Parokey-30 Davipharm tablets for treatment of depression, rape obsession (6 blisters x 10 tablets)

Pharmacological group: Anti -depression.

Paroxetin, derivative of phenylpiperidin, is a antidepressants of the group of Serotonin reconstruction inhibitors at the previous synap of serotoninergic nerve cells, increasing serotonin levels to the later synap, thereby improving depression symptoms in depression patients.

Like antidepressant drugs and selective inhibition groups of Serotonin (SSRI) (SSRI) (SSRI) (Fluoxetin, Sertralin, Citalopram, Fluvoxamin), Paroxetin has the effect of rapidly increasing serotonin levels in Synap slot of serotoninergic nerve cells but improving depression symptoms on patients very slowly, usually 3 weeks, 5 weeks Severe depression cannot be relieved immediately when used with this medication.

Dynamic 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.

non -linear pharmacokinetics when increasing dose.

Stable concentration throughout the body achieved in 7-14 days after starting treatment with instant release drugs or controlled and pharmacokinetic release does not change when long -term treatment.

distribution

Paroxetin is widely distributed in body tissues, can be through the brain blood, milk and high bonds with plasma proteins, approximately 95%.

Volume of distribution is very fluctuated, although it has not been determined in humans, but in animals ranges from 3 to 28 l kg.

There is no correlation between plasma paroxetin concentrations and clinical effects (unwanted effects and effects).

metabolism, excretion

The drug is strongly metabolized in the liver because the enzyme CYP2D6 is in the form of oxidation and methylation, 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

Selling waste time of paroxetin is about 21 - 24 hours.

Special subjects

Elderly

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

People with liver failure

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 initial paroxetin dose and be cautious when increasing the dose in this patient.

Renal failure

In patients with chlorine kidney failure

Very common, can affect more than 1 in 10 people:

Instructions on how to handle ADR:

You need to stop taking the drug when you have a skin rash or urticaria and go to medical centers for treatment with antihistamine or glucocorticoid drugs.

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

Notice immediately to the doctor if you have any changes in behavior such as agitation, irritability, and suicide intentions. If you plan to stop the medication, gradually stop but faster if possible, avoid stopping the drug suddenly.

Notice immediately to the doctor if you have signs including: Change of mind status (such as agitation, hallucinations, coma), unstable plant nerves (such as fast heartbeat, vibrating blood pressure, high fever), muscle tone, muscle vibration ... This can be symptoms of serotonin syndrome.

Be cautious when using

before using this medication, notify your doctor if you are having the following health problems:

When you are taking the drug, tell your doctor or pharmacist if you have symptoms such as confusion, unable to rest, sweat, tremor, hallucinations (see strange images or hear strange sounds), sudden muscle convulsions or fast heartbeat, as these symptoms can be signs of serotonin syndrome.

The drug contains lactose, notifying the doctor if you have been told by the doctor that is not tolerated with any type of sugar.

Drugs that contain polysorbat 80 can cause allergies and castor oils that can cause nausea, vomiting, abdominal pain, diarrhea.

Thinking of suicide and depression or anxiety disorders are worse

If you have depression or anxiety disorders, when you may have the thought of harming yourself or suicide. These symptoms can increase when they start treating because the drug takes some time to be effective (usually about 2 weeks but sometimes longer).

You often have the same thought if you:

I have thought of harming myself or suicide.

is young. Information on clinical trials shows an increase in the risk of suicide behavior in young people ( If you have the thought of harming yourself or suicide, contact the doctor or go to the hospital immediately.

It will be helpful for you if you tell your relatives or best friends you are suffering from depression or anxiety disorders, and ask them to read this user manual. You can ask them to tell you if they think your depression or anxiety is worse, or if they worry about changes in your behavior.

use drugs for children

Do not use paroxetin in children and teenagers under 18 years old.

Pregnant or lactating women

If you are pregnant or nursing, think you may be pregnant or intend to get pregnant, consult your doctor before taking this medication.

If you find yourself pregnant while using paroxetin, immediately notify your doctor. Because some studies suggest that the risk of an increased heart defects in children whose mothers use paroxetin in the first months of pregnancy. The doctor may decide to reduce the dose from pregnancy. However, depending on your condition, the doctor can decide to continue taking the drug better for you.

Pregnant women

If used in pregnancy, especially in the last 3 months, paroxetin may increase the risk of serious condition in children called persistent pulmonary hypertension in newborns (PPHN).

PPHN increases blood pressure in the pulmonary blood vessels that can lead to abnormal blood flow in the lungs and hearts and children may not get enough oxygen into the bloodstream. These symptoms usually occur within the first 24 hours after birth and include unable to sleep or eat normally, breathe faster, pale blue skin or too hot or too cold, sick, cry more, hard or soft muscle, coma, tremor, restlessness or seizure. If your child has the above symptoms, contact your doctor or midwife for advice.

breastfeeding women

Small amount of paroxetin secretion through breast milk. The serum concentration of breastfeeding is not detected (

There is no sign of the effect of the drug on newborns so breastfeeding may be considered.

fertility

Paroxetin reduces sperm quality in animal tests. In theory, this may affect fertility but have not observed the impact on fertility in humans.

affects the ability to drive and operate machinery

paroxetin can cause dizziness, confusion or visual change. If you are affected by the above effects, do not drive or operate machinery.

Drug interaction

Serotonergic drugs

As other SSRIs, used with other serotonergic drugs that can increase the unwanted frequency of 5-HT (serotonin syndrome, see "Causes of caution when taking the drug"). Precautions and closely monitoring when using serotonergic drugs (L -tryptophan, Triptan, Tramadol, Linezolid, Methylen Blue, SSRIS, Lithi, Pethidin and St. John - Hypericum Perforatum) along with paroxetin.

Be cautious when using fentanyl in chronic anesthesia or treatment of chronic pain.

Concultural control of paroxetin with monoamine inhibitors such as moclobemid and Selegilin (see the contraindication section), because it can be confused, agitated, ADR in the digestive tract, high fever, severe seizures or hypertension. Paroxetin strongly inhibits CYP2D6 liver enzymes.

Simultaneous treatment with metabolic drugs thanks to this enzyme and narrow therapeutic index (for example, Flecainid, Encainid, Vinblastin, Carbamazepine and 3 -round antidepressants) must start or adjust these drugs at low doses. This also applies if Paroxetin was used within 1 week earlier.

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 to simultaneously use paroxetin with pimozid, because it can increase 2.5 times the pimozid concentration, increase the toxicity on the heart of pimozid, which can cause extension of QT.

thioridazin

Contraindications for coordination with Thioridazin, because it can increase the toxicity of thioridazin on the heart such as extending the QT, torsion, cardiac arrest.

Modified enzymes

Paroxetin metabolism and pharmacokinetics may be affected by the induction or inhibition of drug metabolic enzymes.

When paroxetin is used with drug metabolic inhibitors, the lowest dose of paroxetin. There is no need to adjust the starting dose when used with known drugs that have an enzyme induction effect (carbamazepin, rifampicin, phenobartbital, phenytoin) or with fosamprenavirl ritonavir.

Any dose adjustment (after the beginning of treatment or after stopping the enzyme induction), depending on the clinical effect (intake and effectiveness).

fosamprenavir/ritonavir

Used with Fosamprenavirl 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 the plasma concentration of paroxetin. Plasma concentrations of fosamprenavir/ritonavir when used with paroxetin are similar to the value in other studies, indicating that paroxetin does not affect the effect of fosamprenavir ritonavir.

There is no clinical data on the use of fosamprenavirl ritonavir with paroxetin for more than 10 days.

processin

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

anti -convulsions

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

Paroxetin's CYP2D6 inhibitor

As other antidepressants, including SSRIs, Paroxetin inhibit the liver's Cytochrom P450, the CYP2D6 enzyme. CYP2D6 inhibitor may increase the plasma concentration of shared drugs metabolized by these enzymes.

Including drugs: 3 -round antidepressants (Clomipramin, Nortriptylin, Despiramin), Phenothiazin sedative (perphenazin and thioridazin), Risperidon, Atomoxetin, 1C anti -arrhythmic drug (propafenon, flecainid) and Methoprolol. It is not recommended to use paroxetin with metoprolol in the treatment of heart failure, due to the narrow therapeutic index of Metoprolol in this case.

tamoxifen

Mobile pharmacokinetic interaction between CYP2D6 and Tamoxifen inhibitors, showing the plasma concentration of one of the activity metabolites of Tamoxifen (endoxifen) decreased by 65 - 75% in medical 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.

Alcoholic beverages (like alcohol)

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

anticoagulants

The pharmacological interaction between paroxetin 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 anticoagulants.

nsAIDS and Acetyl Salicylic Acid, and platelets anti -platelets

The pharmacological interaction between paroxetin and nsaids/acetyl salicylic acid may occur.

Paroxetin and NSAIDD/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, acetyl salicylic acid, NSAIDs, COX-2 inhibitors) as well as patients with a history of bleeding 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 or insulin.

A lot of 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.

Electrical shock therapy

There is no clinical research on combination of paroxetin and electric shock therapy.