Combipack, 6 mg+200 mg, 5

In terms of structure and action, salbutamol is close to other beta2-adrenergic stimulants.

It has bronchodilator and tocolytic (relaxes uterine muscles) effects.

In therapeutic doses usually does not cause tachycardia (palpitations) and changes in blood pressure.

Indications

Treatment and prevention of reversible airway obstruction in

– bronchial asthma (including night attacks of bronchial asthma;

– chronic obstructive pulmonary disease:

– bronchial asthma (including nocturnal attacks of bronchial asthma);

– chronic obstructive bronchitis;

– pulmonary emphysema and other respiratory diseases accompanied by the occurrence of bronchospasm.

Active ingredient

Composition

1 tablet contains 6 mg salbutamol,

Theophylline 200 mg.

How to take, the dosage

Combipack is taken orally after a meal with water. The tablet should not be crushed, chewed or dissolved in water. Adults are prescribed 1 tablet 2 times a day.

The maximum daily dose of theophylline should not exceed 12-14 mg per kg body weight, but no more than 1.2 g. The maximum daily dose of salbutamol is 32 mg.

The optimal dose of salbutamol and duration of application are determined by the doctor individually taking into account clinical picture of bronchial obstruction and body weight of the patient (starting from minimal dose of salbutamol), individual tolerance of the drug, concomitant diseases, simultaneous use of other medicines. The duration of treatment averages 1-3 months. In case of good tolerability and efficacy a longer period of prescription is possible.

Interaction

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

Antidiarrheals and enterosorbents decrease absorption of theophylline.

Rifampicin, phenobarbital, phenytoin, isoniazid, carbamazepine, sulfinpyrazone, aminoglutethimide, oral estrogen-containing contraceptives and morazine, being inducers of microsomal liver enzymes, increase clearance of theophylline, which may require increasing its dose.

. When used concomitantly with cytochrome P 450 inhibitors of macrolide antibiotics, lincomycin, allopurinol, cimetidine, isoprenaline, enoxacin, small doses of ethanol, disulfiram, fluoroquinolones, Recombinant interferon-alpha, methotrexate, mexiletine, propafenone, thiabendazole, ticlopidine, verapamil, and during influenza vaccination, theophylline may increase in intensity, which may require reducing the dose.

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

Theophylline is compatible with antispasmodics, is not used with other xanthine derivatives, and caution is used concomitantly with anticoagulants.

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

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

Xanthines when used concomitantly with salbutamol increase the likelihood of tachyarrhythmias; agents for inhaled anesthesia, levodopa – severe ventricular arrhythmias.

Monoamine oxidase inhibitors and tricyclic antidepressants, by enhancing the effects of salbutamol, may lead to a sharp decrease in BP.

Salbutamol is incompatible with non-selective beta-adrenoblockers.

The concomitant use of salbutamol with anticholinergic agents (including inhaled agents) may contribute to increased intraocular pressure.

Diuretics and glucocorticosteroids increase the hypokalemic effect of salbutamol.

Special Instructions

The effectiveness of theophylline may be reduced in smokers.

Perform caution with large quantities of caffeinated foods or drinks during treatment.

In view of the side effect profile, it is not recommended to drive vehicles and engage in other potentially hazardous activities requiring increased concentration and quick psychomotor reactions while taking the drug.

Combipec is not intended to relieve emergencies. Treatment with prolonged forms is carried out with periodic monitoring of theophylline blood concentration.

The long-acting medications greatly reduce the likelihood of dose-dependent side effects.

Contraindications

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

– acute myocardial infarction;

– unstable angina pectoris;

– tachyarrhythmia;

– extrasystole;

– ischemic heart disease;

– chronic heart failure;

– myocarditis;

– heart defects, including aortic stenosis;

– pheochromocytoma;

– glaucoma;

– pyloroduodenal constriction;

– hepatic or renal failure;

– pulmonary edema;

– sepsis;

– gastroesophageal reflux;

– recent history of gastrointestinal bleeding;

– severe arterial hyper- or hypotension;

– widespread vascular atherosclerosis;

– hemorrhagic stroke;

– retinal hemorrhage;

– thyrotoxicosis;

– decompensated diabetes mellitus;

– epilepsy;

– increased seizure activity;

– gastric and duodenal ulcer in the acute stage;

– pregnancy;

– children under 16 years of age.

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

Side effects

The following side effects may occur when using Combipack.

Nervous system disorders: dizziness, headache, insomnia, nervous tension, agitation, anxiety, irritability, cramps, tremors.

Cardiovascular system disorders: palpitations, tachycardia, arrhythmia, cardialgia, extrasystole, decreased blood pressure (BP), collapse, myocardial ischemia, increased frequency of angina attacks, feeling of blood “rushes” to the face.

Respiratory system: tachypnea, pulmonary edema.

Digestive system disorders: feeling of heaviness in the stomach, gastralgia, nausea, vomiting, dry mouth, gastroesophageal reflux, heartburn, aggravation of peptic ulcer disease, diarrhea, with long-term use – loss of appetite.

Allergic reactions: skin rash, itching, angioedema.

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

Others: increased sweating.

The side effects decrease with reduction of the drug dose or go away on their own if the treatment is continued during the first 2-3 weeks of therapy.

The literature describes side effects of the monotherapies that make up Combipec (theophylline and salbutamol) in case of overdose: Allergic reactions (urticaria, erythematous rashes, angioneurotic edema), urinary retention, neuropsychiatric disorders, including psychomotor agitation, finger tremors, confusion, anxiety, hallucinations, photophobia, seizures.

The long-acting combination drug Combipec compares favorably to monotherapies because, due to the slow release of the active substances, the multidirectional action for some indications (e.g., urinary retention with salbutamol and the diuretic effect of theophylline), the adverse reactions typical of monotherapies are largely eliminated.

Overdose

Symptoms: gastralgia, diarrhea, nausea, vomiting (including with blood), gastrointestinal bleeding, tachypnoea, facial hyperemia, tachycardia, ventricular arrhythmias, headache, hallucinations, insomnia, motor agitation, anxiety, photophobia, tremors, seizures. Severe poisoning may cause epileptoid seizures (especially in children aged 16 to 18 without any precursors), hypoxia, metabolic acidosis, hyperglycemia, hypokalemia, BP decrease, skeletal muscle necrosis, confusion, renal failure with myoglobinuria.

Treatment: drug withdrawal, gastric lavage, activated charcoal, laxatives, bowel lavage with a combination of polyethylene glycol and electrolytes, forced diuresis, hemosorption, plasma sorption, hemodialysis (effectiveness is not high, peritoneal dialysis is not effective), symptomatic therapy with cardioselective beta adrenoblockers for tachycardia. If convulsions occur, maintain airway patency and oxygen therapy. For seizure management, intravenous diazepam 0.1-0.3 mg/kg (but no more than 10 mg). For severe nausea and vomiting – metoclopramide or ondansetron (intravenously).

Pregnancy use

Pregnancy is contraindicated. During lactation, breastfeeding should be stopped during treatment with the drug.