Description
Irireos Antihistamine Oral Drops 10 Vials 10 mg/ml
Cetirizine Dihydrochloride
Product Sheet
Antihistamines for systemic use, piperazine derivatives.
Directions
Cetirizine hydrochloride 10 mg/ml oral drops, solution is indicated in adults and paediatric patients aged 2 years and above: for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis; for the symptomatic treatment of chronic idiopathic urticaria.
Contraindications
Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any piperazine derivative. Patients with severe renal insufficiency with creatinine clearance less than 10 ml/min.
Interactions
Due to the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, no interactions with this antihistamine are expected. In drug-drug interaction studies, in fact, neither pharmacodynamic nor significant pharmacokinetic interactions have been reported, in particular with pseudoephedrine or theophylline (400 mg/day). The degree of absorption of cetirizine is not reduced by food intake, although the percentage of absorption is decreased. In sensitive patients, the concomitant intake of cetirizine with alcohol or other substances with a depressant action on the CNS, can cause a further decrease in the state of alertness and alteration of performance, although cetirizine does not potentiate the effect of alcohol (0.5 g/L blood levels).
Side Effects
Clinical studies. General: Clinical studies have shown that cetirizine at the recommended dosage has minor CNS adverse effects, including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective antagonist of peripheral H1 receptors and is relatively free of anticholinergic activity, isolated cases of difficulty in urination, disturbances of ocular accommodation and dry mouth have been reported. Cases of abnormal liver function with elevated liver enzymes accompanied by elevated bilirubin have been reported, most of which resolved following discontinuation of cetirizine dihydrochloride treatment. List of adverse reactions: In double-blind controlled clinical trials or clinical pharmacology studies comparing the effects of cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine) for which quantitative safety data are available, more than 3200 subjects were treated with cetirizine. Based on these cumulative data, the following adverse reactions were reported in placebo-controlled trials with an incidence of ≥ 1.0% for cetirizine 10 mg. General disorders and administration site conditions: fatigue. Nervous system disorders: dizziness, headache. Gastrointestinal disorders: abdominal pain, dry mouth, nausea. Psychiatric disorders: somnolence. Respiratory, thoracic and mediastinal disorders: pharyngitis. Although statistically the incidence of somnolence is more common than with placebo, this event was mild to moderate in severity in the majority of cases. Further studies in which objective tests were performed have shown that usual daily activities are not impaired at the recommended daily dose in healthy young volunteers. Paediatric population: adverse reactions with an incidence equal to or greater than 1.0% in children aged 6 months to 12 years in placebo-controlled clinical trials are as follows. Gastrointestinal disorders: diarrhoea. Psychiatric disorders: somnolence. Respiratory, thoracic and mediastinal disorders: rhinitis. General disorders and administration site conditions: fatigue. Post-marketing experience: in addition to the adverse reactions observed during clinical trials, listed in the previous paragraph, the following undesirable effects have been reported during post-marketing experience. The undesirable effects are described according to the MedDRA system organ classification and in accordance with the frequency defined on the basis of post-marketing experience. Frequencies are defined as follows: very common (>=1/10); common (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Blood and lymphatic system disorders: Very rare: thrombocytopenia. Immune system disorders: Rare: hypersensitivity; very rare: anaphylactic shock. Metabolism and nutrition disorders: Not known: increased appetite. Psychiatric disorders: Uncommon: agitation; rare: aggression, confusion, depression, hallucinations, insomnia; very rare: tics; not known: suicidal ideation. Nervous system disorders: Uncommon: paraesthesia; rare: convulsions; very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia; not known: amnesia, memory impairment. Eye disorders. Very rare: accommodation disorder, blurred vision, oculotation. Ear and labyrinth disorders: vertigo. Cardiac disorders. Rare: tachycardia. Gastrointestinal disorders. Uncommon: diarrhoea. Hepatobiliary disorders. Rare: abnormal liver function (increased transaminases, alkaline phosphatase, gamma-GT and bilirubin). Skin and subcutaneous tissue disorders. Uncommon: pruritus, rash; rare: urticaria; very rare: angioneurotic oedema, fixed drug eruption. Renal and urinary disorders. Very rare: dysuria, enuresis; not known: urinary retention. General disorders and administration site conditions. Uncommon: asthenia, malaise; rare: oedema. Diagnostic tests. Rare: weight gain. Description of selected adverse reactions: Pruritus (intense itching) and/or urticaria have been reported after discontinuation of cetirizine treatment.
Directions for Use and Dosage
Dosage: 10 mg (20 drops) once daily. Special populations. Elderly patients: Based on available data, no dose reduction is necessary in elderly subjects with normal renal function. Patients with moderate to severe renal impairment: There are no data available to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is predominantly excreted via the kidneys, in cases where alternative treatments cannot be used, dosing intervals should be individualized based on renal function. Refer to the following list and adjust the dose as indicated. To use this dosage list, it is necessary to have an estimate of the patient's creatinine clearance (CLcr) expressed in ml/min. CL cr (ml/min) can be calculated from serum creatinine (mg/dl) using the following formula: CL^cr = [140 - age (years)] x weight (kg) / 72 x serum creatinine (mg/dl) (x 0.85 for females). Dosage adjustment for adults with impaired renal function. Group: normal; creatinine clearance: >= 80 ml/min; dosage and frequency: 10 mg once daily. Group: mild; creatinine clearance: 50 - 79 ml/min; dosage and frequency: 10 mg once daily. Group: moderate; creatinine clearance: 30 - 49 ml/min; dosage and frequency: 5 mg once daily. Group: severe; creatinine clearance: < 30 ml/min; dosage and frequency: 5 mg once every 2 days. Group: end-stage renal disease - dialysis patients; Creatinine clearance: < 10 ml/min; Dosage and frequency: Contraindicated. Patients with hepatic impairment: Patients with hepatic impairment alone do not require any dose adjustment. In patients with both hepatic and renal impairment, dose adjustment is recommended (see above "Patients with moderate to severe renal impairment"). Paediatric population: Children aged 2 to 6 years: 2.5 mg (5 drops) twice daily. Children aged 6 to 12 years: 5 mg (10 drops) twice daily. Adolescents aged 12 years and over: 10 mg (20 drops) daily. In paediatric patients with renal impairment, the dose should be individually adjusted, taking into account the renal clearance, age and body weight of the patient. Method of administration: The drops should be placed on a spoon or diluted in water and taken orally. If dilution is used, it should be considered that the volume of water added to the drops must be in such a quantity that can be taken by the patient, especially for pediatric administration. The solution must be administered immediately.
Warnings and Contraindications
At therapeutic doses, no clinically significant interactions with alcohol have been observed (for blood alcohol levels of 0.5 g/l). However, caution is recommended when taking alcohol concomitantly. Caution should be exercised in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention. Caution is recommended in epileptic patients and in patients at risk of convulsions. Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). The response to allergy skin tests is inhibited by antihistamines and a wash-out period (3 days) is required before performing them. Itching and/or urticaria may occur when treatment with cetirizine is stopped, even if these symptoms were not present before the start of treatment. In some cases, symptoms may be severe and treatment may need to be restarted. Symptoms should resolve when treatment is restarted. Paediatric population: The use of the medicinal product is not recommended in infants and children under 2 years of age.
Pregnancy: Prospective data collected for cetirizine on pregnancy outcomes do not suggest potential maternal or embryo/fetal toxicity above baseline values. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development. Prescribing to pregnant women should be done with caution. Breastfeeding: Cetirizine is excreted in breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the sampling time after administration. Therefore, prescribing to nursing women should be done with caution. Fertility': Limited data on fertility in humans are available but no safety concerns have been identified. Animal data do not reveal safety concerns for human production.
Composition
1 ml of solution contains 10 mg of cetirizine dihydrochloride, one drop of solution contains 0.5 mg of cetirizine dihydrochloride. A single-dose container contains: 10 mg of cetirizine dihydrochloride. Irireos antihistamine 10 mg/ml oral drops, solution 20 ml bottle, excipients: 1 ml of solution contains 1.35 mg of methyl parahydroxybenzoate; 1 ml of solution contains 0.15 mg of propyl parahydroxybenzoate.
Irireos Antihistamine 10 mg/ml oral drops, single-dose solution: glycerol 85%, propylene glycol, sodium saccharin, sodium acetate trihydrate, glacial acetic acid, water for injections Irireos Antihistamine 10 mg/ml oral drops, solution 20 ml bottle: glycerol 85%, propylene glycol, sodium saccharin, sodium acetate trihydrate, glacial acetic acid, methyl p-hydroxybenzoate (E 218), propyl p-hydroxybenzoate (E 216), water for injections
Format
10 bottles.
