Cetirizine Eg 10mg 7 Film-Coated Tablets

NAME
CETIRIZINE EG 10 MG TABLETS COATED WITH FILM

PHARMACOTHERAPEUTIC CATEGORY
Piperazine derivatives.

ACTIVE PRINCIPLES
Cetirizine dihydrochloride.

EXCIPIENTS
Microcrystalline cellulose; lactose monohydrate; colloidal anhydrous silica; magnesium stearate. Coating: opadry II white (consisting of hypromellose, titanium dioxide (E171), polydextrose (E1200), talc, maltodextrin, medium chain triglycerides).

INDICATIONS
Adults and pediatric patients from 6 years of age: cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis; cetirizine is indicated for the symptomatic treatment of chronic idiopathic urticaria.

CONTRAINDICATIONS / SECONDARY EFFECT
History of hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any derivative of piperazine; patients with severe renal insufficiency with creatinine clearance below 10 ml / min.

DOSAGE
Children aged 6 to 12 years: 5 mg twice a day (half tablet twice a day). Adults and children over 12 years of age: 10 mg once daily (1 tablet). The tablets should be taken with a glass of liquid. Elderly patients: based on available data, no dose reduction is required in elderly subjects with normal renal function. Patients with moderate to severe renal insufficiency: No data are available documenting the efficacy / safety ratio in patients with renal insufficiency. Since cetirizine is predominantly excreted by the kidney, in cases where alternative treatments cannot be used, the intervals between doses should be customized according to renal function. >> Dosage adjustment for adults with impaired renal function. Normal Clcr> = 80 mL / min: 10 mg once daily; mild clcr 50-79ml / min: 10mg once daily; moderate clcr 30-49 ml / min: 5 mg once daily; severe clcr <30 mL / min: 5 mg once every 2 days; end-stage renal disease - Patients on dialysis <10 ml / min: contraindicated. In pediatric patients with renal insufficiency, the dose should be individually adjusted, taking into account the renal clearance, age and body weight of the patient. Patients with hepatic insufficiency: Patients with hepatic insufficiency only do not require any dosage adjustments. Patients with hepatic and renal insufficiency: dosage adjustment is recommended.

STORAGE
This drug does not require any special storage conditions.

WARNINGS
At therapeutic doses, there was no evidence of clinically significant interactions with alcohol (for blood alcohol levels of 0.5 g / l). However, caution is advised in case of concomitant alcohol intake. 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 advised in epileptic patients and in patients at risk for seizures. Pediatric population: The use of the film-coated tablet formulation is not recommended in children younger than 6 years as this formulation does not allow for appropriate dose adjustment. Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

INTERACTIONS
For 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 were reported, in particular with pseudoephedrine or theophylline (400 mg / day). The extent of absorption of cetirizine is not reduced by food, although the rate of absorption is decreased.

SIDE EFFECTS
Clinical studies have shown that cetirizine at the recommended dosage has minor CNS undesirable effects, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective inhibitor of peripheral H1 receptors and is relatively devoid of anticholinergic activity, rare cases of micturition difficulty, eye accommodation disturbances and dry mouth have been reported. There have been reports of abnormal liver function with liver enzyme elevations accompanied by elevated bilirubin, most of which resolved following discontinuation of cetirizine dihydrochloride. In double-blind controlled clinical trials or clinical pharmacology studies comparing cetirizine versus placebo or other antihistamines at the recommended dosage (10 mg per day for cetirizine), for which quantitative safety data are available, more than 3200 subjects were treated with cetirizine. Based on these data, the following adverse events were reported in placebo-controlled trials with an incidence of 1.0% or greater with cetirizine 10 mg. Body as a whole - general pathologies: fatigue. Central and peripheral nervous system disorders: dizziness, headache. Disorders of the gastrointestinal system: abdominal pain, dry mouth, nausea. Psychiatric disorders: sleepiness. Although statistically the incidence of somnolence with cetirizine was more common than with placebo, this event was mild to moderate in severity in the majority of cases. Further studies in which objective tests have been carried out have shown that usual daily activities are not compromised at the recommended daily dose in young healthy volunteers. 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 or clinical pharmacology studies. Disorders of the gastrointestinal system: diarrhea. Psychiatric disorders: sleepiness. Respiratory system diseases: rhinitis. Body as a whole - general pathologies: fatigue. >> Post-marketing experience. Frequencies are defined as follows: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1/1000, <1/100); rare (> = 1 / 10,000, <1 / 1,000), very rare (<1 / 10,000), not known. Disorders of the blood and lymphatic system. Very rare: thrombocytopenia. Disorders of the immune system. 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, dystonia, dyskinesia, syncope, tremor; not known: amnesia, memory impairment. Eye disorders. Very rare: accommodation disorder, blurred vision, oculogyric crisis. Ear and labyrinth disorders. Not known: vertigo. Cardiac pathologies. Rare: tachycardia. Gastrointestinal disorders: Uncommon: diarrhea. Hepatobiliary disorders. Rare: impaired liver function (elevation of transaminases, alkaline phosphatase, gamma-GT and bilirubin). Skin and subcutaneous tissue disorders. Uncommon: pruritus, rash; rare: urticaria; very rare: angioneurotic edema, 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: edema. Examidiagnostics. Rare: weight gain. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Very few clinical data on treatment-exposed pregnancies are available for cetirizine. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonic / fetal development, parturition or postnatal development. Prescribing for pregnant women should be done with caution. 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 lactan women should be done with caution.