Sumiko 20mg Medochemie Treatment Treatment of depression (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Paroxetine

Ingredient

Composition information	Content
Paroxetine	20mg

Uses

Indications

Sumiko drug are indicated in the following cases:

Severe depression.

Types of anxiety disorders such as social anxiety (also known as social obsession) or common anxiety disorders.

Resigning obsessions .

Panic disadvantaged with or without obsession with fear of space.

Stress disorder after injury.

The chemical structure of Paroxetin is not related to the structure of 3 -round, 4 -round antidepressants and most existing antidepressants.

pharmacokinetic

absorption

Paroxetin is well tolerated after oral use and is first metabolized through the liver. Due to the first metabolic metabolism, paroxetin concentration is present in the general circulatory system lower than the drug concentration absorbed by oral. The stable concentration reached 7-14 days after the beginning of treatment and pharmacokinetics did not change during the treatment period.

Distribution

paroxetin is widely distributed throughout the tissue and pharmacokinetic indicators that show that the amount of paroxetin distributed in plasma accounts for only 1% of the total amount of paroxetin in the body.

Paroxetin binds about 95% of plasma proteins at treatment concentrations. There is no correlation between paroxetin plasma concentrations and clinical effects.

The drug is distributed to the mother's milk and the fetus of the testing animals in small amounts.

Metabolism

The main metabolites of Paroxetin are polarized, which is a combined product of oxidation and methylation and is easily removed. Therefore, they hardly contribute to the therapeutic effect of paroxetin.

Metabolism does not reduce the selective impact of paroxetin on the recovery of 5 - HT.

Elimination

The excretion through the urine of paroxetin is constant, usually lower than 2% of the dose, while the metabolites are about 64% of the dose. About 36% of the dose is excreted in the feces in which paroxetin does not constantly lower than 1% of the dose. So paroxetin is excreted almost entirely by metabolism.

The excretion of metabolites goes through two phases, the first is the result of the metabolism through the liver for the first time and being controlled next by the release of paroxetin from the body.

Sell waste time is very different but generally about 1 day.

Special subjects

The elderly and patients with liver - kidney failure: plasma paroxetin concentrations in the elderly and severe kidney failure or liver failure.

Before taking Sumiko 20mg Medochemie Treatment Treatment of depression (5 blisters x 10 tablets)

How to use

only use oral. The tablet should be taken in the tablet with a sufficient amount of water, not chewing. Paroxetin should be used once a day in the morning with food.

Dosage

The general recommendation must be long enough to ensure that there are no more symptoms, usually a few months for depression and maybe longer for cases of murdering and panic disorders.

Depression:

The recommended dose of 20 mg per day, the dose may be increased gradually every 10 mg to 50 mg per day depending on the response of the patient.

Social anxiety/social obsession and common anxiety disorders:

Dosage recommended 20 mg daily. If after a few weeks of recommended dose without response to the drug, it may increase gradually every 10 mg to a maximum of 50 mg/day. Long -term use should be evaluated regularly.

Resigning disorder:

The recommended dose of 40 mg per day should start at a dose of 20 mg and may increase gradually every 10 mg to the recommended dose. Some patients achieve treatment benefits at a maximum dose of 60 mg/day.

Panic disorder:

The recommended dose of 40 mg per day should start at a dose of 10 mg and may increase gradually every 10 mg to the recommended dose depending on the response of the patient. Some patients achieve treatment benefits at a maximum dose of 60 mg/day. The general record shows that the possibility of panic symptoms becomes worse in the early stages of treatment, so it is recommended to use low starting dose.

Stress disorder after injury:

Starting dose recommends 20 mg/day and often gives good response to most patients. If the response is not sufficient at this dose, some patients may achieve treatment benefits after increasing the dose every 10 mg depending on the clinical response. Maximum daily dose of 50 mg. Long -term treatment should be evaluated regularly.

Hepatic or kidney failure:

Increasing plasma paroxetin concentrations in patients with severe renal failure (creatinine clearance

Old people:

Increasing paroxetin levels in the elderly. The dose should be started at 20 mg/day and gradually increase every 10 mg to a maximum dose of 40 mg/day depending on the response of the patient.

Children:

It is not recommended to use paroxetin for children due to the safety and effectiveness of drug treatment in children who have not been determined,

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?

Symptoms

In addition to the reactions stated in the unwanted effect of the drug, the overdose symptoms include vomiting, fever and smooth muscle spasms. Usually the patient recovers no serious sequelae even when taking the dose of 2000 mg. Cases of coma or electrocardiogram changes are sometimes reported and very rare with deadly consequences, but often only encountered when sharing paroxetin with drugs that affect other mental or not drinking alcohol.

Handling

There is no specific antidote. Treatment should only be applied commonly used in overdose treatment due to any antidepressants. If appropriate should empty the stomach or by causing vomiting, gastric lavage or both. After emptying the stomach, drink 20 - 30 g of activated carbon every 4-6 hours during the first 24 hours after using the drug overdose. Patients should be supported with support with regular checks of living and closely monitored.

What to do when you forget 1 dose? Do not use double the dose at the next time to compensate for the forgotten dose.

Side Effects

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

Very common, ADR> 1/10

Digestive: Nausea.

Common, 1/100

Metabolism and nutrition: Increasing cholesterol levels, reducing appetite.

Mental: Sleeping, insomnia, agitation.

Neurology: dizziness, tremor, headache .

Eye: visual disorders.

Respiratory: Reflective yawning.

Digestive: constipation, diarrhea, dry mouth.

Skin: sweat.

Breasts and reproductive systems: Genital disorders.

Body: weakness, weight gain.

Uncommon, 1/1000

Blood and lymphatic system: abnormal bleeding, mainly in the skin and mucosa.

Mental: confused, hallucinations.

Neurological: Periodic disorders.

Eyes: Delonged pupils.

heart: sinus tachycardia.

vascular: increased or lowered blood pressure, posture hypotension.

Skin: Skin rash, itching.

urinary tract: keep urine, incontinence.

Rare, 1/10000

Metabolism and nutrition: Hemorrhage reduction, reported mainly in older patients and sometimes due to the inappropriate ADH secretion syndrome (SIADH).

Mental: Excessive stimulating reaction, anxiety, wrinkles, panic, restless sitting.

Neurology: convulsions.

Heart: Slow heart rate.

liver - bile: increase liver enzymes.

Skin: Light sensitive reaction.

Breasts and reproductive systems: increased blood prolactin/ increased milk secretion.

muscle - bone: joint pain, muscle pain.

Very rare, ADR

Blood and lymphatic system: platelets.

The immune system: allergic reactions (including urticaria and angioedema).

Endocrine system: ADH secretion syndrome (SIADH).

Neurological: Serotonin syndrome (symptoms may include agitation, confusion, sweating, hallucinations, increased reflexes, muscle spasms, tachycardia, tremor).

Eyes: Grade glaucoma.

Gastrointestinal: gastric bleeding.

liver - bile: liver events (such as hepatitis, sometimes accompanied by jaundice and/or liver failure).

Breasts and reproductive systems: Penis.

Body: Peripheral edema.

Not determined frequency

Mental: thoughts and behaviors.

ears: tinnitus.

Instructions on how to handle ADR:

Stop use and report immediately to the doctor if the side effects become worse or have any other reactions that occur apart from the above effects.

Warnings

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

Contraindicated

Sumiko drug contraindicated in the following cases:

Patients are known to be hypersensitivity to paroxetin or any ingredients in the pill.

Patients are taking Monoamin oxidase inhibitors (IMAO).

Used in combination with thioridazin or pimozid.

Caution when using

Do not share paroxetin with imao or within 2 weeks after finishing treatment with imao. Therefore, the treatment should be started carefully and increased the dose slowly until the desired response. Similarly, do not use imao within 2 weeks from the date of stopping treatment with paroxetin.

Symptoms of lack of drugs after stopping treatment with paroxetin

The risk of drug deficiency symptoms may depend on the duration of treatment and treatment dose and the degree of dose reduction.

Some drug shortcomings have been reported including dizziness, sensory disorders (such as independence, electric shock and tinnitus), sleep disorders, irritation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhea, chest drum ... Slowly within a few weeks or months depending on the needs of the patient.

, like other antidepressants, should be carefully used in Paroxetin in patients with an obsession.

In addition, it is advisable to use paroxetin carefully in the following cases:

Cardiovascular:

Paroxetin does not cause significant changes in blood pressure, heart rate, and ECG. However, for all mental impact drugs, it is recommended to be cautious when treating in patients with cardiovascular disease.

epilepsy:

Like with other antidepressants, caution should be used with Paroxetin in epilepsy patients.

convulsions:

The whole ratio of seizures is less than 0.1% occurs in patients treated with paroxetin, so it is necessary to stop paroxetin treatment in patients with seizures.

Electrical shock therapy (EC):

There is very little experience when using paroxetin with electric shock therapy.

Serotonin syndrome/malignant syndrome due to sedative

In some very few cases, serotonin syndrome or malignant syndrome caused by sedatives are related to the use of paroxetin, especially when coordinated with serotonin and/or other sedative drugs. High fever, spasticity, muscle convulsions, irritability, excessive excitement ...) and should start treating symptoms and support.

The ability to drive and operate machinery

Treatment with paroxetin does not show that it affects the mental or motor skills, however, like all drugs that have an impact on intelligence, patients should be noted about the ability to drive and operate machinery.

Although paroxetin does not increase the weakening of motor and mental skills, do not recommend sharing paroxetin with alcohol.

Pregnancy

although studies on animals do not show any teratogenic or toxic harm to the embryo, the safety of paroxetin in pregnant women has not been established. Therefore, it is recommended not to use paroxetin for pregnant women unless the benefits are higher than the possible harm.

breastfeeding period

recommendation not to use paroxetin for women who are raising children to make up for the treatment benefits higher than possible harm.

Drug interaction

Serotonin secretion:

As other SSRIs, simultaneously used with serotonin secretion drugs can lead to serotonin syndrome. Patients should be recommended to take care of the medication and clinical monitoring closely when using Serotonin secretion drugs (such as L-tryptophan, Triptan, Tramadol, Linezolid, SSRI, and Lithi) with paroxetin. Concentrated control of paroxetin with Maoi due to the risk of serotonin syndrome.

pimozid:

Pimozid concentration increased by 2.5 times in a study with a low -dose pimozid (2 mg) in combination with 60 mg of paroxetin. Contraindicated Pimozid with paroxetin.

ENVIDE METHODS:

Paroxetin's metabolism and pharmacokinetic properties may be affected by induction or inhibition of drug metabolic enzymes. When using paroxetin with metabolic enzyme inhibitors, paroxetin should be used at the lowest dose in the recommended dose range. There is no need to adjust the dose when sharing paroxetin with metabolic enzyme induction drugs (such as carbamazepin, rifampicin, phenobarbital, phenytoin) or with fosamprenavir/ritonavir.

Procyclidin:

Paroxetin daily use significantly increases plasma process levels. Procyclidin should be reduced if anti -secreting effects.

The drug is metabolized by CYP2D6 enzyme:

Paroxetin inhibits the CYP2D6 enzyme of the cytochrom P450 enzyme system in the liver. This inhibitor can lead to increased plasma concentrations of combined drugs metabolized by this enzyme. These drugs include a number of 3 -round antidepressants (such as Clomipramin, Nortriptylin, and Desipramin), Phenothiazin sedatives (such as perphenazin and thioridazin), Risperidon, Atomoxetin, some type 1C anti -rhythmic drugs (such as Propafenon and Flecainid) and methoprololol.

Oral anticoagulant:

Simultaneous use of Paroxetin with oral anticoagulant drugs may increase anticoagulant effects and increase the risk of bleeding.

Non -steroid anti -inflammatory drugs (NSAID), acetylsalicylic acid and other platelet anti -dumping drugs:

Shared paroxetin with nonsteroidal anti -inflammatory drugs (NSAID) or acetylsalicylic acid may increase the risk of bleeding.

The drug acts on the stomach pH:

Medicines that affect the gastric pH (such as antacids, proton pump inhibitors or hypamine antagonistic pumps) may affect plasma paroxetin concentrations in patients using oral mixture.

alcohol:

Should avoid drinking alcohol during use of paroxetin.

Storage

In closed packaging, temperatures below 30 ° C. Avoid light.

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