Mizolastine

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[edit] BRAND NAMES

[edit] STRUCTURE

Mizolastine.jpg

[edit] MECHANISM OF ACTION

Mizolastine has anti-allergic and antihistamine properties due to specific and selective blockade of peripheral histamine H1 receptors. Mizolastine has a rapid onset and a long action duration (24 hours).

[edit] INDICATIONS

Mizolastine is indicated for the symptomatic treatment of seasonal allergic rhino-conjunctivitis (hay fever), perennial allergic rhino-conjunctivitis and urticaria.

[edit] DOSAGE

Adults, including the elderly, and children over 12 years old: The recommended daily dose is one 10 mg tablet

[edit] CONTRAINDICATIONS

  • Hypersensitivity to the active substance or any of the other ingredients.
  • Concomitant treatment with macrolide antibiotics or systemic antifungals of the imidazole type.
  • Concomitant treatment with a drug known to prolong the QT interval, such as class I and III anti-arrhythmics.
  • Significant impairment of liver function.
  • Clinically significant cardiac disease, or history of symptomatic arrhtmias.
  • Patients with known or suspected prolongation of the QT interval or with electrolyte imbalance, in particular hypokalemia.
  • Clinically significant bradycardia.

[edit] WARNINGS AND PRECAUTIONS

Mizolastine has a weak potential to prolong the QT interval, only observed in a few cases. The degree of prolongation is modest and is not associated with cardiac arrhythmias.

Elderly patients may be particularly sensitive to the sedative effects of mizolastine and its potential effects on cardiac repolarization.

[edit] INTERACTIONS

  • ketoconazole and erythromycin moderately increase the plasma concentration of mizolastine; therefore it is contraindicated to use these drugs with mizolastine.

[edit] PREGNANCY AND LACTATION

As a precautionary measure, administration of mizolastine should be avoided during pregnancy, particularly during the first trimester.

Mizolastine is excreted into breast milk, and is not recommended to breast-feeding women.

[edit] SIDE EFFECTS

Gastrointestinal disorders:
Common (1-10%): diarrhea, abdominal pain (including dyspepsia), dry mouth, nausea.


Central nervous system and psychiatric disorders :
Common (1-10%): drowsiness, often transient, headache, dizziness,
Uncommon (0.1-1%): anxiety and depression.


Hepatic disorders:
Uncommon (0.1-1%): increase in liver enzymes.


Hematological disorders:
Very rare (<0.01%): low neutrophil count.


Body as a whole:
Common (1-10%): asthenia, often transient, increase in appetite accompanied by weight gain.
Very rare (<0.01%): allergic reactions: anaphylaxis, angioedema, generalized rash, urticaria, pruritus and hypotension.


Cardiovascular disorders:
Uncommon (0.1-1%): hypotension, tachycardia, palpitations,
Very rare(<0.01%) : Vasovagal attack

Muscle and skeletal disorders:
Uncommon (0.1-1%): : arthralgia and myalgia.


Cases of bronchospasm and aggravation of asthma have been reported but, in view of the high frequency of asthma in the treated population, the causal relationship remains uncertain.

A prolongation of the QT interval has been observed in the course of treatment with certain antihistamines, increasing the risk of severe cardiac arrhythmia in patients at risk.

Minor variations in blood sugar levels and electrolytes have been observed in rare cases.

The clinical relevance of these changes in otherwise healthy individuals remains uncertain.

Patients at risk (diabetics, those susceptible to electrolyte imbalance or cardiac arrhythmias) should be monitored periodically.

Due to the presence of castor oil, gastrointestinal disorders (nausea, vomiting, abdominal pain) may occur.

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