Staril Tablets

The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

STARIL TABLETS

Fosinopril Sodium

Read all of this leaflet carefully before you start taking this medicine.

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  Keep this leaflet. You may need to read it again.
  


• 
  If you have any further questions, ask your doctor or pharmacist.
  


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  This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  


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  If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
  

In this leaflet:

• 1. About STARIL


• 2. Before you take STARIL


• 3. How to take STARIL


• 4. Possible side effects


• 5. How to store STARIL


• 6. Further information

About Staril

Staril belongs to a group of medicines called Angiotensin Converting Enzyme Inhibitors, or ACE Inhibitors for short. Staril is used to lower high blood pressure. You may feel quite well but high blood pressure is one of the causes of heart attacks and strokes.

In addition, Staril can make it easier for the heart to pump blood around the body and is used in the treatment of heart failure.

Before You Take Staril

Do not take STARIL

• if you are allergic (hypersensitive) to fosinopril or any of the other ingredients of STARIL.


• if you are pregnant.


• if you are breastfeeding.

Take special care with STARIL

• if you have recently lost a lot of fluid, e.g. if you have been experiencing severe vomiting or diarrhoea


• if you suffer from systemic lupus erythematosus (SLE, "Lupus") or other collagen vascular disease


• if you suffer from heart disease, diabetes or kidney disease that your doctor does not know about

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor you are taking Staril before surgery or any emergency treatment where you may need an anaesthetic.

Do not take any other medicines unless they have been discussed with your doctor or pharmacist. These include medicines from pharmacies for colds, coughs, hayfever or sinus problems as these may increase your blood pressure. If you take non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen, your dose of Staril may need to be adjusted.

Some medicines which are used to treat indigestion may reduce the absorption of Staril and so administraton of Staril and antacids should be separated by 2 hours. If you are also taking lithium, potassium supplements or salt substitutes containing potassium, or any other treatment for high blood pressure, remind your doctor before taking Staril.

Taking STARIL with food and drink

It does not matter whether you take STARIL before or after food.

There is no interaction between Staril and moderate amounts of alcohol. However, you should check with your doctor whether drinking is advisable for you.

Pregnancy and breast-feeding

You should not take Staril if you are pregnant unless you have discussed this with your doctor. Breast-feeding mothers should not take Staril.

Be sure to tell your doctor immediately if you are breastfeeding, pregnant, think you may be pregnant or if you are planning to become pregnant. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Staril Tablets do not usually affect your ability to drive or to use any tools or machines. However, if you feel light-headed or dizzy, check with your doctor.

Important information about some of the ingredients of STARIL

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Staril

Always take STARIL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual starting dose for adults, including the elderly, is 10mg once a day. This dose may be increased by your doctor up to 40mg daily.

Tablets should be swallowed with a glass of water.

This product is not for use in children.

Staril may be taken alone or in combination with a diuretic. If you are already taking diuretics (water tablets), your doctor may tell you to reduce the dose of the diuretic or to stop taking them for several days before you start taking Staril.

If you take too many STARIL tablets or if a child swallows some

Go to your nearest Casualty Department or tell your doctor immediately. If you are going to hospital, take the empty container and any remaining tablets with you. If the person has fainted, lay them down and raise their feet higher than their head.

If you forget to take STARIL

If you miss a dose, do not worry. Just carry on taking your normal dose when the next one is due. DO NOT take a double dose to make up for the one you missed.

If you stop taking STARIL

It is important that you take Staril Tablets until your doctor tells you to stop. Keep your doctor’s appointments even if you feel well.

When you are on treatment, the doctor will need to examine you from time to time and may need to perform a blood test to check how your kidneys are working.

How much exercise should I take?

As you start feeling better you may try to do too much and feel faint, especially in hot weather. Make sure you discuss with your doctor a safe amount of exercise for you.

Staril Tablets Side Effects

Like all medicines, STARIL can cause side effects, although not everybody gets them.

Any medicine may cause some unwanted or ‘side’ effects in a few patients. Tell your doctor immediately if you notice any of these:

• swelling of the hands, lips or tongue


• difficulty in breathing


• sore throat or fever


• persistent skin rash


• persistent cough


• abdominal pain; which can be severe or a specific penetrating pain in the upper area which may spread to the back


• unusually fast or irregular heart beat


• temporary changes to the blood may occur, which will be noticed if you have a blood test


• severe fainting or dizziness particularly when standing up.

Sometimes Staril causes nausea, vomiting, diarrhoea, chest pain, pains in the bones and muscles, pins and needles, tiredness, itching or taste impairment. Very rarely, people taking ACE inhibitors can develop jaundice (yellow skin/eyes).

Tell your doctor or pharmacist if any of these become serious or if you notice any other troublesome side effects.

How To Store Staril

Keep out of the reach and sight of children.

You will see an ‘EXPIRY DATE’ on the outer packaging of Staril Tablets. Do not use after this date. Keep Staril Tablets in a dry place and do not store above 30°C. They should not get too hot or damp; so do not leave your tablets near a radiator, on a window sill, or in a bathroom.

If your doctor decides to stop the tablets, take the remainder back to a pharmacy. Medicines should not be disposed of via wastewater or household waste.

Further Information

What STARIL contains

• The active substance is fosinopril sodium.


• The other ingredients are crospovidone, lactose, microcrystalline cellulose, povidone and sodium stearyl fumarate.

What STARIL looks like and contents of the pack

The tablets come in two different strengths: 10mg and 20mg.

Staril 10mg tablets are white and diamond shaped. They are marked with 'SQUIBB 158' on one side and a star on the other.

Staril 20mg tablets are white and round. They are marked with 'SQUIBB 609' on one side and a star on the other.

Staril tablets are supplied in blister strips of 28 or 84 tablets per carton or in bottles of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

E. R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex

UB8 1DH

Tel:0800-7311736

Manufacturer:

Bristol-Myers Squibb Srl.,

Contrada Fontana del Ceraso

03012 Anagni (Fr.)

Italy

This leaflet was last approved in: February 2008

ezetimibe and simvastatin

ez-ET-i-mide, sim-va-STAT-in

Commonly used brand name(s)

In the U.S.

• Vytorin

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Cholesterol Absorption Inhibitor

Uses For ezetimibe and simvastatin

Ezetimibe and simvastatin combination is used together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood. ezetimibe and simvastatin may help prevent medical problems caused by clogged blood vessels such as heart attacks and strokes.

Ezetimibe is a cholesterol absorption inhibitor and simvastatin is an HMG-CoA reductase inhibitor or "statin." ezetimibe and simvastatin will reduce the absorption of cholesterol from foods and the production of cholesterol in your body.

ezetimibe and simvastatin is available only with your doctor's prescription.

Before Using ezetimibe and simvastatin

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 ezetimibe and simvastatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ezetimibe and simvastatin 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ezetimibe and simvastatin combination in children older than 10 years of age. The safety and efficacy of ezetimibe and simvastatin combination in children younger than 10 years of age have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ezetimibe and simvastatin combination in the elderly. However, elderly patients are more likely to have age-related muscle problems, which may require caution in patients receiving ezetimibe and simvastatin combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. When you are taking ezetimibe and simvastatin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ezetimibe and simvastatin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir


• Atazanavir


• Boceprevir


• Clarithromycin


• Cyclosporine


• Danazol


• Darunavir


• Erythromycin


• Fosamprenavir


• Gemfibrozil


• Indinavir


• Itraconazole


• Ketoconazole


• Lopinavir


• Mibefradil


• Nefazodone


• Nelfinavir


• Posaconazole


• Ritonavir


• Saquinavir


• Telaprevir


• Telithromycin


• Tipranavir

Using ezetimibe and simvastatin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Amiodarone


• Amlodipine


• Azithromycin


• Bezafibrate


• Ciprofibrate


• Ciprofloxacin


• Clofibrate


• Colchicine


• Conivaptan


• Dalfopristin


• Daptomycin


• Delavirdine


• Diltiazem


• Everolimus


• Fenofibrate


• Fluconazole


• Fusidic Acid


• Gemfibrozil


• Niacin


• Quinupristin


• Ranolazine


• Risperidone


• Tadalafil


• Verapamil


• Voriconazole


• Warfarin

Using ezetimibe and simvastatin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alitretinoin


• Bosentan


• Carbamazepine


• Cholestyramine


• Colestipol


• Cyclosporine


• Dasatinib


• Digoxin


• Dronedarone


• Efavirenz


• Fenofibrate


• Fosphenytoin


• Imatinib


• Levothyroxine


• Oat Bran


• Oxcarbazepine


• Pectin


• Phenytoin


• Rifampin


• St John's Wort


• Ticagrelor

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ezetimibe and simvastatin with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ezetimibe and simvastatin, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of ezetimibe and simvastatin. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or


• Chinese ancestry or


• Hypothyroidism (an underactive thyroid), uncontrolled or


• Kidney disease, severe or


• Liver disease, history of—Use with caution. May cause side effects to become worse.

• Liver disease, active or


• Liver enzymes elevated—Should not be used in patients with these conditions.

• Muscle pain or tenderness, history of or


• Muscle weakness, history of—Use with caution. May make these conditions worse.

Proper Use of ezetimibe and simvastatin

Take ezetimibe and simvastatin only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

In addition to ezetimibe and simvastatin, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

If you are taking amiodarone (Cordarone®), diltiazem (Cardizem®), or verapamil (Calan®, Isoptin®, Verelan®) together with ezetimibe and simvastatin combination, your dose should not be higher than ezetimibe 10 milligrams (mg) plus simvastatin 10 mg per day, unless otherwise directed by your doctor. Do not use more than ezetimibe 10 mg plus simvastatin 20 mg per day together with amlodipine (Norvasc®) or ranolazine (Ranexa®). When used together with higher doses of simvastatin, these medicines may increase your risk of muscle injury and could result in kidney problems.

You may take the tablet with or without food.

Avoid large amounts of grapefruit juice (more than 1 quart each day) while you are taking ezetimibe and simvastatin. Grapefruit juice may increase your risk of muscle injury and could result in kidney problems.

Do not drink large amounts of alcohol with ezetimibe and simvastatin. This could cause unwanted effects on the liver.

If you are also using cholestyramine (Questran®), take it at least 2 hours after or 4 hours before you take ezetimibe and simvastatin.

ezetimibe and simvastatin comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of ezetimibe and simvastatin 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 ezetimibe and simvastatin. 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 oral dosage form (tablets):
  
  • For high cholesterol:
    
    • Adults—One tablet with ezetimibe 10 milligrams (mg) plus simvastatin 10 mg or ezetimibe 10 mg plus simvastatin 20 mg once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than ezetimibe 10 mg plus simvastatin 40 mg per day.
    
    
    • Children 10 to 17 years of age—One tablet with ezetimibe 10 milligrams (mg) plus simvastatin 10 mg or ezetimibe 10 mg plus simvastatin 20 mg once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than ezetimibe 10 mg plus simvastatin 40 mg per day.
    
    
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of ezetimibe and simvastatin, 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 ezetimibe and simvastatin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using ezetimibe and simvastatin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use ezetimibe and simvastatin combination if you are also taking any of the following medicines: cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, Biaxin®, Ery-Tab®, Ketek®, Nizoral®, Noxafil®, or Sporanox®), or medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Agenerase®, Crixivan®, Invirase®, Kaletra®, Lexiva®, Norvir®, Reyataz®, or Viracept®). Using these medicines together with ezetimibe and simvastatin may increase your risk of muscle injury and could result in kidney problems.

Stop using ezetimibe and simvastatin and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy. Myopathy is more common when high doses of simvastatin (eg, 80 milligrams (mg)) with ezetimibe 10 mg are used, but some people get myopathy with lower doses.

Stop using ezetimibe and simvastatin and check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Before having any kind of surgery or emergency treatment, tell the medical doctor in charge that you are using ezetimibe and simvastatin. You may need to stop using ezetimibe and simvastatin several days before having surgery or medical procedures. Talk to your doctor if you have any questions about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

ezetimibe and simvastatin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Abdominal or stomach fullness


• bloating


• chills


• constipation


• darkened urine


• fast heartbeat


• fever


• gaseous abdominal or stomach pain


• hives


• hoarseness


• indigestion


• irritation


• itching


• joint pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of appetite


• nausea


• pains in the stomach, side, or abdomen, possibly radiating to the back


• rash


• recurrent fever


• redness of the skin


• severe nausea


• shortness of breath


• stiffness


• swelling of the eyelids, face, lips, hands, or feet


• tightness in the chest


• troubled breathing or swallowing


• vomiting


• wheezing


• yellow eyes or skin

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:

Less common

• Body aches or pain


• cough


• diarrhea


• difficulty with breathing


• difficulty with moving


• ear congestion


• general feeling of discomfort or illness


• headache


• loss of voice


• muscle aches and pains or cramping


• muscle stiffness


• nasal congestion


• pain in the arms or legs


• runny nose


• shivering


• sneezing


• sore throat


• sweating


• swollen joints


• trouble sleeping


• unusual tiredness or weakness

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.

See also: ezetimibe and simvastatin side effects (in more detail)

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More ezetimibe and simvastatin resources

• Ezetimibe and simvastatin Side Effects (in more detail)
• Ezetimibe and simvastatin Dosage
• Ezetimibe and simvastatin Use in Pregnancy & Breastfeeding
• Ezetimibe and simvastatin Drug Interactions
• Ezetimibe and simvastatin Support Group
• 14 Reviews for Ezetimibe and simvastatin - Add your own review/rating

Compare ezetimibe and simvastatin with other medications

• High Cholesterol
• High Cholesterol, Familial Heterozygous
• High Cholesterol, Familial Homozygous

Valsartan

Pronunciation: val-SAR-tan
Generic Name: Valsartan
Brand Name: Diovan

Valsartan may cause injury or death to the fetus if used during pregnancy. If you think you may be pregnant, contact your doctor right away.

Valsartan is used for:

Treating high blood pressure alone or with other medicines. It is used to treat heart failure. It is used in certain patients to decrease the risk of death after a heart attack. It may also be used for other conditions as determined by your doctor.

Valsartan is an angiotensin II receptor blocker. It works by relaxing the blood vessels. This helps to lower blood pressure.

Do NOT use Valsartan if:

• you are allergic to any ingredient in Valsartan


• you are pregnant


• the patient is a child with severe kidney problems

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

Before using Valsartan:

Some medical conditions may interact with Valsartan. 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 able to become pregnant


• 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 angioedema (eg, swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness), including angioedema caused by treatment with another angiotensin II receptor blocker (eg, losartan) or an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)


• if you have a history of heart problems (eg, heart failure), blood vessel problems, blood flow problems, liver or kidney problems, or gallbladder problems


• if you have a history of stroke or recent heart attack


• if you are dehydrated or have low blood volume


• if you have electrolyte problems (eg, high blood potassium levels, low blood sodium levels) or are on a low-salt (sodium) diet


• if you have diabetes, especially if you are also taking aliskiren


• if you are on dialysis or are scheduled to have major surgery


• if you take another medicine for blood pressure or heart problems

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

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased


• Aliskiren, potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased


• ACE inhibitors (eg, lisinopril) because the risk of kidney problems and high blood potassium levels may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen, celecoxib) because they may decrease Valsartans effectiveness and the risk of serious kidney problems may be increased


• Cyclosporine, rifampin, or ritonavir because they may increase the risk of Valsartan's side effects


• Lithium because the risk of its side effects may be increased by Valsartan

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

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

• An extra patient leaflet is available with Valsartan. Talk to your pharmacist if you have questions about this information.


• Take Valsartan by mouth with or without food.


• If you cannot swallow tablets, ask your doctor or pharmacist about preparing a suspension of Valsartan.


• Take Valsartan on a regular schedule to get the most benefit from it. Taking Valsartan at the same time each day will help you remember to take it.


• Continue to take Valsartan even if you feel well. Do not miss any doses.


• If you miss a dose of Valsartan, 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 Valsartan.

Important safety information:

• Valsartan may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Valsartan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Valsartan may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• It may take up to 2 weeks or more for Valsartan to work fully. Do not stop using Valsartan or change your dose of Valsartan without checking with your doctor.


• Valsartan may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.


• Valsartan may not work as well in black patients. Discuss any questions or concerns with your doctor.


• Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Tell your doctor or dentist that you take Valsartan before you receive any medical or dental care, emergency care, or surgery.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Lab tests, including blood pressure, blood electrolyte levels, and heart, kidney, or liver function, may be performed while you use Valsartan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Valsartan should not be used in CHILDREN younger than 6 years old; safety in these children has not been confirmed.


• PREGNANCY and BREAST-FEEDING: Valsartan may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Valsartan is found in breast milk. Do not breast-feed while taking Valsartan.

Possible side effects of Valsartan:

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:

Cough; diarrhea; dizziness; headache; joint or back pain; mild stomach pain; tiredness.

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; unusual hoarseness); blurred vision; burning, numbness, or tingling; change in the amount of urine produced; chest pain; difficulty swallowing; fainting; irregular heartbeat; muscle pain, weakness, or cramps; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); symptoms of low blood pressure (eg, fainting, light-headedness, severe dizziness); unusual bruising or bleeding.

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: Valsartan 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 fainting; fast or slow heartbeat; severe dizziness or light-headedness.

Proper storage of Valsartan:

Store Valsartan at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. If your pharmacist prepares a suspension of Valsartan, store as directed by your pharmacist. Keep Valsartan out of the reach of children and away from pets.

General information:

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


• Valsartan 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 Valsartan. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Valsartan resources

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

• Valsartan Professional Patient Advice (Wolters Kluwer)


• Valsartan Monograph (AHFS DI)


• valsartan Advanced Consumer (Micromedex) - Includes Dosage Information


• Diovan Prescribing Information (FDA)


• Diovan Consumer Overview

Compare Valsartan with other medications

• Heart Failure
• High Blood Pressure
• Left Ventricular Dysfunction

Vidaza

Generic Name: azacitidine (ay za SYE ti deen)

Brand Names: Vidaza

What is azacitidine?

Azacitidine is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Azacitidine is used to treat certain types of bone marrow cancers and blood cell disorders.

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

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

Do not use this medication if you are allergic to azacitidine or mannitol, or if you have liver cancer.

Before receiving azacitidine, tell your doctor if you are allergic to any drugs, or if you have kidney disease or liver disease.

Do not receive this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 4 weeks after you stop using azacitidine.

Tell your caregiver right away if this medication accidentally gets on your skin. Wash the area thoroughly with soap and warm water.

Do not receive a "live" vaccine while you are being treated with azacitidine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Azacitidine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor. Do not miss any scheduled visits to your doctor.

What should I discuss with my healthcare provider before receiving azacitidine?

You should not be given this medication if you are allergic to azacitidine or mannitol, or if you have advanced liver cancer.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. Before you receive azacitidine, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;


• liver disease; or


• 
  

  a history of liver cancer.

  
  

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive azacitidine without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 4 weeks after you stop using azacitidine.

It is not known whether azacitidine passes into breast milk, but it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby. You may need to either stop nursing or stop receiving azacitidine.

How is azacitidine given?

Azacitidine is given as an injection through a needle placed into a vein, or as a shot given under the skin. Your doctor, nurse, or other healthcare provider will give you this injection in a clinic or hospital setting.

Azacitidine must be given slowly through an IV infusion, and can take up to 40 minutes to complete. If you are receiving a shot under your skin, you may require two injections to complete your dose.

You may also be given medications to reduce nausea and vomiting while you are receiving azacitidine.

This medication is usually given for 7 days in a row every 4 weeks for at least 4 treatment cycles. Your treatment schedule may be different. Follow your doctor's instructions.

Tell your caregiver right away if this medication accidentally gets on your skin. Wash the area thoroughly with soap and warm water.

Azacitidine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your azacitidine injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose can cause diarrhea, nausea, and vomiting.

What should I avoid while using azacitidine?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Avoid getting any of this medicine on your skin. If this does happen, tell your caregiver right away and wash the area with soap and warm water.

Do not receive a "live" vaccine while you are being treated with azacitidine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

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

• 
  

  pale skin, easy bruising or bleeding, unusual weakness;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  dry mouth, increased thirst, confusion, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;

  
  


• 
  

  pain, itching, burning, bleeding, or skin changes where the injection was given;

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  seizure (black-out or convulsions);

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  severe ongoing nausea, vomiting, or diarrhea.

  
  

Less serious side effects may include:

• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  mild nausea, vomiting, loss of appetite;

  
  


• 
  

  diarrhea, constipation;

  
  


• 
  

  redness where the injection was given;

  
  


• 
  

  headache; or

  
  


• 
  

  joint pain.

  
  

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 azacitidine?

There may be other drugs that can interact with azacitidine. 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 Vidaza resources

• Vidaza Side Effects (in more detail)
• Vidaza Use in Pregnancy & Breastfeeding
• Vidaza Drug Interactions
• Vidaza Support Group
• 3 Reviews for Vidaza - Add your own review/rating

• Vidaza Monograph (AHFS DI)


• Vidaza Prescribing Information (FDA)


• Vidaza Consumer Overview


• Vidaza MedFacts Consumer Leaflet (Wolters Kluwer)


• Azacitidine Professional Patient Advice (Wolters Kluwer)


• azacitidine Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Vidaza with other medications

• Myelodysplastic Syndrome

Where can I get more information?

• Your doctor or pharmacist can provide more information about azacitidine.

See also: Vidaza side effects (in more detail)

Ed-Tuss HC

Generic Name: chlorpheniramine, hydrocodone, and phenylephrine (KLOR fe NEER a meen, HYE droe KOE done, FEN il EFF rin)

Brand Names: B-Tuss, Coughtuss, Cytuss HC, De-Chlor HC, DroTuss-CP, Ed-TLC, Ed-Tuss HC, Endal-HD Plus, H-C Tussive, Histussin-HC, Hydro-PC II, Hydro-PC II Plus, Hydron CP, Liquicough HC, Maxi-Tuss HCX, Mintuss MS, Neo HC, Poly-Tussin, Poly-Tussin HD, Relacon-HC, Relacon-HC NR, Relasin-HC, Rindal HD Plus, Rindal-HD, Triant-HC, Tusana-D, Z-Cof HC

What is Ed-Tuss HC (chlorpheniramine, hydrocodone, 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.

Hydrocodone is a narcotic cough medicine.

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, hydrocodone, and phenylephrine is used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.

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

What is the most important information I should know about Ed-Tuss HC (chlorpheniramine, hydrocodone, and phenylephrine)?

Do not take this medication 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. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. Chlorpheniramine, hydrocodone, and phenylephrine 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 chlorpheniramine, hydrocodone, 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 chlorpheniramine, hydrocodone, and phenylephrine. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

What should I discuss with my healthcare provider before taking Ed-Tuss HC (chlorpheniramine, hydrocodone, and phenylephrine)?

Do not take this medication 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. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. You should not use chlorpheniramine, hydrocodone, and phenylephrine if you are allergic to it.

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

• 
  

  asthma, COPD, sleep apnea, or other breathing disorder;

  
  


• liver or kidney disease;


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  enlarged prostate, urination problems;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using chlorpheniramine, hydrocodone, and phenylephrine. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Ed-Tuss HC (chlorpheniramine, hydrocodone, and phenylephrine)?

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.

You may take this medication 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.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

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 hydrocodone can be fatal.

Overdose symptoms may include extreme drowsiness, feeling restless or nervous, vomiting, stomach pain, warmth or tingly feeling, seizure (convulsions), pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking Ed-Tuss HC (chlorpheniramine, hydrocodone, and phenylephrine)?

Chlorpheniramine, hydrocodone, and phenylephrine 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 chlorpheniramine, hydrocodone, and phenylephrine.

Ed-Tuss HC (chlorpheniramine, hydrocodone, 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 a serious side effect such as:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

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

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, seizure); or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, upset stomach, constipation;

  
  


• 
  

  dry mouth;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  warmth, tingling, or redness under your skin; or

  
  


• 
  

  skin rash or itching.

  
  

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 Ed-Tuss HC (chlorpheniramine, hydrocodone, 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 chlorpheniramine, hydrocodone, and phenylephrine.

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

• 
  

  blood pressure medication;

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  an antidepressant;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  

This list is not complete and other drugs may interact with chlorpheniramine, hydrocodone, and phenylephrine. 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 Ed-Tuss HC resources

• Ed-Tuss HC Side Effects (in more detail)
• Ed-Tuss HC Use in Pregnancy & Breastfeeding
• Ed-Tuss HC Drug Interactions
• Ed-Tuss HC Support Group
• 0 Reviews for Ed-Tuss HC - Add your own review/rating

• Chlorpheniramine/Hydrocodone/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ed-Tuss HC with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and phenylephrine.

See also: Ed-Tuss HC side effects (in more detail)

Ceftibuten

Class: Third Generation Cephalosporins
Molecular Formula: C₁₅H₁₄N₄O₆S₂
CAS Number: 97519-39-6
Brands: Cedax

Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.^{1 3}

Uses for Ceftibuten

Otitis Media

Treatment of acute otitis media (AOM) caused by H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes (group A β-hemolytic streptococci).^{1 2 3 5 7 8 42} (See Acute Otitis Media under Cautions.)

Management of otitis media with effusion†.³⁶ Use of anti-infectives controversial; they provide only limited benefit in enhancing resolution of effusion and may promote resistance.^{36 49 50 51 52 67 68}

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).^{1 2 16} Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.¹

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;^{12 13 25 53} oral cephalosporins and oral macrolides considered alternatives.^{12 13 25 53} Amoxicillin sometimes used instead of penicillin V, especially for young children.^{13 53}

Respiratory Tract Infections

Treatment of acute bacterial exacerbations of chronic bronchitis caused by Streptococcus pneumoniae (penicillin-susceptible strains only), Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).^{1 2 9 26 37}

Treatment of acute maxillary sinusitis† caused by susceptible S. pneumoniae, H. influenzae, or M. catarrhalis.^{3 45}

Treatment of acute bronchitis†,^{3 26 27 46} bronchiectasis†,⁴⁷ or pneumonia†^{3 46 47} caused by susceptible bacteria.

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs† caused by susceptible Escherichia coli, Klebsiella, Proteus mirabilis, Enterobacter, or staphylococci.^{3 63 64}

Treatment of complicated or recurrent UTIs† caused by susceptible E. coli, Klebsiella, P. mirabilis, Enterobacter, or staphylococci.^{3 63 64}

Ceftibuten Dosage and Administration

Administration

Oral Administration

Administer capsules orally without regard to meals.^{1 17}

Administer oral suspension at least 2 hours before or 1 hour after meals.^{1 2}

Reconstitution

Reconstitute oral suspension at time of dispensing by adding the amount of water specified on the container in 2 portions; invert bottle and shake after each addition.¹

Dosage

Available as ceftibuten dihydrate; dosage expressed in terms of anhydrous ceftibuten.¹

Pediatric Patients

Otitis Media

Acute Otitis Media (AOM)

Oral

Children 6 months through 11 years of age: 9 mg/kg (up to 400 mg) once daily for 10 days.¹

Children ≥12 years of age: 400 mg once daily for 10 days.^{1 3}

Pediatric Dosage of Ceftibuten Oral Suspension for AOM1

Weight (kg)	Daily Dosage
10	90 mg once daily1
20	180 mg once daily1
40	360 mg once daily1
>45	400 mg once daily1

Otitis Media with Effusion†

Oral

Children 7 months to 12 years of age: 9 mg/kg (up to 400 mg) once daily for 14 days.³⁶

Pharyngitis and Tonsillitis

Oral

Children 6 months through 11 years of age: 9 mg/kg (up to 400 mg) once daily for 10 days.¹

Children ≥12 years of age: 400 mg once daily for 10 days.¹

Pediatric Dosage of Ceftibuten Oral Suspension for Pharyngitis and Tonsillitis1

Weight (kg)	Daily Dosage
10	90 mg once daily1
20	180 mg once daily1
40	360 mg once daily1
>45	400 mg once daily1

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

Children ≥12 years of age: 400 mg once daily for 10 days.^{1 3}

Adults

Acute Otitis Media (AOM)

Oral

400 mg once daily for 10 days.^{1 3}

Pharyngitis and Tonsillitis

Oral

400 mg once daily for 10 days.^{1 3}

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

400 mg once daily for 10 days.^{1 3}

Uncomplicated UTIs†

Oral

400 mg once daily for 7 days.⁶⁴

Prescribing Limits

Pediatric Patients

Oral

Maximum 400 mg once daily for children 6 months through 11 years of age.¹

Adults

Oral

Maximum 400 mg once daily.¹

Special Populations

Hepatic Impairment

No dosage adjustments required.¹

Renal Impairment

Dosage for Renal Impairment1

Clcr (mL/min)	Daily Dosage
>50	9 mg/kg or 400 mg once every 24 hours1
30–49	4.5 mg/kg or 200 mg once every 24 hours1 4
5–29	2.25 mg/kg or 100 mg once every 24 hours1 4

For patients undergoing hemodialysis 2 or 3 times weekly, a single 400-mg dose (given as a capsule) or 9 mg/kg (up to 400 mg; given as the oral suspension) may be given at the end of each dialysis period.^{1 5}

Geriatric Patients

No dosage adjustments required other than those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Ceftibuten

Contraindications

• 
  

  Known hypersensitivity to ceftibuten or other cephalosporins.¹

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible organisms (e.g., Enterobacter, Pseudomonas, enterococci, Candida) with prolonged use.^a Careful observation of the patient is essential.¹ Institute appropriate therapy if superinfection occurs.^{1 a}

Treatment with anti-infectives may permit overgrowth of Clostridium difficile.¹ C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including ceftibuten, and may range in severity from mild diarrhea to fatal colitis.¹

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹ Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued. Some mild cases may respond to discontinuance alone.¹ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.¹

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions such as urticaria, pruritus, rash (maculopapular, erythematous, morbilliform), fever and chills, eosinophilia, joint pain or inflammation, edema, erythema, genital and anal pruritus, angioedema, shock, hypotension, vasodilatation, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, and anaphylaxis.^a

If hypersensitivity reaction occurs, discontinue ceftibuten and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.^{1 43}

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to any cephalosporins or penicillins.¹ Cautious use recommended in individuals hypersensitive to penicillins:^a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction^{1 43 44} and administer with caution to those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

Diabetes Mellitus

Reconstituted oral suspension contains 1 g of sucrose per 5 mL.¹

Acute Otitis Media

Possibly less effective than some other β-lactam antibiotics for the treatment of AOM caused by S. pneumoniae.^{1 2 7} Use for empiric therapy only when adequate antimicrobial coverage against S. pneumoniae has been previously administered.^{1 2}

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.¹ (See Superinfection/Clostridium difficile-associated Colitis under Cautions.)

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into milk;¹ use with caution.¹

Pediatric Use

Safety and efficacy not established in children <6 months of age.¹

Increased incidence of diarrhea in pediatric patients ≤2 years of age compared with older pediatric patients.¹

Geriatric Use

Increased peak plasma concentrations and half-life may be due to age-related changes in renal function.^{1 3 5 17} Adjust dosage based on the degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not altered; dosage adjustments not required.^{1 3}

Renal Impairment

Increased plasma half-life and decreased total body clearance.^{1 4}

Use with caution and reduce dosage.^a (See Renal Impairment under Dosage and Administration.)

Careful clinical observation and renal function tests recommended prior to and during cephalosporin therapy.^a

Common Adverse Effects

GI effects (e.g., nausea, diarrhea, dyspepsia, vomiting, abdominal pain), headache, dizziness, increased BUN concentrations, eosinophilia.^{1 3 5 34}

Interactions for Ceftibuten

Specific Drugs

Drug	Interaction
Antacids	No known pharmacokinetic interaction1
Histamine H2-receptor antagonists (ranitidine)	Potential for increased ceftibuten concentrations1
Theophylline	No evidence of pharmacokinetic interaction with IV theophylline;1 effects of concomitant oral theophylline unknown

Ceftibuten Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration.^{1 5 28 29 31} Oral bioavailability is 75–90%.⁵

In adults, a 400-mg ceftibuten dose given as the oral suspension is bioequivalent to a 400-mg dose given as 400-mg capsules.⁴⁰

Food

Food decreases rate and extent of absorption of ceftibuten; this effect is more pronounced with the oral suspension than with capsules.^{1 2 31}

Distribution

Extent

Distributed into blister fluid,³¹ bronchial secretions,^{1 31 33} nasal secretions,³¹ sputum,¹ middle ear fluid,^{1 31 32} tracheal secretions,³¹ and tonsillar tissue.⁴¹

Not known whether the drug crosses the placenta or is distributed into milk.^{1 66}

Plasma Protein Binding

Approximately 65%.¹

Elimination

Metabolism

Ceftibuten is present in plasma and urine principally as cis-ceftibuten; about 10% of a dose is converted in vivo to trans-ceftibuten.^{1 29} The trans-isomer has only about 12% of the antibacterial activity of the cis-isomer.^{1 30}

Elimination Route

The cis- and trans-isomers of ceftibuten eliminated principally in urine.^{1 29 30} Approximately 56% of a dose eliminated in urine and 39% excreted in feces within 24 hours.¹

Half-life

Adults with normal renal function: 2–2.6 hours.^{1 29 30 31}

Children 6 months to 16 years of age: 1.9–2.5 hours.^{31 35}

Special Populations

In renal impairment, plasma half-life averages 7.1–22.3 hours depending on creatinine clearance.¹

Stability

Storage

Oral

Capsules

Tight container at 2–25°C.¹

For Suspension

2–25°C.¹ Following reconstitution, store suspension at 2–8°C for up to 14 days.¹

Actions and SpectrumActions

• 
  

  Third generation cephalosporin with an expanded spectrum of activity against aerobic gram-negative bacteria compared with first and second generation cephalosporins.^{3 5}

  
  


• 
  

  Usually bactericidal.^a

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.^a

  
  


• 
  

  In vitro spectrum of activity includes some gram-positive aerobic bacteria and some gram-negative aerobic bacteria; inactive against most anaerobes; inactive against fungi and viruses.^{3 19 a}

  
  


• 
  

  Gram-positive aerobes: active in vitro and in clinical infections against Streptococcus pneumoniae (penicillin-susceptible strains only) and S. pyogenes (group A β-hemolytic streptococci).¹ Inactive against other streptococci, staphylococci, and enterococci (e.g., Enterococcus faecalis).^{3 19 a}

  
  


• 
  

  Gram-negative aerobes: active in vitro and in clinical infections against Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains).¹ Inactive against Pseudomonas aeruginosa.^{1 3 5 19 22 23}

  
  


• 
  

  Stable in the presence of a variety of plasmid-mediated β-lactamases produced by gram-positive and gram-negative bacteria;^{1 2 3 5 7 8 19 20 21 22 23} more active in vitro than other currently available oral third generation cephalosporins against Enterobacteriaceae that produce plasmid-mediated β-lactamases.^{3 5 7 19 20 21 22 23} Unstable in the presence of chromosomally-mediated cephalosporinases.¹

  
  


• 
  

  Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant [methicillin-resistant] staphylococci) should be considered resistant to ceftibuten, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.²⁴

  
  

Advice to Patients

• 
  

  Importance of administering oral suspension at least 2 hours before or 1 hour after meals.^{1 2} Capsules may be administered without regard to meals.^{1 17}

  
  


• 
  

  Importance of completing full course of therapy.¹

  
  


• 
  

  Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

  
  


• 
  

  Importance of discontinuing ceftibuten and informing clinician if an allergic reaction occurs.¹

  
  


• 
  

  For patients with diabetes, importance of being informed of sucrose content of oral suspension.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ceftibuten Dihydrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	400 mg (of anhydrous ceftibuten)	Cedax	Shionogi
	For suspension	90 mg (of anhydrous ceftibuten) per 5 mL	Cedax	Shionogi

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cedax 400MG Capsules (PERNIX THERAPEUTICS): 20/$299.99 or 60/$859.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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2. Schering Corporation. Cedax profile. Kenilworth, NJ.

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4. Kelloway JS, Awni WM, Lin CC et al. Pharmacokinetics of ceftibuten-cis and its trans metabolite in healthy volunteers and in patients with chronic renal insufficiency. Antimicrob Agents Chemother. 1991; 35:2267-74. [IDIS 295994] [PubMed 1803999]

5. Spector S. Review of the properties and features of ceftibuten: a new orally active antibiotic. Infect Dis Clinical Pract. 1995; 4(Suppl 2): S113-23.

6. Klein JO. Selection of oral antimicrobial agents for otitis media and pharyngitis. Infect Dis Clin Pract. 1995; 4(Suppl 2):S88-94.

7. Blumer JL, McLinn SE, Deabate CA et al. Multinational multicenter controlled trial comparing ceftibuten with cefaclor for the treatment of acute otitis media. Pediatr Infect Dis J. 1995; 14(Suppl):S115-20. [IDIS 349762] [PubMed 7567311]

8. McLinn SE, McCarty JM, Perrotta R et al. Multicenter controlled trial comparing ceftibuten with amoxicillin/clavulanate in the empiric treatment of acute otitis media. Pediatr Infect Dis J. 1995; 14(Suppl):S108-14.

9. Bensch GW, Klaustermeyer WB, McCarty J et al. Efficacy and safety of once-daily ceftibuten vs. twice-daily ciprofloxacin in the treatment of acute exacerbation of chronic bronchitis. Infect Dis Clin Pract. 1995; 4(Suppl 2): S80-7.

10. Chin NX, Huang HB, Neu HC. Postantibiotic effect of ceftibuten on respiratory pathogens. Pediatr Infect Dis J. 1995; 14(Suppl):S84-7.

11. Neu HC. Ceftibuten: minimal inhibitory concentration, postantibiotic effect and beta-lactamase stability—a rationale for dosing programs. Pediatr Infect Dis J. 1995; 14:S88-92.

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15. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2004; 2:15-16.

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17. Schering Corporation, Kenilworth, NJ: Personal communication.

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27. Chirurgi VA, Edelstein H, Oster SE et al. Ceftibuten versus cefaclor for the treatment of bronchitis. J Antimicrob Chemother. 1991; 28:577-80. [PubMed 1761452]

28. Bressolle F, Galtier M, Kinowski JM et al. Multiple-dose pharmacokinetics of ceftibuten after oral administration to healthy volunteers. J Pharm Sci. 1994; 83:1236-40. [IDIS 334891] [PubMed 7830237]

29. Lin C, Lim J, Radwanski E et al. Pharmacokinetics and dose proportionality of ceftibuten in men. Antimicrob Agents Chemother. 1995; 39:359-61. [IDIS 341970] [PubMed 7726498]

30. Lin C, Radwanski E, Affrime M et al. Multiple-dose pharmacokinetics of ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 1995; 39:356-8. [IDIS 341969] [PubMed 7726497]

31. Barr WH, Affrime M, Lin CC et al. Pharmacokinetics of ceftibuten in children. Pediatr Infect Dis J. 1995; 14(Suppl):S93-101. [IDIS 349759] [PubMed 7567317]

32. Lin C, Kumari P, Perrotta RJ et al. Penetration of ceftibuten into middle ear fluid. Antimicrob Agents Chemother. 1996; 40:1394-6. [IDIS 368420] [PubMed 8726007]

33. Scaglione F, Triscari F, Demartini G et al. Concentrations of ceftibuten in bronchial secretions. Chemotherapy. 1995; 41:229-33. [IDIS 352360] [PubMed 7555201]

34. Reidenberg BE. Worldwide safety experience with ceftibuten pediatric suspension. Pediatr Infect Dis J. 1995; 14(Suppl):S130-3.

35. Kearns GL, Reed MD, Jacobs RF et al. Single-dose pharmacokinetics of ceftibuten (SCH 39720) in infants and children. Antimicrob Agents Chemother. 1991; 35:2078-84. [IDIS 288658] [PubMed 1759830]

36. Mandel EM, Casselbrant ML, Kurs-Lasky M et al. Efficacy of ceftibuten compared with amoxicillin for otitis media with effusion in infants and children. Pediatr Infect Dis J. 1996; 15:409-14. [IDIS 366219] [PubMed 8724062]

37. McAdoo MA, Rice K, Gordon GR et al. Comparison of ceftibuten once daily and amoxicillin-clavulanate three times daily in the treatment of acute exacerbations of chronic bronchitis. Clin Ther. 1998; 20:88-100. [IDIS 402073] [PubMed 9522107]

38. Ziering W, McElvaine P. Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis. Infection. 1998; 26:68-75. [PubMed 9505188]

39. Aubier MA. Comparison of ceftibuten versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. Chemotherapy. 1997; 43:297-302. [IDIS 389325] [PubMed 9209787]

40. Lin CC, Affrime M, Radwanski E et al. Comparative bioavailability of ceftibuten in capsule and suspension forms. Clin Ther. 1996; 18:1139-49. [IDIS 380772] [PubMed 9001830]

41. Scaglione F, Pintucci JP, Demartini G et al. Ceftibuten concentrations in human tonsillar tissue. Eur J Clin Microbiol Infect Dis. 1996; 15:940-3. [PubMed 9031878]

42. Blumer JL, Forti WP, Summerhouse TL. Comparison of the efficacy and tolerability of once-daily ceftibuten and twice-daily cefprozil in the treatment of children with acute otitis media. Clin Ther. 1996; 18:811-20. [IDIS 376625] [PubMed 8930425]

43. Kishiyam JL, Adelman DC. The cross-reactivity and immunology of β-lactam antibiotics. Drug Saf. 1994; 10:318-27. [PubMed 8018304]

44. Thompson JW, Jacobs RF. Adverse effects of newer cephalosporins: an update. Drug Saf. 1993; 9:132-42. [PubMed 8397890]

45. De Abate CA, Perrotta RJ, Dennington ML et al. The efficacy and safety of once-daily ceftibuten compared with co-amoxiclav in the treatment of acute sinusitis. J Chemother. 1992; 4:358-63. [PubMed 1287138]

46. Kammer RB, Ress R. Randomized comparative study of ceftibuten versus cefaclor in the treatment of acute lower respiratory tract infections. Diagn Microbiol Infect Dis. 1991; 14:101-5. [PubMed 2013204]

47. McCabe R, Rumans L, Perrotta R et al. Comparison and efficacy and safety of ceftibuten and cefaclor in the treatment of pneumonia and bronchiectasis. J Chemother. 1993; 5:124-32. [PubMed 8515295]

48. Stool SE, Gerg AO, Berman S et al. Otitis media with effusion in young children. Clinical practice guideline No 12. AHCPR publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services; 1994 Jul.

49. Williams RL, Chalmers TC, Stange KC et al. Use of antibiotics in preventing recurrent acute otitis media and in treating otitis media with effusion: a meta-analytic attempt to resolve the brouhaha. JAMA. 1993; 270:1344-51. [IDIS 319598] [PubMed 8141875]

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51. Berman S. Otitis media in children. N Engl J Med. 1995; 332:1560-5. [IDIS 348227] [PubMed 7739711]

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53. Bisno AL, Gerber MA, Gwaltney JM. Practice guidelines for the diagnosis and management of group A streptococcal pharyngitis. Clin Infect Dis. 2002; 35:113-25. [IDIS 484228] [PubMed 12087516]

54. Klein JO. Management of streptococcal pharyngitis. Pediatr Infect Dis J. 1994; 13:572-5. [IDIS 331902] [PubMed 8078757]

55. Pichichero ME, Cohen R. Shortened course of antibiotic therapy for acute otitis media, sinusitis and tonsillopharyngitis. Pediatr Infect Dis J. 1997; 16:680-95. [IDIS 390075] [PubMed 9239773]

56. Tack KJ, Henry DC, Gooch WM et al et al. Five-day cefdinir treatment for streptococcal pharyngitis. Antimicrob Agents Chemother. 1998; 42:1073-5. [IDIS 404900] [PubMed 9593129]

57. Milatovic D, Adam D, Hamilton H et al. Cefprozil versus penicillin V in treatment of streptococcal tonsillopharyngitis. Antimicrob Agents Chemother. 1993; 37:1620-3. [IDIS 318765] [PubMed 8215273]

58. Aujard Y, Boucot I, Brahimi N et al. Comparative efficacy and safety of four-day cefuroxime axetil and ten-day penicillin treatment of group A beta-hemolytic streptococcal pharyngitis in children. Pediatr Infect Dis J. 1995; 14:295-300. [IDIS 345876] [PubMed 7603811]

59. Mehra S, Van Moerkerke M, Welck J et al. Short course therapy with cefuroxime axetil for group A streptococcal tonsillopharyngitis in children. Pediatr Infect Dis J. 1998; 17:452-7. [IDIS 408830] [PubMed 9655533]

60. Dajani AS, Kessler SL, Mendelson R et al. Cefpodoxime proxetil vs. penicillin V in pediatric streptococcal pharyngitis/tonsillitis. Pediatr Infect Dis J. 1993; 12:275-9. [PubMed 8483620]

61. Pichichero ME. Cephalosporins are superior to penicillin for treatment of streptococcal tonsillopharyngitis: is the difference worth it? Pediatr Infect Dis. 1993; 12:268-74.

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63. Banfi A, Gabriele G, Hill-Juarez MJ et al. Multinational comparative trial of ceftibuten and trimethoprim-sulfamethoxazole in the treatment of children with complicated or recurrent urinary tract infections. Pediatr Infect Dis J. 1993; 12:S84-91.

64. Stein GE, Christensen S, Mummaw N. Treatment of acute uncomplicated urinary tract infection with ceftibuten. Infection. 1991; 19:125-7.

65. Reviewers’s comments (personal observations).

66. Schering, Kenilworth, NJ: Personal communication.

67. Dowell SF, Marcy SM, Phillips WR et al. Otitis media—principles of judicious use of antimicrobial agents. Pediatrics. 1998; 101:165-71.

68. Stool SE, Berg AO, Berman S et al for the Otitis Media Guideline Panel. Otitis media with effusion in young children. Clinical practice guideline. Number 12. AHCPR Publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Resources. July 1994.

69. American Academy of Pediatrics and American Academy of Family Physicians Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics. 2004: 113:1451-65.

70. American Academy of Pediatrics, American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, and American Academy of Pediatrics Subcommittee on Otitis Media with Effusion. Otitis media with effusion. Pediatrics. 2004: 113:1412-29.

a. AHFS Drug Information 2003. McEvoy GK, ed. Cephalosporins General Statement. American Society of Health-System Pharmacists; 2003:125-39.

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