Panatus^® forte (Tablets, Syrup) Instructions for Use

ATC Code

R05DB13 (Butamirate)

Active Substance

Butamirate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antitussive drug

Pharmacotherapeutic Group

Drugs used for cough and colds; antitussives, excluding combinations with expectorants; other antitussives

Pharmacological Action

Centrally acting antitussive agent. Butamirate is not an opium alkaloid. It does not cause dependence or addiction.

It suppresses cough by exerting a direct effect on the cough center. It has a moderate bronchodilatory effect. It facilitates breathing, improves spirometry parameters (reduces airway resistance) and blood oxygenation.

Pharmacokinetics

After oral administration, Butamirate is rapidly and completely absorbed; measurable concentrations are detected in the blood 5-10 minutes after administration.

C_max in plasma is reached within 1 hour. Mean plasma concentrations of 2-phenylbutyric acid are reached within 1.5 hours.

Butamirate has a large V_d in the range of 81-112 L (adjusted for body weight in kg), as well as a high degree of plasma protein binding. 2-phenylbutyric acid has a high degree of plasma protein binding – on average 89.3 – 91.6%. The ability of diethylaminoethoxyethanol to bind to plasma proteins is also detected, with average rates ranging from 28.8% to 45.7%. It is not known whether Butamirate crosses the placenta or is excreted in breast milk.

Hydrolysis of butamirate, resulting in the formation of 2-phenylbutyric acid and diethylaminoethoxyethanol, which have antitussive activity, occurs very rapidly. 2-phenylbutyric acid undergoes further partial metabolism by hydroxylation in the para position.

Excretion of the three metabolites occurs mainly through the kidneys; after conjugation in the liver, acid-reactive metabolites are largely bound to glucuronic acid. Conjugates of 2-phenylbutyric acid are detected in urine in significantly higher concentrations than in plasma. Butamirate is detected in urine for 48 hours. Butamirate is excreted in the urine in greater amounts as diethylaminoethoxyethanol than as unchanged Butamirate or as unconjugated 2-phenylbutyric acid.

The measured T_1/2 of 2-phenylbutyric acid, butamirate, and diethylaminoethoxyethanol is 23.26-24.42 h, 1.48-1.93 h, and 2.27-2.90 h, respectively.

Indications

Treatment of dry cough of various etiologies: for cough suppression in the pre- and postoperative period, during surgical interventions, bronchoscopy, in whooping cough.

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of liquid.

Adhere strictly to the age-specific dosing instructions for the selected formulation.

For Panatus^® forte syrup, use the measuring device provided. For Panatus^® forte tablets, swallow whole; do not chew or crush.

For adults and children over 12 years, the typical dosage is one tablet or 15 ml of syrup three times daily.

For children aged 6 to 12 years, administer one tablet or 10 ml of syrup three times daily.

For children aged 3 to 6 years, administer 5 ml of syrup three times daily.

Do not administer syrup to children under 3 years of age. Do not administer tablets to children under 6 years of age.

For pre-operative cough suppression, administer a single dose approximately one hour before the procedure.

The maximum daily dose for adults should not exceed 90 mg of butamirate.

The duration of treatment is typically short-term; do not exceed 5-7 days without medical consultation.

If symptoms persist or worsen, discontinue use and seek medical advice.

Adverse Reactions

From the CNS rarely – drowsiness, dizziness.

From the digestive system rarely – nausea, vomiting, diarrhea.

From the skin rarely – exanthema.

Other allergic reactions may develop.

Contraindications

Hypersensitivity to butamirate; first trimester of pregnancy, lactation (breastfeeding); children under 2 months of age; children under 3 years of age (for syrup), children under 6 years of age (for tablets); children under 18 years of age (for modified-release tablets).

With caution

Second and third trimesters of pregnancy. Use dosage forms containing ethyl alcohol with caution in patients prone to drug dependence, with liver disease, alcoholism, epilepsy, brain diseases, and in children.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy and during lactation (breastfeeding). In the second and third trimesters of pregnancy, use with caution and only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Pediatric Use

Contraindication: children under 2 months (for drops), under 3 years (for syrup), under 12 years (for modified-release tablets).

Special Precautions

In children, it should be used only in dosage forms that are specifically intended for this category of patients according to age.

Effect on ability to drive vehicles and machinery

Butamirate can cause drowsiness, so during treatment, patients should exercise caution when driving vehicles and engaging in other activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Since Butamirate suppresses the cough reflex, the concomitant use of expectorants should be avoided to prevent the accumulation of sputum in the airways.

During treatment with butamirate, it is not recommended to use drugs that have a depressant effect on the central nervous system (including hypnotics, antipsychotics, tranquilizers).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.