Zykids Forte Adverse Reactions

Montelukast: Montelukast has been evaluated for clinical studies in approximately 4,000 adult and adolescent patients 15 years of age and older for 10 mg and approximately 1,750 paediatric patients and adolescents 6 to 14 years of age for 5 mg.
The following drug related adverse reaction in clinical studies were reported commonly (≥1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo: Adult and Adolescent Patients 15 years and older (two 12-week studies; n=795 (A), Paediatric Patients 6 to 14 years old (one 8-week study; n=201) (two 56-week studies; n=615) (P), Nervous system disorders: (A) headache, (P) headache, Gastrointestinal disorders: (A) abdominal pain.
Tabulated list of Adverse Reactions: Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific Adverse Experience Term, in the table as follows. Frequency Categories were estimated based on relevant clinical trials. (See Table.)

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Levocetirizine: Adults and adolescents above 12 years of age: In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the patients in the Levocetirizine 5 mg group had at least one adverse drug reaction compared to 11.3% in the placebo group. 91.6% of these adverse drug reactions were mild to moderate. In therapeutic trials, the dropout rate due to adverse events was 1.0% (9/935) with Levocetirizine 5 mg and 1.8% (14/771) with placebo. Clinical therapeutic trials with Levocetirizine included 935 subjects exposed to the drug at the recommended dose of 5 mg daily. From this data, the following adverse drug reactions were reported at rates of 1% or greater during treatment with Levocetirizine 5 mg (L) or placebo (P): Headache: L (2.6%), P (3.2%). Somnolence: L (5.2%), P (1.4%). Dry Mouth: L (2.6%), P (1.6%). Fatigue: L (2.5%), P (1.2%).
Pediatric population: In two placebo-controlled studies in pediatric patients aged 6-11 months and aged 1 year to less than 6 years, 159 subjects were exposed to levocetirizine at the dose of 1.25 mg daily for 2 weeks and 1.25 mg twice daily respectively. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo (L) or placebo (P); Diarrhea: L (1.9%), Vomiting: L (0.6%), P (1.2%). Constipation: L (1.3%), Somnolence: L (1.9%), P (2.4%), Sleep disorder: L (1.3%).
In children aged 6-12 years double blind placebo controlled studies were performed where 243 children were exposed to 5 mg levocetirizine daily for variable periods ranging from less than 1 week to 13 weeks. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo (L) or placebo (P); Headache: L (0.8%), P (2.1%), Somnolence: L (2.9%), P (0.4%).
List of Adverse Reactions: Adverse reaction from post-marketing experience are per System Organ Class and per frequency. The frequency is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Immune system disorders: Not known: hypersensitivity including Anaphylaxis.
Psychiatric disorders: Not known: aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare.
Ear and labyrinth disorders: Not known: vertigo.
Eyes disorders: Not known: visual disturbances, blurred vision, oculogyration.
Cardiac disorders: Not known: palpitations, tachycardia.
Respiratory, thoracic and mediastinal disorders: Not known: dyspnoea.
Gastrointestinal disorders: Not known: nausea, vomiting, diarrhoea.
Hepatobiliary disorders: Not known: hepatitis.
Renal and urinary disorders: Not known: dysuria, urinary retention.
Skin and subcutaneous tissue disorders: Not known: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria not known (cannot be estimated from the available data).
Musculoskeletal, connective tissues, and bone disorders: Not known: myalgia, arthralgia.
General disorders and administration site conditions: Not known: oedema.
Investigations: weight increased, abnormal liver function tests. After levocetirizine discontinuation, pruritus has been reported.