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Luai Al Bakour
El Temamy Pharmacy
Akoni Hijyen Teknolojileri Sanayi ve Dış Ticaret LTD. ŞTİ
Britton Chance Center for Biomedical Photonics
Arabian Trade Center - ATC
Medical Facility (32206):
Legality International. (Pvt.) Ltd.
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For the treatment of perennial rhinitis, seasonal allergic rhinitis (hay fever) and chronic idiopathic urticaria in adults and children aged 12 years and over.
Cetirizine is contraindicated in patients who are hypersensitive to cetirizine, hydroxyzine or any constituent of the tablets. Cetirizine has been reported to be excreted in human breast milk. Cetirizine is contraindicated in lactating women, due to lack of evidence of safety.
Clinical studies have shown that cetirizine at the recommended dosage has minor adverse effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported. For those patients who are affected the dosage should be halved and taken twice daily (i.e. take 5mg in the morning and 5mg in the evening). Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the drug. The following adverse drug reactions have also been reported: Abdominal pain, nausea, diarrhoea, pharyngitis and rhinitis. Isolated cases of the following adverse drug reactions have been reported in post-marketing experience. Data are insufficient to support an estimate of their incidence in the population to be treated. Blood and lymphatic disorders: thrombocytopenia. Cardiac disorders: tachycardia. Eye disorders: accommodation disorder, blurred vision. Gastro-intestinal disorders: diarrhoea. General disorders and administration site conditions: asthenia, malaise, oedema. Immune system disorders: anaphylactic shock, hypersensitivity. Hepatobiliary disorders: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin). Investigations: weight increased. Nervous system disorders: convulsions, dysgeusia, paraesthesia, syncope. Psychiatric disorders: aggression, agitation, confusion, depression, insomnia. Renal and urinary disorders: micturition difficulty. Skin and subcutaneous tissue disorders: angioneurotic oedema, pruritus, rash, urticaria.
Theophylline decreases the clearance of cetirizine although the disposition of theophylline is not affected. In common with other antihistamines it is recommended that excessive alcohol consumption be avoided. Concurrent use of cetirizine with other CNS depressants should also be avoided as reduction in alertness and impairment of performance may occur. No evidence of interactions with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, ketoconazole and pseudoephedrine has been reported.
Dosage adjustment is necessary in patients with moderate or severe renal impairment and in liver impairment. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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Samir Moussa M.D.
Dr. Tahsin Martini
Dr. Hani Najjar
Dr. Talal Sabouni
Dr . Dirar Abboud
Yaser Habrawi , F.R.C.S.Ed
Dr. Faisal Dibsi
Dr. Samer Al-Jneidy