Asentra 50mg Krka drugs treat depression, community anxiety disorders (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Sertraline
Ingredient Krka
Ingredient
| Composition information | Content |
| Sertraline | 50mg |
Uses
Indications
Asentra 50mg drug is indicated in the following cases:
According to the selective inhibition of 5-HT absorption, Sertralin does not enhance catecholaminergic activity. Sertralin has no affinity with Muscarinic (Cholinergic), Serotonergic, Dopaminergic, Adrenergic, Histaminergic, Gaba receptor or Benzodiazepin. Using a long-term sertralin in animals related to the nor-medinephrin receptor has been observed clinically and anti-depression.
Sertralin does not prove the potential of abuse. In random study, double blindness, which is controlled to compare the abuse in sertralin, alprazolam and d-amphetamin on humans, Sertralin does not show positive subjective effects in abuse potential. In contrast, the object of assessment of alprazolam and d-amphetamine is significantly more significantly than placebo over the interest of drugs, excitement and drug abuse potential.
Sertralin does not show stimulation and anxiety related to d-amphetamin or sedation and mental weakness in Alprazolam. Sertralin does not function as a stimulant in brown monkeys like cocaine, nor as a stimulant replacing d-amphetamin or pentobarbital on brown monkeys.
Clinical trials
Depression disorders
Conducting research related to outpatient depression patients who respond from the beginning to the end of 8 weeks of treatment with Sertralin 50 - 200mg/day. These patients (n = 295) are randomly selected for another 44 weeks, double blinds using sertralin 50 - 200mg/day or placebo. Observing a lower statistical recurrence rate in patients using sertralin compared to patients with placebo. The average dose for researchers is 70mg/day. The percentage (defined as patients who do not recur) with sertralin and placebo are 83.4% and 60.8% respectively.
Stress disorder after injury (PTSD)
Combining data from 3 studies on PTSD in the common community shows that the response rate is lower in men with women. In two general community studies, the response rate of men and women with fake is the same (women: 57.2% compared to 34.5%; male: 53.9% compared to 38.2%). The number of male and female patients in common community trials is 184 and 430 and due to the results in women are more obvious and men are related to other events (abuse of stimulants, long treatment time, trauma origin ...), showing the correlation effect is decreasing.
Children with obsession OCD obsession
Safety and effectiveness of Sertralin (50 - 200mg/day) have been assessed in the treatment of depression in children (6 - 12 years old) and adolescents (13-17 years old) in outpatient patients with rapid obsessive disorders (COD). After a week placebo, the patient is randomly treated with flexible doses of Sertralin or placebo. Children (6 - 12 years old) are started at a dose of 25mg. The patient randomly using Sertralin shows a significant greater improvement than those who randomly use fake in children with an obsession with Yale-Brown CYP-Bocs (P = 0.005), with Nimh global obsession (P = 0.019), and CGI improvement group (P = 0.002). In addition, the greater improvement in the group using Sertralin compared to the placebo group has also observed the severity of CGI (P = 0.89). For Cy -bocs, the average ratio varies from the original level for the placebo group, equivalent to 22.25 ± 6, i5 and -3.4 ± 0.82, while for sertralin groups, the average ratio varies from the initial level, equivalent to 23.36 ± 4.56 and -8 ± 0.87. In the analysis of the following data, the definition of responding to patients is a 25% or higher reduction in Cy-bocs (the main effective measure) from the initial level to the end of 53% in patients treated with sertralin compared to 37% of patients treated with fake (P = 0.03).
With pediatric group, long -term safety data is missing. There is no data for children under 6 years old.
pharmacokinetic
absorption
Sertralin shows the corresponding pharmacokinetic dose ranging from 50 to 200mg. In men, with daily doses of 50 - 200mg in 14 days, the CMAX concentration of Sertralin in plasma is achieved after 4.5 - 8.4 hours after taking the drug. Food does not significantly change the bioavailability of Sertralin tablets.
Distribution
About 98% of the drug is associated with plasma proteins.
Metabolism
Sertralin has initial metabolism in the liver.
Elimination
Sertralin average selling time is about 26 hours (from 22 - 36 hours). At the end of the sale time, there is a cumulative of about 2 times the stable concentration, achieved after taking the drug once a day a week. The sale time of N -Desmethylsertralin is about 62 - 104 hours. Sertralin and N-Desmethylsertralin are strongly metabolized in humans and through testing shows the amount of metabolites excreted through feces and urine is the same. Small amount of raw sertralin (
pharmacokinetics with special patients
Pediatric patients with OCD
Sertralin'spharmacokinetics has been studied in 29 children from 6 to 12 years old, and in 32 minor patients from 13-17 years old. The patient gained a gradual dosage to 200mg per day for 32 days, with a starting dose of 25mg and step by step, or the starting dose was 50mg and increased step by step. At the dose of 25mg and 50mg, the tolerance is good. When stabilized at 200mg, Sertralin concentration in groups in groups 6 - 12 years old is about 35% higher than the 13-17 year old group, and 21% in the adult group. There is no significant difference between men and women related to clearance. It is recommended to start from low doses at a standard dose of 25mg for children, especially for low weight subjects. Teenagers may be as weight as adults.
teenagers and the elderly
Mobile pharmacokinetics in teenagers or elderly people are not significant compared to adults aged 18 - 65 years old.
Reduce liver function
In patients with liver damage, Sertralin's waste time extends and AUC increases to 3 times.
kidney failure
There is no significant accumulation of sertralin in moderate to severe kidney failure.
Before taking Asentra 50mg Krka drugs treat depression, community anxiety disorders (4 blisters x 7 tablets)
How to use
The drug is only used when prescribed by a doctor.
Asentra can drink with or not ate the same meal.
Take medicine once a day in the morning or evening.
Dosage
Adults
Depression and obsessive obsession: For depression and OCD, the usual effect is 50mg/day. Daily dose may increase by 50mg and at least 1 week of use. The maximum dose is 200mg/day.
Panic disorders, community anxiety disorders and stress disorders after injury
With panic disorders, community anxiety disorders and stress disorders after psychological trauma, treatment dose should start at 25mg/day, and increase to 50 mg/day after a week.
Daily dose can be increased to 50mg in a period of 1 week. The maximum dose is 200mg/day.
children and teenagers
Only use Asentra with children and teenagers with OCD from 6 to 17 years old.
Red obsession disorder
Children 6 to 12 years old: The recommended dose is 25mg once a day. After a week, the doctor may increase the dose to 50mg daily. The maximum dose is 200mg per day.
Youth 13 to 17 years old: The recommended starting dose is 50mg per day. The maximum dose is 200mg per day.
Special subjects
Hepatic failure: Because there are no studies on this patient, there is no use until official studies are available.
kidney failure
No need to adjust the dose in patients with renal failure.
Time to use the drug depends on the level and responding to treatment. It may take a few weeks before the symptoms begin to be limited.
If you stop drinking Asentra
constantly use Asentra unless the doctor prescribes. The doctor will reduce the dose of Asentra over a few weeks, before stopping this medication. If you suddenly stop taking this medication, you may experience unwanted effects such as dizziness, paralysis, sleep disorders, agitation, anxiety, headache, feeling sick, being sick and swaying. If you encounter any of the above -mentioned effects, or any effect while stopping Asamra, please tell the doctor.
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? Always bring medicine label, whether the drug is still or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, tachycardia, trembling, agitation, dizziness and rare cases of unconsciousness.
What to do when forgetting a dose? Just take the next dose at the right time. Do not take double the dose to compensate for the forgotten dose.
Side Effects
When using Asentra 50mg, you may experience unwanted effects (ADR). The most common effect is nausea. Unwanted effect depends on the dose.
Very common, ADR> 1/10
Common, 1/100 Nervous, hot, yawning. Uncommon, 1/1000 esophagitis, difficulty swallowing, hemorrhoids, saliva, tongue disorders, heartburn. vaginal bleeding, sexual dysfunction in women, discomfort, chills, fever, weakness, thirst, weight loss, weight gain. Rare, 1/10,000 Symptoms of stress or emotion, drug dependence, mental disorders, aggression, paranoia, suicide intentions, sleepwalking, premature ejaculation. Bloody in the stool, mouth pain, gum ulcer, tooth disorders, tongue problems, mouth ulcers, problems with liver function. Excessive vaginal bleeding, vaginal dryness, penis pain and foreskin, fluid flow in the genitals, prolonged erection, breast fluid. Very rare, ADR Not determined frequency Abnormal dreams. Abnormal vision, bleeding problems (such as nosebleeds, stomach bleeding, blood in urine), pancreatitis, serious problems of liver, jaundice and eye (jaundice). Skin edema, paresthesia with sunlight, itching, joint pain, cramps, breast enlargement, irregular menstruation, swelling of the legs, blood clotting problems, and serious allergic reactions. Unwanted effects for children and teenagers: In clinical trials on children and adolescents, unwanted effects are similar to adults. The most unwanted effects in children and teenagers are headaches, insomnia, diarrhea and feeling sick. Symptoms may occur during treatment: If you suddenly stop the drug, you may experience unwanted effects such as dizziness, paralysis, sleep disorders, agitation, anxiety, oil pain, feeling sick, sick and swaying. Increased risk of fractures observed in patients using this drug. Instructions on how to handle ADR Please inform your doctor immediately if you've ever experienced the following symptoms after taking this medication, these symptoms may be serious: Serious skin progression causes blistering (diverse rash), this can affect the mouth and tongue. This may be a sign of the Stevens-Johnson syndrome, the epidermal necrosis (Ten). The doctor will stop treatment in these cases. Allergic or allergic reactions, may include symptoms such as itchy rash, shortness of breath, wheezing, swelling of the eyelids or lips. Some rare cases of serotonin syndrome with agitation, confusion, diarrhea, high temperatures and blood pressure, excessive sweating and tachycardia. Stop treatment when these symptoms occur. If jaundice, yellow eyes progress, this may be liver damage. Symptoms of depression with suicide intentions. Feeling restless and unable to sit or stand still after starting Asamra. There may be seizures, the stage of revival. If any unwanted effects become serious, or not listed in this information, please notify your doctor or pharmacist.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
ASentra 50mg contraindications in the following cases:
Caution when using
The drug is not always suitable for everyone. Please inform your doctor before taking Asentra, if you are or have suffered the following conditions:
Serotonin syndrome: It is very rare for these cases to occur when using some other drugs with Sertralin
Low blood sodium concentration: This can happen as a result of treatment with Asentra. Notify your doctor if you are taking some high blood pressure medications, as these drugs can also change the concentration of sodium in the blood.
Elderly: Caution for the elderly due to the higher risk of hypoglycemia.
Liver disease: The doctor will decide to take low -dose asentra.
diabetes: blood sugar levels may be changed by Asentra and may need to adjust the dosage of diabetes.
epilepsy or a history of convulsions: If an attack (epilepsy), contact your doctor immediately. Bloody disorders: coagulation disorders or have been used anticoagulants (such as acetylsalicyclic acid (aspirin), or warfarin) or may increase the risk of bleeding.
Children or teenagers under 18 years of age: Asentra is only used for treatment in children and teenagers from 6 to 17 years old, haunting disorders. The doctor will closely monitor if it is being treated for this disorder.
Treatment of convulsions (ECT): should also be cautious for this object
restlessness/sensory disorders: Use sertralin in sensory disorders (restlessness and need to move, usually unable to sit or stand still). This may occur in the first few weeks of treatment. Increasing dose can be harmful to patients with such symptoms.
The intention to commit suicide and the deterioration of depression or anxiety disorders
Depression (bipolar disorder) or schizophrenia: If you have a period of manic, contact your doctor immediately.
depressed and/or anxiety disorders, sometimes there may be thoughts to harm themselves or commit suicide. These can increase when it starts treatment with antidepressants, until these drugs are effective, usually about 2 weeks but sometimes longer.
There may be more thoughts below if they have intended to commit suicide or hurt themselves.
Young people: Information from clinical trials has shown that there is a risk of increasing suicide behavior in adults under 25 years of age when mental status is treated with antidepressants.
Use drugs with children and adolescents: Asentra should not be commonly used in children and teenagers under 18 years old, except for patients with obsessive obsessive disorders. Patients under the age of 18 are at risk of increasing unwanted effects, such as trying to commit suicide, suicide intentions and hostility (mostly aggressive, anti -opposition and anger) when they are used this group of drugs. However, the doctor may decide to prescribe Asentra for patients under 18 years of age for the benefit of the patient. The long -term safety of Asentra is related to maturity, growth and cognitive development and behavior in this age group that has not been proven.
reaction when stopping the drug
The stopping reaction when stopping treatment is common, especially if stopping sudden treatment. The risks of symptoms when stopping the drug depend on the treatment time, the dose and the dose reduction rate. Overall, such symptoms are usually mild to medium. However, they can become serious in some patients. They usually occur within the first few days after stopping treatment. Overall, these symptoms will disappear within 2 weeks. In some patients, it may last longer (2-3 months or more). When stopping treatment with Asentra recommends reducing the dose gradually for a few weeks or months, depending on the needs of the patient.
The ability to drive and operate machinery
Mental drugs such as Sertralin can affect the ability to drive or operate machinery. Therefore, it is necessary to be cautious when using Asentra for these objects.
Pregnancy
Please give your doctor or pharmacist's advice before taking any medication.
Sertralin's safety is not fully estimated in pregnant women. Asentra should only be used in pregnant women if the doctor thinks the benefits for the mother to overcome any risk for the fetus. Women have the potential for childbirth should use appropriate contraception if using sertralin. During pregnancy, especially in the last 3 months of pregnancy, drugs like Asentra may increase the risk of a serious condition in babies, called continuous increase in pulmonary blood pressure in infants (PPHN), causing children to breathe faster and appear green.These symptoms usually take place in the first 24 hours when the child is born. They include breathing, breathing, blue skin, overheating or too cold, unable to eat properly, vomiting, low blood sugar levels, hard or soft muscles, reflexes that do not respond, tremor, restlessness, discomfort, indifference, crying a lot, sleepy or unable to sleep.
Reproductive ability
Some drugs such as Sertralin can reduce sperm quality in animal studies. Theoretically, this may affect fertility, but the impact on human fertility has not observed.
Breastfeeding period
There is evidence that sertralin is excreted through breast milk. Asentra should only be used in the period of breastfeeding when the doctor considers the benefits that exceed any risks for children.
Medicinal interaction
Please inform your doctor if you are taking or recently taking any other drugs, including non -prescribing drugs.
Some drugs may affect the effects of Asentra, or Asentra can reduce the effects of other drugs when taken at the same time.
Contraindicated in combination with monoamin oxidase inhibitors (IMAO)
Maois drugs (drugs used to treat Parkinson's disease)
Sertralin is not allowed to be used in combination with non -selective Maois as Parkinson's treatment. Treatment with sertralin is only started after stopping treatment with an non -selective Maois drug for at least 14 days. Stop using Sertralin at least 7 days before starting treatment with an non -selective drug.
Selective inhibitors - A (moclobemid)
Due to the risk of serotonin syndrome, it is not recommended for a combination of sertralin with a Maoi selection like moclobemid. After treatment with a selective MAOI inhibitor, this drug stopped at least 14 days before starting treatment with Sertralin. It is recommended to stop using Sertralin at least 7 days before starting treatment with a MAOI selective drug.
Non -selective drugs (Linezolid)
Linezolid antibiotic is a weak, non -selective inhibitor and should not be used for patients treated with sertralin.
Serious unwanted effects have been recorded in newly stopped patients with a Maoi and started with Sertralin, or just stopped treatment with Sertralin to start with a Maoi. These reactions include tremor, muscle spasms, sweating, nausea, vomiting, flushing, dizziness and high body temperature with similar manifestations as malignant neuroleptic syndrome, convulsions and death.
Contraindicated in combination with pimozid
Pimozid concentration increased by about 35% has been shown in a low -dose pimozide study (2mg). This increase is not related to any changes in ECK (EKG). Meanwhile, the mechanism of this interaction is unknown, because Pimozid has a narrow treatment index, contraindicated use of Sertralin and Pimozide.
Do not recommend simultaneously with Sertralin.
CNS and alcoholic painkillers
Simultaneously use 200mg of Sertralin every day is not affected by alcohol, carbamazepin, haloperidol, or phenytoin to awareness and motor nerves in healthy people, but it is not recommended to simultaneously use Sertralin with alcohol.
Special attention
lithium
In a placebo -controlled test in ordinary volunteers, simultaneous use of sertralin with lithium does not significantly change lithium pharmacokinetics, but the results of increasing tremor related to Placebo, showing may have pharmacological interactions. When using Sertralin simultaneously with lithium, patients should be monitored appropriately.
phenytoin
A clinical trial with a placebo control (placebo) in normal volunteers shows that regular use of sertralin 200mg/day does not give important clinical inhibitors in the process of phenytoin metabolism. However, as some reports on Phenytoin effects in patients using Sertralin, recommendation to monitor phenytoin concentration in plasma after starting treatment with sertralin, along with appropriate phenytoin adjustment. Also, simultaneously used with phenytoin can reduce sertralin levels.
Triptan
There have been after -sales reports describing patients with weakness, increased reflexes, loss of coordination, anxiety, disorders and agitation after using Sertralin and Sumatriptan. Serotonin syndrome symptoms can also occur with other products of the same group (triptan). Clinical warning if treated with both sertralin and triptan, recommends appropriate monitoring with these patients.
warfarin
Simultaneous use of 200mg of Sertralin every day with warfarin shows a small increase but statistically significant about prothrombin time, which can occur in some very rare cases of Inr value imbalance.
Accordingly, prothrombin should be carefully monitored when starting or stopping treatment with sertralin.
Interacts with other drugs, digoxin, atenolol, cimetidine. Used in combination with cimetidine causes a significant reduction in sertralin's clearance. The clinical significance of these changes is unknown. Sertralin has no influence on the ability to inhibit beta - adrenergic of Atenolol. It does not observe the interaction of Sertralin 200mg daily with digoxin.
Medications affect platelet function
The risk of bleeding may increase when drugs act on platelet function (for example, NSAID, acetylsalicylic and ticlopidin) or other drugs may increase the risk of bleeding with SSRLs including sertralin.
Metabolic drugs by P450
Sertralin can act as a light -to -medium -to -average inhibitor CYP2D6. The daily sertralin daily dose shows moderate height (23% - 37%) of stable state of drug concentration in plasma (signs of enzyme activity CYP2D6). Clinical interactions can occur with other CYP2D6 substrates with the same narrow treatment index such as LC anti -arrhythmia group such as propafenon and flecainid, TCAS and typical anti -psychotic drugs, especially with higher doses of Sertralin.
Sertralin has no active inhibitors CYP3A4, CYP2C9, CYP2C19, and CYP1A2 to the point of clinical signs. This has been confirmed by printing - Vivo interactive studies with CYP3A4 substrates (endogenous cortisol, carbamazepin, terfenadin, alprazolam), diazepam of CYP2C19, and substrates of CYP2C9 Tolbutamid, Glibenclamide and Phenytoin. In vitro research shows that Sertralin has very little or unable to inhibit CYP1A2.
Interaction with food and drinks
Can take Asentra tablets with or without meals.
Avoid drinking alcohol when using Asentra.
Storage
Store less than 30 ° C, avoiding light and moisture. Store in original packaging.
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