Search Libya

Friday, September 16, 2016

Children's Tylenol Meltaway

Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)

Brand Names: Acetaminophen Quickmelt, Actamin, Adprin B, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Children's Tylenol Meltaway, Ed-APAP, Elixsure Fever/Pain, Genebs, Infants Tylenol Concentrated Drops, Leader 8 Hour Pain Reliever, Little Fevers, Little Fevers Children's Fever/Pain Reliever, Mapap, Mapap Arthritis Pain, Mapap Extra Strength Rapid Burst, Mapap Infant Drops, Mapap Infants', Mapap Meltaway, Mapap Rapid Release Gelcaps, Mapap Rapid Tabs, Medi-Tabs, Q-Pap, Q-Pap Extra Strength, Silapap Childrens, Silapap Infants, St. Joseph Aspirin-Free, Tactinal, Tempra, Tempra Quicklets, Triaminic Fever & Pain, Triaminic Infant Drops, Tycolene, Tylenol, Tylenol Arthritis Caplet, Tylenol Arthritis Gelcap, Tylenol Caplet, Tylenol Caplet Extra Strength, Tylenol Childrens, Tylenol Cool Caplet Extra Strength, Tylenol Extra Strength, Tylenol Extra Strength Cool Caplet, Tylenol Extra Strength EZ, Tylenol Gelcap Extra Strength, Tylenol Geltab Extra Strength, Tylenol Infant's Drops, Tylenol Junior Meltaway, Tylenol Rapid Release Gelcap, Tylenol Sore Throat Daytime, Vitapap

What is acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

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

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

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Know the amount of acetaminophen in the specific product you are taking.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking acetaminophen?

You should not take acetaminophen if you are allergic to it.

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

liver disease; or

a history of alcoholism.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. It is not known whether acetaminophen will harm an unborn baby. Before taking acetaminophen, tell your doctor if you are pregnant. Acetaminophen 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. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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

If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label. Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen. You may need to shake the liquid before each use. Follow the directions on the medicine label.

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

Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking acetaminophen and call your doctor if:

you still have a fever after 3 days of use;

you still have pain after 7 days of use (or 5 days if treating a child);

you have a skin rash, ongoing headache, or any redness or swelling; or

if your symptoms get worse, or if you have any new symptoms.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.

Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking acetaminophen?

Acetaminophen 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 taking this medication and call your doctor at once if you have a serious side effect such as:

nausea, upper stomach pain, itching, loss of appetite;

dark urine, clay-colored stools; or

jaundice (yellowing of the skin or eyes).

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 acetaminophen?

Ask a doctor or pharmacist if it is safe for you to use acetaminophen if you are also using any of the following drugs:

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

birth control pills or hormone replacement therapy;

blood pressure medication;

cancer medications;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medications;

medicines to treat psychiatric disorders;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medications.

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

More Children's Tylenol Meltaway resources

Children's Tylenol Meltaway Side Effects (in more detail)
Children's Tylenol Meltaway Use in Pregnancy & Breastfeeding
Drug Images
Children's Tylenol Meltaway Drug Interactions
Children's Tylenol Meltaway Support Group
0 Reviews for Children's Tylenol Meltaway - Add your own review/rating

acetaminophen Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Acetaminophen MedFacts Consumer Leaflet (Wolters Kluwer)

Acetaminophen Monograph (AHFS DI)

Acetazolamide Monograph (AHFS DI)

Apra Advanced Consumer (Micromedex) - Includes Dosage Information

Apraclonidine Hydrochloride Monograph (AHFS DI)

Genapap Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Mapap Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

Ofirmev Consumer Overview

Ofirmev Injection MedFacts Consumer Leaflet (Wolters Kluwer)

Ofirmev Prescribing Information (FDA)

Paracetamol Consumer Overview

Tempra 1 Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Tylenol Consumer Overview

Tylenol MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Children's Tylenol Meltaway with other medications

Fever
Pain

Where can I get more information?

Your pharmacist can provide more information about acetaminophen.

See also: Children's Tylenol Meltaway side effects (in more detail)

chloramphenicol ophthalmic

Generic Name: chloramphenicol ophthalmic (klor am FEN i kole)

Brand names: Chloroptic, Chloroptic S.O.P., AK-Chlor, Chloromycetin Ophthalmic, Ocu-Chlor

What is chloramphenicol ophthalmic?

Chloramphenicol is an antibiotic.

The ophthalmic form of chloramphenicol is used to treat bacterial infections of the eyes.

Chloramphenicol ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about chloramphenicol ophthalmic?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

What should I discuss with my healthcare provider before using chloramphenicol ophthalmic?

Do not use chloramphenicol ophthalmic if you have a viral or fungal infection in your eye. It is used only to treat infections caused by bacteria. It is not known whether chloramphenicol ophthalmic will harm an unborn baby. Do not use chloramphenicol ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether chloramphenicol ophthalmic passes into breast milk. Do not use chloramphenicol ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use chloramphenicol ophthalmic?

Use chloramphenicol ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eyedrops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

To apply the ointment:

Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store chloramphenicol ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using chloramphenicol ophthalmic?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Chloramphenicol ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Chloramphenicol ophthalmic side effects

Serious side effects are not expected with this medication. Rarely, prolonged use of this medication has damaged bone marrow. Call your doctor if you experience extreme fatigue or unusual bleeding or bruising.

More commonly, some burning, stinging, irritation, itching, redness, blurred vision, or sensitivity to light may occur. Continue to use chloramphenicol ophthalmic and talk to your doctor about any side effects that you experience.

What other drugs will affect chloramphenicol ophthalmic?

Avoid using other eyedrops or eye medications unless they are approved by your doctor.

Drugs other than those listed here may also interact with chloramphenicol ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More chloramphenicol ophthalmic resources

Chloramphenicol ophthalmic Drug Interactions
Chloramphenicol ophthalmic Support Group
0 Reviews for Chloramphenicol - Add your own review/rating

Ak-Chlor Advanced Consumer (Micromedex) - Includes Dosage Information

Compare chloramphenicol ophthalmic with other medications

Conjunctivitis, Bacterial

Where can I get more information?

Your pharmacist has additional information about chloramphenicol ophthalmic written for health professionals that you may read.

What does my medication look like?

Chloramphenicol ophthalmic is available with a prescription under several brand and generic names as a solution and as an ointment. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

AK-Chlor 5 mg per mL solution

AK-Chlor 10 mg per gram ointment

Chloroptic 5 mg per mL solution

Chloroptic S.O.P. 10 mg per gram ointment

Chloromycetin 10 mg per gram ointment

Chloromycetin 25 mg per vial, powder for solution

Childrens Ibuprofen Berry

Generic Name: ibuprofen (EYE bue PROE fen)

Brand Names: Advil, Advil Childrens, Advil Junior Strength, Advil Liquigel, Advil Migraine, Advil Pediatric, Children's Ibuprofen Berry, Genpril, IBU, Midol IB, Midol Maximum Strength Cramp Formula, Motrin Childrens, Motrin IB, Motrin Infant Drops, Motrin Junior Strength, Motrin Migraine Pain, Nuprin

What is Childrens Ibuprofen Berry (ibuprofen)?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.

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

What is the most important information I should know about Childrens Ibuprofen Berry (ibuprofen)?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use ibuprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking ibuprofen, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines. Use only the smallest amount of ibuprofen needed to get relief from your pain, swelling, or fever.

What should I discuss with my healthcare provider before taking Childrens Ibuprofen Berry (ibuprofen)?

Do not use ibuprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

You should not use this medication if you are allergic to ibuprofen, aspirin or other NSAIDs.

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

a history of heart attack, stroke, or blood clot;

heart disease, congestive heart failure, high blood pressure;

a history of stomach ulcers or bleeding;

asthma;

polyps in your nose;

liver or kidney disease;

systemic lupus erythematosus (SLE);

a bleeding or blood clotting disorder; or

if you smoke.

FDA pregnancy category D. Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using ibuprofen. It is not known whether ibuprofen 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 give this medicine to a child without the advice of a doctor.

How should I take Childrens Ibuprofen Berry (ibuprofen)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of ibuprofen needed to get relief from your pain, swelling, or fever. Take ibuprofen with food or milk to lessen stomach upset. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

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

If you take ibuprofen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Since ibuprofen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking Childrens Ibuprofen Berry (ibuprofen)?

Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Ibuprofen and other NSAIDs are contained in many combination medicines. Taking certain products together can cause you to get too much ibuprofen. Check the label to see if a medicine contains ibuprofen or similar NSAIDs (aspirin, naproxen, ketoprofen). Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Childrens Ibuprofen Berry (ibuprofen) 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 taking ibuprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

swelling or rapid weight gain;

urinating less than usual or not at all;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

bruising, severe tingling, numbness, pain, muscle weakness; or

severe headache, neck stiffness, chills, increased sensitivity to light, and/or seizure (convulsions).

Less serious side effects may include:

upset stomach, mild heartburn, diarrhea, constipation;

bloating, gas;

dizziness, headache, nervousness;

skin itching or rash;

blurred vision; or

ringing in your ears.

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

What other drugs will affect Childrens Ibuprofen Berry (ibuprofen)?

Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

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

aspirin or other NSAIDs such as naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

heart or blood pressure medicine such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;

lithium (Eskalith, Lithobid);

diuretics (water pills) such as furosemide (Lasix);

methotrexate (Rheumatrex, Trexall);

steroids (prednisone and others); or

a blood thinner such as warfarin (Coumadin, Jantoven).

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

More Childrens Ibuprofen Berry resources

Childrens Ibuprofen Berry Side Effects (in more detail)
Childrens Ibuprofen Berry Use in Pregnancy & Breastfeeding
Childrens Ibuprofen Berry Drug Interactions
Childrens Ibuprofen Berry Support Group
0 Reviews for Childrens Ibuprofen Berry - Add your own review/rating

Compare Childrens Ibuprofen Berry with other medications

Fever
Pain
Spondylolisthesis

Where can I get more information?

Your pharmacist can provide more information about ibuprofen.

See also: Childrens Ibuprofen Berry side effects (in more detail)

Chloral Hydrate

Pronunciation: KLOR-uhl HYE-drate
Generic Name: Chloral Hydrate
Brand Name: Somnote

Chloral Hydrate is used for:

Treating sleep disorders. It may be used to prevent symptoms of alcohol withdrawal or to treat existing withdrawal symptoms. It may also be used to produce sedation or sleep before certain procedures, or to relieve anxiety due to certain procedures or substance withdrawal. It may also be used to treat other conditions as determined by your doctor.

Chloral Hydrate is a nonbarbiturate sedative and hypnotic. It works by depressing the central nervous system (brain). This causes drowsiness and helps you to fall asleep. It is less likely to cause a slower breathing rate than barbiturate-type sedatives/hypnotics.

Do NOT use Chloral Hydrate if:

you are allergic to any ingredient in Chloral Hydrate

you have moderate to severe liver or kidney problems, severe heart problems, or severe inflammation of your stomach

you are currently taking dofetilide, H₁ antagonists (eg, astemizole, terfenadine), or sodium oxybate (GHB)

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

Before using Chloral Hydrate:

Some medical conditions may interact with Chloral Hydrate. 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 inflammation of the esophagus, an ulcer, a blood disorder (eg, porphyria), or you have a history of depression, suicidal thoughts, or substance abuse or dependence

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

Arsenic, cisapride, dofetilide, or H₁ antagonists (eg, astemizole, terfenadine) because side effects, such as serious heart problems, may occur

Barbiturates (eg, phenobarbital), paraldehyde, or sodium oxybate (GHB) because the actions and side effects of these medicines may be increased

Loop diuretics (eg, furosemide) because unexpected side effects, such as fast heart rate and changing blood pressure, may occur

Anticoagulants (eg, warfarin) because actions and side effects may be altered by Chloral Hydrates

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

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

Chloral Hydrate may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Swallow Chloral Hydrate whole. Do not break, crush, or chew before swallowing.

Take Chloral Hydrate with a full glass of water or other liquid to reduce stomach upset.

If you miss a dose of Chloral Hydrate and you are taking it regularly, 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 Chloral Hydrate.

Important safety information:

Chloral Hydrate may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Chloral Hydrate. Using Chloral Hydrate alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Chloral Hydrate. Chloral Hydrate will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Chloral Hydrate is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Chloral Hydrate during pregnancy. Chloral Hydrate is excreted in breast milk. If you are or will be breast-feeding while you are using Chloral Hydrate, check with your doctor or pharmacist to discuss the risks to your baby.

Chloral Hydrate may be habit-forming and lead to DEPENDENCE if used in high doses or for a long period of time. If you are on long-term or high dosage therapy, you may have WITHDRAWAL symptoms (eg, convulsions, tremor, stomach and muscle cramps, vomiting, sweating) if you suddenly stop taking Chloral Hydrate. Do not stop therapy abruptly or change dosage without asking your pharmacist or doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Chloral Hydrate:

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:

Diarrhea; dizziness; drowsiness upon awakening; gas; nausea; unpleasant taste in mouth; upset stomach.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); disorientation; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Chloral Hydrate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased pupil size; slow or fast and shallow breathing; vomiting.

Proper storage of Chloral Hydrate:

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

General information:

If you have any questions about Chloral Hydrate, please talk with your doctor, pharmacist, or other health care provider.

Chloral Hydrate 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.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Chloral Hydrate. 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.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Chloral Hydrate resources

Chloral Hydrate Side Effects (in more detail)
Chloral Hydrate Dosage
Chloral Hydrate Use in Pregnancy & Breastfeeding
Chloral Hydrate Drug Interactions
Chloral Hydrate Support Group
10 Reviews for Chloral Hydrate - Add your own review/rating

Chloral Hydrate Professional Patient Advice (Wolters Kluwer)

Chloral Hydrate Monograph (AHFS DI)

chloral hydrate Concise Consumer Information (Cerner Multum)

chloral hydrate Oral, Rectal Advanced Consumer (Micromedex) - Includes Dosage Information

Aquachloral Supprettes Concise Consumer Information (Cerner Multum)

Somnote Prescribing Information (FDA)

Compare Chloral Hydrate with other medications

Insomnia
Sedation

chlophedianol, guaifenesin, and pseudoephedrine

Generic Name: chlophedianol, guaifenesin, and pseudoephedrine (KLOE fe DYE a nol, gwye FEN e sin, SOO doe ee FED rin)

Brand names: Vanacof DX, Vanatab DX

What is chlophedianol, guaifenesin, and pseudoephedrine?

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

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

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

The combination of chlophedianol, guaifenesin, and pseudoephedrine is used to treat stuffy nose, cough, chest congestion, and sinus congestion caused by allergies, the common cold, or the flu.

Chlophedianol, guaifenesin, and pseudoephedrine will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlophedianol, guaifenesin, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about chlophedianol, guaifenesin, and pseudoephedrine?

Do not give this medication to a child younger than 4 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 cough or cold medicine if you have untreated or uncontrolled diseases such as high blood pressure, heart disease, coronary artery disease, or a thyroid disorder. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking chlophedianol, guaifenesin, and pseudoephedrine?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as high blood pressure, heart disease, coronary artery disease, or a thyroid disorder.

To make sure you can safely use this medicine, tell your doctor if you have any of these other conditions:

diabetes;

epilepsy or other seizure disorder;

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

enlarged prostate or urination problems; or

pheochromocytoma (an adrenal gland tumor).

It is not known whether chlophedianol, guaifenesin, and pseudoephedrine will harm an unborn baby. Do not use cough or cold medicine without telling your doctor if you are pregnant or plan to become pregnant while using the medicine. Chlophedianol, guaifenesin, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use cough or cold medicine without telling your doctor if you are breast-feeding a baby.

How should I take chlophedianol, guaifenesin, and pseudoephedrine?

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

Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

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

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not freeze.

See also: Chlophedianol, guaifenesin, and pseudoephedrine dosage (in more detail)

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking chlophedianol, guaifenesin, and pseudoephedrine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlophedianol, guaifenesin, and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or cough medicine. Antitussives, expectorants, and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antitussive, expectorant, or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Chlophedianol, guaifenesin, and pseudoephedrine 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 chlophedianol, guaifenesin, and pseudoephedrine and call your doctor at once if you have a serious side effect such as:

fast, slow, or uneven heart rate;

severe dizziness or anxiety, feeling like you might pass out;

mood changes, hallucinations;

severe headache;

tremor, seizure (convulsions);

fever; or

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

mild dizziness or drowsiness;

mild headache;

diarrhea, constipation, nausea, upset stomach;

sleep problems (insomnia); or

feeling nervous or restless.

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.

Chlophedianol, guaifenesin, and pseudoephedrine Dosing Information

Usual Adult Dose for Cough and Nasal Congestion:

Chlophedianol/guaifenesin/pseudoephedrine 12.5 mg-100 mg-30 mg/5 mL oral liquid:
10 mL orally every 6 to 8 hours not to exceed 40 mL daily.

Chlophedianol/guaifenesin/pseudoephedrine 12.5 mg-200 mg-30 mg oral tablet:
2 tablets orally every 6 to 8 hours not to exceed 8 tablets daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

Chlophedianol/guaifenesin/pseudoephedrine 12.5 mg-100 mg-30 mg/5 mL oral liquid:
6 to 11 years: 5 mL orally every 6 to 8 hours not to exceed 20 mL daily.
12 years or older: 10 mL orally every 6 to 8 hours not to exceed 40 mL daily.

Chlophedianol/guaifenesin/pseudoephedrine 12.5 mg-200 mg-30 mg oral tablet:
6 to 11 years: 1 tablet orally every 6 to 8 hours not to exceed 4 tablets daily.
12 years or older: 2 tablets orally every 6 to 8 hours not to exceed 8 tablets daily.

What other drugs will affect chlophedianol, guaifenesin, and pseudoephedrine?

Before using chlophedianol, guaifenesin, and pseudoephedrine, 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 chlophedianol or guaifenesin.

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

More chlophedianol, guaifenesin, and pseudoephedrine resources

Chlophedianol, guaifenesin, and pseudoephedrine Side Effects (in more detail)
Chlophedianol, guaifenesin, and pseudoephedrine Dosage
Chlophedianol, guaifenesin, and pseudoephedrine Use in Pregnancy & Breastfeeding
Chlophedianol, guaifenesin, and pseudoephedrine Drug Interactions
Chlophedianol, guaifenesin, and pseudoephedrine Support Group
1 Review for Chlophedianol, guaifenesin, and pseudoephedrine - Add your own review/rating

Compare chlophedianol, guaifenesin, and pseudoephedrine with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about chlophedianol, guaifenesin, and pseudoephedrine.

See also: chlophedianol, guaifenesin, and pseudoephedrine side effects (in more detail)

Cortisporin-TC otic

Generic Name: colistin, hydrocortisone, neomycin, and thonzonium (otic) (koe LIS tin, HYE droe KOR ti sone, NEE oh MYE sin, thon ZOE nee um)

Brand Names: Coly Mycin S, Coly-Mycin S, Cortisporin-TC

What is colistin, hydrocortisone, neomycin, and thonzonium?

Colistin and neomycin are antibiotics that fight bacteria.

Hydrocortisone is in a class of drugs called steroids. Hydrocortisone prevents the release of substances in the body that cause inflammation.

Thonzonium is a wetting agent.

The combination of colistin, hydrocortisone, neomycin, and thonzonium otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Colistin, hydrocortisone, neomycin, and thonzonium otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about colistin, hydrocortisone, neomycin, and thonzonium?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum..

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing. Stop using this medication and call your doctor at once if you have a skin rash, redness, swelling, itching, dryness, or scaling.

What should I discuss with my health care provider before using colistin, hydrocortisone, neomycin, and thonzonium?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum.. FDA pregnancy category C. It is not known whether colistin, hydrocortisone, neomycin, and thonzonium ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin 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.

How should I use colistin, hydrocortisone, neomycin, and thonzonium?

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

Before using this medication, clean and dry your ear canal with sterile cotton.

Shake the ear drops well just before you measure a dose.

The usual dose of this medication is 5 drops into the affected ear every 6 to 8 hours. If you are using this medicine on a child, use only 4 drops per affected ear.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 hours. Replace the cotton at least every 24 hours. Follow your doctor's instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. 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.

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using colistin, hydrocortisone, neomycin, and thonzonium?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.

Colistin, hydrocortisone, neomycin, and thonzonium 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:

skin rash, redness, swelling, itching, dryness, or scaling;

hearing loss; or

urinating less than usual or not at all.

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 colistin, hydrocortisone, neomycin, and thonzonium?

There may be other drugs that can interact with colistin, hydrocortisone, neomycin, and thonzonium. 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.

More Cortisporin-TC resources

Cortisporin-TC Side Effects (in more detail)
Cortisporin-TC Dosage
Cortisporin-TC Use in Pregnancy & Breastfeeding
Cortisporin-TC Drug Interactions
Cortisporin-TC Support Group
0 Reviews for Cortisporin-TC - Add your own review/rating

Compare Cortisporin-TC with other medications

Acute Otitis Externa
Chronic Otitis Media
Otitis Externa
Otitis Media

Where can I get more information?

Your pharmacist can provide more information about colistin, hydrocortisone, neomycin, and thonzonium otic.

See also: Cortisporin-TC side effects (in more detail)

Cortisporin TC

colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate

Dosage Form: otic suspension
Cortisporin®-TC Otic Suspension with Neomycin and

Hydrocortisone (colistin sulfate—neomycin sulfate—thonzonium

bromide—hydrocortisone acetate otic suspension)

Cortisporin TC Description

Cortisporin®-TC Otic Suspension with Neomycin and Hydrocortisone (colistin sulfate—neomycin sulfate—thonzonium bromide—hydrocortisone acetate otic suspension) is a sterile antibacterial and anti-inflammatory aqueous suspension containing in each mL: Colistin base activity, 3 mg (as the sulfate); Neomycin base activity, 3.3 mg (as the sulfate); Hydrocortisone acetate, 10 mg (1%); Thonzonium bromide,

0.5 mg (0.05%); Polysorbate 80, acetic acid, and sodium acetate in a buffered aqueous vehicle. Thimerosal (mercury derivative), 0.002%, is added as a preservative. It is a nonviscous liquid, buffered at pH 5, for instillation into the canal of the external ear or direct application to the affected aural skin.

The structural formulas of colistin sulfate (mixture of Colistin A & B), neomycin sulfate (mixture of neomycin A, B & C), hydrocortisone acetate ((11β)-21-(acetyloxy)-11,17-dihydroxypregn) methyl]-2 pyrimidinylamino] ethyl]-N,N-dimethyl-1-hexadecanaminium, bromide) are represented below:

Thonzonium Bromide

Colistin sulfate

Neomycin A

Neomycin B Sulfate

Hydrocortisone Acetate

Neomycin C Sulfate

Cortisporin TC - Clinical Pharmacology

Colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Neomycin sulfate is an aminoglycoside antibiotic which inhibits protein synthesis, disrupting the normal cycle of ribosomal function. Hydrocortisone acetate is a corticosteroid hormone which is thought to act by regulating the rate of protein synthesis; it controls inflammation, edema, pruritus and other dermal reactions. Cortiscosteroids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

Thonzonium bromide is a surface-active agent that promotes tissue contact by dispersion and penetration of the cellular debris and exudate.

Microbiology

Together, colistin sulfate and neomycin sulfate have bactericidal activity against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobic gram-positive microorganisms:

Staphylococcus aureus.

Aerobic gram-negative microorganisms:

Enterobacter aerogenes

Escherichia coli

Klebsiella pneumoniae

Pseudomonas aeruginosa.

Susceptibility Tests

It is not recommended that colistin sulfate or neomycin sulfate be routinely tested and reported by clinical microbiology laboratories.

Indications and Usage for Cortisporin TC

Cortisporin®-TC Otic Suspension is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics.

Contraindications

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (e.g., herpes simplex virus or varicella zoster virus).

Warnings

Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk is greater with prolonged use. Therapy should be limited to 10 consecutive days. (See PRECAUTIONS-General.) Patients being treated with eardrops containing neomycin should be under close clinical observation. Cortisporin®-TC Otic Suspension should be used cautiously in any patient with a perforated tympanic membrane.

Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. Discontinue promptly if sensitivity or irritation occurs.

When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin. The manifestation of sensitization to neomycin is ususally a low-grade reddening with swelling, dry scaling, and itching; it may be manifest simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms regress quickly on withdrawing the medication. Neomycin containing applications should be avoided for the patient thereafter.

Precautions

General

As with any other antibiotic preparation, prolonged treatment may result in overgrowth of nonsusceptible organisms and fungi. If the infection is not improved after one week, cultures should be repeated to verify the identity of the organism and to determine whether therapy should be changed.

Treatment should not be continued for longer than ten days.

Allergic cross-reactions may occur which could prevent the use of any or all of the aminoglycoside antibiotics for the treatment of future infections.

Information for Patients

Avoid contaminating the dropper with material from the ear, fingers, or other source. This caution is necessary if the sterility of the drops is to be preserved.

If sensitization or irritation occurs, discontinue use immediately and contact your physician.

Do not use in the eyes.

If you prefer to warm the medication before using it, do not heat the suspension above body temperature in order to avoid loss of potency.

SHAKE WELL BEFORE USING.

Laboratory Tests

Systemic effects of excessive levels of hydrocortisone may include a reduction in the number of circulating eosinophils and a decrease in urinary excretion of 17-hydroxycorticosteroids.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal carcinogenicity studies have not been performed with colistin or neomycin, or Cortisporin®-TC Otic Suspension. An increased incidence of chromosome aberrations in human lymphocytes has been reported following in vitro exposure to colistin or neomycin.

Fertility studies have not been performed with neomycin, but reports from the scientific literature suggest that it may decrease spermatogenesis in rats. No adverse effects on fertility were observed in male or female rats given intramuscular doses of colistimethate sodium, the methanesulfonate salt of colistin, up to 20 mg/kg (equivalent to 9.3 mg/kg of colistin base). This is approximately 30 times the clinical daily dose based on body surface area, assuming 100% absorption from the ear; however, significant systemic levels of colistin or neomycin would not be anticipated in humans when Cortisporin®-TC Otic Suspension is used as directed.

Long term studies in rodents showed no evidence of carcinogenicity attributable to oral administration of corticosteroids. Mutagenicity studies with hydrocortisone were negative. Studies have not been performed to evaluate the effect on fertility of topical corticosteroids.

Pregnancy

Teratogenic Effects

Pregnancy Category C

There are no adequate and well controlled studies of Cortisporin®-TC Otic Suspension in pregnant women. It is not known whether Cortisporin®-TC Otic Suspension can cause fetal harm when administered to a pregnant woman.

Colistimethate sodium, the methanesulfonate salt of colistin, was not teratogenic in rats or rabbits given intramuscular doses up to 20 mg/kg (equivalent to 9.3 mg/kg of colisitin base, approximately 30 times (rats) or 55 times (rabbits) the clinical daily dose based on body suface area and assuming 100% absorption from the ear). Increased resorptions were observed in rabbits at 20 mg/kg, but not 10 mg/kg (equivalent to 4.15 mg/kg of colistin base). Decreased pup survival at weaning was observed in rats at 20 mg/kg, a maternally toxic dose of colistin, but not 10 mg/kg. Colistin has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount that will be delivered ototopically at the recommended clinical doses.

Although aminoglycosides can cause congenital deafness in humans if administered during pregnancy, significant systemic levels of neomycin would not be anticipated when Cortisporin®-TC Otic Suspension is used as directed.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Cortisporin®-TC Otic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Hydrocortisone and colistin sulfate appear in human milk following oral administration of the drugs. Since systemic absorption of these drugs may occur when they are used topically, caution should be exercised when Cortisporin®-TC Otic Suspension is used by a nursing woman.

Pediatric Use

See DOSAGE AND ADMINISTRATION.

The safety and effectiveness of Cortisporin®-TC Otic Suspension in infants below one year of age have not been established. The efficacy of Cortisporin®-TC Otic Suspension in pediatric patients one year or older in the treatment of superficial bacterial infections of the external auditory canal and for the treatment of infections of mastoidectomy and fenestration cavities has been demonstrated in a controlled clinical trial.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

Neomycin occasionally causes skin sensitization.

Ototoxicity (see WARNINGS section) and nephrotoxicity have also been reported. Adverse reactions have occurred with topical use of antibiotic combinations. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general populaton. In another study the incidence was found to be approximately 1%.

The following local adverse events have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

Cortisporin TC Dosage and Administration

Therapy with this product should be limited to 10 days. (See WARNINGS.)

The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.

When using the calibrated dropper:

For adults, 5 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For pediatric patients, 4 drops are suggested because of the smaller capacity of the ear canal.

The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.

How is Cortisporin TC Supplied

Cortisporin®-TC Otic Suspension is supplied as:

NDC 42023-109-01 ............... 10 mL bottle with dropper

Each mL contains: Colistin sulfate equivalent to 3 mg of colistin base activity, Neomycin sulfate equivalent to 3.3 mg neomycin base activity, Hydrocortisone acetate 10 mg (1%), Thonzonium bromide 0.5 mg (0.05%), and Polysorbate 80 in an aqueous vehicle buffered with acetic acid and sodium acetate. Thimerosal (mercury derivative) 0.002% is added as a preservative.

A sterilized dropper-cap assembly for use on the bottle of suspension is included in the package.

Shake well before using.

Store at 20°–25°C (68°–77°F).

Rx only.

Prescribing Information as of July 2009

Manufactured by: JHP Pharmaceuticals, LLC, Rochester, MI 48307

3000828C

PRINCIPAL DISPLAY PANEL - 10 mL Label

NDC 42023-109-01

Cortisporin®-TC

(colistin sulfate–neomycin sulfate–

thonzonium bromide–hydrocortisone

acetate otic suspension)

STERILE

10mL

JHP

PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 10 mL Carton

NDC 42023-109-01

Cortisporin®-TC

(colistin sulfate–neomycin sulfate–

thonzonium bromide–hydrocortisone

acetate otic suspension)

NOTE – The enclosed dropper has been sterilized. If dropper

wrapper is broken or open, sterility cannot be guaranteed.

Rx Only

STERILE

Shake Well Before Using.

10mL bottle with dropper

JHP

PHARMACEUTICALS

CORTISPORIN-TC
colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	42023-109
Route of Administration	AURICULAR (OTIC)	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
colistin sulfate (colistin)	colistin	3 mg in 1 mL
neomycin sulfate (neomycin)	neomycin	3.3 mg in 1 mL
thonzonium bromide (thonzonium bromide)	thonzonium bromide	0.5 mg in 1 mL
hydrocortisone acetate (hydrocortisone)	hydrocortisone	10 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	42023-109-01	10 mL In 1 BOTTLE, DROPPER	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050356	11/01/2007

Labeler - JHP Pharmaceuticals LLC (804894611)

Revised: 01/2010JHP Pharmaceuticals LLC

More Cortisporin TC resources

Cortisporin TC Side Effects (in more detail)
Cortisporin TC Dosage
Cortisporin TC Use in Pregnancy & Breastfeeding
Cortisporin TC Drug Interactions
Cortisporin TC Support Group
0 Reviews for Cortisporin TC - Add your own review/rating

Compare Cortisporin TC with other medications

Acute Otitis Externa
Chronic Otitis Media
Otitis Externa
Otitis Media