pseudoephedrine sulfate


Also found in: Dictionary, Thesaurus.

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.

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.

References in periodicals archive ?
The first chapter introduces the (+)- Pseudoephedrine Sulfate Industry by Brief Introduction, Development & Status of (+)- Pseudoephedrine Sulfate Industry.
The second chapter focuses on Manufacturing Technology of (+)- Pseudoephedrine Sulfate, the third one gives Analysis of Global Key Manufacturers (Including Company Profile, Product Specification, 2009-2014 Production Information etc.
CLARINEX(R) D-24 Hour Extended Release Tablets, a once-daily version with pseudoephedrine sulfate, is currently in Phase III.
Too much pseudoephedrine sulfate can cause nervousness, sleeplessness, dizziness and other related side effects.
Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration (FDA) has tentatively approved the marketing of its Abbreviated New Drug Application (ANDA) for loratadine and pseudoephedrine sulfate, USP extended release tablets, which is bioequivalent to Schering-Plough Corporation's Claritin-D(R) 24 Hour product.
In clinical trials, CLARITIN-D was found to be significantly more effective than placebo, loratadine alone, or pseudoephedrine sulfate alone in relieving the symptoms of seasonal allergic rhinitis.
IMPAX Laboratories announced FDA acceptance of the Company's ANDA filing for Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 5mg/120mg (12-hour formulation) in January 2001 and commented on the filing of a lawsuit by Schering Corporation alleging patent infringement relating to the ANDA in February 2001.
This is our third tentative ANDA approval containing a Paragraph IV certification, following the announcement of our second one, for Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10mg/240mg (24-hour formulation), earlier this week.
IMPAX Laboratories announced FDA acceptance of the Company's ANDA filing for Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10mg/240mg (24-hour formulation) in November 2000 and commented on the filing of a lawsuit by Schering Corporation alleging patent infringement relating to the ANDA in January 2001.
We are very pleased to receive this notification for Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10mg/240mg (24-hour formulation), our second tentative approval of an ANDA containing a Paragraph IV certification," said Larry Hsu, Ph.