Glycodin (Syrup) Instructions for Use

Marketing Authorization Holder

Alembic Pharmaceuticals Limited (India)

ATC Code

R05FB02 (Antitussive drugs in combination with expectorants)

Active Substances

Dextromethorphan (Rec.INN registered by WHO)

Terpin hydrate (BAN adopted for use in the UK)

Levomenthol (Rec.INN registered by WHO)

Dosage Form

Glycodin

Syrup 10 mg+10 mg+3.75 mg/5 ml: bottle 50 ml or 100 ml, bottle 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Syrup from yellow to dark yellow with a brownish tint, thick, viscous, opalescent, with a characteristic odor.

Excipients: sucrose – 3250 mg, sodium methylparaben – 5.5 mg, sodium propylparaben – 2.75 mg, citric acid monohydrate – 0.85 mg, propylene glycol – 400 mg, glycerol – 600 mg, sodium saccharin – 10 mg, caramel – 65 mg, alem (BBA) – 0.0165 mg, purified silicon – q.s., purified water – up to 5 ml.

50 ml – dark glass bottles (1) with a measuring cup – cardboard boxes.
100 ml – dark glass bottles (1) with a measuring cup – cardboard boxes.
50 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard boxes.
100 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard boxes.

Clinical-Pharmacological Group

Drug with antitussive and expectorant action

Pharmacotherapeutic Group

Combined antitussive agent (opioid antitussive agent + expectorant agent)

Pharmacological Action

Dextromethorphan is an antitussive drug, similar in potency to codeine, increases the sensitivity threshold of the cough center in the medulla oblongata, suppresses cough of any origin, eliminates the effect of dry non-productive cough and is well tolerated by all age groups. It has some sedative effect. It does not have analgesic, narcotic, or hypnotic effects. It does not depress the respiratory center or the activity of the ciliated epithelium. Onset of action is within 10-30 minutes after oral administration, duration is for 5-6 hours in adults and up to 6-9 hours in children.

Terpin hydrate has an expectorant effect; it increases the secretory function of the epithelial glands of the respiratory tract, increases the volume of secretion and reduces the viscosity of the secreted mucus, protects the inflamed epithelial surface of the respiratory tract from direct contact with the external environment, which contributes to the acceleration of recovery processes in the epithelium.

Levomenthol has a moderate antispasmodic effect. It alleviates the condition during the manifestation of symptoms of acute rhinitis, pharyngitis, laryngitis, and bronchitis.

Pharmacokinetics

After oral administration, dextromethorphan is completely absorbed in the gastrointestinal tract and metabolized in the liver. Time to reach C_max in blood plasma is 2 hours. Up to 45% of dextromethorphan may be excreted by the kidneys.

Terpin hydrate is rapidly absorbed from the gastrointestinal tract after oral administration. Part of the drug circulates in the blood unchanged and is excreted through the respiratory tract, with urine and sweat, giving them a specific odor. Another part of the drug undergoes oxidation in the body and is excreted by the kidneys in the form of phenols.

Levomenthol is excreted by the kidneys and with bile in the form of a glucuronide.

Indications

• Acute and chronic respiratory diseases accompanied by dry, irritating cough.

ICD codes

Dosage Regimen

Administer orally. Use the provided measuring cup for accurate dosing.

For adults, take 5 ml (one teaspoon) three to four times daily. Maintain a minimum interval of 4-6 hours between doses.

For pediatric patients: Children aged 4 to 6 years should receive 1.25 ml (one-quarter teaspoon) three to four times daily. Children aged 7 to 12 years should receive 2.5 ml (one-half teaspoon) three to four times daily.

The maximum daily dose for adults should not exceed 20 ml. Do not administer to children under 4 years of age.

The duration of treatment is determined by the physician based on clinical response. Do not exceed the recommended dosage or duration of therapy.

Shake the bottle well before each use. If symptoms persist beyond 5 days, consult a physician.

Adverse Reactions

Drowsiness, nausea, dizziness, skin itching, urticaria.

Contraindications

• Bronchial asthma;
• Sucrase/isomaltase deficiency;
• Fructose intolerance;
• Glucose-galactose malabsorption (due to the presence of sucrose);
• Pregnancy;
• Lactation period;
• Children under 4 years of age;
• Hypersensitivity to any of the components of the drug.

With caution: patients with impaired liver function.

Use in Pregnancy and Lactation

The use of Glycodin is contraindicated during pregnancy. Breastfeeding should be discontinued during treatment.

Use in Hepatic Impairment

With caution: patients with impaired liver function.

Use in Renal Impairment

Experience of use in patients with chronic renal failure is limited.

Pediatric Use

Contraindicated in children under 4 years of age.

Children from 4 to 6 years – 1/4 teaspoon 3-4 times/day; from 7 to 12 years – 1/2 teaspoon 3-4 times/day.

Special Precautions

No development of habituation occurs with the use of the drug.

Terpin hydrate, which is part of the drug, gives urine and sweat a specific odor, which has no clinical significance.

When taking Glycodin, patients with diabetes mellitus should take into account the sugar content in the syrup – 3250 mg of sucrose, which is less than 1 Bread Unit (BU).

No specific features of the action upon first administration or withdrawal of Glycodin have been registered.

No special actions by the doctor (paramedic) or patient are required if one or several doses of the drug are missed.

In the absence of impaired renal function, the usual dosing regimen of the drug should be followed. Experience of use in patients with chronic renal failure and/or moderate hepatic insufficiency is limited.

Effect on ability to drive vehicles and operate machinery

During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: agitation, dizziness, respiratory depression, decreased blood pressure, tachycardia, dyspeptic disorders.

Treatment: artificial ventilation of the lungs, symptomatic treatment. The specific antidote is naloxone, which may be used in case of an overdose of 100 times or more.

Drug Interactions

It enhances the effect of narcotic antitussive drugs and other agents that depress the central nervous system.

Interaction with MAO inhibitors is potentially possible (it is advisable to avoid taking dextromethorphan during the course of MAO inhibitor therapy).

Storage Conditions

Store in a light-protected place at a temperature not exceeding 25°C (77°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Do not use after the expiration date stated on the packaging.

Dispensing Status

The drug is available without a prescription.

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.