Bluetine 20mg Bluepharma drugs treat severe depression, panic disorders, stress disorders after injury (6 blisters x 10 tablets)

ATC code: N06AB05

Paroxetin is a strong selective inhibitor for the reabsorption of 5-hydroxytryptamine (5-HT, serotonin), antidepressant and effective effects in the treatment of obsessive-upscase syndrome, social anxiety disorders, general anxiety disorders, stress after trauma and frightening disorders related to the inhibition of 5-H-HT reconciliation.

Paroxetin is not chemically related to the antidepressant three -round paroxetin with low affinity with the cholinergic muscarinic receptors, animal studies show weak cholinergic resistance. With this selective effect, invitro studies have been shown differently from three-round antidepressants, Paroxetinite has affinity with alpha receptors, Alpha 2 and Beta, dopamine (D2), histamine receptors (H1), similar 5-HT1 and 5-HT2. The utopian properties with the following receptors in in vitro studies are also clearly shown in in vivo studies: not inhibiting central nervous systems, not causing hypotension.

Pharmacokinetics

Absorb

Paroxetin is well absorbed after drinking, and undergoing the first metabolism. Due to the first metabolism, the amount of paroxetin goes into the circulatory system is less than the absorbed amount into the digestive tract. The first part of the metabolic effect and a decrease in plasma clearance occur when the amount of drug in the body increases due to an increase in single doses or doses. This increases the concentration of paroxetin in the plasma not in proportion, resulting in unstable pharmacokinetic parameters, and not linearly dynamic. However, non -linear properties are usually small and limited to patients with low plasma concentrations at low doses.

Stable concentration status is achieved after 7-14 days of using drugs with an instant release or slow release, and is not modified when long -term treatment.

Distribution

Paroxetin is widely distributed into tissues, pharmacokinetic calculations show that only about 1% of paroxetin in the body is present in plasma.

About 95% paroxetin binds protein at the concentration of treatment. The connection between Paroxetin's plasma is not found and clinical effect (efficiency and unwanted effect).

Biological metabolism

The main metabolites of paroxetin are polarized, combined products of oxidation and methylation are easy to reverse. These metabolites have no pharmacological properties, and do not contribute to the effectiveness of Paroxetin's treatment.

Elimination

less than 2% Paroxetin is excreted in the form of unchanged, about 64% in the form of metabolites. About 36% of the dose is excreted in feces, mainly through the bile, of which the unprocessed paroxetin accounts for about 1% of the dose. So paroxetin is eliminated mostly the metabolite.

The secretion of metabolites consists of 2 phases, the first phase is the result of the first metabolism, the next phase is the excretion of the whole body paroxin. The selling time changes a lot, but usually about 1 day. Special patient groups

Elderly and patients with liver/renal failure

Paroxetin's plasma concentration increases in the elderly and patients with severe renal failure or liver failure, but the concentration in these patients covers the concentration of healthy normal people.

Disorders of body and urinary tract

Overall, these unwanted effects are mild to medium, but in some patients it is severe and/or prolonged. Therefore, when there is no longer need to treat with paroxetin anymore, should reduce the dose gradually.

Notice immediately to the doctor or pharmacist unwanted effects when using the drug.

Be cautious when using

Pediatric patients

Do not use paroxetin to treat children and teenagers under 18 years old. Acts related to suicide (trying to commit suicide, suicide thoughts), and reversible (aggressive, anti -anger and anger) are often observed in clinical trials in children and teenagers treated with antidepressants compared to placebo. If according to clinical needs, it is necessary to use this medication for treatment, careful monitoring of the appearance of suicide symptoms. Moreover, there is still lack of long -term safety data in children who are concerned about development, maturity, consciousness and behavior.

Monoamin oxidase inhibitors (MAII)

Be careful when starting with paroxetin treatment after stopping using Maoi is not reversible for 2 weeks, and 24 hours for MAII to play in reverse. Paroxetin dose should be increased until the optimal response.

Tu Tu/ suicide or worse clinical manifestation

Depression combines an increased risk of suicide, self -harm and suicide (events related to suicide). This risk lasts until the disease is significantly reduced. The improvement may not occur for a few weeks to start treatment, maybe longer, so the patient should be closely monitored until the situation is improved. Clinical experience shows that suicide can increase in the beginning of recovery.

Other mental illnesses that are indicated to use paroxetin are also at risk of increasing suicide events. Moreover, these diseases can occur simultaneously with the main period of depression. The position when treating patients at the stage of the main depression disorder, it is necessary to monitor if the patient has other mental disorders.

Patients with a history of suicidal events, or patients who have suicide before treatment will have a higher risk of suicide, so strict control should be controlled during the treatment period. A comprehensive analysis of clinical studies antidepressant drugs with placebo, showing an increase in suicide behavior in the group using antidepressants compared to the placebo group in patients under 25 years old.

Strict patient control, especially patients at high risk, during the special treatment period in the early stages and when changing the dose. Patient (and patient) should be warned of the need to control deteriorating clinical manifestations, suicide or suicide intent, or abnormal changes in personality, and should find the advice of a physician as soon as these symptoms.

Sitting restlessly

Using paroxetin is related to restless sitting, manifested by the feeling of not resting and mental agitation as unable to sit still or stand still. This usually occurs in the first few weeks of treatment. For patients with these symptoms, increasing the dose may be harmful. The automatic instability/ mental syndrome of the schizophrenia is rare in the case of automatic instability and the schizophrenia syndrome when treated with paroxetin, especially when combined with other serotonergic or other schizophrenia. Because these symptoms can be life -threatening, paroxetin and supportive treatment must be stopped when these symptoms occur (characterized by symptoms such as fever, convulsions, muscle vibration, automatic instability, vibrating signs of life, changing nerve status including vague, stimulation, agitation leading to coma and delusion). Paroxetin combination should not be used with pre-serotonin precursors (such as l-tryptophan, oxitriptan) due to the risk of serotonin syndrome.

Heart

Like all other antidepressants, paroxetin should be used in patients with a history of manic. Paroxetin should be stopped if the patient entered Pha Hung Cam.

Hepatic/Kidney failure

Caution recommendations in patients with severe renal impairment or patients with hepatic impairment.

diabetes

Serotonin selective reabsorption inhibitors can change blood sugar control. The insulin and/or anti -diabetic drugs may be adjusted. Moreover, there have been studies on hyperglycemia when using simultaneously paroxetin and pravastatin.

Dong Kinh

Like other antidepressants, should be cautious when using paroxetin for epilepsy patients.

convulsions

In patients treated with paroxetin, the convulsions are 0.1%. Should stop taking the drug when the patient has convulsions.

glaucoma

As well as other serotonin reconstruction inhibitors, paroxetin can cause pupils, so be careful when taking this medication for patients with closed angle pluis or a history of glaucoma.Heart disease

Should be careful to monitor heart patients.

Hypoglyc sodium

There are reports on sodium hypoglycemia but rare, clearly manifested in the elderly. Be careful when taking this medication for patients at risk of sodium hypoglycemia, for example, taking other drugs and cirrhosis. Sodium hypoglycemia will usually end when stopping Paroxetin.

Bleeding

There have been reports on abnormal bleeding under the stomach such as hematoma or hemorrhagic rash using Serotonin reconfacelation inhibitors. There are also reports on other hemorrhage manifestations such as gastrointestinal bleeding. Elderly patients are at higher risk.

Should be cautious in patients with simultaneous use of Serotonin Selective Inhibitors with oral anticoagulant drugs, which affect platelet function, or simultaneous use with drugs that increase the risk of bleeding (for example, mental drugs such as clozapin, phenothiazine, most three-ring antidepressants, acetylsalicylic acid, antitoxic drugs, COX-2) Patients with bleeding history.

Interaction with tamoxifen

Paroxetin, which is a strong CYP2D6 inhibitor, can reduce endoxifen levels, one of the most important metabolites of Tamoxifen. Therefore, if possible, avoid using paroxetin during Tamoxifen treatment.

Symptoms of cessation may occur when discontinued with paroxetin.

The effect of drugs on driving and operating machinery

Paroxetin has no influence, or negligible effect on driving and operating machinery.

Clinical experience shows that paroxetin treatment is not related to cognitive decline or mental function. However, like all mental medicine, should note that patients about the ability to drive and operate machinery. Although paroxetin does not increase the effects of alcohol in reducing mental skills and movement, it is recommended not to use paroxetin along with alcohol.

Use drugs for women during pregnancy and lactation

Animal figures show that Paroxetinc can affect sperm quality. In vitro figures also show that it affects the quality of human sperm. However, reports on Serotonin selective reabsorption inhibitors (including Paroxe- Tin) shows the effect on the quality of the human sperm is reversible. Not monitored on the impact on conception in humans.

Pregnant women

Epidemiological studies propose the risk of birth defects, especially cardiovascular (for example, atrial and ventricular disability) when using paroxetin for the first three months of pregnancy. Unknown mechanism. The data shows that the proportion of children with cardiovascular disability is 2/100 when the mother uses paroxetin, compared to the normal rate of about 1/100.

Only use paroxetin during pregnancy when there is a strict indication. A single physician should consider choosing an alternative treatment when the patient is pregnant or has a pregnancy plan.

Avoid stopping the drug suddenly during pregnancy.

Should monitor babies if paroxetin is used continuously until the later stage of pregnancy, especially in the last three months.

The following symptoms can occur for babies when mothers use paroxetin in the later stage of pregnancy: acute respiratory failure, cyanosis, apnea, seizures, unstable body temperature, difficulty feeding, vomiting, hypoglycemia, hypertension, reducing reflexes, tremor, stimulation, sleep, crying continuously, sleeping, sleeping, sleeping hard. These symptoms are caused by both serotonergic effects and smoking symptoms. Most of these complications often appear early (

Epidemiological data proposed on the use of Serotonin selective reabsorption inhibitors during pregnancy, especially in the final stage, may increase the risk of prolonged pulmonary hypertension in infants, about 5/1000, compared to normal ratio of 1 - 2/1000.

breastfeeding women

Small amount of paroxetin is secreted into breast milk. According to published studies, serum concentration in breastfed babies is not detected (

Drug interaction

Other serotonergic drugs

As well as other Serotonin reconfacelon inhibitors, simultaneously used with serotonergic drugs will increase the effect on 5-HT.

Recommendations should be cautious and closely monitored when using paroxetin simultaneously with serotonergic drugs (such as l-tryptophan, triptan, tramadol, linezolid, methylthionin chloride (green methylene), Serotonin, Lithidin, Pethidin and Hyperumum-containing preparations Perforatum). Contraindicated to use paroxetin simultaneously with Maoi due to the risk of serotonin syndrome.

pravastatin

Resistance from studies and interactions between paroxetin and pravastatin may increase blood sugar levels. Patients with diabetes use both paroxetin and pravastatin vows to adjust the dose of anti -diabetic drugs in oral and/or insulin.

pimozid

Pimozid concentration increased by an average of 2.5 times in a low -dose pimozide study (2 mg) combined with 60 mg of paroxetin. This can be explained by CYP2D6 inhibitors of Paroxetin. Because Pimozid has narrow treatment indicators and can extend the qt segment, contraindicated use simultaneously pimozid and paroxetin.

Drug metabolic enzymes

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

When using paroxetin simultaneously with an enzyme inhibitor, should consider using low -dose paroxetin.

No need to adjust the starting dose of paroxetin when combined with metabolic enzyme induction drugs (for example, carbamazepin, rifampicin, phenobarbital, phenytoin) or combined with fosampre-naviritonavir. Paroxetin dose should be adjusted according to tolerance and clinical effect (at the beginning and at the end of the metabolic enzyme drug).

fosamprenavir/ritonavir

Use Fosamprenavir/Ritonavir 700/100 mg twice daily in combination with Paroxetin 20 mg/day in healthy volunteers for 10 days: Paroxetin plasma concentration is significantly reduced, about 55%. The plasma concentration of fosamprenavir/ritonavir when used in combination with paroxetin is similar to the reference values ​​from other studies, this shows that Paroxetin does not significantly affect the metabolism of Fosamprenavir/Ritonavir. There is no data on the effects of paroxetin and fosamprenavir/ri-tonavir when used in combination lasting over 10 days.

Procyclidin

Use paroxetin every day significantly increasing the plasma concentration of processes. If you see the anti -cholinergic effect, the dose of processes should be reduced.

Anti -seizure drugs

carbamazepin, phenytoin, sodium valproate: simultaneously used with paroxetin does not affect pharmacokinetics/ pharmacokinetics in epilepsy patients.

Paroxetin's CYP2D6 inhibitor

as well as other antidepressants, including Serotonin Selective Restrain Inhibitors, Paroxetin inhibits the P450 CYP2D6 enzyme. CYP2D6 inhibitors may increase the plasma concentration of medications that metabolize through this enzyme when bravely combined with paroxetin. These drugs include three -round antidepressants (e.g. clomipramin, nortriptylin and desipramin), phenothiazin sedatives (e.g. perphenazin and thioridazin), risperidon, atomoxetin, some anti -rhythmic drugs type 1C (force of propafenon and flecainid) and methyrolol. It is recommended not to combine paroxetin with metoprolol for heart failure, because Metoprolol has a very narrow indication for this disease.

Mobile pharmacokinetic interaction between CYP2D6 and Tamoxifen inhibitors has been reported in the literature: decreasing 65-75% of the plasma concentration of endoxifen, one of the active metabolites of Tamoxifen. Tamoxifen's effectiveness has also been reduced in several other studies when used in combination with Serotonin recovery inhibitors. Because it is not possible to eliminate the effect of tamoxifen, if possible, avoid combining with strong inhibitors on CYP2D6 (including paroxetin).

deer

Like other mental medications, it is recommended that patients avoid drinking alcohol when using paroxetin.

Oral anti -dynamic drugs

There may be an interactive pharmacological interaction between paroxetin and oral anticoagulant drugs. Using Paroxetin at the same time with oral anticoagulant drugs can increase blood coagulation activity and increase the risk of bleeding. Therefore, be careful when using paroxetin for patients treated with oral anticoagulant drugs.

Thuan Hana Inflammation of non -steroid inflammation (NSAIDS), Acetylcylic acid and other anti -plateletic drugs.

There may be pharmacological interaction between paroxetin and nonsteroidal anti -inflammatory drugs, acetylsalicylic acid. Using paroxetin and NSAIDs/ acetylsalicylic acid may increase the risk of bleeding. Should be cautious in patients with simultaneous use of Serotonin Selective Inhibitors with oral anticoagulant drugs, are drugs that affect platelet function, or simultaneous use with drugs that increase the risk of bleeding (for example, mental drugs such as clozapin, phenothiazine, most three-round antidepressants, acetylsalicylic acid, non-physi acety History of bleeding.

neurotransmitter inhibitors: Paroxetin can reduce cholinesterase activity in plasma, prolonging the effects of Mivacurium, Suxamethonium.