Patchell medicine 20mg Davi Pharm treat depression, anxiety disorders (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Paroxetine

Ingredient

Composition information	Content
Paroxetine	20mg

Uses

indications

Patchell pills are indicated in the following cases:

Depression. Phenylpiperidin, is a antidepressant of a group of Serotonin reabsorption inhibitors at the previous synap of serotoninergic nerve cells, increases serotonin levels to the later synap, thereby improving depression symptoms in depression patients. Like antidepressants and selective inhibition groups of Serotonin reabsorption (SSRI) (Fluoxetin, Sertralin, Citalopram, Luvoxamin), Paroxetin has the effect of rapidly increasing serotonin levels at the Synap slot of serotoninergic neurons. However, the effectiveness of improving the clinical symptoms of depression in patients is very slow, usually from 3-5 weeks. Therefore, the case of severe depression cannot be relieved when used with this medicine.

Unlike old 3-round antidepressants or a few other antidepressants, with Paroxetin treatment, it only has a selective inhibitory effect on Serotonin recovery channels, but it is less effective on other receptors such as cheolinergic resistance, select 01-adrenergic or histamine resistance or have no adverse effects on psychological and moving functions and does not have much effect on heart frequency, blood pressure. Therefore, the risk of side effects due to cholinergic resistance (dry mouth, blurred vision, urinary retention, constipation), al-commenergic blockers (vertical posture hypotension) or antihistamine (drowsiness) rarely encountered when used with paroxetin treatment.

Pharmacokinetics

absorption

Paroxetin absorbs slowly but completely in the gastrointestinal tract after drinking and reaches the maximum concentration after 5 hours. Food does not significantly affect the absorption process of the drug.

Distribution

Paroxetin is widely distributed in the body tissue, can be through the brain blood barrier, milk and high bonding with plasma proteins, approximately 95%. The distribution volume is very fluctuated, although it has not been identified in humans, but in animals is about 3 - 28 liters/kg.

Metabolism - Elimination

The drug is initially metabolized in the liver because the enzyme CYP2D6 is in the form of oxygen and methyl-diverges, then this metabolite combines with glucuronic acid to eliminate feces (about 36%) and urine (62%). A small part of 2% paroxetin does not change excretion in the urine and

Special subjects

Elderly: In the elderly patients, the disposal time of the drug can increase to 36 hours.

Hepatic impairments: Because paroxetin metabolizes very strongly in the liver, liver damage can affect the elimination of drugs, people with severe liver failure need to recommend the lowest paroxetin dose of paroxetin and must be cautious when increasing the dose in this patient.

People with renal failure: In patients with renal impairment, CLCR

Before taking Patchell medicine 20mg Davi Pharm treat depression, anxiety disorders (10 blisters x 10 tablets)

How to use

Paroxetin is often used by oral. Food does not affect absorption, but should drink with food to minimize ADR on the digestive tract.

Dosage

Adult depression

The starting dose is usually 20mg/day, taken once in the morning. The maintenance dose is changed according to the clinical response of each person. In some patients who respond poorly for 20 mg, the dose may increase gradually 10 mg, the maximum dosage is 50mg/day. Usually after a few weeks to achieve adequate treatment effect, so do not increase the prescribed overdose. It is necessary to treat at least 6 months to ensure the patient is out of symptoms.

Obsessive obsession in adults

recommended dose 40 mg/day. Patients should start at 20 mg/day and increase 10 mg each time to recommended dose. If after a few weeks of treatment at the recommended dose that patients respond poorly, may increase to the highest dose of 60 mg/day.

Panic disorders in adults

The starting dose is 10 mg/day, taken once in the morning. After at least 1 week of treatment, the dose can be increased to 10 mg/day, until the recommended dose of 40 mg/day. The effectiveness of the drug has been proven in clinical trials using 10 - 60 mg/day. Must be treated for a sufficient time so that the disease does not recur. This time can last for a few months, sometimes longer.

Social obsession

Start recommended 20 mg/day, then increase each week to 10 mg, up to 60 mg/day.

All anxiety disorders in adults

Dosage recommended immediately 20 mg/day, taken 1 time in the morning, then increased each week to 10 mg, up to 50 mg/day. Treatment time must be at least 8 weeks of treatment.

In trauma tensions in adults

Dosage recommended 20 mg/day, then if there is no sign of improvement, an additional 10 mg, up to 40 mg/day. Tracking patient evaluation periodically during long -term treatment.

Elderly

Initial dose 10 mg/day, taken 1 time in the morning. If not supported, maximum dose can be increased by 40 mg/day.

Hepatic or severe kidney failure

Initial dose 10 mg/day, taken 1 time in the morning. If not, the maximum dose can be increased by 40 mg/day.

Children

Do not use drugs for children under 18 years old. Safety and effectiveness of drugs for children (

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

When overdose, symptoms may occur are nausea, vomiting, dizziness, sweating. Also see symptoms of excitement, mild mania and central nerve stimulation signs.

Land of Tri

Mainly treat symptoms and support. Can be used for active carbon and sorbitol. Maintain respiration, heart activity and body temperature. If necessary, use anti -convulsions like diazepam.

Measures for hemolysis, mandatory diuretic or blood change may not be effective due to the large distribution of the distribution and high -linked drugs with protein.

What to do when you forget a dose? If you remember before going to bed, take the forgotten dose immediately. If you remember at night or the next day, skip the forgotten dose and take the drug according to the old schedule. Do not drink twice as doses.

Side Effects

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

When starting treatment, restlessness, anxiety or difficulty sleep may be increased (10-20% of treatment cases). The initial nausea reaction and depending on the dose may also occur up to 10%.

Very common, ADR ≥ 1/10

Central nerve: distracting.

Digestive: Nausea.

Genital: impaired sexual function.

Common, 1/100 ≤ ADR

Body: fatigue, dizziness, sweating, yawning, weakness, weight gain.

Central nerve: dizziness, tremor, headache, decreased libido.

Digestive: diarrhea, constipation, vomiting.

Eyes: blurred vision.

Skin: Sweating.

Mental: restlessness, insomnia, excitement, fear, dreaming of nightmares.

Metabolism: Increased cholesterol levels, decreased appetite.

Uncommon, 1/1 000 ≤ ADR

Central nervous system: ADVICE NOTICE.

Mental: Confusion, hallucinations.

Skin: skin rash, itching, abnormal bleeding under the skin.

circulatory: tachycardia, blood pressure disorders, hypotension when posture changes.

urinary tract: urinary retention, incontinence.

Eyes: dilated pupils.

Metabolism: difficult to control blood sugar.

Rare, 1/10 000 ≤ ADR

Body: muscle pain, joint pain.

Circulation: Slow heart rate.

Central nervous system: manic, anxiety, movement disorders, convulsions, uneasy syndrome.

Digestive: gastrointestinal bleeding.

Endocrine: increased blood prolactin, breast enlargement in men, secretion of milk.

Liver: Increased liver enzyme (hepatitis, sometimes jaundice).

Metabolism: Hemorrhage reduction.

Very rare, ADR

Systemic: peripheral edema.

Central nerve: Serotonin syndrome.

Visual disorders: acute glaucoma.

Endocrine: The anti -hormone secretion syndrome is inappropriate.

Hematology: platelet reduction.

Skin: Stevens-Johnson syndrome, poisoned epidermal necrosis, diverse roses.

Genital: prolonged erection.

Unknown

Mental: suicide ideas or suicide, agitation.

ears: tinnitus.

Instructions on how to handle ADR

Stop taking the drug when it has a skin rash or urticaria. If necessary, can be treated with antihistamines or/and glucocorticoids.

can chew gum or sugar -free gum, or saliva replacement to reduce dry mouth; Go to the doctor if the mouth is dry for more than two weeks.

All patients treated with antidepressants due to any indications must be closely monitored about the severe condition of depression, suicide intentions and behavioral abnormalities, especially in the early stages of treatment and during the dose adjustment phase. Any change in behavior such as excitement, irritability, and suicide intentions must notify the doctor. If you plan to stop the medication, gradually stop but faster if possible, avoid stopping the drug suddenly.

Stop taking the drug and treat symptoms when the Serotonin syndrome appears. The manifestation includes: Changing the mind status (such as agitation, hallucinations, coma), unstable plant neurons (such as fast heartbeat, vibrating blood pressure, high fever), increased muscle tone, muscle vibration ...

Warnings

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

contraindicated

Patchell drugs contraindicated in the following cases:

Hypersensitivity to paroxetin or any ingredients of the drug.

Not coordinated with imao. Start taking the medication after stopping Imao for more than 2 weeks or at least 24 hours after stopping the IMAO.

Do not coordinate with CYP450 2D6 inhibitors such as pimozid, linezolid, methylene blue (intravenous injection) and thioridazine due to extending QT, torsion.

Caution when using

Special prudence

Avoid using the drug simultaneously with monoamin oxydase inhibitors (Mao) because it can cause serotonin syndrome.

Start treatment with paroxetin after stopping the MABN inhibitors not recover for more than 2 weeks or at least 24 hours after stopping the recovery inhibitors. Paroxetin dose should be increased slowly until the optimal efficiency.

Children under 18 years old

Do not use drugs for children under 18 years of age due to not enough evidence to prove the safety and effectiveness of the drug.

suicide/ suicide idea or more serious than clinical manifestations

Depression increases the risk of suicide, self -harm or suicide. This risk remains at a significant remission. The disease cannot improve within the first few weeks after taking the medication, closely monitor the patient during this time. According to clinical experience, when treating antidepressants, suicide risks often increase in the early stages of recovery.

When indicating paroxetin to treat other mental illnesses, the risk of suicide also increases. In addition, it may be due to the diseases that accompany the main depression disorders. Therefore, when treating the main depression disorders, other psychological disorders need to be considered.

Patients with a history of suicide/suicide ideas, or before treatment shows signs of suicide ideas, these patients are at high risk of suicide/suicide, so closely monitor during treatment.

closely monitor in high -risk patients, especially during the dose adjustment period. Patients or relatives of patients should monitor the condition of more severe illness, suicide behavior/idea and abnormal changes in behavior and immediately notify the doctor when detecting abnormalities in the patient.

Unconventional irritation

When using paroxetin, the patient may be uneasy, characterized by the feeling of restlessness and mental agitation as unable to sit or stand still and thus tired patients. Increasing the dose may be harmful in patients developing this evidence.

Serotonin syndrome

When treated with paroxetin, rarely appears serotonin syndrome or malignant neuroleptic syndrome, especially when used with other sedative/serotonergic drugs. Because these syndrome can be life -threatening, Paroxetin should be discontinued when these conditions appear (characterized by symptoms such as high fever, spasticity, muscle convulsions, plant neurological disorders with signs of rapid fluctuations, mental changes that include confusion, irritability, excitement to delusion and coma) occurs, so start supporting treatment. Paroxetin should not be used with precursors of serotonin (such as l-tryptophan, oxitriptan) due to the risk of serotonin syndrome.

Heart

As for other anti -agarwood drugs, cautious when using paroxetin for patients with a history of mania. If the patient has a manic phase, should stop treatment with paroxetin.

fracture

Clinical research shows that patients use antidepressants at risk of fractures, including SSRIs. The most risk when starting treatment. Therefore, be careful when used.

Liver failure/kidney failure

Be cautious when used for patients with liver/renal failure.

diabetes

In patients with diabetes, SSRIs can change blood sugar control. It may be necessary to adjust insulin or hypoglycemic drugs for oral. There are also studies that can increase blood glucose when using a combination of paroxetin with pravastatin.

epilepsy

Be cautious when used for patients with epilepsy.

convulsions

Be cautious when taking medication for people with a history of convulsions, to stop the drug if seizures appear.

Object increase

Paroxetin can cause pupils to dilate, so it is necessary to be cautious for patients with glaucoma of closed angle or a history of Glaucoma.

Cardiovascular disease

Be cautious when used for patients with cardiovascular disease.

Hypoglyc sodium

The drug can cause hypoglycatry hypoglycemia, especially in the elderly and the patient is taking diuretics. Symptoms of sodium hypoglycemia include headache, distraction, memory loss, confusion, unstable standing. Therefore, it is necessary to start using the lowest dose and increase the dose, if there are signs of hypoglycemia, it is necessary to stop treating and consulting the doctor.

Blood pressure

The drug can cause dizziness or headache, so do not stand up suddenly while in a lying position or sitting.

Bleeding

There has been an abnormal bleeding report under the skin such as bruising and hemorrhage when using SSRIs. Other manifestations of hemorrhage such as gastrointestinal bleeding are also reported. Elderly people are at higher risk.

Be cautious when using SSRIs along with oral anticoagulants, platelet aggregation inhibitors or drugs that increase the risk of bleeding (for example, not typical anti-psychotic drugs such as clozapin, phenothiazine, most 3-round antidepressants, acetyl salicylic acid, NSAIDs, COX-2 inhibitors) as well as in patients with a history of blood disorders or bleeding conditions.

Interaction with tamoxifen

paroxctin, the substance that has the ability to inhibit CYP2D6, can reduce the concentration of endoxifen, one of the most important metabolites of Tamoxifen. Therefore, it is advisable to avoid using paroxetin during use of tamoxifen.

Symptoms of quitting smoking when stopping treatment with paroxetin

Symptoms of cessation when stopping treatment are quite common, especially if stopped suddenly. In clinical trials, unwanted effects when stopping treatment occur in 30% of patients with paroxetin treatment compared to 20% in placebo patients.

The risk of cessation syndrome is based on risk factors including drug use, treatment dose and dosage reduction.

Dizziness, sensory disorders (including abnormalities and electric shock), sleep disorders (including nightmares), agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhea, chest drum. Unstable emotions, easily stimulated, visual disorders have been reported. Usually mild to medium symptoms, however, some patients may be severe. These symptoms usually occur within the first few days after stopping the drug, but there are also rare cases of patients who experience this symptom after accidentally forgetting to take 1 dose.

Usually these symptoms are self -limited and after 2 weeks, although some people may last (2-3 months or more). Therefore, when you want to stop paroxetin, it is necessary to gradually reduce the dose for a few weeks or months, depending on the needs of the patient. Preparations containing lactose, patients with galactose tolerance disorders, lactase deficiency or glucose-galactose absorption disorders should not be used.

The ability to drive and operate machinery

The drug can cause drowsiness, reduce the ability to consider, judge, think or mobilize, so be careful when driving, operating the machine or the jobs that need to be alert.

Pregnancy

The studies have shown when using paroxetin at a dose of over 25 mg/day for pregnant women in the first 3 months of pregnancy, which is likely to increase the risk of fetal birth defects, especially on the cardiovascular system. Using the drug at the last 3 months of pregnancy, babies may appear symptoms such as respiratory failure, cyanosis, apnea, convulsions, hypoglycemia, constant crying, sleep disorders, lung pressure. Therefore, Paroxetin should not be used for pregnant women, only indicated when there is no other medication instead and need to consider the benefits/risks of the drug.

The period of breastfeeding

Small amount of secretion into breast milk, does not see any effect on children should consider using when breastfeeding.

reproductive system

Animal data shows that paroxetin affects sperm quality. In vitro research shows that the drug has a sperm quality. However, some reports to SSRIs (including paroxetin) show that the effect on the reproductive system can recover. The effect of the fertility of the person has not been studied.

Interactive drug

Serotonergian drugs

As other SSRIs, used with other serotonergic drugs that can increase the unwanted frequency of 5-HT (Serotonin Cuong Serotonin syndrome). Caution and closely monitoring when using serotonergic drugs (L -tryptophan, Triptan, Tramadol, Linezolid, Methylen Blue, SSRI, Lithi, Pethidin and St. John's Wort - Hypericwm Perforatum) along with paroxetin. Be cautious when using fentanyl in chronic anesthesia or treatment of chronic pain.

Concultural control of paroxelin with monoamine oxidase inhibitors such as moclobemid and Selegilin (see the contraindications), because it can be confused, agitated, ADR in the digestive tract, high fever, severe seizures or hypertension. Paroxetin strongly inhibits liver enzymes cytochrom P450 2D6. Simultaneous treatment with metabolic drugs thanks to this enzyme and narrow therapeutic index (for example, Flecainid, Encainid, Vinblastin, Carbamazepin and 3 -round antidepressants) must start or adjust these drugs at low doses. This also applies if Paroxetin was used within the previous 5 weeks.

The concentration of 3 -round antidepressants, Maprotilin or Trazodon in plasma can be doubled when used simultaneously with paroxetin. Some physicians recommend reducing about 50% of the dose of these drugs when used simultaneously with paroxetin.

Use paroxetin simultaneously with lithiums that can or increase or decrease the level of lithium in the blood, and there have been cases of lithium poisoning occurs. Therefore, lithium concentration should be monitored.

pimozid

Paroxetin has the effect of inhibiting CYP2D6, contraindicated use of paroxetin with pimozid, as it can increase 2.5 times the pimozid concentration, increase the toxicity on the heart of pimozid, which can cause QT range.

thioridazin

Contraindicated in combination with Thioridazin, because it can increase the toxicity of Thioridazin on the heart such as extending the QT, torsion, cardiac arrest. Metabolic enzymes. Paroxetin's metabolism and pharmacokinetics may be affected by the induction or inhibition of drug metabolic enzymes. When Paroxetin is used with enzyme inhibitors, the lowest dose of Paroxetin. No need to adjust the starting dose when used with known drugs has an enzyme induction effect (carbamazepin, rifampicin, phenobartbital, phenytoin) or with fosamprenavir/ritonavir. Any dose adjustment (after the beginning of treatment or after stopping the enzyme induction), it depends on the clinical effect (intake and effectiveness).

fosamprenavir/ritonavir

Used with Fosamprenavir/Ritonavir 700/100 mg twice a day with Paroxetin 20 mg daily in healthy volunteers for 10 days shows a reduction of about 55% of plasma concentrations of paroxetin. Plasma concentrations of fosamprenavir/ritonavir when used with paroxetin are similar to the value in other studies, showing that paroxetin does not affect the effect of fosamprenavir/ritonavir. There is no clinical data on the use of fosamprenavir/ritonavir with paroxetin for more than 10 days.

Procyclidin

Daily common use with paroxetin significantly increases the concentration of processes. If the sympathetic effect occurs, the propyclidin dose should be reduced.

Anti -seizure drugs

Used with carbamazepin, phenytoin, and valproat does not affect pharmacokinetics and pharmacokinetic energy in patients with epilepsy.

Paroxetin's CYP2D6 inhibitor

As other antidepressants, including SSRIs, Paroxetin inhibit the liver's Cytochrom P450, the CYP2D6 enzyme. The inhibition of CYP2D6 may increase the plasma concentration of shared drugs metabolized by these enzymes. Including drugs: 3 -round antidepressants (clomipramin, nortriptylin, despiramin), phenothiazin sedation (perphenazin and thioridazin), Risperidon, Atomoxetin, 1C anti -arrhythmic drugs (Propafenon, Flecainid) and Metoprolol. It is not recommended to use paroxetin with metoprolol in the treatment of heart failure, due to the narrow treatment index of metoprolol in this case.

tamoxifen

Mobile pharmacokinetics between CYP2D6 and Tamoxifen inhibitors, showing the plasma concentration of one of the activity metabolites of Tamoxifen (endoxifen) decreased by 65 - 75% in literary reports. There have been studies on reducing the effectiveness of tamoxifen when, used with SSRIs antidepressants. Therefore, it is not recommended to use Tamoxifen with CYP2D6 inhibitors, including paroxetin.

alcohol

Like other mental medications, patients should not drink alcohol when using paroxetin.

anticoagulants

The dynamic interaction between paroxctin and oral anticoagulants may occur. Using paroxetin along with oral anticoagulants increases anticoagulant and risk of bleeding. Therefore, be careful when using paroxetin in patients using oral anticoagulant drugs.

NSAIDS and Acetyl Salicylic Acid, and anti -platelets

The pharmacological interaction between paroxetin and NSAIDS/Acetyl Salicylic Acid may occur. Using Paroxetin and NSAIDS/Acetyl Salicylic Acid may increase the risk of bleeding. Be cautious when using SSRIs along with oral anticoagulants, drugs that affect platelet function or increase the risk of bleeding (anti-psychotic drugs are not typical such as clozapin, phenothiazine, most three-round antidepressants, acerylic acid, NSAIDs, COX-2 inhibitors) as well as patients with a history of bleeding disorders or bleeding.

pravastatin

Interaction between pravastatin and paroxetin has been studied. The common use of pravastatin and paroxetin may increase blood glucose levels.

Patients with diabetes using pravastatin and paroxetin may have to adjust the dose of diabetes and/or insulin.

Linking drugs with plasma proteins

Periodic drugs with plasma proteins such as anticoagulant, digitalis or digitoxin, simultaneously used with paroxetin may be pushed out of the protein bonding position, increasing the concentration of free -blood drugs in plasma and increasing side effects.

Storage

Leave the drug in a dry place, avoid light, the temperature does not exceed 30 ° C, out of the reach of children.

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