Pseudoephedrine

Pseudoephedrine temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, and nasal congestion associated with sinusitis. Pseudoephedrine also temporarily relieves sinus congestion and pressure.

• Pseudoephedrine is available under the following different brand names: Sudafed, Nexafed, and Zephrex-D.

Dosage Forms and Strengths

Tablet, immediate-release

• 30 mg
• 60 mg
• 120 mg

Tablet, extended-release

• 120 mg
• 240 mg

Tablet, IMPEDE technology (Nexafed)

• 30 mg
• IMPEDE technology utilizes an advanced polymer matrix to limit the extraction of pseudoephedrine from tablets and deter methamphetamine manufacturing

  Tablet, TAREX technology (Zephrex-D)

• 30 mg
• TAREX technology utilizes an advanced polymer matrix to limit the extraction of pseudoephedrine from tablets and deter methamphetamine manufacturing

Syrup

• 3 mg/mL

Dosage Considerations – Should be Given as Follows:

Nasal Congestion

• Adult, immediate release: 60 mg orally every 4-6 hours as needed
• Adult, extended-release: 120 mg orally every 12 hours or 240 mg orally every 24 hours
• Children under 2 years: Safety and efficacy not established
• Children 2-6 years: 5-30 mg orally every 4-6 hours as needed
• Children 6-12 years: 30 mg orally every 4-6 hours, OR 4 mg/kg/day divided every 6 hours; not to exceed 120 mg/day
• Children over 12 years: 60 mg orally every 6 hours as needed (immediate-release); alternatively, 120 mg orally every 12 hours (extended-release) or 240 mg orally every 24 hours (extended-release)

Dosing Considerations

• Potential toxic dose children under 6 years: 11 mg/kg

Priapism (Off-label), Adult

• 60-120 mg orally

Side effects associated with the use of Pseudoephedrine, include the following:

• drowsiness,
• impaired ability to accurately operate machinery,
• worsening of glaucoma,
• worsening of asthma or chronic lung diseases,
• rash,
• hives,
• perspiration,
• chills
• dry mouth or throat,
• low blood counts,
• restlessness,
• ringing in the ears,
• stomach upset, and
• urinary frequency or difficulty.

Frequency Not Defined

• Tremor
• Restlessness
• Insomnia
• Nausea
• Vomiting
• Nervousness
• Hypertension
• Atrial fibrillation
• Myocardial infarction
• Ventricular premature beats
• Ischemic colitis

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe Interactions of Pseudoephedrine Include:
  • astemizole
  • cisapride
  • dantrolene
  • flibanserin
  • lomitapide
  • pimozide
  • terfenadine
  • desmopressin
  • eucalyptus
  • sage
• Pseudoephedrine has serious interactions with at least 29 different drugs.
• Pseudoephedrine has moderate interactions with at least 178 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• This medication contains pseudoephedrine. Do not take Sudafed, Nexafed, or Zephrex-D if you are allergic to pseudoephedrine or any ingredients contained in this drug
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Hypersensitivity
• Severe hypertension, severe coronary artery disease (CAD)
• Within 14 days of MAO inhibitor therapy
• Newborns, preemies
• Administration of extended-release to patients under 12 years

Effects of Drug Abuse

• No information provided
• Many combo formulations are switching to phenylephrine due to restrictions arising from easy conversion to methamphetamine (the Combat Methamphetamine Epidemic Act of 2005 bans over-the-counter (OTC) sales of cold medicines that contain ingredients, such as pseudoephedrine, commonly used to make methamphetamine).

Short-Term Effects

• See "What Are Side Effects Associated with Using Pseudoephedrine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Pseudoephedrine?”

Cautions

• Use caution in mild to moderate hypertension, cardiac disease, hyperthyroidism, hyperglycemia, BPH, DM, renal impairment, seizure disorder, thyroid dysfunction, and glaucoma
• Lactation
• The elderly may be more sensitive to side effects
• See a healthcare provider if symptoms do not improve within 7 days or are accompanied by fever
• Many combo formulations are switching to phenylephrine due to restrictions arising from easy conversion to methamphetamine (the Combat Methamphetamine Epidemic Act of 2005 bans over-the-counter (OTC) sales of cold medicines that contain ingredients, such as pseudoephedrine, commonly used to make methamphetamine)

Pregnancy and Lactation

• Use pseudoephedrine with caution during pregnancy if benefits outweigh risks
• Animal studies show risk and human studies are not available or neither animal nor human studies were done
• Pseudoephedrine is concentrated in breast milk; manufacturer contraindicates use while breastfeeding (American Association of Pediatrics/AAP Committee states compatible with nursing)