Azithromycin Intravenous

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 younger than 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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving azithromycin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using 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.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dihydroergotamine
• Dronedarone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Methylergonovine
• Methysergide
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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
• Afatinib
• Alfuzosin
• Amiodarone
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azimilide
• Bretylium
• Buserelin
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Digoxin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Efavirenz
• Erythromycin
• Escitalopram
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lopinavir
• Lumefantrine
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pentamidine
• Pimavanserin
• Pitolisant
• Pixantrone
• Posaconazole
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Salmeterol
• Sematilide
• Sevoflurane
• Simvastatin
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telithromycin
• Tetrabenazine
• Topotecan
• Toremifene
• Trazodone
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voriconazole
• Warfarin
• Zuclopenthixol

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
• Lovastatin
• Nelfinavir
• Rifabutin
• Theophylline

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.

Other Medical Problems

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

• Congestive heart failure or
• Diarrhea or
• Heart disease or
• Heart rhythm problems (eg, bradyarrhythmia, prolonged QT interval), history of or
• Hypokalemia (low potassium levels in the blood), uncorrected or
• Hypomagnesemia (low magnesium levels in the blood), uncorrected or
• Liver disease or
• Myasthenia gravis (severe muscle weakness)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. .

• Liver disease, history of—Should not be used in patients with this condition.

A nurse or other trained health professional will give you azithromycin. azithromycin is given through a needle placed in one of your veins. azithromycin is given slowly, so the needle will remain in place for about an hour.

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.

Your doctor will check your progress closely while you are receiving azithromycin. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

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, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive azithromycin.

Serious skin reactions can occur with azithromycin. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using azithromycin.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Infantile hypertrophic pyloric stenosis (tube is too narrow where food passes out of the stomach) may occur in newborn babies after receiving azithromycin. Tell your child's doctor right away if your child vomits or irritability with feeding occurs.

Azithromycin injection may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using azithromycin. Do not take any medicine to treat diarrhea without checking first 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 the skin, itching, lumps, pain, rash, redness, or swelling at the injection site.

azithromycin can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

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.

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:

• Pain, redness, and swelling at the injection site

• Difficult or labored breathing
• loose stools
• tightness in the chest

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

• Agitation
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bloody or cloudy urine
• blurred vision
• chest pain or discomfort
• chills
• coma
• confusion
• constipation
• convulsions
• cough
• darkened urine
• decreased urine output
• depression
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever with or without chills
• general feeling of discomfort or illness
• greatly decreased frequency of urination or amount of urine
• headache
• hives or itching
• hostility
• increased thirst
• indigestion
• irregular heartbeat recurrent
• irregular or slow heart rate
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• light-colored stools
• loss of appetite
• muscle pain
• muscle twitching
• nausea or vomiting
• pain
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stupor
• sweating
• swelling of the hands, ankles, feet, or lower legs
• unusual bleeding or bruising
• unusual tiredness or weakness
• 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:

• Diarrhea (mild)
• nausea
• stomach pain or discomfort (mild)
• weight loss

• Acid or sour stomach
• belching
• burning feeling in the chest or stomach
• cracked lips
• excess air or gas in the stomach or intestines
• full feeling
• heartburn
• passing gas
• sleepiness or unusual drowsiness
• sore mouth or tongue
• stomach discomfort, upset, or pain
• white patches in the mouth, tongue, or throat

• Attack, assault, or force
• bad, unusual, or unpleasant (after) taste
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty with moving
• discoloration of the tongue
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• hearing loss
• itching of the vagina or genital area
• lack or loss of strength
• loss of sense of smell
• muscle pain or stiffness
• pain during sexual intercourse
• sensation of spinning
• thick, white vaginal discharge with no odor or with a mild odor
• 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.

Nausea, vomiting, diarrhea/loose stools, stomach pain, or pain/redness at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: hearing changes (e.g., ringing in the ears, hearing loss), swelling legs/feet, eye problems (e.g., drooping eyelids, blurred vision), slurred speech, muscle weakness, persistent nausea/vomiting, severe abdominal/stomach pain, unusual weakness/tiredness, dark urine, yellowing skin/eyes.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches/sores in your mouth, a change in vaginal discharge, or other new symptoms.

Get medical help right away if any of these rare but serioussevere dizziness, fainting, fast/irregular heartbeat.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: fever that doesn't go away, new or worsening lymph node swelling, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

An allergic reaction to this medication may return even if you stop the drug. If you have an allergic reaction, continue to watch for any of the above symptoms for several days after your last dose.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using azithromycin, tell your doctor or pharmacist if you are allergic to it; or to any other macrolide/ketolide antibiotics (e.g., clarithromycin, erythromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain muscle disease (myasthenia gravis).

Azithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using azithromycin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using azithromycin safely.

This medication contains sodium. Consult your doctor for more information if you are on a salt-restricted diet or if increased salt intake could worsen your condition (e.g., congestive heart failure).

Azithromycin may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Older adults may be more sensitive to the side effects of this drug, especially swelling legs/feet (due to sodium and water retention) and QT prolongation (see above).

Babies (especially younger than 6 weeks) may be at higher risk for a certain serious stomach problem. Contact your child's doctor right away if your child vomits or becomes irritable with feeding.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.