ALDUET Montelukast Sodium / Cetirizine Hydrochloride 10mg / 10mg Film-Coated Tablet 1's
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Features
- Cetirizine
- Montelukast
Description
Indications/Uses
Dosage/Direction for Use
Elderly: At present there are no data to suggest that the dose need to be reduced in elderly patients.
Patients with Hepatic and Renal Impairment: Dosage should be reduced to half the usual daily dose in patients with hepatic or renal impairment.
Administration
Contraindications
Special Precautions
Effects on the Ability to Drive or Operate Machinery: Studies in healthy volunteers at 20 and 25mg/day have not revealed effects on alertness or reaction time; however, patients are advised not to exceed the recommended dose if driving or operating machinery.
Use In Pregnancy & Lactation
Adverse Reactions
Body As A Whole: Asthenia/fatigue M (1.8%), P (1.2%). Fever: M (0.6%), P (3.0%). Abdominal Pain: M (2.9%), P (2.5%) Trauma: M (1.0%), P (0.8%).
Digestive System Disorders: Dyspepsia M (2.1%), P (1.1%). Infectious gastroenteritis: M (2.1%), P (1.1%). Dental Pain: M (1.7%), P (1.0%).
Nervous System/Psychiatric: Dizziness M (1.9%), P (1.4%). Headache: M (18.4%), P (18.1%).
Respiratory System Disorders: Congestion, nasal M (1.6%), P (1.3%). Cough M (2.7%), P (2.4%). Influenza: M (4.2%), P (3.9%).
Skin/Skin Appendages Disorder: Rash M (1.6%), P (1.2%).
Laboratory Adverse Experiences:* ALT increased M (2.1%), P (2.0%). AST increased M (1.6%), P (1.2%). Pyuria: M (1.0%), P (0.9%).
Cetirizine: There have been occasional reports of mild and transient subjective side effects e.g., headache, dizziness, drowsiness, agitation, dry mouth and gastrointestinal discomfort.
Arrhythmias: The ECG effects of Cetirizine when administered a dose of up to six times the usual recommended dose did not prolong the QT interval.
Hypersensitivity: Hypersensitivity reactions manifest as urticaria and fixed drug eruptions have been reported with Cetirizine.
Sedation: CNS depression is the most common adverse effect of Cetirizine. The sedative effect can range from slight drowsiness to deep sleep.
Drug Interactions
Cetirizine: Some interactions are less likely with Cetirizine than with non-sedating antihistamines such as astemizole and terfenadine, since Cetirizine appears to have low hepatic metabolism and little arrhythmogenic potential.
Concomitant use of Cetirizine and pilsicainide may increase the serum concentration of both drugs which may lead to drug toxicities.
Anticoagulants: There has been a report of a raised INR and severe epistaxis in a patient after the addition of Cetirizine to long-term acenocoumarol.
Storage
Action
Cetirizine: Cetirizine hydrochloride, a piperazine derivative and metabolite of hydroxyzine, is described as a non-sedating antihistamine which is long-acting and has some mast-cell stabilizing activity. It appears to have a low potential for drowsiness in usual doses and to be virtually free of antimuscarinic activity. It is a selective H1-antagonist with negligible effects on other receptors and so it is virtually free from anticholinergic and antiserotonin effects. Cetirizine inhibits the histamine-mediated "early" phase of the allergic reaction and also reduces the migration of inflammatory cells e.g., eosinophils and the release of mediators associated with the "late" allergic response.
Pharmacokinetics: Montelukast: Absorption: Montelukast is rapidly absorbed 2 to 4 hours following oral administration. Mean peak plasma concentration (Cmax) is achieved 3 hours (Tmax) after administration of a 10 mg dose in adults in the fasted state. The mean oral bioavailability is 64%. The oral bioavailability and Cmax are not influenced by a standard meal. Safety and efficacy were demonstrated in clinical trials where the 10-mg film-coated tablet was administered without regard to the timing of food ingestion. Cmax is achieved in 2 hours after administration of the 5 mg chewable tablet in adults in the fasted state. The mean oral bioavailability is 73% and is decreased to 63% by a standard meal.