TUSSICAPS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TUSSICAPS (TUSSICAPS).

How it works

TUSSICAPS is a combination of antihistamines (diphenhydramine or chlorpheniramine) and decongestants (pseudoephedrine or phenylephrine). Diphenhydramine/chlorpheniramine block H1 histamine receptors, reducing allergic symptoms; decongestants stimulate alpha-adrenergic receptors to cause vasoconstriction in nasal mucosa, relieving congestion.

What the body does with it

Metabolism	Diphenhydramine is metabolized primarily via CYP2D6 to diphenylmethoxyacetic acid. Chlorpheniramine is metabolized via CYP2D6 and other pathways. Pseudoephedrine is partially metabolized in the liver by N-demethylation and excreted unchanged in urine.
Excretion	Renal excretion of unchanged drug and metabolites accounts for approximately 60-70% of elimination; biliary/fecal excretion accounts for 20-30%; the remainder is metabolized.
Half-life	Terminal elimination half-life is 3-4 hours in adults; prolonged to 6-8 hours in elderly or renal impairment. Clinical context: dosing interval typically every 4-6 hours.
Protein binding	Approximately 40-50% bound to plasma proteins, primarily albumin.
Volume of Distribution	Vd approximately 3-4 L/kg, indicating extensive tissue distribution.
Bioavailability	Oral bioavailability ~50% due to first-pass metabolism; rectal bioavailability ~60%.
Onset of Action	Oral: 15-30 minutes for antitussive effect; rectal: 30-60 minutes.
Duration of Action	Oral: 4-6 hours; rectal: 6-8 hours. Clinical notes: Duration may be shorter in children.

Classification & Brands

Dosing & administration

1 capsule orally every 12 hours as needed for cough. Each capsule contains hydrocodone bitartrate 5 mg and phenylpropanolamine HCl 25 mg.

Dosage form	CAPSULE, EXTENDED RELEASE
Renal impairment	Contraindicated in patients with severe renal impairment (CrCl <30 mL/min). For moderate impairment (CrCl 30-50 mL/min), administer with caution and consider dose reduction by 50%. For mild impairment (CrCl >50 mL/min), no adjustment required.
Liver impairment	Contraindicated in severe hepatic impairment (Child-Pugh class C). For moderate impairment (Child-Pugh class B), reduce dose by 50% and monitor for CNS depression. For mild impairment (Child-Pugh class A), no adjustment necessary.
Pediatric use	Not recommended for children under 6 years of age. For children 6-12 years: 0.5 capsules (5 mg hydrocodone component) orally every 12 hours as needed. For adolescents 12-18 years: same as adult dosing (1 capsule orally every 12 hours).
Geriatric use	Initiate with half the usual adult dose (0.5 capsule) given increased sensitivity to CNS effects, and titrate cautiously due to risk of falls and respiratory depression.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TUSSICAPS (TUSSICAPS).

Breastfeeding	Chlorpheniramine and dextromethorphan are excreted in breast milk in small amounts; phenylephrine levels are low. M/P ratio not established. Risk of infant sedation or irritability. Use caution, especially in preterm or neonates. Consider alternatives.
Teratogenic Risk	TUSSICAPS contains chlorpheniramine, phenylephrine, and dextromethorphan. First trimester: Limited data, possible risk of minor malformations from chlorpheniramine (Class B). Second/Third trimester: Avoid due to potential for uterine contractions from phenylephrine and neonatal respiratory depression from dextromethorphan. Overall, use only if benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

No FDA black box warning is currently documented for TUSSICAPS. However, diphenhydramine-containing products carry a warning against use in children under 6 years due to risk of severe adverse effects.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to any component; concurrent use of MAOIs; severe hypertension; severe coronary artery disease; narrow-angle glaucoma; urinary retention; peptic ulcer; children under 6 years (for diphenhydramine-containing forms).

Clinical Precautions

Precautions

Do not exceed recommended dosage; may cause drowsiness (avoid driving). Caution in patients with hypertension, cardiovascular disease, glaucoma, hyperthyroidism, diabetes, prostatic hypertrophy, or urinary retention. Avoid use with MAOIs or within 14 days of stopping them. Contraindicated in severe hypertension or coronary artery disease due to decongestant constrictive effects.

Clinical Tips & Counseling

Drug interactions

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TUSSICAPS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TUSSICAPS (TUSSICAPS).

How it works

What the body does with it

Metabolism	Diphenhydramine is metabolized primarily via CYP2D6 to diphenylmethoxyacetic acid. Chlorpheniramine is metabolized via CYP2D6 and other pathways. Pseudoephedrine is partially metabolized in the liver by N-demethylation and excreted unchanged in urine.
Excretion	Renal excretion of unchanged drug and metabolites accounts for approximately 60-70% of elimination; biliary/fecal excretion accounts for 20-30%; the remainder is metabolized.
Half-life	Terminal elimination half-life is 3-4 hours in adults; prolonged to 6-8 hours in elderly or renal impairment. Clinical context: dosing interval typically every 4-6 hours.
Protein binding	Approximately 40-50% bound to plasma proteins, primarily albumin.
Volume of Distribution	Vd approximately 3-4 L/kg, indicating extensive tissue distribution.
Bioavailability	Oral bioavailability ~50% due to first-pass metabolism; rectal bioavailability ~60%.
Onset of Action	Oral: 15-30 minutes for antitussive effect; rectal: 30-60 minutes.
Duration of Action	Oral: 4-6 hours; rectal: 6-8 hours. Clinical notes: Duration may be shorter in children.

Classification & Brands

Dosing & administration

1 capsule orally every 12 hours as needed for cough. Each capsule contains hydrocodone bitartrate 5 mg and phenylpropanolamine HCl 25 mg.

Dosage form	CAPSULE, EXTENDED RELEASE
Renal impairment	Contraindicated in patients with severe renal impairment (CrCl <30 mL/min). For moderate impairment (CrCl 30-50 mL/min), administer with caution and consider dose reduction by 50%. For mild impairment (CrCl >50 mL/min), no adjustment required.
Liver impairment	Contraindicated in severe hepatic impairment (Child-Pugh class C). For moderate impairment (Child-Pugh class B), reduce dose by 50% and monitor for CNS depression. For mild impairment (Child-Pugh class A), no adjustment necessary.
Pediatric use	Not recommended for children under 6 years of age. For children 6-12 years: 0.5 capsules (5 mg hydrocodone component) orally every 12 hours as needed. For adolescents 12-18 years: same as adult dosing (1 capsule orally every 12 hours).
Geriatric use	Initiate with half the usual adult dose (0.5 capsule) given increased sensitivity to CNS effects, and titrate cautiously due to risk of falls and respiratory depression.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TUSSICAPS (TUSSICAPS).

Breastfeeding	Chlorpheniramine and dextromethorphan are excreted in breast milk in small amounts; phenylephrine levels are low. M/P ratio not established. Risk of infant sedation or irritability. Use caution, especially in preterm or neonates. Consider alternatives.
Teratogenic Risk	TUSSICAPS contains chlorpheniramine, phenylephrine, and dextromethorphan. First trimester: Limited data, possible risk of minor malformations from chlorpheniramine (Class B). Second/Third trimester: Avoid due to potential for uterine contractions from phenylephrine and neonatal respiratory depression from dextromethorphan. Overall, use only if benefit outweighs risk.