FLUDIL CAPSULES

THERAPEUTIC INDICATION

Cough suppressant with expectorant action that fluidifies phlegm. Helps eliminate phlegm associated with the common cold, bronchitis, pharyngitis and sinusitis.

PHARMACOLOGICAL CATEGORY

Cough suppressant expectorant/ fluidifying agent

PHARMACOKINETICS AND PHARMACODYNAMICS

Clinical pharmacology:
Dextromethorphan (d-3-methoxy-N-methylmorphinan) is the d isomer of the codeine analogue of levorphanol, but unlike the l isomer, it has no analgesic or addictive properties. The drug acts centrally by raising the cough threshold. Its effectiveness in patients with pathological cough has been proven in controlled studies showing that it is about equal to codeine.
Guaifenesin stimulates respiratory tract secretions to make expectoration easier. It is used in the systemic management of productive cough associated with the common cold, bronchitis, laryngitis, pharyngitis, whooping cough, influenza and measles and for cough caused by chronic sinusitis.

Pharmacokinetics and pharmacodynamics:
Dextromethorphan for oral administration is completely absorbed by the gastrointestinal tract from where it reaches the liver to undergo metabolism. Major metabolites are excreted through the kidneys. Action onset is 20-30 minutes after administration. This action lasts for up to 6 hours.
Guaifenesin is quickly absorbed at gastrointestinal level with blood concentrations of 1.5 µ/ml detected 15 to 30 minutes after the administration of 600 mg. Guaifenesin is oxidized into beta (2-methoxyphenoxyi) lactic acid. Other metabolites are catechol glyceryl ether, formed by an OR-demethylase in the liver e hydroxyguaifenesin. It is quickly cleared with an elimination half-life of 45 to 60 minutes.

CONTRAINDICATIONS

Do not give to children under the age of 2 years, diabetics, patients with asthma, gastritis, peptic ulcer or liver disease.

GENERAL PRECAUTIONS

Do not give with tranquilizers, antidepressants or drugs containing furazolidone or with MAO inhibitors.

WARNINGS

RESTRICTIONS FOR USE DURING PREGNANCY AND NURSING: In some patients may cause dry mouth, pupil contraction, nausea, vomiting, anorexia, dizziness and drowsiness, which quickly resolve by reducing the dose or discontinue administration.
May cause nervous depression and intense dyspnea at doses higher than recommended.

SIDE AND ADVERSE REACTIONS

Occasionally drowsiness, nervousness, nausea, dizziness or mild gastrointestinal discomfort. At high doses dextromethorphan may cause nervous depression and breathing difficulties.

DOSAGE AND ADMINISTRATION ROUTE

Oral
- Adults and children ages 12 years and older: 2 capsules every 4 hours. Do not exceed the recommended dose.
- Children between 6 and 12 years of age: One capsule every 4 hours. Do not exceed 4 doses in 24 hours.

PRESENTATIONS

Carton with 10, 30 and 50 capsules, in blister de 10 capsules.

STORAGE RECOMMENDATIONS

Keep below 30°C and in a dry place. Keep out of the reach of children.

Active Ingredient

Dextromethorphan, Guaifenesin


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