Paxil (Paroxetine Hydrochloride) Drug Information: Side

The role of this enzyme in paroxetine metabolism also suggests potential drug-drug interactions (see precautions). Approximately 64 of a 30-mg oral solution dose of paroxetine was excreted in the urine with 2 as the parent compound and 62 as metabolites over a 10-day post-dosing period.The metabolism of paroxetine is accomplished in part by CYP2D6. Saturation of this enzyme at clinical doses appears to account for the nonlinearity of paroxetine kinetics with increasing dose and increasing duration of treatment.Under clinical conditions, paroxetine concentrations would normally be less than 400 ng/mL. Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin. Metabolism and Excretion The mean elimination half-life is approximately 21 hours (CV 32) after oral dosing of 30 mg tablets daily for 30 days of paxil.Because the relative potencies of paroxetines major metabolites are at most 1/50 of the parent compound, they are essentially inactive. Pharmacokinetics, paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt.Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, flavorings, FD C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha 1, alpha 2, beta-adrenergic-, dopamine (D 2 )-, 5-HT 1, 5-HT 2, and histamine (H 1 )-receptors; antagonism of muscarinic, histaminergic, and alpha 1 -adrenergic receptors has been associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs.

Paxil (paroxetine hydrochloride) Tablets and Oral Suspension

Paroxetine - m Prescription Drug Information

Clinical Trials Major Depressive Disorder The efficacy of paxil as a treatment for major depressive disorder has been established in 6 placebo-controlled studies of patients with major depressive disorder (aged 18 to 73).Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake.Nonlinearity in pharmacokinetics is observed with increasing doses. Paroxetine metabolism is mediated in part by CYP2D6, and the metabolites are primarily excreted in the urine and to some extent in the feces.Tablets. Each film-coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mgyellow (scored 20 mgpink (scored 30 mgblue, 40 mggreen. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D C Red No. 30Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake.Pharmacodynamics, the efficacy of paroxetine in the treatment of major depressive disorder, social anxiety disorder, obsessive compulsive disorder (OCD panic disorder (PD generalized anxiety disorder (GAD and posttraumatic stress disorder (ptsd) is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine.

Paroxetine - Wikipedia, the free encyclopedia

The effects of food on the bioavailability of paroxetine were studied in subjects administered a single dose with and without food. AUC was only slightly increased (6) when drug was administered with food but the C max was 29 greater, while the time to reach peak plasma concentration decreased from 6.4 hours post-dosing to 4.9 hours.Steady-state drug exposure based on AUC 0-24 was about 8 times greater than would have been predicted from single-dose data in these subjects. The excess accumulation is a consequence of the fact that 1 of the enzymes that metabolizes paroxetine is readily saturable.About 36 was excreted in the feces (probably via the bile mostly as metabolites and less than 1 as the parent compound over the 10-day post-dosing period. Other Clinical Pharmacology Information Specific Populations Renal and Liver Disease Increased plasma concentrations of paroxetine occur in subjects with renal and hepatic impairment.In steady-state dose proportionality studies involving elderly and nonelderly patients, at doses of 20 mg to 40 mg daily for the elderly and 20 mg to 50 mg daily for the nonelderly, some nonlinearity was observed in both populations, again reflecting a saturable metabolic pathway.Pharmacokinetic behavior of paroxetine has not been evaluated in subjects who are deficient in CYP2D6 (poor metabolizers). Absorption and Distribution. Paroxetine is equally bioavailable from the oral suspension and tablet. Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt.Therefore the initial dosage in the elderly should be reduced (see dosage AND administration). Drug-Drug Interactions In vitro drug interaction studies reveal that paroxetine inhibits CYP2D6. Clinical drug interaction studies have been performed with substrates of CYP2D6 and show that paroxetine can inhibit the metabolism of drugs metabolized by CYP2D6 including desipramine, risperidone, and atomoxetine.

Paroxetine HCl Oral : Uses, Side Effects, Interactions


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