Pseudoephedrine

What is Pseudoephedrine?

• Pseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes used to relieve nasal congestion caused by colds, allergies, and hay fever.
• It is also used to temporarily relieve sinus congestion and pressure.

Pseudoephedrine

Pseudoephedrine-3d-CPK

What are the uses of this medicine?

Pseudoephedrine is used for:

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies.
• temporarily relieves sinus congestion and pressure.

How does this medicine work?

• Pseudoephedrine is a phenethylamine and a diastereomer of ephedrine with sympathomimetic property.
• Pseudoephedrine displaces norepinephrine from storage vesicles in presynaptic neurones, thereby releasing norepinephrine into the neuronal synapses where it stimulates primarily alpha-adrenergic receptors.
• It also has weak direct agonist activity at alpha- and beta- adrenergic receptors.
• Receptor stimulation results in vasoconstriction and decreases nasal and sinus congestion.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• diabetes mellitus
• cardiovascular disease
• severe or uncontrolled hypertension
• severe coronary artery disease
• prostatic hypertrophy
• hyperthyroidism
• closed angle glaucoma
• pregnant people

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking one of these medications within the past 2 weeks.
• medications for diet or appetite control, asthma, colds, or high blood pressure.

Is this medicine FDA approved?

• yes is was FDA approved.

How should this medicine be used?

Recommended dosage: Adults and children 12 years and over:

• Take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours.

Children ages 6 to 11 years:

• Take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours.

Administration:

• Pseudoephedrine comes as a regular tablet, a 12-hour extended-release (long-acting) tablet, a 24-hour extended-release tablet, and a solution (liquid) to be taken by mouth.
• The regular tablets and liquid are usually taken every 4 to 6 hours.
• The 12-hour extended-release tablets usually are taken every 12 hours, and you should not take more than two doses in a 24-hour period.
• The 24-hour extended-release tablets usually are taken once a day, and you should not take more than one dose in a 24-hour period.
• To help prevent trouble sleeping, take the last dose of the day several hours before bedtime.
• Do not give nonprescription pseudoephedrine products to children younger than 4 years of age.
• If you give these products to children 4-11 years of age, use caution and follow the package directions carefully. Do not give pseudoephedrine extended-release tablets to children younger than 12 years of age.
• If you are taking the liquid, do not use a household spoon to measure your dose.
• Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.
• If your symptoms do not get better within 7 days or if you have a fever, stop taking pseudoephedrine and call your doctor.
• Swallow the extended-release tablets whole; do not break, crush, or chew them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet, a 12-hour extended-release (long-acting) tablet, a 24-hour extended-release tablet, and a solution (liquid

This medicine is available in fallowing brand namesː

• Afrinol
• Cenafed
• Children's Sudafed Nasal Decongestant
• Congestaclear
• Efidac
• Myfedrine
• Pseudocot
• Ridafed
• Silfedrine
• Sudafed 12/24 Hour
• Sudafed Congestion
• Sudodrin
• SudoGest
• Sudrine
• Superfed
• Suphedrin
• Allegra-D (as a combination product containing Fexofenadine, Pseudoephedrine)

What side effects can this medication cause?

The most common side effects of this medicine include:

• central nervous system stimulation
• insomnia
• nervousness
• excitability
• dizziness and anxiety
• tachycardia or palpitations
• mydriasis (dilated pupils)
• hallucinations
• arrhythmias
• hypertension
• seizures
• ischemic colitis
• pseudo-scarlatina
• systemic contact dermatitis
• stroke

• Pseudoephedrine, particularly when combined with other drugs including narcotics, may also play a role in the precipitation of episodes of paranoid psychosis.

What special precautions should I follow?

If you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. Do not exceed recommended dosage. Stop use and ask a doctor if:

• nervousness, dizziness, or sleeplessness occur.
• symptoms do not improve within 7 days or occur with fever.
• Tell your doctor if you have or have ever had high blood pressure, glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision), diabetes, difficulty urinating (due to an enlarged prostate gland), or thyroid or heart disease. If you plan to take the 24-hour extended-release tablets, tell your doctor if you have had a narrowing or blockage of your digestive system.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pseudoephedrine.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pseudoephedrine is contraindicated during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of nasal decongestant use in children is unclear.
• Do not give nonprescription pseudoephedrine products to children younger than 4 years of age.
• Do not give pseudoephedrine extended-release tablets to children younger than 12 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• PSEUDOEPHEDRINE HYDROCHLORIDE

Inactive Ingredients:

• CROSCARMELLOSE SODIUM
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POLYDEXTROSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• SILICON DIOXIDE
• TITANIUM DIOXIDE
• TRIACETIN

Who manufactures and distributes this medicine?

Distributed by:

• LNK INTERNATIONAL, INC.
• 60 Arkay Drive, Hauppauge, NY USA

What should I know about storage and disposal of this medication?

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• use by expiration date on package.

• Dailymed label info on Pseudoephedrine
• FDA Pseudoephedrine