| Dossier: | Ctd |
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| Transport Package: | Free |
| Specification: | 200mg |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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Audited Supplier 
| Generic Name | Lamotrigine Extended-Release Tablets 200mg |
| Strength | 200mg |
| Packing | 10tabs/blister,3blisters/box |
| Origin | China |
This product is light yellow square shaped tablet.
Epilepsy: Monotherapy for children and adults over 12 years of age:
1. Simple partial seizure
2. Complex partial seizure
3. Secondary generalized tonic-clonic seizures
4. Primary generalized tonic-clonic seizures
Monotherapy is not currently recommended for children under 12 years of age because data from controlled trials in this specific target population are not yet available.
add-on therapy for children and adults over 2 years of age:
1. Simple partial seizure
2. Complex partial seizure
3. Secondary generalized tonic-clonic seizures
4. Primary generalized tonic-clonic seizures
It may also be used to treat seizures associated with Lennox-Gastaut syndrome.
Usage and dosage:
[u] How to take [/u]
This product should be swallowed whole with a small amount of water.
To ensure the maintenance of the therapeutic dose, the patient's weight should be monitored and the dose should be checked when the weight changes.
If the calculated dose of lamotrigine (for children and patients with liver dysfunction) is not a full tablet number, the dose used should be the lowest full tablet number.
The effect of the above changes on the pharmacokinetics of lamotrigine should be considered when other co-antiepileptic drugs are discontinued and used as monotherapy or other antiepileptic drugs are added to the addition regimen of lamotrigine
(See Drug Interactions).
[u] monotherapy dose [/u]
Adults and children over 12 years old:
The initial dose of this monotherapy is 25mg once daily for two weeks. Then 50mg once daily for two weeks. Thereafter, the dose is increased every 1-2 weeks, with a maximum increase of 50-100mg, until optimal efficacy is achieved. The maintenance dose that usually achieves the best efficacy is 100-200mg/ day, administered once daily or in two separate doses. However, some patients need to take 500mg of lamotrigine daily to achieve the desired effect.
The recommended dose-escalation methods for monotherapy in adults and children over 12 years of age are shown in the table below:
1+2 weeks 3+4 weeks is usually a maintenance dose
25mg(once daily) 50mg(once daily) 100-200mg(once daily or in two doses)
To achieve maintenance, the daily dose may be increased by 50-100mg every 1-2 weeks
To reduce the risk of developing a rash, do not increase the initial dose or subsequent dose increments beyond the table above (see Precautions).
[u] Dosage of added therapy [/u]
Adults and children over 12 years old:
For patients taking valproate, regardless of whether they are taking other antiepileptic drugs, the initial dose of this product is 25mg, taken every other day for two weeks; 25mg once daily for two weeks. Thereafter, the dose should be increased every 1-2 weeks, with a maximum increase of 25-50mg, until optimal efficacy is achieved. The maintenance dose that usually achieves the best effect is 100-200mg daily, taken once or in two doses.
The initial dose of this product is 50mg once daily for 2 weeks in patients with enzyme-induced antiepileptics, regardless of whether they are taking other antiepileptics (other than sodium valproate); 100mg daily for two weeks. Thereafter, the dose is increased every 1-2 weeks with a maximum increase of 100mg until optimal efficacy is achieved. The maintenance dose that usually achieves the best effect is 200-400mg daily, taken in two doses. Some patients need to take 700mg daily to achieve the desired effect.
In patients taking other drugs that do not significantly inhibit or induce lamotrigine gluconalylation (see Drug Interactions), the initial dose of this product is 25mg once daily for two weeks; 50mg once daily for two weeks. Thereafter, the dose level should be increased every 1-2 weeks by 50-100mg/ day, and subsequently the dose should be increased to achieve optimal efficacy. The maintenance dose for optimal efficacy is usually 100-200mg/ day, taken once daily or in two doses.
The recommended dose escalation method for combination therapy in adults and children over 12 years of age is shown in the following table:
Combined drug 1+2 weeks 3+4 weeks usually maintenance dose
Sodium valproate with or without other antiepileptics 12.5mg(25mg, once every other day) 25mg(once daily) 100-200mg(once daily or in two doses) To achieve maintenance can be increased by 25-50mg every 1-2 weeks
Enzyme induced antiepileptic * with/without other 50mg(once daily) 100mg(taken in two doses) 200-400mg(taken in two doses) To achieve maintenance can be increased by 100mg every 1-2 weeks
Antiepileptic drugs (except sodium valproate)
Others do not significantly inhibit or induce lamotrigine glucose 25mg(once daily) 50mg(once daily) 100-200mg(once daily or in two doses) To achieve maintenance levels can be increased by 50-100mg every 1-2 weeks
Therapeutic dose escalation of aldosing drugs
* Such as phenytoin, carbamazepine, phenobarbital and proeclampone
Note: If the pharmacokinetic interaction between the antiepileptic drug and lamotrigine is not known, the recommended dose of lamotrigine in combination with sodium valproate should be used, followed by a gradual increase to achieve optimal efficacy.
To reduce the risk of developing a rash, do not increase the initial dose or subsequent dose increments beyond the table above (see Precautions).
Children (2-12 years old) :
For patients taking sodium valproate with or without any other antiepileptic drug, the initial dose of this product is 0.15mg/kg/ day once daily for 2 weeks; The dosage was 0.3mg/kg once daily for the next two weeks. Thereafter, the dose should be increased every 1-2 weeks, with a maximum increase of 0.3mg/kg, until optimal efficacy is achieved. The maintenance dose that usually achieves the best effect is 1-5mg/kg/ day, taken single or in two doses.
The initial dose of this product is 0.6mg/kg/ day in two doses for two weeks in patients taking AEDs or other drugs that induce lamotrigine gluconiosis (see Drug Interactions), with or without other antiepileptics (other than valproate); The dose for the following two weeks was 1.2mg/kg/ day, divided into two doses. Thereafter, the dose should be increased every 1-2 weeks, with a maximum increase of 1.2mg/kg, until optimal efficacy is achieved. The maintenance dose that usually achieves the best effect is 5-15mg/kg/ day, taken in two doses.
To obtain an effective maintenance dose, the child's weight must be monitored and the dose reassessed in light of the change in weight.
In patients taking other drugs that do not significantly inhibit or induce lamotrigine gluconalylation (see Drug Interactions), the initial dose of this product is 0.3mg/kg/ day once or twice daily for two weeks, followed by 0.6mg/kg/ day once or twice daily for two weeks. The dose is then increased every 1-2 weeks with a maximum daily increase of 0.6mg/kg/ day until optimal efficacy is achieved. The maintenance dose that usually achieves the best efficacy is 1-10mg/kg daily, taken once daily or in two doses, with a maximum daily dose of 200mg.
In children (2-12 years old), the recommended dose escalation method (total daily mg/kg/ day) for drug combination therapy is shown in the following table:
Combined drug 1+2 weeks 3+4 weeks usually maintenance dose
Sodium valproate with/without other antiepileptic drugs 0.15mg/kg**(once daily) 0.3mg/kg(once daily) can be increased by 0.3mg/kg every 1-2 weeks to achieve a maintenance level of 1-5mg/kg(once daily or in two doses)
Enzyme induced antiepileptic drug * with/without other 0.6mg/kg(taken in two doses) 1.2mg/kg(taken in two doses) can be increased by 1.2mg/kg for 1-2 weeks to achieve maintenance level of 5-15mg/kg(taken in two doses)
Antiepileptic drugs (except sodium valproate)
Other not significantly inhibit or induce lamotrigine 0.3mg/kg(once or in 2 doses) 0.6mg/kg(once or in 2 doses) To achieve maintenance dose 1-10mg/kg Increase 0.6mg/kg(once or in 2 doses) every 1-2 weeks
The maximum daily dose of glucose-acidizing drugs is 200mg
* Such as phenytoin, carbamazepine, phenobarbital and proeclampone
Note: If the pharmacokinetic interaction between the antiepileptic drug and lamotrigine is not known, the recommended dose of lamotrigine in combination with sodium valproate should be used, followed by a gradual increase to achieve optimal efficacy.
** Note: If the daily dose is calculated to be 1-2mg, 2mg should be taken for the first two weeks, once every other day. If the calculated dose is less than 1mg, this product should not be taken.
To reduce the risk of developing a rash, do not increase the initial dose or subsequent dose increments beyond the table above (see Precautions).
Patients aged 2-6 years:
The required maintenance may be at the upper end of the recommended dose range.
Children under 2 years old:
For children younger than 2 years of age, there is not enough information on the use of this product, so lamotrigine tablets are not recommended for use in children younger than 2 years of age.
General medication recommendations for lamotrigine for special patient populations
Women taking hormonal contraceptives
(a) Initiation of lamotrigine in women already taking hormonal contraceptives:
Although oral contraceptives may increase lamotrigine clearance (see Precautions and Drug Interactions), the recommended lamotrigine dose-escalation guidelines need not be adjusted based solely on the patient's use of hormonal contraceptives. Dose escalation should be based on whether lamotrigine is combined with sodium valproate (an enzyme inhibitor of lamotrigine); Or whether it is combined with an enzyme inducer of lamotrigine; Or whether lamotrigine should be added in the absence of valproate or lamotrigine gluconaldehyde, following the proposed guidelines for dose escalation (see Table 1 for epileptic patients).
(b) Initiation of hormonal contraceptives in patients who have taken maintenance doses of lamotrigine but have not taken the lamotrigine glucaldehyde inducer:
The maintenance dose of lamotrigine needs to be increased in most cases, possibly by up to a factor of 2 (see Precautions and Drug Interactions). It is recommended that the lamotrigine dose be increased at a rate of 50-100mg/ day per week from the beginning of hormonal contraceptives, depending on the individual's clinical response. Unless a clinical response supports a larger dose increase, the dose increase should not exceed this rate.
(c) Discontinuation of hormonal contraceptives in patients who have taken maintenance doses of lamotrigine but are not taking the lamotrigine glucaldehyde inducer:
Maintenance doses of lamotrigine need to be reduced by up to 50% in most cases (see Precautions and Drug Interactions). Gradual reduction of the daily dose of lamotrigine (at a rate of no more than 25% of the total daily dose per week) at 50-100mg/ week is recommended for more than 3 weeks, unless clinical response shows otherwise.
[u] In combination with Azanavir/Ritonavir [/u]
Although azanavir/ritonavir has been shown to reduce plasma concentrations of lamotrigine (see Drug Interactions), the recommended dose escalation guidelines for lamotrigine do not need to be adjusted based solely on the use of azanavir/ritonavir in patients. Dose escalation should be based on whether lamotrigine is used for sodium valproate (an enzyme inhibitor of lamotrigine); Or whether lamotrigine is used as an inducer for glucosylation; Or whether lamotrigine is administered in the absence of sodium valproate or an inducer of lamotrigine glucosylation, with dose escalation following the proposed guidelines. In patients who have taken maintenance doses of lamotrigine and are not being treated with an inducer of glucoside action, the dose of lamotrigine needs to be increased if azanavir/ritonavir is added, and reduced if azanavir/ritonavir is discontinued.
[u] Dose for patients with impaired liver function [/u]
Initial, increasing, and maintenance doses of lamotrigine at moderate (Child-Pugh grade B) and severe (Child-Pugh grade C) levels of liver impairment should generally be reduced by approximately 50% and 75%, respectively. Incremental and maintenance doses should be adjusted according to clinical efficacy.
[u] Dose for patients with impaired renal function [/u]
Patients with impaired renal function should be cautious when taking lamotrigine. In patients with advanced renal failure, the initial dose of lamotrigine should follow the regimen used in combination with other antiepileptic drugs, and the maintenance dose should be reduced in patients with significantly impaired renal function (see [Precautions]). For more information on pharmacokinetics, see Pharmacokinetics.
Matters needing attention:
[u] rash [/u]
There have been reports of skin adverse reactions, generally occurring during the first 8 weeks of lamotrigine tablet initiation. Most rashes are mild and self-limiting. However, it has been rare and serious. Life-threatening rashes including Stevens-Johnson syndrome and toxic epithelial necrolysis (TEN) have been reported (see Adverse reactions).
Severe rashes such as SJS syndrome occur in approximately 1 in 1000 adults and children over 12 years of age. Children under 12 years of age are at higher risk than adults. Studies have shown that the ratio of rashes requiring hospitalization in children under 12 years of age is 1:300 to 1:100 (see Adverse Reactions).
A rash that initially develops in a child can be mistaken for an infection; During the first 8 weeks of treatment, the doctor should consider the possibility of a reaction if the child develops a rash and fever.
In addition, the overall risk of developing a rash is strongly associated with:
- The initial dose of lamotrigine is too high and subsequent dose increases exceed the recommended dose (see Usage and Dosage).
- Sodium valproate should also be applied (see [Usage and Dosage]).
It should also be noted that patients with a history of allergy or rash to other antiepileptic drugs are approximately three times more likely to develop a non-severe rash after lamotrigine treatment than patients without such a history.
All patients (adults and children) who develop a rash should be evaluated promptly and lamotrigine discontinued immediately, unless the rash can be confirmed to be unrelated to this drug. For patients who have stopped using this product due to rash during prior treatment, re-use of this product is not recommended unless the expected benefits outweigh the potential risks.
It has also been reported that the rash is part of the allergic syndrome, which is accompanied by various forms of systemic symptoms, including fever and adenopathy. Facial edema and blood and liver abnormalities. The severity of clinical reactions to this syndrome varies greatly; Rare diffuse intravascular coagulation (DIC) and multiple organ failure. Even if the rash is not obvious, it is important to pay attention to the early signs of an allergic reaction (e.g. fever, adenopathy). If signs and symptoms appear, tell the patient to seek medical attention immediately. If signs and symptoms of early reaction appear, the patient should be evaluated immediately; If another cause cannot be determined, this product should be discontinued.
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