DAYTRANA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DAYTRANA (DAYTRANA).

How it works

Methylphenidate is a central nervous system stimulant that blocks the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their extracellular concentrations.

What the body does with it

Metabolism	Hepatic via carboxylesterase CES1A1 to ritalinic acid; minor CYP2D6 involvement.
Excretion	Renal (approx. 78% unchanged) and fecal (approx. 10%); remainder as metabolites.
Half-life	Terminal half-life in children is approximately 5–6 hours; in adults, approximately 5 hours; wears off within 12 hours of patch removal.
Protein binding	Approximately 15% bound to plasma proteins.
Volume of Distribution	Apparent Vd is approximately 2.65 L/kg, indicating extensive tissue distribution.
Bioavailability	Transdermal: Approximately 37% of the nominal dose over the wear period due to residual drug left in patch; conversion from oral methylphenidate is not 1:1, so transdermal dose requires titration.
Onset of Action	Transdermal: Clinical effect observed within 1–2 hours of patch application; absorption continues over the 9-hour wear time.
Duration of Action	Approximately 9 hours wear per patch; effect persists for up to 12 hours after application; no residual effect after patch removal.

Classification & Brands

Dosing & administration

Initial: 10 mg transdermal patch applied to hip for 9 hours daily; may titrate weekly in increments of 5 mg to a maximum of 30 mg/day.

Dosage form	FILM, EXTENDED RELEASE
Renal impairment	No specific guidelines; use with caution in severe renal impairment (GFR < 30 mL/min) due to potential for increased exposure.
Liver impairment	Not recommended in severe hepatic impairment (Child-Pugh Class C). No adjustment for mild-moderate (Child-Pugh A or B) unless tolerability issues.
Pediatric use	Approved for ages 6-12 years: initial dose 10 mg/day as a 9-hour patch; may titrate to 20 mg/day after 1 week. Weight-based: 10 mg for 18-30 kg, 20 mg for >30 kg.
Geriatric use	Start at lower end of dosing range (10 mg/day) due to increased sensitivity and higher risk of adverse effects; monitor carefully.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DAYTRANA (DAYTRANA).

Breastfeeding	Contraindicated due to potential for infant adverse effects. M/P ratio unknown; methylphenidate is excreted in human milk in low amounts but may cause irritability, insomnia, or appetite suppression in breastfed infants.
Teratogenic Risk	Teratogenic risk is undefined due to insufficient human data. Animal studies suggest potential for embryotoxicity at high doses. Avoid in first trimester unless benefit outweighs risk. Second/third trimester: Use only if maternal benefit justifies fetal risk; may cause fetal tachycardia, growth restriction, or behavioral effects.

Warnings & precautions

■ FDA Black Box Warning

Methylphenidate has a high potential for abuse and dependence. Prolonged use may lead to drug dependence. Misuse may cause sudden death or serious cardiovascular adverse events.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to methylphenidate or patch components","Concurrent use with or within 14 days of monoamine oxidase inhibitors","Glaucoma","Tics or family history of Tourette's syndrome","Severe hypertension or tachyarrhythmias"]

Clinical Precautions

Precautions

["Serious cardiovascular events including sudden death in patients with structural cardiac abnormalities","Psychiatric adverse reactions (e.g., psychosis, mania)","Seizures in patients with history of seizure disorder","Long-term suppression of growth (height and weight) in children","Peripheral vasculopathy including Raynaud's phenomenon","Potential for allergic reactions to transdermal system components"]

Clinical Tips & Counseling

Drug interactions

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DAYTRANA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DAYTRANA (DAYTRANA).

How it works

Methylphenidate is a central nervous system stimulant that blocks the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their extracellular concentrations.

What the body does with it

Metabolism	Hepatic via carboxylesterase CES1A1 to ritalinic acid; minor CYP2D6 involvement.
Excretion	Renal (approx. 78% unchanged) and fecal (approx. 10%); remainder as metabolites.
Half-life	Terminal half-life in children is approximately 5–6 hours; in adults, approximately 5 hours; wears off within 12 hours of patch removal.
Protein binding	Approximately 15% bound to plasma proteins.
Volume of Distribution	Apparent Vd is approximately 2.65 L/kg, indicating extensive tissue distribution.
Bioavailability	Transdermal: Approximately 37% of the nominal dose over the wear period due to residual drug left in patch; conversion from oral methylphenidate is not 1:1, so transdermal dose requires titration.
Onset of Action	Transdermal: Clinical effect observed within 1–2 hours of patch application; absorption continues over the 9-hour wear time.
Duration of Action	Approximately 9 hours wear per patch; effect persists for up to 12 hours after application; no residual effect after patch removal.

Classification & Brands

Dosing & administration

Initial: 10 mg transdermal patch applied to hip for 9 hours daily; may titrate weekly in increments of 5 mg to a maximum of 30 mg/day.

Dosage form	FILM, EXTENDED RELEASE
Renal impairment	No specific guidelines; use with caution in severe renal impairment (GFR < 30 mL/min) due to potential for increased exposure.
Liver impairment	Not recommended in severe hepatic impairment (Child-Pugh Class C). No adjustment for mild-moderate (Child-Pugh A or B) unless tolerability issues.
Pediatric use	Approved for ages 6-12 years: initial dose 10 mg/day as a 9-hour patch; may titrate to 20 mg/day after 1 week. Weight-based: 10 mg for 18-30 kg, 20 mg for >30 kg.
Geriatric use	Start at lower end of dosing range (10 mg/day) due to increased sensitivity and higher risk of adverse effects; monitor carefully.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DAYTRANA (DAYTRANA).

Breastfeeding	Contraindicated due to potential for infant adverse effects. M/P ratio unknown; methylphenidate is excreted in human milk in low amounts but may cause irritability, insomnia, or appetite suppression in breastfed infants.
Teratogenic Risk	Teratogenic risk is undefined due to insufficient human data. Animal studies suggest potential for embryotoxicity at high doses. Avoid in first trimester unless benefit outweighs risk. Second/third trimester: Use only if maternal benefit justifies fetal risk; may cause fetal tachycardia, growth restriction, or behavioral effects.

Warnings & precautions

■ FDA Black Box Warning

Methylphenidate has a high potential for abuse and dependence. Prolonged use may lead to drug dependence. Misuse may cause sudden death or serious cardiovascular adverse events.