Trileptal
Trileptal (Oxcarbazepine)Pharmacological action
Antiepileptic preparation. The Oxcarbazepine action mechanism is bound, basically, with blockade potential-dependent of sodium channels that leads to stabilisation of a membrane of the reraised neurones, to inhibition of occurrence of serial categories of neurones. The enlarged conductivity of a potassium and modulation of the calcium channels activated in high potential of a membrane, also can bring the contribution to anticonvulsant action of a preparation.
Trileptal Efficiency at partial (focal) epileptic attacks (simple, difficult and again-generalised) and at generalised toniko-clonic attacks has been shown in and as monotherapy.
Indications
- Simple and difficult partial epileptic attacks (with loss or without a loss of consciousness), with secondary generalisation or without it;
- Generalised toniko-clonic epileptic attacks.
Trileptal is prescribed as a preparation of the first choice as monotherapy, and as a part of the combined therapy. At incomplete cupping of epileptic attacks replacement of other anticonvulsants on Trileptal is possible.
Dosage regimen
Trileptal can be applied both in the form of monotherapy, and in a combination with other antiepileptic preparations. In both cases course of treatment begins with clinically effective dose parted on two receptions. The dosage can be enlarged depending on the answer to therapy. At replacement of other antiepileptic preparation on Trileptal in the beginning of Trileptal reception it is necessary to reduce a dose of a replaced preparation gradually.
Trileptal is possible to accept during time, after meal or in intervals between food intakes together with a liquid small amount.
The resulted references concern patients with normal function of kidneys. Definition of its concentration in plasma is unessential to optimisation of Trileptal therapy.
To adult and elderly patients as monotherapy the initial dose makes 600 mg/sut (8-10 mg/kg of mass of a body in 24h), parted on two receptions. The good therapeutic answer was observed in a range of doses of 600-2400 mg/days the Dosage can be enlarged gradually no more than by 600 mg/24h with week intervals before achievement of the desirable therapeutic answer. In stationary conditions probably fast rising of a dose to 2400 mg/sut during 48 h.
At appointment as a part of the combined therapy the initial dose makes 600 mg/sut (8-10 mg/kg/sut), parted on two receptions. The good therapeutic answer was observed in a range of doses of 600-2400 mg/days In the presence of clinical indications a dose can be enlarged gradually no more than by 600 mg/sut approximately with week intervals before achievement of the desirable therapeutic answer.
In controllable clinical researches application of daily doses above 2400 mg was not studied. There is a limited experience of application of daily doses to 4200 mg.
The vial should be stirred up before the use. The recommended quantity is typed by means of an applied syringe. After use densely to close a vial and to wipe a syringe a pure dry tissue. Suspension can be accepted in not divorced kind directly from a syringe or to be diluted with a water small amount.
Side effect
Side effects usually weakly or are moderately expressed, wear a temporality and are observed basically in the therapy beginning.
From an organism as a whole: very often - undue fatigability; often - an asthenia; very seldom - a Quincke's disease, multiorgan reactions of hypersensitivity (an eruption, a fever, a lymphadenopathy, rising of hepatic assays, an eosinophilia, an arthralgia).
From party TSNS: very often - giddiness, a headache, drowsiness; often - excitation, an amnesia, apathy, disturbance of concentration of attention, a disorientation, depression, emotional lability, a nystagmus, a tremor.
From cardiovascular system: very seldom - rhythm and conductivity (AV-blockade) disturbance.
From the alimentary system: very often - a nausea, vomiting; often - a constipation, pains in the field of a stomach, a diarrhoeia; sometimes - rising of serumal transaminases and-or an alkaline phosphatase, is very rare - a hepatitis.
From a hemopoiesis: sometimes - a leukopenia, it is very rare - a thrombocytopenia.
From a metabolism: often - a hyponatremia; very seldom - the symptomatic hyponatremia leading to convulsive attacks, confusion of consciousness, an encephalopathy, sight disturbances (foggy sight).
Dermatological reactions: often - an alopecia, an eruption; sometimes - an urticaria, it is very rare - Stevens-Johnson's syndrome, a system lupus erythematosus.
From sense organs: very often - a diplopia; often - foggy sight, giddiness.
Contraindications
- A hypersensibility to Oxcarbazepine or to any other components of a preparation.
Pregnancy and lactemia
Experience of Trileptal application at pregnancy is limited. As separate reports on possible communication between reception of a preparation and congenital teratisms are known (for example, the wolf mouth) it is necessary to compare carefully expected advantages of therapy and its possible complications, especially in I trimester of pregnancy in the event that at the woman receiving Trileptal.
It is necessary to use the minimum effective doses. At women of genital age it is recommended to use Trileptal as monotherapy.
It is known, that at pregnancy deficiency of Acidum folicum develops, antiepileptic agents can strengthen this deficiency representing one of the possible reasons of disturbances of a fetation, additional reception of Acidum folicum therefore is recommended.
Application of antiepileptic preparations at pregnancy can lead to the raised staxis at newborns, as a safety measure appointment of vitamin K1 in the last some weeks of pregnancy and to the newborn is recommended.
Special indicatings
With care prescribe a preparation to patients with a known hypersensibility to carbamazepine since approximately at 25-30 % of these patients hypersensitivity reactions on Oxcarbazepine can develop.
The hyponatremia (serumal concentration of sodium below 125 mmol/l) clinically usually is not shown and does not demand correction of a regimen of dosage, is observed at 2.7 % of patients. Concentration of sodium is normalised at Trileptal cancellation (dose reduction) or conservative treatment (restriction of reception of a liquid).
At all patients with a heart failure, including with secondary, the control of mass of a body is necessary for timely definition of a delay of a liquid. In case of a delay of a liquid or advance of symptoms of a heart failure it is necessary to define serumal concentration of sodium. In case of hyponatremia occurrence it is necessary to limit quantity of a consumed liquid. In spite of the fact that in clinical researches cases of disturbance of warm conductivity have not been noted, careful observation over patients with disturbance of a rhythm and conductivity in the anamnesis is necessary.
There are separate reports on cases of development of a hepatitis which were safely resolved.
Overdosage
There are individual reports on a preparation overdosage. The maximum dose described in reports, made 24
Symptoms: drowsiness, giddiness, a nausea, vomiting, a hypokinesia, a hyponatremia, a nystagmus.
Treatment: the specific antidote does not exist, treatment is basically symptomatic and supporting. In case of recent reception of a preparation the gastric lavage and reception of the activated coal for absorption reduction is recommended.
Conditions and periods of storage
The preparation should be stored in a place inaccessible to children, at temperature not above 30 C, in original packing, without special precautions.
Period of validity - 3 years. Not to use after the termination of the period of validity specified on packing.
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