pseudoephedrine sulfate

pseudoephedrine sulfate

Drixoral Nasal Decongestant, Drixoral Non-Drowsy Formula

Pharmacologic class: Sympathomimetic

Therapeutic class: Decongestant (systemic)

Pregnancy risk category C

Action

Stimulates alpha-adrenergic receptors, causing vasoconstriction of respiratory tract; relaxes bronchial smooth muscle through beta₂-adrenergic stimulation

Availability

pseudoephedrine hydrochloride

Capsules: 60 mg

Capsules (extended-release): 120 mg, 240 mg

Capsules (soft gel): 30 mg

Oral solution: 15 mg/5 ml, 30 mg/5 ml

Syrup: 30 mg/5 ml

Tablets: 30 mg, 60 mg

Tablets (chewable): 15 mg

Tablets (extended-release): 120 mg, 240 mg

pseudoephedrine sulfate

Tablets (extended-release, film-coated): 120 mg

⊘Indications and dosages

➣ Nasal, sinus, or eustachian tube congestion

Adults and children ages 12 and older: 60 mg P.O. q 4 to 6 hours p.r.n. (not to exceed 240 mg/day); or 120 mg (extended-release) q 12 hours or 240 mg (extended-release) q 24 hours

Contraindications

• Hypersensitivity to drug or other sympathomimetics
• Alcohol intolerance (with some liquid products)
• Hypertension
• Severe coronary artery disease
• MAO inhibitor use within past 14 days
• Children younger than age 12 (extended-release forms)

Precautions

Use cautiously in:
• hyperthyroidism, diabetes mellitus, prostatic hypertrophy, ischemic heart disease, glaucoma
• elderly patients (more sensitive to drug's CNS effects)
• pregnant or breastfeeding patients.

Administration

• Give at least 2 hours before bedtime to minimize insomnia.

Route	Onset	Peak	Duration
P.O.	30 min	Unknown	4-8 hr
P.O. (extended)	60 min	Unknown	12 hr

Adverse reactions

CNS: anxiety, nervousness, dizziness, drowsiness, excitability, fear, hallucinations, headache, insomnia, restlessness, asthenia, seizures

CV: palpitations, hypertension, tachycardia, cardiovascular collapse

GI: anorexia, dry mouth

GU: dysuria

Respiratory: respiratory difficulty

Interactions

Drug-drug. Beta-adrenergic blockers: increased pressor effects of pseudoephedrine

MAO inhibitors: hypertensive crisis

Mecamylamine, methyldopa, reserpine: decreased antihypertensive effect of these drugs

Other sympathomimetics: additive effects, greater risk of toxicity

Drug-food. Foods that acidify urine: decreased drug efficacy

Foods that alkalize urine: increased drug efficacy

Patient monitoring

• Monitor vital signs.
• Assess neurologic and cardiovascular status regularly.

Patient teaching

• Advise patient to take at least 2 hours before bedtime to reduce insomnia.
• Tell patient not to crush or break extended-release tablets or capsules.
• Advise patient to discontinue use and consult prescriber if he experiences nervousness, dizziness, or insomnia.
• Tell patient to consult prescriber before taking other over-the-counter products.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and foods mentioned above.