Antihistamines and Decongestants (Systemic)

Before Using This Medicine

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For antihistamine and decongestant combinations, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to antihistamines or to amphetamine, dextroamphetamine (e.g., Dexedrine), ephedrine (e.g., Ephed II), epinephrine (e.g., Adrenalin), isoproterenol (e.g., Isuprel), metaproterenol (e.g., Alupent), methamphetamine (e.g., Desoxyn), norepinephrine (e.g., Levophed), phenylephrine (e.g., Neo-Synephrine), pseudoephedrine (e.g., Sudafed), PPA (e.g., Dexatrim), or terbutaline (e.g., Brethine).

Pregnancy - The occasional use of antihistamine and decongestant combinations is not likely to cause problems in the fetus or in the newborn baby. However, when these medicines are used at higher doses and/or for a long time, the chance that problems might occur may increase. For the individual ingredients of these combinations, the following apply:

• Alcohol - Some of these combination medicines contain alcohol. Too much use of alcohol during pregnancy may cause birth defects.
• Antihistamines - Antihistamines have not been shown to cause problems in humans.
• Phenylephrine - Studies on birth defects have not been done in either humans or animals with phenylephrine.
• Promethazine - Phenothiazines, such as promethazine (contained in some of these combination medicines [e.g., Phenergan-D]), have been shown to cause jaundice and muscle tremors in a few newborn infants whose mothers received phenothiazines during pregnancy. Also, the newborn baby may have blood clotting problems if promethazine is taken by the mother within 2 weeks before delivery.
• Pseudoephedrine - Studies on birth defects with pseudoephedrine have not been done in humans. In animal studies pseudoephedrine did not cause birth defects but did cause a decrease in average weight, length, and rate of bone formation in the animal fetus when administered in high doses.

Breast-feeding - Small amounts of antihistamines and decongestants pass into the breast milk. Use is not recommended since the chances are greater for this medicine to cause side effects, such as unusual excitement or irritability, in the nursing baby. Also, since antihistamines tend to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients. It is not known yet whether loratadine causes these same side effects.

Children - Very young children are usually more sensitive to the effects of this medicine. Increases in blood pressure, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. Before giving any of these combination medicines to a child, check the package label very carefully. Some of these medicines are too strong for use in children . If you are not certain whether a specific product can be given to a child, or if you have any questions about the amount to give, check with your health care professional.

Older adults - Confusion, difficult and painful urination, dizziness, drowsiness, dryness of mouth, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive to the effects of this medicine. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients.

Other medicines - Although certain medicines should not be used together at all, in other cases different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking antihistamines it is especially important that your health care professional know if you are taking any of the following:

• Alcohol - Effects such as drowsiness may be worsened.

• Anticholinergics (medicine for abdominal or stomach spasms or cramps) - Side effects, such as dryness of mouth, of antihistamines or anticholinergics may be more likely to occur

• Central nervous system (CNS) depressants - Effects, such as drowsiness, of CNS depressants or antihistamines may be worsened

• Digitalis glycosides (e.g., Digoxin) - Use of this medicine may affect heartbeats.

• Maprotiline (e.g., Ludiomil) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) - Effects, such as drowsiness, of CNS depressants or antihistamines may be worsened; also, taking these medicines together may cause some of their side effects, such as dryness of mouth, to become more severe

• Monoamine oxidase (MAO) inhibitor activity ( isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) - If you are now taking, or have taken within the past 2 weeks, any of the MAO inhibitors, the side effects of the antihistamines may become more severe; these medicines should not be used together

• Rauwolfia alkaloids (alseroxylon [e.g., Rauwiloid], deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil]) - These medicines may increase or decrease the effect of the decongestant

Also, if you are taking one of the combinations containing pseudoephedrine and are also taking:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Appetite suppressants (diet pills), except fenfluramine (e.g., Pondimin) or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet) or
• Pemoline (e.g., Cylert) - Using any of these medicines together with an antihistamine and decongestant combination may cause excessive stimulant side effects, such as difficulty in sleeping, heart rate problems, nervousness, and irritability

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propanolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren]) - Using any of these medicines together with an antihistamine and decongestant combination may cause high blood pressure and heart problems (e.g., unusually slow heartbeat)

Other medical problems - The presence of other medical problems may affect the use of antihistamine and decongestant combinations. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes) - The decongestant in this medicine may put diabetic patients at a greater risk of having heart or blood vessel disease

• Enlarged prostate or
• Urinary tract blockage or difficult urination - Some of the effects of antihistamines may make urinary problems worse

• Glaucoma - A slight increase in inner eye pressure may occur

• Heart or blood vessel disease or
• High blood pressure - The decongestant in this medicine may cause the blood pressure to increase and may also speed up the heart rate

• Kidney disease - Higher blood levels of loratadine may result, which may increase the chance of side effects. The dosage of loratadine-containing combination may need to be reduced
• Liver disease - Higher blood levels of loratadine may result, which may increase the chance of side effects

• Overactive thyroid - If the overactive thyroid has caused a fast heart rate, the decongestant in this medicine may cause the heart rate to speed up further

• Urinary retention - Condition may be worsened with use of pseudoephedrine