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Depakin 200 Mg 40 Tablets ingredient valproic acid

DEPAKİN ORAL SOLUTION DEPAKİN® 20% Oral Solution

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buy depakin online 200 mg epilepsy treatment no need prescription

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DEPUTINE ORAL SOLUTION

Clinical experience in the field of epilepsy has shown that; children under 3 years of age with brain damage, mental retardation and / or congenital metabolic or degenerative disease and severe epileptic seizures are the most at risk, especially if they are receiving combined anticonvulsant therapy. After 3 years of age, the incidence decreases significantly and the risk decreases gradually as the age increases. In most of the cases, liver damage is seen during the first 6 months of treatment, mostly between the 2nd and 12th weeks and usually during multiple treatment with antiepileptics.

Symptoms: Clinical findings are important for early diagnosis. The following symptoms, which may be seen prior to jaundice, should be considered, especially in patients at risk (see özellikle Liver Failure Sar).

- Asthenia, anorexia, fatigue, and dizziness associated with non-specific and usually sudden and sometimes continuous vomiting and abdominal pain - Recurrence of epileptic seizures despite appropriate treatment

It should be noted that if this type of clinical symptoms occurs, the patient should immediately consult a doctor. If the patient is a child, the same warning should be made to the family. Clinical examination and biological evaluation of liver function should be performed immediately.

Follow-up: First, liver function test should be performed and then liver function should be checked periodically in the first 6 months of treatment. Tests demonstrating protein synthesis, especially prothrombin levels, are important in known studies. If abnormally low prothrombin levels are found and other laboratory findings are available (significant reduction in fibrinogen and clotting factors, increase in bilirubin level and elevation in transaminases - see ıh Precautions sa), sodium valproate treatment should be stopped and the same metabolic pathway used as a measure For use with sodium valproate, the use of salicylate should also be discontinued.

Pancreatitis has been reported in very rare cases of severe pancreatitis resulting in Fatal. This complication can be seen in all age groups during the whole treatment period. This risk increases especially in young children. Severe epileptic seizures or brain lesions or multiple anticonvulsant therapy may be risk factors. Liver failure associated with pancreatitis increases the risk of fatality.

CSI: 03.10.2005 (Updated version: 10) SB approval date: 15.10.2009 SB demand: 05.04.2006 & 24.02.2009 SB circular 20.01.2009

DEPUTINE ORAL SOLUTION For

women of childbearing potential, only after careful evaluation and use If the benefits are outweighed by the risk of congenital anomaly, the decision to use sodium valproate should be taken. This decision should be taken before a sodium valproate is prescribed for the first time and at the same time a woman who is still being treated with VPA is planning a pregnancy.

Suicidal ideation and suicidal behavior: Suicidal thoughts and behavior have been reported in patients treated with this drug. Therefore, patients should be closely monitored for suicidal thoughts and behavior. When the suicidal ideation and behavior arise, it should be advised that the patient and his / her patient should receive medical support.

Measures: Liver function tests should be performed periodically, especially in patients at risk (see av Warnings odik) and in the first 6 months of treatment, as in most antiepileptic cases, especially at the beginning of treatment, without clinical signs of liver transaminases. In these patients, a larger biological study (including prothrombin levels) is recommended, the dose should be adjusted and the tests repeated if necessary. Children under 3 years of age should be given monotherapy if sodium valproate is to be administered, but before starting treatment, this may be a risk of liver damage or pancreatitis. In patients in the group should be well evaluated (see)

kiler Cautions Et) Blood tests in the case of spontaneous bleeding or hematoma (see veya Side Effects / Adverse Effects ılarbefore starting treatment or before surgery, including blood count including platelet count, bleeding a time and coagulation tests). It should also not be recommended in children because of the use of salicylate, liver toxicity (see “Warnings Çocuklar) and the risk of bleeding. As follow-up of plasma concentrations in patients with renal insufficiency may be misleading, the dosage should be adjusted according to clinical observation (see ın Pharmacokinetic properties Bö). It should be noted that unbound serum concentrations of valproic acid may increase and the dose should be reduced. Although pancreatitis is rarely reported, immediate medical evaluation should be performed in patients with acute abdominal pain. If pancreatitis develops, valproate should be discontinued. Pancreatitis should be considered in patients with acute abdominal pain or those with gastrointestinal complaints such as nausea, vomiting and anorexia. If pancreatic enzyme levels increase, treatment should be discontinued and appropriate alternative treatment should be given.

CSI: 03.10.2005 (Updated version: 10) SB approval date: 15.10.2009 SB demand: 05.04.2006 & 24.02.2009 SB circulatory 20.01.2009

DEPOTIN ORAL SOLUTIONisotropic

Patients with enzyme defect in urea cycle, the use ofvalproate is not recommended, and the treatment of these patients is not recommended. metabolic examinations should be performed before. In some patients, several cases of hyperammonemia have been observed with stupor or coma. Before the treatment of all kinds of sodium valproate in children with unexplained hepatogastrointestinal symptoms (anorexia, vomiting, cytolysis crisis), lethargy episodes or coma, history of mental retardation or in families with neonatal or child deaths, metabolic examinations and ammonia levels should be considered. Although immune disorders are very rare during the use of this medicinal product, the risk for the use of Depakin in patients with systemic lupus erythematosus should be well evaluated. Patients should be warned about the risk of weight gain at the beginning of treatment and necessary adjustments should be made to reduce this risk, mostly on diet. Women of childbearing age (see Pregnancy) All epileptic women of childbearing age should be adequately informed about the risks associated with pregnancy.

In pregnancy: Pregnancy category is D.

Women of childbearing age Women who have epilepsy and who are likely to become pregnant should be consulted by a specialist before valproate is prescribed. Because of the potential risk to fetus, the risk / benefit ratio should be evaluated. If valproate treatment is deemed necessary, measures should be taken to minimize the potential teratogenic risk (see takdir In the light of the above data Val).

As a result of the experience gained from mothers with treated epilepsy, the risks associated with using valproate during pregnancy are defined as follows:

Risk of seizures: Status epilepticus, which occurs during pregnancy with tonic clonic seizures or hypoxia during pregnancy, may result in death for the mother and the unborn child.

Risk associated with valproate: Teratogenic effects were observed. The present data indicate the incidence of major and minor malformations, including multiple anomalies involving epilepsy, craniofacial defects, extremity malformations, cardiovascular malformations, and various body systems, in children born to mothers who have epilepsy and treated with valproate compared to the incidence determined for some other antiepileptic drugs. suggest an increase.

CSI: 03.10.2005 (Updated version: 10) SBA approval date: 15.10.2009 SB Demand: 05.04.2006 & 24.02.2009 SB circular 20.01.2009

DEPA ORAL SOLUTION

Data shows that, during the combined antiepileptic treatment with valproate, the risk of teratogenicity of valproate monotherapy is higher than. The data suggest an increase in the risk of partial delay in verbal IQ development due to the use of valproate during pregnancy. This condition is generally associated with malformations and dysmorphic disorders. It is difficult to associate this situation with other possible factors, including low IQ, genetic, social and developmental factors, and poor seizure control during pregnancy.

In the light of the above data: Physicians are strongly advised to discuss issues related to conception before planning a woman's pregnancy before being prescribed sodium valproate for the first time, or with a woman treated with sodium valproate. If the patient wishes to become pregnant, this should be considered as an opportunity to review the indication that requires antiepileptic treatment. If any indication, risks and benefits are carefully evaluated, sodium valproate treatment should be continued during pregnancy and the minimum effective daily dose and dose should be spread over the day. The use of a long-acting formulation should be preferred over any other form of treatment. If appropriate, folate (5 mg daily) supplementation should be initiated before pregnancy to reduce the risk of neural tube defects. During pregnancy, discontinuation of treatment with valproate is not recommended without redefining the benefit / risk assessment. The patient should be kept under special control during the antenatal period and should be determined on time if a neural tube defect or other malformation occurs.

Risks in newborn: This medicinal product may cause hemorrhagic syndrome in newborns. It is thought that the haemorrhagic syndrome occurring in the use of sodium valproate is probably not related to vitamin K deficiency. This hemorrhagic syndrome is associated with hypofibrinogenemia; afibrinogenemia, which may be fatal, has also been reported. This hypofibrinogenemia is probably related to the reduction of coagulation factors. Maternal prenatal platelet count, fibrinogen and coagulation time measurement (aPTT: Activated Partial Thromboplastin Time) should be performed. Normal results from the mother do not rule out hemostasis abnormalities in the newborn. Therefore, platelet count, fibrinogen plasma level, coagulation tests and coagulation factors should be investigated in newborn. Traumatic birth increases the risk of bleeding.

In lactation: The amount of valproate in the mother's milk is low and it is between 1% and 10% of the mother's serum level. The mother who takes the medication should not breast-feed or be careful. According to the literature and clinical experience, breastfeeding can be taken into consideration by considering the safety profile of sodium valproate, especially hematological disorders. (see side effects / Advers Effects)

CSI: 03.10.2005 (Updated version: 10) SB approval date: 15.10.2009 SB demand: 05.04.2006 & 24.02.2009 SB circulars 20.01.2009

DEPUTINE ORAL SOLUTION

Effect on Vehicle and Machine Use: Patients should be warned against the risk of sleep, especially in combination with anticonvulsant polytherapy or benzodiazepines (see “Drug Interactions)

uyar. Görülebilir Pregnancy diy - Liver and gall bladder-related disorders: Rarely cases of liver dysfunction (see hast Warnings bozukluk) - Gastrointestinal disorders: Some patients may experience side effects (nausea, stomach pain, diarrhea) frequently occurring during the first days of treatment. Very few cases of pancreatitis, which may sometimes be lethal, may require early discontinuation of the treatment (see erken Warnings olabil) - Metabolic disorders: Very rare cases of hyponatremia have been reported - Central Nervous System Disorders associated with lethargy, alone or with a paradoxical increase in convulsions, may be associated with either a stupor or occasional transient coma (encephalopathy) during treatment, and decreased when the treatment is stopped or the dose is reduced. RAM (especially phenobarbital), and occurs when one dose of valproate increased. Reversible dementia with reversible brain atrophy has been rarely reported. Cognitive disorders (which may show all clinical features of dementia) are reported very rarely in a few weeks or months after discontinuation of insidious and slow-onset treatment. Isolated reversible parkinsonism is reported to be rare. Rarely, cases of ataxia have been reported. Thin tremor, drowsiness and drowsiness are frequently reported in the case of temporal and (or) dose-related postural tremor / rest. Headache has also been reported. Isolated and moderate hyperammonemia may occur during treatment with multiple drugs, which often do not cause changes in liver function tests. This does not require discontinuation of treatment. Hyperammonemia accompanied by neurological symptoms has also been reported. Further investigations should be performed in these cases (see "Warnings"). - Blood and lymphatic system disorders: In general, cases of dose-related thrombocytopenia that are systematically recognized and do not show clinical signs have been reported. If thrombocytopenia is asymptomatic, it is usually possible to correct this thrombocytopenia by decreasing the sodium valproate exposure only if the amount of platelets is appropriate and epileptic disease control is possible.

CSI: 03.10.2005 (Updated version: 10) SB approval date: 15.10.2009 SB demand: 05.04.2006 & 24.02.2009 SB circular 20.01.2009

DEPOTIN ORAL SOLUTION

It is observed that there are not any clinical symptoms, especially at high doses; Isolation in fibrinogen or prolongation of bleeding time (sodium valproate has an inhibitory effect on the second phase of platelet aggregation) has been reported. It is reported that cases of anemia, macrocytemia and leukopenia and rarely pancytopenia are rare.- Skin and subcutaneous tissue disorders. -Johnson syndrome and erythema multiforme have also been reported, and hair loss is frequently reported due to transient and / or dose - Reproductive disorders: Amenorrhea and menstrual disorders have been reported - Vascular disorders: Vasculitis has been reported - Hearing disorders: Recycled or irreversible hearing loss is rarely reported, however, a definite cause and effect relationship has not been determined yet - Kidney and urinary tract disorders: Reversible Fanconi syndrome due to valproate treatment has been reported in a few cases, but the mechanism of action has yet to be determined. Very rare cases of enuresis have been reported. - Immune system disorders: Allergic reactions have been reported. - General disorders and conditions at the site of use: Non-severe peripheral edema is rarely observed. Weight gain may be seen. Weight gain for polycystic ovary syndrome should be carefully monitored as a risk factor.

- Teratogenic risk (see ”Warnings“, (Pregnancy -).

CONSULT YOUR DOCTOR WHEN AN UNEXPECTED EFFECT IS SEEN.

DRUG INTERACTIONS AND OTHER INTERACTIONS Care should be taken in combination with drugs that have the potential for seizure or lowering the epilepsy threshold, and even the severity of the risk in question should be advised not to use such drugs together or they should be contraindicated. These drugs include most of the antidepressants (imipramine antidepressants, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine (see below), bupropion and tramadolu.

Contraindicated combinations: - Meflokine: Increases valproic acid metabolism in epilepsy patients and has convulsant effect; therefore, epileptic seizures may be seen in the combined treatment.

CSI: 03.10.2005 (Updated version: 10) SB approval date: 15.10.2009 SB demand: 05.04.2006 & 24.02.2009 SB circular 20.01.2009

DEPOTIN ORAL SOLUTION

Combinations not recommended: - Lamotrigine: Co-administration of valproic acid and lamotrigine for severe skin reactions (Lyell syndrome) increases the risk. When lamotrigine is added to the valproate, the risk of rash may increase. Valproate reduces the metabolism of lamotrigine and increases its mean half-life; If necessary, doses (reducing the dose of lamotrigine) should be rearranged. If this combination is considered necessary, close clinical follow-up is required.

Combinations required to take precautions in use: - Neuroleptics, MAO inhibitors, antidepressants and benzodiazepines: Depakin may potentiate the effect of other psychotropes such as neuroleptics, MAO inhibitors, antidepressants and benzodiazepines. Therefore, clinical follow-up and dose adjustment is recommended. - Carbamazepine: Plasma concentrations of active metabolite of carbamazepine increase with overdose symptoms. In addition, because the rate of metabolism of valproic acid in the liver is increased by carbamazepine, plasma concentrations decrease. Since valproate can potentiate the toxic effect of carbamazepine, clinical toxicity has been reported in the combined use of valproate and carbamazepine. In the initial period of combined therapy, clinical follow-up with dose adjustment is recommended, if necessary. - Carbapenems, monobactams: Meropenem, panipenem, aztreonam, imipenem. When combined with panipenem or meropenem, there is sometimes a decrease in the level of valproic acid blood along with convulsions. If these antibiotics are used, it is recommended to closely monitor the valproic acid blood level. - Felbamate: Serum increases valproic acid concentrations and the risk of overdose occurs. After combined treatment with felbamate and after discontinuation of the combined therapy, clinical follow-up, laboratory control and valproic acid dose adjustment may be required. - Phenobarbital, primidone: With the inhibition of hepatic metabolism and overdose symptoms, the plasma concentrations of phenobarbital or primidone usually increase in children. Furthermore, as the rate of metabolism of valproic acid in the liver is increased by phenobarbital or primidone, plasma concentrations decrease. Clinical follow-up should be performed during the first 15 days of the combined therapy and the doses of phenobarbital or primidone should be reduced immediately when signs of sedation begin to appear; in particular, the plasma concentrations of two anticonvulsive drugs should be checked.

The: CSI: 03.10.2005 (Updated version: 10) SB approval: 05.04.2006 & 24.02.2009 SB circular 20.01.2009

DEPAGIN ORAL SOLUTION

plasma concentrations of phenytoin are changed- Phenytoin: Phenytoin plasma concentrations vary. Depakin increases the total plasma concentration of phenytoin. Furthermore, the free phenytoin concentration may increase, in which case symptoms of overdose may occur (valproic acid replaces phenytoin at the sites of binding to plasma proteins and slows down its disintegration in the liver). When determining phenytoin plasma levels, free form should be considered. Moreover, since the rate of metabolism of valproic acid in the liver is increased by phenytoin, the risk of plasma concentrations decreasing is increased. Clinical follow-up should be performed and plasma dosages and posologies of both antiepileptic drugs should be adjusted. - Topiramate: When combined with valproic acid topiramate, the risk of hyperammonemia or encephalopathy, which is generally thought to be caused by valproic acid, increases. Clinical and biological follow-up (at the start of treatment and in cases suggesting these symptoms) should be performed. - Zidovudine: Valproate can increase the toxicity of zidovudine, increasing the plasma concentration of zidovudine.

The effect of other drugs on valproate: - Antiepileptics (phenytoin, phenobarbital, carbamazepine) with enzyme-inducing effect reduce the serum concentrations of valproate. Doses in combination therapy should be adjusted according to clinical response and blood levels. On the other hand, the combined use of felbamate and valproate may increase the serum concentration of valproate. Valproate blood level should be monitored. - When valproate and agents that bind highly to proteins (acetylsalicylic acid) are used, the level of free valproate in the serum may increase. - Prothrombin level should be followed closely if it is used with vitamin K bound anticoagulant factor. - Valproate serum levels may also increase if cimetidine or erythromycin is used (because liver metabolism decreases).

Other interactions: Valproate generally has no enzyme-inducing effect; therefore, it does not diminish the effect of estrogen in women using hormonal contraceptives. No clinically significant interactions with medications such as antacids, haloperidol, cimetidine and ranitidine have been observed.

Combinations that should be taken into account: - Nimodipine (orally and by injection): increased plasma concentrations of nimodipine (metabolized by valproic acid), increased hypotensive effect.

CSI: 03.10.2005 (Updated version: 10) SB approval date: 15.10.2009 SB demand: 05.04.2006 & 24.02.2009 SB circulars 20.01.2009

DEPUTINE ORAL SOLUTION

USAGE AND DOSAGE The daily dose should be adjusted taking into account the age and body weight of the patient. the person-to-person response should be considered. Since a clear relationship cannot be established between the daily dose, serum concentration and therapeutic effect, the optimal dose should be determined according to the clinical response. If the control of the seizures is not sufficient or the adverse effects are suspected, it may be considered to determine the plasma level of valproic acid in addition to clinical follow-up. The reported effective amount is generally 40 - 100 mg / liter (300-700 μmol / liter).

- It should be used for complex 10 years and above in partial seizures.

Initiation of sodium valproate treatment (oral administration) - In patients not administered another antiepileptic dose, the dose can be increased by 2-3 days to reach the optimum dose within a week.

- When switching from treatment with another antiepileptic to sodium valproate treatment, the optimal dose should be adjusted gradually by increasing the dose of sodium valproate within two weeks and the treatment with other preparations reduced.

- If necessary, the addition of another antiepileptic should be done gradually by increasing the dose (see "Drug Interactions")

Dosage: The initial dose is usually 10-15 mg / kg per day, then the optimal dosage is reached (see "Starting sodium valproate treatment"). 24 hour average dose: - 30 mg / kg in infants and children (oral solution form should be preferred); - 20-30 mg / kg (enteric coated tablet, Chrono form should be preferred in adolescent children and adults). If the pharmacokinetics vary, the clinical significance is limited, and the dosage should be regulated according to the control of seizures.This

medicinal product is prescribed as milligrams (or milliliters) Depakin Oral Syringe packaging contains a graduated dosing syringe. the other face was graded to show doses in ml (0.5-1-1.5-2 ml). It should not be used for other medications, as it is specifically rated for the solution.

CSI: 03.10.2005 (Updated version: 10) SBA approval date: 15.10.2009 SB Demand: 05.04.2006 & 24.02.2009 20.01.2009SB circular

DEPA ORAL SOLUTION

Application:

The solution is administered by oral dosing syringe pistons located just pink box. The daily dose should preferably be given in meals. - In patients less than 1 year old, 2 times in patients older than 1 year, the solution should be mixed with water or fruit juice (with non-carbonated drinks). The cap of the bottle should be closed after each use.

Figure 1 Figure 2 Figure 3

Open the bottle lid.syringe of the syringe

Dose written in the prescription (milligrams or milliliters) of the

. However, if the dose was missed shortly before the next dose, the dose should not be taken twice to compensate for the missed dose. If more than one dose is missed, seek medical advice immediately.

Remove the syringe from the vial. Dosed dosage injector

Immerse the measured dose in water or bottle.

with fruit juice (gaseous Graduated dosing syringe to

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