• Symptomatic management of nasal congestion associated with acute viral upper respiratory tract infections.
• Used in combination with antihistamines in the management of allergic conditions.
• Used to open obstructed eustachian tubes in chronic otic inflammation or infection.

Contraindicated in:

• Hypersensitivity to sympathomimetic amines
• Hypertension, severe coronary artery disease
• Concurrent MAO inhibitor therapy
• Known alcohol intolerance (some liquid products).

Use Cautiously in:

• Hyperthyroidism
• Diabetes mellitus
• Prostatic hyperplasia
• Ischemic heart disease
• Glaucoma
• OB: Lactation: Safety not established
• Pedi: Avoid OTC cough and cold products containing this medication in children <4 yr.

CV: palpitations, CARDIOVASCULAR COLLAPSE, hypertension, tachycardia.

Derm: diaphoresis.

GI: anorexia, dry mouth.

GU: dysuria.

Neuro: anxiety, nervousness, dizziness, drowsiness, excitability, fear, hallucinations, headache, insomnia, restlessness, SEIZURES, weakness.

Resp: respiratory difficulty.

Drug-Drug:

• Concurrent use withMAO inhibitors may cause hypertensive crisis.
• Additive adrenergic effects with other adrenergics.
• Concurrent use with beta blockers may result in hypertension or bradycardia.
• Drugs that acidify the urine may ↓ effectiveness.
• Phenothiazines and tricyclic antidepressants potentiate pressor effects.
• Drugs that alkalinize the urine (sodium bicarbonate, high-dose antacid therapy) may intensify effectiveness.

Drug-Food:

• Foods that acidify the urine may ↓ effectiveness.
• Foods that alkalinize the urine may intensify effectiveness (see lists in Appendix M).

(Generic available)

• Tablets: 30 mg^OTC; 60 mg^OTC;
• Extended-release tablets: 120 mg^OTC; 240 mg^OTC;
• Capsules: 60 mg^OTC;
• Extended-release capsules: 240 mg^OTC;
• Liquid (grape and others): 15 mg/5 mL^OTC; 30 mg/5 mL^OTC;
• In combination with: antihistamines, acetaminophen, cough suppressants, and expectorants^OTC. See Appendix [not included in this PDA edition].

• PO (Adults and Children >12 yr): 60 mg every 6 hr as needed (not to exceed 240 mg/day) or 120 mg extended-release preparation every 12 hr or 240 mg extended-release preparation every 24 hr.
• PO (Children 6–12 yr): 30 mg every 6 hr as needed (not to exceed 120 mg/day).
• PO (Children 4–5 yr): 15 mg every 6 hr (not to exceed 60 mg/day).

Silfedrine Children's, Sudafed 12 Hour, Sudafed 24 Hour, Sudafed Children's, SudoGest, SudoGest 12 Hour

• Stimulates alpha- and beta-adrenergic receptors.
• Produces vasoconstriction in the respiratory tract mucosa (alpha-adrenergic stimulation) and possibly bronchodilation (beta₂-adrenergic stimulation).

• Reduction of nasal congestion, hyperemia, and swelling in nasal passages.

Therapeutic Classification: allergy, cold and cough remedies, nasal drying agents/decongestants

Pharmacologic Classification: adrenergics

Absorption: Well absorbed after oral administration.

Distribution: Appears to enter the CSF.

Metabolism/Excretion: Partially metabolized by the liver. 55–75% excreted unchanged by the kidneys (depends on urine pH).

Half-life: Children: 3.1 hr; Adults: 9–16 hr (depends on urine pH).

(decongestant effects)

• Instruct patient to take medication as directed and not to take more than recommended. Take missed doses within 1 hr; if remembered later, omit. Do not double doses. Caution parents to avoid OTC cough and cold products in children <4 yr.
• Instruct patient to notify health care professional if nervousness, slow or fast heart rate, breathing difficulties, hallucinations, or seizures occur, because these symptoms may indicate overdose.
• Instruct patient to contact health care professional if symptoms do not improve within 7 days or if fever is present.
• Avoid use during 1st trimester of pregnancy because of potential fetal harm. Prolonged use later in pregnancy should also be avoided. Avoid use during breastfeeding.

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