Ambroxol/cetirizine

Acute & chronic disorders of resp tract associated w/ abnormal bronchial secretions; productive cough & cold; allergic, chronic & asthmatic bronchitis; allergic rhinitis or sinusitis; bronchial asthma, along w/ bronchodilators; in resp tract infections, along w/ appropriate antibiotics.

Adult Acute conditions 1 tab bd-tds. Chronic conditions 1 tab daily, preferably at bedtime. In case of renal or hepatic insufficiency, reduce the dose to ½. Childn ≥10 yr Acute conditions 1 tsp (or ½ tab) bd; 5-10 yr ½ tsp bd; 2-5 yr 1/3 tsp tds For chronic administration, reduce the dose to ½.

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.

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.

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.