Theraflu^® KV (Drops) Instructions for Use

Marketing Authorization Holder

Novartis Consumer Health S.A. (Switzerland)

ATC Code

R05CA03 (Guaifenesin)

Active Substance

Guaifenesin (Rec.INN registered by WHO)

Dosage Forms

	Theraflu® KV	Oral drops 100 mg/1 ml: 20 ml bottle
		Syrup 100 mg/5 ml: 100 ml or 200 ml bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a clear solution from colorless to pale yellow, with an anise odor.

Excipients: anise oil, anethole, ethanol 96%, glycerol, saccharin.

20 ml – dark glass bottles with a dropper (1) – cardboard packs.

Syrup clear, slightly opalescent, light brown in color, with a licorice odor.

Excipients: flavor IFF 12H 310, ethanol 96%, glycerol, sodium saccharin, sorbitol 70%, purified water.

100 ml – dark glass bottles (1) with a dosing cap – cardboard packs.
200 ml – dark glass bottles (1) with a dosing cap – cardboard packs.

Clinical-Pharmacological Group

Expectorant

Pharmacotherapeutic Group

Expectorant

Pharmacological Action

Expectorant. The mucolytic action of guaifenesin is based on reducing the surface tension and adhesion of sputum to the bronchial mucosa and reducing its viscosity due to the depolymerization of acidic mucopolysaccharides of mucus.

Simultaneously, Guaifenesin has the ability characteristic of expectorants to increase mucus secretion by stimulating the secretory cells of the bronchial mucosa that produce neutral polysaccharides.

Along with the liquefaction of bronchial secretions and a decrease in sputum viscosity, the ciliary apparatus of the bronchi is activated, which contributes to enhanced sputum removal and the transition of an unproductive cough to a productive one.

The duration of action after a single dose is 3.5-4 hours.

Pharmacokinetics

Absorption

Absorption of guaifenesin from the gastrointestinal tract occurs rapidly – within 25-30 minutes after oral administration, the time to reach C_max is 15-30 minutes after oral administration.

Distribution

Plasma protein binding is about 37%. Guaifenesin penetrates into tissues containing acidic mucopolysaccharides.

Metabolism

It is metabolized in the liver. The main metabolite is β-(2-methoxyphenoxy) lactic acid.

Excretion

The T_1/2 of guaifenesin from blood plasma is 1 hour. It is excreted by the lungs with sputum and by the kidneys both unchanged and in the form of inactive metabolites (mainly in the form of glucuronides and sulfonates).

Indications

• Diseases of the respiratory tract with difficult expectoration of viscous sputum: pharyngitis, sinusitis, influenza, acute tracheitis, bronchitis of various etiologies, bronchiectasis, bronchial asthma, pulmonary tuberculosis, pneumonia, cystic fibrosis;
• Sanitation of the bronchial tree in the pre- and postoperative periods.

ICD codes

Dosage Regimen

The drug is taken orally.

Syrup is prescribed to adults 5-10 ml 4 times/day.

Drops are diluted in water or herbal decoction before use or dripped onto a piece of sugar.

Children aged 2-3 years are prescribed 8-10 drops 2 times/day; 3-6 years – 12-15 drops 2 times/day; 6-12 years – 15-20 drops 3-4 times/day.

Adults and children over 12 years – 20-30 drops 3-4 times/day.

Adverse Reactions

From the digestive system nausea, vomiting, gastralgia, abdominal pain, diarrhea.

From the CNS dizziness, headache, drowsiness.

Allergic reactions skin rash, urticaria, fever.

Contraindications

• Gastric or duodenal ulcer;
• Gastric bleeding (in history);
• Wet cough with copious sputum production;
• Children under 2 years of age (for drops);
• Children under 18 years of age (for syrup);
• Hypersensitivity to the components of the drug.

With caution, the drug in the form of drops should be used for persistent or chronic cough against the background of bronchial asthma or with increased sputum production (prescription of guaifenesin requires careful medical supervision); in the form of syrup – in patients with hepatic insufficiency, epilepsy, CNS diseases (contains ethanol).

Use in Pregnancy and Lactation

The drug in the form of drops should be used with caution during pregnancy and lactation.

Use in Hepatic Impairment

Theraflu^® KV in the form of syrup should be prescribed with caution to patients with hepatic insufficiency.

Pediatric Use

The efficacy and safety of the drug in the form of drops in children under 2 years of age, in the form of syrup – in children under 18 years of age have not been studied.

Children aged 2-3 years are prescribed 8-10 drops 2 times/day; 3-6 years – 12-15 drops 2 times/day; 6-12 years – 15-20 drops 3-4 times/day.

Special Precautions

Simultaneously with treatment, plenty of fluids are recommended (infusions, decoctions of medicinal herbs, fruit juices, etc.). It is advisable to combine with postural drainage or vibration chest massage.

In case of persistent cough, the need for the use of guaifenesin is determined by the doctor individually. If after 7 days of taking the drug the cough persists or if cough is accompanied by hyperthermia, skin rash, prolonged headache, sore throat, the patient should consult a doctor.

Urine may turn pink.

The results of the determination of 5-hydroxyindoleacetic acid in urine (when using nitrosynaphthol reagent) may be falsely elevated due to the influence of guaifenesin metabolites on color (guaifenesin should be discontinued 48 hours before urine collection for this test).

Guaifenesin and its metabolites may cause a color change in the determination of vanillylmandelic acid in urine and falsely elevate the result of the catecholamine test. Guaifenesin should be discontinued 48 hours before urine collection for this test.

Use in pediatrics

The efficacy and safety of the drug in the form of drops in children under 2 years of age, in the form of syrup – in children under 18 years of age have not been studied.

Overdose

Cases of overdose have not been described.

Drug Interactions

The drug is compatible with bronchodilators, antimicrobial agents, cardiac glycosides.

Codeine impedes the discharge of liquefied sputum.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

The shelf life is 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.