Generic Name: sodium chloride (Ophthalmic route)

SOE-dee-um KLOR-ide

Commonly used brand name(s):

In the U.S.

• AK-NaCl
• Muro-128
• OcuFresh
• Sochlor

In Canada

• Cordema
• Eye Wash
• In A Wink Daily Cleaner
• In A Wink Neutralizing Rinse

Available Dosage Forms:

• Solution
• Ointment

Therapeutic Class: Osmotherapy Agent

Uses For Eye Wash

Hypertonic sodium chloride solution for the eye is used to draw water out of a swollen cornea. The extra water in the cornea can cause your vision to be poor. You may also see halos or rings around point light sources. The cornea is the clear cover over the colored part of your eye.

This medicine is available only with your doctor’s prescription.

Before Using Eye Wash

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of hypertonic sodium chloride in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of hypertonic sodium chloride in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of sodium chloride

This section provides information on the proper use of a number of products that contain sodium chloride. It may not be specific to Eye Wash. Please read with care.

To use:

• The bottle is only partially full to provide proper drop control.
• First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution (eye drops) dosage form:
  • For swelling of the cornea:
    • Adults—Use 1 drop every three or four hours.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Eye Wash

Use only under the advice and supervision of a doctor.

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if your symptoms continue for more than 3 days or become worse, check with your doctor.

Importance of not contaminating the product. Do not touch the tip of the container to the eye or any surface.

Do not use if the solution changes color or becomes cloudy.

Replace cap after each use. Store container upright.

Eye Wash Side Effects

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

• temporary burning sensation of the eye
• temporary eye irritation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: eyebright (EYE brite)
Brand Names:

What is eyebright?

The use of eyebright in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

Eyebright is also known as Euphrasia officinalis and euphrasia.

Eyebright has been used for congestion of the nose, sinuses, and eyes; inflammation of the eyelids; eye styes; eye fatigue symptoms; other eye disorders; and coughs and hoarseness. Since the efficacy of eyebright has not been proven in the treatment of eye disorders and application to the eyes may be unsanitary, the use of eyebright in the eye is generally not recommended.

Eyebright has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of eyebright may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Eyebright may also have uses other than those listed in this medication guide.

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

Since the efficacy of eyebright has not been proven in the treatment of eye disorders and application to the eyes may be unsanitary, the use of eyebright in the eyes is generally not recommended.

Inflammation or irritation of the eyes could be signs of a potentially serious infection. Eyebright should not be used to treat an eye condition without consulting a physician. Eyebright should also not be used in the eyes if you wear any type of contact lenses or if you have had any recent eye surgery (laser vision correction, cataract surgery, cornea transplant surgery, etc.).

Eyebright has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of eyebright may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Who should not use eyebright?

Inflammation or irritation of the eyes could be signs of a potentially serious infection. Eyebright should not be used to treat an eye condition without consulting a physician. Eyebright should also not be used in the eyes if you wear any type of contact lenses or if you have had any recent eye surgery (laser vision correction, cataract surgery, cornea transplant surgery, etc.).

Before using eyebright, talk to your doctor, pharmacist, or health care professional if you have allergies (especially to plants), have any medical condition, or if you take other medicines or other herbal/health supplements. Eyebright may not be recommended in some situations.

Do not use eyebright without first talking to your doctor if you are pregnant or could become pregnant. It is not known whether eyebright will harm an unborn baby. Do not use eyebright without first talking to your doctor if you are breast-feeding a baby. It is also not known whether eyebright will harm a nursing infant. There is no information available regarding the use of eyebright by children. Do not give any herbal/health supplement to a child without first talking to the child’s doctor.

How should I use eyebright?

The use of eyebright in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

If you choose to use eyebright, use it as directed on the package or as directed by your doctor, pharmacist, or other health care provider.

Since the efficacy of eyebright has not been proven in the treatment of eye disorders and application to the eyes may be unsanitary, the use of eyebright in the eyes is generally not recommended.

Standardized extracts, tinctures, and solid formulations of herbal/health supplements may provide a more reliable dose of the product.

To ensure the correct dose, measure the liquid forms of eyebright with a dropper or a dose-measuring spoon or cup.

Do not use different formulations (e.g., liquids, teas, and others) of eyebright at the same time, unless specifically directed to do so by a health care professional. Using different formulations together increases the risk of an overdose of eyebright.

Store eyebright as directed on the package. In general, eyebright should be protected from light and moisture.

What happens if I miss a dose?

No information is available regarding a missed dose of eyebright. Consult your doctor, pharmacist, or health care professional if you require further information.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an eyebright overdose are not known.

What should I avoid while using eyebright?

There are no restrictions on food, beverages, or activity while using eyebright, unless otherwise directed by your health care provider.

Eyebright side effects

Although rare, allergic reactions to eyebright may occur. Stop using eyebright and seek emergency medical attention if you experience symptoms of a serious allergic reaction including difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives.

Other side effects have been reported with the use of large amounts of eyebright. Stop using eyebright and consult your doctor or health care professional if you experience

• pressure in the eyes causing tearing, itching, redness, or swelling of the eyelids;

• eye sensitivity to light;

• dim vision;

• confusion;

• weakness;

• sneezing or runny nose;

• toothache;

• constipation;

• hoarseness, cough, or shortness of breath;

• yawning;

• insomnia;

• sweating; or

• increased urination.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect eyebright?

Interactions between eyebright and other prescription or over-the-counter medicines or herbal/health supplements have not been reported. Talk to your doctor, pharmacist, or health care professional before taking eyebright if you are taking any other medicines or supplements.

Where can I get more information?

• Your doctor, pharmacist, or health care provider may have more information about eyebright.

• Consultation with a licensed health care professional is advisable before using any herbal/health supplement. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial and coordination of treatment among all health care providers involved may be advantageous. Remember, keep this and all other prescription drug products, over-the-counter drug products, and herbal/health supplements out of the reach of children.
• 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: 1.03. Revision Date: 2/13/04 4:08:22 PM.

Generic Name: Dexchlorpheniramine/Phenylephrine/Methscopolamine (DEX-klor-fen-IR-a-meen/FEN-il-EF-rin/METH-skoe-POL-a-meen)
Brand Name: Examples include Dexphen M and Extendryl

Extendryl Solution is used for:

Relieving nasal and chest congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or allergies. It is also used to make a dry cough more productive and less frequent. It may also be used for other conditions as determined by your doctor.

Extendryl Solution is an antihistamine, decongestant, and anticholinergic combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The anticholinergic works by drying mucous membranes in the nose and airway.

Do NOT use Extendryl Solution if:

• you are allergic to any ingredient in Extendryl Solution
• you are pregnant or breast-feeding
• you are taking droxidopa, furazolidone, sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days
• you have severe heart blood vessel problems, severe high blood pressure, narrow-angle glaucoma, difficulty urinating due to enlarged prostate, peptic ulcer, or uncontrolled bleeding
• you are having an asthma attack
• the patient is a newborn or infant

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

Before using Extendryl Solution:

Some medical conditions may interact with Extendryl Solution. 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 are taking or have taken medicine for high blood pressure or depression in the last 14 days, or if you take potassium chloride
• if you have bladder blockage, blood vessel problems (eg, hardening of the arteries), diabetes, an enlarged prostate, glaucoma or increased pressure in the eye, nerve problems, memory problems, heart problems (eg, fast or irregular heartbeat, heart failure), heart blood vessel problems, high blood pressure, kidney or liver problems, lung or breathing problems (eg asthma, sleep apnea), a hiatal hernia, esophagus problems, stomach or bowel problems (eg, ulcerative colitis), mental or mood problems (eg, depression), an adrenal gland tumor (pheochromocytoma), myasthenia gravis (muscle weakness), stomach or bowel problems (eg, constipation, inflammation, motility problems, blockage), trouble sleeping, or an overactive thyroid
• if the patient is a child who has Down syndrome, spastic paralysis, or brain damage
• if you have a history of alcohol abuse or if you are very ill

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

• Alkalizers (eg, calcium or magnesium antacids), alpha-blockers (eg, doxazosin), anesthetics (eg, chloroform, lidocaine), anticholinergics (eg, atropine, benztropine, dicyclomine), beta-blockers (eg, propranolol), carbonic anhydrase inhibitors (eg, acetazolamide), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), certain antidiarrheals (eg, bismuth subsalicylate), ergotamine, furazolidone, MAOIs (eg, phenelzine), sodium bicarbonate, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Extendryl Solution’s side effects
• Bromocriptine, certain stimulants (eg, doxapram, pseudoephedrine), digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by Extendryl Solution
• Guanadrel, guanethidine, mecamylamine, methyldopa, reserpine, or other medicine for high blood pressure because their effectiveness may be decreased by Extendryl Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Extendryl Solution 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 Extendryl Solution:

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

• Take Extendryl Solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Do not take Extendryl Solution at the same time as antacids, certain medicines for diarrhea (eg, attapulgite, bismuth, kaolin, pectin), or ketoconazole. Take these medicines 2 or 3 hours before or after taking Extendryl Solution.
• If you miss a dose of Extendryl Solution 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 Extendryl Solution.

Important safety information:

• Extendryl Solution may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Extendryl Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Extendryl Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• The risk of dizziness, nervousness, and trouble sleeping may be greater if you take Extendryl Solution in high doses or for a long time. Do NOT take more than the recommended dose without checking with your doctor.
• If your cough or other symptoms persist for more than 1 week, if they come back, or if you also have fever, rash, or persistent headache, check with your doctor.
• Tell your doctor or dentist that you take Extendryl Solution before you receive any medical or dental care, emergency care, or surgery.
• Extendryl Solution may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
• Extendryl Solution may reduce sweating. Do not become overheated in hot weather or during exercise or other activities because heatstroke may occur.
• Extendryl Solution may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Extendryl Solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Extendryl Solution may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Extendryl Solution has phenylephrine and an antihistamine in it. Before you start any new medicine, check the label to see if it has phenylephrine or an antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Diabetes patients – Extendryl Solution may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Extendryl Solution may interfere with certain lab test results. Be sure your doctors and laboratory personnel know that you are taking Extendryl Solution.
• Lab tests, including blood pressure and eye pressure, may be performed while you use Extendryl Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Extendryl Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially excitability, agitation, drowsiness, or confusion.
• Extendryl Solution should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• Caution is advised when using Extendryl Solution in CHILDREN; they may be more sensitive to its effects, especially excitability.
• PREGNANCY and BREAST-FEEDING: It is not known if Extendryl Solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Extendryl Solution while you are pregnant. Extendryl Solution is found in breast milk. Do not breast-feed while taking Extendryl Solution.

Possible side effects of Extendryl Solution:

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:

Blurred vision; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); giddiness; headache; lightheadedness; loss of appetite; nausea; nervousness; stomach upset; trouble sleeping; unsteadiness; unusual tiredness or weakness.

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); fast or irregular heartbeat; fever or sore throat; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness; severe sunburn; shortness of breath; tingling in hands or feet; tremor; unusual bruising or bleeding; 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 irregular heartbeat; mental or mood changes (eg, confusion, anxiety); pupil enlargement; seizure; severe dizziness, drowsiness, headache, nausea, or vomiting; tremor; trouble swallowing.

Proper storage of Extendryl Solution:

Store Extendryl Solution in a tightly closed container between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Keep Extendryl Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Extendryl Solution, please talk with your doctor, pharmacist, or other health care provider.
• Extendryl Solution 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 Extendryl Solution. 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: chlorpheniramine, methscopolamine, and phenylephrine (KLOR fe NEER a meen, METH skoe POL a meen, FEN il EFF rin)
Brand Names: Aerohist Plus, Ah-Chew, Chlor-Mes, Dallergy, Denaze, Duradryl, Durahist PE, DuraTan PE, Extendryl Chews, Histatab PH, Omnihist L.A., Ralix, Redur-PCM, Rescon MX

What is Extendryl Chews (chlorpheniramine, methscopolamine, and phenylephrine)?

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

Methscopolamine is an anticholinergic (an-tye-kol-in-URJ-ik) that has a drying effect on the nasal passages.

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

The combination of chlorpheniramine, methscopolamine, and phenylephrine is used to treat runny nose, sneezing, itchy throat, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Chlorpheniramine, methscopolamine, and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Extendryl Chews (chlorpheniramine, methscopolamine, and phenylephrine)?

Do not use this 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 cold or allergy medicine before the MAO inhibitor has cleared from your body.

Before using this medicine, tell your doctor if you have heart disease, high blood pressure, or a heart rhythm disorder, circulation problems, glaucoma, diabetes, a thyroid disorder, kidney disease, or problems with urination.

Do not use any other over-the-counter cold, cough, or allergy 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 chlorpheniramine or phenylephrine. Talk with your doctor if your symptoms do not improve after 5 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my health care provider before taking Extendryl Chews (chlorpheniramine, methscopolamine, and phenylephrine)?

Do not take this medication if you are allergic to chlorpheniramine, methscopolamine, phenylephrine, or to other cold or allergy medicines, diet pills, stimulants, or ADHD medications. Do not use this 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 a cold or allergy medicine before the MAO inhibitor has cleared from your body.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease, high blood pressure, or a heart rhythm disorder;

• a blood vessel disorder or circulation problems;

• glaucoma;

• diabetes;

• a thyroid disorder;

• kidney disease;

• asthma;

• 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. This medication can decrease breast milk production, and also 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.

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 Extendryl Chews (chlorpheniramine, methscopolamine, and phenylephrine)?

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. Cold medicine is usually taken for only a short time until your symptoms clear up.

Take this medicine with a full glass of water. It is best to take this medicine with food.

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. The suspension liquid form should be shaken well just before you measure a dose.

Do not crush, chew, break, or open an extended-release tablet unless your doctor tells you to. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. However, some extended-release pills can be broken to split the dose. Ask your doctor or pharmacist if you have questions.

The chewable tablet must be chewed completely before you swallow it.

Tell your doctor if your symptoms do not improve after 5 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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?

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, extreme drowsiness, confusion, hallucinations, uneven heart rate, fainting, or seizure (convulsions).

What should I avoid while taking Extendryl Chews (chlorpheniramine, methscopolamine, and phenylephrine)?

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.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine or methscopolamine. Tell your doctor if you need to use any of these other medicines.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.

Do not use any other over-the-counter cold, cough, or allergy medication without first asking your doctor or pharmacist. Chlorpheniramine and phenylephrine are contained in many medicines available over the counter. 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 chlorpheniramine or phenylephrine. Avoid drinking alcohol. It can add to drowsiness caused by an antihistamine.

Extendryl Chews (chlorpheniramine, methscopolamine, and phenylephrine) 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;

• confusion, hallucinations, unusual thoughts or behavior;

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

• urinating less than usual or not at all;

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

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

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• blurred vision;

• dry mouth;

• nausea, stomach pain, constipation;

• mild loss of appetite;

• dizziness, drowsiness, headache;

• problems with memory or concentration;

• ringing in your ears;

• restlessness or excitability (especially in children);

• warmth, tingling, or redness under your skin;

• cold feeling in your hands or feet;

• 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 Extendryl Chews (chlorpheniramine, methscopolamine, and phenylephrine)?

Before taking this medication, tell your doctor if you are using any other antihistamine or decongestant pills, liquids, or nasal sprays. Also tell your doctor if you are using any of the following drugs:

• pramlintide (Symlin);

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

• an antidepressant such as amitriptyline (Elavil, Etrafon) or desipramine (Norpramin);

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

• a diuretic (water pill), or medicines to treat high blood pressure, angina (chest pain), or other heart conditions;

• medication to treat irritable bowel syndrome;

• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), risperidone (Risperdal), trazodone (Desyrel);

• migraine headache medication such as sumatriptan (Imitrex), naratriptan (Amerge), zolmitriptan (Zomig), ergotamine (Ergostat, Ergomar); or

• seizure medication such as carbamazepine (Carbatrol) or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with chlorpheniramine, methscopolamine, and phenylephrine. 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 chlorpheniramine, methscopolamine, and phenylephrine.

• 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: 1.03. Revision Date: 4/12/2009 4:40:52 PM.

Generic Name: carbetapentane, guaifenesin, and phenylephrine (kar BET a PEN tane, gwye FEN e sin, and FEN il EFF rin)
Brand Names: Aquatab C, Carbatab-12, Carbetaplex, Extendryl GCP, Gentex 30, Gentex LQ, Levall, MonteCough, Phencarb GG

What is Extendryl GCP (carbetapentane, guaifenesin, and phenylephrine)?

Carbetapentane is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.

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

The combination of carbetapentane, guaifenesin, and phenylephrine is used to treat stuffy nose, cough, and chest congestion caused by the common cold or flu.

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

Carbetapentane, guaifenesin, and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Extendryl GCP (carbetapentane, guaifenesin, and phenylephrine)?

You should not use this medication if you are allergic to carbetapentane, guaifenesin, or phenylephrine. 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 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.

Before you take carbetapentane, guaifenesin, and phenylephrine, tell your doctor if you have asthma or other breathing disorder, heart disease, high blood pressure, glaucoma, diabetes, liver or kidney disease, urination problems, or an overactive thyroid.

Also tell your doctor about all other medications you use.

This medication can cause side effects that may cause drowsiness, dizziness, or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Talk with your doctor if your symptoms do not improve after 7 days of taking this medication. Call your doctor any time if your symptoms get worse or if you also have a fever, headache, or skin rash.

What should I discuss with my health care provider before taking Extendryl GCP (carbetapentane, guaifenesin, and phenylephrine)?

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 a cough or cold medicine before the MAO inhibitor has cleared from your body. You should not use this medication if you are allergic to carbetapentane, guaifenesin, or phenylephrine.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take carbetapentane, guaifenesin, and phenylephrine, tell your doctor if you have:

• asthma, emphysema, or other breathing problems;

• heart disease or high blood pressure;

• glaucoma;

• diabetes;

• liver or kidney disease;

• an enlarged prostate or urination problems; or

• overactive thyroid.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking carbetapentane, guaifenesin, and phenylephrine, tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication 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. Older adults may be more likely to have side effects from this medication.

How should I take Extendryl GCP (carbetapentane, guaifenesin, and phenylephrine)?

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. Cold medicine is usually taken for only 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 medication with a full glass of water. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. You may take this medication with or without food. Taking it with food or milk may decrease stomach upset.

Measure the liquid 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.

Do not crush, chew or break an extended-release tablet. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Talk with your doctor if your symptoms do not improve after 7 days of taking this medication. Call your doctor any time if your symptoms get worse or if you also have a fever, headache, or skin rash.

This medication can cause you to have unusual results with medical tests. Tell any doctor who treats you if you have taken a cold medicine within the past few days.

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.

Store this medication at room temperature away from moisture, heat, and light. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since cold or allergy medicine is often 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. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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 can cause confusion, agitation, hallucinations, or seizure (convulsions).

What should I avoid while taking Extendryl GCP (carbetapentane, guaifenesin, and phenylephrine)?

This medication can cause side effects that may cause drowsiness, dizziness, or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. Guaifenesin and decongestants are contained in many combination medicines available over the counter. 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 a guaifenesin or a decongestant.

Extendryl GCP (carbetapentane, guaifenesin, and phenylephrine) side effects

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

• confusion, hallucinations;

• tremors; or

• extreme weakness.

Less serious side effects may include:

• drowsiness, dizziness;

• headache;

• feeling nervous;

• sleep problems (insomnia); or

• nausea.

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 Extendryl GCP (carbetapentane, guaifenesin, and phenylephrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by carbetapentane, guaifenesin, and phenylephrine.

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

• blood pressure medications;

• methyldopa (Aldomet);

• reserpine;

• an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or

• a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

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

Where can I get more information?

• Your pharmacist can provide more information about carbetapentane, guaifenesin, and phenylephrine.

• 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: 1.03. Revision Date: 11/17/2009 2:37:56 PM.

Generic Name: guaifenesin and hydrocodone (gwye FEN e sin and HYE droe KOE done)
Brand Names: A-Cof DH, Canges-XP, Codiclear DH, Condasin, Cotuss V, Execlear, Extendryl HC, Hycotuss Expectorant, Hydrocod-GF, Kwelcof, Monte-G HC, Narcof, Pancof XP, Pneumotussin 2.5, Relasin-HCX, Touro HC, Tussicle, Tusso-DF, Vi-Q-Tuss, Vitussin Expectorant, Xpect-HC, Z-Cof HCX

What is Extendryl HC (guaifenesin and hydrocodone)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Hydrocodone is a narcotic cough suppressant.

Guaifenesin and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

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

What is the most important information I should know about Extendryl HC (guaifenesin and hydrocodone)?

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 may increase drowsiness and dizziness caused by guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be given to 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.

What should I discuss with my healthcare provider before taking Extendryl HC (guaifenesin and hydrocodone)?

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. Do not use this medicine if you are allergic to hydrocodone or guaifenesin.

Before taking this medication, tell your doctor if you have:

• kidney disease;
• liver disease;

• asthma;

• urination problems;

• an enlarged prostate;

• a thyroid disorder;

• seizures or epilepsy;

• gallbladder disease;

• a head injury; or

• Addison’s disease.

If you have any of these conditions, you may not be able to take guaifenesin and hydrocodone, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Guaifenesin and hydrocodone passes into breast milk and may be harmful to a nursing baby. Do not take guaifenesin and hydrocodone without telling your doctor if you are breast-feeding a baby.

How should I take Extendryl HC (guaifenesin and hydrocodone)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Guaifenesin and hydrocodone can be taken with or without food.

Measure liquid 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.

Do not take more of this medication or take it for longer than is recommended. Call your doctor if your symptoms do not improve, or if they get worse. Store guaifenesin and hydrocodone at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. 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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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 extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dry mouth, confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, seizure (convulsions), weak or shallow breathing, or breathing that stops.

What should I avoid while taking Extendryl HC (guaifenesin and hydrocodone)?

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 may increase drowsiness and dizziness caused by guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone.

Do not take other over-the-counter cough, cold, allergy, pain, or sleep medications without first asking your doctor or pharmacist. Guaifenesin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much guaifenesin. Read the label of any other medicine you are using to see if it contains guaifenesin.

Extendryl HC (guaifenesin and hydrocodone) 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 a serious side effect such as:

• slow heart rate, weak or shallow breathing;

• feeling like you might pass out;

• confusion, fear, unusual thoughts or behavior;

• seizure (convulsions); or

• urinating less than usual or not at all.

Less serious side effects may include:

• dizziness, drowsiness;

• nausea, vomiting, upset stomach;

• blurred vision;

• constipation;

• dry mouth; or

• sweating.

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 Extendryl HC (guaifenesin and hydrocodone)?

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

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

• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

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

• a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with guaifenesin and hydrocodone. 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 guaifenesin and hydrocodone.

• 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: 2.02. Revision Date: 4/12/2009 4:41:00 PM.

Generic Name: Methscopolamine/Phenylephrine (METH-skoe-POL-a-meen/FEN-il-EF-rin)
Brand Name: Extendryl PEM

Extendryl PEM Extended-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Extendryl PEM Extended-Release Tablets are an anticholinergic and decongestant combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use Extendryl PEM Extended-Release Tablets if:

• you are allergic to any ingredient in Extendryl PEM Extended-Release Tablets
• you are taking sodium oxybate (GHB) or droxidopa, or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) in the last 14 days
• you have narrow-angle glaucoma; a blockage of the bladder, stomach, or intestines; peptic ulcer disease; severe bowel problems (eg, ulcerative colitis); inflammation of the esophagus from reflux disease; difficulty swallowing; myasthenia gravis (muscle weakness); or uncontrolled bleeding
• you have severe heart disease, severe high blood pressure, severe heart blood vessel problems, or a rapid heartbeat, or you are unable to urinate
• you are having an asthma attack

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

Before using Extendryl PEM Extended-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 an adrenal gland tumor, asthma, bladder or kidney problems, blood clots, blood vessel problems, breathing problems during sleep, an enlarged prostate, heart problems (eg, ischemic heart disease, irregular heartbeat), a hiatal hernia, high blood pressure, increased glaucoma, lung problems (eg, emphysema), a history of diabetes, nerve problems, an overactive thyroid, pressure in the eye, risk factors for glaucoma, seizures, stroke, or trouble urinating
• if you have diarrhea

Some MEDICINES MAY INTERACT with Extendryl PEM Extended-Release Tablets.

• Sodium oxybate (GHB) because the risk of severe drowsiness or coma may be increased
• Furazolidone or MAOIs (eg, phenelzine) because severe high blood pressure, fast or irregular heartbeat, or seizures may occur
• Alpha-blockers (eg, prazosin), anesthetics (eg, chloroform, lidocaine), anticholinergics (eg, atropine, benztropine, dicyclomine), beta-blockers (eg, propranolol), carbonic anhydrase inhibitors (eg, acetazolamide), diuretics (eg, furosemide, hydrochlorothiazide), ergotamine, tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Extendryl PEM Extended-Release Tablets’s side effects
• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, or potassium chloride because the risk of their side effects may be increased by Extendryl PEM Extended-Release Tablets
• Clonidine, guanethidine, guanfacine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Extendryl PEM Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Extendryl PEM Extended-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 Extendryl PEM Extended-Release Tablets:

Use Extendryl PEM Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Extendryl PEM Extended-Release Tablets by mouth with or without food.
• Swallow Extendryl PEM Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Extendryl PEM Extended-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
• Do not take Extendryl PEM Extended-Release Tablets at the same time as antacids, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after you take Extendryl PEM Extended-Release Tablets.
• If you miss a dose of Extendryl PEM Extended-Release Tablets 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 Extendryl PEM Extended-Release Tablets.

Important safety information:

• Extendryl PEM Extended-Release Tablets may cause blurred vision, dizziness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Extendryl PEM Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Extendryl PEM Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• If your symptoms do not get better within 7 days or if you develop a high fever or persistent headache, check with your doctor.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Extendryl PEM Extended-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
• Extendryl PEM Extended-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Extendryl PEM Extended-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Do not take diet or appetite control medicines while you are taking Extendryl PEM Extended-Release Tablets without checking with your doctor.
• Extendryl PEM Extended-Release Tablets has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Extendryl PEM Extended-Release Tablets.
• Tell your doctor or dentist that you take Extendryl PEM Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients – Extendryl PEM Extended-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Extendryl PEM Extended-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Extendryl PEM Extended-Release Tablets.
• Use Extendryl PEM Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, hallucinations, and seizures.
• Extendryl PEM Extended-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• Caution is advised when using Extendryl PEM Extended-Release Tablets in CHILDREN; they may be more sensitive to its effects, especially excitability.
• PREGNANCY and BREAST-FEEDING: It is not known if Extendryl PEM Extended-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Extendryl PEM Extended-Release Tablets while you are pregnant. It is not known if Extendryl PEM Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Extendryl PEM Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Extendryl PEM Extended-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:

Constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); flushing; headache; nausea; nervousness.

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

Severe allergic reactions (difficulty breathing; hives; itching; rash; swelling of the mouth, tightness in the chest; face, lips, or tongue); blurred vision; clumsiness; difficulty swallowing; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; tremor; trouble sleeping; trouble urinating; unusual bleeding or bruising; 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 deep sleep or loss of consciousness; hallucinations; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing; vomiting.

Proper storage of Extendryl PEM Extended-Release Tablets:

Store Extendryl PEM Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 15 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Extendryl PEM Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Extendryl PEM Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Extendryl PEM Extended-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 Extendryl PEM Extended-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: Methscopolamine/Pseudoephedrine (meth-skoe-POL-a-meen/soo-doe-e-FED-rin)
Brand Name: Examples include Amdry-D and Extendryl PSE

Extendryl PSE Extended-Release Tablets are used for:

Relieving congestion due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Extendryl PSE Extended-Release Tablets are a decongestant and anticholinergic combination. It works by relieving nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and decreasing lung secretions, which dries the chest.

Do NOT use Extendryl PSE Extended-Release Tablets if:

• you are allergic to any ingredient in Extendryl PSE Extended-Release Tablets or to similar medicines (eg, ephedrine)
• you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
• you have severe heart blood vessel disease; severe high blood pressure; severe heart problems; a rapid heartbeat; narrow-angle glaucoma; severe or uncontrolled bleeding; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); peptic ulcer; a blockage of your stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); or certain muscle problems (eg, myasthenia gravis)
• you are unable to urinate or you are having an asthma attack

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

Before using Extendryl PSE Extended-Release Tablets:

Some medical conditions may interact with Extendryl PSE Extended-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 a history of diabetes, an enlarged prostate or other prostate problems, bladder or kidney problems, severe bowel problems, high blood pressure, asthma, nerve problems, heart problems, blood vessel problems, blood clots, trouble urinating, a hiatal hernia, an adrenal gland tumor, glaucoma or increased eye pressure, breathing problems during sleep, stroke, seizures, or an overactive thyroid
• if you have diarrhea

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

• Beta-blockers (eg, propranolol), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or methyldopa because the risk of severe high blood pressure, fever, fast heartbeat, and seizures may be increased
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Anticholinergic medicines (eg, benztropine, hyoscyamine, trihexyphenidyl), certain medicines for mental or mood disorders (eg, thioridazine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Extendryl PSE Extended-Release Tablets’s side effects
• Bromocriptine because the risk of its side effects may be increased by Extendryl PSE Extended-Release Tablets
• Guanadrel, guanethidine, mecamylamine, or reserpine because their effectiveness may be decreased by Extendryl PSE Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Extendryl PSE Extended-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 Extendryl PSE Extended-Release Tablets:

Use Extendryl PSE Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Extendryl PSE Extended-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Extendryl PSE Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Extendryl PSE Extended-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
• If you miss a dose of Extendryl PSE Extended-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for the 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 Extendryl PSE Extended-Release Tablets.

Important safety information:

• Extendryl PSE Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Extendryl PSE Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If your symptoms do not get better within 7 days or if they get worse, or if you develop a high fever or persistent headache, check with your doctor.
• Extendryl PSE Extended-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
• Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).
• Extendryl PSE Extended-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Extendryl PSE Extended-Release Tablets may reduce sweating. Do not become overheated in hot weather or during exercise or other activities; heatstroke may occur.
• Do not take diet or appetite control medicines while you are taking Extendryl PSE Extended-Release Tablets without checking with your doctor first.
• Extendryl PSE Extended-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Extendryl PSE Extended-Release Tablets.
• Tell your doctor or dentist that you take Extendryl PSE Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients – Extendryl PSE Extended-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Extendryl PSE Extended-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Extendryl PSE Extended-Release Tablets.
• Use Extendryl PSE Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Extendryl PSE Extended-Release Tablets 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: It is not known if Extendryl PSE Extended-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Extendryl PSE Extended-Release Tablets while you are pregnant. Extendryl PSE Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Extendryl PSE Extended-Release Tablets.

Possible side effects of Extendryl PSE Extended-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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; restlessness; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

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 deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.

Proper storage of Extendryl PSE Extended-Release Tablets:

Store Extendryl PSE Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Extendryl PSE Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Extendryl PSE Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Extendryl PSE Extended-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 Extendryl PSE Extended-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: ketoconazole topical (kee toe KOE na zole)
Brand Names: Extina, Kuric, Nizoral A-D, Nizoral Topical, Xolegel

What is ketoconazole topical?

Ketoconazole topical is an antifungal medication. Ketoconazole topical prevents fungus from growing on your skin.

Ketoconazole topical is used to treat fungal infections of the skin such as athlete’s foot, jock itch, ringworm, and seborrhea (dry, flaking skin).

Ketoconazole topical is available as a cream, gel, and as a shampoo. The shampoo is used for the treatment of dandruff.

Ketoconazole topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about ketoconazole topical?

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to. Avoid getting this medication in your eyes, nose, or mouth.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Stop using ketoconazole topical and call your doctor if you have severe burning, irritation, redness, pain, or oozing where the medicine is applied. Ketoconazole topical gel is flammable. Do not use it while you are smoking or near an open flame. Do not use this medication on a child younger than 12 years old.

What should I discuss with my healthcare provider berfore using ketoconazole topical?

Do not use this medication if you are allergic to ketoconazole. FDA pregnancy category C. This medication may 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 ketoconazole topical 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. Do not use this medication on a child younger than 12 years old.

How should I apply ketoconazole topical?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Do not use this medication for any skin condition that has not been diagnosed by a doctor.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a thin layer of the cream or gel to the affected skin area as directed. This medicine is usually used for only 2 to 4 weeks.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Use the shampoo twice per week, unless your doctor has told you otherwise. Apply enough shampoo to create a lather and massage the scalp for 1 minute. Rinse thoroughly and repeat, leaving the lather on for an additional 3 minutes. Then rinse it off completely. Allow at least 3 days to pass between uses of ketoconazole shampoo.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Store ketoconazole topical at room temperature away from moisture and heat. Ketoconazole topical gel is flammable. Do not use it while you are smoking or near an open flame.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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, or if anyone has accidentally swallowed it.

An overdose of ketoconazole topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using ketoconazole topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn’t allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

Avoid using other skin or hair products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Ketoconazole topical 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 ketoconazole topical and call your doctor if you have any of these serious side effects:

• severe itching, burning, or irritation where the medicine is applied;

• oily or dry scalp, mild hair loss;

• redness, pain, or oozing of treated skin areas; or

• eye redness, swelling, or irritation.

Less serious side effects include:

• mild skin itching or irritation;

• dry skin; or

• headache.

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 ketoconazole topical?

There may be other drugs that can affect ketoconazole topical. 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 ketoconazole.

• 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: 2.03. Revision Date: 4/12/2009 4:40:19 PM.

Generic Name: Ketoconazole (KEE-toe-KON-a-zole)
Brand Name: Extina

Extina Foam is used for:

Treating seborrheic dermatitis (a skin condition). It may also be used for other conditions as determined by your doctor.

Extina Foam is an imidazole antifungal. Exactly how it works to treat seborrheic dermatitis is not known. Extina Foam kills sensitive fungi.

Do NOT use Extina Foam if:

• you are allergic to any ingredient in Extina Foam

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

Before using Extina Foam:

Some medical conditions may interact with Extina Foam. 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 a weakened immune system

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

Ask your health care provider if Extina Foam 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 Extina Foam:

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

• An extra patient leaflet is available with Extina Foam. Talk to your pharmacist if you have questions about this information.
• Wash your hands in cool water and dry well before you use Extina Foam. If your fingers are too warm, the medicine will begin to melt right away when it touches your skin.
• To use Extina Foam, hold the can upright. Dispense the medicine into the cap or onto a cool surface. Do not dispense the medicine directly onto your skin or hands because it will melt too soon. If the can seems warm or the foam seems runny, hold the can under cold running water to cool it.
• Using your fingertips, gently massage Extina Foam into the affected areas until the foam disappears. To treat your scalp or other skin areas with hair, move your hair away so that the medicine can be applied to the affected skin.
• After you use Extina Foam, wipe any excess foam off of the container.
• Wash your hands immediately after you use Extina Foam, unless your hands are part of the treated area.
• To clear up your infection completely, use Extina Foam for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Extina Foam, use 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 use 2 doses at once.

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

Important safety information:

• Extina Foam is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse at once with cool tap water.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 4 weeks or if they get worse, check with your doctor.
• Do not use Extina Foam for other skin conditions at a later time.
• Talk with your doctor before you use any other medicines or cleansers on your skin.
• Extina Foam may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Extina Foam. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Extina Foam is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Extina Foam.
• Extina Foam 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 become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Extina Foam while you are pregnant. It is not known if Extina Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Extina Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Extina Foam:

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:

Mild, temporary burning or stinging.

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); redness, irritation, or severe burning of the skin.

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 Extina Foam:

Store Extina Foam at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 120 degrees F (49 degrees C). Do not refrigerate or freeze. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Extina Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Extina Foam, please talk with your doctor, pharmacist, or other health care provider.
• Extina Foam 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 Extina Foam. 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.