Lodrane D

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use this medication if you are allergic to brompheniramine or pseudoephedrine.

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

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

• a blockage in your stomach or intestines;

• kidney or liver disease;

• high blood pressure, heart disease, coronary artery disease, or recent heart attack;

• enlarged prostate or urination problems;

• glaucoma;

• diabetes;

• epilepsy or other seizure disorder;

• pheochromocytoma (an adrenal gland tumor);

• overactive thyroid; or

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

It is not known whether brompheniramine and pseudoephedrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

It is not known whether brompheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medicine.

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

Since cold medicine 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.

Drinking alcohol can increase certain side effects of brompheniramine and pseudoephedrine.

Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Many combination medicines contain brompheniramine or pseudoephedrine. Taking certain products together can cause you to get too much of this medicine.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

• If you take Lodrane D on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to brompheniramine / pseudoephedrine: oral capsule, oral capsule extended release, oral elixir, oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Nervous system

A few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of brompheniramine extended over a period of up to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms in these patients. Spasmodic torticollis has been reported in a child given brompheniramine over an eight month period.[Ref]

Nervous system side effects of brompheniramine have included central nervous system (CNS) depression, resulting in drowsiness and sedation in nearly 50% of patients treated. This effect has often been transient and ceased with continued use. Motor skills have be impaired and patients should be advised to avoid tasks which require attention. Patients should also avoid concomitant use with alcohol and other sedative-hypnotic drugs. Dyskinesias have rarely been reported following chronic use of brompheniramine. Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects of brompheniramine have include nausea, dry mouth and constipation. 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.[Ref]

Cardiovascular

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

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]

Ocular

Ocular side effects of brompheniramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Hematologic

Hematologic side effects of brompheniramine have included rare cases of hemolytic anemia, thrombocytopenia, and agranulocytosis.[Ref]

Hypersensitivity

Hypersensitivity side effects in patients receiving pseudoephedrine have included fixed drug eruptions.[Ref]

Genitourinary

Genitourinary side effects of brompheniramine have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention.[Ref]

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