Mizolastine sustained-release tablets

In life, we often see children suffering from skin urticaria or some common allergies. For them, the related medicines they take usually contain some drugs such as midostaurin sustained-release tablets. Mizolastine sustained-release tablets are mainly used as long-acting histamine H1 receptor antagonists and are suitable for skin allergy symptoms such as urticaria, seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis in adults or children over 12 years old. Let's take a look at Mizolastine sustained-release tablets!

1. Ingredients

Active ingredient: Mizolastine

2. Properties

This product is white coated tablets.

3. Indications

This product is a long-acting histamine H1 receptor antagonist, suitable for skin allergic symptoms such as urticaria, seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis in adults or children over 12 years old.

IV. Usage and Dosage

oral. Adults (including the elderly) and children over 12 years old: 1 tablet (10 mg) once a day. Or take as directed by your doctor. This product is a sustained-release film-coated tablet and cannot be broken apart for oral administration.

5. Adverse Reactions

This drug may cause adverse reactions in individual patients, in descending order of incidence: – Occasionally: drowsiness and fatigue (usually transient), increased appetite accompanied by weight gain.

– Rare: dry mouth, diarrhoea, abdominal pain (including indigestion), or headache. – Rare cases: hypotension, vagal abnormalities (may cause syncope), anxiety, depression, decreased white blood cell count, and elevated liver enzymes.

– Very rare allergic reactions, angioedema, generalized rash, urticaria, pruritus and hypotension.

– Bronchospasm and exacerbations of asthma have been reported. However, given the high incidence of asthma in the treated population, the relevance to mizolastine cannot be determined. – QT has been observed with certain antihistamines

This can increase the risk of serious arrhythmias in high-risk groups.

– Very rare, minor changes in blood glucose or electrolyte levels, even in healthy individuals, of unclear clinical significance. For high-risk patients (particularly those with diabetes, suspected electrolyte imbalance, and cardiac arrhythmias), appropriate parameters should be monitored regularly.

– Since this product contains castor oil, it may cause digestive tract discomfort such as nausea, vomiting and abdominal pain. Please contact your doctor if any adverse reactions occur during treatment.

6. Taboo

This medicine is contraindicated in the following cases: - Hypersensitivity to any of the ingredients in this product. – Severe liver impairment. – Use in combination with imidazole antifungal drugs (for systemic use) or macrolide antibiotics. – Known to prolong QT

Combination of drugs for the interval, such as Class I and Class III antiarrhythmic drugs. – History of syncope. – Severe heart disease or a history of heart rhythm disturbances (bradycardia, arrhythmia, or tachycardia). – Clear or suspected QT

Interval prolongation or electrolyte imbalance, especially hypokalemia. – Severe bradycardia. If in doubt, ask your doctor or pharmacist for advice.

VII. Precautions

– Mizolastine has the potential to slightly prolong the QT interval in isolated cases, but the extent of this prolongation is modest and not associated with cardiac rhythm disturbances.

– If you have a history of heart disease, cardiac discomfort or palpitations, please seek medical advice before taking this medicine.

– Most patients taking mizolastine can drive or perform tasks that require mental concentration. However, in order to identify individuals who are particularly sensitive to the drug, it is recommended that individuals be evaluated before driving and performing complex tasks.

– If in doubt, consult your doctor or pharmacist. – Keep out of reach of children.

8. Use of the drug by pregnant and lactating women

The safety of mizolastine use in pregnant women has not been established. Animal studies have not shown that mizolastine has direct or indirect toxicity to the development of the embryo or fetus during pregnancy, the perinatal period, and the postpartum period. There is currently no sufficient data on the teratogenicity and fetal toxicity of mizolastine in pregnant women, but like other drugs, it is not recommended during pregnancy, especially in the first three months.

Breast-feeding: There is a lack of data on the concentration of mizolastine in breast milk after administration, so its use during breast-feeding is not recommended.

IX. Use of medication in children

There is no information on the use of this drug in children under 12 years of age.

10. Medication for the Elderly

The medication for elderly patients is the same as that for adults. Elderly patients may be more sensitive to the potential sedative and cardiac repolarizing effects of mizolastine.

11. Drug Interactions

Although this product has a high oral availability and is mainly metabolized by glucuronidation, the plasma concentration of mizolastine will be increased to a certain extent when it is used simultaneously with systemically administered imidazole antifungal drugs (such as ketoconazole) or macrolide antibiotics (such as erythromycin, troleandomycin, clarithromycin or josamycin). Therefore, this product should not be used in combination with the above-mentioned drugs.

Caution should be exercised when used in combination with strong inhibitors or substrates of the hepatic oxidase CYP3A4. These substrates include: cimetidine, cyclosporine, nifedipine, etc. Studies have shown that mizolastine does not exacerbate alcohol-induced sedation and behavioral abnormalities.

When taking multiple medications, please contact your doctor or pharmacist to avoid possible drug interactions.

12. Drug Overdose

In the event of overdose, comprehensive symptom monitoring, including cardiac monitoring (QT interval and heart rate), for at least 24 hours is recommended while routine methods of elimination of unabsorbed drug are used.

Results from studies in patients with renal impairment indicate that hemodialysis does not increase drug clearance.