Allerphed

Triprolidine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of pseudoephedrine and triprolidine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Pseudoephedrine and triprolidine may also be used for purposes not listed in this medication guide.

Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or a thyroid disorder.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

• diabetes;

• liver or kidney disease;

• epilepsy or other seizure disorder;

• cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor); or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether pseudoephedrine and triprolidine will harm an unborn baby. Do not use this medicine without medical advice if you are pregnant.

Pseudoephedrine and triprolidine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Since this medicine is taken when 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.

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of triprolidine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble passing urine.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Shortness of breath.
• Shakiness.
• Seizures.
• Blurred eyesight.

Applies to pseudoephedrine / triprolidine: oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet extended release

Cardiovascular

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (stimulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]

Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.[Ref]

Nervous system

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported with the use of pseudoephedrine. Antihistamines such as triprolidine have been reported to cause drowsiness.[Ref]

Gastrointestinal

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients receiving pseudoephedrine. Antihistamines such as triprolidine have also been reported to cause dry mouth. Pseudoephedrine-triprolidine may cause diarrhea.[Ref]

Hypersensitivity

Hypersensitivity side effects with the use of pseudoephedrine have included fixed drug eruptions.[Ref]

Some side effects of Allerphed may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.