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Paxil

Paxil
Paxil is used for the treatment of depression or obsessive convulsive disorder. It can be used for the treatment of panic disorder or post traumatic stress disorder (PTSD) and other cases defined by the doctor.

Brand: Paroxetine

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: June 2024
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Paxil 40 mg
180 pills - 40 mg
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$243.53 $1.35 $164.41 Add to cart
120 pills - 40 mg
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$181.97 $1.52 $89.99 Add to cart
90 pills - 40 mg
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60 pills - 40 mg
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$107.95 $1.80 $28.03 Add to cart
30 pills - 40 mg $67.99 $2.27 No Add to cart
Paxil 30 mg
270 pills - 30 mg
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$261.95 $0.97 $259.96 Add to cart
180 pills - 30 mg
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$185.91 $1.03 $162.03 Add to cart
120 pills - 30 mg
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$139.93 $1.17 $92.03 Add to cart
90 pills - 30 mg
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$115.95 $1.29 $58.02 Add to cart
60 pills - 30 mg $91.95 $1.53 $24.03 Add to cart
30 pills - 30 mg $57.99 $1.93 No Add to cart
Paxil 20 mg
270 pills - 20 mg
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$235.55 $0.87 $178.36 Add to cart
180 pills - 20 mg
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120 pills - 20 mg
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$129.97 $1.08 $53.99 Add to cart
90 pills - 20 mg
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$108.95 $1.21 $29.02 Add to cart
60 pills - 20 mg $77.95 $1.30 $14.03 Add to cart
30 pills - 20 mg $45.99 $1.53 No Add to cart
Paxil 10 mg
270 pills - 10 mg
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$169.93 $0.63 $153.98 Add to cart
180 pills - 10 mg
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$124.97 $0.69 $90.97 Add to cart
120 pills - 10 mg $94.95 $0.79 $49.01 Add to cart
90 pills - 10 mg $78.95 $0.88 $29.02 Add to cart
60 pills - 10 mg $56.93 $0.95 $15.05 Add to cart
30 pills - 10 mg $35.99 $1.20 No Add to cart

Product description

Drug title

Paxil (Paroxetine)

Pharmacological action

Mechanism of action


Paxil (Paroxetine) is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) reuptake. Its antidepressant activity and effectiveness in treating obsessive-compulsive disorder (OCD) and panic disorder are believed to be due to specific inhibition of 5-NT reuptake in brain neurons.


Paxil (Paroxetine) differs chemically from tricyclic, tetracyclic, and other known antidepressants.


Paxil (Paroxetine) is characterized by low affinity for muscarinic cholinergic receptors, and animal studies have shown that it has only weak anticholinergic properties.


Consistent with this selective action, paroxetine has been shown in in vitro studies to have little affinity for α1, α2 and β-adrenoreceptors as well as dopamine (D2), 5-HT1-like, 5-HT2 and histamine (H1) receptors in contrast to tricyclic antidepressants. The absence of interaction with postsynaptic receptors in vitro is confirmed by the results of in vivo studies, which show that paroxetine neither suppresses CNS nor causes arterial hypotension.


Pharmacodynamic properties


Paxil (Paroxetine) does not impair psychomotor function or enhance the CNS depressant effect of ethanol.


Like other selective 5-NT reuptake inhibitors, paroxetine causes symptoms of overstimulation of 5-NT receptors when administered to animals that have previously received MAO inhibitors or tryptophan.


In behavioral and EEG assessment studies, paroxetine has been shown to cause weak activating effects at doses higher than those required to inhibit 5-NT reuptake. Its activating properties are not amphetamine-like in nature.


Good cardiovascular tolerance has been shown in animal studies.


After use in healthy individuals, paroxetine does not cause clinically significant changes in BP, HR and ECG.


Studies have shown that, unlike antidepressants that inhibit norepinephrine reuptake, paroxetine has much less ability to inhibit the antihypertensive properties of guanethidine.


Pharmacokinetics

Absorption


After oral administration, paroxetine is well absorbed and undergoes "first pass" metabolism.


Due to "first pass" metabolism, a smaller amount of paroxetine enters the systemic bloodstream than is absorbed from the gastrointestinal tract. As the amount of paroxetine in the body increases with a single high-dose administration or with multiple conventional doses, there is partial saturation of the first-pass metabolic pathway and a decrease in the clearance of paroxetine from plasma. This results in a disproportionate increase in plasma concentrations of paroxetine. Therefore, its pharmacokinetic parameters are not stable, a consequence of which is nonlinear kinetics. However, the nonlinearity of kinetics is usually weak and is observed only in those patients in whom low plasma levels of paroxetine are achieved at low doses of the drug. Equilibrium plasma concentrations are reached 7-14 days after initiation of paroxetine treatment. Its pharmacokinetic parameters are unlikely to change during long-term therapy.


Distribution


Paroxetine is widely distributed in tissues, and pharmacokinetic calculations indicate that only 1% of the total amount of paroxetine present in the plasma remains. At therapeutic concentrations, approximately 95% of plasma paroxetine is bound to proteins.


No correlation has been found between paroxetine plasma concentrations and its clinical effects (i.e., adverse reactions and efficacy).


Metabolism

The major metabolites of paroxetine are polar and conjugated oxidation and methylation products, which are readily eliminated from the body. Because of the practical absence of pharmacological activity of these metabolites, their contribution to the therapeutic properties of paroxetine is unlikely.

Metabolism does not limit the ability of paroxetine to act selectively against 5-HT reuptake in neurons.

Excretion

Less than 2% of the dose of paroxetine taken is excreted unchanged in the urine, whereas metabolite excretion reaches 64% of the dose. About 36% of the dose is excreted in the feces, probably ingested with the bile; less than 1% of the dose is excreted unchanged in the feces. Thus, paroxetine is eliminated almost entirely by metabolism.

The excretion of metabolites is biphasic: first, it is the result of "first-pass" metabolism, then it is controlled by the systemic elimination of paroxetine.

The T1/2 of paroxetine varies, but is usually about 24 hours.

Pharmacokinetics in special patient groups

In elderly patients, patients with severe renal or hepatic impairment, plasma concentrations of paroxetine may increase, but the range of its plasma concentrations is the same as in healthy adults.


Contraindications to use

  • Hypersensitivity to paroxetine and any other component of the drug;
  • in combination with MAO inhibitors. In exceptional cases, linezolid (an antibiotic that is a reversible non-selective MAO inhibitor) may be combined with paroxetine, provided that acceptable alternatives to linezolid treatment are not available and the potential benefit of linezolid exceeds the risks of serotonin syndrome or malignant neuroleptic syndrome as a reaction in a particular patient. Equipment must be available for close monitoring of serotonin syndrome symptoms and BP monitoring.Treatment with paroxetine is allowed:                                                                                                                 - 2 weeks after discontinuation of treatment with irreversible IMAOs;                                                                               - at least 24 hours after stopping treatment with reversible MAOI inhibitors (e.g., moclobemide, linezolid,                              methylthionine chloride (methylene blue));                                                                                                                 - at least 1 week should pass between discontinuation of paroxetine and initiation of therapy with any MAOI inhibitor;
  • in combination with thioridazine because, like other drugs that inhibit hepatic CYP2D6 isoenzyme activity, paroxetine may increase plasma concentrations of thioridazine. This may lead to prolongation of the QTc interval and development of associated ventricular pirouette arrhythmia and sudden death;
  • Combined use with pimozide;
  • childhood and adolescence under 18 years of age. Controlled clinical trials of paroxetine in the treatment of moderate to severe depressive episodes and recurrent depressive disorder in children and adolescents have not proven its effectiveness, so paroxetine is not indicated for the treatment of this age group. Safety and efficacy of paroxetine have not been studied for use in younger patients (less than 7 years of age).

Application in pregnancy and lactation

Fertility


According to animal studies, paroxetine may affect sperm quality characteristics. Data from in vitro human studies may indicate some effects on semen quality characteristics, but in reported cases of human use of some SSRIs (including paroxetine) it has been shown that the effects on semen quality characteristics were reversible.


To date, no effects on human fertility have been observed.


Pregnancy


Animal studies have shown no teratogenic or selective embryotoxic activity with paroxetine.


Epidemiological studies of pregnancy outcomes while taking antidepressants in the first trimester have found an increased risk of congenital anomalies, particularly cardiovascular (e.g., interventricular and interatrial septal defects), associated with paroxetine administration. The reported incidence of cardiovascular defects with paroxetine use during pregnancy is approximately 1/50, while the expected incidence of such defects in the general population is approximately 1/100 of newborns.


When prescribing paroxetine, the physician should consider alternative treatment in pregnant and planning women. Paroxetine should be prescribed only if the potential benefit exceeds the possible risk. If the decision is made to discontinue treatment with paroxetine during pregnancy, the physician should follow the recommendations in the Dosing Regimen and Special Instructions sections.


Preterm births have been reported in women who received paroxetine or other SSRIs during pregnancy, although a causal relationship between taking these drugs and preterm births has not been established.


The health of newborns whose mothers took paroxetine during late pregnancy should be closely monitored, as there have been reports of neonatal complications associated with the use of paroxetine or other SSRIs in the third trimester of pregnancy. However, a causal relationship between these complications and this drug therapy has not been confirmed. Described clinical complications included: respiratory distress syndrome, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, arterial hypertension, arterial hypotension, hyperreflexia, tremor, increased neuroreflexivity syndrome, irritability, lethargy, persistent crying, and sleepiness. Some reports have described the symptoms as neonatal manifestations of withdrawal syndrome. In most cases, the described complications occurred immediately after delivery or shortly thereafter (<24 h).


According to epidemiological studies, taking SSRIs (including paroxetine) during pregnancy, especially in the late term, is associated with an increased risk of persistent pulmonary hypertension in newborns. The increased risk observed in children born to mothers who took SSRIs in late pregnancy is 4-5 times greater than that observed in the general population (1-2 per 1,000 pregnancies). The results of animal studies showed reproductive toxicity of the drug, but no direct adverse effects on pregnancy, embryo and fetal development, labor or postnatal development were shown.


Breastfeeding period


Minor amounts of paroxetine penetrate into breast milk. In published studies in breastfed infants, paroxetine concentrations were undetectable (<2 ng/mL) or very low (<4 ng/mL). No evidence of drug exposure was detected in children. However, paroxetine should not be taken during breastfeeding unless the benefit to the mother exceeds the potential risk to the baby.

Use in impaired hepatic function

In patients with significant hepatic impairment, the drug dose should be reduced to the lower limit of the dose range.

Administration in impaired renal function

In patients with significant renal impairment (CKD less than 30 ml/min) the drug dose should be reduced to the lower limit of the dose range.

Administration in children

Administration in children and adolescents under 18 years old is contraindicated.


Administration in elderly patients

In elderly patients, treatment should be started from the adult dose and further the dose can be increased to 40 mg/day.

Indications for Paxil (Paroxetine)

Depressive episodes of moderate to severe severity


Recurrent depressive disorder


Studies in which patients have taken paroxetine for up to 1 year show that it is effective in preventing relapses and the return of depressive symptoms.


Obsessive-compulsive disorder


Paroxetine is effective in the treatment of obsessive-compulsive disorder (OCD), including as maintenance and preventive therapy.


According to placebo-controlled studies, paroxetine's effectiveness in treating OCD was maintained for at least 1 year. In addition, paroxetine is effective in preventing relapses of OCD.


Panic disorder.


Paroxetine is effective in the treatment of panic disorder with and without agoraphobia, including as maintenance and preventive therapy.


The combination of paroxetine and cognitive-behavioral therapy was found to be significantly more effective in treating panic disorder than cognitive-behavioral therapy alone.


According to placebo-controlled studies, the efficacy of paroxetine in treating panic disorder was maintained for more than 1 year. In addition, paroxetine is effective in preventing recurrences of panic disorder.


Social phobia


Paroxetine is effective in the treatment of social phobia, including as long-term maintenance and preventive therapy. The continued efficacy of paroxetine in the long-term treatment of social phobia has been demonstrated in a relapse prevention study.


Generalized anxiety disorder


Paroxetine is effective in the treatment of generalized anxiety disorder, including as long-term maintenance and prophylactic therapy.


The continued efficacy of paroxetine in the long-term treatment of generalized anxiety disorder has been demonstrated in a relapse prevention study.


Post-traumatic stress disorder


Paroxetine is effective in the treatment of post-traumatic stress disorder.


Dosing regimen

It is recommended to take the drug once a day in the morning with meals. The tablet should be swallowed whole without chewing. The applied risk allows dividing the tablet in half, if necessary, to obtain a dose of 10 mg.


Moderate to severe depressive episodes and recurrent depressive disorder


The recommended dose is 20 mg/day. If necessary, the dose may be increased in increments of 10 mg/day to a maximum dose of 50 mg/day, depending on clinical response. As with any antidepressant treatment, the efficacy of therapy should be evaluated and, if necessary, the dose of Paxil® should be adjusted 2-3 weeks after the start of treatment and thereafter, depending on clinical indications.


Patients with depression should be treated for a sufficient period of time to achieve an asymptomatic state. This period may be several months.


Obsessive-compulsive disorder (OCD)


The recommended dose is 40 mg/day. Patients should begin treatment with a dose of 20 mg/day, which may be increased weekly by 10 mg/day. If necessary, the dose may be increased to a maximum dose of 60 mg/day.


Patients with OCD should be treated for a sufficient period of time to achieve an asymptomatic state. This period may be several months.


Panic disorder.


The recommended dose is 40 mg/day. Patients should begin treatment with a dose of 10 mg/day, which may be increased weekly by 10 mg/day depending on clinical response. If necessary, the dose may be increased to a maximum dose of 60 mg/day.


A low starting dose is recommended to minimize the possible exacerbation of panic disorder symptoms that may occur at the beginning of treatment for this disorder.


Patients with panic disorder should be treated for a sufficient period of time to achieve an asymptomatic state. This period may be several months or longer.


Social Phobia.


The recommended dose is 20 mg/day. If necessary, patients who do not respond with 20 mg/day may have the dose increased in increments of 10 mg/day to a maximum dose of 50 mg/day depending on clinical response.


Generalized anxiety disorder.


The recommended dose is 20 mg/day. If necessary, the dose may be increased in increments of 10 mg/day to a maximum dose of 50 mg/day depending on clinical response.


Post-traumatic stress disorder


The recommended dose is 20 mg/day. If necessary, the dose may be increased in 10 mg increments to a maximum dose of 50 mg/day depending on clinical response.


Withdrawal of paroxetine


As with treatment with other psychotropic drugs, abrupt withdrawal of Paxil® should be avoided. The gradual dose reduction scheme used in recent clinical trials was to reduce the daily dose by 10 mg/week. After reaching a dose of 20 mg/day, patients continued to take this dose for 1 week, and only then was the drug withdrawn completely. If withdrawal symptoms develop during dose reduction or after withdrawal of the drug, it is reasonable to resume the previously prescribed dose. Subsequently, the physician may continue to reduce the dose, but at a slower pace.


Special patient groups


Plasma concentrations of paroxetine may increase in elderly patients, but the range of plasma concentrations is the same as in younger patients. In this group of patients, therapy should be started with the dose recommended for adults, which may be increased to 40 mg/day.


Plasma concentrations of paroxetine are increased in patients with severe renal impairment (CKR less than 30 ml/min) or in patients with impaired liver function. Therefore, in such patients, the drug doses should be prescribed at the lower limit of the therapeutic dose range.


Paroxetine use in children and adolescents (under 18 years) is contraindicated.