Pseudoephedrine

CAS RN: 90-82-4

Range of Toxicity

A) TOXICITY: Symptoms can occur typically after 4- to 5-fold therapeutic doses. Four times the single therapeutic dose (about 240 mg) is required to cause an increase in diastolic blood pressure above 90 mmHg in normotensive subjects. Hypertensive crisis with non-ST elevation myocardial infarction occurred in an elderly adult after inadvertently ingesting 3 sustained release tablets (240 mg) in 6 hours. PEDIATRIC: In one study, children aged 2 to 6 years old developed only minor symptoms following ingestions of up to 180 mg. Acute exposures of 11 mg/kg were well-tolerated.
B) ADULT: THERAPEUTIC GENERAL DOSING: Typical doses are 180 to 360 mg daily. SPECIFIC INDICATIONS or FORMULATIONS: Allergic Rhinitis OR Congestion of Nasal Sinus: 60 mg orally every 4 to 6 hrs; maximum 240 mg/day or SR tablets 120 mg orally every 12 hrs or 24-hour tablets; 240 mg orally every 24 hours.
C) PEDIATRIC: THERAPEUTIC GENERAL DOSING: 3 to 5 mg/kg in children. Not approved for use in children 12 years of age or younger. SPECIFIC INDICATIONS or FORMULATIONS: Allergic rhinitis OR Congestion of Nasal Sinus: 2 to 5 years: Immediate-release products only: 15 mg orally every 4 to 6 hrs; maximum 60 mg/day. 6 to 12 years: Immediate-release products only: 30 mg orally every 4 to 6 hrs; maximum 120 mg/day. 12 years of age and older: 60 mg orally every 4 to 6 hrs; maximum 240 mg/day or SR tablets, 120 mg orally every 12 hrs or 24-hour tablets, 240 mg orally every 24 hours.
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