Xytozen

Xytozen

Manufacturer:

Globela Pharma

Distributor:

Trumed
Concise Prescribing Info
Contents
Per 10 mg/5 mg FC tab Montelukast Na 10 mg, levocetirizine HCl 5 mg
Indications/Uses
Allergic reactions eg, chronic urticaria, obstructive airway diseases & rhinitis.
Dosage/Direction for Use
Chronic asthma Adult 10 mg once daily in the evening. Childn >15 yr 10 mg once daily, 6-14 yr 5 mg daily, 2-5 yr 4 mg daily. All doses to be taken in the evening. Allergic rhinitis Adult 10 mg once daily in the evening. Prophylaxis of exercise-induced asthma Adult & childn >15 yr 10 mg at least 2 hr prior to exercise; do not administer additional doses w/in 24 hr.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to montelukast Na, levocetirizine or cetirizine. Patients w/ completely impaired renal function (anuria).
Special Precautions
A wash-out period (of 3 days) is required before performing allergy skin tests. Reports of neuropsychiatric events in adults, adolescents, & childn. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Use a short-acting inhaled β-agonist if an acute attack occurs. Contains lactose monohydrate. Caution w/ concurrent intake of alcohol. Not to be used during pregnancy only if it is considered to be clearly essential. Not recommended in childn <6 yr. Levocetirizine: May increase the risk of urinary retention in patients w/ predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia). May cause seizure aggravation in patients w/ epilepsy & at risk of convulsion. Pruritus may occur if levocetirizine is stopped even if those symptoms were not present before treatment initiation. Caution when prescribing levocetirizine to lactating women. Montelukast: Never use oral dosage form to treat acute asthma attacks. Not to be substituted abruptly for inhaled or oral corticosteroids. Does not alter the need for patients w/ aspirin-sensitive asthma to avoid taking aspirin & other NSAIDs. May be used in breast-feeding only if it is considered to be clearly essential.
Adverse Reactions
URTI. Diarrhoea, vomiting; rash. Dyspepsia, abdominal pain, dizziness, headache, fatigue, & somnolence. Hypersensitivity, irritability, restlessness, insomnia. Nausea; elevated levels of serum transaminases (ALT & AST); pyrexia.
Drug Interactions
Levocetirizine: Increased extent of exposure w/ & slightly altered disposition of ritonavir. Decreased rate of absorption w/ food. Concurrent administration w/ alcohol or other CNS depressants may cause additional reductions in alertness & impairment of performance. Montelukast: Decreased AUC w/ phenobarb. Caution, particularly in childn, when co-administered w/ inducers of CYP3A4, 2C8, & 2C9 eg, phenytoin, phenobarb & rifampicin. Increased systemic exposure w/ gemfibrozil or other potent inhibitors of CYP2C8.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R03DC53 - montelukast, combinations ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Presentation/Packing
Form
Xytozen 10 mg/5 mg FC tab
Packing/Price
30's