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DESCRIPTION

Azithromycin for oral suspension, USP contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R) -13-[(2,6-dideoxy-3- C -methyl-3- O -methyl-α- L-ribo hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β- D-xylo -hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38 H 72 N 2 O 12. and its molecular weight is 749.00.

Azithromycin has the following structural formula:

Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 •H 2 O and a molecular weight of 767.0.

Each tablet for oral administration contains azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin. In addition each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, polyethylene glycol, magnesium stearate, microcrystalline cellulose, partially pregelantinized starch, sodium citrate, sodium lauryl sulfate, titanium dioxide and FD&C Blue No. 2 (500 mg only).

CLINICAL PHARMACOLOGY

Pharmacokinetics

Following oral administration of a single 500 mg dose (two 250 mg tablets) to 36 fasted healthy male volunteers, the mean (SD) pharmacokinetic parameters were AUC 0-72 = 4.3 (1.2) mcg·h/mL; C max = 0.5 (0.2) mcg/mL; T max = 2.2 (0.9) hours.

With a regimen of 500 mg (two 250 mg capsules*) on day 1, followed by 250 mg daily (one 250 mg capsule) on days 2 through 5, the pharmacokinetic parameters of azithromycin in plasma in healthy young adults (18-40 years of age) are portrayed in the chart below. C min and C max remained essentially unchanged from day 2 through day 5 of therapy.



INDICATIONS

ZITHROMAX (azithromycin for injection) is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. As recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for dosing recommendations.

Community-acquired pneumonia due to Chlamydia pneumoniae . Haemophilus influenzae . Legionella pneumophila . Moraxella catarrhalis . Mycoplasma pneumoniae . Staphylococcus aureus . or Streptococcus pneumoniae in patients who require initial intravenous therapy.

Pelvic inflammatory disease due to Chlamydia trachomatis . Neisseria gonorrhoeae . or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZITHROMAX.

ZITHROMAX (azithromycin for injection) should be followed by ZITHROMAX by the oral route as required. (See DOSAGE AND ADMINISTRATION .)

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative microorganism and its susceptibility to azithromycin. Therapy with ZITHROMAX may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY .)

The recommended dose of ZITHROMAX (azithromycin for injection) for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.

The recommended dose of ZITHROMAX (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZITHROMAX.

Renal Insufficiency

No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY . Special Populations . Renal Insufficiency .)

Hepatic Insufficiency

The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY . Special Populations . Hepatic Insufficiency .)

No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY . Special Populations .)

The infusate concentration and rate of infusion for ZITHROMAX (azithromycin for injection) should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. ZITHROMAX (azithromycin for injection) should not be given as a bolus or as an intramuscular injection.

Preparation of the solution for intravenous administration is as follows:

Reconstitution

Prepare the initial solution of ZITHROMAX (azithromycin for injection) by adding 4.8 mL of Sterile Water For Injection to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since ZITHROMAX (azithromycin for injection) is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of Sterile Water is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C (86°F).

Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.

Dilute this solution further prior to administration as instructed below.

Dilution

To provide azithromycin over a concentration range of 1.0-2.0 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below:

Normal Saline (0.9% sodium chloride)

½ Normal Saline (0.45% sodium chloride)

5% Dextrose in Water Lactated Ringer's Solution

5% Dextrose in ½ Normal Saline (0.45% sodium chloride) with 20 mEq KCl

Normosol®-M in 5% Dextrose

Normosol®-R in 5% Dextrose

When used with the Vial-Mate® drug reconstitution device, please reference the Vial-Mate® instructions for assembly and reconstitution.



PEDIATRIC DOSAGE

Community Acquired Pneumonia

Inj:

≥16 Years:

500mg IV qd for at least 2 days, then 500mg PO (two 250mg tabs) qd to complete a 7- to 10-day course

≥16 Years:

500mg qd IV for 1-2 days, followed by 250mg qd PO to complete a 7 day course

ADMINISTRATION

Take w/ or w/o food

Sus (100/5mL, 200/5mL)

Reconstitution:

Add 9mL of water to 300mg or 600mg sus bottle, 12mL of water to 900mg sus bottle, or 15mL of water to 1200mg sus bottle

Sus (Single-Dose Pkt)

Do not use to administer doses other than 1000mg

Not for pediatric use

Reconstitution:

Mix entire contents of pkt w/ 2 oz (approx 60mL) of water

Drink entire contents immediately and add an additional 2 oz of water, mix, and drink to ensure complete consumption of dosage

Inj

Infusate concentration and rate of infusion should be either 1mg/mL over 3 hrs or 2mg/mL over 1 hr; avoid higher concentrations

Infuse over at least 60 min

Do not give as bolus or as IM inj

Do not add other IV substances, additives, or other medications or infuse simultaneously through same IV line

Reconstitution:

Reconstitute initial sol w/ 4.8mL of SWFI to 500mg vial using a standard 5mL (non-automated) syringe; each mL of reconstituted sol should contain 100mg azithromycin

Dilute further prior to administration

Refer to Vial-Mate instructions if using this device for reconstitution

Dilution:

Transfer 5mL of the 100mg/mL sol into the appropriate amount of any compatible diluent

Compatible Diluents:

0.9% NaCl, 0.45% NaCl, D5W, Lactated Ringer's Sol, D5 in 0.45% NaCl w/ 20 mEq KCl, D5 in Lactated Ringer's Sol, D5 in 0.3% NaCl, D5 in 0.45NaCl, Normosol-M in D5, Normosol-R in D5



DESCRIPTION

ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name ( 2R,3S,4R,5R,8R, 10R,11R,12S,13S,14R )-13-[(2,6-dideoxy-3- C -methyl-3- O -methyl-α- L - ribo -hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D-xylo -hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38 H 72 N 2 O 12. and its molecular weight is 749.00. Azithromycin has the following structural formula:

Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 •2H 2 O and a molecular weight of 785.0.

ZITHROMAX is supplied for oral administration as film-coated, modified capsular shaped tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin and D&C Red #30 aluminum lake.

ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.

CLINICAL PHARMACOLOGY

Pharmacokinetics

Following oral administration of a single 500 mg dose (two 250 mg tablets) to 36 fasted healthy male volunteers, the mean (SD) pharmacokinetic parameters were AUC 0–72 = 4.3 (1.2) µg∙h/mL; C max = 0.5 (0.2) µg/mL; T max = 2.2 (0.9) hours.

With a regimen of 500 mg (two 250 mg capsules1 ) on day 1, followed by 250 mg daily (one 250 mg capsule) on days 2 through 5, the pharmacokinetic parameters of azithromycin in plasma in healthy young adults (18–40 years of age) are portrayed in the chart below. C min and C max remained essentially unchanged from day 2 through day 5 of therapy.



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Antibiotics

Zithromax

Active Ingredient: Azithromycin

Zithromax is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases. In children, it is used to treat middle ear infection, pneumonia, tonsillitis, and strep throat.

Zithromax 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. Zithromax 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.

Use Zithromax as directed by your doctor.

Take Zithromax by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Do not take an antacid that has aluminum or magnesium in it within 1 hour before or 2 hours after you take Zithromax.

Zithromax works best if it is taken at the same time each day.

To clear up your infection completely, use Zithromax for the full course of treatment. Keep using it even if you feel better in a few days.

If you miss a dose of Zithromax, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Store Zithromax below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zithromax out of the reach of children and away from pets.

Active Ingredient: Azithromycin.

Do NOT use Zithromax if:

you are allergic to any ingredient in Zithromax, 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.

Some medical conditions may interact with Zithromax. 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 Zithromax. 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 Zithromax's side effects

Rifampin because it may decrease Zithromax'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 Zithromax.

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

Important safety information:

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

Zithromax may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Zithromax. 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 Zithromax before you receive any medical or dental care, emergency care, or surgery.

Long-term or repeated use of Zithromax 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 Zithromax 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.

Zithromax only works against bacteria; it does not treat viral infections (eg, the common cold).

Zithromax 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 Zithromax while you are pregnant. It is not known if Zithromax is found in breast milk. If you are or will be breast-feeding while you use Zithromax, check with your doctor. Discuss any possible risks to your baby.

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.

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.



azithromycin 250/500 mg - oral, Zithromax (cont.)

DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: live bacterial vaccines.Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.Many drugs besides azithromycin may affect the heart rhythm (QT prolongation), including amiodarone. disopyramide, dofetilide, dronedarone, ibutilide, pimozide, procainamide. quinidine. sotalol, among others.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.



DESCRIPTION

ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name ( 2R,3S,4R,5R,8R,10R,11R,12S,13S,14R )-13-[(2,6-dideoxy-3- C -methyl-3- O -methyl-α- L - ribo -hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D - xylo -hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38 H 72 N 2 O 12. and its molecular weight is 749.0. Azithromycin has the following structural formula:

Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 •2H 2 O and a molecular weight of 785.0.

ZITHROMAX tablets contain azithromycin dihydrate equivalent to 600 mg azithromycin. The tablets are supplied as white, modified oval-shaped, film-coated tablets. They also contain the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate and an aqueous film coat consisting of hypromellose, titanium dioxide, lactose and triacetin.

ZITHROMAX for oral suspension is supplied in a single dose packet containing azithromycin dihydrate equivalent to 1 g azithromycin. It also contains the following inactive ingredients: colloidal silicon dioxide, sodium phosphate tribasic, anhydrous; spray dried artificial banana flavor, spray dried artificial cherry flavor, and sucrose.

CLINICAL PHARMACOLOGY

Pharmacokinetics

Following oral administration, azithromycin is rapidly absorbed and widely distributed throughout the body. Rapid distribution of azithromycin into tissues and high concentration within cells result in significantly higher azithromycin concentrations in tissues than in plasma or serum. The 1 g single dose packet is bioequivalent to four 250 mg azithromycin capsules.

The pharmacokinetic parameters of azithromycin in plasma after dosing as per labeled recommendations in healthy young adults and asymptomatic HIV-seropositive adults (age 18–40 years old) are portrayed in the following chart:



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