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PARoxetine

PARoxetine

Drug Name	Form	Strength	Non-Formulary	Restricted	TX Sub	Notes
Paxil	TABLET, ORAL	10 mg; 20 mg

Display Selective Serotonin Reuptake Inhibitors Class : 28160420

Medication comments:

Per policy, orders for these non-formulary agents will be changed to formulary equivalents.
Non-Formulary Agent	Formulary Equivalent
PARoxetine CR (Paxil CR) 12.5 mg daily	PARoxetine (Paxil) 10 mg daily
PARoxetine CR (Paxil CR) 25 mg daily	PARoxetine (Paxil) 20 mg daily
PARoxetine CR (Paxil CR) 37.5 mg daily	PARoxetine (Paxil) 30 mg daily

USP <800> Hazardous Drug Assessment of Risk (AOR)
Per policy, these drugs are exempt from USP <800> handling requirements under normal circumstances. The following outlines must be followed.
generic (Brand) Route [Packaging: Manufacturer ⇒ Dispense]	Activities
PARoxetine (Paxil) PO [UD ⇒ UD]	10 mg tablet 20 mg tablet	Stock @ IDBH? Y NIOSH Table 2^B↑
Pharmacy: Receiving / Storage / Preparation Exposure Risk: minimal	• Handling/preparation PPE Requirements: n/a
	• Receiving from Distributor: Standard
	• Pharmacy Storage Area: Carousel
	• Packaging/Reconstitution Location: n/a
	• Compounding (Non-Sterile/Sterile) Location: n/a
	• Omnicell Load: Yes
Transport	• Transport (dose is placed inside a plastic sealable bag): Standard
Nursing: Storage / Administration Exposure Risk: low	• Handling/administration PPE Requirements: Single pair of CX approved gloves. Wash hands after handling
	• Storage of Finished dose in Nursing Area/Procedural Area: Omnicell
	• Signage on Patient Door Required: No
	• Manipulation of Dosage Form: Standard
	• Special Manipulation for Administration: do not crush tablet
Disposal / Spills	• Disposal of Drug Waste: Full- blue bin , Trace/packaging- trash
	• Disposol of Used PPE: trash bin (inside plastic bag)
	• Spill management: n/a
NIOSH Supplemental Information: Increased risk of congenital abnormalities when taken in first trimester; complications in pregnancy when taken in 3rd trimester
Reason for exemption of USP<800> Containment Requirements: Purchased in final dosage form; packaged as unit dose. Does not require additional manipulation for dispensing.

2023 American Geriatrics Society Beers Criteria^® for potentially inappropriate medication use in older adults.
Medication:	PARoxetine (Paxil)
Criteria 1: Potentially inappropriate medication use in older adults. (Table 2)
Drug(s)	antidepressants with strong anticholinergic activity, alone or in combination
Rationale	Highly anticholinergic, sedating, and cause orthostatic hypotension.
Recommendation	Avoid
Quality of evidence: High, Strength of Recommendation: Strong

Criteria 2: Potentially inappropriate medication use in older adults due to drug–disease or drug–syndrome interactions that may exacerbate the disease or syndrome. (Table 3)
Drug(s) ⇆ disease or syndrome	anticholinergics ⇄ Delirium
Rationale	Avoid in older adults with or at high risk of delirium because of the potential of inducing or worsening delirium.
Recommendation	Avoid
Quality of evidence: Moderate, Strength of Recommendation: Strong

Drug(s) ⇆ disease or syndrome	anticholinergics ⇄ Dementia or cognitive impairment
Rationale	Avoid because of adverse CNS effects. If used, periodic deprescribing attempts should be considered to assess ongoing need and/or the lowest effective dose.
Recommendation	Avoid
Quality of evidence: Moderate, Strength of Recommendation: Strong

Drug(s) ⇆ disease or syndrome	anticholinergics ⇄ History of falls or fractures
Rationale	May cause ataxia, impaired psychomotor function, syncope, or additional falls. If one of the drugs must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures. (i.e., anticholinergics, selected antidepressants, antiepileptics, antipsychotics, sedative/hypnotics including benzodiazepines and, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids) and implement other strategies to reduce fall risk.
Recommendation	Avoid unless safer alternatives are not available.
Quality of evidence: High, Strength of Recommendation: Strong

Drug(s) ⇆ disease or syndrome	antidepressants (selected classes: SSRIs) ⇄ History of falls or fractures
Rationale	May cause ataxia, impaired psychomotor function, syncope, or additional falls. Antidepressants (selected classes): evidence for risk of falls and fractures is mixed; newer evidence suggests that SNRIs may increase falls risk. If one of the drugs must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures. (i.e., anticholinergics, selected antidepressants, antiepileptics, antipsychotics, sedative/hypnotics including benzodiazepines and, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids) and implement other strategies to reduce fall risk.
Recommendation	Avoid unless safer alternatives are not available.
Quality of evidence: Moderate, Strength of Recommendation: Strong

Drug(s) ⇆ disease or syndrome	strongly anticholinergic drugs, except antimuscarinics for urinary incontinence ⇄ Lower urinary tract symptoms, benign prostatic hyperplasia
Rationale	May decrease urinary flow and cause urinary retention
Recommendation	Avoid in men
Quality of evidence: Moderate, Strength of Recommendation: Strong

Criteria 3: Potentially inappropriate medications: drugs to be used with caution in older adults. (Table 4)
Drug(s)	antidepressants (selected: SSRIs)
Rationale	May exacerbate or cause SIADH or hyponatremia; monitor sodium levels closely when starting or changing dosages in older adults.
Recommendation	Use with caution
Quality of evidence: Moderate, Strength of Recommendation: Strong

Criteria 4: Potentially clinically important drug-drug interactions that should be avoided in older adults. (Table 5)
Interacting drug(s) or class(es)	anticholinergics ⇄ anticholinergics
Risk Rationale	Use of more than one medication with anticholinergic properties increases the risk of cognitive decline, delirium, and falls or fractures.
Recommendation	Avoid; minimize the number of anticholinergic drugs Click for list.
Quality of evidence: Moderate, Strength of Recommendation: Strong

Interacting drug(s) or class(es)	antidepressants (TCAs, SSRIs, and SNRIs) ⇄ CNS-active agents
Risk Rationale	Increased risk of falls and of fracture with the concurrent use of ≥3 CNS-active agents (antiepileptics including gabapentinoids, antidepressants, antipsychotics, benzodiazepines, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids, and skeletal muscle relaxants).
Recommendation	Avoid concurrent use of ≥3 CNS-active drugs Click for list; minimize the number of CNS-active drugs.
Quality of evidence: High, Strength of Recommendation: Strong

Last updated: Sep. 19, 2025

Hazard.Drug Handling(USP 800) USP<800> Hazardous Drug / Assessment of Risk
Black Box Warnings Suicidal ideation
Look-Alike/Sound-Alike PARoxetine confused with DULoxetine, FLUoxetine, piroxicam

UpToDate Lexidrug

Pharmacy Contact Info:

Main Inpatient Pharmacy: ext 4599, 3503
Fax: 704-878-7283

Director of Pharmacy - Randi Raynor, PharmD: ext 4501
Clinical Coordinator - Laura Rollings, PharmD: ext 4597
Pharmacy Informaticist - Stephen Pringle, PharmD: ext 7645
Pharmacy Technician Supervisor - Amy Wingler, CPhT: ext 7385
Pharmacy Automation Coordinator (Omnicell) - Melissa Fulford, CPhT: ext 3556

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