Pseudoephedrine (Sudafed) is a stimulant drug that has got vasoconstrictor properties. It is used for the symptomatic treatment of flu, common cold, and sinusitis. It is also available in combination with naproxen sodium for the treatment of sinusitis (Aleve D Sinus and Headache (Naproxen and Pseudoephedrine).

Pseudoephedrine (Sudafed) Uses:

• Nasal congestion:

  • It increases nasal or sinus drainage, temporarily relieving nasal congestion and making it easier to breathe through the nose due to upper respiratory allergies, hay fever, or the common cold.
  • It also provides temporary relief of sinus congestion and pressure.

Pseudoephedrine (Sudafed) Dose in Adults

Pseudoephedrine (Sudafed) Dose in the treatment of Nasal congestion in adults:

• General dosing guidelines: Oral:

  • Immediate-release tablets:
    • 60 mg every 4 to 6 hours;
  • Extended-release tablets:
    • 120 mg every 12 hours or 240 mg every 24 hours;
    • maximum: 240 mg per 24 hours

Pseudoephedrine (Sudafed) Dose in Children:

Note:

• The safety and efficacy for the use of cough and cold products in infants and young children are limited;
• the AAP warns against the use of these products for respiratory illnesses in infants and young children.
• FDA doesn't recommend over the counter use in infants and children under 2 years of age.
• It recommends cautious use in children over 2 years of age due to the risk of serious and life-threatening adverse effects (including death).

Pseudoephedrine (Sudafed) Dose in the treatment of Nasal congestion (decongestant):

• Children <4 years: Limited data available:

  • Immediate-release tablets:
    • 1 mg/kg/dose every 6 hours;
    • maximum dose: 15 mg/dose.

• Children 4 to <6 years: Immediate-release:

  • Fixed-dose:
    • 15 mg every 4 to 6 hours; maximum daily dose: 60 mg/24 hours
  • Weight-directed dosing:
    • 1 mg/kg/dose every 6 hours;
    • maximum dose: 15 mg/dose

• Children 6 to <12 years:

  • Immediate-release:
    • 30 mg every 4 to 6 hours;
    • maximum daily dose: 120 mg/24 hours

• Children ≥12 years and Adolescents:

  • Immediate-release:
    • 60 mg every 4 to 6 hours;
    • maximum daily dose: 240 mg/day
  • Extended-release:
    • 120 mg every 12 hours or 240 mg once daily;
    • maximum daily dose: 240 mg/24 hours

Pregnancy Risk Category: B2

• Use of pseudoephedrine during pregnancy can cause vasoconstriction.
• This could lead to gastroschisis and small intestinal atresia. Additional studies are required to determine the extent of the risk.
• One-time doses of pseudoephedrine did not adversely affect the fetus in the third trimester (limited data).
• However, fetal tachycardia was reported in a case report that involved maternal use for several days of extended-release products.
• Decongestants should not be used during pregnancy as a treatment for rhinitis.
• Avoid oral pseudoephedrine during the first trimester.

Pseudoephedrine use during breastfeeding:

• Breast milk contains pseudoephedrine.
• The relative infant dose (RID), of pseudoephedrine, is 6.7%.
• This was calculated using the highest breast milk concentration and compared with a maternal weight-adjusted dose of 240mg/day.
• When the RID is less than 10%, breastfeeding is generally acceptable.
• Breast milk had a mean half-life of 5.3 hours (CI: 4.3 to 6.3)
• Infants who were breastfed pseudoephedrine have shown symptoms of agitation and Irritation.
• Some breastfeeding mothers experienced a sharp decrease in milk production after taking a 60 mg dose pseudoephedrine.
• This resulted in a 24% average drop in milk production in 24 hours.
• Experts recommend using pseudoephedrine to suppress milk production in hypergalactic women who are breastfeeding.

Dose in Kidney disease

No adjustments provided by the manufacturer's labeling.

Dose in Liver disease:

There are no dosage adjustments provided by the manufacturer

Side effects of Pseudoephedrine (Sudafed):

• Cardiovascular:

  • Cardiac Arrhythmia
  • Chest Tightness
  • Circulatory Shock (With Hypotension)
  • Hypertension
  • Palpitations
  • Tachycardia

• Central Nervous System:

  • Ataxia
  • Central Nervous System Stimulation (Transient)
  • Chills
  • Confusion
  • Dizziness
  • Drowsiness
  • Excitability
  • Fatigue
  • Hallucination
  • Headache
  • Insomnia
  • Nervousness
  • Neuritis
  • Restlessness
  • Seizure
  • Vertigo

• Dermatologic:

  • Diaphoresis
  • Skin Photosensitivity
  • Skin Rash
  • Urticaria

• Gastrointestinal:

  • Anorexia
  • Constipation
  • Diarrhea
  • Dry Throat
  • Ischemic Colitis
  • Nausea
  • Vomiting
  • Xerostomia

• Genitourinary:

  • Difficulty In Micturition
  • Dysuria
  • Urinary Retention

• Hematologic & Oncologic:

  • Agranulocytosis
  • Hemolytic Anemia
  • Thrombocytopenia

• Hypersensitivity:

  • Anaphylaxis

• Neuromuscular & Skeletal:

  • Tremor
  • Weakness

• Ophthalmic:

  • Blurred Vision
  • Diplopia

• Otic:

  • Tinnitus

• Renal:

  • Polyuria

• Respiratory:

  • Dry Nose
  • Dyspnea
  • Nasal Congestion
  • Pharyngeal Edema
  • Thickening Of Bronchial Secretions
  • Wheezing

Contraindications to Pseudoephedrine (sudafed):

• Within 2 weeks of stopping an MAO inhibitor, coadministration

Warnings and precautions

• Cardiovascular disease

  • Patients with heart disease, including hypertension, should be cautious.

• Diabetes:

  • Diabetic patients should be cautious.

• Glaucoma/increased intraocular pressure

  • Patients with elevated intraocular pressure and angle-closure Glaucoma should be cautious.

• Prostatic hyperplasia, urinary obstruction

  • Patients with prostatic hyperplasia or genitourinary obstruction should be cautious.

• Renal impairment

  • Patients with impaired renal function should be cautious.
  • Consider dosage adjustments.

• Seizure disorder:

  • Patients with seizure disorders should be cautious as it can cause CNS stimulation.

• Thyroid dysfunction:

  • Patients with thyroid dysfunction should be cautious.

Monitoring parameters:

Not mentioned, however, since it is a stimulant drug, monitor blood pressure and heart rate.

How to administer Pseudoephedrine (sudafed)?

• Swallow the tablets whole, do not crush.
• Can administer with or without food.

Mechanism of action of Pseudoephedrine (Sudafed):

It stimulated the alpha-adrenergic receptors in the respiratory mucosa, causing vasoconstriction. It also stimulates beta-adrenergic cells directly, resulting in bronchial relaxation and increased heart rate.

The onset of action:

• Decongestant: Oral: 30 minutes

Peak effect:

• Decongestant: Oral: ~1-2 hours

Duration:

• Immediate release tablet: 3-8 hours

Absorption:

• Rapid

Metabolism:

• It is metabolized via n-demethylation to convert into its active form nor-pseudoephedrine
• Hepatic (<1%).

Half-life elimination:

• Variable according to urine pH and flow rate;
  • alkaline urine decreases renal elimination of pseudoephedrine.
• Children: ~3 hours (urine pH ~6.5)
• Adults: 9-16 hours (pH 8); 3-6 hours (pH 5)

Time to peak:

• Children (immediate-release) ~2 hours
• Adults (immediate-release): 1-3 hours (dose dependent)

Excretion:

• Urine (43% to 96% as unchanged drug, 1% to 6% as active norpseudoephedrine);
• The excretion depends on urine pH and flow rate;
  • alkaline urine decreases renal elimination of pseudoephedrine.

International Brand Names of Pseudoephedrine:

• Childrens Silfedrine
• Decongestant 12Hour Max St
• Genaphed
• Nasal Decongestant
• Nexafed
• Shopko Nasal Decongestant Max
• Shopko Nasal Decongestant
• Simply Stuffy
• Sudafed 12 Hour
• Sudafed 24 Hour
• Sudafed Childrens
• Sudafed Congestion
• Sudafed Sinus Congestion 12HR
• Sudafed
• SudoGest 12 Hour
• SudoGest Maximum Strength
• SudoGest
• Zephrex-D
• Acunaso
• Afalpi Syrup
• Boots Pharmaceutical Decongestant
• Brocon
• Chemists' Own Sinus Relief
• Cosac
• Cosue
• Decongess
• Devosix
• Dexan
• Disofrol
• Disudrin
• Kopseu
• Logicin Sinus
• Mex 24
• Nasa-12
• Pseudono
• Rinafed
• Rinoral
• Sedofan
• Sedofan II
• Soludril Rhinites
• Subulin
• Sudafed
• Sudafed Elixir
• Sudafed Sinus 12 Hour Relief
• Sudofen
• Sudomyl
• Sudorin
• Sudosian
• Sudotab
• Tiptipot
• Vasocedine

Pseudoephedrine Brand Names in Pakistan: