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Sinfonil 300mg 20 tabs, Oxcarbazapine

Sinfonil 300mg 20 tabs, Oxcarbazapine
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Sinfonil 300mg 20 tabs, Oxcarbazapine

Sinfonil  is indicated for the treatment of partial seizures (including seizure subtypes of simple, complex partial and generalized seizures that progress to secondary), and tonic-clonic seizures in adults and children from 1 month old .

TRILEPTAL ® is indicated as an antiepileptic drug of first choice, either as monotherapy or adjunctive therapy.

TRILEPTAL ® can replace other current antiepileptic treatment occurs when poorly controlled seizures (see Pharmacodynamics, Clinical Studies).

TRILEPTAL ® is indicated for the symptomatic treatment of trigeminal neuralgia, either as monotherapy or adjunctive therapy.

Pharmacokinetics in Humans:


Absorption: Following oral administration of Trileptal ®, oxcarbazepine is completely absorbed and metabolized significantly in its pharmacologically active metabolite (monohydroxy derivative 10, or MHD).

After administration of a single dose of Trileptal ® 600 mg to fasting healthy male volunteers, the mean Cmax of MHD was 34 mmol / l, with a corresponding Tmax of 4.5 hours on average.

In a mass balance study in humans, only 2% of the total plasma radioactivity was due to unchanged oxcarbazepine, approximately 70% to MHD and the rest was attributed to minor secondary metabolites were rapidly eliminated.

Food has no effect on the rate and extent of absorption of oxcarbazepine, therefore, TRILEPTAL ® can be taken with or without food.

Distribution: The apparent volume of distribution of MHD is 49 liters.

Approximately 40% of MHD is bound to serum proteins, especially albumin. The binding is independent of the serum concentration in the therapeutic range of interest. Oxcarbazepine and MHD do not bind to acid glycoprotein? 1.

Biotransformation: hepatic cytosolic enzymes quickly become oxcarbazepine in MHD, primarily responsible for the pharmacological effect of Trileptal ®. The MHD is further metabolized by conjugation with glucuronic acid. Minor amounts (4% of the dose) are transformed by oxidation is not pharmacologically active metabolite (derived from 10, 11-dihydroxy, or DID).

Elimination: Oxcarbazepine is cleared from the body primarily as metabolites excreted primarily by the kidneys. Over 95% of the dose was excreted in the urine, with less than 1% as unchanged oxcarbazepine. Fecal excretion accounts for less than 4% of the administered dose. Approximately 80% of the dose was excreted in urine as glucuronides of MHD (49%) or as unchanged MHD (27%), whereas the inactive DHD accounts for approximately 3% of the dose and the conjugates of oxcarbazepine 13%.

Oxcarbazepine is rapidly eliminated from plasma with half-life values ​​between 1.3 and 2.3 hours, while the half-life of MHD is on average 9.3 ± 1.8 hours.

Proportionality between the pharmacokinetics and dosage: Plasma concentrations of MHD in the steady state is reached after 2 to 3 days TRILEPTAL ® administered twice daily. In steady state, the pharmacokinetics of MHD are linear and dose proportional between 300 and 2,400 mg / day.

Special Populations

Patients with hepatic impairment: The pharmacokinetics and metabolism of oxcarbazepine and MHD were evaluated in healthy volunteers and in patients with liver failure after administration of a single oral dose of 900 mg.

The mild to moderate hepatic impairment had no effect on the pharmacokinetics of oxcarbazepine and MHD. TRILEPTAL ® has not been studied in patients with severe hepatic impairment.

Patients with renal impairment: There is a linear relationship between creatinine clearance and renal clearance of MHD. By managing TRILEPTAL ® to patients with renal impairment (creatinine clearance <30 ml / min) as a single dose of 300 mg, the elimination half-life of MHD is prolonged to 19 hours, and AUC doubles.

Children: MHD clearance of weight-adjusted decreases as age and weight are approaching those of an adult. The mean clearance adjusted by the weight of children aged 1 month to under 4 years is 93% higher than in adults, therefore, it is expected that exposure to MHD of these children is approximately 50% of the adult treated with a similar dose-adjusted weight. The mean clearance adjusted by the weight of children aged 4 to 12 years is 43% higher than in adults, therefore, it is expected that exposure to MHD of these children represents about two thirds of adults treated with a similar dose weight-adjusted. It is expected that after 13 years, with increasing weight, the clearance of MHD-adjusted weight will approach the values ​​observed in adults.

Elderly: After administration of single doses (300 mg) and multiple (600 mg / day) of Trileptal ® to elderly volunteers (60-82 years), peak plasma concentrations and AUC values ​​of MHD were 30 to 60% higher than in young volunteers (18-32 years). Comparisons of creatinine clearances between young volunteers and elderly volunteers indicate that the difference is due to reductions in creatinine clearance associated with age. It is not necessary to define special dosage recommendations and therapeutic doses are individually adjusted.

Gender: No pharmacokinetic differences were observed related to sex in children, adults or elderly patients.

Pharmacodynamic properties Pharmacotherapeutic group: anti-epileptics.

ATC code: N03A F02

Pharmacodynamics: The pharmacological activity of Trileptal ® (oxcarbazepine) is primarily exerted through the MHD metabolite of oxcarbazepine (see Pharmacokinetics, Biotransformation). It is thought that the mechanism of action of oxcarbazepine and MHD are based mainly on blocking sodium channel voltage-dependent, stabilizing neuronal membranes hyperexcited, inhibiting repetitive neuronal firing and decreasing the propagation of synaptic impulses. In addition, increased potassium conductance and modulation channel high voltage activated calcium can also contribute to the anticonvulsant effects. No sites found significant interactions with neurotransmitter receptors or modulators brain.

Oxcarbazepine and its active metabolite (MHD) are potent and effective anticonvulsant in animals have protected mice from tonic-clonic and, to a lesser degree, clonic and eliminated or reduced the frequency of partial seizures and chronic recurrent India in macaques with aluminum implants. No tolerance was observed (ie, attenuation of anticonvulsive effect) against tonic-clonic seizures to treat mice and rats daily for five days or four weeks, respectively, with oxcarbazepine or MHD.

Clinical Studies have been performed in total 10 double-blind, controlled, two on the complementary treatment and eight over monotherapy in patients with partial seizures including seizure subtypes simple and complex partial seizures progressing to secondarily generalized. All comparative studies also included patients with generalized tonic-clonic seizures. Two dose-controlled studies in which replaced various antiepileptics (carbamazepine, gabapentin, lamotrigine, phenytoin and valproate) in the monotherapy TRILEPTAL ® confirm the effectiveness of the latter. There were two studies in children (3 to 17 years), one complementary treatment compared with placebo and one on monotherapy compared with phenytoin. The efficacy of doses between 600 mg / day and 2.400 mg / day in all major efficacy parameters included the mean change in seizure frequency (or percentage change) with respect to baseline studies on the adjunctive therapy, and time to reach predefined termination criteria or the percentage of patients achieving these criteria in studies of monotherapy.

A double-blind study compared two doses of oxcarbazepine as adjunctive therapy in children over one month and four years younger than those who had not achieved satisfactory control of partial seizures with one or two antiepileptic drugs coadministered. The primary endpoint of efficacy was a comparison between the groups in absolute change in frequency of seizures in 24 hours during the study compared to baseline. This comparison revealed a statistically significant difference in favor of TRILEPTAL ® dose of 60 mg / kg / day. Another double-blind study compared two doses of oxcarbazepine monotherapy in children aged one month to 16 years with inadequately controlled partial seizures or recurrent seizures. The primary endpoint of efficacy was a comparison between the groups time to reach predefined termination criteria. We did not obtain a statistically significant difference in this comparison. Most patients in both groups had no seizures during the study (confirmed by video-EEG) and this study concluded five days without reaching the predefined termination criteria.

It has been shown that the effectiveness of TRILEPTAL ® is similar to that of other first generation antiepileptics (such as valproate, phenytoin and carbamazepine), but its tolerability profile is significantly better than that of phenytoin (fewer discontinuations due to adverse reactions), as well as its retention rate (proportion of patients on treatment). In these studies, similar proportions of patients with partial seizures and generalized tonic-clonic seizures stopped for presentation during the period 12 months of treatment with Trileptal ®.

CONTRAINDICATIONS: Hypersensitivity to the active substance or one of the excipients.


Hypersensitivity: In post-marketing reports have been received of hypersensitivity reaction type I (immediate), including rash, pruritus, urticaria, angioedema and anaphylaxis reports. Cases of angioedema anafilixia and larynx, glottis, lips, eyelids have been reported in patients after the first dose or subsequent doses of Trileptal ®. If a patient develops these reactions after treatment with Trileptal ®, the drug should be discontinued and starting an alternative therapy.

It should be noted that patients approximately 25-30% of those who have shown hypersensitivity reactions to carbamazepine may have similar reactions with Trileptal ® (see ADVERSE REACTIONS).

They can also be observed hypersensitivity reactions (including multi-organ hypersensitivity reactions) in patients without a history of hypersensitivity to carbamazepine. Such reactions can affect the skin, liver, blood, lymphatic system or other organs, either individually or jointly in the context of a systemic reaction (see ADVERSE REACTIONS). In general, TRILEPTAL ® should be discontinued immediately if signs and symptoms suggestive of hypersensitivity reactions.

Dermatological effects: have been reported very rarely serious skin reactions in association with Trileptal ®, which have included Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and erythema multiforme. You may need to hospitalize patients with severe skin reactions, since the conditions can be very dangerous but very rarely fatal. Reactions have been associated with Trileptal ® in both children and adults. The median time to onset of reaction was 19 days. Have been reported several isolated cases of recurrence of the severe skin reaction to restart Trileptal ®. If a patient develops a skin reaction with Trileptal ® should be considered stopping and prescribing another antiepileptic drug.

Hyponatremia: In up to 2.7% of patients treated with Trileptal ® have observed serum sodium <125 mmol / l, usually asymptomatic and not requiring any treatment setting. Experience in clinical trials shows that serum sodium levels returned to normal by reducing the dose of Trileptal ®, to suspend or to give the patient a conservative treatment (eg, limiting fluid intake). Before starting treatment should be measured in serum sodium in patients with pre-existing renal conditions associated with low sodium, and in patients concomitantly treated with hyponatremic drugs (eg diuretics, which cause an inadequate secretion of hormone antidiuretic [ADH]). Subsequently, these concentrations should be measured after about two weeks and then monthly for the first three months of treatment, or as required by the patient's clinical status. These risk factors apply especially to the elderly. In patients receiving TRILEPTAL ® and hyponatremic entering treatment by using the same method of verification in the concentrations of sodium. In general, if during treatment with Trileptal ® clinical symptoms develop hyponatremia suggest (see ADVERSE REACTIONS), should be considered for measuring the concentrations of sodium. Other patients should be subject to assessment of sodium in the framework of their routine laboratory studies. All patients with primary or secondary heart failure should be weighed regularly to detect possible water retention. Upon detection of such retention or heart condition deteriorates, should be verified in serum sodium. If hyponatraemia is observed, the restriction of water consumption is an important remedy.

As oxcarbazepine may rarely cause cardiac conduction abnormalities, patients with pre-existing disorders of conduction (eg, atrioventricular block, arrhythmias) should be subject to careful monitoring.

Hepatic: There have been very rarely reported cases of hepatitis, most of which were resolved favorably. If hepatitis is suspected, consideration should be suspended TRILEPTAL ®.

Hematologic Effects: During the pharmacovigilance have been reported very rarely cases of agranulocytosis, aplastic anemia and pancytopenia in patients treated with Trileptal ® (see ADVERSE REACTIONS). However, due to the very low incidence of these reactions and the presence of confounding factors (eg underlying disease, co-medication), it is impossible to establish a cause and effect.

If signs of significant bone marrow depression, you should consider stopping treatment.

Hormonal contraceptives should be advised women of childbearing age that co-administration of Trileptal ® and hormonal contraceptives may render ineffective the latter (see Interactions and other genus). Upon receiving TRILEPTAL ® is recommended further nonhormonal contraception.

Alcohol: Caution should be exercised when consuming alcohol during treatment with Trileptal ® as a possible additive sedative effect.

Stopping the drug: Like all anti-epileptic TRILEPTAL ® should be discontinued gradually to minimize the possible increase in seizure frequency.

Effects on ability to drive and use machines: The use of Trileptal ® has been associated with adverse reactions such as dizziness or somnolence (see Adverse Effects). Therefore, patients should be advised that TRILEPTAL ® can alter their physical and / or mentally fit to operate machinery or drive a vehicle.

Use in Pregnancy and Lactation

Pregnancy: Data from a limited number of pregnancies indicate that oxcarbazepine can cause severe birth defects (eg cleft palate) when administered during pregnancy. In animal studies showed increased embryonic mortality, delayed growth and malformations at maternally toxic doses (see Preclinical safety data).

Given this information:

• If the woman treated with Trileptal ® are pregnant or wish to become pregnant or if the need arises to initiating treatment with Trileptal ® during pregnancy, should be examined carefully the potential benefits of the drug with respect to the potential risk of fetal malformations. This is particularly important during the first three months of pregnancy.

• Administer the lowest dose that is effective.

• In women of reproductive age, TRILEPTAL ® should be administered as monotherapy when possible.

• Patients should be pointed to the possibility of an increased risk of malformations and recommend prenatal testing.

• An effective anti-epileptic treatment should not be discontinued during pregnancy because the aggravation of the disease could harm the mother and fetus.

Monitoring and prevention: Antiepileptic drugs may contribute to folic acid deficiency, which can be a source of fetal abnormalities. We recommend folic acid supplements before pregnancy and during it.

In newborns: In the newborn have been reported bleeding disorders caused by antiepileptic drugs. As a precaution, should be given prophylactic treatment with vitamin K1 in the last weeks of pregnancy and the newborn.

Oxcarbazepine and its active metabolite (MHD) cross the placental barrier. Plasma concentrations of MHD from the mother and newborn were similar in one case.

Breastfeeding: Oxcarbazepine and its active metabolite (MHD) are excreted in human milk. In both cases, the ratio of concentrations between milk and plasma was 0.5. The effects of Trileptal ® in infants exposed in this way. Therefore, TRILEPTAL ® should not be used during lactation.

ADVERSE REACTIONS: Adverse reactions have been reported more frequently (more than 10% of patients) are drowsiness, headache, dizziness, diplopia, nausea, vomiting and fatigue.

In clinical studies, adverse reactions were generally mild to moderate, transient and occurred mainly at the beginning of treatment.

Profile analysis of the adverse effects of the different body systems is based on the adverse reactions recorded in clinical studies related to Trileptal ®. They also took into account the clinical reports of significant adverse reactions observed in the context of individualized programs of distribution of the drug to patients and for pharmacovigilance.

Frequencies estimated *:

• Very common? 1/10.

• Common:? 1/100 - <1/10.

• Uncommon:? 1/1.000 - <1/100.

• Rare:? 1/10, 000 - <1/1, 000.

• Very rare: <1/10, 000.

Blood and lymphatic system


Very rare

Bone marrow depression, agranulocytosis, aplastic anemia, pancytopenia, neutral-

penia, thrombocytopenia.
Immune system disorders

Very rare
 Hypersensitivity (including multi-organ hypersensitivity) characterized

by manifestations such as rash or fever. Hypersensitivity can

affect other organs or systems such as blood and lymph system (for

example, eosinophilia, thrombocytopenia, leucopenia, lymphadenopathy, splenomegaly

megalia), the hepatic system (eg, abnormal test values

liver function, hepatitis), muscles and joints (eg

joint swelling, myalgia, arthralgia), nervous system (for example,

hepatic encephalopathy), kidneys (eg, proteinuria, nephritis

interstitial, renal failure), lungs (eg, dyspnea, edema

lung, asthma, bronchospasm, interstitial pneumonia), angioedema,

anaphylactic reaction.
Metabolism and nutrition


Very rare

Hyponatremia accompanied by signs and symptoms such as seizures, with-

fusion, alteration of consciousness, encephalopathy (see Disorders

nervous system), visual disturbances (eg blurred vision), vomiting,

nausea, folic acid deficiency.
Psychiatric Disorders

 State of confusion, depression, apathy, agitation (eg, nervousness),

affective instability.
Nervous system disorders

Very common

 Drowsiness, headache, dizziness.

Ataxia, tremor, nystagmus, disturbance in attention, amnesia.
Eye disorders

Very common


Blurred vision, visual disturbances.
Ear and labyrinth

Vascular disorders

Very rare
 Arrhythmia, atrioventricular block.
Gastrointestinal disorders

Very common


Very rare
 Nausea, vomiting.

Diarrhea, constipation, abdominal pain.

Pancreatitis and / or increased levels of lipase and amylase.
Hepatobiliary disorders

Very rare
Skin and subcutaneous tissue



Very rare
 Rash, alopecia, acne.


Angioneurotic edema, Stevens-Johnson syndrome, toxic epidermal

toxic (Lyell's syndrome), erythema multiforme.
Musculoskeletal Disorders

and connective tissue

Very rare
 Lupus erythematosus.
General disorders and

at the administration site

Very common


Other disorders

 Elevations of liver enzymes and blood concentrations

alkaline phosphatase.

While using TRILEPTAL ® can develop rarely clinically significant hyponatremia (sodium <125 mmol / l), it has generally occurred during the first 3 months of treatment with Trileptal ®, although some patients first developed serum sodium <125 mmol / l over a year after starting treatment (see Warnings and Precautions).

In clinical studies in children over one month and less than four years, somnolence was the most common adverse reaction (approximately 11% of patients). Adverse reactions that occurred with an incidence? 1% and <10% (common) were: ataxia, irritability, vomiting, lethargy, fatigue, nystagmus, tremors, decreased appetite and elevated blood levels of uric acid.


Inhibition of enzymes: Oxcarbazepine was evaluated in human liver microsomes to determine whether inhibiting the major forms of cytochrome P-450 responsible for metabolism of other drugs. The results showed that oxcarbazepine and its pharmacologically active metabolite [the monohydroxy derivative (MHD)] inhibit CYP2C19 form. Therefore, interactions could be observed at TRILEPTAL ® coadministered with drugs metabolized by CYP2C19 form (eg, phenobarbital, phenytoin, see below). In some patients treated with Trileptal ® and drugs metabolized by CYP2C19 as may be necessary to reduce the dose of coadministered drugs. In human liver microsomes, oxcarbazepine and MHD do not inhibit the following ways (or only very little): CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP2E1, CYP4A9 and CYP4A11.

Induction of enzymes: Oxcarbazepine and MHD induce in vitro and in vivo forms of CYP3A4 and CYP3A5 responsible for the metabolism of calcium channel blockers of the dihydropyridine family of oral contraceptives and antiepileptics (including carbamazepine) by decreasing plasma concentrations of these drugs. This degree of decrease in plasma can also be seen with other drugs whose metabolism depends primarily CYP3A4 and CYP3A5 forms, such as some immunosuppressants such as cyclosporine.

In vitro, oxcarbazepine and MHD are weak inducers of UDP-glucuronosyltransferase, so it is unlikely that in vivo to exert an effect on drugs eliminated mainly by conjugation through UDP-glucuronyl (eg, valproic acid, lamotrigine). Even considering the weak induction potential of oxcarbazepine and MHD may require a higher dose of coadministered drugs metabolized by CYP3A4 form or by conjugation (UDP-glucuronosyltransferase). When stopping treatment with Trileptal ® may be necessary to reduce the dose of coadministered drugs.

Induction studies conducted with human hepatocytes confirmed oxcarbazepine and MHD are weak inducers of the forms of the subfamilies 2B and CYP 3A4. Unknown potential induction of oxcabazepina / MHD in other forms of CYP.

Antiepileptic drugs: Clinical studies evaluating possible interactions between TRILEPTAL ® and other anti-epileptic. The following table summarizes the effect of these interactions in the mean AUC and C min.

Summary of interactions between TRILEPTAL ® and other antiepileptic drugs:



Trileptal ®


of antiepileptic

of antiepileptic



of 0-22%

 Has not been studied
 No influence
 Has not been studied
 No influence


of 30-31%


of 29-35%
Valproic acid
 No influence

of 0-18%

In vivo, plasma concentrations of phenytoin increased by up to 40% at doses of Trileptal ®> 1.200 mg / day. Therefore, a dose of Trileptal ®> 1.200 mg / day as part of a complementary treatment may require dose reduction of phenytoin (see DOSAGE AND ADMINISTRATION). However, concentrations of phenobarbital increased slightly (15%) to coadministrarlo with TRILEPTAL ®.

It has been shown that the potent inducers of cytochrome P forms-450 (such as carbamazepine, phenytoin and phenobarbital) reduce plasma concentrations of MHD (29-40%).

No autoinduction has been observed with Trileptal ®.

Hormonal contraceptives: Trileptal ® was shown to affect both components of an oral contraceptive, ethinylestradiol (EE) and levonorgestrel (LNG). The average values ​​of EE and LNG ABC declined 48-52% and 32-52% respectively. There have been no studies with other oral or implant. Therefore, coadministration of Trileptal ® and hormonal contraceptives can cause inefficiency of the latter (see Precautions).

Calcium channel blockers: After repeated coadministration of Trileptal ®, felodipine AUC decreased by 28%. In contrast, plasma concentrations were maintained at the recommended therapeutic range.

On the other hand, verapamil 20% reduced plasma concentrations of MHD, although this reduction was not considered clinically significant.

Drug Interactions: Cimetidine, erythromycin and dextropropoxyphene had no effect on the pharmacokinetics of MHD, whereas viloxazine produced minor changes in plasma concentrations of MHD (10% increase after repeated co-administration). Warfarin with no signs of interaction after administration of single or repeated doses of Trileptal ®.

CHANGES IN THE LABORATORY TEST RESULTS: In approximately 2.7% of patients treated with Trileptal ® have observed serum sodium below 125 mmol / l, usually remain asymptomatic and require no adjustment of therapy. Experience from clinical trials shows that serum sodium is normalized when the dose of Trileptal ® is reduced, discontinued or the patient is treated conservatively (eg restricted fluid intake). In patients with pre-existing kidney problems associated with hyponatremia or patients concomitantly treated with drugs that lower serum sodium (eg, diuretics, drugs associated with inappropriate ADH secretion) should be measured sodium levels before the start treatment. Thereafter, sodium levels should be measured after about two weeks and at monthly intervals during the first three months of treatment, or according to clinical needs of the patient. These factors apply especially to elderly patients. For those patients taking Trileptal ® and to initiate treatment with drugs that lower the sodium, they should make periodic reviews of the sodium levels. In general, if they have symptoms suggestive of hyponatremia during treatment with Trileptal ®, should be considered to assess the level of serum sodium. Other patients should be measured in serum sodium levels as part of their routine laboratory studies.

PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: Preclinical data reveal no special hazard for humans based on studies of repeated dose toxicity, safety pharmacology and genotoxicity performed with oxcarbazepine and the pharmacologically active metabolite , the monohydroxy derivative (MHD).

Drug Name: Sinfonil
Brand comparison: Trileptal
Active ingredient: Oxcarbazepine
Presentation: Tablets
Concentration: 300 mg
Response time: No
Lab: Maver, S. A. de CV
Box of 20 Pills
Manufactured in: Mexico

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