Pseudoephedrine generic name: pseudoephedrine (SOO doe ee FED rin) is a phenethylamine and a diastereoisomer of ephedrine with sympathomimetic properties , used to treat nasal and sinus congestion, or congestion in the tubes that drain fluid from your inner ears, called Eustachian tubes.
it can be used as an awakening agent at higher doses.
Accession Number : DB00852 (APRD00634)
It was first characterized in 1889, by the German chemists Ladenburg and Oelschlägel, who used a sample that had been isolated from Ephedra vulgaris by the Merck pharmaceutical corporation of Darmstadt, Germany. The salts pseudoephedrine hydrochloride and pseudoephedrine sulfate are found in many over-the-counter preparations, either as a single ingredient or (more commonly) in a fixed-dose combination with one or more additional active ingredients such as antihistamines, guaifenesin, dextromethorphan, paracetamol (acetaminophen) or an NSAID (such as aspirin
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Use of pseudoephedrine
Use pseudoephedrine exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
o not give pseudoephedrine to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.
Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You may need to shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.
Do not take pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. If you need surgery, tell the surgeon ahead of time that you are using pseudoephedrine. You may need to stop using the medicine for a short time.
Store pseudoephedrine at room temperature away from moisture and heat.
Benefit of ephedrine and pseudoephedrine as nasal decongestants
In rhinology in France, ephedrine is administered nasally and is a prescription drug . Pseudoephedrine, on the other hand, whether alone or associated to various other drug classes, is taken orally and is available over the counter.
Ephedrine applied to the nasal mucosa reduces nasal resistance more quickly and strongly than oral pseudoephedrine, but with shorter action time . At end of treatment, there may be a rebound effect with increased nasal resistance and recurrence of congestion, for which several hypotheses have been suggested. The 2011 French Society of Otorhinolaryngology guidelines stress that rebound has been described only in experimental contexts with healthy volunteers and might be no more than progression of the disease for which the vasoconstrictor was prescribed. Other hypotheses involve either repeated α-2 receptor stimulation, inducing intense vasoconstriction with mucosal ischemia and interstitial edema, or else α-2 receptor down-regulation, inducing relative dilation and a tachyphylaxic effect leading to increased need of decongestants, or again accessory affinity for β adrenergic receptors which, when stimulated, induce secondary vasodilation once the α effect has worn off .
Several studies in various pharmaceutical laboratories demonstrated efficacy for oral pseudoephedrine against nasal congestion during common cold. In 2004, the Bayer laboratories , in a multicenter prospective randomized double-blind trial against placebo including 643 patients with common cold, found reduction of nasal congestion without side-effects 6 hours after oral intake of pseudoephedrine (30 or 60 mg) associated either to acetylsalicylic acid (1 g) or to paracetamol (500 mg or 1 g). Likewise, in 2007, Procter and Gamble [15], in a multicenter prospective randomized double-blind trial against placebo including 485 patients with common cold, found improvement in symptoms (including congestion) 3 hours after intake of syrup containing 8 mg ephedrine associated to 600 mg paracetamol and a steroidal anti-inflammatory. Finally, Eccles et a, in a prospective randomized double-blind trial against placebo including 238 patients with common cold, reported efficacy against nasal congestion without side-effects for 3 days’ 60 mg oral pseudoephedrine.
These results in common cold have been backed up by other randomized double-blind studies of associated H1 antihistamines and pseudoephedrine in allergic rhinitis . Grosclaude et al. found that the association of an H1 antihistamine (cetirizine 5 mg) and pseudoephedrine (120 mg) for 15 days did not improve nasal congestion more than pseudoephedrine (120 mg) alone but did improve other symptoms. Berkowitz et al. found symptomatic efficacy for associated H1 antihistamine (fexofenadine) and pseudoephedrine (60 mg) at 45–60 minutes after intake, lasting 6 hours. Likewise, Chiang et al. found symptomatic efficacy for associations of H1 antihistamines (cetirizine or loratadine) and pseudoephedrine. In allergic rhinitis with moderate asthma, Nathan et al. found efficacy compared to placebo for 4 weeks’ associated H1 antihistamine (cetirizine 5 mg) and pseudoephedrine (120 mg). And finally, Mucha et al. found 15 days’ oral pseudoephedrine (240 mg) to be more effective against nasal congestion than an oral leukotriene receptor antagonist (montelukast 10 mg).
Detection of use
Pseudoephedrine may be quantified in blood, plasma, or urine to monitor any possible performance-enhancing use by athletes, confirm a diagnosis of poisoning, or to assist in a medicolegal death investigation. Many commercial immunoassay screening tests directed at the amphetamines cross-react appreciably with pseudoephedrine, but chromatographic techniques can easily distinguish pseudoephedrine from other phenethylamine derivatives. Blood or plasma pseudoephedrine concentrations are typically in the 50–300 µg/l range in persons taking the drug therapeutically, 500–3000 µg/l in people with substance use disorder involving pseudoephedrine, or poisoned patients and 10–70 mg/l in cases of acute fatal overdose
What side effects may you experience with pseudoephedrine?
Get emergency medical help if you have any of these signs of an allergic reaction to pseudoephedrine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using pseudoephedrine and call your doctor at once if you have a serious side effect such as:
– fast, pounding, or uneven heartbeat;
– severe dizziness or anxiety;
– easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
-dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).
Less serious pseudoephedrine side effects may include:
– loss of appetite;
– warmth, tingling, or redness under your skin;
– feeling restless or excited (especially in children);
– sleep problems (insomnia); or
– skin rash or itching.
Pseudoephedrine dosing information
Usual Adult Dose of Pseudoephedrine for Nasal Congestion:
Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed.
Sustained release: 120 mg orally every 12 hours as needed.
Sustained release suspension: 45 to 100 mg orally every 12 hours as needed.
Maximum daily dose is 240 mg/day.
Usual Pediatric Dose of Pseudoephedrine for Nasal Congestion:
2 years to 5 years:
Immediate release: 15 mg every 6 hours.
Sustained release suspension: 12.5 to 25 mg orally every 12 hours as needed.
Maximum daily dose is 60 mg/day.
Alternative dosing: 1 mg/kg/dose every 6 hours; maximum dose: 15 mg.
6 years to 12 years:
Immediate release: 30 mg every 6 hours.
Sustained release suspension: 25 to 50 mg orally every 12 hours as needed.
Maximum daily dose is 120 mg/day.
over 12 years:
Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed.
Sustained release: 120 mg orally every 12 hours as needed.
Sustained release suspension: 50 to 100 mg orally every 12 hours as needed.
Maximum daily dose is 240 mg/day.
What happens if I miss a dose?
Since pseudoephedrine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line .
Overdose symptoms may include feeling restless or nervous.
What other drugs will affect pseudoephedrine?
Interactions
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor’s approval.
Some products that may interact with this drug include: stimulants (such as caffeine, dextroamphetamine, methamphetamine, herbal products like ephedra/ma huang), terbutaline.
– a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
– an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others.
Pseudoephedrine and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
There are no well controlled studies that have been done in pregnant women. Pseudoephedrine should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.
Conclusion
The present review of the literature tends to show that their vasoconstrictive action on the nasal mucosa makes both ephedrine and pseudoephedrine highly effective against nasal congestion. Like any vasoconstrictor, as stressed by the 2011 guidelines of the French Society of Otorhinolaryngology [2], they should not be prescribed for children under the age of 15 years. It further seems that the severe adverse cardiovascular and neurological effects reported with these amines, of unpredictable onset and potentially associated with low doses in the absence of any relevant history, should lead ENT physicians not to resort to them to treat common cold and to exercise the greatest rigor in assessing the cost/benefit trade-off in prescribing them for allergic rhinitis. Given these risks, distribution should be regulated and over-the-counter sale should be avoided.