythmic drugs should be avoided, such as lidocaine, so as not to cause or outgrade the attack.
If the theophylline poisoning is assumed, it should be regularly measured its concentration in the blood plasma until it falls.
Vomot should be treated with anti-ansulistic drugs, such as metoclopramide or ondansetron.
Tachycardia with normal cardiac emissions does not require specific treatment. Beta blockers may be given in extreme cases, provided that the patient is not an asthmatic. In convulsions (provided that they are not caused by hypokalemia) intravenously introduced diazepams.

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Interaction with other medicines

With the simultaneous purpose of theophylline and furosemide, beta-adreminimetics, other methylxantins are increased the effect of theophylline.
Ephedrine and ephedrine-containing drugs can enhance both straight and side
Theophylline effects.