Table Omnitus n / pl / rev modif.vysv. 20mg 10 pc

Description

Composition
Active substance:
1 c modified-release tablet, film-coated 20mg comprises:
Butamirata citrate 20 mg ;.
Excipients:
Lactose monohydrate – 218.5 mg Hypromellose – 70.0 mg Talc – 10.0 mg Magnesium stearate – 8.0 mg colloidal silicon dioxide, anhydrous – 2.0 mg Povidone – 1.5 mg;
Composition of the shell
Hypromellose – 5,105 mg talc – 4.700 mg ethylcellulose – 3,140 mg, macrogol – 1.253 mg of titanium dioxide – 1,041 mg, sunset yellow dye [E 110] (11%) – 1,261 mg.
Description:
Dosage 20 mg: Round biconvex tablets, film-coated from yellow to orange. On the cross-section of the kernel white or off-white color.
Product form:
C modified release tablets, film-coated 20mg
10 tablets in a blister made of PVC / AL. 1 blister together with instructions for use placed into cardboard pack.
Contraindications
Increased sensitivity to the drug, pregnancy (I term), lactation, children under 6 years of age – 20 mg tablets, children up to 18 years – 50 mg tablets. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (formulation contains lactose).
Dosage
20 mg
Indications
Dry cough from any cause (for colds, flu, whooping cough and other conditions). cough suppression in the preoperative and postoperative period, during surgery, bronchoscopy.
Interaction with other drugs
Any drug interactions are not described for butamirata. During the period of treatment with the drug is not recommended to drink alcohol, and drugs that suppress the central nervous system (hypnotics, neuroleptics, tranquilizers, etc..).
Overdose
Symptoms: dizziness, drowsiness, nausea, vomiting, diarrhea, incoordination, decreased blood pressure.
Treatment: gastric lavage; activated charcoal, saline laxatives, symptomatic therapy (if indicated).
pharmachologic effect
Pharmacological group:
Antitussive central action.
Pharmacological properties:
Antitussive, expectorant provides moderate bronchodilatory and anti-inflammatory effect.
Butamirata citrate is neither chemical nor farmakologicheski alkaloidami akin to opium and has a direct effect on the cough center, improves spirometry and blood oxygenation.
Pharmacodynamics:
Butamirata, Omnitus® active substance preparation is a centrally acting antitussive. Either chemically or farmakologicheski not apply to alkaloidam opium. It does not produce dependence or addiction. Suppresses cough, having a direct effect on the cough center. It has bronchodilatory effect (expands bronchi). It helps to alleviate respiratory spirometry improves (reduces airway resistance) and blood oxygenation (saturates the blood with oxygen).
Pharmacokinetics:
Absorption – high. After oral syrup in a dose containing 150 mg butamirata citrate maximum plasma concentration of the main metabolite (2-phenylbutyric acid) was observed after 1.5 hours and is 6.4 ug / ml, when receiving tablets with modified release (50 mg), respectively, – 9 h and 1.4 ug / ml. The half syrup – 6 hours, for tablets – 13 hours no cumulative effect.. Butamirata tsitrat rapidly hydrolyzed in plazme 2-fenilmaslyanuyu acid and dietilaminoetoksietanol. Oba these metabolita, obladayuschie takzhe antitussive effect, largely bound to plasma proteins, which explains their long presence in the plasma. Subsequently major metabolite 2-fenilmaslyanaya kislota 14C is oxidized to p-hydroxy-2-phenylbutyric acid. All three metabolita pochkami output, wherein the acidic metabolity svyazany mainly with glucuronic acid.
Pregnancy and breast-feeding
There are no data on the safety of drugs in pregnancy, and it passes through the placental barrier. Use of the drug in the I trimester of pregnancy is contraindicated. In II and III trimester of pregnancy, the use of the drug may be the case if the expected benefit to the mother outweighs the potential risk to the fetus. It is not known whether the active substance penetrates the drug or its metabolites in breast milk, therefore the use of the drug in the breastfeeding period is not recommended.
Conditions of supply of pharmacies
Without recipe.
side effects
Classification of the incidence of adverse reactions: very common (> 1/10), common (
From the digestive system: rarely – nausea, diarrhea.
Allergic reactions: seldom – skin rash, itching, hives.
special instructions
Contraindicated in children under 6 years old. Due to the fact that butamirata suppresses the cough reflex, avoid simultaneous use of expectorants to avoid accumulation of mucus in the airways of the risk of bronchospasm and respiratory tract infections.
Omnitus® can cause dizziness and drowsiness, so the period of treatment must be careful when driving and performing other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Stored in a dry place, protected from light, at a temperature from 15 to 25 ° C.
Dosing and Administration
Inside.
Tablets are taken before a meal, without chewing.
Children from 6 to 12 years – 1 tabletka raza 2 per day; older than 12 years – 1 tabletka 3 raza in day Adults: 2 tabletki 2-3 raza in day
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist