RM CETIRIZINE 5MG SYRUP 60ML

Medicine Information

What is this medicine used for?

Cetirizine hydrochloride is used as a symptomatic relief of allergic conditions including rhinitis and chronic urticaria.

How much and how often should you use this medicine?

6 months to 2 years old: Initial dose 2.5 mg (1/2 teaspoon) per day. This may be increased to a maximum of 5 mg (1 teaspoon) per day, given two times per day.

2 to 5 years old: 2.5 mg (1/2 teaspoon) twice a day or 5 mg (1 teaspoon) per day as one dose

Or, as prescribed by the physician.

Warnings and Precautions:

Cetirizine hydrochloride should be given with caution in patients who require mental awareness or physical coordination in their work, such as drivers or machine operators, since it may cause drowsiness.

Use in pregnant women: No data is available on the safety of administration of Cetirizine hydrochloride in pregnant women apart from an animal study which reveals the absence of teratogenicity. As such, Cetirizine hydrochloride must be given to pregnant patients only when necessary.

Use in lactating mothers: Cetirizine is excreted in breast milk. Thus, use in lactating mothers is not recommended.

Use in infants: Infants and children may not be given Cetirizine hydrochloride as this may increase the risk of experiencing antimuscarinic effects.

Use in elderly patients: Cetirizine hydrochloride must be given with caution to elderly patients who most likely have impaired renal and hepatic function. Since the drug is metabolized through the renal mechanism, the half-life of Cetirizine hydrochloride in such patients will be prolonged. The dose of the drug must be reduced in elderly patients.

Undesirable Effects:

Cetirizine hydrochloride, though considered a 'non-sedating' antihistamine, was found to cause drowsiness. Recurrent acute hepatitis developed in one patient taking Cetirizine hydrochloride for the control of seasonal allergic rhinitis. Other adverse effects associated with the use of Cetirizine hydrochloride are:

• Irritability
• Insomnia
• Fatigue
• Dry mouth
• Pharyngitis
• Dizziness
• Headache
• Abdominal pain
• Diarrhea
• Epistaxis
• Bronchospasm
• Nausea and vomiting
• Hypersensitivity manifested by urticaria and fixed drug eruptions

Although Cetirizine hydrochloride has low potential for severe hepatotoxicity, the possibility of developing autoimmune-mediated hepatotoxicity should be considered when administering the drug. A patient under long-term treatment with Cetirizine hydrochloride for atopic dermatitis was reported to have developed life-threatening hepatitis.

Interaction with other medicaments:

Sedation may be enhanced upon concomitant use of antihistamines in general with central nervous system depressants such as barbiturates, alcohol, hypnotics, opioid analgesics, anxiolytic sedatives, and neuroleptics.

The use of Cetirizine hydrochloride with drugs that inhibit the cytochrome P450 microsomal enzymes, such as azithromycin, erythromycin, and ketoconazole, did not cause clinically significant changes.

Effects of alcohol and other CNS depressants are enhanced by Cetirizine hydrochloride. Pharmacokinetics of ritonavir, an HIV-protease inhibitor, are not affected by Cetirizine hydrochloride.

Indication

Cetirizine hydrochloride is used as a symptomatic relief of allergic conditions including rhinitis and chronic urticaria.

Ingredients

Each 5 mL (1 teaspoonful) syrup contains: Cetirizine hydrochloride5 mgFlavor: Grape