Ospolot is a sulfonamide derivative antiepileptic drug that has no structural similarity to other anticonvulsant drugs.

1、 Drug name

1. Common name: Sultiame

2. Product Name: Ospolo

2、 Indications

Used for the treatment of persistent spinous slow wave syndrome (POCS) during sleep, limited to use after the failure of other available and appropriate treatment methods.

3、 Specifications and characteristics

1. Specification: 50mg/tablet.

2. Appearance: Film coated tablets.

3. Main ingredient: The active ingredient is thiamethoxam.

4、 Usage and dosage

1. Initial treatment: It must be initiated under the guidance of a doctor with epilepsy treatment experience (neurologist, pediatrician).

2. Maintenance dose: The daily maintenance dose is approximately 5-10mg/kg body weight.

3. Dose adjustment: The dose should be gradually increased and can reach the maintenance dose within 1-2 weeks; Treatment can also start directly from the maintenance dose.

4. Medication frequency: The total daily dose should be divided into three doses as much as possible.

5. Medication method: Swallow the whole tablet, do not chew, and take it with about one cup of water.

6. Duration of treatment: If no therapeutic effect is observed after taking the medication for about a month, the use of thiamethoxam should be discontinued.

5、 Dose adjustment

1. Mainly by calculating individualized doses based on body weight (mg/kg/day).

2. When used in combination with other antiepileptic drugs (such as phenytoin, phenobarbital, etc.), it may be necessary to adjust the dosage of thiamethoxam, and it is recommended to monitor plasma concentration.

6、 Medication precautions

1. Usage: Take with sufficient water and do not chew.

2. Discontinuation method: Do not abruptly stop the medication, the cessation process can be quickly completed within 1-2 weeks.

3. Omission treatment: The literature does not provide clear instructions. It is recommended to maintain a regular three times daily medication regimen as much as possible.

4. Alcohol consumption: It is not recommended to drink alcohol during medication as thiamethoxam is a sulfonamide derivative that theoretically may cause adverse reactions similar to disulfiram.

7、 Medication for special populations

1. Children: Not suitable for children under 6 years old.

2. Pregnancy: Not recommended for use. Animal experiments have shown embryotoxicity, and there is currently insufficient data on human use during pregnancy.

3. Breastfeeding period: Not recommended for use. Medications may be secreted through breast milk.

4. Liver/kidney dysfunction: Prohibited for individuals with renal dysfunction. Regular monitoring of renal function is necessary during long-term treatment.

8、 Adverse reactions

1. Extremely common (≥ 1/10): stomach pain (especially in the early stages of treatment).

2. Common (1/10-1/100): shortness of breath or difficulty breathing, nausea and vomiting, loss of appetite, weight loss, angina pectoris, tachycardia, abnormal limb or facial sensations, dizziness, headache, diplopia.

3. Rare (1/10000-1/1000): rash, renal failure, urinary retention, impotence.

4. Very rare (<1/10000): leukopenia, granulocytopenia, thrombocytopenia, metabolic acidosis, elevated liver enzymes, etc.

5. Other serious reactions: Stevens Johnson syndrome, Lyell syndrome, or DRESS syndrome may occur, and once they occur, the medication must be permanently discontinued immediately.

9、 Contraindications

1. Individuals who are allergic to thiamethoxam, other sulfonamide drugs, or any excipients.

2. Individuals with renal dysfunction.

3. Individuals with a history of mental illness.

4. Patients with porphyria.

5. Individuals with hyperthyroidism.

6. Hypertensive patients without economic control.

10、 Drug interactions

1. Increasing the concentration of other drugs: Thiabendazole inhibits CYP2C enzyme and can increase the blood drug concentration of drugs such as phenytoin, barbiturates, diazepam, promethazine, diclofenac, ibuprofen, naproxen, warfarin, omeprazole, propranolol, and tolbutamide.

2. Reducing the concentration of thiamethoxam: Phenobarbital, phenytoin, propafenone, and carbamazepine can lower the blood concentration of thiamethoxam.

3. Special combination: When used in combination with phenytoin, strict monitoring is required; Co administration with Pumidone may increase side effects such as dizziness and ataxia in children; When used in combination with lamotrigine, the blood concentration of lamotrigine should be monitored.

4. Antacids: Magnesium containing antacids (such as magnesium trisilicate) may adsorb thiamethoxam, affecting absorption.

11、 Storage method

1. Store in its original packaging at a temperature below 25 ° C.

2. After the expiration date, it cannot be used.

Ospolotinformation