Anaplex HD

Generic Name: brompheniramine, hydrocodone, and pseudoephedrine (brom fen EER a meen, hye droe KOE dohn, soo doe e FED rin)Brand Names: Anaplex HD, Bromcomp HC, Bromph HD, Bromplex HD, BroveX HC, Drocon-CS, Endacof HC, J-Tan D HC, M-END, SymTan A, Visvex

What is Anaplex HD (brompheniramine, hydrocodone, and pseudoephedrine)?

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

Hydrocodone is in a group of drugs called narcotics and is similar to codeine. Hydrocodone is a cough suppressant that affects the signals in the brain that trigger cough reflex.

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

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

Brompheniramine, hydrocodone, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Anaplex HD (brompheniramine, hydrocodone, and pseudoephedrine)?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. Do not take this medication with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.What should I discuss with my healthcare provider before taking Anaplex HD (brompheniramine, hydrocodone, and pseudoephedrine)?Do not use this medication if you are allergic to hydrocodone or other narcotic pain relievers such as fentanyl (Actiq, Duragesic), hydromorphone (Dilaudid, Palladone), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (OxyContin), and oxymorphone (Opana). Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking brompheniramine, hydrocodone, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• kidney or liver disease;

• heart disease or high blood pressure;

• enlarged prostate or urination problems;

• diabetes;

• glaucoma;

• a thyroid disorder;

• asthma, COPD, sleep apnea, or other breathing disorders;

• a history of head injury or brain tumor;

• epilepsy or other seizure disorder;

• low blood pressure;

• gallbladder disease;

• Addison's disease or other adrenal gland disorders;

• mental illness; or

• a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. Hydrocodone may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.How should I take Anaplex HD (brompheniramine, hydrocodone, and pseudoephedrine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cough or cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

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 to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydrocodone can be fatal. Overdose symptoms may include extreme dizziness or drowsiness, confusion, feeling restless or nervous, cold and clammy skin, warmth or tingly feeling, nausea, vomiting, slow or shallow breathing, slow heart rate, pinpoint pupils, fainting, seizure (convulsions), or coma.What should I avoid while taking Anaplex HD (brompheniramine, hydrocodone, and pseudoephedrine)?This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Do not drink alcohol while you are taking this medication. Alcohol can increase some of the side effects of brompheniramine, hydrocodone, and pseudoephedrine. Do not take this medication with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Life-threatening side effects may result.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Brompheniramine and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains brompheniramine or pseudoephedrine.

Anaplex HD (brompheniramine, hydrocodone, and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeats;

• shallow breathing, slow heartbeat;

• severe dizziness, fainting, anxiety, restless feeling, nervousness, or tremor;

• confusion, hallucinations, unusual thoughts or behavior;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

• urinating less than usual or not at all; or

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects may include:

• blurred vision;

• dry mouth;

• nausea, vomiting, stomach pain, constipation, mild loss of appetite;

• mild dizziness, drowsiness;

• problems with memory or concentration;

• ringing in your ears;

• warmth, tingling, or redness under your skin;

• restless or excitability (especially in children);

• sleep problems (insomnia); or

• skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Anaplex HD (brompheniramine, hydrocodone, and pseudoephedrine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• cimetidine (Tagamet);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• zidovudine (Retrovir, AZT);

• antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

• aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

• a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;

• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

• a diuretic (water pill), or blood pressure medication;

• medication to treat irritable bowel syndrome;

• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril); or

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with brompheniramine, hydrocodone, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine, hydrocodone, and pseudoephedrine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.06. Revision Date: 4/12/2009 4:45:11 PM.