Oral
Major depressive disorder
Adult: As paroxetine hydrochloride/mesilate conventional tab; oral susp: 20 mg daily. Dose may be gradually increased in 10 mg increments at intervals of at least 1 week if response is inadequate. Max: 50 mg daily. As paroxetine hydrochloride modified-release tab: Initially, 25 mg daily, may be increased in 12.5 mg daily increments at intervals of at least 1 week according to individual response. Max: 62.5 mg daily. All doses are given as a single daily dose preferably in the morning.
Elderly: As paroxetine hydrochloride/mesilate conventional tab; oral susp: Max: 40 mg daily. As paroxetine hydrochloride modified-release tab: Initially, 12.5 mg daily, may be increased up to 50 mg daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
Severe (<30) | Use the lower end of the dosage range. |
Oral
Obsessive compulsive disorder
Adult: As paroxetine hydrochloride/mesilate conventional tab; oral susp: Initially, 20 mg daily preferably in the morning, may be gradually increased in 10 mg increments at intervals of at least 1 week according to individual response. Usual maintenance: 40 mg daily. Max: 60 mg daily.
Elderly: As paroxetine hydrochloride/mesilate conventional tab; oral susp: Max: 40 mg daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
Severe (<30 ) | Use the lower end of the dosage range. |
Oral
Panic disorder with or without agoraphobia
Adult: As paroxetine hydrochloride/mesilate conventional tab; oral susp: Initially, 10 mg daily, may be gradually increased in 10 mg increments at intervals of at least 1 week according to individual response. Recommended maintenance: 40 mg daily. Max: 60 mg daily. As paroxetine hydrochloride modified-release tab: Initially, 12.5 mg daily, may be increased in 12.5 mg daily increments at intervals of at least 1 week according to individual response. Max: 75 mg daily. All doses are given as a single daily dose preferably in the morning.
Elderly: As paroxetine hydrochloride/mesilate conventional tab; oral susp: Max: 40 mg daily. As paroxetine hydrochloride modified-release tab: Initially, 12.5 mg daily, may be increased up to 50 mg daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
Severe (<30) | Use the lower end of the dosage range. |
Oral
Social anxiety disorder
Adult: As paroxetine hydrochloride conventional tab/oral susp: 20 mg daily. Dose may be gradually increased in 10 mg increments if response is inadequate. Max: 50 mg or 60 mg daily. As paroxetine hydrochloride modified-release tab: Initially, 12.5 mg daily, may be increased in 12.5 mg daily increments at intervals of at least 1 week according to individual response. Max: 37.5 mg daily. All doses are given as a single daily dose preferably in the morning.
Elderly: As paroxetine hydrochloride conventional tab/oral susp: Max: 40 mg daily. As paroxetine hydrochloride modified-release tab: Initially, 12.5 mg daily, may be increased up to 37.5 mg daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
Severe (<30) | Use the lower end of the dosage range. |
Oral
Generalised anxiety disorder
Adult: As paroxetine hydrochloride/mesilate conventional tab; oral susp: 20 mg daily preferably in the morning. Dose may be gradually increased in 10 mg increments at intervals of at least 1 week if response is inadequate. Max: 50 mg daily.
Elderly: As paroxetine hydrochloride/mesilate conventional tab; oral susp: Max: 40 mg daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
Severe (<30) | Use the lower end of the dosage range. |
Oral
Posttraumatic stress disorder
Adult: As paroxetine hydrochloride conventional tab/oral susp: Initially, 20 mg daily preferably in the morning, may be gradually increased in 10 mg increments at intervals of at least 1 week according to individual response. Max: 50 mg daily.
Elderly: As paroxetine hydrochloride conventional tab/oral susp: Max: 40 mg daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
Severe (<30) | Use the lower end of the dosage range. |
Oral
Premenstrual dysphoric disorder
Adult: As paroxetine hydrochloride modified-release tab: Initially, 12.5 mg once daily preferably in the morning, may be increased to 25 mg once daily after an interval of at least 1 week if necessary. Doses may be given either continuously (daily throughout the menstrual cycle) or intermittently (during the luteal phase of the menstrual cycle).
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
Severe (<30) | Use the lower end of the dosage range. |
Oral
Moderate to severe vasomotor symptoms associated with menopause
Adult: As paroxetine mesilate cap: 7.5 mg once daily preferably at bedtime.
Special Populations: Pharmacogenomics: Paroxetine is extensively metabolised by CYP2D6 isoenzyme to form glucuronide or sulfate conjugates. CYP2D6 polymorphisms may influence the metabolism, clinical efficacy, and safety of paroxetine. CYP2D6 allele frequencies among individuals of different populations and ethnic backgrounds may be a considering factor that may cause potential uncertainty in genotyping and phenotype predictions. For example, CYP2D6*10 is common in Asians and CYP2D6*17 is common in people of Sub-Saharan African ancestry, while these alleles have considerably lower prevalence in other ethnic groups such as Caucasians of European ancestry. Moreover, Asian populations were also found to carry CYP2D6*14A allele. Thus, the alleles that should be tested may considerably vary for a given population. CYP2D6 ultrarapid metabolisers Carriers of duplications of functional alleles e.g. *1/*1xN, *1/*2xN, *2/*2xN. May have increased paroxetine metabolism as compared with extensive metabolisers, resulting in lower or undetectable plasma levels and increased risk of pharmacotherapy failure. Clinical Pharmacogenetics Implementation Consortium (CPIC) recommends selecting an alternative drug not primarily metabolised or to a lesser extent by CYP2D6 (e.g. citalopram, sertraline). CYP2D6 extensive metabolisers Carriers of 2 normal function alleles, or 2 decreased function alleles, or 1 normal function and 1 no function allele, or 1 normal function and 1 decreased function allele e.g. *1/*1, *1/*2, *1/*4, *1/*5, *1/*9, *1/*41, *2/*2, *41/*41. May have normal paroxetine metabolism. CPIC recommends initiating treatment with the recommended starting dose. CYP2D6 intermediate metabolisers Carriers of 1 decreased function and 1 no function allele e.g. *4/*10, *4/*41, *5/*9. May have reduced paroxetine metabolism as compared with extensive metabolisers, resulting in higher plasma concentrations and increased risk of adverse effects (e.g. insomnia, headache, sexual or gastrointestinal dysfunction). However, CPIC considers initiating treatment with the recommended starting dose. CYP2D6 poor metabolisers Carriers of no functional alleles e.g. *3/*4, *4/*4, *5/*5, *5/*6. May have greatly reduced paroxetine metabolism as compared with extensive metabolisers, resulting in higher plasma concentrations and increased risk of adverse effects (e.g. insomnia, headache, sexual or gastrointestinal dysfunction). CPIC recommends selecting an alternative drug not primarily metabolised by CYP2D6 (e.g. citalopram, sertraline). If paroxetine use is warranted, may consider 50% dose reduction of the recommended initial dose and titrate according to response.