Panatus forte, 7.5 mg/5 ml syrup 200 ml

Cough, Whooping cough, Preparing for bronchoscopy, Cold

Dry cough of any etiology, including whooping cough, to suppress cough in pre- and postoperative period, in surgical interventions and bronchoscopy.

Indications

Dry cough of any etiology, including whooping cough, to suppress cough in the preoperative and postoperative period, during surgical interventions and bronchoscopy.

Pharmacological effect

centrally acting antitussive

Special instructions

Pregnancy (II-III trimesters).

Contraindicated for 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 old: 15 ml 3 times a day.

The drug 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.

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), or 3.5 g of sorbitol (2 scoops), or 1.75 g of sorbitol (1 scoop).

The drug 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.

The drug Panatus® forte may cause drowsiness, so care must be taken when driving vehicles and working with complex technical devices that require increased concentration and speed of psychomotor reactions.

Active ingredient

Butamirat

Composition

for 5 ml syrup

Active ingredient:

Butamirate citrate 7.50 mg

Excipients: citric acid, monohydrate, sorbitol, liquid, glycerol, sodium saccharinate, sodium benzoate, lemon flavor, sodium hydroxide, purified water

Pregnancy

There is no data on the safety of using the drug 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 consultation with a doctor. Given the lack of data on the release of butamirate into breast milk, the use of Panatus® forte during breastfeeding is not recommended.

Contraindications

Hypersensitivity to the components of the drug, pregnancy (first trimester), breastfeeding period, children under 3 years of age, fructose intolerance.

Side Effects

World Health Organization (WHO) side effect frequency classification:

very common ≥ 1/10

often ≥ 1/100 to < 1/10

uncommon ≥ 1/1000 to < 1/100

rarely from ≥ 1/10000 to < 1/1000

very rare from ≥ 1/100000, including isolated reports.

From the central nervous system (CNS):

rarely: drowsiness, dizziness.

From the digestive system:

rarely: nausea, vomiting, diarrhea.

From the skin:

rarely: exanthema.

Other: allergic reactions may develop.

Interaction

No drug interactions have been reported for butamirate.

Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to avoid the accumulation of sputum in the respiratory tract.

During the period of use of the drug Panatus® forte, the use of ethanol, as well as drugs that depress the central nervous system (hypnotics, antipsychotics, tranquilizers, etc.) is not recommended.

Overdose

Symptoms: drowsiness, dizziness, nausea, vomiting, abdominal pain, diarrhea, irritability, impaired coordination of movements, decreased blood pressure.

Treatment: rinse 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.

Clinical pharmacology

Pharmacodynamics

Butamirate, the active ingredient of the drug Panatus® forte, is a centrally acting antitussive agent that is not related to opium alkaloids either chemically or pharmacologically. Suppresses cough, having a direct effect on the cough center. Has a bronchodilator effect. Helps make breathing easier by improving spirometry (reduces airway resistance) and blood oxygenation.

Pharmacokinetics

Butamirate is quickly 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 after approximately 1.5 hours and is 6.4 μg/ml.

With repeated use of butamirate, its concentration in the 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 an almost maximum (about 95%) degree of binding to plasma proteins, which determines their long half-life (T1/2) and long-term antitussive effect. Metabolites are excreted primarily by the kidneys, with acidic metabolites largely associated with glucuronic acid. T1/2 is 6 hours.

Recommendations for use

For oral administration.

The dose is set individually, depending on the dosage form used and the age of the patient.

Functional features

Quickly and completely absorbed when taken orally.

Storage conditions

At a temperature not exceeding 25 ºС, in the original packaging.

Keep out of the reach of children.

Shelf life

4 years.

Do not use the drug after the expiration date.

Manufacturer

KRKA dd Novo Mesto, Slovenia