FLUDREX Syrup 120 ml

Fludrex syrup

Active ingredients: Each 5 ml contain:
Paracetamol 120 mg
Pseudoephedrine HCl 15 mg
Chlorpheniramine maleate 0.75 mg

Mode of Action:
Paracetamol: based on the inhibition of prostaglandin biosynthesis.
Pseudoephedrine: has direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant.
Chlorphenamine maleate: potent antihistamine (H1-antagonist).

Indications:
FLUDREX is particularly effective against the symptoms of cold and flu. 
• Relieving nasal congestion and rhinorrhea.
• Lowering temperature due to common cold & flu.
• Relieving pain and headache.

Posology: 
Children 6-12 years: Two teaspoonful (10 ml), 3 times daily (every 8 hours).

Precautions:
• Do not exceed the stated dose.
• Caution when used in children from 6-12 years, patients with diabetes, hypertension, hyperthyroidism and ischemic heart disease, in case of epilepsy, prostatic hypertrophy, urinary retention, glaucoma and hepatic diseases.

Contraindications:
• Hypersensitivity to any component of Fludrex preparations.
• Children <6 years.
• Pregnancy (unless prescribed) and breastfeeding.
• In combination with Monoamine Oxidase Inhibitors (MAOIs).

Undesirable effects:
The following side effects may occur during the treatment: somnolence, insomnia, dizziness, allergic skin rashes, palpitations and gastrointestinal disturbances.

Pharmacokinetic properties:
• ABSORPTION: Paracetamol: is rapidly and almost completely absorbed from the gastrointestinal tract. Pseudoephedrine: the C max of pseudoephedrine was approximately 180 ng/ml with t-max occurring at approximately 1.5 hours for the tablets after drug administration. Chlorphenamine maleate is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours. 
• DISTRIBUTION: The apparent volume of distribution of pseudoephedrine (Vd/F) was approximately 2.8 l/kg.
• METABOLISM AND ELIMINATION: Paracetamol: The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Plasma Protein Binding of the drug is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Pseudoephedrine: the t½ was approximately 5.5 hours. Pseudoephedrine is partly metabolized in the liver by N-demethylation to nor-pseudoephedrine, an active metabolite. Pseudoephedrine and its metabolite are excreted in the urine; 55% to 90% of a dose is excreted unchanged. Chlorphenamine: is metabolized to monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine.

Storage and disposal:
• Keep in a safe place, out of the reach and sight of children.
• Store below 30 ºC, Protect from light.

How to use? 

Children 6-12 years: Two teaspoonful (10 ml), 3 times daily (every 8 hours).

Ingredients

Paracetamol 120 mg
Pseudoephedrine HCl 15 mg
Chlorpheniramine maleate 0.75 mg