Fingolimod Hydrochloride Capsules

Fingolimod hydrochloride capsules are mainly used to treat relapsing multiple sclerosis (RMS) in patients aged 10 years and above.
This product generally needs to be taken for a long time.
Do not stop taking it suddenly, do not take more, do not increase the number of times you take the medicine, and do not take the medicine for longer than your doctor requires… Details 
Comprehensive interpretation of fingolimod hydrochloride capsules
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Effects and efficacy:
This product is mainly used to treat relapsing multiple sclerosis (RMS) in patients aged 10 years and above.
Dosage and administration:
For adults and children aged 10 years and above and weighing more than 40 kg, the recommended dose is 0.5 mg orally once a day. Fingolimod dose levels higher than 0.5 mg have no additional benefits and are associated with an increased incidence of adverse reactions. Before starting this product, cardiac assessment; complete blood cell count (CBC); previous medication; vaccination status need to be evaluated. Patients who start treatment with this product and those who restart treatment after stopping the drug for more than 14 days need to undergo the first medication monitoring. This product can be taken on an empty stomach or with food. The capsule should be swallowed intact and the capsule shell should not be opened for use. Initial treatment with tamoxifen causes a slowing of the heart rate, for which monitoring is recommended. Obtain an electrocardiogram (ECG) before dosing and at the end of the observation period for all patients. 6-Hour Monitoring for First Dose Administer the first dose of tamoxifen at a facility equipped to treat symptomatic bradycardia. All patients should be monitored for 6 hours after the first dose for signs and symptoms of bradycardia and hourly pulse and blood pressure measurements. Additional Monitoring after 6 Hours If any of the following occur after 6 hours (even if there are no symptoms), continue monitoring until the abnormality resolves: 6 hours after dosing: Heart rate less than 45 bpm in adults, less than 55 bpm in pediatric patients 12 years and older, and less than 60 bpm in pediatric patients 10 or 11 years of age. The heart rate 6 hours after dosing is the lowest value since dosing, indicating that the maximum effect of the drug on the heart may not have been reached. An ECG 6 hours after dosing indicates new onset of 2nd degree or higher atrioventricular block. If symptomatic bradycardia occurs after dosing, appropriate treatment should be given and continuous ECG monitoring should be initiated. If medication is not required, monitoring should continue until symptoms resolve. If medication is required, continue overnight monitoring and repeat 6 hours after the second dose. Overnight Monitoring Continuous overnight ECG monitoring should be performed in a healthcare setting: For patients with symptomatic bradycardia who require pharmacological intervention. In these patients, the monitoring strategy after the first dose should be repeated after the second dose of this product. For patients with certain pre-existing cardiac and cerebrovascular diseases. For patients with a prolonged QTc interval before dosing or during the 6-hour observation period or who are at additional risk for QT prolongation or are concomitantly taking QT prolonging drugs known to have a risk of torsades de pointes. For patients who are also receiving medications that slow the heart rate or AV conduction. Monitoring after restarting treatment after stopping the drug The same post-first dose monitoring as at the start of treatment is recommended if treatment is interrupted as follows: Interruption of ≥1 day within the first 2 weeks of treatment. Interruption of more than 7 days during the 3rd and 4th weeks of treatment. Interruption of more than 2 weeks after 1 month of treatment. If the interruption period is shorter than the above period, continue treatment at the next planned dose.
Contraindications:
Contraindicated for those who are allergic to this product. Use with caution in children. Use with caution during pregnancy and lactation.
Related dosage forms:
Capsules