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When using Trileptal in clinical practice in some cases (postmarketing reports) noted the development of immediate hypersensitivity type (I type), including rash, pruritus, urticaria, angioneurotic edema and anaphylactic reactions. Angioedema and anaphylactic reactions with the defeat of the larynx, vocal folds (glottis region), lips, eyelids developed as in the first and in readmission Trileptal. In deca steroids case of hypersensitivity köpa testogel of immediate type Trileptap should be lifted immediately appoint an alternative therapy.
It should be used with caution to patients with known hypersensitivity to carbamazepine, since this group of patients in approximately 25-30% of cases may develop hypersensitivity reactions to oxcarbazepine. In patients without a history of indications hypersensitivity to carbamazepine, also may develop hypersensitivity reactions to the drug, including multiple organ disorders.
The use  for patients with severe hepatic impairment has not been studied so caution should be used drug in these patients.

The use of pregnancy and lactation Experience with  during pregnancy is limited. Available reports indicate a possible connection of the drug during pregnancy with the development of birth defects (such as cleft palate). In experimental studies, the application l in toxic doses showed an increase in fetal mortality, retardation and impaired development and fetal growth. If the patient becomes pregnant or plans to become pregnant while using the drug, as well as in the event of the issue of the appointment  during pregnancy need to carefully compare the expected benefits of therapy and the possible risks to the fetus, especially in the I trimester of pregnancy.

 

  • If pregnancy should use the minimum effective dose.
  • When sufficient clinical efficacy for women of child-bearing period, Trileptal should be administered as a monotherapy.
  • The patient must be advised of the possible violations of fetal development and the need for antenatal diagnosis.
  • During pregnancy should not interrupt deca steroids an effective antiepileptic treatment, because the progression of the disease can have a negative impact on the mother and the fetus.
    It is known that during pregnancy develop folic acid deficiency. Antiepileptic drugs can enhance the deficit, which is one of the possible causes of violations of fetal development, so it is recommended additional intake of folic acid.
    Using the drug during pregnancy should take into account that the physiological changes that occur in the body of a pregnant patient may lead to a gradual reduction in the level of 10 -monogidroksiproizvodnogo oxcarbazepine  in the blood plasma. For maximum control köpa anabola steroider i sverige of the symptoms of the disease in pregnant patients the clinical effect of the drug is necessary to regularly assess and define concentration in blood plasma. Determination recommended  plasma levels also carry out during the postpartum period, especially if during pregnancy increased dose of the drug. There are reports that the use of antiepileptic drugs during pregnancy can lead to increased bleeding in newborns. As a precaution, it is recommended the appointment in the last few weeks of pregnancy, and newborns who receive Trileptal mother. Oxcarbazepine  cross the placental barrier.
    Oxcarbazepine are excreted in breast milk. The ratio of the concentration in milk and plasma was 0.5 for both substances. Since the impact on newborns oxcarbazepine  received breast milk deca steroids is unknown, Trileptal should not be used during breastfeeding.
  • Use in children under the age of 1 month . Use of the drug in children under the age of 1 month in controlled clinical trials has not been studied.

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After oral administration, oxcarbazepine is completely absorbed and largely metabolized with the formation of the pharmacologically active metabolite.  After a single in the form of a suspension for oral administration at a dose of 600 mg in healthy volunteers fasted  maximum plasma deca durabolin concentration, the average time to achieve it – about 6 hours. After a single dose Trileptal in the form of tablets, coated tablets, 600 mg dose in healthy volunteers fasted , the median time to achieve – about 4.5 hours. The pharmacokinetic studies demonstrated that the plasma is determined of oxcarbazepine ; the rest comes from secondary metabolites rapidly eliminated from the blood plasma. Food intake does not affect the rate and extent of absorption. The connection to plasma proteins and the distribution of apparent volume of distribution  49 liters.Approximately binds to plasma proteins, mainly albumin. The therapeutic range of the degree of binding is not dependent on the concentration of oxcarbazepine in serum. Oxcarbazepine and do not bind to alpha-1-acid glycoprotein.

Metabolism Oxcarbazepine is rapidly metabolized by the liver cytosolic enzymes to the active metabolite , which causes a pharmacological effect is further conjugated with glkzhuronovoy acid. Minor quantities (about 4% of the dose) are oxidized with formation of inactive metabolites . Derivation ofoxcarbazepine is excreted mainly as metabolites, mainly by the kidneys. More than 95% of the dose excreted by the kidneys as metabolites, less than 1% – unchanged. Approximately 80% of the dose is excreted , in the form of glucuronides (49%) and as unchanged IHP (27%); inactive is about 3%, conjugates of oxcarbazepine – about 13% of the dose. About 4% of the dose is excreted in the feces. Oxcarbazepine is rapidly eliminated from the blood plasma, the apparent half-life is 1.3 – 2.3 hours. In contrast to oxcarbazepine, the apparent half-life  is an average of 9,3 ± 1,8 hours. The equilibrium concentration of IHL in plasma are reached 2-3 hours while taking Trileptal 2 times a day. In the equilibrium state pharmacokinetic parameters are dose-dependent and linear in the range of daily .

Patients with hepatic impairment pharmacokinetic parameters and metabolism of oxcarbazepine and IHL after a single oral administration of the drug at a dose of 900 mg were evaluated in healthy volunteers and in patients with impaired hepatic function. Human liver mild to moderate degrees do not affect the pharmacokinetic parameters of oxcarbazepine . Pharmacokinetics with severe deca durabolin hepatic impairment has not been studied. Patients with impaired renal function. There is a linear dependence of the renal clearance of creatinine clearance . In patients with impaired renal function (creatinine clearance less than 30 ml / min) after a single dose of 300 mg oxcarbazepine during IHP-life increases to 19 hours, and the area under the curve “concentration – time”  increased by 2 times. Children Clearancadjusted for body mass, in children decreases with increasing age and body weight, approaching a clearance adults. Clearance adjusted for body mass, in children aged 1 to 4 months of age by an average of 93% higher than in adults. Thus it is assumed that  among children in this age group is expected to be 2 times smaller than that of adults when using the same dosage (when adjusting for body weight). Clearance adjusted for body weight in children aged 4 to 12 years old on average 43% higher than in adults. Alleged in children of this age group is 2/3 of that of adults when using the same dosage (when adjusting for body weight). It is assumed that children aged 13 years and over due to the increase in body weight  clearance corrected for body weight, corresponds to the clearance  in adults. Pregnant patients in pregnant women is a series of physiological changes that can lead to a gradual reduction  level in plasma during pregnancy. elderly patients after receiving once  and again (at a dose of 600 mg / day) in the elderly volunteers aged 60-82 years30-60% higher compared to the same parameters in young volunteers (18-32 years), which is associated with age-related reduction in creatinine clearance. Gender is not observed any differences in pharmacokinetic parameters according to sex in childhood, adulthood or old age.

 

Indications

 

  • Simple, complex partial seizures with secondary generalization and without adults and children aged 1 month and over.
  • Generalized tonic-clonic seizures in deca durabolin adults and children aged 2 years and older.
    Trileptap is the drug of first-line monotherapy or in combination therapy.
    Trileptap can be used to replace other antiepileptic drugs in cases where the application of the latter is not achieved a satisfactory therapeutic response.Contraindications
  • Hypersensitivity to oxcarbazepine or any other components of the drug,
  • For tablets, film-coated: children up to 3 years.
  • For suspension for the reception inside: children up to 1 month

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Circulatory disorders also may occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease and sickle cell anemia. The increase in frequency and severity of migraine during use of combined oral contraceptives (which may be preceded by cerebrovascular disorders) can be grounds for immediate discontinuation of these drugs. Biochemical parameters which can be indicative of hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated , hyperhomocysteinemia, what is decadeficiency, protein C deficiency, protein deficiency , antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Tumors of the increased risk of cervical cancer in long-term use of combined oral contraceptives has been reported in some epidemiological studies. His connection with the intake of combined oral contraceptives has not been proved. Contradictions persist as to the extent to which these findings relate to the characteristics of sexual behavior and other factors such as human papilloma . There is evidence of a slightly increased relative risk of developing breast cancer diagnosed in women who are at the time of the study were used combined oral contraceptives. His connection with the intake of combined oral contraceptives has not been proved. The observed increase in risk may be due to an earlier diagnosis of breast cancer in women using combined oral contraceptives. Breast cancers in women who had ever used combined oral contraceptives were clinically less severe than in women, never did not use them. In rare cases, against the background of the use of combined oral contraceptives was observed the development of liver tumors. In case of severe pain in the abdomen, liver enlargement or signs of intra-abdominal bleeding it should be considered in the differential diagnosis.

Other conditions Women with hypertriglyceridemia, or the presence of her family history, may increase the risk of developing pancreatitis while taking combined oral contraceptives. Although a slight increase in blood pressure have been reported in many women taking what is deca, clinically relevant increases were rare. However, if while taking combined oral contraceptives develops persistent, clinically significant increase in blood pressure, should be discontinued these drugs and begin treatment of hypertension. Acceptance of combined oral contraceptives may be continued if using antihypertensive treatment achieved normal blood pressure values. The following conditions have been reported to develop or worsen both during pregnancy and while taking combined oral contraceptives, but their relationship with the intake of combined oral contraceptives It has not been proven: jaundice and / or pruritus related to cholestasis; the formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes gestationis; hearing loss associated with otosclerosis. Disease and ulcerative colitis during treatment with combined oral contraceptives have also been described. Acute or chronic disturbances of liver function may require the elimination of the use of combined oral contraceptives, as long as liver function tests have not returned to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives. Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetics using. However, women with diabetes should be carefully observed while taking combined oral contraceptives. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to sunlight and ultraviolet radiation.

Laboratory tests
using combined oral contraceptives can affect the results of certain lab tests, including liver function, kidney, thyroid, adrenal, levels of transport proteins in the plasma, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes do not usually go beyond the normal range.

The effect on the menstrual cycle
While taking combined oral contraceptives may experience irregular bleeding (spotting or breakthrough bleeding), especially during the first months of use.
Therefore, the evaluation of any irregular bleeding should be done only after a period of adaptation of approximately three cycles.
If the irregular repeated bleeding or develop after previous regular cycles, you should conduct a thorough examination to exclude malignancy or pregnancy.
some women during the tablet-free interval may not develop withdrawal bleeding if combined oral contraceptives are taken according to directions, it is unlikely that the woman is pregnant. Nevertheless, if before that combined oral contraceptives are taken irregularly or if there are no two consecutive withdrawal bleeding, to continue receiving the drug should be excluded pregnancy.

Medical examinations
recommended to undergo a thorough general medical and gynecological examination before the beginning of the application trikvilar woman (including the study of mammary glands and cytological examination of cervical mucus), exclude pregnancy. Furthermore, it should exclude blood coagulation disorders.
In the case of long-term use of the drug is necessary every 6 months to conduct follow-up examinations. It should warn the woman that type trikvilar drugs do not
protect against what is deca and other sexually transmitted diseases through!