Tegretol CR 200 medicine for epilepsy (5 blisters x 10 tablets)
Dosage form Box of 5 blisters x 10 tablets
Specifications Carbamazepine
Ingredient
| Composition information | Content |
| Carbamazepine | 200mg |
Uses
Indications
Tegretol Cr 200mg is indicated in the following cases:
Diabetes caused by diabetes. central diabetes. Multi -urwares and thirsts are derived from neurological hormones. is an anti -epileptic drug, its operating spectrum includes: local epilepsy (simple and complex), with or not developing the whole secondary, spasticity - vibration of the whole body, as well as the combination of these types of seizures. In clinical studies, Tegretol Cr 200mg is used in the form of monomers for patients with epilepsy - especially children and teenagers - which have been reported mentally -oriented, including positive effects on anxiety and depression symptoms as well as reducing irritability and aggression. In some studies, the effects are uncertain or have no effect on awareness and psychiatric manifestation - movement, depending on the dose, have been reported. In other studies, observed the effect of beneficial to attention, perception/memory. As a mental medicine, Tegretol Cr 200mg has a clinical effect in some neurological disorders, such as preventing pain in spontaneous and secondary nerve pain, in addition to the drug used to reduce neurological pain in different conditions, including tabet disease, post -traumatic abnormalities after herpes infection, alcoholic symptoms, and alcoholic symptoms (alcoholic syndrome, alcoholic symptoms, alcoholic symptoms, alcoholic symptoms. Examples too excited, trembling, weak gait), in the central diabetes, Tegretol Cr 200mg reduces the volume of urine and reduces thirst. As a psychotropic medicine, Tegretol Cr 200mg has proved clinical effects in emotional disorders, that is, treating the acute mania as well as the maintenance of bipolar emotional disorders (revival - depression), when used in the form of single therapy or in combination with sedative drugs, antidepressants, or lithiums, in the stimulus of the stimulus, the emotional stimulus and the other kind of stimulating drugs The recurrence period in fast cycle. absorption Carbamazepine tablets are absorbed almost completely but relatively slow. Normal tablets and chewing tablets have peak concentrations in the plasma of the drug with a constant drug within 12 hours and 6 hours after taking oral doses according to the corresponding appropriate. With oral fluid form, the peak concentration of plasma is achieved within 2 hours and with the form of peak concentration in plasma within 12 hours. About the active ingredient is absorbed, there is no clinical difference between oral dosage forms. After taking a single dose of 400mg of carbamazepine (tablets), the peak concentration of carbamazepine does not change in plasma about 4.5mcg/ml. When using a single dose CR tablet and repeated dose, the CR tablets produce the peak concentration of the active ingredient in plasma about 25% lower than conventional tablets, the peak concentration is within 24 hours. The CR tablet gives a statistical volatility reduction, but does not reduce the lowest concentration in plasma (cmin is meaningful in a stable state. The fluctuations of plasma concentrations with the dose mode are 2 times/day is low. Birth of Tegretol Cr 200mg tablets is about 15% lower than the bioavailability of other oral dosage forms. When using bullets, the amount of carbamazepine is absorbed by about 25% lower than the tablet. There is no change in fluctuations, but the highest decrease in plasma concentrations (cmax) and the lowest concentration in plasma (cmin) compared to the tablet are found in a stable state. For doses of up to 300mg of carbamazepine, about 75% of total absorption reaches body blood circulation within 6 hours after use. The result leads to recommendations as the maximum daily dose is limited to 250mg, 4 times/day. Carbamazepine concentration in plasma in a stable state is achieved within 1-2 weeks, depending on the induction of carbamazepine in each individual and inductive in different individuals due to enzyme induction drugs, as well as depending on the condition before treatment, dosage and treatment time. Carbamazepine concentration in plasma in a stable state is considered a "concentration of treatment" significantly changing among patients: For most patients, the concentration of 4 - 12mcg/ml corresponds to 17 - 50mmol/liter has been reported. Carbamazepine-10, 11-Epoxid concentration (pharmacological metabolites): about 30% of carbamazepine concentration. Food does not significantly affect the speed and level of absorption, regardless of the preparation form of Tegretol Cr 200mg. Distribution Suppose the absorption of carbamazepine is completely, the indicator distribution volume is from 0.8 - 1.9 liters/kg. carbamazepine passes through the placenta. Carbamazepine is connected to serum protein at 70 - 80%. The concentration of the substance does not change in the cerebrospinal fluid and saliva reflects the unite with protein in plasma (20 - 30%). The concentration in breast milk is found to be equivalent to 25 - 60% of the corresponding concentration in plasma. Metabolism Carbamazepine is metabolized in the liver, where Epoxid biological changes are the most important sugar, creating 10.11-transdiol and glucuronide derivatives are the main metabolites. Cytochrom P450 3A4 has been identified as the main pattern responsible for the formation of carbamazepine-10.11 Epoxid with pharmacological activity from carbamazepine. 9-Hydroxy-methyl-10-Cabamoyl ACridan is a small metabolic associated with this line. After taking a single dose of carbamazepine, about 30% of the drug appears in the urine in the form of final products via Epoxid. Other important biological changes for carbamazepine leads to various types of monohydroxylation compounds, as well as for carbamazepine n-glucuronids created by UGT2B7. Elimination Carbamazepine's semi -waste time is about 36 hours after taking a single dose, while after repeated use, on average only 16 - 24 hours (the induction of the mono -oxygenase system in the liver), depending on the time of medication, in patients being treated simultaneously with other liver enzyme induction drugs (for example, Phenytoin, Phenobarbiton) The average selling space is from 9 - 10 hours. The average selling time of metabolites 10.11-Epoxid in plasma is about 6 hours after taking oral doses itself. After taking a single dose of carbamazepine 400 mg, 72% the dose is excreted in urine and 28% in feces. In urine, about 2 % of the dose is restored in the form of unchanged drugs and about 1 % in the metabolic 10.11-Epoxid has pharmacological activity. Special patient groups Children Due to increased carbamazepine excretion, children may need higher carbamazepine doses (in mg/kg) compared to adults. Elderly There is no sign of carbamazepine pharmacokinetics in elderly patients compared to young adults. Patients with liver failure or kidney failure There is no data on carbamazepine pharmacokinetics in patients with liver or kidney failure. Pharmacokology
pharmacokinetic
Before taking Tegretol CR 200 medicine for epilepsy (5 blisters x 10 tablets)
How to use
tablets and drinking mixture (shake before use) can be taken while eating, after eating or between meals. Should use tablets with some drinks and the rest of the chewing tablet should be swallowed with some drinks.
Creams Cr (both tablets or if prescribed only half a tablet) should swallow without chewing with some drinks. Chewing tablets and oral chewing (1 unit of measuring = 5ml = 100mg, half a measuring unit = 2.5ml = 50mg) is especially suitable for patients with difficulty swallowing pills or need to adjust the initial dose carefully.
As a result of slow, controlled relief of the active ingredient from the CR tablet, this drug is used at a dose 2 times/day.
Because the towerol CR 200mg oral dosage is used to create a higher concentration than the same dose in Mg in the form of tablets, start with low doses and increase the dose slowly to avoid adverse reactions.
When transferring patients from Tegretol Cr 200mg to oral discharge: This should be done by using the same number of mg per day with smaller doses, more often (for example, oral fluid 3 times/day instead of 2 times/day tablets).
When transferring patients from conventional tablets to CR tablets: Clinical experience shows that in some patients, the dose in the form of CR tablets may need to increase.
When converting patients from oral formulas to bullets: Dosage in the form of bullets should be increased by about 25% and are used to divide small doses, up to 250mg, 4 times/day, 6 hours apart. Experience in the use of tablets is limited in just 7 days as an alternative therapy in temporary patients who cannot treat oral epilepsy, for example in people after surgery or people who are lost consciousness.
Dosage
epilepsy
When possible, Tegretol Cr 200mg should be prescribed in single therapy.
Should start treatment at low doses every day, increase slowly until the optimal effect.
Should adjust the carbamazepine dose according to the needs of each patient to achieve full control of seizures. Determining the plasma concentration can help determine the optimal dose. In the treatment of seizures, the carbamazepine dose usually requires total carbamazepine concentration in plasma about 4 - 12mcg/ml (17 - 50mmol/liter) (see the cautious part when used).
When adding Tegretol Cr 200mg to the anti -epilepsy treatment, this should be done slowly while maintaining, or if necessary, adjust the dose of other anti -epileptic drugs (see the interaction parts and pharmacokinetics, pharmacokinetics).
Target patients in general (adults)
Dosage in epilepsy
Types of oral:
Starting 100mg to 200mg, 1 time or 2 times/day, should increase the dose slowly - generally at 400mg, 2-3 times/day - until the meeting is optimal. In some patients, the dose of 1600mg or even 2000mg/day may be appropriate.
Bullets
When using the form of ammunition instead of oral forms, the maximum daily dose is limited to 1000mg (250mg, 4 times/day, 6 hours apart).
There is no clinical data on the use of bullets in indications other than epilepsy.
Dosage in acute mania and treatment to maintain bipolar emotional disorders
The dose level: about 400 - 1600mg/day, the usual dose is 400 - 600mg/day divided into 2-3 times. During the acute mania, it is advisable to increase the dose quite quickly, while the recommendation of each small dose increases in the treatment of bipolar disorders to ensure optimal tolerance.
Dosage in alcohol syndrome
Average dose: 200mg, 3 times/day. In severe doses may increase in the first few days (for example, up to 400mg, 3 times/day). At the beginning of the treatment of severe signs of alcohol, it is recommended to combine Tegretol Cr 200mg with sedative - sleeping drugs (for example Clomethiazol, Chlordiazepoxid). After the acute phase has decreased, Tegretol CR 200mg can be continued in the form of single therapy.
Dosage in nerve pain in Birthdays
The starting dose of 200 - 400mg should increase slowly every day until the pain is over (usually 200mg, 3-4 times/day). Then reduce the dose gradually to the lowest maintenance dose possible. The maximum dose is recommended for 1200mg/day. When analgesic is achieved, try to stop treating gradually, until another pain occurs.
Dosage in diabetes caused by diabetes
Average dose: 200mg, 2-4 times/day.
Dosage in central diabetes
Average dose for adults: 200mg, 2-3 times/day. In children should reduce the dose corresponding to the age and weight of children.
Special patient groups
kidney failure/liver failure
There is currently no carbamazepine pharmacokinetic data in patients with liver function or renal function.
Children/children and teenagers
Dosage in epilepsy
Types of oral:
For children 4 years of age and less, recommend the starting dose of 20 - 60mg/day, increasing to 20mg to 60 mg, every 2 days. For children over 4 years old, can start treatment with 100mg/day, increasing to 100mg each week.
Maintenance dose: 10 - 20mg/kg body weight/day divided into several times
Example:
under 6 years old: 35mg/kg/day.
6 - 15 years old: 1000mg/day.
> 15 years old: 1200mg/day.
Bullets
When using the form of ammunition instead of oral forms, the maximum daily dose is limited to 1000mg (250mg, 4 times/day, 6 hours apart).
There is no clinical data on the use of bullets in indications other than epilepsy.
Dosage in central diabetes
In children should reduce the dose corresponding to the age and weight of children. Average dose for adults: 200mg, 2-3 times/day.
Elderly
Dosage in nerve pain in Birthdays
Due to the various anti -epileptic drug and pharmacokinetics, it is necessary to be cautious when choosing Tegretol Cr 200mg for elderly patients. In elderly patients, it is recommended to start the starting dose of 100mg, 2 times/day. The starting dose of 100mg, 2 times/day should increase slowly every day until the pain is over (usually 200mg, 3-4 times/day). Then reduce the dose gradually to the lowest maintenance dose possible. The maximum dose is recommended for 1200mg/day. When analgesic is achieved, try to stop treating gradually, until another pain occurs.
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?
Signs and symptoms
Signs and existing overdose often include the central nervous system, cardiovascular, respiratory and adverse reactions of the drug mentioned in the side effect.
Central nervous system: Central nervous system depression, loss of orientation, level of consciousness, drowsiness, excitement, hallucinations, coma, blurred vision, stuttering, speech, eye shock, loss of air conditioning, movement disorders, initial reflexes then reduced reflexes, seizures, mental disorders - movement, muscle vibration, reduced body temperature.
Respiratory system: Respiratory failure, pulmonary edema.
Cardiovascular system: tachycardia, hypotension, occasional hypertension, conduction disorders with wide QRS complex, fainting associated with cardiac arrest.
Digestive system: vomiting, slow empty stomach, reducing intestinal motility.
Muscle system: There have been some cases of muscle patterns that have been reported related to carbamazepine poisoning.
Kidney function: Urinary retention, urinary or anuria, fluid, water poisoning due to the anti -urinary hormone (ADH) of carbamazepine.
Testing results: Hypotenia, may have metabolic acidosis, may have hyperglycemia, increased creatin phosphokinase.
Treatment
No specific antidote.
It is necessary to handle it based on the clinical state of patients hospitalized.
Measure drug concentration in plasma to confirm carbamazepine poisoning and verify the overdose level.
Gastrointestinal lavage and active carbon. The delay in gastric lavage can delay the absorption, leading to recurrence while recovering from poisoning. Medical care supports at active treatment units, heart monitoring and careful adjustment of electrolyte imbalance.
Special recommendations
Recommended removing toxins from blood by activated carbon. Hemolysis is an effective treatment for carbamazepine overdose.
It is necessary to predict the recurrence and aggravation of symptoms on the 2nd and 3rd day after an overdose due to delayed absorption.
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 Tegretol Cr 200mg, you may experience unwanted effects (ADR).
Safety summary
Special at the beginning of treatment with Tegretol CR 200mg, or if the starting dose is too high, or when treating for elderly patients, some types of adverse reactions are common or common, for example, adverse reactions in the central nervous system (dizziness, headache, drowsiness, fatigue, dungeon), digestive disorders (nausea, vomiting).
The adverse reactions related to the dose usually decrease within a few days naturally or after temporary dose reduction. The appearance of adverse reactions in the central nervous system may be a manifestation of relative overdose or significant fluctuations in plasma concentrations. In these cases should monitor plasma concentrations.
Summary of adverse drug reactions from clinical trials and from spontaneous reports
The adverse reaction of the drug from clinical trials is listed in the medra group system. In each group of organs, the adverse reactions of the drug are arranged by frequency, the first is the most common adverse reactions. In each frequency group, the adverse reactions of the drug are presented in the order of severity. In addition, the corresponding frequency type for each adverse reaction is based on the following convention (Cioms III): Very common (≥ 1/10), common (≥ 1/100 to
Blood disorders and lymphatic systems
Very common: leukopenia.
Common: thrombocytopenia, eosinophilia.
Rare: leukemia, lymph nodes.
Very rare: granulocyte loss, anemia, reduced all bloody, non -hydrophobia, anemia, huge red blood cell anemia, increased mesh red blood cells, hemolytic anemia.
immune system disorders
Rare: Multi -organ sealing disorders with fever, rash, vasculitis, lymph nodes, lymphoma, joint pain, leukopenia, eosin hypernagus, enlarged spleen, abnormal liver function tests and gone bile duct syndrome (destroying and disappearing of bile ducts in the liver) occurs in many different combinations of drugs. Other organs may also be affected (for example, lungs, kidneys, pancreas, heart muscle, colon).
Very rare: Anaphylactic reaction, angioedema, reducing blood gamma blood.
Endocrine disorders
Common: edema, fluid retention, weight gain, sodium reduction and blood permeability reduction due to anti -urinary hormone (ADH) lead to rare cases with water poisoning accompanied by sleep, vomiting, headache, confusion, neurological disorders.
Very rare: secretion of milk, big breasts in men.
Metabolic and nutrition disorders
Rare: Folate deficiency, anorexia.
Very rare: acute porphyrin metabolism disorders (abidier porphyrin metabolic disorders and mixed porphyrin metabolic disorders), non -acute porphyrin metabolic disorders (porphyrin metabolic disorders that show late skin).
Mental disorders
Rare: illusion (vision or hearing), depression, aggression, excitement, restlessness, confusion.
Very rare: Activating mental disorders.
Nervous system disorders
Very common: loss of air conditioning, dizziness, drowsiness.
Common: Song Thi, headache.
Uncommon: abnormal arbitrary movement (eg tremor, posture disorder, muscle disorder, mechanical machine), vibration of eyeball.
Rarely: movement disorders, eye movement disorders, pronunciation disorders (for example, speech, stuttering), dance-shocking, peripheral neuropathy, abnormal, mild paralysis.
Very rare: malignant syndrome caused by sedative drugs, sterile meningitis with muscle vibration and hyperlemen likes eosin in the peripheral, taste disorder.
Eye disorders
Common: regulating disorders (for example, blurred vision).
Very rare: cataracts, conjunctivitis.
Disorders of ears and mesmerizing
Very rare: hearing disorders, for example, tinnitus, hearing hypertensions, hearing loss, change of sound recognition.Heart disorders
Rare: heart disease disorders.
Very rare: arrhythmia, atrial bloc with fainting, slow heart rate, congestive heart failure, coronary artery disease.
circuit disorders
Rare: Hypertension or hypotension.
Very rare: circulation, embolism (eg pulmonary embolism), thrombosis.
Respiratory, chest and mediastinum disorders
Very rare: Pulmonary hypersensitivity for example, fever, shortness of breath, alveolar inflammation or pneumonia.
Gastrointestinal disorders
Very common: vomiting, nausea.
Common: dry mouth; Rectal stimulation can occur with ammunition.
Less: diarrhea, constipation.
Rare: abdominal pain.
Very rare: pancreatitis, tongue inflammation, stomatitis.
Liver disorders
Rare: cholestatic hepatitis, liver parenchyma (liver cells) or mixed hepatitis, bile duct syndrome disappears, jaundice.
Very rare: liver failure, granular liver disease.
Skin and tissue disorders
Very common: Hres may be serious, atopic dermatitis.
Less: peeling dermatitis.
Rare: Lupus erythematosus, itching.
Very rare: Steven - Johnson*syndrome, poisoned epidermal necrosis, light sensitive reaction, diverse erythema, erythema, pigment disorders, hemorrhage, acne, sweating, hair loss, hair.
Disorders of musculoskeletal, connective tissue and bone
Rare: Weakness.
Very rare: bone metabolism disorders (decreased by plasma and 25-hydroxy-cholecalciferol reduction in blood) leading to bone puree/osteoporosis, joint pain, muscle pain, muscle spasm.
Kidney and urinary disorders
Very rare: interstitial renal tubular inflammation, renal impairment, impaired renal function (eg albuminuria, urinary blood, urinary disorders and hyperemia/increased blood nitrogen), urinary retention, urination many times.
reproductive system
Very rare: sexual dysfunction/erection dysfunction, sperm abnormalities (with the number and/or movement of sperm decreases).
Systemic disorders and medical condition
Very common: fatigue.
Testing
Very common: increasing gamma-glutamyltransferase (due to liver enzyme induction), often without clinical significance.
Common: increased alkaline phosphatase in the blood.
Uncommon: increasing transaminase.Very rare: increased pressure in the eye, hypertonic blood cholesterol, hyperlotein hypertrophy, high density, increased blood triglycerides. Abnormal thyroid function test: L-thyroxin reduction (free thyroxin, thyroxin, tri-iodothyronin) and increased hormones in the blood thyroid stimulation in the blood, often without clinical manifestations, hyperlactin blood prolactin.
* In some Asian countries, it is also reported as rare. See more caution when using.
The side effects of the drug from spontaneous reports (unknown frequency)
The following adverse drug reactions are derived from after -sales experience with Tegretol Cr 200mg through spontaneous cases and cases in literature. Because these reactions have been voluntarily reported from a group of unknown scale population, indefinite estimates of frequency, so it is classified as unclear. The adverse reactions are listed in the Meddra's organ system. In each organ system, the adverse reactions of the drug are presented in the order of severity.
Blood disorders and lymphatic systems: Bone marrow failure.
Digestive disorders: colitis. The immune system disorders: The rash caused by the drug with eosin cells and the systemic symptoms (Dress). Instructions on how to handle ADR 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
Tegretol Cr 200mg Contraindicated in the following cases:
Precautions when using
should only use Tegretol Cr 200mg under medical monitoring. Tegretol CR 200mg should only be prescribed after careful evaluation of benefits and risks and under the closeness of patients with a history of heart, liver or kidney damage, there are side hematological reactions for other drugs, or Tegretol Cr 200mg treatment is interrupted.
Hematology effects
Seed leukocytes and immutable anemia are associated with Tegretol Cr 200mg, but due to the low proportion of these conditions, it is difficult to estimate the risk of significant for Tegretol Cr 200mg. The common risk among untreated patients is generally estimated to be 4.7/1,000,000/year for grain leukemia and 2 people/1,000,000/year for prolifer anemia.
Reducing the number of platelets or temporary or prolonged white blood cells occurs from occasional to frequent related to the use of Tegretol Cr 200mg. However, in most cases, these effects are transient and not necessarily a sign of anemia onstrumental anemia or grain leukemia. However, it is necessary to count the total amount of blood cells, including platelets before treatment (and maybe both red blood cells and serum iron) at first and periodically.
If the number of white blood cells or platelets is clear or clearly reduced during the treatment period, the patient closely monitor and count the whole blood cell. Tegretol Cr 200mg must be stopped if there is any sign of bone marrow failure significantly.
Patients should be notified of early signs and symptoms of poisoning for hematology that may occur, as well as symptoms of skin reaction or liver reaction. If there are reactions such as fever, sore throat, rash, mouth ulcer, easily bruised, hemorrhagic spots or hemorrhage, patients should come to consult the doctor immediately.
Serious skin reaction
Serious skin reactions, including poisoned epidermal necrosis (ten, also known as Lyell syndrome) and Stevens-Johnson syndrome (SJS) have been reported very rare with Tegretol Cr 200mg. Patients with serious skin reactions may be hospitalized, as these conditions may be life -threatening and may cause death. Most cases of Stevens-Johnson syndrome/poisoning epidermal necrosis (SJS/Ten) appear in the first few months of treatment with Tegretol Cr 200mg. These reactions are estimated to occur at 1 - 6/10,000 new users in countries with the most populated population. If the signs and symptoms suggest serious skin reactions (for example, Stevens-Johnson syndrome, lyell syndrome/poisoned epidermal syndrome), Tegretol CR 200mg must be stopped immediately and should consider replacement treatment.
Pharmacogenomics
There is an increasing evidence of the role of various Alleles of white blood cell antigen (HLA) that makes patients more susceptible to adverse immunity reactions.
Related to HLA-B*1502
Rescue studies in patients with Chinese and Thai Han and Thailand have found a strong correlation between skin reactions in the case of Stevens-Johnson syndrome (SJS)/toxic epidermis (ten) related to carbamazepine and the presence of allele antigen antigen (HLA) -B*1502 in these patients. The frequency of Allele HLA -B*1502 in the range of 2 - 12% in Chinese population groups and about 8% in Thai population groups. The higher rate of Stevens-Johnson syndrome (rarely rare) has been reported in some Asian countries (for example, Taiwan, Malaysia and the Philippines), which has a higher Allele HLA-B*1502 frequency among population groups (for example, over 15% in Philippine population groups and some Malaysian population groups). The frequency of allele up to about 2% was reported in Korea and about 6% was reported in India. The Allele HLA-B*1502 was not significant in Europeans, some African people, local Americans, the Spanish and Portuguese population groups were sampled and Japanese (
Consider the test of Allele HLA-B*1502 in patients with ancestors in the population groups at a genetic risk before starting the Tegretol Cr 200mg (see information for medical staff below). Tegretol Cr 200mg should be avoided in patients whose test results are positive for HLA-B*1502 unless the benefits are significantly higher than the risk. HLA-B*1502 can be a risk factor for the development of Stevens-Johnson syndrome/poisoning epidermal necrosis (SJS/Ten) in Chinese patients taking other anti-epileptic drugs associated with Stevens-Johnson syndrome/poisoned epidermal necrosis. Therefore, it is advisable to avoid the use of other drugs related to Stevens-Johnson syndrome/poisoned epidermal necrosis in patients with HLA-B*1502 positive, when alternative therapies are equivalent to acceptable ways. In general, it is not recommended for screening for patients of population groups with low HLA-B*1502 ratio. Screening is not recommended for anyone currently using Tegretol Cr 200mg because of the risk of Stevens-Johnson syndrome/poisoned epidermal necrosis limited to the first few months of treatment, regardless of HLA-B*1502.
Determining the people with Allele HLA-B*1502 and avoiding carbamazepine treatment in these people has been shown to reduce the rate of stevens-johnson syndrome/poisoned epidermal necrosis caused by carbamazepine.
Related to HLA-A*3101
Human leukemia (HLA) -A*3101 can be a risk factor for developing side effects such as Stevens-Johnson syndrome (SJS), poisoned epidermal necrosis (Ten), EOSIN-like medications and systemic symptoms (Dress), acute pustules (AGEP) and lumpy bills. Rescue studies related to the entire genome in Japanese and Northern population groups have reported the relationship between serious skin reactions (Stevens-Johnson syndrome, poisoned epidermal necrotic, eosin-like medication and general symptoms, acute overall pustules and lumpy rash) related to the use of Carbamazepine and the presence Hey.
The frequency of Allele Hla -A*3101 is very change between racial groups, about 2-5% in European population groups and about 10% in Japanese population. The frequency of this Allele is estimated at less than 5% in the majority of the population of Australian, Asia, Africa and North America in some exceptions within 5 - 12%. The frequency of over 15% is estimated in some racial groups in South America (Argentina and Brazil), North America (US Navajo, Sioux, and Mexico Sonora Seri), southern India (Tamil Nadu) and from 10% - 15% in other local races in the same region.
The frequency of Allele is listed here that represents the chromosomal rate in the special population group that carries Allele, which means that the proportion of patients carrying a copy of this Allele on at least one of their two chromosomes (ie the "frequency of the carrier") is nearly twice the Allele frequency. Therefore, the proportion of patients may be nearly twice the risk of allele.
Testing should be considered for the presence of Allele Hla-A*3101 in patients with ancestors in the population groups at genetics (for example, patients of Japanese population and whites, patients of native American population groups, Spanish and Portuguese population groups, southern Indians and Arabic people before starting treatment with Tegretol CR 200MG. Tegretol Cr 200mg should be avoided for patients to detect positive for HLA-A*3101 unless the benefits are significantly higher than the risk. In general, it is not recommended for anyone who is currently using Tegretol Cr 200mg because of the risk of Stevens-Johnson syndrome/ poisoned epidermal necrosis limited to the first few months of treatment, regardless of HLA-A*3101.
The limitation of genetic screening
Genetic screening results must never replace the appropriate vigilance clinically and control patients. Many Asian patients are positive for HLA-B*1502 and treated with Tegretol Cr 200mg will not develop Stevens-Johnson syndrome/poisoned epidermal necrosis and negative patients for HLA-B*1502 in any race that can still develop Stevens-Johnson syndrome/poisoned epidermal necrosis. Similarly, many patients are positive for HLA-A*and 3101 and treated with Tegretol Cr 200mg will not develop Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis (Ten), Eosin-like medication and systemic symptoms (Dress), Systemic pustules (AGEP) or Non-Calculated patients with HLA Which racial period can still develop these serious skin side effects. The role of factors may be different in the development of serious adverse skin reactions and the sufficient adverse reactions in this serious skin such as anti -epileptic drugs, medications, concurrent drugs, accompanying diseases and unused skin monitoring levels.
Information for medical staff
If tested for the presence of Allele HLA-B*1502, recommends "determining HLA-B*Genotype HLA-B*1502" with high resolution. The test is positive if one or two Allele HLA-B*1502 and the test are negative if the Allele HLA-B*1502 is not detected. Similarly, if the test of Allele HLA-A*3101, recommends "determine the HLA-A**3101 genotype" with the corresponding high resolution. Testing is positive if one or two Allele HLA- A*3101 and the test is negative if the Allele HLA- A*3101 is not detected.
Other skin reactions
Light skin reactions such as scattered skin rash or lumpy skin rash can also occur, most of them are transient and not dangerous. These reactions disappear within a few days or weeks or during continuous treatment or after decreased dose. However, because it may be difficult to distinguish early signs of skin reactions more seriously with mild reactions, patients need to be closely monitored and consider stopping the drug immediately if the reaction is worse when continuing to use the drug.
Allele Hla-A*3101 is found associated with adverse skin reactions less serious by using carbamazepine and may predict the risk of these reactions due to carbamazepine such as hypersensitivity syndrome due to anti-convulsions or non-serious rash (lumpy rash). However, Allele HLA-B*1502 must not be found for the risk of the above skin reactions.
hypersensitivity
Tegretol Cr 200mg can cause hypersensitivity reactions including rashes due to eosin -like medications and systemic symptoms (dress), dyserty dysfunction disorders with fever, rash, vasculitis, lymph node disease, lymphoma, joint pain, leukopenia, eosinophilia, liver and liver test, abnormal loss of liver and liver. Can occur in many different combinations of drugs. Other organs may also be affected (for example, lungs, kidneys, pancreas, heart muscle, colon). (See side effects).
Allele HLA-A*3101 has been found associated with the appearance of hypersensitivity syndrome, including lumpy rash.
It is necessary to notify patients with hypersensitivity reactions to carbamazepine that about 25-30% of these patients may have hypersensitivity reactions to oxcarbazepine (trileptal).
Cross -hypersensitivity can occur between carbamazepine and phenytoin.
In general, if the signs and symptoms suggest the hypersensitivity reaction, the Tegretol Cr 200mg must be stopped immediately.
epilepsy
Be careful when using Tegretol Cr 200mg for patients with seizures, mixed mixture, typical or not typical. In all this situation, Tegretol Cr 200mg can make seizures worse. In the case of severe seizures, Tegretol Cr 200mg must be stopped.
There may be an increase in the frequency of epilepsy while changing from oral formula to ammunition.
Liver function
Must conduct liver function evaluation at the beginning of treatment and periodically during the treatment with Tegretol Cr 200mg, especially in patients with a history of liver disease and in elderly patients. Must stop the drug in the case of more severe liver dysfunction or progressive liver disease.
Kidney function
Recommendations for total urine analysis and nitrogen test, blood urea (bun) at the beginning of treatment and periodically.
Hemorrhage reduction
Hemorrhage reduction has been known to carbamazepine. In patients with previous kidney conditions associated with low sodium or patients treated simultaneously with drugs that reduce sodium (for example, diuretics, drugs associated with anti -urinary hormones (ADH) are inappropriate), sodium concentration should be measured before the start of carbamazepine treatment. After that, sodium concentration should be measured after about 2 weeks and then at the distance of each month for the first 3 months of the course or according to clinical needs. Especially these risk factors can occur for elderly patients. If observations are reduced in sodium blood, water restriction is an important measure if clinically indicated.
thyroid disabilities
Carbamazepine can reduce serum thyroid hormone levels through enzyme induction, which may need to increase the dose of thyroid hormone replacement therapy in patients with thyroid disabilities. Therefore, monitoring the thyroid function is proposed to adjust the dose of thyroid replacement therapy.
anti -cholinergic effect
Tegretol Cr 200mg shows light anti -cholinergic activity. Therefore, patients with increased intraocular pressure and urinary retention should be closely monitored during the treatment period (see side effects).
Mental effects
It should be noted that the ability to activate potential mental disorders and in the elderly patients is confused and agitated.
suicide thoughts and suicide 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 that are controlled to the placebo of anti -epileptic drugs has shown a slight increase in the risk of suicide thoughts and suicide behavior. The mechanism of this risk is unknown.
Therefore, it is necessary to monitor patients with signs of suicide thoughts and suicide behaviors and should consider appropriate treatment. It is advisable to advise patients (and patient care) to apply for medical advice if the thought of suicide or suicide behavior.
Hormonal effects
Bleeding between cycle has been reported in women using Tegretol Cr 200mg while taking hormone contraceptives. The reliability of hormone contraceptives can be adversely affected by Tegretol Cr 200mg, which should recommend women who are likely to be able to consider using other forms of contraceptives while using Tegretol Cr 200mg.
Monitor plasma concentrations
Although the correlation between the dose and carbamazepine levels in plasma and between plasma concentrations and clinical effects or tolerance are slightly, monitoring of plasma concentrations can be helpful in the following cases: Sudden increase in epilepsy frequency/Check patient adhesion, during pregnancy, when treating children or teenagers; suspect absorption disorders; Suspecting poisoning when taking more than one drug (see the drug interaction).
Effects when reducing the dose and stopping the drug
Sudden stopping of Tegretol Cr 200mg can start the seizure, so it is necessary to stop the drug gradually for a period of 6 months. If you have to stop Tegretol Cr 200mg suddenly in patients with epilepsy, switching to a new anti -epileptic compound should be done with a suitable drug.
Tegretol Cr 200mg oral fluid contains parahydroxybenzoate which can cause allergic reactions (may be slow allergies). It also contains sorbitol, so it should not be used for patients with rare genetic problems about fructose intolerance.
In newborns
To prevent bleeding disorders in the baby, there is also recommendations to use vitamin K, for mothers in the last weeks of pregnancy as well as for babies.
There have been several cases of convulsions in infants and/or respiratory failure associated with the mother using Tegretol Cr 200mg and other anti -epileptic drugs simultaneously. A few cases of vomiting, diarrhea or reducing breastfeeding in babies are also reported related to the mother using Tegretol Cr 200mg. These reactions can represent drug suspension syndrome in infants.
Women are likely to be pregnant and contraceptive measures
Due to enzyme induction, Tegretol Cr 200mg can lead to loss of treatment effects of oral contraceptives containing estrogen or progesterone. Pregnant women should recommend using other contraceptive methods while being treated with Tegretol Cr 200mg.
Reproduction
There have been reports of very rare cases of fertility impairment in men and abnormal sperm.
The ability to drive and operate machinery
The patient's reaction ability may be reduced due to the condition leading to seizures and adverse reactions including dizziness, drowsiness, loss of air conditioning, but reduced regulation and blurred vision that has been reported to Tegretol Cr 200mg, especially at the beginning of treatment. Therefore, patients are careful when driving or operating machinery.
Pregnancy
Children of mothers with epilepsy have been known to have developing disorders, including malformations. Despite the lack of decisive evidence from controlled studies with carbamazepine treatments, there has been a report on development of development disorders and malformations, including vertebra cracking and other birth defects, such as facial skull defects, cardiovascular defects, low urine defects and defects including different organ systems that have been reported related to the use of Tegretol CR 200MG.
Based on data in a program to store pregnant women's facts in North America, the rate of severe birth defects, defined as an extraordinary structure abnormalities of surgical, medical or aesthetic importance, diagnosed within 12 weeks after birth is 3.0% (reliable interval (CL) 95% 2.1 - 4.2%) among mothers using carbamazepine in the first 3 months of pregnancy and 1.1% of the first 3 months of pregnancy and 1.1 95% 0.35 - 2.5%) Of the pregnant women who do not use any anti -epileptic drugs (the risk is relatively 2.7, 95% reliability is 1.1 - 7.0).
Need to pay attention to the following:
In women who are likely to be pregnant, whenever possible, Tegretol Cr 200mg should be prescribed in the form of single therapy, because the rate of birth defects in children of women who are treated combined with anti -epileptic drugs is higher than in their children, women who use separate drugs in the form of monomers. The risk of deformities after using carbamazepine in the form of therapeutic therapy may vary depending on the specific drugs used and may be higher in the form of multi -therapy combination including valproate.
Monitor and Prevention
Folic acid deficiency has been known during pregnancy. There have been reports that anti -epileptic drugs worsen folic acid deficiency. This deficiency can contribute to increasing the rate of birth defects in children of epilepsy women treated. Therefore, it is recommended to supplement folic acid before and during pregnancy.
Breastfeeding period
Carbamazepine enters breast milk (about 25 - 60% of plasma concentrations). It is necessary to consider the benefits of breastfeeding compared to the possibility of having negative adverse effects for children. Mothers who are using Tegretol Cr 200mg may be breastfeeding, as long as they are monitored with the possible adverse reactions (for example, excessive drowsiness, skin allergic reaction). There have been a number of reports on bile stasis in newborn babies exposed to carbamazepine during before birth and/or during breastfeeding. Therefore, breastfed babies of mothers treated with carbamazepine must be carefully monitored for adverse effects on the liver.
Medicinal interaction
Cytochrome P450 3A4 (CYP3A4) is the main enzyme that catalyzes the formation of carbamazepine-10,11-epoxid metabolites. Concentrated with CYP3A4 inhibitors can lead to increased carbamazepine levels in plasma, which can cause adverse reactions. Concentrated with CYP3A4 induction drugs can increase the speed of carbamazepine metabolism, thus leading to the ability to reduce carbamazepine levels in serum and reduce the effectiveness of treatment. Similarly, stop taking CYP3A4 induction drugs may reduce the rate of carbamazepine metabolism leading to increased carbamazepine levels in plasma.
Carbamazepine is a strong CYP3A4 induction drug and other enzyme system I and II in the liver, so it can reduce the plasma concentration of drugs that are simultaneously metabolized by CYP3A4 due to their metabolism.
Epoxid Hydrolase in Microsom Human has been identified as enzyme responsible for the creation of 10.11 - transdiol derivatives from Carbamazepine - 10.11 Epoxid. Concentrated with Epoxid Hydrolase inhibitors in microsom people can lead to increased carbamazepine levels - 10.11 epoxid in plasma.
Interactions lead to contraindications
Contraindicated using Tegretol Cr 200mg in combination with monoamine-oidase inhibitors (MAOI), before using Tegretol Cr 200mg must stop the Mao inhibitors for at least 2 weeks or longer if the clinical status is allowed (see the contraindication section).
Drugs can increase carbamazepine levels in plasma
Because carbamazepine concentration in plasma can lead to adverse reactions (for example, dizziness, drowsiness, loss of air conditioning, but need to adjust the dose of Tegretol CR 200mg accordingly or monitor plasma concentrations when used simultaneously with the substances described below:
Antidepressant drugs: may be desipramin, fluoxetin, fluvoxamin, nefazodon, paroxetin, trazodon, viloxazin. Anti -epileptic drugs: Stiripentol, Vigabatrin. Antihistamine anti -histamine: Loratadin, Terfenadin. Other interactions: grapefruit juice, nicotinamid (with high doses). The drugs may increase the concentration of metabolic metabolites with carpamazepine-10, 11-Epoxid in plasma. Because the increase in carbamazepine-10.11-epoxid in plasma can lead to adverse reactions (for example, dizziness, drowsiness, loss of air conditioning, but carefully adjust the dose of Tegretol CR 200mg accordingly or monitor the plasma concentration when used simultaneously with the substances described below: Loxapin, Quetiapine, Primidon, Progabid, Progabid, Valproic acid, Valproic acid and Valpromid. Medications may reduce carbamazepine levels in plasma. Tegretol CR 200mg dose may have to be adjusted when used simultaneously with the substances described below: anti -tumor tumor: cisplatin or doxorubicin. Anti -tuberculosis: Rifampicin. Dermatology: Isotretinoin. Other interactions: Herbal preparations containing J John's Wort (Hypericum Perforatum). The effect of Tegretol Cr 200mg on plasma concentrations of simultaneous medications Carbamazepine may reduce plasma concentrations, or even lose the activity of some drugs. May need to adjust the dose of the following drugs according to clinical requirements: Antidepressants: Bupropion, Citalopram, Mianserin, Nefazodon, Sertralin, Trazodon, 3 -round antidepressants (e.g. imipramin, amitriptylin, nortriptylin, Domopramin). Anti -vomiting drugs: Aprepitant. Anti -epileptic drugs: Clobazam, Clonazepam, Ethosuximid, Felbamat, Lamotrigin, Oxcarbazepine, Primidon, Tiagabin, Topiramat, Valproic Acid, Zonisamid. To avoid phenytoin poisoning and carbamazepine levels below the treatment level, the recommendation to adjust the phenytoin concentration in plasma is 13mcg/ml before using more carbamazepine to the treatment. There have been rare reports on increased mephenytoin levels in plasma. Anti -born tumor drugs: Imatinib, cydophosphamid, lapatinib, temsirolimus. Anti -psychotic drugs: dozapin, haloperidol and bromperidol, olanzapin, quetiapin, risperidon, ziprasidon, aripiprazol, palipidon. Anti -viral drugs: Protease inhibitors to treat viruses that cause immunodeficiency in humans (HIV) (for example: indinavir, ritonavir, saquinavir). Immunosuppressant: Ciclosporin, Everolimus, Tacrolimus, Sirolimus. The combination to consider There have been simultaneous reports on carbamazepine and isoniazid that increases the toxicity of the liver due to isoniazid. Interpretation of seral tests
Storage
Store less than 30 ° C and avoid moisture.
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