Universal reference book for medicines

Active substance: salbutamol, theophylline

Type: Bronchodilator-beta- 2- adrenomimetic

Manufacturer: ФАРМАПЭК (Russia)
Composition, form of production and packaging
Tablets of prolonged action
1 tab.

salbutamol 10 mg

theophylline 200 mg

10 pieces.
- packings cellular planimetric (5) - packs cardboard.
50 pcs.
- plastic cans (1) - packs of cardboard.
Tablets of prolonged action 1 tab.

salbutamol 6 mg

theophylline 200 mg

10 pieces.
- packings cellular planimetric (5) - packs cardboard.
50 pcs.
- plastic cans (1) - packs of cardboard.
Tablets of prolonged action 1 tab.

salbutamol 8 mg

theophylline 200 mg

10 pieces.
- packings cellular planimetric (5) - packs cardboard.
50 pcs.
- plastic cans (1) - packs of cardboard.

Description of the drug approved by the manufacturer for the printed edition of 2013.


Kombipek possesses the pharmacological properties inherent in theophylline and salbutamol.
Theophylline refers to inhibitors of phosphodiesterase, increases accumulation in the tissues of cAMP, which reduces the contractile activity of smooth muscle. Theophylline dilates the bronchi, blood vessels (mainly the vessels of the brain, skin and kidneys). Reduces pulmonary vascular resistance, reduces pressure in a small circle of blood circulation. Has a stimulating effect on the respiratory center, increases the frequency and strength of the heartbeats, kidney blood flow. Has a moderate diuretic effect. Inhibits the aggregation of platelets.
Salbutamol is selective?
2- adrenomimetic. Has a pronounced bronchodilator effect, prevents bronchospasm; reduces resistance in the airways, increases the vital capacity of the lungs; prevents the release of histamine and neutrophil chemotaxis factors,
In its pharmacodynamic effects, Kombipack is a drug with slow release of theophylline and salbutamol, so the drug is not prescribed for relief of emergency conditions.

The bronchodilating effect of KombiPek develops gradually after 30 minutes, it manifests itself in 3-6 hours after administration.
The active components of the drug are released from the polymer matrix in a dose-dependent manner, thereby ensuring constant concentrations in the blood for 10-12 hours, and a persistent clinical effect is achieved after several days of treatment. Effective concentration of theophylline in the blood during the day is maintained by taking the drug 2 times a day.
The purpose of Kombipek leads to additivity or potentiation of the bronchodilating effect of theophylline and salbutamol, since as early as a week the maximum increase in FVD values ​​with a significant decrease in bronchial resistance is noted.


With a single use of Kombipek tablets, the processes of absorption and excretion of active substances proceed slowly: the maximum concentration of both theophylline and salbutamol in the blood is determined after 3-9 hours and reaches a level of 4.07 В± 0.24 Ојg / ml for theophylline and 6.58 В± 0.49 ng / ml for salbutamol.
The half-absorption period is 1.38 В± 0.79 h for theophylline and 1.43 В± 0.63 h for salbutamol, and the half-life is 11.7 В± 8.3 h and 7.15 В± 2.55 h, respectively. The average retention time of active substances is 19 В± 11.4 h for theophylline and 12.7 В± 3.2 h for salbutamol.
However, the maximum concentration of theophylline and salbutamol in the blood serum of patients does not reach the level that, according to the literature, corresponds to the therapeutic one.

With repeated use of tablets, the equilibrium concentration for theophylline was 6.67 В± 1.17 Ојg / ml;
for salbutamol - 4.25 В± 0.591 ng / ml.
Absolute bioavailability of theophylline in Kombipack tablets is 56.6%.
The volume of distribution of theophylline is 0.536 В± 0.124 L, salbutamol is 11.6 В± 2.3 L.
Theophylline undergoes biotransformation in the liver with the formation of inactive metabolites.
Excreted mainly by the kidneys, partially excreted in breast milk. In unchanged form in adults, 10% of theophylline is excreted.
Salbutamol undergoes biotransformation in the liver.
It is excreted in urine and bile, mainly in unmodified form (90%) or in the form of glucuronide.

Treatment and prevention of reversible airway obstruction with:

- bronchial asthma (including nocturnal seizures of bronchial asthma);

- chronic obstructive bronchitis;

- emphysema of the lungs and other diseases of the respiratory system, accompanied by the appearance of bronchospasm.


Kombipek taken inside after eating, washed down with water.
The tablet can not be grinded, chewed and dissolved in water. Adults appoint 1 tablet 2 times a day.
The maximum daily dose of theophylline should not exceed 12-14 mg per kg of body weight, but not more than 1.2 grams. The maximum daily dose of salbutamol is 32 mg.

The optimum doses of salbutamol and the duration of the drug are selected by the doctor individually, taking into account the clinical picture of bronchial obstruction and body weight of the patient (starting from the minimum dose of salbutamol), individual drug tolerance, concomitant diseases, simultaneous administration of other medications.
The duration of treatment is an average of 1-3 months. With good tolerability and efficacy, a longer duration of prescription is possible.

When using Kombipeka, the following side effects may occur.

From the nervous system: dizziness, headache, insomnia, nervous tension, agitation, anxiety, irritability, cramps, tremor.

From the cardiovascular system: palpitation, tachycardia, arrhythmia, cardialgia, extrasystole, lowering of arterial pressure (BP), collapse, myocardial ischemia, an increase in the frequency of angina attacks, a feeling of "tides" of blood to the skin of the face.

From the respiratory system: tachypnea, pulmonary edema.

From the digestive system: a feeling of heaviness in the stomach, gastralgia, nausea, vomiting, dry mouth, gastroesophageal reflux, heartburn, exacerbation of peptic ulcer, diarrhea, with prolonged intake-decrease in appetite.

Allergic reactions: skin rash, itching, angioedema.

Laboratory indicators: albuminuria, hematuria, hyperglycemia, increased concentration in the blood of free fatty acids, hypokalemia.

Other: increased sweating.

Side effects decrease with a decrease in the dose of the drug or pass on their own during the continuation of treatment during the first 2-3 weeks of therapy.

In the literature, the side effect of the mono-preparations that make up Kombipek (theophylline and salbutamol) in case of their overdose is described: allergic reactions (urticaria, erythematous rashes, angioedema), urinary retention, psychoneurological disorders, including psychomotor agitation, tremor of fingers, confusion , anxiety, hallucinations, photophobia, convulsions.

The combination drug of prolonged action Kombipek favorably differs from monopreparations, because, in view of the slow release of active substances, multidirectional action on some indicators (for example, urinary retention with salbutamol and diuretic effect of theophylline), unwanted side reactions characteristic of mono preparations are largely leveled.


- hypersensitivity to theophylline (including other derivatives of xanthine - caffeine, pentoxifylline, theobromine) and salbutamol;

acute myocardial infarction;

- unstable angina;

- Tachyarrhythmia;

- extrasystole;

- cardiac ischemia;

- Chronic heart failure;

- myocarditis;

- heart diseases, including aortic stenosis;

- pheochromocytoma;

- glaucoma;

- pyloroduodenal constriction;

- hepatic or renal insufficiency;

- pulmonary edema;

- sepsis;

- gastroesophageal reflux;

- gastrointestinal bleeding in a recent history;

- severe arterial hyper- or hypotension;

- widespread atherosclerosis of blood vessels;

- hemorrhagic stroke;

- hemorrhage in the retina of the eye;

- thyrotoxicosis;

Decompensated diabetes mellitus;

- epilepsy;

- increased convulsive activity;

- Stomach ulcer and duodenal ulcer in the stage of exacerbation;

- Pregnancy;

- Children under 16 years old.

With caution: with gastric ulcer and duodenal ulcer (in anamnesis), uncontrolled hypothyroidism (possibility of cumulation), prolonged hyperthermia, prostatic hyperplasia, in old age.


When pregnancy is contraindicated.
During lactation during the treatment with the drug, lactation is stopped.

Contraindicated in renal failure.


Contraindicated in liver failure.


Contraindicated for children under 16 years.


The effectiveness of the action of theophylline may decrease in smokers.

Be careful when consuming large quantities of caffeine-containing foods or drinks during the treatment period.

Given the profile of side effects, it is not recommended when administering the drug to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Kombipack is not intended for emergency situations.
Treatment with prolonged forms is carried out with periodic monitoring of theophylline concentration in the blood.
Drugs of prolonged action significantly reduce the likelihood of a dose-dependent side effect.


Symptoms: gastralgia, diarrhea, nausea, vomiting (including with blood), gastrointestinal bleeding, tachypnea, facial skin hyperemia, tachycardia, ventricular arrhythmias, headache, hallucinations, insomnia, motor excitement, anxiety, photophobia, tremor , convulsions.
In severe poisoning, epileptic seizures may develop (especially in children aged 16 to 18 without any precursors), hypoxia, metabolic acidosis, hyperglycemia, hypokalemia, decreased blood pressure, necrosis of skeletal muscles, confusion, renal insufficiency with myoglobinuria.
Treatment: drug withdrawal, gastric lavage, activated charcoal, laxative drugs, intestinal washing with a combination of polyethylene glycol and electrolytes, forced diuresis, hemosorption, plasmasorption, hemodialysis (efficacy is not high, peritoneal dialysis is not effective), symptomatic therapy with cardioselective beta adrenoblockers in tachycardia .
If seizures occur, maintain airway patency and conduct oxygen therapy. For cramping seizures - in / in diazepam, 0.1-0.3 mg / kg (but not more than 10 mg). With severe nausea and vomiting, metoclopramide or ondansetron (intravenously).

Theophylline increases the likelihood of side effects of glucocorticosteroids, mineral corticosteroids (hypernatremia), funds for general anesthesia (increases the risk of ventricular arrhythmias), drugs that excite the central nervous system (increases neurotoxicity).

Antidiarrhoeal drugs and enterosorbents reduce the absorption of theophylline.

Rifampicin, phenobarbital, phenytoin, isoniazid, carbamazepine, sulfinpyrazone, aminoglutethimide, oral estrogen-containing contraceptives and moracisin, as inducers of microsomal liver enzymes, increase the clearance of theophylline, which may require an increase in its dose.

When used simultaneously with cytochrome P 450 inhibitors, macrolide antibiotics, lincomycin, allopurinol, cimetidine, isoprenaline, enoxacin, small doses of ethanol, disulfiram, fluoroquinolones, recombinant interferon-alpha, methotrexate, mexiletine, propafenone, thiabendazole, ticlopidine, verapamil and in vaccination against the intensity of theophylline may increase, which may require a reduction in its dose.

Theophylline increases the effect of beta-adrenomimetics and diuretics (including by increasing glomerular filtration), reduces the effectiveness of lithium and beta-blockers.

Theophylline is compatible with antispasmodics, do not use together with other xanthine derivatives, with caution prescribed simultaneously with anticoagulants.

Salbutamol enhances the effect of stimulants of the central nervous system, cardiotropic thyroid hormones.

Salbutamol increases the likelihood of glycoside intoxication, reduces the effectiveness of antihypertensive drugs, nitrates.

Xanthines with simultaneous application with salbutamol increase the likelihood of developing tachyarrhythmias;
means for inhalation anesthesia, levodopa - severe ventricular arrhythmias.
Inhibitors of monoamine oxidase and tricyclic antidepressants, increasing the effect of salbutamol, can lead to a sharp decrease in blood pressure.

Salbutamol is incompatible with nonselective beta-blockers.

Simultaneous use of salbutamol with anticholinergics (including inhalation) may help increase intraocular pressure.

Diuretics and glucocorticosteroids increase the hypokalemic effect of salbutamol.


On prescription.


Storage conditions: In a dry place, protected from light, out of reach of children, at a temperature not exceeding + 25 В° РЎ.
Shelf life - 5 years.
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