H-One

Tablet and oral drops: Cetirizine dihydrochloride.
Oral solution: Cetirizine hydrochloride.

Tablet: Each tablet contains: Cetirizine dihydrochloride, USP 10 mg.
Oral solution: Each mL contains: Cetirizine (as HCl), USP 1 mg.
Oral drops: Each mL contains: Cetirizine (as dihydrochloride) 2.5 mg.

Pharmacology: Cetirizine, a piperazine derivative and metabolite of hydroxyzine, is described as a non-sedating antihistamine reported to be long-acting and with some mast-cell stabilizing activity. It appears to have a low potential for drowsiness in usual doses and to be virtually free of antimuscarinic activity.
Pharmacokinetics: Oral drops: Cetirizine is rapidly absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations being attained in about one hour. Food delays the time to peak plasma concentrations but does not decrease the amount of drug absorbed. It is highly bound to plasma proteins and has an elimination half-life of about 10 hours. Cetirizine has been detected in breast milk. Cetirizine does not appear to cross the blood brain barrier to a significant extent.

Cetirizine is used for the symptomatic relief of allergic conditions including rhinitis and chronic urticaria.

Tablet: Adults and Children over 7 years of age: 1 tablet (10 mg) daily.
½ tablet (5 mg) twice daily.
Children aged from 2 to 6 years: ½ tablet (5 mg) daily.
¼ tablet (2.5 mg) twice daily.
Missed Dose: Take the missed dose as soon as the patient remembers. Skip the missed dose if it is almost time for the next scheduled dose. Do not take extra medicine to make up the missed dose.
Oral solution: Adults & Children (7 years & above): 10 mL once daily or 5 mL twice daily by mouth.
Children aged from 2 to 6 years: 5 mL once daily or 2.5 mL twice daily.
Or as prescribed by the physician.
Missed Dose: Do not take a double dose to make up for a forgotten dose.
Oral drops: Infants: 6 months to less than 12 months: 2.5 mg (1 mL) once daily.
Children: 12 months to less than 2 years: 2.5 mg (1 mL) once or twice daily every 12 hours.
2 - 5 years: 5 mg (2 mL) once daily or 2.5 mg (1 mL) twice daily every 12 hours.
Or as prescribed by the physician.

Tablet: Signs and Symptoms of Overdose: Antimuscarinic effects are less marked with cetirizine overdose.
Treatment: If the patient has taken more than the recommended dosage, consult a doctor immediately.
There is no known antidote for overdose with cetirizine. Symptomatic or supportive treatment is recommended.
Oral solution: Signs and Symptoms of Overdosage: Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest adverse events reported after an intake of at least 5 times the recommended daily dose.
If the Patient Has Taken More Than the Recommended Dosage: There is no known specific antidote to cetirizine. Should overdose occur, symptomatic or supportive treatment is recommended. Seek emergency medical attention.

Tablet: If the patient is allergic to the component of the product.
Oral solution: If the patient is allergic to cetirizine hydrochloride.

Tablet: In the case of non-sedating antihistamines, although drowsiness is rare, it can occur and may affect the performance of skilled tasks.
Occasional reports of convulsions in patients taking antihistamines suggest a need for caution in patients with epilepsy.
Reduced dosage is recommended for patients with hepatic or renal impairment.
Consult the doctor if any undesirable effect occurs.
Oral solution: If the patient is with renal insufficiency, please ask a doctor for advice.
When Should a Patient Consult the Doctor: Ask a doctor before using this product.
Oral drops: Drowsiness is a major problem with antihistamine and those affected should not drive or operate machinery. Reduced dosage is recommended for patients with renal impairment and is contraindicated for patients with cardiac disease. Antihistamine should not be given to neonates owing to their increased susceptibility to antimuscarinic effects. It has also been recommended that antihistamines should be avoided in young children. Elderly patients are also more susceptible to many of the adverse effects of antihistamines and in particular, their inappropriate use for postural giddiness should be avoided.

Tablet/oral drops: It causes mild or transient drowsiness, dry mouth, thickened respiratory tract secretions, blurred vision, urinary difficulty or retention, constipation and increased gastric reflux. Occasional gastrointestinal side effects of antihistamines include nausea, vomiting, diarrhea or epigastric pain.
Oral solution: Get emergency medical help if the patient has signs of an allergic reaction including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat).

Tablet/oral drops: Sedative interactions apply to a lesser extent with the non-sedating antihistamines; they do not appear to potentiate the effects of alcohol, but it should be avoided in excess.
Oral solution: Do not take to any of the constituents of this formulation, hydroxyzine or to any piperazine derivatives.
Oral drops: May enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and antipsychotics.

Store at temperatures not exceeding 30°C.

Antihistamines & Antiallergics

R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

Tab/Oral soln:Non-Rx;Oral drops:Rx