Trileptal 60mg/ml novartis treatment for seizures (100ml)
Dosage form Box X 100ml
Specifications Oxcarbazepine
Ingredient
| Composition information | Content |
| Oxcarbazepine | 60mg/ml |
Uses
Indications
Trileptal 60mg/ml drugs are indicated in the following cases:
trileptal 60mg/ml is used in the form of single therapy or supplementary therapy for adults and children aged 6 and older.
Pharmacy
Pharmacological effects
The pharmacological activity of oxcarbazepine is mainly made through metabolites (MHD). The mechanism of action of oxcarbazepine and MHD is thought to be mainly based on the voltage sodium channel blockage, thus leading to stabilized nerve membrane stability, inhibiting repeated discharge in nerve cells and reducing the spread of impulses through synap. In addition, the increased potassium transmission and the modulation of calcium channels are activated by the high voltage that can also contribute to the anti -seizure effect of the drug. No significant interaction has been recorded with the reception of neurotransmitters or brain transformers.Oxcarbazepine and its metabolites (MHD) are anti -convulsed and effective anti -convulsions on animals. These substances protect rodents against spasticity - vibration seizures developing all and to a lesser extent than shock seizures and loss of or reducing the frequency of chronic recurrent recurrent seizures on Rhesus monkeys are implanted with aluminum pieces. No tolerance (ie reduced anti -seizure activity) for spastic - vibration seizures during daily treatment for mice for 5 days and rats for 4 weeks with oxcarbazepine or MHD.
pharmacokinetic
absorption
After taking Trileptal tablets 60mg/ml, Oxcarbazepine is completely absorbed and strongly converted into its transformation with pharmacological activity (MHD). After using a single dose of 600mg of Triileptal oral delicacy 60mg/ml for men to volunteer to be healthy when hungry, the highest concentration value in plasma (CMAX) of MHD average is 24.9µmol/l, corresponding to the time of achieving the highest concentration in plasma (TMAX) is 6 hours.
In a human balancing study study, only 2% of the total number of radioactive in plasma is due to the constant oxcarbazepine, about 70% due to MHD and the rest is thought to be due to small auxiliary metabolites which are quickly excreted.
Food does not affect the speed and absorption of oxcarbazepine, so it can be used trileptal 60mg/ml or not with food.
Distribution
MHD's apparent distribution integral is 49 liters.About 40% MHD binds to serum protein, mainly with albumin. This cohesion does not depend on serum concentration within the area related to treatment. Oxcarbazepine and MHD are not associated with alpha-1-acid glycoprotein.
Oxcarbazepine and MHD pass through the placenta. MHD concentration in plasma in newborns and in the mother is equivalent in a case.
Metabolism
Oxcarbazepine is quickly metabolized by cytosolic enzymes in the liver to be transformed into MHD as the main responsible substance for the pharmacological effect of Trileptal 60mg/ml. MHD is metabolized more through the combination with glucuronic acid. Small amounts (4% of the dose) are oxidized into non-pharmacological metabolic substances (derivative 10, 11-dihydroxy-DHD).
Elimination
Oxcarbazepine is released from the body largely in the form of metabolites, mainly excreted through the kidneys. More than 95% of the dose appears in urine, less than 1% in the form of unchanged oxcarbazepine.
The amount of excretion through feces below 4% of the dose.
About 80% of the dose is excreted in the urine in the form of MHD's glucuronide (49%) or in the form of a constant MHD (27%), while the amount of DHD has no activity of about 3% and the conjugate form of Oxcarbazepine is 13% of the dose. Oxcarbazepine is quickly excreted from plasma with the semi -cancellation time from 1.3 to 2.3 hours. In contrast, the semi -cancellation time in the plasma of MHD averages is 9.3 ± 1.8 hours.
linearity of the dose
MHD concentration in plasma in a stable state is achieved within 2-3 days in patients when using trileptal 60mg/ml 2 times/day. The pharmacokinetics of MHD in a stable state are linearly and indicates the balance of the dose balance at 300 - 2,400mg/day.
Special patient group
Patients with liver failure
pharmacokinetics and metabolism of oxcarbazepine and MHD have been evaluated on healthy volunteers and people with liver failure after taking a single -dose of 900mg oral. Mild to medium liver failure does not affect the kineticness of oxcarbazepine and MHD.
trileptal 60mg/ml has not been studied in patients with severe liver failure.
Patients with renal failure
There is a linear correlation between creatinine clearance and renal clearance of MHD. When using trileptal 60mg/ml with a single dose of 300mg in patients with renal impairment (creatinine clearance
Children
pharmacokinetics of trileptal 60mg/ml have been assessed in clinical trials in children using trileptal 60mg/ml at a dose of 10 - 60mg/kg/day. The clearance of the MHD has been adjusted to the age of decreasing with age and increases with the weight almost equal to the clearance in adults. The clearance of the average weight in children 4 - 12 years old is about 40% higher than the clearance in adults. Therefore, the level of contact with MHD in these children is expected to be equal to about two -thirds of the contact level in adults when treated with an equivalent dose that has been adjusted according to the weight.
When the weight increases, for a 13 -year -old and older patient, the MHD clearance has been adjusted according to the weight that is expected to reach the level of adults.
Pregnant women
Data from a limited number of women shows that MHD concentration in plasma may gradually decrease during pregnancy.
Elderly
After the elderly volunteers (60 to 82 years old) use trileptal 60mg/ml of single dose (300mg) and multiple doses (600mg/day), the highest concentration values in the blood. The area and the area under the curve (AUC) of MHD are 30-60% higher than the concentration in young volunteers (18 - 32 years old). The comparison of creatinine clearance in young and elderly volunteers shows that the difference is due to reduced creatinine clearance related to age. No special recommendations for dosage because the treatment dose is adjusted for each patient.
Gender
No difference in pharmacokinetics is related to gender in children, adults or the elderly.
Before taking Trileptal 60mg/ml novartis treatment for seizures (100ml)
How to use
Take orally or not with food.
Before using Triileptal 60mg/ml, should shake the drug thoroughly and prepare the dose shortly thereafter. It is recommended to use oral pump pump that is provided to withdraw the amount of oral mixture prescribed from the bottle. It is possible to take the Triileptal 60mg/ml orally orally oral pump or oral pump. After each use, cover the bottle and wipe the pump pump with a dry, clean paper towel.
Dosage
In additional treatment and supplementary therapy, treatment with trileptal 60mg/ml started with a clinical effect divided into 2 times. The dose may be increased depending on the clinical response of the patient. When replacing other anti -epileptic drugs with trileptal 60mg/ml, it is advisable to gradually reduce the anti -epileptic dose used at the same time at the beginning of treatment with trileptal 60mg/ml. In supplementary therapy, because the total amount of anti -epileptic drugs in the patient increases, it may be necessary to reduce the dose of anti -epileptic drugs simultaneously and/or increase the dosage of trileptal 60mg/ml slower (see the drug interaction).
Should prescribe oral trieptal 60mg/ml or oral fluid according to Mililit (see the table, convert below from the doses of Miligam to Mililites). The dose prescribed in milliliters is rounded to the nearest 0.5ml.
The dose mentioned in the table below can only be applied to patients from 6 years of age. These doses are used 2 times/day.
doses in milligrams
(use 2 times/day)
Dosage in milliliters
(use 2 times/day)
45 - 75mg
1.0ml
76 - 105mg
1.5ml
106 - 135mg
2.0ml
136 - 165mg
2.5ml
166 - 195mg
3.0ml
196 - 225mg
3.5ml
226 - 255mg
4.0 ml
256 - 285mg
4.5ml
286 - 315mg
5.0ml
316 - 345mg
5.5ml
346 - 375mg
6.0ml
376 - 405mg
6.5ml
406 - 435mg
7.0ml
436 - 465mg
75ml
466 - 495mg
8.0ml
496 - 525mg
8.5ml
526 - 555mg
9.0ml
556 - 585mg
9.5ml
586 - 615mg
10.0ml
616 - 645mg
10.5ml
646 - 675mg
11.0ml
676 - 705mg
11.5ml
706 - 735mg
12.0ml
736 - 765mg
12.5ml
766 - 795mg
13.0ml
796 - 825mg
13.5ml
826 - 855mg
14.0ml
856 - 885mg
14.5ml
886 - 915mg
15.0ml
916 - 945mg
15.5ml
946 - 975mg
16.0ml
976 - 1,005mg
16.5ml
1,006 - 1,035mg
17.0 ml
1,036 - 1,065 mg
17.5ml
18.0ml
18.5ml
1,126 - 1,155mg 19.0ml
1,156 - 1,185mg 19.5ml 20.0ml
The following dosage recommendations apply to all patients without renal function (see pharmacokinetics). There is no need to monitor drug concentration in plasma to optimize trileptal therapy 60mg/ml.
Adults
Unit of treatment
start trileptal 60mg/ml at a dose of 600mg/day (8 - 10mg/kg/day) divided into 2 times. If clinically indicated, an additional dose of a maximum increase is 600mg/day about the period from the beginning to the desired clinical response. Has recorded the effectiveness of treatment at doses from 600mg/day to 2,400mg/day.
Singing tests with control in patients are not being treated with anti -epileptic drugs have shown an effective dose of 1,200mg/day, but the dose of 2,400mg/day has been shown to be more effective in patients with more resistance to being transferred from single -therapies with other anti -epileptic drugs to single therapy with trileptal 60mg/ml.
In a control hospital, the dose increased to 2,400mg/day achieved after 48 hours.
Supplementary therapy
start trileptal 60mg/ml at a dose of 600mg/day (8 - 10mg/kg/day) divided into 2 times. If clinically indicated, an additional dose of a maximum increase is 600mg/day about the period from the beginning to the desired clinical response. Has recorded the effectiveness of treatment at doses from 600mg/day to 2,400mg/day.
In a complementary treatment test, daily doses of 600 - 2,400mg/day have been shown to be effective, although most patients have been unable to tolerate 2,400mg/day without reducing anti -epileptic doses simultaneously, mainly due to adverse events related to the central nervous system (CNS). The daily dose is over 2,400mg/day without being systematically studied in clinical trials.
Elderly
Recommendations to adjust the dose in the elderly with kidney function damage (see "patients with kidney failure"). Couples with patients at risk of hypoglycemia, see carefully when used).
Children
In additional treatment and supplementary therapy, it is recommended to start using trileptal 60mg/ml at a dose of 8 - 10mg/kg/day divided into 2 times. In supplementary therapy, the effectiveness of treatment at the average maintenance dose is about 30mg/kg/day. If clinically indicated, it may increase. The added dose increases maximum 10mg/kg/day about the period of each week from the beginning to the maximum dose of 46mg/kg/day to achieve the desired clinical response.
Trileptal 60mg/ml is recommended for children from 6 years of age. Safety and efficiency have been assessed in controlled clinical trials including about 230 children under 6 years old (or less to 1 month). It is not recommended to use trileptal 60mg/ml for children under 6 years old because of the safety and effectiveness that has not been fully proven. All of the above dosage recommendations (adults, elderly and children) are based on the doses that have been studied in clinical trials for all age groups. However, it is possible to consider lower starting dose when appropriate.
Patients with liver failure
No dose adjustment for patients with mild to moderate liver failure. Trileptal 60mg/ml has not been studied in patients with severe hepatic failure, so it is necessary to be cautious when taking medication for patients with severe liver failure.
Patients with renal failure
In patients with renal function (creatinine clearance below 30ml/minute), it is recommended to start Triileptal therapy 60mg/ml at half the dose from the user -used head (300mg/day) and increase the dose by at least each week to achieve the desired clinical response.
Increasing dose in patients with renal failure may require more careful monitoring.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? The maximum dose used is about 24000mg. All patients have recovered with symptomatic treatment. Symptoms of overdose include drowsiness, dizziness, nausea, vomiting, hyperactivity, blood sodium lowering, loss of air conditioning and eyeball vibration.
There is no specific antidote. Symptomatic treatment and appropriate support treatment should be conducted. Should consider removing smoking with stomach or inactivation by using activated carbon.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using trileptal 60mg/ml, you may experience unwanted effects (ADR).
The most commonly reported side effects are drowsiness, headache, dizziness, gravity, nausea, vomiting and fatigue in more than 10% of patients.
Data on unwanted effects according to the body's organs based on side effects from clinical trials have been assessed to be related to trileptal 60mg/ml. In addition, clinical significance reports on side effects from programs with patients have been identified and after -sales experience have also been taken into account.
Estimated tons of tons: Very common:> 1/10, common:> 1/100 and 1/1,000, 1/10,000,
In each frequency group, unwanted effects are presented in the order of severity. Blood disorders and lymphatic systems leukopenia. Very rare Platelet reduction. Unknown Bone marrow failure, property anemia, grain leukemia, reduced hemorrhage, neutropenia. immune system disorders Very rare Hypersensitivity#. Unknown Anaphylactic reactions, rashes due to drugs with eosin cells and systemic symptoms (dress) * *. Common Hemorrhage reduction. Very rare Hemorrhage reduction associated with signs and symptoms such as convulsions, confusion, consciousness, brain disease, visual disorders (for example, blurred vision), vomiting, nausea*. Unknown Thyroid reduction. Common Confusion, depression, indifference, agitation (for example: restlessness) Unstable emotions. Sleep, headache, dizziness. Common Lost air conditioning, tremor, vibration of the eyeball, disorder of attention, forgetting. Song. Common Fuzzy, visual disorders. Common Dizziness. heart disorders Very rare Rhym, atrial block. Unknown Hypertension. Nausea, vomiting. Common diarrhea, constipation, abdominal pain. Pancreatitis or increased lipase or increase amylase. Very rare hepatitis. Common rash, hair loss, acne. urticaria. Very rare Fantasy, Stevens-Johnson syndrome, poisoning epidermal necrosis (Lyell syndrome), diverse erythema. Unknown Excavity of acne acne (AGEP) * * * Very rare Systemic Red Reds. tired. Common. weakness. Testing Increased liver enzyme, alkaline phosphatase in the blood. Unknown Discount T4 (unknown clinical significance). * * The side effects of the drug from spontaneous reports and cases in the literature (unknown frequency): The following side effects are derived from after -sales experience with trileptal 60mg/ml through spontaneous reports and cases in literature. Because these reactions have been voluntarily reported from a group of unknown scale population, indefinite estimated frequency reliability, so it is classified as unclear. # hypersensitivity (including hypersensitivity to many organs) is characterized by characteristics such as rash, fever. Agencies or systems may be affected such as blood and lymphatic systems (for example, eosinophilia loves EOSIN, thrombocytopenia, leukopenia, lymph nodes, enlarged spleen), liver (eg abnormal liver function test, hepatitis), muscle and joints (for example, joint swelling, muscle pain, joint pain), nervous system (for example bronchospases, interstitial lung disease), angioedema. Disorders of musculoskeletal, connective tissue and bone There have been reports on reduced bone density, bone reduction, osteoporosis and fractures in patients being treated with long -term tribePheptal 60mg/ml. Trileptal mechanism 60mg/ml affects the metabolism of the bone has not been determined. Notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
trileptal 60mg/ml contraindicated drug in cases of hypersensitivity to active ingredients or any excipients of the drug.
Precautions when using
Read the instructions carefully before use. If you need more information, please consult your doctor. This drug is only used as prescribed by a doctor.
hypersensitivity
Type 1 hypersensitivity reaction (instant occurs) includes rash, itching, urticaria, angioedema and anaphylaxis reports received during after -sales period. There have been reports on evaluation and angioior cases including larynx, bar, lips and eyelids in patients after taking the first doses of trileptal 60mg/ml or the next dose. If the patient has these reactions after treatment with trileptal 60mg/ml, the medication must be stopped and started treatment with an alternative drug. It is recommended that patients who have had hypersensitivity reactions, with carbamazepine are about 25 - 30% of these patients may have hypersensitivity reactions to trileptal 60mg/ml (for example: severe skin reaction).
Hypersensitivity reactions, including hypersensitivity reactions in many organs can also occur in patients without a history of hypersensitivity to carbamazepine. These reactions may affect the skin, liver, blood and lymphatic system or other organs, occur individually or combine together in the disease, the whole body. In general, if there are signs and symptoms suggesting hypersensitivity reactions, trileptal must be stopped immediately.
Effects on skin
There have been reports in very rare cases of serious skin reactions, including Stevens - Johnson syndrome, poisoned epidermal necrosis (Lyell syndrome) and diverse erythema related to the use of trileptal 60mg/ml. Patients with serious skin reactions may need to be hospitalized because these conditions may be life -threatening and in a very rare case of death. Cases related to trileptal 60mg/ml occur in both children and adults. The average starting time is 19 days.
Some individual cases have a serious skin reaction recurrence when reusing trileptal 60mg/ml has been reported. Patients who generate a skin reaction with trileptal 60mg/ml must be evaluated immediately and stop using trileptal 60mg/ml immediately unless the rash is obviously not related to the drug. In case of stopping treatment, it is recommended to replace trileptal 60mg/ml with other anti -epileptic drugs to avoid epilepsy due to stopping the drug. Do not start again in patients who stop treatment due to hypersensitivity reactions.
Allele of human white blood cell antigen (HLA) HLA -B*1502 - in Chinese population groups. Thai and other Asians
HLA-B*1502 in people of Chinese and Thai Han and Thailand has been proven to be closely related to the risk of severe skin reactions such as Stevens-Johnson syndrome (SJS) when treated with carbamazepine. The chemical structure of oxcarbazepine is similar to that of carbamazepine and may be a positive patient with HLA -B*1502 may also be at risk of Stevens - Johnson syndrome after treatment with oxcarbazepine. There are some data that shows such an involved for oxcarbazepine. The percentage of HLA-B*I502 carrying people is about 10% in Chinese and Thai population groups. Whenever possible, you should screen the above -mentioned people today before starting with carbamazepine or a chemical related active ingredient. If the patient is of these origins, the test is positive for Allele Hla B*1502, may consider using oxcarbazepine if the benefits are thought to be more than risk.
Due to the ratio of this Allele in Asian population groups (for example, over 15% in the Filipino and Malaysian population groups), it is possible to consider genetic testing in population groups at risk of Huu-B* 1502.
The ratio of Allele Hla-B*1502 is negligible in European, African, Spain and Portuguese population groups and are sampled and in Japanese and Korean population groups (
Allele HLA -A*3101 - European and Japanese population groups
There are some data that shows that HLA -A*3101 is associated with increased risk of side -to -skin side effects due to carbamazepine including Stevens - Johnson (SJS) syndrome, poisoned epidermis (Ten), EOSIN (Dress) or foreign pustular tanks (AGEP) less heavier in Europeans and Japanese people.
Frequency Allele HLA-A*3101 is very different among racial groups. Allele HLA-A*3101 has a ratio of 2-5% in European population groups and about 10% in Japanese population groups.
The presence of Allele HLA-A*3101 may increase the risk of skin reactions caused by carbamazepine (most less heavy) from 5.0% in the population group in general to 26.0% in European-born people, while no Allele HLA-A*831 can reduce this risk from 5.0% to 3.8%.
There is no full data to support the recommendation of HLA-A*3101 before starting the treatment of carbamazepine bands or chemical related compounds.
If a European or Japanese-born patient is a positive for Allele HLA-A*831, it is possible to consider using carbamazepine or chemical compounds if the benefits are considered to be more than risk.
Hemorrhage reduction
Serum concentration in serum below 125mmol/l, usually asymptomatic and no need to adjust the treatment dose has been observed in 2.7% of patients treated with trileptal 60mg/ml. Experience from tests and clinicals shows that the sodium concentration in the serum returns to normal when reducing the dose, stopping trileptal 60mg/ml or the patient is treated for conservation (for example, epidemic recording restriction). In patients with anti -nephrotic diseases associated with low sodium or treated patients in combination with drugs that reduce sodium (for example, diuretics, desmopressin) as well as nonsteroidal anti -inflammatory drugs (NSAID) (eg indometacin), quantify serum sodium levels before starting treatment. After that, the amount of serum sodium concentration should be quantified after about 2 weeks and then follow the monthly distance in the first 3 months of treatment, or at the requirements of the clinical. Especially these risk factors can occur to elderly patients. For patients being treated with trileptal 60mg/ml that start using the drug to reduce sodium, it is necessary to conduct sodium tests in the above way. In general, if clinical symptoms suggest that sodium hypoglycemia while using trileptal 60mg/ml (see side effects), there may be a consideration of serum sodium quantification. For other patients, sodium can be assessed as part of the regular studies in the laboratory.
All patients with impaired search function and secondary heart failure need to be tested regularly to determine fluid retention. In case of fluid fluid or deterioration, serum sodium examination is required. If sodium hypoglycemia is found, important treatment is limited: using water. Because in very rare cases, oxcarbazepine can lead to heart transmission weakness, careful monitoring of patients with previous conduction disorders (eg atrioventricular bloc, arrhythmia).
Liver function
Very rare hepatitis has been reported, most cases are easily treated. If hepatitis is suspected, liver function is needed and should consider stopping trileptal 60mg/ml.
Hematology works
There have been reports in very rare cases of granulocytosis, anemia and reduced hemorrhage in patients treated with trileptal 60mg/ml according to after -sales experience.
consider stopping the drug if there is any sign of bone marrow failure significantly.
Behavior
There have been reports on suicide thoughts and suicide behaviors in patients treated with anti -epileptic drugs in some indications. A comprehensive analysis of random tests with placebo also shows a slight increase in the risk of suicide thoughts and suicide behavior. It is unclear the mechanism of this risk and existing data does not exclude the risk of increasing risk to oxcarbazepine.
Therefore, it is necessary to follow patients with signs of suicide thoughts and suicide behavior and should consider appropriate treatment. It is advisable to advise patients (and patient care) to seek medical advice if suicide and suicide.
Hormone contraceptives
Warning for female patients in childbearing age is the simultaneous use of trileptal 60mg/ml with hormone contraceptives that can lose the effectiveness of this contraceptive pills. Recommendation of other forms of contraceptives is not hormone when using trileptal 60mg/ml.
alcohol
Should be cautious when drinking alcohol in combination with Trileptal 60mg/ml treatment because it can increase the effect of drowsiness.
Stop taking medicine
As with all other anti -epileptic drugs, Trileptal should be stopped slowly to minimize the possibility of increasing epilepsy frequency.
Other cautions
Triileptal oral fluid 60mg/ml contains ethanol below 100mg per dose. The drug also contains parabens that can cause allergic reactions (may be slow allergies). The drug also contains sorbitol, so it should not be used for patients with rare genetic problems in tolerance fructose.
The ability to drive and operate machinery
The use of trileptal 60mg/ml is related to side effects such as dizziness or drowsiness. Therefore, it is advisable to advise patients to be physically or mentally necessary for machinery or driving operation may be impaired.
Pregnancy
Risk associated with epilepsy and anti -epileptic drugs in general
It has been shown that in women's children with epilepsy, the rate of defects is 2-3 times higher than the rate of about 3% in the population group in general. In the subjects of treatment, it has recorded an increase in defects when using multi -therapies, but the extent that the treatment or the disease is responsible has not been clarified.
Moreover, do not interrupt the treatment with anti -epilepsy drugs effectively because of the severe disease will be harmful to both the mother and the fetus.
Risk associated with oxcarbazepine
Clinical data on drug use during pregnancy is still incomplete to assess the teratogenicity of oxcarbazepine. In animal studies, it is observed that increased embryos, developmental retardation and embryo deformities when using toxic doses for mother animals.
Need to pay attention to the following
If a woman is using trileptal 60mg/ml that is pregnant or intends to get pregnant, should be carefully evaluated to use this product. Should use the lowest dose that is effective and should be given priority to use the treatment whenever possible, at least in the first 3 months of pregnancy.
Patients must be advised on the possibility of increased risk of deformities and have the opportunity to be screened before birth.
During pregnancy, it is not interrupted with anti -anti -anti -oxcarbazepine medication because the severe disease will be harmful to both the mother and the fetus.
Monitor and Prevention
Anti -epileptic drugs that can contribute to folic acid deficiency are the cause of the fetal defect. It is recommended to use folic acid supplements before and during pregnancy. Due to the effectiveness of this figure, it is not possible to perform a special diagnosis before birth even for a woman who has been treated with additional folic acid.
Data from a limited number of women shows that the concentration of metabolites has the activity of oxcarbazepine in plasma is 10-Monohydroxy derivatives (MHD) that can gradually decrease during pregnancy. It is recommended to follow carefully clinical response in women being treated with trileptal 60mg/ml during pregnancy to ensure the maintenance of adequate control of seizures. Consider to identify changes in MHD concentration in plasma. If the dose has been increased during pregnancy, it may also be necessary to consider monitoring MHD concentration in plasma after birth.
In newborns
There have been reports on bleeding disorders in newborns due to anti -epileptic drugs. To prevent it, Vitamin K1 should be used as a preventive measure in the last few weeks of pregnancy and for babies.
Breastfeeding period
Oxacarbazepine and its metabolites (MHD) are excreted into breast milk. The rate of milk/plasma concentration is found for both substances. It is not clear the effects on children in contact with trileptal 60mg/ml in this path. Therefore, Triileptal should not be used 60mg/ml during breastfeeding.
Drug interaction
Causes enzyme induction
In vitro and in vivo, oxcarbazepine and its pharmacological metabolites (monoshydroxy derivatives, MHD) are the induction substances that weaken the cytochrome p450 CYP3A4 and CYP3A5 enzymes responsible for the metabolism of a large number of drugs, for example, immunosuppressants (for example: cyclosporin, tacrolimus) Oral form (see below) and some other anti -epileptic drugs (for example, carbamazepine) leads to a decrease in the concentration of these drugs in plasma (see the table below summarizes the results of other anti -epileptic drugs).
In vitro, Oxcarbazepine and MHD are UDP-glucuronyl transferase weak induction (unknown effects on specific enzymes in this enzyme family). Therefore, In Vivo Oxcarbazepine and MHD can have a slight induction effect on the metabolism of drugs mainly eliminated by the conjugate through UDP Glucuronyl Transferase. At the beginning of treatment with trileptal 60mg/ml or when changing the dose, it may take 2-3 weeks to achieve a new level of touch.
In case of stopping treatment with Trileptal 60mg/ml, it may be necessary to reduce the dose of medications simultaneously and should decide based on clinical monitoring or plasma concentrations. The induction can decrease gradually after 2-3 weeks after stopping treatment.
Hormone contraceptives: trileptal 60mg/ml has been known to have an influence on two components, EthinyleLestradiol (EE) and Levonorgestrel (LNG) of an oral contraceptive. The area of the area under the curve (AUC) of EE's average decreased by 48 - 52% and LNG decreased by 32 - 52%. Therefore, simultaneous use of trileptal 60mg/ml with hormone contraceptives may cause loss of the effectiveness of these contraceptives. Other reliable contraceptive methods should be used.
Enzyme inhibitors
Oxcarbazepine and MHD inhibit CYP2C19. Therefore, it may occur when used, combining trileptal 60mg/ml of high doses with drugs mainly metabolized by CYP2C19 (eg phenytoin). Plasma phenytoin concentration increases to 40% when trileptal 60mg/ml is used in doses of over 1,200 mg/day (see the table below summarizes the results with other anti -epileptic drugs) .In this case, the phenytoin dose may be reduced in combination (see the dose section and usage).
Other anti -epileptic drugs
Potential interactions between trileptal 60mg/ml and other anti -epileptic drugs have been evaluated through clinical studies. The influence of these interactions on the area under the curve (AUC) is the lowest and lowest agriculture in plasma (cmin) summarized in the following table.
Summary of interaction of anti -epileptic drugs with trileptal 60mg/ml
anti -epileptic drugs
The impact of trileptal 60mg/ml on anti -epileptic drugs
The effect of anti -epileptic drugs on MHD
Concentration Concentration
Carbamazepine decreased by 0 - 22% (an increase of 30% to carbamazepine epoxide) Discount 40% Not yet studied No effect
felbamate
Not yet studied
No effect
lamotrigine
Discount*
No effect
phenobarbitone
increased by 14 - 15%
DISCOUNT 30 - 31%
phenytoin Give 0 - 40% Discount 29 - 35%
Valproic Acid No effect Discount 0 - 18%
Peraciously induction drugs of Cytochrome P450 enzymes (i.e. carbamazepine, phenytoin and phenobarbitone) have shown to reduce MHD concentration in plasma (29-40%) in adults, children aged 4-12, MHD clearance increases about 35% when taking one of the 3 anti-epileptic drugs causing enzyme compared to the prescription. Treatment of trileptal 60mg/ml and lamotrigine are associated with increased risk of side effects (nausea, drowsiness, dizziness and headache). When using one or several anti -epileptic drugs with trileptal 60mg/ml, it may be necessary to consider adjusting the dose carefully and/or monitoring plasma concentrations on the basis of each case, especially in children treated simultaneously with Lamotrigine.
Not observed the induction of trileptal 60mg/ml.
Other drug interactions
cimetidine, erythromycin, viloxazine, warfarin and dextropropoxyphen have no effect on the pharmacokinetics of MHD. Interaction between oxcarbazepine and Monoamine oxidase inhibitors (MA MAI) Theoretically may be based on the structural association of oxcarbazepine with triple antidepressants.
Patients who are undergoing three -round antidepressants have been put into clinical trials and do not observe any clinical significance.
Lithium and oxcarbazepine combination may increase nerves.
Storage
Store after opening: 7 weeks at temperatures not exceeding 30 ° C.
Use within 7 weeks after opening the bottle for the first time.
Store drugs in the original packaging.
Do not use overdue drugs that are written "exp" on the packaging.
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