Opexa20 mg

Opexa 20 mg is indicated for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.

Non-sedating antihistamines

Opexa 20 mg is a non-sedative H1 receptor selective antagonist. Its principal effects are mediated via selective inhibition of peripheral H1-receptors. It shows moderate to high affinity for histamine H1-receptors and no affinity for muscarinic, serotonergic, dopaminergic and noradrenergic receptors.

Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Opexa 20 mg mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Opexa 20 mg (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Opexa 20 mg tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Opexa 20 mg

Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Opexa 20 mg (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Opexa 20 mg tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Opexa 20 mg.Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Opexa 20 mg mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.Children between 2 to 11 years: 4 ml once daily.

Concomitant intake of Opexa 20 mg and Ketoconazole or Erythromycin or Diltiazem increased C max of Opexa 20 mg. The psychomotor performance after concomitant intake of alcohol and Opexa 20 mg was similar to that observed after intake of alcohol and placebo. Concomitant intake of Opexa 20 mg and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.

Opexa 20 mg is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of the tablet.

The most commonly reported side effects in clinical trial are headache, dizziness, somnolence and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.

There are no adequate or limited amount of data for the use of Opexa 20 mg in pregnant women and during breast feeding and on the effects on fertility. In case of pregnancy or breast feeding, Opexa 20 mg should be avoided during pregnancy, unless advised otherwise by a physician.

Co-administration of Opexa 20 mg and P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.

In clinical trials, after administration of Opexa 20 mg at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) frequency of treatment-emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported.

Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.

Use in patients with impaired hepatic & renal function: There is no clinical experience in patients with hepatic impairment. Since Opexa 20 mg is not metabolized and renal clearance is its major elimination route, hepatic impairment is not expected to increase the systemic exposure above the safety margin. Therefore, no dosage adjustment is required in patients with hepatic impairment. No dosage adjustment is required in patients with renal impairment.Geriatrics (>65 years of age): No dosage adjustments are necessary in patients over 65 years.Pediatrics (<6 years of age): The safety and efficacy of Opexa 20 mg in children under 6 years of age have not been established.

Non-sedating antihistamines

Opexa 20 mg is a non-sedating, long-acting histamine antagonist with selective peripheral H 1 receptor antagonist affinity and no affinity for muscarinic receptors. Opexa 20 mg inhibits histamine-induced wheal and flare skin reactions for 24 hours following single doses.

There are no or limited amount of data from the use of Opexa 20 mg in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Opexa 20 mg during pregnancy. The excretion of Opexa 20 mg in milk has not been studied in humans. A decision must be made taking into account the benefit of breast-feeding for the child and the benefit of Opexa 20 mg therapy for the mother.

Efficacy and safety of Opexa 20 mg in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore Opexa 20 mg should not be used in these age groups.