Generic Name: brompheniramine, dextromethorphan, and pseudoephedrine (brom fen EER a meen, dex troe me THOR fan, soo doe e FED rin)
Brand Names: Allanhist PDX Drops, Anaplex DM, Anaplex DMX, Andehist DM NR Syrup, Brom Tann, Brometane DX, Bromfed DM, Bromhist PDX, Bromhist-DM Drops, Bromophed-DX, Bromph DM, Bromplex DM, BroveX PSB DM, BroveX PSE DM, Carbofed DM Syrup, Dallergy DM, EndaCof-DM, Histacol BD Drops, Myphetane DX Cough, PBM Allergy, Pediahist DM Drops, ProHist DM, Q-Tapp DM, Resperal-DM Drops, Robitussin Allergy & Cough, Sildec DM

What is Myphetane DX (brompheniramine, dextromethorphan, 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.

Dextromethorphan is a cough suppressant. It 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, dextromethorphan, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, cough, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Brompheniramine, dextromethorphan, 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 Myphetane DX (brompheniramine, dextromethorphan, and pseudoephedrine)?

Do not give this medication to a child younger than 2 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. 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 a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. 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. Brompheniramine, dextromethorphan, and pseudoephedrine 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 drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking Myphetane DX (brompheniramine, dextromethorphan, and pseudoephedrine)?

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.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine, dextromethorphan, and pseudoephedrine if you have:

• kidney disease;

• diabetes;

• glaucoma;

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• emphysema or chronic bronchitis;

• an enlarged prostate; or

• problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine, dextromethorphan, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Myphetane DX (brompheniramine, dextromethorphan, and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 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.

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 the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough and 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.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Myphetane DX (brompheniramine, dextromethorphan, 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 drinking alcohol. It can increase some of the side effects of this medication.

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. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Myphetane DX (brompheniramine, dextromethorphan, 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 heartbeat;

• slow, shallow breathing;

• confusion, hallucinations, unusual thoughts or behavior;

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

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

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

• urinating less than usual or not at all.

Less serious side effects may include:

• dry mouth;

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

• blurred vision;

• warmth, tingling, or redness under your skin;

• sleep problems (insomnia);

• restless or excitability (especially in children);

• skin rash or itching;

• dizziness, drowsiness, or headache;

• problems with memory or concentration; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Myphetane DX (brompheniramine, dextromethorphan, and pseudoephedrine)?

Tell your doctor if you regularly use other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by brompheniramine.

Tell your doctor about all other medications you use, especially:

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

• medication to treat irritable bowel syndrome;

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

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

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

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

This list is not complete and there may be other drugs that can interact with brompheniramine, dextromethorphan, 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, dextromethorphan, 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: 5.11. Revision Date: 11/19/2009 1:45:15 PM.

Generic Name: brompheniramine, dextromethorphan, and pseudoephedrine (brom fen EER a meen, dex troe me THOR fan, soo doe e FED rin)
Brand Names: Allanhist PDX Drops, Anaplex DM, Anaplex DMX, Andehist DM NR Syrup, Brom Tann, Brometane DX, Bromfed DM, Bromhist PDX, Bromhist-DM Drops, Bromophed-DX, Bromph DM, Bromplex DM, BroveX PSB DM, BroveX PSE DM, Carbofed DM Syrup, Dallergy DM, EndaCof-DM, Histacol BD Drops, Myphetane DX Cough, PBM Allergy, Pediahist DM Drops, ProHist DM, Q-Tapp DM, Resperal-DM Drops, Robitussin Allergy & Cough, Sildec DM

What is Myphetane DX Cough (brompheniramine, dextromethorphan, 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.

Dextromethorphan is a cough suppressant. It 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, dextromethorphan, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, cough, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Brompheniramine, dextromethorphan, 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 Myphetane DX Cough (brompheniramine, dextromethorphan, and pseudoephedrine)?

Do not give this medication to a child younger than 2 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. 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 a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. 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. Brompheniramine, dextromethorphan, and pseudoephedrine 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 drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking Myphetane DX Cough (brompheniramine, dextromethorphan, and pseudoephedrine)?

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.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine, dextromethorphan, and pseudoephedrine if you have:

• kidney disease;

• diabetes;

• glaucoma;

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• emphysema or chronic bronchitis;

• an enlarged prostate; or

• problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine, dextromethorphan, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Myphetane DX Cough (brompheniramine, dextromethorphan, and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 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.

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 the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough and 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.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Myphetane DX Cough (brompheniramine, dextromethorphan, 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 drinking alcohol. It can increase some of the side effects of this medication.

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. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Myphetane DX Cough (brompheniramine, dextromethorphan, 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 heartbeat;

• slow, shallow breathing;

• confusion, hallucinations, unusual thoughts or behavior;

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

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

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

• urinating less than usual or not at all.

Less serious side effects may include:

• dry mouth;

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

• blurred vision;

• warmth, tingling, or redness under your skin;

• sleep problems (insomnia);

• restless or excitability (especially in children);

• skin rash or itching;

• dizziness, drowsiness, or headache;

• problems with memory or concentration; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Myphetane DX Cough (brompheniramine, dextromethorphan, and pseudoephedrine)?

Tell your doctor if you regularly use other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by brompheniramine.

Tell your doctor about all other medications you use, especially:

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

• medication to treat irritable bowel syndrome;

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

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

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

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

This list is not complete and there may be other drugs that can interact with brompheniramine, dextromethorphan, 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, dextromethorphan, 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: 5.11. Revision Date: 11/19/2009 1:45:15 PM.

Generic Name: Magnesium Salicylate/Phenyltoloxamine (mag-NEE-shum sa-LIS-ah-late/fen-ill-tole-OX-a-meen)
Brand Name: Examples include Magsal and Myogesic

Myogesic is used for:

Treating mild to moderate aches and pains associated with arthritis. It may also be used for other conditions as determined by your doctor.

Myogesic is a salicylate and antihistamine combination. It works by blocking substances in the body that cause fever, pain, and inflammation.

Do NOT use Myogesic if:

• you are allergic to any ingredient in Myogesic
• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, celecoxib, ibuprofen, naproxen)
• you have bleeding problems, such as hemophilia, von Willebrand disease, or low blood platelets
• you have lung problems (asthma, emphysema, chronic obstructive pulmonary disease [COPD]), difficulty urinating due to an enlarged prostate, or glaucoma
• you are a child or teenager with influenza (flu) or chickenpox
• you are taking an anticoagulant (eg, warfarin), methotrexate, or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Myogesic:

Some medical conditions may interact with Myogesic. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have bleeding problems, blood vessel problems in the brain, blockage of the stomach or bowel, chickenpox, flu, rheumatoid arthritis, Kawasaki syndrome, prostate problems, blockage of the bladder, or difficulty urinating
• if you have a history of asthma, growths in the nose (nasal polyps), kidney or liver problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, or vitamin K deficiency

Some MEDICINES MAY INTERACT with Myogesic. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease Myogesic’s effectiveness
• Anticoagulants (eg, warfarin) or NSAIDs (eg, celecoxib, ibuprofen, naproxen) because the risk of their side effects, including the risk of bleeding, may be increased by Myogesic
• Insulin, isoniazid, oral hypoglycemics (eg, glyburide), orsodium oxybate (GHB) because the risk of their side effects may be increased by Myogesic
• Methotrexate or valproic acid because the risk of their side effects may be increased by Myogesic
• Angiotensin-converting enzyme inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Myogesic

This may not be a complete list of all interactions that may occur. Ask your health care provider if Myogesic may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Myogesic:

Use Myogesic as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Myogesic by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take Myogesic with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Myogesic.
• Use Myogesic exactly as directed on the package, unless instructed differently by your doctor. If you are taking Myogesic without a prescription, follow any warnings and precautions on the label.
• If you miss a dose of Myogesic and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Myogesic.

Important safety information:

• Myogesic may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Myogesic with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Myogesic has a salicylate in it. Before you start any new medicine, check the label to see if it has a salicylate in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Myogesic has a salicylate in it, which has been linked to a serious illness called Reye syndrome. Do not give Myogesic to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Myogesic; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If you are taking Myogesic for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor.
• Serious stomach ulcers or bleeding can occur with the use of Myogesic. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Myogesic with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
• Myogesic may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Tell your doctor or dentist that you take Myogesic before you receive any medical or dental care, emergency care, or surgery.
• Myogesic should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Myogesic during the last 3 months of pregnancy; it may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Myogesic while you are pregnant. Myogesic is found in breast milk. If you are or will be breast-feeding while you use Myogesic, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Myogesic:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black stools; confusion; dark urine or pale stools; decreased urination; diarrhea; difficulty swallowing; dizziness; hearing loss; hoarseness; persistent sore throat or other signs of infection; ringing in the ears; severe stomach pain; unusual bruising or bleeding; unusual tiredness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include abnormal behavior; dark urine; excessive sweating; extreme tiredness; fast or deep breathing; loss of consciousness; ringing in the ears; stomach pain; vomiting.

Proper storage of Myogesic:

Store Myogesic at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Myogesic out of the reach of children and away from pets.

General information:

• If you have any questions about Myogesic, please talk with your doctor, pharmacist, or other health care provider.
• Myogesic is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Myogesic. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Acetaminophen/Phenyltoloxamine (ah-seet-ah-MIN-oh-fen/fen-ill-tole-OX-a-meen)
Brand Name: Examples include Lagesic and Myophen

Myophen Controlled-Release Tablets are used for:

Treating mild to moderate aches and pains associated with headache, muscle and joint soreness, backache, menstrual cramps, colds and flu, sinusitis, toothache, and minor pain from arthritis, and to reduce fever. It may also be used for other conditions as determined by your doctor.

Myophen Controlled-Release Tablets are an analgesic, antihistamine, and antipyretic combination. It works by blocking substances in the body that cause fever, pain, and inflammation. It also blocks histamine, which causes sneezing and itchy, watery eyes.

Do NOT use Myophen Controlled-Release Tablets if:

• you are allergic to any ingredient in Myophen Controlled-Release Tablets
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Myophen Controlled-Release Tablets:

Some medical conditions may interact with Myophen Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have bleeding problems, blood vessel problems in the brain, a blockage of the stomach or bowel, a blockage of the bladder, or difficulty urinating
• if you have lung problems (eg, asthma, emphysema, chronic obstructive pulmonary disease [COPD]), an enlarged prostate, glaucoma, kidney problems, or liver problems

Some MEDICINES MAY INTERACT with Myophen Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Isoniazid, monoamine oxidase (MAO) inhibitors (eg, phenelzine), or sodium oxybate (GHB) because the risk of side effects may be increased
• Anticoagulants (eg, warfarin) because the risk of side effects, including the risk of bruising or bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Myophen Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Myophen Controlled-Release Tablets:

Use Myophen Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Myophen Controlled-Release Tablets may be taken with or without food.
• Swallow Myophen Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Myophen Controlled-Release Tablets and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Myophen Controlled-Release Tablets.

Important safety information:

• Myophen Controlled-Release Tablets may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Myophen Controlled-Release Tablets. Using Myophen Controlled-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Myophen Controlled-Release Tablets contains acetaminophen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.
• Avoid taking medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Myophen Controlled-Release Tablets. Myophen Controlled-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not exceed the recommended dosage or take Myophen Controlled-Release Tablets for longer than prescribed without checking with your doctor.
• If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Myophen Controlled-Release Tablets or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Myophen Controlled-Release Tablets may increase your risk for liver damage.
• If you are taking Myophen Controlled-Release Tablets for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor.
• Before you have any medical or dental treatments or surgery, tell the doctor or dentist that you are taking Myophen Controlled-Release Tablets.
• Caution is advised when using Myophen Controlled-Release Tablets in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: It is unknown if Myophen Controlled-Release Tablets can cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Myophen Controlled-Release Tablets during pregnancy. Myophen Controlled-Release Tablets are excreted in breast milk. Do not breast-feed while taking Myophen Controlled-Release Tablets.

Possible side effects of Myophen Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dark urine or pale stools; decreased urination; severe stomach pain; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include abnormal behavior; dark urine; excessive sweating; extreme tiredness; fast or deep breathing; loss of consciousness; ringing in the ears; stomach pain; vomiting.

Proper storage of Myophen Controlled-Release Tablets:

Store Myophen Controlled-Release Tablets at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Myophen Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Myophen Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Myophen Controlled-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Myophen Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: alglucosidase alfa (injection) (AL gloo KOE si dase AL fa)
Brand Names: Myozyme

What is alglucosidase alfa?

Alglucosidase alfa contains an enzyme that naturally occurs in the body in healthy people. Some people lack this enzyme because of a genetic disorder. Alglucosidase alfa helps replace this missing enzyme in such people.

Alglucosidase alfa is used to treat a glycogen storage disorder called Pompe disease, (also called GAA deficiency).

Alglucosidase alfa may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about alglucosidase alfa?

Before receiving this medication, tell your doctor if you are allergic to mice, hamsters, or drug products made with “murine” proteins.

Alglucosidase alfa is given as an injection through a needle placed into a vein. You will receive this injection with an infusion pump in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

This medication is usually given every 2 weeks.

Some people receiving an injection of alglucosidase alfa have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, cold hands, blue lips, tightness in your chest or throat, wheezing, or trouble breathing during the injection.

What should I discuss with my health care provider before receiving alglucosidase alfa?

You should not use this medication if you are allergic to alglucosidase alfa.

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

• heart disease;

• lung disease or breathing disorder;

• if you are allergic to mice, hamsters, or drug products made with “murine” proteins.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alglucosidase alfa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is alglucosidase alfa given?

Alglucosidase alfa is given as an injection through a needle placed into a vein. You will receive this injection with an infusion pump in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

This medication is usually given every 2 weeks.

Before each injection, tell your doctor if you have recently been sick with a cold, flu, or other illness.

Your name may need to be listed on a patient registry for people with Pompe disease when you start using this medication.

What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. An overdose of alglucosidase alfa is not expected to produce life-threatening symptoms.

What should I avoid while receiving alglucosidase alfa?

There are no restrictions on food, beverages, or activity while receiving alglucosidase alfa unless your doctor has told you otherwise.

Alglucosidase alfa side effects

Some people receiving an injection of alglucosidase alfa have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, cold hands, blue lips, tightness in your chest or throat, wheezing, or trouble breathing during the injection.

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. Call your doctor at once if you have any of these serious side effects:

• fast, slow, or uneven heartbeats;

• weak pulse, fainting, slow breathing (breathing may stop);

• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;

• ongoing cough with heaviness in your chest;

• tremors or shaking;

• feeling light-headed, fainting;

• muscle weakness; or

• skin ulcers.

Other less serious side effects are more likely to occur, such as:

• headache;

• fever;

• diarrhea, nausea, vomiting, stomach pain;

• pain or fullness in your ear;

• runny or stuffy nose, sore throat, cough; or

• feeling irritable or agitated.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alglucosidase alfa?

There may be other drugs that can affect alglucosidase alfa. 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 has more information about alglucosidase alfa written for health professionals that you may read.

• 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 receiving, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 06/04/2009 9:56:31 AM.

Generic Name: gold sodium thiomalate (gold SOE dee um thye OH ma late)
Brand Names: Myochrysine

What is Myochrysine (gold sodium thiomalate)?

Gold sodium thiomalate is a form of gold. Gold suppresses the inflammatory process.

Gold sodium thiomalate is used as an injection to treat adult and juvenile rheumatoid arthritis.

Gold sodium thiomalate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Myochrysine (gold sodium thiomalate)?

Contact your doctor immediately if you experience itching, a rash, a sore mouth, indigestion, a metallic taste in the mouth, severe or bloody diarrhea, easy bruising, or a nosebleed. These could be early signs of a toxic effect.

In rare cases, exposure to sunlight may cause areas of the skin to turn a bluish-gray color. To lessen this effect, minimize exposure to sunlight and wear a sunscreen and protective clothing when exposure to the sun is unavoidable.

What should I discuss with my healthcare provider before taking Myochrysine (gold sodium thiomalate)?

Before taking gold sodium thiomalate, tell your doctor if you

• have ever had any type of reaction to a gold compound or to any other medication;

• have a history of bone marrow depression or blood problems;

• have kidney disease;
• have liver disease;

• have congestive heart failure, high blood pressure, or any other type of heart disease;

• have diabetes;

• have inflammatory bowel disease;

• have a rash; or

• have severe lung disease.

You may not be able to take gold sodium thiomalate, or you may require a dosage adjustment or special monitoring during your therapy if you have any of these conditions.

Gold sodium thiomalate is in the FDA pregnancy category C. This means that it is not known whether gold sodium thiomalate will be harmful to an unborn baby. Gold sodium thiomalate does cross the placenta, and may accumulate in the tissue of a baby. Do not take gold sodium thiomalate without first talking to your doctor if you are pregnant or could become pregnant during treatment. Gold sodium thiomalate passes into breast milk and may affect a nursing infant. Gold sodium thiomalate is not recommended for use during breast-feeding. Do not take gold sodium thiomalate without first talking to your doctor if you are breast-feeding a baby.

How should I take Myochrysine (gold sodium thiomalate)?

Gold sodium thiomalate is given by injection. Your doctor or nurse will administer your doses, usually on a weekly basis to begin with, then every other week to monthly, depending upon your response to the medication.

You may want to lie down after injections, and your doctor will want to monitor you for side effects for 10 to 15 minutes following each shot.

Gold sodium thiomalate can cause serious side effects involving white and red blood cells. Your doctor will want to test your blood and urine before each injection to monitor any changes before they become dangerous.

Do not stop using gold sodium thiomalate without first talking to your doctor. It may take up to 3 months for you to see any effects from this medication, and it may be 6 months or more before the full benefits are realized.

What happens if I miss a dose?

Doses are given on a weekly basis. You should receive the missed dose as soon as possible, but a double dose should not be injected to make up for a missed dose.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an gold sodium thiomalate overdose include blood in the urine, painful urination, fever, sores or ulcers in the mouth, nausea, vomiting, diarrhea, rash, and itching. A gold sodium thiomalate overdose can result in death.

What should I avoid while using Myochrysine (gold sodium thiomalate)?

In rare cases, exposure to sunlight may cause areas of the skin to turn a bluish-gray color. To lessen this effect, minimize exposure to sunlight and wear a sunscreen and protective clothing when exposure to the sun is unavoidable.

Myochrysine (gold sodium thiomalate) side effects

Stop taking gold sodium thiomalate and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Rarely, other serious side effects may also occur. Call your doctor immediately if you experience any of the following:

• itching or a rash;

• a sore mouth, indigestion, or a metallic taste in the mouth;

• severe or bloody diarrhea;

• easy bruising or a nosebleed;

• yellow skin or eyes;

• abdominal pain;

• seizures;

• confusion or hallucinations;

• blood in vomit or stools;

• blood in the urine or painful urination; or

• shortness of breath; or

• weakness, dizziness, nausea, vomiting, sweating, fainting, and flushing shortly after an injection.

In addition, less serious side effects may be more likely to occur. Talk to your doctor if you experience any of the following:

• diarrhea or loose stools;

• nausea, stomach upset, decreased appetite;

• changes in taste; or

• sores or ulcers in the mouth.

Arthritic symptoms may appear to worsen for 1 to 2 days following an injection and should decrease with subsequent injections.

Gold sodium thiomalate can cause serious side effects involving white and red blood cells. Your doctor will want to test your blood and urine before each injection to monitor any changes before they become dangerous.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Myochrysine (gold sodium thiomalate)?

Before using gold sodium thiomalate, tell your doctor and pharmacist about all prescription and over-the-counter medicines that you take, including vitamins, minerals, and herbal products, so that your treatment can be monitored for interactions.

Where can I get more information?

• Your pharmacist has more information about gold sodium thiomalate written for health professionals that you may read.

• 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: 3.06. Revision Date: 4/12/2009 4:36:40 PM.

Generic Name: Trolamine Salicylate (TROE-la-meen sa-LIS-i-late)
Brand Name: Examples include Aspercreme Cream and Myoflex Cream

Myoflex Cream is used for:

Temporarily relieving minor pain and inflammation.

Myoflex Cream is a topical salicylate pain reliever. It works by reducing swelling and inflammation in the muscle and joints.

Do NOT use Myoflex Cream if:

• you are allergic to any ingredient in Myoflex Cream
• you have had an allergic reaction to aspirin or other salicylate products

Contact your doctor or health care provider right away if any of these apply to you.

Before using Myoflex Cream:

Some medical conditions may interact with Myoflex Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Myoflex Cream. Because little, if any, of Myoflex Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Myoflex Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine

How to use Myoflex Cream:

Use Myoflex Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a generous amount to the affected area. Gently rub the medicine into the skin until it is completely absorbed.
• Do NOT apply to open wounds or to skin that is broken, damaged, or irritated in any way.
• Do not bandage or wrap the affected area unless directed otherwise by your doctor.
• Wash your hands immediately after using Myoflex Cream, unless they are part of the treated area.
• Do not use Myoflex Cream more than 4 times per day, unless your doctor tells you to.
• If you miss a dose of Myoflex Cream, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Myoflex Cream.

Important safety information:

• Do NOT get Myoflex Cream in the eyes, mouth, or nose.
• Tell your doctor if the painful area is red of if the skin becomes irritated.
• Tell your doctor if your symptoms clear up and then return within a few days.
• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.
• Myoflex Cream should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Myoflex Cream while you are pregnant. It is not known if Myoflex Cream is found in breast milk after topical use.

Possible side effects of Myoflex Cream:

All medicines may cause side effects, but many people have no, or minor side effects. No COMMON side effects have been reported with Myoflex Cream. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); skin redness or irritation

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Myoflex Cream:

Store away from heat, moisture, and light. Do not store in the bathroom. Keep Myoflex Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Myoflex Cream, please talk with your doctor, pharmacist, or other health care provider.
• Myoflex Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Myoflex Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: rimabotulinumtoxinB (Myobloc) (RYE ma BOT ue LYE num TOX in B)
Brand Names: Myobloc

What is rimabotulinumtoxinB (Myobloc)?

RimabotulinumtoxinB (Myobloc), also called botulinum toxin type B, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Myobloc is used to treat cervical dystonia (severe spasms in the neck muscles).

Myobloc may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Myobloc?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection. Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin, or if you have a skin infection in the area where the medicine will be injected.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

What should I discuss with my healthcare provider before I receive Myobloc?

You should not receive this medication if you are allergic to botulinum toxin, or if you have a skin infection in the area where the medicine will be injected. Tell your doctor if you have ever had a side effect after receiving botulinum toxin in the past.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• amyotrophic lateral sclerosis (ALS, or “Lou Gehrig’s disease”);

• myasthenia gravis;

• Lambert-Eaton syndrome;

• a breathing problem such as asthma or emphysema;

• problems with swallowing;

• bleeding problems;

• if you are planning to have surgery; or

• if you have ever received other botulinum toxin injections such as Botox or Dysport (especially in the last 4 months).

Myobloc is made using human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not know whether botulinum toxin is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether botulinum toxin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is Myobloc given?

This medication is injected into a muscle. A doctor, nurse, or other healthcare provider will give you this injection. Myobloc injections should be spaced at least 3 months apart.

Your injection may be given into more than one area at a time, depending on the condition being treated.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin. Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving Myobloc?

Myobloc may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.

Myobloc 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.

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

• trouble breathing, talking, or swallowing;

• hoarse voice, drooping eyelids;

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

• loss of bladder control;

• problems with vision; or

• chest pain.

Less serious side effects may include:

• pain or muscle weakness near where the medicine was injected;

• headache, joint or back pain;

• dry mouth, nausea, upset stomach;

• fever, cough, sore throat, flu symptoms;

• pain or stiffness in your neck; or

• dizziness, drowsiness, anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect botulinum toxin type B?

Other drugs such as cold or allergy medicines, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medications, and irritable bowel medications can increase some of the side effects of Myobloc. Tell your doctor if you regularly use any of these medicines.

Tell your doctor about all other medicines you use, especially:

• an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), paromomycin (Humatin, Paromycin), streptomycin, tobramycin (Nebcin, Tobi).

This list is not complete and other drugs may interact with Myobloc. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Myobloc (rimabotulinumtoxinB).

• 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: 2.02. Revision Date: 03/17/2010 3:59:40 PM.

Generic Name: Simethicone (sih-METH-ih-cone)
Brand Name: Examples include Genasyme and Mylicon

Mylicon Suspension is used for:

Relieving pressure, bloating, and gas in the digestive tract. It may also be used for other conditions as determined by your doctor.

Mylicon Suspension is an antiflatulent. It works by breaking up gas bubbles, which makes gas easier to eliminate.

Do NOT use Mylicon Suspension if:

• you are allergic to any ingredient in Mylicon Suspension

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mylicon Suspension:

Some medical conditions may interact with Mylicon Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Mylicon Suspension. However, no specific interactions with Mylicon Suspension are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mylicon Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mylicon Suspension:

Use Mylicon Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Mylicon Suspension as needed after meals and at bedtime, unless otherwise directed by your doctor.
• Shake Mylicon Suspension well before using. Fill the enclosed dropper to the recommended dose level and dispense liquid slowly into the infant’s mouth, toward the inner cheek.
• The dose may be mixed with 1 ounce cool water, infant formula, or juice. Do not add Mylicon Suspension to hot liquid.
• Clean dropper after each use and replace original cap.
• If you miss a dose of Mylicon Suspension and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mylicon Suspension.

Important safety information:

• Do not exceed the recommended dose without checking with your doctor.
• If your condition persists, contact your health care provider.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Mylicon Suspension, discuss with your doctor the benefits and risks of using Mylicon Suspension during pregnancy. It is unknown if Mylicon Suspension is excreted in breast milk. If you are or will be breast-feeding while you are taking Mylicon Suspension, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Mylicon Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Mylicon Suspension:

Store Mylicon Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mylicon Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Mylicon Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Mylicon Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Mylicon Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.