Mizolastine tablets are indicated for the symptomatic relief of:

• Seasonal allergic rhinoconjunctivitis (hay fever)
• Perennial allergic rhinoconjunctivitis
• Urticaria (hives)

Mizolastine is a non-sedating antihistamine that blocks H1 histamine receptors on effector cells in the gastrointestinal tract, blood vessels, and respiratory system. It also possesses mast cell–stabilizing properties.

Adult and children above 12 years: The usual recommended dose is one 10 mg tablet daily.

Children below 12 years: Not recommended.

Systemic administration of ketoconazole, erythromycin, and certain antiarrhythmics (e.g., amiodarone) can moderately increase plasma levels of mizolastine, which may raise the risk of arrhythmias. Caution is advised when using other potent CYP3A4 inhibitors, such as ciclosporin, concurrently. Mizolastine has not been shown to enhance alcohol-induced sedation or impair performance.

Mizolastine is contraindicated in patients with significant heart disease, a history of symptomatic arrhythmias, known or suspected QT prolongation, electrolyte imbalances (especially hypokalemia), or clinically significant bradycardia. It should also not be used in individuals taking medications that reduce its metabolism, those with severe liver impairment, or patients with a known hypersensitivity to the drug.

Mizolastine is generally well tolerated when taken at recommended doses. Common side effects include dry mouth, diarrhea, abdominal pain, nausea, drowsiness, headache, dizziness, elevated liver enzymes, low blood pressure, rapid heart rate, and palpitations. Cases of bronchospasm and worsening asthma have been reported; however, since asthma is common among patients receiving this medication, a direct causal relationship has not been clearly established.

The safety of mizolastine during human pregnancy has not been established. Animal studies have not shown any direct or indirect harmful effects on embryo or fetal development, pregnancy, or peri- and postnatal growth. However, mizolastine should be avoided during pregnancy, especially in the first trimester. Since the drug is excreted in breast milk, its use is not recommended while breastfeeding.

Patients should be informed that a small number of individuals may experience drowsiness. It is recommended to assess personal tolerance before driving or performing tasks that require full alertness.

In the event of an overdose, general symptomatic monitoring with cardiac observation—including QT interval and heart rhythm—for at least 24 hours is recommended, along with standard measures to eliminate any unabsorbed medication. Studies in patients with renal insufficiency indicate that hemodialysis does not enhance the drug’s clearance.

Non-sedating antihistamines

Store in a cool, dry place, protected from light, and keep out of reach of children.