Composition
per 5 ml of syrup
Active ingredient:
Butamirate Citrate 7.50 mg
Auxiliary substances: citric acid, monohydrate, sorbitol, liquid, glycerol, sodium saccharinate, sodium benzoate, lemon flavor, sodium hydroxide, purified water
Pharmacological action
antitussive agent of central action
Clinical Pharmacology
Pharmacodynamics
Butamirate, the Active ingredient of Panatus Forte, is a centrally acting antitussive agent that is neither chemically nor pharmacologically related to opium alkaloids. Suppresses cough, having a direct effect on the cough center. It has a bronchodilating effect. Helps facilitate breathing by improving spirometry (reduces airway resistance) and blood oxygenation.
Pharmacokinetics
Butamirate is rapidly and completely absorbed when taken orally. After taking 150 mg of butamirate, the maximum plasma concentration of the main metabolite (2-phenylbutyric acid) is reached in about 1.5 hours and is 6.4 mcg / ml.
With repeated use of butamirate, its concentration in blood plasma remains linear and no accumulation is observed.
Hydrolysis of butamirate, initially to 2-phenylbutyric acid and diethylaminoethoxyethanol, begins in the blood. These metabolites also have antitussive activity. Butamirate and its metabolites have almost the maximum (about 95%) degree of binding to plasma proteins, which causes their long half-life (T1/2) and long-term antitussive effect. Metabolites are mainly excreted by the kidneys, and acidic metabolites are largely associated with glucuronic acid. T1/2 is 6 hours.
Indications
Dry cough of any etiology, including whooping cough, for cough suppression in the preoperative and postoperative period, during surgical interventions and bronchoscopy.
Use during pregnancy and lactation
There are no data on the safety of using Panatus forte during pregnancy and its passage through the placental barrier. The drug is not recommended for use in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug can be used only after consulting a doctor. Given the lack of data on the excretion of butamirate in breast milk, the use of Panatus® forte during breastfeeding is not recommended.
Recommendations for use
For oral use.
The dose is set individually, depending on the dosage form used and the patient’s age.
Contraindications
Hypersensitivity to the components of the drug, pregnancy (I trimester), breastfeeding, children under 3 years of age, fructose intolerance.
Side effects
World Health Organization (WHO)classification of the incidence of side effects:
very common ≥ 1/10
common ≥ 1/100 to < 1/10
uncommon ≥ 1/1000 to < 1/100
rare ≥ 1/10000 to < 1/1000
very rare ≥ 1/100000, including individual reports.
Central nervous system (CNS)disorders:
rarely: drowsiness, dizziness.
From the digestive system:
rare: nausea, vomiting, diarrhea.
From the side of the skin:
rare: exanthema.
Other: allergic reactions may occur.
Interaction
No drug interactions have been described for butamirate.
Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided in order to avoid accumulation of sputum in the respiratory tract.
During the period of use of Panatus® forte, the use of ethanol, as well as drugs that depress the central nervous system (sleeping pills, neuroleptics, tranquilizers, etc. ) is not recommended.
How to take, course of use and dosage
Inside, before eating.
Children from 3 to 6 years: 5 ml 3 times a day; children from 6 to 12 years: 10 ml 3 times a day; children over 12 years of age: 15 ml 3 times a day; adults: 15 ml 4 times a day.
Use a measuring spoon (included).1 scoop = 5 ml.
If the cough persists for more than 5-7 days, you should consult a doctor.
Overdose
Symptoms: drowsiness, dizziness, nausea, vomiting, abdominal pain, diarrhea, irritability, impaired coordination of movements, low blood pressure.
Treatment: wash out the stomach, prescribe activated charcoal, laxatives, and take measures to maintain the function of the cardiovascular and respiratory systems. There is no antidote. Treatment is symptomatic.
Description
Transparent liquid from colorless to light yellow color with a characteristic smell.
Functional features
It is rapidly and completely absorbed when taken orally. With repeated use, its concentration in blood plasma remains linear and no accumulation is observed. In the blood, it undergoes hydrolysis to form 2-phenylbutyric acid and diethylaminoethoxyethanol. These metabolites also have antitussive activity. Binding of butamirate and its metabolites to plasma proteins is about 95%, which is due to their long T1/2 and long-term antitussive effect. Metabolites are mainly excreted by the kidneys, and acidic metabolites are largely associated with glucuronic acid. T1/2 – 6 hours.
Special instructions
Pregnancy (II-III trimesters).
Contraindicated in children under 3 years of age.
Children from 3 to 6 years: 5 ml 3 times a day;
children from 6 to 12 years: 10 ml 3 times a day;
children over 12 years of age: take 15 ml 3 times a day.
Panatus forte is not used in patients with fructose intolerance.
The syrup contains sodium saccharinate and sorbitol as sweeteners, so it can be used in patients with diabetes mellitus.
5 ml of syrup (1 scoop) contains 1.75 g of sorbitol. With each single dose of the drug, the patient receives either 5.25 g of sorbitol (3 scoops),3.5 g of sorbitol (2 scoops), or 1.75 g of sorbitol (1 scoopful).
Panatus forte is not used in patients with fructose intolerance.
If after 5-7 days of using Panatus forte, the cough does not stop, you should consult a doctor.
Panatus forte can cause drowsiness, so caution should be exercised when driving vehicles and working with complex technical devices that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Syrup,7.5 mg/5 ml.
200 ml of syrup in a dark glass bottle, capped with a plastic stopper with a liquid divider and a plastic lid with control of the first opening. 1 bottle is placed in a cardboard pack together with a measuring spoon and instructions for use.
Storage conditions
At a temperature not exceeding 25 ° C, in the original packaging.
Keep out of reach of children.
Shelf
life is 4 years.
Do not use the drug after the expiration date.
Active ingredient
Butamirate
Description
Pregnant women in the second and third trimester as prescribed by a doctor, Children over 3 years of age, For adults, Children as prescribed by a doctor
Indications
Preparation for Bronchoscopy, Cold, Cough, Whooping Cough
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