Utralene-100 Umedica drug treatment (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Sertraline

Ingredient

Composition information	Content
Sertraline	100mg

Uses

Indications

Utralene 100 is indicated in the following cases:

Treatment of depression , rape disorder and cases of panic, bewilderment, fear accompanied or not accompanied by fear of crowded places characterized by sudden panic attacks and anxiety about increased disease, anxiety about complications and consequences of the disease or changes in attitude, behavior related to this disease.

Pharmacokological

The mechanism of action of sertraline is thought to be associated with the inhibitory effect on the recovery of serotonin on the nerve ends of the central nervous system (5HT).

Studies on clinical doses in humans have shown serotonin's serotonin absorption in human platelets. Animal in vitro studies also assume that sertraline is an effective inhibitor and selective nervous Serotonin reabsorption and only has a very weak effect on the reabsorption of norepinephrine and dopamine of the nerves.

In vitro studies show that sertraline has no significant affinity for adrenergic receptors (Alphal, Alpha2, Beta), Cholinergic, GABA, Dopaminergic, Histaminergic, Serotonergic (5HT1A, 5HT1B, 5HT2), or Benzodiazepine, antagonism of these recipients for these recipients for these receptors for these receptors to be reserved for these receptors for these receptors to be able Is related to the antiolinergic, sedative and cardiovascular effects of other mental medications. The long -term use of sertraline on animals reduces the average level in the brain of norepinephrin receptors, which is also observed with drugs that are effective in the treatment of mental disorders in people with severe depression. Sertraline does not inhibit monoamine oxidase.

pharmacokinetics

After taking many doses of 200mg, once a day, the average maximum concentration in Sertraline's plasma (CMAX) is 0.19 mcg/ml that appears in the range of 6 - 8 hours after drinking. The area under the curve of time concentration in plasma is 2.8mg/hour/l. For Desmethylsertraline, CMAX is 0.14mcg/ml, the waste time is 65 hours and the area under the time curve of time concentration is 2.3mg/hour/l. After using a single dose or taking several times of 50 - 400mg, 1 time, the last waste time is approximately 26 hours. The linear ratio of the dose is shown on the clinical dose range from 50 - 200mg/day.

Food increases the bioavailability of the drug about 40%: This suggests that sertraline should be used with meals.

Sertraline is converted mostly into N-Desmethylsertraline, which has a significant effect on pharmacological. Both Sertraline and N-Desmethylsertraline undergo amitelectomy oxidation and then descendant, hydroxy and connect with glucuronide. Significant excretion of metabolites.

approximately 98% of Sertraline is connected to plasma proteins. Interaction between sertraline and other high -binding drugs with plasma proteins has not been fully evaluated.

Sertraline pharmacokinetics in young patients and old patients are the same. N-Desmethylsertraline levels in the elderly are 3 times higher than in young people after using multi-sertraline doses. However, the clinical significance of this finding is not known.

People with liver disease and kidney disease

Sertraline pharmacokinetics in patients with significant disorders of liver function or kidney dysfunction has not been determined.

Before taking Utralene-100 Umedica drug treatment (10 blisters x 10 tablets)

How to use

Sertraline is taken twice a day, in the morning or evening, with a sufficient amount of water. The drug can be used or not with food. Sertraline film tablets 100mg are only used by oral.

Dosage

with non -use doses that can use this content, can use other appropriate types of drugs.

Adults

The daily dose is 50mg of Sertraline. If necessary, the dose may increase to 100mg/day.

Maximum daily dose is 200mg of sertraline. If required to increase the dose, it is necessary to increase slowly by 50mg for at least 1 week.

When treated for a long time, it is necessary to consider using the lowest dose possible to bring appropriate treatment effect.

Children and teenagers

Sertraline film tablets should not be used for children and people under 18 years old.

Older people

Because the disposal time of the drug may be prolonged in the elderly, it is necessary to reduce the dose appropriately for the elderly patients.

Patients with impaired liver function

Need to use sertraline for patients with impaired liver function. Although it is not necessary to adjust the dose in patients with liver function impairment, recommend that the dose should be reduced or extended the time between the use of the drug. Sertraline is not recommended for cases of severe liver failure because there is no valuable clinical data.

Patients with impaired renal function

No dose adjustment in patients impaired renal function . Patients with severe renal failure should be closely monitored when treated for a long time.

How to use and use time

The drug may start to have antidepressant effects within 7 days, however, the maximum effect is usually achieved within 2-4 weeks of treatment, patients should be notified of this.

The treatment time depends on the nature and severity of mental disorders. After the symptoms of depression have improved, the prolonged treatment to control this improved condition at least 6 months may be proposed.

Symptoms of stopping drugs when stopping using drugs

Avoid stopping the drug suddenly. When stopping treatment with sertraline, whether it should be reduced slowly for at least 1-2 weeks to minimize the risk of the drug-stop reaction. If the symptoms cannot be tolerated after a decrease in the dose or when stopping treatment, it may be necessary to continue using the dose before decreasing or stopping the drug. After that, the doctor can continue to reduce the dose slowly.

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? Coma has been reported in a rare number of cases. The available documents show that sertraline has a large safety index when using an overdose. There have been reports on single dose of sertraline up to 13.5 g. Harm effects mainly appear after sertraline poisoning due to simultaneous use with other drugs or drinking alcohol during treatment with sertraline. At that time, it is necessary to actively treat overdose.

There is no specific antidote for sertraline. The following measures should be indicated: ensuring airway ventilation and adequate oxygen to patients. Using activated carbon, combined with sorbitol solution or another type of enema if necessary, the least effective is gastric lavage. Taking vomiting is inappropriate. Overall cardiovascular function should be monitored and conducted supportive treatments.

diuretic, juris, blood transfusion and blood transfusion is not sure in case the drug has a large distribution such as Sertraline.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Utralene 100 , you may experience unwanted effects (ADR).

Notify the doctor about unwanted effects when using the drug.

Common

Plant nervous system disorders: helplessly.

Cardiovascular system: Brushing chest drum, chest pain.

Central nervous system disorders and peripheral nervous systems: increasing tone, reducing sensation.

Gastric disorders: Increase appetite.

Common disorders: back pain, weakness, discomfort, weight gain.

Disorders of musculoskeletal system: muscle pain.

Mental disorders: yawning, sexual disorders.

Respiratory disorders: rhinitis .

The tinnitus: tinnitus.

Less

Plant nervous system disorders: flushing, increased salivation, cold and moist skin, pupils.

Cardiovascular system: hypertension, fast heartbeat, dizziness, dizziness, posture hypotension, edema around the eye sockets, peripheral edema, hypotension, peripheral ischemic, fainting, edema.

Central nervous system disorders and peripheral nervous systems: shrinkage, confusion, increased movement, dizziness, loss of air conditioning, unusual coordination, sensory increase, cramps and legs, abnormal gait, reduced movement.

Disorders of skin and appendages: itching, acne, urticaria, bald, dry skin, erythema, light sensitive reaction, lumpy rash.

Gastrointestinal disorders: Difficult swallowing, worsening bone, belching, esophagitis, gastritis.

General disorders: fever, shiver, edema.

Metabolic and nutrition disorders: thirst.

Mental disorders: weakness, forgetfulness, nightmares, grinding teeth, mental instability, indifference, abnormal dreams, phoenic state, paranoia, hallucinations, aggressive reactions, worse weakness.

Reproductive system: Menstrual cycle disorders , abnormal menstrual periods, bleeding in genital tract, vaginal bleeding, menstruation, discharge.

Respiratory disorders: cough, shortness of breath, upper respiratory infection, nosebleeds, bronchospasm, sinusitis.

The senses: Membrane inflammation, ear pain, eye pain.

Disorders in the urinary tract: often urinating, much, urinating, difficult to go, urinating, urinating.

Rare

Plant nervous system disorders: pale, pale, glaucoma, penis energy, vasodilation.

Systemic disorders: Allergic reactions.

Cardiovascular system: chest pain in the epigastrium, chest pain under the breastbone, worsen hypertension, myocardial infarction, brain vascular disorders.

Central nervous system disorders and peripheral nervous systems: difficult to pronounce, coma, reduce tone, eyelid prolapse, shock dance, reduce reflexes.

Disorders of skin and appendages: follicles, eczema, dermatitis, contact dermatitis, blistering, hair, skin pigmentation disorders, pustules.

Endocrine disorders: Eye, big breasts in men.

Hearing disorders and vestibular disorders: Hearing, mesmerizing disorders at.

Bloody and lymph vessels: Anemia, eye sockets.

Disorders of liver and bile system: Liver function abnormalities.

Metabolic and nutrient disorders: Hypoglycemia, hypoglycemic reaction.

Mental disorders: detoxification syndrome, want to commit suicide, increase sex, sleepwalking, illusion.

Reproductive system: chest pain in women, menstrual bleeding, foreskin inflammation, big breasts, vaginal atrophy, acute mastitis in women.

Respiratory disorders: rapid deep breathing, slow breathing, wheezing, apnea, bronchitis, coughing up blood, reducing ventilation, larynx spasm, laryngitis.

The senses: dry eyes, fear of light, abnormal tears, limiting vision.

Disorders in the urinary tract: cystitis, urinary decrease, renal-nephritis, hematuria, kidney pain, pain.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Utralene 100 contraindicated in the following cases:

Hypersensitivity to sertraline or any ingredients of the drug.

Sertraline is not used simultaneously with monoamino oxidase inhibitors (Max) including Selegiline, Moclobemide and Linezolide-An antibacterial substance that has a reversible inhibitor Monoamino oxidase (MAO).

Settarine is not used simultaneously with Pimozide.

Precautions when using

used for children and teenagers under 18 years old

Serraline film tablets should not be used for children and teenagers under 18 years old.

Acts related to suicide (suicidal and suicidal thoughts), and opposing attitudes (mostly aggressive, anti -anger) are often observed more in clinical trials in children and teenagers treated with antidepressants compared to placebo treatment.

If due to clinical necessity and medication, these patients must be carefully monitored about the risk of symptoms that want to suicide. Moreover, documents on the safety of the drug in the long run in children and teenagers for development, maturity, awareness and behavior are limited.

Serotoninergic syndrome

Cases of several life -threatening reactions have been reported in patients using sertraline in combination with a monoamino oxidase inhibitor (MA MAII). Therefore, Sertraline tablets are not used simultaneously with Mao inhibitors including selective Selegililine and Moclobemide inhibitors inhibitors (RIMA), or with Linezolide.

Concomitance sertraline with other serotoninergic substances such as tryptophan, fenfluramine and serotonin shipping owners are not recommended due to the risk of serious harmful reactions. Sertraline tablets can start using after 14 days of stopping treatment with unfavorable Mao inhibitors. At least after 14 days of stopping using Sertraline, it is possible to start treating with a Mao inhibitor or MA0 inhibitors.

Therefore, when changing selective inhibitors, Serotonin absorption or other antidepressants need kidneys to avoid the risk of pharmacological interaction. Careful monitoring is especially important when sertraline is started to use after stopping an antidepressant with long -lasting semi -exhaust time like fluoxetine. There is no clear demonstration of the time of dilatation between treatments when changing from antidepressants to antidepressants.

The main characteristics of Serotoninergic syndrome are high body temperature, muscle vibration, loss of autonomy with the ability to quickly change important manifestations, change the mental state including confusion, irritability, and the end is also an anxious confusion that leads to delusion and coma.

Other serotoninergic inhibitors include dextromethorphan, pettidine, tramadol and other serotonin absorption inhibitors.

acts of suicide, suicidal desire or clinical deterioration

Depression is concerned about an increase in the risk of suicide, causing self -harm to the body and committing suicide actions (there are actions related to suicide). This risk always exists until the disease is significantly improved. If the condition does not improve after the first few weeks of treatment, patients should be carefully monitored until the patient's condition is better. Clinical common experience is a risk of suicide that can increase in the early stages of recovery.

Prehistoric patients who have acts related to suicide, or have a clear manifestation of suicidal wishes before starting treatment, is known to have a greater risk of suicide or suicide, and need to closely monitor these patients during treatment.

By analysis obtained from clinical trials that control the use of antidepressants in adults with mental disorders showing the risk of increasing suicide behavior in the anti -depressive drug group compared to the fake group for patients under 25 years of age. It is necessary to closely monitor the patient and pay attention to this high risk when using the drug, especially in the early stages of the treatment process or after the dose changes. Patients (and patient care) need to be notified of the need to monitor any bad hill clinically, suicidal action or suicide and abnormal changes in behavior and need to consult a doctor as soon as the symptoms appear.

Sitting, restless/mental disorders

The use of sertraline is related to the progression of mental disorders, clinical manifestations can be very similar to restless sitting, characterized by discomfort in people or anxiety, anxiety and need to move regularly, unable to stand or sit still. This most appears in the first few weeks of treatment. In patients developing these symptoms, increasing the dose may be detrimental.

Symptoms when stopping using Sertraline

Symptoms of detoxification when stopping using drugs are usually common, especially in patients who stop the drug suddenly. In clinical trials, harmful effects are observed when stopping the drug appears at approximately 20% of patients treated with sertraline.The risk of detoxification symptoms may depend on a number of factors including dosage, drug use time and dose reduction speed. Eyes, dizziness, sensory disorders (including abnormalities and electric shock), sleep disorders (including insomnia and nightmares), confused or anxious mood, nausea or vomiting, tremor, confusion, sweating, headache, diarrhea, chest drum, mental instability, irritability and visual disorders that have been reported after stopping the serotonin absorption inhibitors norepinephrine.

Usually these symptoms occur from mild to medium, however, some patients, they may be severe. Harmful reactions may appear within the first few days after stopping the drug, however, there are reports on these symptoms in some very rare patients who accidentally forget a dose. Usually these symptoms are limited and usually within 2 weeks, but in some special cases, they may last (up to 2-3 months or more). Therefore, it is necessary to stop treating with sertraline with a decrease in a few weeks to several months, depending on the need for patients.

Increases crazy or mildly rising

In clinical trials, crazy evidence or mild mania has been recorded at approximately 0.4% of patients. Therefore, Sertraline is used cautiously in patients with a history of crazy and mild mania. Doctors need to monitor patients closely. Sertraline should be stopped when the patient starts a crazy stage.

schizophrenia

Symptoms of neuropathy can become more serious in schizophrenia patients.

Convulative disorders

In studies on depression, the phenomenon of epilepsy is reported at approximately 0.08% of patients treated with sertraline.

Because sertraline has not been studied in patients with convulsions, avoiding drugs for patients with erratic epilepsy, and only use drugs for patients with stable epilepsy control with strict monitoring. If the seizure appears, it is necessary to stop treating with sertraline.

Treatment with electrical shock

There is very little experience in using the drug simultaneously with the treatment with electric shock, which should be cautious in this case.

diabetes

In patients with diabetes, treating with a selective inhibitor to reabsorb serotonin can cause changes in blood sugar control. Blood sugar levels need to be checked regularly. The dose of insulin or oral hypoglycemic drugs may need to be adjusted.

Bleeding

There have been reports on abnormal skin bleeding such as bruising and hemorrhage when using selective inhibitors to re -absorb Serotonin. Caution should be careful when patients use these drugs, especially when used simultaneously with anti -dynamic drugs, the drugs are known to affect the function of platelets (such as non -typical mental inhibitors and phenothiazine, most 3 -round antidepressants, acetylsalicylic acid and nonsteroidal anti -inflammatory drugs) as well as in patients with prehistoric hematuria.

Heart disease

Sertraline safety has not been set in new patients through heart attack or unstable heart disease patients. Patients diagnosed with these disorders are excluded from clinical studies. The electrocardiogram of patients who use sertraline in clinical studies by method shows that sertraline is not significantly involved in the abnormalities of the electrocardiogram.

Older people

The type and incidence of unwanted effects in old patients can be compared to young patients. Old patients are more sensitive to unwanted effects of antidepressants. The likelihood of sodium hypoglycemia, especially cases of simultaneous use with drugs that can cause these abnormalities, should be anticipated, especially in old patients, in malnutrition and cirrhosis patients.

People with impaired liver function

Sertraline is widely metabolized in the liver. The pharmacokinetic studies of the reminders of the drug in patients with mild and stable cirrhosis show that the semi -waste time lasts longer, the area under the concentration curve of time and maximum concentration in plasma (CMAX) is approximately 3 times higher than patients with normal liver function. There is no significant difference in cohesion with plasma proteins observed between groups. Sertraline is not used for patients with severe liver failure.

Persons of renal function

Because the drug is mainly metabolized in the liver, only a negligible part of Sertraline is excreted through the kidneys in the form of unchanged. In patients with mild to medium -sized renal function (ceatinine clearance of 3060ml/minute) or from average to severe (Ceatinine clearance 10 - 29ml/minute), pharmacokinetic indicators (AUC0-24 and CMAX) after reminded dose is not significant compared to patients with normal kidney function.

The semi -discharged time is the same and does not see the difference in cohesion with plasma proteins between research groups. This research shows that, as observed in cases of low kidney clearance, sertraline dose does not need to be adjusted in patients with impaired renal function. However, the stable pharmacokinetics of Sertraline have not been fully studied in this patient population, so it is necessary to be cautious when using drugs for people with renal failure.

The ability to drive and operate machinery

Psychotropic drugs in general can reduce the ability to work in intelligence or muscles necessary for high -risk jobs such as driving and operating machinery. Therefore, patients need to be warned about this.

Pregnancy

There are no complete and strictly controlled studies in pregnant women. Sertraline is only used for pregnant women when the benefits of treatment are greater than the possibility of fetal risk.

Breastfeeding period

Do not know if the sertraline is excreted in breast milk or not if so, in how much. Because many drugs are excreted in breast milk, be careful when using sertraline for breastfeeding women.

Medicinal interaction

Simultaneous use of some drugs in patients who are taking selective inhibitors in Serotonin reabsorption can cause serotoninergic syndrome.

Contraindicated

Mao inhibitors

Sertraline is not used simultaneously with Mao inhibitors, including selective inhibitors Selegiline and Moclobemide inhibitors. There have been reports on serious harmful reactions, in some cases leading to death, in patients using sertraline simultaneously with Mao inhibitors. In some cases, symptoms are similar to Serotoninergic syndrome.

pimozide

Increased plasma pimozide levels have been observed in clinical studies after simultaneous use of Sertraline and 1 low -dose Pimozide (2mg). These increase levels are not related to the transformation of electrocardiograms. The mechanism of this interaction is not known. Contraindications to simultaneous use of sertraline and pimozide because it can increase the risk of arrhythmia and extend the time period of QT related to the use of Pimozide.

drugs do not recommend simultaneously with sertraline

Serotonergic substances

In fact, there is no sufficient document on simultaneous use of Sertraline with serotonergic substances such as: Tryptophan, Fenfluramine, Sumatriptan, Dextromethorphan, Pethidine, Tramadol and serotonin owners, this combination is avoided and used only when appropriate monitoring.

Change the use of selective inhibitors to recover Serotonin or other antidepressants

Experience in optimal time to switch from the use of other antidepressants to sertraline is limited. It is necessary to pay attention and carefully evaluate medicine when transferring drugs, especially for long -term effects. The time of dilating time when transforming from a selective inhibitor to re -absorb Serotonin to another drug has not been set.

with medicine from sting sting john

Avoid using the same medicine from St John's plants (measles venom) in patients who are taking selective inhibitors to reabsorb serotonin because of the risk of serotoninergic syndrome.

Precautions

with other drugs

Powerful substances with plasma proteins

Due to the high level of cohesion to the protein, Sertraline's interaction with drugs is also highly connected to other plasma proteins.

Other interactions recorded in studies

Simultaneous use of sertraline and diazepam or tolbutamid causes slight but significant modifications in terms of statistical pharmacokinetics parameters. Cimetidine reduces the rates of sertraline when used simultaneously. The clinical relevance of these effects is not known.

Sertraline does not affect the effect of Atenolol, does not interact with glibenclamide or digoxin. The effects of carbamazepine, haloperidol, phenytoin and alcohol are not affected when used simultaneously with sertraline. However, it is recommended not to drink alcohol during treatment with sertraline.

Hypoglycemic drugs

Sertraline may cause changes in blood sugar control. Therefore, it is necessary to control the glucose level in the blood when starting to use sertraline in diabetic patients.

Oral anticoagulants, salicylic acid derivatives and nonsteroidal anti -inflammatory drugs

Simultaneous use of sertraline and warfarin increases slightly but significantly in terms of prothrombin time statistics, it is necessary to closely check prothrombin time at the beginning or at the end of treatment with sertraline.

There is the risk of increasing the risk of bleeding when serotonin re -inhibitors are combined with oral anticoagulants, salicylic acid derivatives, nonsteroidal anti -inflammatory drugs, typical mental inhibitors, phenothiazine and most 3 -ring antidepressants.

Medications are metabolized by cytochrom P450 enzyme

CYP 2D6: In the studies of drug interaction, the plasma stable concentration of Desipramine only increases a very small amount (23 - 37% of the average value) for a long time using Sertraline at a dose of 50mg/day.

CYP 3A3/4: In vivo studies on drug interactions have shown that: using Sertraline for a long time with a dose of 200mg daily does not inhibit CYP 3A3/4-mediated 6-3-hydroxylation of endogenous cortisol or metabolism of carbamazepine and terfenadine. There is no inhibition of intermediate metabolites CYP 3A3/4 of Alprazolam for a long time using Sertraline at a dose of 50mg/day. Results of studies show that there is no active inhibition of CYP 3A3/4 clinically due to sertraline.

CYP 2C9: Research on drug interactions conducted for a long time on Sertraline 20mg/day along with Tolbutamide, Phenytoin and Warfarin, the results can be seen inhibitors CYP 2C9.

CYP 2C19: There is no significant clinical effect when sertraline is used at a dose of 200mg/day for plasma concentrations of diazepam, which allows the Sertraline conclusion that does not inhibit CYP 2C19 at any clinical scale.

CYP 1A2: In vitro studies have shown that sertraline inhibits very little or does not inhibit CYP 1A2.

Lithi and trypthophan

In restricted studies with placebo when using Lithi and Sertraline on healthy people: There is no change in lithium pharmacokinetics, although there is an increase in tremor, shivering compared to the placebo group, this shows that there may be an impact on pharmacological energy. Simultaneous use can lead to serotoninergic syndrome. There have been other reports on increasing the effects when selective inhibitors of Serotonin reabsorption are used with lithium or trypthophan and thus the combination of these drugs should be conducted cautiously.

Diuretics

When used simultaneously with diuretics (especially in the elderly), the risk of reducing sodium blood increases, as well as the risk of anti -hormone secretion inappropriate.

phenytoin

Even though there is no clinical significant inhibition of phenytoin metabolism, which is observed in a controlled study with a healthy pharmaceutical price, need to monitor phenytoin concentration in plasma when starting treatment with sertraline and adjust the phenytoin dose appropriately. Simultaneous use with phenytoin can reduce sertraline levels in plasma.

Sumatriptan

Of the rare cases, weakness, increased reflexes, difficulty coordinating, confusing, anxiety and confusion have been reported related to simultaneous use of Sertraline and Sumtriptan. Patients with clinical requirements must be used simultaneously sertraline and sumtriptan must be monitored appropriately.

Phenazone (antipipine)

Antyrine's waste sale time is reduced when used simultaneously with sertraline.

3 -round antidepressants

Be cautious when using Serotonin reconstruction inhibitors along with 3 -round antidepressants because of the risk of increasing the concentration of the drug in plasma.

Storage

Store at a temperature not exceeding 30 ° C.

Expiry date: 3 years from the date of manufacture. Do not use overdue drugs stated on the packaging.

Manufacturer: Umedica Laboratories PVT. Ltd.

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