ZADONASE
Fexofenadine Hydrochloride + Montelukast Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each film
coated tablet contains Fexofenadine Hydrochloride (120) + Montelukast
(10mg). INDICATION: For treatment of allergic rhinitis
in adults only. DOSAGE AND METHOD OF ADMINISTRATION: To
be taken orally, indicated once daily.
CONTRAINDICATIONS: In patients with a known
hypersensitivity to montelukast, fexofenadine or to any of the
excipients. WARNING AND PRECAUTION: Montelukast is not
suitable for treating acute asthma attacks; patients should use
short-acting beta- agonists instead and seek medical advice promptly if
needed. Abruptly substituting montelukast for corticosteroids is not
recommended, and caution is advised for potential systemic eosinophilia.
Neuropsychiatric events have been reported in adults, adolescents, and
children taking montelukast Additionally, patients with specific
lactose-related conditions should avoid this medication.
UNDESIRABLE EFFECTS: Headache, drowsiness, dizziness,
nausea, upper respiratory infection, increased bleeding tendency,
hypersensitivity reactions including anaphylaxis, dream abnormalities
including nightmares, insomnia, somnambulism, anxiety, agitation
including aggressive behaviour or hostility, depression, psychomotor
hyperactivity (including irritability, restlessness, tremor).
DRUG INTERACTIONS: co–administration of fexofenadine
hydrochloride with ketoconazole and erythromycin led to increased plasma
levels of fexofenadine hydrochloride. Bioavailability of fexofenadine
decreases when taken with aluminum and magnesium antacids, suggesting a
2-hour interval between administrations. Montelukast shall be dosed with
caution along with phenobarbital, which may decrease montelukast levels,
while inhibitors like gemfibrozil may increase its exposure.
USE IN SPECIAL POPULATION: Pregnancy & lactating women
– No data available. Hepatic impairment: The pharmacokinetics of
fexofenadine hydrochloride in subjects with hepatic impairment did not
differ. Renal impairment: Fexofenadine: A dose of 60 mg once daily is
recommended as the starting dose in adult patients with decreased renal
function. These highlights do not include all the information needed to
use Zadonase tablets effectively and safely. Please refer to full
prescribing information [available on request].
FOR FURTHER INFORMATION, CONTACT: Medical Affairs;
Alkem House; Senapati Bapat Marg, Lower Parel, Mumbai, Maharashtra: 400
013. Prepared on 7th June 2024. Source: Prescribing Information Zadonase
tablets