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Pseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It may be used as a nasal/sinus decongestant, as a stimulant, or as a wakefulness-promoting agent.
The salts pseudoephedrine hydrochloride and pseudoephedrine sulfate are found in many over-the-counter preparations, either as a single ingredient or (more commonly) in combination with antihistamines, guaifenesin, dextromethorphan, and/or paracetamol (acetaminophen) or an NSAID (such as aspirin or ibuprofen).
Chemistry
Pseudoephedrine is a diastereomer of ephedrine and is readily reduced into methamphetamine or oxidized into methcathinone.
The dextrorotary (+)- or d- enantiomer is (1S,2S)-pseudoephedrine, whereas the levorotating (−)- or l- form is (1R,2R)-pseudoephedrine.
In the outdated d/l system (+)-pseudoephedrine is also referred to as l-pseudoephedrine and (−)-pseudoephedrine as d-pseudoephedrine (in the Fisher projection then the phenyl ring is drawn at bottom)
Synthesis
Although pseudoephedrine occurs naturally as an alkaloid in certain plant species (for example, as a constituent of extracts from the Ephedra species, also known as ma huang, in which it occurs together with other isomers of ephedrine), the majority of pseudoephedrine produced for commercial use is derived from yeast fermentation of dextrose in the presence of benzaldehyde.
Mechanism of action
Pseudoephedrine is a sympathomimetic amine. Its principal mechanism of action relies on its direct action on the adrenergic receptor system.The vasoconstriction that pseudoephedrine produces is believed to be principally an α-adrenergic receptor response.
National legislation
Australia
Illicit diversion of pseudoephedrine in Australia has caused significant changes to the way the products are regulated. As of 2006, all products containing pseudoephedrine have been rescheduled as either "Pharmacist Only Medicines" (Schedule 3) or "Prescription Only Medicines" , depending on the amount of pseudoephedrine in the product. A Pharmacist Only Medicine may only be sold to the public if a pharmacist is directly involved in the transaction. These medicines must be kept behind the counter, away from public access.
As a result, many pharmacies simply no longer stock Sudafed (the common brand of pseudoephedrine cold/sinus tablets), opting instead to sell Sudafed PE, a phenylephrine product which has not been proven effective in clinical trials.
Colombia
The Colombian government prohibited the trade of pseudoephedrine in 2010.
Mexico
On November 23, 2007, the use and trade of pseudoephedrine in Mexico was made illicit, as it was argued that it was extremely popular as a precursor in the synthesis of methamphetamine.
New Zealand
In New Zealand, from 15 October 2004, as a result of large intercepts of pseudoephedrine and ephedrine, any product containing these substances, e.g. cold and flu medicines, were classified as Class C Part III (partially exempted) controlled drugs in the Misuse of Drugs Act 1975.New Zealand Customs and police officers are continuing to make large interceptions of precursor substances believed to be destined for methamphetamine production. On 9 October 2009, Prime Minister John Key announced pseudoephedrine-based cold and flu tablets would become prescription-only drugs and reclassified as a class B2 drug.The Misuse of Drugs Amendment Bill 2010 has not yet been finalised.
United Kingdom
In the UK, pseudoephedrine is available over the counter under the supervision of a qualified pharmacist, or on prescription. In 2007, the MHRA reacted to concerns over diversion of ephedrine and pseudoephedrine for the illicit manufacture of methamphetamine by introducing voluntary restrictions limiting over the counter sales to one box containing no more than 720 mg of pseudoephedrine in total per transaction. These restrictions became law in April, 2008. However no form of ID is required.
United States
The United States Congress has recognized that pseudoephedrine is used in the illegal manufacture of methamphetamine. In 2005, the Committee on Education and the Workforce heard testimony concerning education programs and state legislation designed to curb this illegal practice.
Do not use 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. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Although pseudoephedrine has no significant pressure effect in normotensive patients, It should be used with caution in the patient with hypertension, patients using tricyclic antidepressants, decongestant, appetite suppressants and amphetamine like psychostimulants. Particular care should also be taken in treating patient with underlyning diseases associated with autonomic dysfunction, such as long standing insulin-dependent diabetes mellitus or thyroid disease. Other conditions also exacerbated by pseudoephedrine include myocardial ischmia, cardiac arrhythmia, glucoma, and urinary retension. Do not take the drug more than seven days. Use with great caution in the presence of liver or the kidney impairment. Use topical decongestant (pseudoephedrine) only in acute conditions, not longer than 3 to 5 days. It should be used sparingly in all patients, especially in infants, children and in cardiac patients. Patient should not derive or operate machinery until they have determined their own response. Concomitant use of alcohol or other centrally acting sedative should be avoided. not to be used in nursing mother. Not to be used in patient MAOI inhibitors.
This combination medication is used to temporarily treat cough, chest congestion, and stuffy nose symptoms caused by the common cold, flu, or other breathing illnesses (e.g., sinusitis, bronchitis). Guaifenesin is an expectorant that helps thin and loosen mucus in the lungs, making it easier to cough up the mucus. The decongestant helps relieve stuffy nose symptoms. This product also contains a narcotic cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough.
This medication is not usually used for ongoing coughs from smoking, asthma, other long-term breathing problems (e.g., emphysema), or coughs with a lot of mucus unless directed by your doctor.
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.
How to use pseudoephedrine-codeine-GG
Take this medication by mouth with or without food with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication can be taken with food if stomach upset occurs. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor. The fluid will help loosen the mucus in your lungs.
If you are using the liquid form, use a medication-measuring device or spoon to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.
Dosage is based on your medical condition, age, and response to treatment.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, restlessness, sweating, shaking, chills, nausea, vomiting, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.
When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.
Drowsiness, dizziness, dry mouth/nose/throat, headache, upset stomach, constipation, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
If your doctor has directed you to use this product, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using the product do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), ringing in the ears, difficulty urinating, vision changes (such as blurred/double vision).
Seek immediate medical attention if any of these rare but very serious side effects occur: fast/irregular heartbeat, seizure.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, emphysema), diabetes, glaucoma, heart problems, high blood pressure, kidney problems, liver disease, seizures, stomach/intestinal problems (such as ulcers, blockage), overactive thyroid (hyperthyroidism), difficulty urinating (such as due to enlarged prostate).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Liquid products, chewable tablets, or dissolving tablets/strips may contain sugar or aspartame. Liquid products may also contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Children may be more sensitive to the side effects of this product, especially excitation and agitation.
Older adults may be more sensitive to the side effects of this product, especially dizziness, drowsiness, confusion, constipation, fast/irregular heartbeat, trouble sleeping, or urination problems. Dizziness, drowsiness, trouble sleeping, and confusion can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication may pass into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.
If you are taking this product under your doctor's direction, 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 or pharmacist first.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: anti-seizure medications (e.g., phenytoin, carbamazepine, phenobarbital), beta blockers (e.g., metoprolol, atenolol), "blood thinners" (e.g., warfarin), guanethidine, isoniazid, ketoconazole, methyldopa, phenothiazines (e.g., chlorpromazine), reserpine, tricyclic antidepressants (e.g., amitriptyline, desipramine).
The ingredients in this product are available in many prescription and nonprescription products. Check the labels on all your medications carefully to make sure you are not taking more than one product with the same ingredient(s). Consult your pharmacist if you are unsure of the ingredients in any of your medications.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., other cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Check the labels on all your medicines (e.g., other cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.
This medication may interfere with certain urine laboratory tests (e.g., 5-HIAA levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. 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 the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include: irregular heartbeat, hallucinations, fainting, seizures.
Notes
If your doctor has prescribed this medication, do not share it with others.
Keep all regular medical and laboratory appointments.
Do not take this product for several days before allergy testing because test results can be affected.
Missed Dose
If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Storage
Store at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.
