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Azopt Drops

29/06/10

Generic Name: Brinzolamide (brin-ZOE-lah-mide)
Brand Name: Azopt

Azopt Drops are used for:

Treating elevated pressure inside the eye in patients with open-angle glaucoma or ocular hypertension.

Azopt Drops are a carbonic anhydrase inhibitor. It works by decreasing the production of fluid inside the eye, thereby lowering pressure within the eye.

Do NOT use Azopt Drops if:

you are allergic to any ingredient in Azopt Drops

Contact your doctor or health care provider right away if this applies to you.

Before using Azopt Drops:

Tell your health care provider 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 liver or kidney disease
if you wear contact lenses
if you have had a severe allergic reaction (eg, a severe rash, hives, breathing difficulties, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide

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

Ask your health care provider if Azopt Drops 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 Azopt Drops:

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

Shake well before each use.
To use Azopt Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
If you are using another medicine for your eye, use the medicines at least 10 minutes apart.
Remove soft contact lenses before you use Azopt Drops; lenses may be placed back in the eyes 15 minutes after use of Azopt Drops.
If you miss a dose of Azopt Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

Azopt Drops may cause blurred vision. Use Azopt Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
If you suffer an eye injury, contact your doctor before using any more of Azopt Drops.
Brief stinging or burning of the eye may occur after use. This is normal. Contact your doctor if symptoms continue or worsen.
Azopt Drops should not be used in CHILDREN; safety and effectiveness in 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 Azopt Drops while you are pregnant. It is not known if Azopt Drops are found in breast milk. Do not breast-feed while taking Azopt Drops.

Possible side effects of Azopt Drops:

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:

Bitter, sour, or unusual taste; blurred vision; discomfort, tearing, or dryness of the eyes when first applied; dry eyes; eye discharge; foreign body sensation in the eye; headache; inflammation of the eyelids; runny nose; swelling of the cornea.

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); eye pain or itching; irritated eyelids.

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. Azopt Drops may be harmful if swallowed.

Proper storage of Azopt Drops:

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

General information:

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

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Azopt 1%

29/06/10

Generic Name: brinzolamide (Ophthalmic route)

brin-ZOE-la-mide

Commonly used brand name(s):

In the U.S.

Azopt

In Canada

Azopt 1%

Available Dosage Forms:

Suspension

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Carbonic Anhydrase Inhibitor

Uses For Azopt 1%

Brinzolamide is a carbonic anhydrase inhibitor that is used in the eye. It is used to treat increased pressure in the eye caused by open-angle glaucoma. It is also used to treat a condition called hypertension of the eye.

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

Before Using Azopt 1%

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

Allergies

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

Pediatric

Studies on this medicine have been done only in adult patients and there is no specific information comparing use of brinzolamide in children with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Proper Use of brinzolamide

This section provides information on the proper use of a number of products that contain brinzolamide. It may not be specific to Azopt 1%. Please read with care.

This medicine should be shaken before each use.

To use: First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

If your doctor ordered two different eye drops to be used together, wait at least 10 minutes between the times you apply the medicines. This will help to keep the second medicine from “washing out” the first one.

Dosing

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

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

For ophthalmic dosage form (eye drops):
- For glaucoma or hypertension of the eye:
  - Adults—Use 1 drop in the eye three times a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Azopt 1%

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and is not causing unwanted effects.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you are allergic to ophthalmic brinzolamide.

The preservative used in these eye drops may be absorbed by soft contact lenses and cause irritation of your eyes. Soft contact lenses should be taken out before you use brinzolamide eye drops. Lenses may be put back in the eyes 15 minutes after you have used the medicine.

Check with your doctor if you get an injury or infection in your eye or if you are scheduled to have eye surgery. Your doctor may want you to use a fresh bottle of brinzolamide eye drops in case the present bottle of eye drops has become contaminated during use.

This medicine may cause some people to have blurred vision for a short time after each use. 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 cannot see properly.

Azopt 1% 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

Discharge from the eye
feeling of something in the eye
headache
redness, soreness, irritation, or pain of eye or eyelid
skin rash

Rare

Chest pain
dizziness
excessive muscle tone
hair loss
hives
kidney pain
itching, swelling, or other signs of eye or eyelid irritation
seeing double
shortness of breath
sore throat

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

More common

Bitter, sour, or other unusual taste
blurred vision for a short time after use of medicine

Less common

Burning, stinging, or discomfort when medicine is applied
dry eye
runny nose

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

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

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

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

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Azor

29/06/10

Generic Name: amlodipine and olmesartan (am LOE de peen ol me SAR tan)
Brand Names: Azor

What is amlodipine and olmesartan?

Amlodipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Olmesartan is in a group of drugs called angiotensin II receptor antagonists. Olmesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of amlodipine and olmesartan is used to treat high blood pressure (hypertension).

Amlodipine and olmesartan may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about amlodipine and olmesartan?

Do not use this medication without telling your doctor if you are pregnant. Olmesartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use potassium supplements or salt substitutes while you are taking amlodipine and olmesartan, unless your doctor has told you to. Call your doctor at once if you have swelling in your hands or feet, rapid weight gain, fast or pounding heartbeats, jaundice (yellowing of the skin or eyes), chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling, or if you feel like you might pass out. In rare cases, amlodipine and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

What should I discuss with my healthcare provider before taking amlodipine and olmesartan?

You should not use this medication if you are allergic to amlodipine (Norvasc) or olmesartan (Benicar).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take amlodipine and olmesartan.

kidney disease (or if you are on dialysis);
liver disease;
congestive heart failure;
if you are vomiting or having diarrhea; or
if you have recently had a heart attack.

If you are also taking a beta-blocker drug (such as Blocadren, Corgard, Inderal, Normodyne, Tenormin, Toprol, Trandate, Zibeta, and others) do not suddenly stop using the beta-blocker without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping a beta-blocker too quickly can cause serious heart problems that will not be prevented by amlodipine and olmesartan. FDA pregnancy category D. This medication can cause harm to an unborn baby. Olmesartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Do not use amlodipine and olmesartan without your doctor’s consent if you are pregnant. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment. It is not known whether amlodipine and olmesartan 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 amlodipine and olmesartan?

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take this medication with a full glass (8 ounces) of water.

You may take this medication with or without food.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor.

If you need to undergo kidney dialysis or have any type of surgery, tell the doctor ahead of time that you are using amlodipine and olmesartan.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store amlodipine and olmesartan at room temperature away from moisture and heat.

See also: Azor dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include fast heart rate, warmth or tingling, feeling light-headed, or fainting.

What should I avoid while taking amlodipine and olmesartan?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use potassium supplements or salt substitutes while you are taking amlodipine and olmesartan, unless your doctor has told you to.

Amlodipine and olmesartan 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. In rare cases, amlodipine and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine. Call your doctor at once if you have any other serious side effects, such as:

feeling like you might pass out;
swelling in your hands or feet, rapid weight gain;
fast or pounding heartbeats;
urinating less than usual or not at all;
jaundice (yellowing of the skin or eyes); or
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects include:

dizziness, drowsiness;
warmth, redness, or tingly feeling under your skin;
hair loss; or
mild 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 amlodipine and olmesartan?

Before taking amlodipine and olmesartan, tell your doctor if you are using any of the following drugs:

heart medication;
potassium supplements or salt substitutes;
diuretics (water pills); or
other medications that lower blood pressure.

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

Where can I get more information?

Your pharmacist can provide more information about amlodipine and olmesartan.

Remember, keep this and all other medicines out of the reach of children. Never share your medicines with others and only use this medication for the condition 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.

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azithromycin (Intravenous route)

29/06/10

ay-zith-roe-MYE-sin

Commonly used brand name(s):

In the U.S.

Zithromax

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Uses For azithromycin

Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV).

Azithromycin injection belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, azithromycin will not work for colds, flu, or other viral infections. Azithromycin injection may be used for other problems as determined by your doctor.

Azithromycin injection is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, azithromycin is used in certain patients with the following medical condition:

Trachoma (treatment)

Before Using azithromycin

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 azithromycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to azithromycin 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 have not been performed on the relationship of age to the effects of azithromycin injection in children and teenagers below 16 years of age. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using azithromycin 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.

Dihydroergotamine
Dronedarone
Ergoloid Mesylates
Ergonovine
Ergotamine
Methylergonovine
Methysergide
Pimozide

Using azithromycin 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.

Acecainide
Amiodarone
Azimilide
Bretylium
Disopyramide
Dofetilide
Ibutilide
Propafenone
Sematilide
Sotalol
Tedisamil

Using azithromycin 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.

Atorvastatin
Digoxin
Fentanyl
Lovastatin
Nelfinavir
Rifabutin
Simvastatin
Theophylline
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of azithromycin

A nurse or other trained health professional will give you azithromycin. azithromycin is given through a needle placed in one of your veins.

Your doctor may give you a few doses of azithromycin until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using azithromycin

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

azithromycin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash; itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive azithromycin.

Azithromycin injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tell your doctor if you have bleeding, blistering, burning, discoloration of skin, itching, lumps, pain, rash, redness, swelling, at the site of injection.

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.

azithromycin 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 or nurse immediately if any of the following side effects occur:

More common

Pain, redness, and swelling at the site of injection

Rare

Abdominal or stomach cramps or pain (severe)
abdominal tenderness
diarrhea (watery and severe, which may be bloody)
difficulty in breathing
fever
joint pain
skin rash
swelling of the face, mouth, neck, hands, and feet

Less common

Diarrhea (mild)
nausea
stomach pain or discomfort

Rare

Dizziness
headache

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.

A,Advanced

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azithromycin (Ophthalmic route)

29/06/10

ay-zith-roe-MYE-sin

Commonly used brand name(s):

In the U.S.

AzaSite

Available Dosage Forms:

Solution

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Uses For azithromycin

Azithromycin belongs to a group of medicines called macrolide antibiotics. The azithromycin ophthalmic (eye) preparation is used to treat infections of the eye, such as bacterial conjunctivitis. azithromycin works by killing certain bacteria that cause conjunctivitis .

azithromycin is available only with your doctor’s prescription .

Before Using azithromycin

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ophthalmic azithromycin in children younger than 1 year of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ophthalmic azithromycin in the elderly .

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of azithromycin

To use the eye drops:

First, wash your hands. Then turn the closed bottle upside down and shake it one time before putting the medicine in your eye. Remove the cap with the bottle still being held upside down.
Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to be absorbed .
If you think you did not get the drop of medicine into your eye properly, use another drop .
To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed .

To help clear up your eye infection completely, keep using azithromycin for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon .

Dosing

The dose of azithromycin 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 azithromycin. If your dose is different, do not change it unless your doctor tells you to do so.

For ophthalmic dosage form (eye drops):
- For bacterial conjunctivitis:
  - Adults and children 1 year of age and older—Put one drop in the affected eye two times a day for 2 days, with each dose being at least eight to twelve hours apart. Then, put one drop in the affected eye once a day for the next five days.
  - Infants and children younger than 1 year of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of azithromycin, 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.

Do not keep outdated medicine or medicine no longer needed.

Store the unopened bottle in the refrigerator. Do not freeze. Once the medicine is opened, you may store it in the refrigerator or in a closed container at room temperature, away from heat, moisture, and direct light for up to 14 days .

Ask your healthcare professional how you should dispose of any medicine you do not use. Discard any leftover medicine after 14 days .

Precautions While Using azithromycin

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor .

Do not wear contact lenses while you are using azithromycin to avoid further eye irritation .

azithromycin 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:

Less common

Burning, redness, stinging, or other eye irritation

Rare

Blistering, burning, crusting, dryness, or flaking of the skin
cough
discharge from the eye
fever
headache
itching, scaling, severe redness, soreness, or swelling of the skin
pain or tenderness around the eyes and cheekbones
painful irritation of the clear front part of the eye
shortness of breath or troubled breathing
stuffy or runny nose
tightness of the chest or wheezing

Rare

Change in taste
dry eyes
loss of taste

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.

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azithromycin (Oral route)

29/06/10

ay-zith-roe-MYE-sin

Commonly used brand name(s):

In the U.S.

Zithromax
Zithromax Tri-Pak
Zithromax Z-Pak
Zmax

Available Dosage Forms:

Powder for Suspension
Tablet
Capsule
Powder for Suspension, Extended Release

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Uses For azithromycin

Azithromycin is used to treat certain bacterial infections in many different parts of the body. azithromycin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Azithromycin belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, azithromycin will not work for colds, flu, or other virus infections.

azithromycin is available only with your doctor’s prescription.

Before Using azithromycin

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of azithromycin in children and infants 6 months of age and older. Safety and efficacy have not been established in infants below 6 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of azithromycin in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using azithromycin 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.

Dihydroergotamine
Dronedarone
Ergoloid Mesylates
Ergonovine
Ergotamine
Methylergonovine
Methysergide
Pimozide

Acecainide
Amiodarone
Azimilide
Bretylium
Disopyramide
Dofetilide
Ibutilide
Propafenone
Sematilide
Sotalol
Tedisamil

Atorvastatin
Digoxin
Fentanyl
Lovastatin
Nelfinavir
Rifabutin
Simvastatin
Theophylline
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of azithromycin

Take azithromycin 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.

azithromycin comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take azithromycin tablets with or without food.

Measure the extended-release oral liquid with a marked measuring spoon, syringe, or cup. You or your child must take azithromycin within 12 hours after it has been mixed with water. It is best to take the extended-release oral liquid on an empty stomach or at least 1 hour before or 2 hours after a meal. If your child does not use all of the medicine in the bottle, throw it away after you give the dose.

Keep using azithromycin for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

For oral dosage form (extended-release suspension):
- For treatment of infections:
  - Adults—2 grams (g) once a day as a single dose.
  - Children weighing 75 pounds (34 kg) or more— 2 g once a day as a single dose.
  - Children and infants 6 months of age and older weighing less than 75 pounds (34 kg)—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 60 milligrams (mg) per kilogram (kg) of body weight once a day as a single dose.
  - Infants below 6 months of age—Use and dose must be determined by your doctor.
For oral dosage forms (suspension or tablets):
- For treatment of infections:
  - Adults—500 to 2000 milligrams (mg) once a day as a single dose. Depending on the type of infection, this may be followed with doses of 250 to 500 mg once a day for several days.
  - Children and infants 6 months of age and older—Dose is based on body weight and must be determined by your doctor. However, the recommended dose is 10 to 30 milligrams (mg) per kilogram (kg) once a day as a single dose. Depending on the type of infection, this may be followed with doses of 5 to 12 mg/kg once a day for several days.
  - Infants below 6 months of age—Use and dose must be determined by your doctor.

Missed Dose

Storage

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.

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

Do not refrigerate or freeze the extended-release oral liquid. Throw away any unused liquid after your dose.

You may store the oral liquid at room temperature or in the refrigerator. Do not freeze the bottle. Do not keep the oral liquid for more than 10 days. Throw away any unused liquid after all doses are completed.

Precautions While Using azithromycin

If you or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor.

azithromycin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you take azithromycin.

Azithromycin may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

If you or your child vomits within one hour of taking the extended-release oral liquid, call your doctor right away to see if more medicine is needed.

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.

azithromycin 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:

More common

Diarrhea
loose stools

Less common

Blistering, crusting, irritation, itching, or reddening of the skin
cracked, dry, or scaly skin
fever
swelling

Rare

Abdominal or stomach pain
blistering, peeling, or loosening of the skin
bloody or cloudy urine
bloody, black, or tarry stools
body aches or pain
burning while urinating
chest pain
chills
congestion
cough increased
cough producing mucus
dark urine
difficult or labored breathing
difficult or painful urination
difficulty with breathing
dizziness
drowsiness
dryness or soreness of the throat
earache
fainting
fast, irregular, pounding, or racing heartbeat or pulse
general feeling of discomfort or illness
general feeling of tiredness or weakness
headache
indigestion
irregular or slow heart rate
itching
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
loss of appetite
muscle aches and pains
nausea or vomiting
noisy breathing
passing of gas
rash
red irritated eyes
red skin lesions, often with a purple center
redness or swelling in the ear
runny nose
shivering
shortness of breath
sneezing
sores, ulcers, or white spots on the lips or in the mouth
stomach pain, continuing
stomach pain, fullness, or discomfort
stuffy nose
sweating
swelling of the face, ankles, hands, feet, or lower legs
tender, swollen glands in the neck
tightness in the chest
trouble in swallowing
trouble sleeping
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
upper right abdominal pain
voice changes
vomiting of blood
wheezing
yellow eyes or skin

Incidence not known

Abdominal or stomach cramps
abdominal tenderness
bleeding gums
bloating
blood in the urine or stools
blurred vision
change in hearing
clay-colored stools
coma
confusion
constipation
continuing ringing or buzzing or other unexplained noise in the ears
decreased urine output
depression
diarrhea, watery and severe, which may also be bloody
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fainting
greatly decreased frequency of urination or amount of urine
hives
hostility
increased thirst
irritability
lethargy
loss of hearing
lower back or side pain
muscle twitching
pains in stomach, side, or abdomen, possibly radiating to the back
pale skin
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
seizures
stupor
unusual weight loss

Rare

Acid or sour stomach
aggressive, angry
bad, unusual, or unpleasant (after) taste
belching
burning feeling in the chest or stomach
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in taste
changes in the color of the tongue
crying
depersonalization
dry mouth
dysphoria
euphoria
excess air or gas in the stomach or intestines
feeling of constant movement of self or surroundings
full feeling
heartburn
hyperventilation
increase in body movements
itching of the vagina or genital area
lack or loss of strength
mental depression
nervousness
pain during sexual intercourse
paranoia
quick to react or overreact emotionally
rapidly changing moods
rash with flat lesions or small raised lesions on the skin
redness of the skin
restlessness
sensation of spinning
shaking
shortness of breath
sleepiness or unusual drowsiness
sleeplessness
sore mouth or tongue
stomach upset
thick, white vaginal discharge with no odor or with a mild odor
unable to sleep
white patches in the mouth, tongue, or throat

Incidence not known

Difficulty in moving
fear or nervousness
increased sensitivity of skin to sunlight
muscle pain or stiffness
pain in joints
redness or other discoloration of the skin
severe sunburn
trouble sitting still

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.

A,Advanced

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Azithromycin Single-Dose Packet

29/06/10

Generic Name: Azithromycin (ay-ZITH-roe-MYE-sin)
Brand Name: Zithromax

Azithromycin Single-Dose Packet is used for:

Treating mild to moderate infections caused by certain bacteria. It may also be used alone or with other medicines to treat or prevent certain infections in persons with advanced HIV infection. It may also be used for other conditions as determined by your doctor.

Azithromycin Single-Dose Packet is a macrolide antibiotic. It slows the growth of, or sometimes kills, sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Do NOT use Azithromycin Single-Dose Packet if:

you are allergic to any ingredient in Azithromycin Single-Dose Packet, to other macrolide antibiotics (eg, erythromycin), or to ketolide antibiotics (eg, telithromycin)
you are taking dofetilide, nilotinib, pimozide, propafenone, or tetrabenazine

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

Before using Azithromycin Single-Dose Packet:

Some medical conditions may interact with Azithromycin Single-Dose Packet. 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 liver or kidney problems, myasthenia gravis, or abnormal heart rhythms

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

Antiarrhythmics (eg, disopyramide, dofetilide), arsenic, astemizole, cisapride, domperidone, maprotiline, methadone, paliperidone, pimozide, propafenone, quinolone antibiotics (eg, levofloxacin), terfenadine, or tetrabenazine because the risk of heart problems, including irregular heartbeat, may be increased
Nelfinavir because it may increase the risk of Azithromycin Single-Dose Packet’s side effects
Rifampin because it may decrease Azithromycin Single-Dose Packet’s effectiveness
Anticoagulants (eg, warfarin), carbamazepine, cyclosporine, digoxin, ergot derivatives (eg, ergotamine), nilotinib, phenytoin, rifampin, theophylline, triazolam, or tyrosine kinase receptor inhibitors (eg, dasatinib) because the risk of their side effects may be increased by Azithromycin Single-Dose Packet

This may not be a complete list of all interactions that may occur. Ask your health care provider if Azithromycin Single-Dose Packet 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 Azithromycin Single-Dose Packet:

Use Azithromycin Single-Dose Packet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Azithromycin Single-Dose Packet by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Mix the entire contents of the packet thoroughly with 2 ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional 2 ounces of water, mix, and drink to be certain you receive all the medicine.
Do not take an antacid that has aluminum or magnesium in it within 1 hour before or 2 hours after you take Azithromycin Single-Dose Packet.
To clear up your infection completely, take Azithromycin Single-Dose Packet for the full course of treatment. Keep taking it even if you feel better in a few days.
Only one dose of Azithromycin Single-Dose Packet is required. If you forget to take Azithromycin Single-Dose Packet, take it as soon as you remember.

Ask your health care provider any questions you may have about how to use Azithromycin Single-Dose Packet.

Important safety information:

Azithromycin Single-Dose Packet may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Azithromycin Single-Dose Packet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Azithromycin Single-Dose Packet may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Azithromycin Single-Dose Packet. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
Tell your doctor or dentist that you take Azithromycin Single-Dose Packet before you receive any medical or dental care, emergency care, or surgery.
Long-term or repeated use of Azithromycin Single-Dose Packet may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Be sure to use Azithromycin Single-Dose Packet for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Azithromycin Single-Dose Packet only works against bacteria; it does not treat viral infections (eg, the common cold).
Azithromycin Single-Dose Packet should not be used in CHILDREN; safety and effectiveness in 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 Azithromycin Single-Dose Packet while you are pregnant. It is not known if Azithromycin Single-Dose Packet is found in breast milk. If you are or will be breast-feeding while you use Azithromycin Single-Dose Packet, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Azithromycin Single-Dose Packet:

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; headache; loose stools; nausea; stomach pain; upset stomach; vomiting.

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); bloody stools; changes in hearing or hearing loss; chest pain; eye or vision problems; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; seizure; severe diarrhea; stomach cramps/pain; trouble speaking or swallowing; yellowing of the skin or eyes.

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 diarrhea; nausea; upset stomach; vomiting.

Proper storage of Azithromycin Single-Dose Packet:

Store unopened packets between 41 and 86 degrees F (5 and 30 degrees C). Store away from heat, moisture, and light. Keep medicine in original packet until use. Do not store in the bathroom. Keep Azithromycin Single-Dose Packet out of the reach of children and away from pets.

General information:

If you have any questions about Azithromycin Single-Dose Packet, please talk with your doctor, pharmacist, or other health care provider.
Azithromycin Single-Dose Packet is to be used only by the patient for whom it is prescribed. Do not share it with other people. Do not use Azithromycin Single-Dose Packet for other health conditions.
If your symptoms do not improve within a few days or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Azithromycin Single-Dose Packet. 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

A,Med-facts

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Azithromycin Suspension

29/06/10

Generic Name: Azithromycin (ay-ZITH-roe-MYE-sin)
Brand Name: Zmax

Azithromycin Suspension is used for:

Treating mild to moderate infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Azithromycin Suspension is a macrolide antibiotic. It slows the growth of, or sometimes kills, sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Do NOT use Azithromycin Suspension if:

you are allergic to any ingredient in Azithromycin Suspension, to other macrolide antibiotics (eg, erythromycin), or to ketolide antibiotics (eg, telithromycin)
you are taking dofetilide, nilotinib, pimozide, propafenone, or tetrabenazine

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

Before using Azithromycin Suspension:

Some medical conditions may interact with Azithromycin 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
if you have liver or kidney problems, an irregular heartbeat, myasthenia gravis, or are on a low-sodium (salt) diet.

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

Antiarrhythmics (eg, disopyramide, dofetilide), arsenic, astemizole, cisapride, domperidone, maprotiline, methadone, paliperidone, pimozide, propafenone, quinolone antibiotics (eg, levofloxacin), terfenadine, or tetrabenazine because the risk of heart problems, including irregular heartbeat, may be increased
Nelfinavir because it may increase the risk of Azithromycin Suspension’s side effects
Rifampin because it may decrease Azithromycin Suspension’s effectiveness
Anticoagulants (eg, warfarin), carbamazepine, cyclosporine, digoxin, ergot derivatives (eg, ergotamine), nilotinib, phenytoin, rifampin, theophylline, triazolam, or tyrosine kinase receptor inhibitors (eg, dasatinib) because the risk of their side effects may be increased by Azithromycin Suspension

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

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

Azithromycin Suspension comes as a powder that must be mixed with water before you take it. Your pharmacist will usually mix it for you. If you receive Azithromycin Suspension as a powder, check with your pharmacist for instructions on how to mix it. You should take Azithromycin Suspension within 12 hours after it is mixed with water.
Take Azithromycin Suspension by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Shake well before each use.
Contact your doctor if you vomit within 1 hour after you take Azithromycin Suspension. You may need additional medicine to treat your infection.
To clear up your infection completely, take the entire dose of Azithromycin Suspension.
Only one dose of Azithromycin Suspension is required. If you forget to take Azithromycin Suspension, take it as soon as you remember.

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

Important safety information:

Azithromycin Suspension may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Azithromycin Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Azithromycin Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Azithromycin Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
Long-term or repeated use of Azithromycin Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Tell your doctor or dentist that you take Azithromycin Suspension before you receive any medical or dental care, emergency care, or surgery.
Be sure to use Azithromycin Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Azithromycin Suspension only works against bacteria; it does not treat viral infections (eg, the common cold).
Azithromycin Suspension should not be used in CHILDREN; safety and effectiveness in 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 Azithromycin Suspension while you are pregnant. It is not known if Azithromycin Suspension is found in breast milk. If you are or will be breast-feeding while you use Azithromycin Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Azithromycin 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:

Diarrhea; headache; loose stools; nausea; stomach pain; upset stomach; vomiting.

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); bloody stools; changes in hearing or hearing loss; chest pain; dark, red, raised areas of the skin; eye or vision problems; fainting; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, or blistered skin; ringing in the ears; seizures; severe diarrhea; severe stomach cramps/pain; trouble speaking or swallowing; unusual vaginal itching, odor, or discharge; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Proper storage of Azithromycin Suspension:

Store Azithromycin Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not refrigerate or freeze. Do not store in the bathroom. Keep Azithromycin Suspension out of the reach of children and away from pets.

General information:

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

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

A,Med-facts

Comments (0)

Azithromycin Drops

29/06/10

Generic Name: Azithromycin (ay-ZITH-roe-MYE-sin)
Brand Name: Azasite

Azithromycin Drops are used for:

Treating eye infections caused by certain bacteria.

Azithromycin Drops are a macrolide antibiotic. It works by killing sensitive bacteria.

Do NOT use Azithromycin Drops if:

you are allergic to any ingredient in Azithromycin Drops

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

Before using Azithromycin Drops:

Some medical conditions may interact with Azithromycin Drops. 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 had an allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to a macrolide antibiotic (eg, erythromycin, azithromycin)

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

Ask your health care provider if Azithromycin Drops 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 Azithromycin Drops:

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

Azithromycin Drops are for use in the eye only. Do not swallow it.
Wash your hands immediately before you use Azithromycin Drops.
Turn the bottle upside down and shake once before each use. Remove the cap while the bottle is still upside down.
To use Azithromycin Drops, tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Gently squeeze the bottle to drop the medicine into the pouch, then gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
Do not wear contact lenses while you are using Azithromycin Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
To clear up your infection completely, use Azithromycin Drops for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Azithromycin Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

Azithromycin Drops only works against bacteria; it does not treat viral infections.
Be sure to use Azithromycin Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Long-term or repeated use of Azithromycin Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Azithromycin Drops should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Azithromycin Drops while you are pregnant. It is not known if Azithromycin Drops are found in breast milk after topical use. If you are or will be breast-feeding while you use Azithromycin Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Azithromycin Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Azithromycin Drops. 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); discharge from the eye; red, swollen, blistered, or peeling skin; severe or persistent burning, stinging, or irritation of the eye.

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 Azithromycin Drops:

Store unopened bottles of Azithromycin Drops in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Once the bottle is opened, it may be stored in the refrigerator or at room temperature below 77 degrees F (25 degrees C) for up to 14 days. Do not freeze. Store away from heat and light. Throw away any unused medicine after the bottle has been open for 14 days. Keep Azithromycin Drops out of the reach of children and away from pets.

General information:

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

A,Med-facts

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Azithromycin 3 Day Dose Pack

29/06/10

Generic Name: azithromycin (a ZITH roe MYE sin)
Brand Names: Azithromycin 3 Day Dose Pack, Azithromycin 5 Day Dose Pack, Zithromax, Zithromax TRI-PAK, Zithromax Z-Pak, Zmax

What is Azithromycin 3 Day Dose Pack (azithromycin)?

Azithromycin is in a group of drugs called macrolide antibiotics. Azithromycin fights bacteria in the body.

Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

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

What is the most important information I should know about Azithromycin 3 Day Dose Pack (azithromycin)?

Do not use this medication if you have ever had an allergic reaction to azithromycin or similar drugs such as erythromycin (E-Mycin, Ery-Tab, E.E.S.), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with azithromycin. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Azithromycin will not treat a viral infection such as the common cold or flu. Take azithromycin capsules on an empty stomach 1 hour before or 2 hours after a meal. Azithromycin tablets or powder oral suspension may be taken with or without food.

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take azithromycin. This includes Rolaids, Maalox, Mylanta, Milk of Magnesia, Pepcid Complete, and others. These antacids can make azithromycin less effective when taken at the same time.

What should I discuss with my healthcare provider before taking Azithromycin 3 Day Dose Pack (azithromycin)?

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

liver disease;
kidney disease;
myasthenia gravis;
a heart rhythm disorder; or
a history of Long QT syndrome.

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

How should I take Azithromycin 3 Day Dose Pack (azithromycin)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. The dose and length of treatment with azithromycin may not be the same for every type of infection.

Take each tablet or capsule with a full glass (8 ounces) of water.

To use the oral suspension single dose packet: Open the packet and pour the medicine into 2 ounces of water. Stir this mixture and drink all of it right away. Do not save for later use. Throw away any mixed oral suspension that has not been used within 12 hours.

To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Azithromycin capsules must be taken on an empty stomach. Take the capsule at least 1 hour before or 2 hours after eating a meal. Azithromycin tablets or powder oral suspension may be taken with or without food. Take the tablet or oral suspension with food if the medicine upsets your stomach. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Azithromycin will not treat a viral infection such as the common cold or flu. Store this medication at room temperature away from moisture and heat. Throw away any unused liquid medicine after 10 days.

What happens if I miss a dose?

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, diarrhea, and stomach discomfort.

What should I avoid while taking Azithromycin 3 Day Dose Pack (azithromycin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Azithromycin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Azithromycin 3 Day Dose Pack (azithromycin) 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 a serious side effect such as:

diarrhea that is watery or bloody;
chest pain, uneven heartbeats;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

mild nausea, vomiting, diarrhea, constipation;
stomach pain or upset;
dizziness, tired feeling, or headache;
nervous feeling, sleep problems (insomnia);
vaginal itching or discharge;
mild itching or skin rash;
ringing in your ears, problems with hearing; or
decreased sense of taste or smell.

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 Azithromycin 3 Day Dose Pack (azithromycin)?

Many drugs can interact with azithromycin. Below is just a partial list. Tell your doctor if you are using:

digoxin (Lanoxin, Lanoxicaps);
carbamazepine (Carbatrol, Tegretol);
cyclosporine (Neoral, Sandimmune);
phenytoin (Dilantin);
pimozide (Orap);
theophylline (Theo-Dur, Theolair, Theochron);
triazolam (Halcion);
warfarin (Coumadin);
another antibiotic, especially clarithromycin (Biaxin) or erythromycin (E-Mycin, E.E.S, Ery-Tab);
a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
cholesterol-lowering medicines such as lovastatin (Mevacor), atorvastatin (Lipitor), or simvastatin (Zocor);
ergot medicine such as methysergide (Sansert), ergotamine (Ergostat, Medihaler, Cafergot, Ercaf, Wigraine), dihydroergotamine mesylate (D.H.E., Migranal Nasal Spray);
HIV medicines such as nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase); or

Where can I get more information?

Your pharmacist can provide more information about azithromycin.

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.

A,Concise

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29/06/10

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General information:

29/06/10

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