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E-mycin

06/08/10

It is very good that pharmacists invented ERYTHROMYCIN, and I thank your store for selling it. I have bought tablets named E-mycin from you, which in fact consist of ERYTHROMYCIN. It helped me very much to fight severe acne. ERYTHROMYCIN is a macrolide antibiotic with a broad spectrum of action. It stops the growth of many kinds of bacteria, and thus fights many kinds of infection.
I was prescribed ERYTHROMYCIN because of my very bad acne, and had to take it for the whole month. It was part of complex treatment, and I think that it did well! Also, I got to know that this medicine cures pneumonia, dermatological infections, some sexually transmitted infections, and Legionnaire’s disease, and also prevents heart problems in patients with rheumatic fever.
Anyway, this is a very useful and pluripotential medicine. And it is rather easy to take. It is said that one should drink it with glass of water, on an empty stomach, at least 30 minutes before or 2 hours after food. I took it very lightly, with no side effects at all. My doctor said that it is most important to take this medicine at regular intervals, not skipping doses or making an overdosage. I followed the directions, and my face and back became cleaner and nicer.
Thank you again!

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ezetimibe and simvastatin (Oral route)

30/06/10

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

The combination product of ezetimibe and simvastatin is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using ezetimibe and simvastatin may help prevent medical problems caused by such substances clogging the blood vessels.

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

ezetimibe and simvastatin has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. ezetimibe and simvastatin should only be used in children 10 years of age or older.

Geriatric

ezetimibe and simvastatin has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults

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

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.

Atazanavir
Darunavir
Fosamprenavir
Itraconazole
Lopinavir
Mibefradil
Ritonavir
Saquinavir
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
Amprenavir
Bezafibrate
Ciprofibrate
Ciprofloxacin
Clarithromycin
Clofibrate
Cyclosporine
Dalfopristin
Danazol
Delavirdine
Erythromycin
Fenofibrate
Fluconazole
Fusidic Acid
Gemfibrozil
Indinavir
Ketoconazole
Nefazodone
Nelfinavir
Niacin
Quinupristin
Risperidone
Tadalafil
Telithromycin
Verapamil
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.

Azithromycin
Bosentan
Carbamazepine
Cholestyramine
Colchicine
Colestipol
Conivaptan
Cyclosporine
Dasatinib
Digoxin
Diltiazem
Efavirenz
Fenofibrate
Fosphenytoin
Imatinib
Levothyroxine
Oat Bran
Oxcarbazepine
Pectin
Phenytoin
Rifampin
St John’s Wort
Voriconazole

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

Proper Use of ezetimibe and simvastatin

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor’s orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, ezetimibe and simvastatin is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

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.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.

For oral dosage form (tablets):
- For high cholesterol:
  - Adults—1 tablet a day, tablet strength is determined by your doctor.
  - Children—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. Do not refrigerate. 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 you at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol. Your doctor can then decide if you should continue to take it.

Check with your doctor immediately if you think that you may be pregnant. Certain cholesterol medications may cause birth defects or other problems in the baby if taken during pregnancy.

Do not take other medicines unless they have been discussed with your doctor. It is very important that you take all of your medicine. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever, because the medicine’s adverse effects on muscle can lead to serious kidney problems.

If you are taking amiodarone (Cordarone(R)) or verapamil (Calan(R), Verelan(R)) together with ezetimibe/simvastatin, your ezetimibe/simvastatin dose should NOT exceed 10 mg/20 mg per day, unless directed by your doctor or pharmacist. If you are taking cyclosporine (Restasis(R), Sandimmune(R)) or danazol (Danocrine(R)) together with ezetimibe/simvastatin, your ezetimibe/simvastatin dose should NOT exceed 10 mg/10 mg per day, unless directed by your doctor or pharmacist. When used together, these medicines may increase your risk of muscle injury which can lead to kidney failure, particularly at higher doses of simvastatin. If you are taking amiodarone, cyclosporine, danazol, or verapamil and ezetimibe/simvastatin, call your doctor right away if you have dark-colored urine, have a fever, have muscle cramps or spasms, have muscle pain or stiffness, feel very tired or weak, or have diarrhea .

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

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 fullness
bloating
chills
constipation
darkened urine
fast heartbeat
fever
gaseous abdominal pain
hives
hoarseness
indigestion
irritation
itching
joint pain
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
loss of appetite
nausea
pains in stomach, side, or abdomen, possibly radiating to the back
severe nausea
stomach pain
rash
recurrent fever
redness of skin
shortness of breath
stiffness
swelling of eyelids, face, lips, hands, or feet
tightness in 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 in breathing
difficulty in 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 arms or legs
runny nose
shivering
sneezing
sore throat
sweating
swollen joints
trouble sleeping
unusual tiredness or weakness
vomiting

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

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

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

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30/06/10

Ezetimibe/

Simvastatin

Generic Name: Ezetimibe/Simvastatin (ez-ET-i-mibe/SIM-va-STAT-in)
Brand Name: Vytorin

Ezetimibe/Simvastatin is used for:

Treating high cholesterol along with a cholesterol-lowering diet. It may also be used for other conditions as determined by your doctor.

Ezetimibe/Simvastatin is a combination of 2 medicines. Ezetimibe works by reducing the amount of cholesterol that your body absorbs from your diet. Simvastatin is an HMG-CoA reductase inhibitor or “statin.” It works by blocking an enzyme that is necessary for your body to make cholesterol. Lowering cholesterol levels in the blood reduces the chance of heart disease, heart attacks, and strokes.

Do NOT use Ezetimibe/Simvastatin if:

you are allergic to any ingredient in Ezetimibe/Simvastatin
you have liver problems or ongoing abnormal liver function test results
you are taking another medicine that contains simvastatin or ezetimibe
you are taking an HIV protease inhibitor (eg, nelfinavir, lopinavir, ritonavir), itraconazole, ketoconazole, a macrolide or ketolide antibiotic (eg, clarithromycin, erythromycin, troleandomycin), mibefradil, or nefazodone
you are pregnant or breast-feeding

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

Before using Ezetimibe/Simvastatin:

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

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you are a woman of childbearing age
if you have kidney problems, muscle problems, or a family history of muscle problems; low blood pressure; uncontrolled seizures; or serious metabolic, endocrine, or electrolyte problems
if you are scheduled for major surgery, have recently had a major trauma, or have a severe infection or history of alcohol abuse
if you have had an organ transplant and are taking medicine to suppress a rejection reaction

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

Amiodarone, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), azole antifungals (eg, itraconazole, ketoconazole), cyclosporine, danazol, delavirdine, diltiazem, fibrates (eg, clofibrate, fenofibrate), fluconazole, gemfibrozil, HIV protease inhibitors (eg, ritonavir), imatinib, macrolide antibiotics (eg, erythromycin), macrolide immunosuppressives (eg, tacrolimus), mibefradil, nefazodone, niacin, nicotinic acid, streptogramins, telithromycin, verapamil, or voriconazole because side effects, such as muscle pain, may occur
Bosentan, carbamazepine, cholestyramine, hydantoins (eg, phenytoin), rifampin, or St. John’s wort because they may decrease Ezetimibe/Simvastatin’s effectiveness
Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Ezetimibe/Simvastatin

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

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

An extra patient leaflet is available with Ezetimibe/Simvastatin. Talk to your pharmacist if you have questions about this information.
Take Ezetimibe/Simvastatin by mouth with or without food, preferably in the evening, unless directed otherwise by your doctor.
Taking Ezetimibe/Simvastatin at the same time each day will help you remember to take it.
If you also take a bile acid sequestrant (eg, cholestyramine, colestipol, colesevelam), do not take it within 2 hours before or 4 hours after taking Ezetimibe/Simvastatin. Check with your doctor if you have questions.
For best results, Ezetimibe/Simvastatin should be used along with exercise, a low-cholesterol/low-fat diet, and a weight-loss program if you are overweight. Follow the diet and exercise program given to you by your health care provider.
Eating grapefruit or drinking grapefruit juice may increase the amount of Ezetimibe/Simvastatin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than one quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Ezetimibe/Simvastatin.
Most people with high cholesterol do not feel sick. Continue to take Ezetimibe/Simvastatin even if you feel well. Do not miss any doses.
If you miss a dose of Ezetimibe/Simvastatin, 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 Ezetimibe/Simvastatin.

Important safety information:

Ezetimibe/Simvastatin may cause dizziness, drowsiness, or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ezetimibe/Simvastatin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
It may take several weeks for Ezetimibe/Simvastatin to work.
Proper dental care is important while you are taking Ezetimibe/Simvastatin. Brush and floss your teeth and visit the dentist regularly.
Ezetimibe/Simvastatin may harm your liver. Your risk may be greater if you drink alcohol while you are using Ezetimibe/Simvastatin. Talk to your doctor before you take Ezetimibe/Simvastatin or other fever reducers if you drink more than 3 drinks with alcohol per day.
Ezetimibe/Simvastatin may cause injury to your muscles, especially when taken at higher doses or when taken with certain other medicines. Contact your doctor right away if you experience muscle pain, tenderness, or weakness, especially with a fever.
Some patients taking Ezetimibe/Simvastatin have reported poor memory or trouble sleeping. If you experience these effects, check with your doctor.
Lab tests, including blood cholesterol levels, liver function tests, or muscle tests, may be performed while you use Ezetimibe/Simvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Ezetimibe/Simvastatin should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not use Ezetimibe/Simvastatin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Ezetimibe/Simvastatin is found in breast milk. Do not breast-feed while taking Ezetimibe/Simvastatin.

Possible side effects of Ezetimibe/Simvastatin:

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; flu-like symptoms; headache; pain in the arms or legs; tiredness; upper respiratory tract infection.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; change in the amount of urine; chest pain; dark urine; depression; fast heartbeat; fever; loss of appetite; muscle tenderness, pain, or weakness; nausea; numbness, tingling, burning, or weakness in the arms, hands, feet, or legs; pale stools; stomach tenderness; unexplained pain in the stomach or mid-upper back; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

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

If OVERDOSE is suspected:

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

Proper storage of Ezetimibe/Simvastatin:

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

General information:

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

This information is a summary only. It does not contain all information about Ezetimibe/Simvastatin. 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: May 5, 2010

Database Edition 10.2.1.002

E,Med-facts

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Ezetimibe / Simvastatin

30/06/10

Pronunciation: (ez-ET-i-mibe/SIM-vah-STAT-in)
Class: Antihyperlipidemic combination

Trade Names:
Vytorin 10/10
- Tablets ezetimibe 10 mg/simvastatin 10 mg

Trade Names:
Vytorin 10/20
- Tablets ezetimibe 10 mg/simvastatin 20 mg

Trade Names:
Vytorin 10/40
- Tablets ezetimibe 10 mg/simvastatin 40 mg

Trade Names:
Vytorin 10/80
- Tablets ezetimibe 10 mg/simvastatin 80 mg

Pharmacology

Ezetimibe

Inhibits absorption of cholesterol by the small intestine.

Simvastatin

Inhibits the conversion of HMG-CoA to mevalonate, an early step in the biosynthetic pathway for cholesterol.

Indications and Usage

Adjunctive treatment to diet for reduction of elevated total-cholesterol, LDL cholesterol, triglycerides, non-HDL cholesterol, and apolipoprotein B (Apo B), and to increase HDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia; as an adjunct to other lipid-lowering treatment for the reduction of total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia.

Contraindications

Active liver disease or unexplained persistent elevations in serum transaminases; pregnancy and lactation; hypersensitivity to any component of the product.

Dosage and Administration

Primary Hypercholesterolemia
Adults

PO Dosage range is 10/10 mg through 10/80 mg daily in the evening. Start with 10/20 mg daily. Lipid levels may be analyzed after 2 or more wk and dosage adjusted. For patients requiring a large reduction in LDL cholesterol (more than 55%), therapy may be started at 10/40 mg daily.

Homozygous Familial Hypercholesterolemia
Adults

PO 10/40 mg daily or 10/80 mg daily in the evening. Use as an adjunct to other lipid lowering treatments.

General Advice

Administer without regard to meals. Administer with food if GI upset occurs.

Storage/Stability

Store tablets at controlled room temperature (68° to 77°F).

Drug Interactions

Amiodarone, verapamil

Risk of myopathy/rhabdomyolysis may be increased. Dose of ezetimibe/simvastatin should not exceed 10/20 mg daily.

Antacids

Aluminum and magnesium antacids decreased C _max of ezetimibe by 30%.

Bile acid sequestrant (eg, cholestyramine)

Ezetimibe concentrations may be reduced, decreasing the therapeutic effect. Give at least 2 h before or 4 h after the bile acid sequestrant.

Carbamazepine, rifampin

Simvastatin concentrations may be reduced, decreasing the efficacy.

Cyclosporine, danazol

Exposure to ezetimibe may be increased, especially in patients with severe renal function impairment. Dose of ezetimibe/simvastatin should not exceed 10/10 mg daily.

Digoxin

Digoxin plasma concentrations may be slightly elevated.

Fibrates (eg, fenofibrate, gemfibrozil)

Ezetimibe and simvastatin concentrations may be increased. Avoid coadministration.

Niacin

Risk of myopathy may be increased, especially with doses of niacin 1 g/day or more.

Potent inhibitors of CYP3A4 (eg, clarithromycin, cyclosporine, delaviridine, diltiazem, efavirenz, erythromycin, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, telithromycin, large quantities of grapefruit juice [more than 1 quart daily])

May reduce the elimination of simvastatin, increasing the risk of myopathy. Avoid coadministration.

Propranolol

Simvastatin peak plasma concentrations may be reduced.

St. John’s wort

Coadministration may result in decreased simvastatin levels.

Warfarin

The anticoagulant effect, as measured by the INR, may be modestly potentiated.

Laboratory Test Interactions

None well documented.

Adverse Reactions

The incidences stated for the following adverse reactions were reported with Vytorin (ezetimibe/simvastatin) administration. Adverse reactions occurring with administration of either ezetimibe or simvastatin can be found in their respective monographs.

CNS

Headache (7%).

Hepatic

Cholelithiasis, cholecystitis, elevated CPK, elevated liver transaminases, (postmarketing).

Hypersensitivity

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria (postmarketing).

Musculoskeletal

Myalgia (4%); pain in extremity (2%); arthralgia (postmarketing).

Pulmonary

Upper respiratory tract infection (4%).

Miscellaneous

Influenza (3%); myopathy, nausea, pancreatitis, rhabdomyolysis, thrombocytopenia (postmarketing).

Precautions

Monitor

Ensure that lipid levels are measured before therapy is started, at least 2 wk after starting ezetimibe/simvastatin therapy or changing the dose, and then periodically thereafter. Monitor LFTs before the initiation of treatment and thereafter when clinically indicated.

Pregnancy

Category X .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Renal Function

Use with caution in patients with severe renal function impairment.

Hepatic Function

Use is not recommended in patients with moderate or severe hepatic function impairment.

Hepatotoxicity

Ensure that serum transaminases are determined before starting therapy and periodically thereafter as clinically indicated. For patients being titrated to 10/80 mg dose, ensure that transaminases are determined before titration, 3 mo after titration to 10/80 mg dose, and periodically thereafter (eg, every 6 mo) for first yr of treatment. If elevated serum transaminase levels develop during treatment, repeat levels more frequently. If transaminase levels rise to 3 times upper limit of normal or greater and persist, be prepared to discontinue therapy.

Liver dysfunction

Use with caution in patients who consume substantial quantities of alcohol or who have history of liver disease. Marked, persistent increases in serum transaminases can occur.

Myopathy/rhabdomyolysis

Simvastatin administration has been associated with dose-related myopathy/rhabdomyolysis. Discontinue therapy immediately if myopathy occurs or is suspected.

Secondary causes of hyperlipidemia

Rule out or treat secondary causes of hyperlipidemia before starting treatment.

Skeletal muscle effects

Rhabdomyolysis with renal function impairment secondary to myoglobinuria has occurred with statin administration. Consider myopathy in any patient with diffuse myalgias, muscle tenderness or weakness, or marked CPK elevation.

Overdosage

Symptoms

Limited data are available. Supportive treatment is recommended.

Patient Information

Explain name, dose, action, potential side effects of medication, and LDL-C goal.
Advise patient that dose of medication may change based on results of cholesterol blood tests in an effort to reach LDL-C goal.
Review other substances (eg, grapefruit juice) and medications (eg, fibrates, potent CYP3A4 inhibitors) that should not be taken with this medication.
Advise patient to take prescribed dose once daily in the evening without regard to meals, but to take with food if stomach upset occurs.
Advise patient that if a dose is missed to take as soon as remembered but to never take more than 1 dose of medicine a day.
Advise patient that drug helps control, but does not cure, cholesterol abnormality and to continue taking drug as prescribed when LDL-C goal has been met.
Instruct patient to continue taking other cholesterol-lowering medications as prescribed by health care provider.
Advise patient who is also taking a bile acid sequestrant (eg, cholestyramine) to take the ezetimibe/simvastatin at least 2 h before or 4 h after the sequestrant.
Instruct patient to immediately notify health care provider if experiencing any unexplained muscle pain, tenderness, and/or weakness, or if they note any other unusual feelings.
Emphasize to patient importance of other modalities on cholesterol control: dietary changes (reduce saturated fat intake, increase soluble fiber intake), weight control, regular exercise, smoking cessation.
Advise women of childbearing potential to use effective contraception during treatment with ezetimibe/simvastatin.

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Ezfe

30/06/10

Generic Name: iron polysaccharide (I ern paw lee SACK ah ride)
Brand Names: Ezfe, Ferrex-150, Ferus Pic-150, Niferex, Niferex Elixir, Nu-Iron 150, Poly Iron, Polysaccharide Iron

What is Ezfe (iron polysaccharide)?

Iron polysaccharide is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Iron polysaccharide is used as a dietary supplement, and to prevent and to treat iron deficiencies and iron deficiency anemia.

Iron polysaccharide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ezfe (iron polysaccharide)?

Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

Iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking iron polysaccharide if you take any other prescription or over-the-counter medicines.

Who should not take Ezfe (iron polysaccharide)?

Do not take iron polysaccharide if you have

hemochromatosis,
hemosiderosis, or
hemolytic anemia.

Iron polysaccharide may be dangerous if you have any of the conditions listed above.

If you do not have an iron deficiency, talk to your doctor about the use of iron polysaccharide. Generally, iron polysaccharide should not be taken chronically by individuals with a normal iron balance.

Talk to your doctor before taking iron polysaccharide if you are pregnant. Talk to your doctor before taking iron polysaccharide if you are breast-feeding a baby.

How should I take Ezfe (iron polysaccharide)?

Take iron polysaccharide exactly as directed by your doctor, or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each tablet with a full glass of water. Shake the suspension well before measuring a dose. To ensure you get the correct dose, use a dose-measuring cup or spoon, not a regular table spoon to measure the dose. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Mix the liquid forms of iron polysaccharide with water, juice, or another beverage as directed and drink the mixture through a straw to prevent staining of the teeth.

Take iron polysaccharide on an empty stomach for best results. If stomach upset occurs, take iron polysaccharide with food or following a meal.

Store iron polysaccharide at room temperature, away from moisture and heat. Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time to take the next dose, skip the dose you missed and take the next regularly scheduled dose as directed. Do not take a double dose.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a iron polysaccharide overdose include decreased energy; nausea; vomiting; abdominal pain; tarry stools; a weak, rapid pulse; fever; coma; seizures; and death.

What should I avoid while taking Ezfe (iron polysaccharide)?

Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

Ezfe (iron polysaccharide) side effects

If you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives), stop taking iron polysaccharide and seek emergency medical attention.

Other less serious side effects are more likely to occur. Continue taking iron polysaccharide and talk to your doctor or pharmacist if you experience

stomach upset,
nausea or vomiting,
constipation,
diarrhea,
black or darker than normal appearing stools, or
temporary staining of the teeth.

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 Ezfe (iron polysaccharide)?

Do not take iron polysaccharide within 2 hours of a dose of any of the following medicines

a tetracycline antibiotic such as tetracycline (Achromycin, Sumycin), minocycline (Minocin, Dynacin), doxycycline (Vibramycin, Monodox), demeclocycline (Declomycin), oxytetracycline (Terramycin), or troleandomycin (TAO);
a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), enoxacin (Penetrex) ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), grepafloxacin (Raxar), sparfloxacin (Zagam), or trovafloxacin (Trovan);
levodopa (Larodopa, Dopar, Sinemet);
levothyroxine (Synthroid, Levoxyl, others);
methyldopa (Aldomet); or
penicillamine (Cuprimine).

Iron polysaccharide may decrease the absorption of the drugs listed above.

Do not take antacids within 2 hours of a dose of iron polysaccharide. Antacids may decrease the absorption of iron polysaccharide.

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

Where can I get more information?

Your pharmacist can provide more information about iron polysaccharide.

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

Concise,E

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Ezol

30/06/10

Generic Name: butalbital and acetaminophen combination (Oral route)

Commonly used brand name(s):

In the U.S.

Anolor 300
Cephadyn
Dolgic LQ
Esgic
Esgic-Plus
Ezol
Fioricet
Geone
Margesic
Medigesic
Phrenilin
Phrenilin Forte

Available Dosage Forms:

Tablet
Capsule
Solution

Uses For Ezol

Butalbital and acetaminophen combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

When you take butalbital for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

Some butalbital and acetaminophen combinations also contain caffeine. Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

Butalbital and acetaminophen combination may also be used for other kinds of headaches or other kinds of pain as determined by your doctor.

These medicines are available only with your doctor’s prescription.

Before Using Ezol

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

For butalbital:

Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them.

For acetaminophen:

Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

For caffeine:

There is no specific information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

For butalbital:

Certain side effects, such as confusion, excitement, or mental depression, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine.

For acetaminophen:

Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

For caffeine:

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

Pregnancy

For butalbital:

Barbiturates such as butalbital have been shown to increase the chance of birth defects in humans. Also, one study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby.
Butalbital may cause breathing problems in the newborn baby if taken just before or during delivery.

For acetaminophen:

Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems.

For caffeine:

Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, use of large amounts of caffeine during pregnancy may cause problems with the heart rhythm and the growth of the fetus. Also, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).

Breast Feeding

For butalbital:

Barbiturates such as butalbital pass into the breast milk and may cause drowsiness, unusually slow heartbeat, shortness of breath, or troubled breathing in nursing babies.

For acetaminophen:

Although acetaminophen has not been shown to cause problems in nursing babies, it passes into the breast milk in small amounts.

For caffeine:

Caffeine (present in some butalbital and acetaminophen combinations) passes into the breast milk in small amounts. Taking caffeine in the amounts present in these medicines has not been shown to cause problems in nursing babies. However, studies have shown that nursing babies may appear jittery and have trouble in sleeping when their mothers drink large amounts of caffeine-containing beverages. Therefore, breast-feeding mothers who use caffeine-containing medicines should probably limit the amount of caffeine they take in from other medicines or from beverages.

Interactions with Medicines

Using medicines in this class 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.

Adinazolam
Alfentanil
Alprazolam
Amobarbital
Anileridine
Anisindione
Aprobarbital
Bromazepam
Brotizolam
Butabarbital
Butalbital
Carisoprodol
Chloral Hydrate
Chlordiazepoxide
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Codeine
Dantrolene
Diazepam
Dicumarol
Estazolam
Ethchlorvynol
Fentanyl
Flunitrazepam
Flurazepam
Halazepam
Hydrocodone
Hydromorphone
Ketazolam
Levorphanol
Lorazepam
Lormetazepam
Medazepam
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Metaxalone
Methocarbamol
Methohexital
Midazolam
Morphine
Morphine Sulfate Liposome
Nitrazepam
Nordazepam
Oxazepam
Oxycodone
Oxymorphone
Pentobarbital
Phenindione
Phenobarbital
Phenprocoumon
Prazepam
Primidone
Propoxyphene
Quazepam
Quetiapine
Remifentanil
Secobarbital
Sodium Oxybate
Sufentanil
Temazepam
Thiopental
Triazolam

Interactions with Food/Tobacco/Alcohol

Using medicines in this class 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 your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of butalbital and acetaminophen combination

This section provides information on the proper use of a number of products that contain butalbital and acetaminophen combination. It may not be specific to Ezol. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If butalbital and acetaminophen combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and acetaminophen combinations can also increase the chance of dependence. Dependence is especially likely to occur in patients who take these medicines to relieve frequent headaches. Taking too much of this medicine may also lead to liver damage or other medical problems.

This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor’s directions about taking the other medicine, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

The dose medicines in this class 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage forms (capsules or tablets):
- For tension headaches:
  - Adults—One or 2 capsules or tablets every four hours as needed. If your medicine contains 325 or 500 milligrams (mg) of acetaminophen in each capsule or tablet, you should not take more than six capsules or tablets a day. If your medicine contains 650 mg of acetaminophen in each capsule or tablet, you should not take more than four capsules or tablets a day.
  - Children—Dose must be determined by your doctor.

Missed Dose

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

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Ezol

Check with your doctor:

If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.
If you are having headaches more often than you did before you started taking this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of this medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate or acetaminophen, check with your health care professional. Taking them together with this medicine may cause an overdose.

The butalbital in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine; narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, drinking large amounts of alcoholic beverages regularly while taking this medicine may increase the chance of liver damage, especially if you take more of this medicine than your doctor ordered or if you take it regularly for a long time. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Before you have any medical tests, tell the person in charge that you are taking this medicine. Caffeine (present in some butalbital and acetaminophen combinations) interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of other tests may also be affected by butalbital and acetaminophen combinations.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital.

If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or possibly death. Signs of butalbital overdose include severe drowsiness, confusion, severe weakness, shortness of breath or unusually slow or troubled breathing, slurred speech, staggering, and unusually slow heartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.

Ezol 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:

Rare

Bleeding or crusting sores on lips
chest pain
fever with or without chills
hive-like swellings (large) on eyelids, face, lips, and/or tongue
muscle cramps or pain
red, thickened, or scaly skin
shortness of breath, troubled breathing, tightness in chest, or wheezing
skin rash, itching, or hives
sores, ulcers, or white spots in mouth (painful)

Symptoms of overdose

Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
convulsions (seizures) (for products containing caffeine)
diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain
dizziness, lightheadedness, drowsiness, or weakness, (severe)
frequent urination (for products containing caffeine)
hallucinations (seeing, hearing, or feeling things that are not there)
increased sensitivity to touch or pain (for products containing caffeine)
muscle trembling or twitching (for products containing caffeine)
nausea or vomiting, sometimes with blood
ringing or other sounds in ears (for products containing caffeine)
seeing flashes of “zig-zag” lights (for products containing caffeine)
shortness of breath or unusually slow or troubled breathing
slow, fast, or irregular heartbeat
slurred speech
staggering
swelling, pain, or tenderness in the upper abdomen or stomach area
unusual movements of the eyes

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Confusion (mild)
mental depression
unusual excitement (mild)

Rare

Bloody or black, tarry stools
bloody urine
pinpoint red spots on skin
swollen or painful glands
unusual bleeding or bruising
unusual tiredness or weakness (mild

More common

Bloated or “gassy” feeling
dizziness or lightheadedness (mild)
drowsiness (mild)
nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)

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.

Advanced,E

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EZ Char Suspension

30/06/10

Generic Name: Activated Charcoal (CHAR-kole)
Brand Name: EZ Char

EZ Char Suspension is used for:

Treating poisoning or overdose in certain circumstances.

EZ Char Suspension is an adsorbent. It works by binding with the poison in the stomach to decrease absorption of the poison into the body.

Do NOT use EZ Char Suspension if:

you are allergic to any ingredient in EZ Char Suspension

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

Before using EZ Char Suspension:

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

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

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

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

How to use EZ Char Suspension:

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

EZ Char Suspension must be mixed with water before using.
Shake well before using.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure this dose.
If you miss a dose of EZ Char Suspension, contact your doctor right away.

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

Important safety information:

EZ Char Suspension may cause your stools to turn black.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking EZ Char Suspension, discuss with your doctor the benefits and risks of using EZ Char Suspension during pregnancy. If you are or will be breast-feeding while you are using EZ Char Suspension, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of EZ Char Suspension:

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

Constipation; diarrhea; temporary darkening of the stool; vomiting.

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

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

If OVERDOSE is suspected:

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

Proper storage of EZ Char Suspension:

Store EZ Char Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep EZ Char Suspension out of the reach of children and away from pets.

General information:

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

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

E,Med-facts

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EZ Gas II Effervescent Granule Packets

30/06/10

Generic Name: Sodium Bicarbonate/Citric Acid/Simethicone (SOE-dee-um bye-KAR-bo-nate/SIT-rik AS-id/sye-METH-i-kone)
Brand Name: EZ Gas II

EZ Gas II Effervescent Granule Packets are used for:

Relieving indigestion, heartburn, sour stomach, upset stomach, or gas.

EZ Gas II Effervescent Granule Packets are an antacid and antiflatulent combination. It works by neutralizing stomach acid, which helps relieve upset stomach. It also breaks up gas bubbles, which makes gas easier to eliminate.

Do NOT use EZ Gas II Effervescent Granule Packets if:

you are allergic to any ingredient in EZ Gas II Effervescent Granule Packets
you have appendicitis or a blockage of your bowel or esophagus
you are on a low-salt diet

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

Before using EZ Gas II Effervescent Granule Packets:

Some medical conditions may interact with EZ Gas II Effervescent Granule Packets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of stomach or intestinal bleeding
if you have congestive heart failure, swelling, liver problems, kidney problems, a decrease in the amount of urination, or rectal bleeding from an unknown cause
if you have pregnancy-induced high blood pressure

Some MEDICINES MAY INTERACT with EZ Gas II Effervescent Granule Packets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aluminum salts (eg, aluminum hydroxide) because the risk of bone or muscle pain, mental or mood changes, and seizures may be increased
Anorexiants (eg, phentermine) or sympathomimetics (eg, pseudoephedrine) because the risk of their side effects may be increased by EZ Gas II Effervescent Granule Packets
Lithium because its effectiveness may be decreased by EZ Gas II Effervescent Granule Packets

This may not be a complete list of all interactions that may occur. Ask your health care provider if EZ Gas II Effervescent Granule Packets 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 EZ Gas II Effervescent Granule Packets:

Use EZ Gas II Effervescent Granule Packets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take EZ Gas II Effervescent Granule Packets by mouth with or without food.
Place half of the contents of 1 packet on the back of the tongue and wash down with a half ounce (15 mL) of water. Repeat with the remaining contents of the packet.
If you take azole antifungals (eg, itraconazole, ketoconazole), cephalosporins (eg, cefdinir), iron (eg, ferrous sulfate), or tetracyclines (eg, doxycycline), ask your doctor or pharmacist how to take it with EZ Gas II Effervescent Granule Packets.
If you miss taking a dose of EZ Gas II Effervescent Granule Packets for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use EZ Gas II Effervescent Granule Packets.

Important safety information:

Do NOT take more than the recommended dose or use more frequently than prescribed without checking with your doctor.
If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.
EZ Gas II Effervescent Granule Packets has sodium in it. Include this when you count your daily intake of sodium.
Use EZ Gas II Effervescent Granule Packets with caution in the ELDERLY; they may be more sensitive to its effects.
EZ Gas II Effervescent Granule Packets should not be used in CHILDREN younger than 6 years old without first checking with your doctor; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using EZ Gas II Effervescent Granule Packets while you are pregnant. It is not known if EZ Gas II Effervescent Granule Packets are found in breast milk. If you are or will be breast-feeding while you use EZ Gas II Effervescent Granule Packets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of EZ Gas II Effervescent Granule Packets:

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; headache; irritability; muscle rigidity; nausea; vomiting; weakness.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion, possibly leading to coma; muscle twitching or tremors; nausea; numbness or tingling in the face or extremities; seizures; vomiting.

Proper storage of EZ Gas II Effervescent Granule Packets:

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

General information:

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

This information is a summary only. It does not contain all information about EZ Gas II Effervescent Granule Packets. 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: May 5, 2010

Database Edition 10.2.1.002

E,Med-facts

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EZ III

30/06/10

Generic Name: acetaminophen and codeine (a SEET a MIN o fen and KOE deen)
Brand Names: Capital with Codeine Suspension, Cocet, EZ III, Tylenol with Codeine #3, Tylenol with Codeine #4, Vopac

What is EZ III (acetaminophen and codeine)?

Codeine is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

The combination of acetaminophen and codeine is used to relieve moderate to severe pain.

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

What is the most important information I should know about EZ III (acetaminophen and codeine)?

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, you should never use more than 2 grams (2000 mg) of acetaminophen per day. Ask a doctor or pharmacist before using any cold, allergy, pain, or sleep medicine. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen. Check the label to see if a medicine contains acetaminophen or APAP. Codeine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Acetaminophen and codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What should I discuss with my healthcare provider before taking EZ III (acetaminophen and codeine)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine. Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share acetaminophen and codine 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.

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

asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
a stomach or intestinal disorder;
underactive thyroid;
Addison’s disease or other adrenal gland disorder;
enlarged prostate, urination problems;
curvature of the spine;
mental illness; or
a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. Acetaminophen and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take EZ III (acetaminophen and codeine)?

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. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

One acetaminophen and codeine tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Take this medicine with food or milk to ease stomach upset.

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.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and codeine. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using acetaminophen and codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and codeine.

This medication can cause unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and codeine.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and codeine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Codeine 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?

Since this medication 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 and codeine can be fatal.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, fainting, weak pulse, seizure (convulsions), coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking EZ III (acetaminophen and codeine)?

Acetaminophen and codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage.

EZ III (acetaminophen and codeine) 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:

shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, unusual thoughts or behavior;
seizure (convulsions);
easy bruising or bleeding; or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

feeling dizzy or drowsy;
mild nausea, vomiting, upset stomach, constipation;
headache;
blurred vision; or
dry mouth.

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 EZ III (acetaminophen and codeine)?

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

Also tell your doctor if you are using any of the following drugs:

glycopyrrolate (Robinul);
mepenzolate (Cantil);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

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

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and codeine.

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

Concise,E

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EZ-Char

30/06/10

Generic Name: charcoal, activated (Oral route)

Commonly used brand name(s):

In the U.S.

Actidose-Aqua
Charcoal
Diarrest
Di-Gon II
Donnagel
EZ-Char
Kaodene NN
Kaolinpec
Kaopectate
Kaopek
Kapectolin
Kerr Insta-Char

In Canada

Aqueous Charcodote Adult
Aqueous Charcodote Pediatric
Charcodote
Charcodote Pediatric
Charcodote Tfs
Charcodote Tfs Pediatric
Donnagel-Mb
Kao-Con
Parepectolin

Available Dosage Forms:

Suspension
Kit
Tablet
Powder for Suspension
Liquid
Tablet, Chewable

Uses For EZ-Char

Activated charcoal is used in the emergency treatment of certain kinds of poisoning. It helps prevent the poison from being absorbed from the stomach into the body. Sometimes, several doses of activated charcoal are needed to treat severe poisoning. Ordinarily, this medicine is not effective and should not be used in poisoning if corrosive agents such as alkalis (lye) and strong acids, iron, boric acid, lithium, petroleum products (e.g., cleaning fluid, coal oil, fuel oil, gasoline, kerosene, paint thinner), or alcohols have been swallowed, since it will not prevent these poisons from being absorbed into the body.

Some activated charcoal products contain sorbitol. Sorbitol is a sweetener. It also works as a laxative, for the elimination of the poison from the body.Products that contain sorbitol should be given only under the direct supervision of a doctor because severe diarrhea and vomiting may result.

Activated charcoal has not been shown to be effective in relieving diarrhea and intestinal gas.

Activated charcoal may be available without a doctor’s prescription; however, before using this medicine, call a poison control center, your doctor, or an emergency room for advice.

Before Using EZ-Char

Allergies

Pediatric

Activated charcoal should be used only under the direct supervision of your doctor, poison control center, or other health care professional.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of activated charcoal in the elderly, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

However, elderly persons with slow digestion are more likely to develop constipation if given more than one dose of activated charcoal.

Pregnancy

Activated charcoal has not been reported to cause birth defects or other problems in humans.

Breast Feeding

Activated charcoal has not been reported to cause problems in nursing babies.

Interactions with Medicines

Mycophenolate Mofetil
Mycophenolic Acid

Interactions with Food/Tobacco/Alcohol

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

Proper Use of charcoal, activated

This section provides information on the proper use of a number of products that contain charcoal, activated. It may not be specific to EZ-Char. Please read with care.

Before taking this medicine, call a poison control center, your doctor, or an emergency room for advice. It is a good idea to have these telephone numbers readily available.

To prevent activated charcoal powder from scattering, be careful when opening and adding water to the powder container.

It is very important that you shake the liquid form of this medicine well before taking it, because some might have settled in the bottom. Be sure to drink all the liquid. Then rinse the container with a small amount of water, shake the container, and drink this mixture to get the full dose of activated charcoal.

If you have been told to take both this medicine and ipecac syrup to treat the poisoning, do not take this medicine until after you have taken the ipecac syrup to cause vomiting and the vomiting has stopped. This usually takes about 30 minutes.

Do not take this medicine mixed with chocolate syrup, ice cream or sherbet, since they may prevent the medicine from working properly.

If you are taking any other medicine, do not take it within 2 hours of the activated charcoal. Taking other medicines together with activated charcoal may prevent the other medicine from being absorbed by your body. If you have any questions about this, check with your health care professional.

Dosing

For activated charcoal
—For oral dosage form (powder):
- For treatment of poisoning:
  - Treatment with one dose:
    - Adults and teenagers—Dose is usually 25 to 100 grams mixed with water.
    - Children 1 through 12 years of age—Dose is usually 25 to 50 grams mixed with water, or the dose may be based on body weight. It may be 0.5 to 1 gram per kilogram (kg) (0.23 to 0.45 gram per pound) of body weight mixed with water.
    - Children up to 1 year of age—Dose is usually 10 to 25 grams mixed with water, or the dose may be based on body weight. It may be 0.5 to 1 gram per kg (0.23 to 0.45 gram per pound) of body weight mixed with water.
  - Treatment with more than one dose:
    - Adults and teenagers—At first, the dose is 50 to 100 grams. Then the dose may be 12.5 grams given every hour, 25 grams given every two hours, or 50 grams given every four hours. Each dose should be mixed with water.
    - Children up to 13 years of age—At first, the dose is 10 to 25 grams. Then the dose is based on body weight. It is usually 1 to 2 grams per kg (0.45 to 0.91 gram per pound) of body weight given every two to four hours. Each dose should be mixed with water.
—For oral dosage form (oral suspension):
- For treatment of poisoning:
  - Treatment with one dose:
    - Adults and teenagers—Dose is usually 25 to 100 grams.
    - Children 1 through 12 years of age—Dose is usually 25 to 50 grams, or the dose may be based on body weight. It may be 0.5 to 1 gram per kg (0.23 to 0.45 gram per pound) of body weight.
    - Children up to 1 year of age—Dose is usually 10 to 25 grams, or the dose may be based on body weight. It may be 0.5 to 1 gram per kg (0.23 to 0.45 gram per pound) of body weight.
  - Treatment with more than one dose:
    - Adults and teenagers—At first, the dose is 50 to 100 grams. Then the dose may be 12.5 grams given every hour, 25 grams given every two hours, or 50 grams given every four hours.
    - Children up to 13 years of age—At first, the dose is 10 to 25 grams. Then the dose is based on body weight. It is usually 1 to 2 grams per kg (0.45 to 0.91 gram per pound) of body weight given every two to four hours.

For activated charcoal and sorbitol
For oral dosage form (oral suspension):
- For treatment of poisoning:
  - Adults and teenagers—Dose is usually 50 to 100 grams of activated charcoal given one time.
  - Children 1 through 12 years of age—Dose is usually 25 to 50 grams of activated charcoal given one time.
  - Children up to 1 year of age—Use is not recommended.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

EZ-Char 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 as soon as possible if any of the following side effects occur:

Less common or rare

Pain or swelling in stomach

Other 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. However, check with your doctor if any of the following side effects continue:

More common

Diarrhea

Less common or rare

Constipation
vomiting

Activated charcoal will cause your stools to turn black. This is to be expected while you are taking this medicine.

There have not been any other side effects reported with this medicine. However, if you notice any other effects, check with your doctor.

Advanced,E

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30/06/10

Uses For ezetimibe and simvastatin

Before Using ezetimibe and simvastatin

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of ezetimibe and simvastatin

Dosing

Missed Dose

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Precautions While Using ezetimibe and simvastatin

ezetimibe and simvastatin Side Effects

30/06/10

Ezetimibe/ Simvastatin

Ezetimibe/Simvastatin is used for:

Do NOT use Ezetimibe/Simvastatin if:

Before using Ezetimibe/Simvastatin:

How to use Ezetimibe/Simvastatin:

Important safety information:

Possible side effects of Ezetimibe/Simvastatin:

If OVERDOSE is suspected:

General information:

30/06/10

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30/06/10

What is Ezfe (iron polysaccharide)?

What is the most important information I should know about Ezfe (iron polysaccharide)?

Who should not take Ezfe (iron polysaccharide)?

How should I take Ezfe (iron polysaccharide)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Ezfe (iron polysaccharide)?

Ezfe (iron polysaccharide) side effects

What other drugs will affect Ezfe (iron polysaccharide)?

Where can I get more information?

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Uses For Ezol

Before Using Ezol

Allergies

Pediatric

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Pregnancy

Ezetimibe/

Simvastatin