DESCRIPTION
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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Azithromycin for oral suspension, USP contains 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. Azithromycin has the following structural formula:
C38H72N2O12 M. W. 749.00
Azithromycin, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12•H2O and a molecular weight of 767.02. 5 mL of constituted suspension of azithromycin for oral suspension, 100 mg/5 mL and 200 mg/5 mL, contains 6 mg of sodium.
Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: arabic gum, artificial aromatic substances, ethyl vanillin, FD&C Red #40, hydroxypropyl cellulose, maltodextrin, nature aromatic substances, nature identical aromatic substances, sucrose, tribasic sodium phosphate dodecahydrate, vanillin, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color.
INDICATIONS AND USAGE
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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Azithromycin for oral suspension is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.
CONTRAINDICATIONS
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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Azithromycin for oral suspension is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.
WARNINGS
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displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported (see CONTRAINDICATIONS). Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
ADVERSE REACTIONS
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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious side effects of angioedema and cholestatic jaundice were reported rarely. Approximately 0.7% of the patients (adults and pediatric patients) from the 5 day multiple-dose clinical trials discontinued azithromycin therapy because of treatment-related side effects. In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related side effects was 0.6%. In clinical trials in pediatric patients given 30 mg/kg, either as a single dose or over 3 days, discontinuation from the trials due to treatment-related side effects was approximately 1% (see DOSAGE AND ADMINISTRATION). Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain (see CLINICAL STUDIES, Pediatric Patients).
DOSAGE AND ADMINISTRATION
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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
HOW SUPPLIED
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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Azithromycin for oral suspension, USP after constitution contains a cherry flavored suspension. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color. Azithromycin for oral suspension, USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows:
Azithromycin contents per bottle
| 300 mg |
(15 mL bottle) |
| 600 mg |
(15 mL bottle) |
| 900 mg |
(22.5 mL bottle) |
| 1200 mg |
(30 mL bottle) |
5 mL of constituted suspension of azithromycin for oral suspension USP, 100 mg/5 mL and 200 mg/5 mL, contains 6 mg of sodium.
100 mg/5 mL
Bottle of 300 mg azithromycin contains 15 mL suspension when constituted with 9 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 100 mg of azithromycin.
200 mg/5 mL
Bottle of 600 mg azithromycin contains 15 mL suspension when constituted with 9 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 200 mg of azithromycin.
Bottle of 900 mg azithromycin contains 22.5 mL suspension when constituted with 12 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 200 mg of azithromycin.
Bottle of 1200 mg azithromycin contains 30 mL suspension when constituted with 15 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 200 mg of azithromycin.
See DOSAGE AND ADMINISTRATION for constitution instructions with each bottle type.
Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store constituted suspension at 5° to 30°C (41° to 86°F) and discard when full dosing is completed.
CLINICAL STUDIES
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displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7
(See INDICATIONS AND USAGE and Pediatric Use.)
ANIMAL TOXICOLOGY
id: 99ab6767-2a8f-41e5-8791-3be7ab38f4c9
displayName: ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION
FDA Article Code: 34091-9
Phospholipidosis (intracellular phospholipid accumulation) has been observed in some tissues of mice, rats, and dogs given multiple doses of azithromycin. It has been demonstrated in numerous organ systems (e.g., eye, dorsal root ganglia, liver, gallbladder, kidney, spleen, and pancreas) in dogs treated with azithromycin at doses which, expressed on the basis of mg/m2, are approximately equal to the recommended adult human dose, and in rats treated at doses approximately one-sixth of the recommended adult human dose. This effect has been shown to be reversible after cessation of azithromycin treatment. Phospholipidosis has been observed to a similar extent in the tissues of neonatal rats and dogs given daily doses of azithromycin ranging from 10 days to 30 days. Based on the pharmacokinetic data, phospholipidosis has been seen in the rat (30 mg/kg dose) at observed Cmax value of 1.3 mcg/mL (six times greater than the observed Cmax of 0.216 mcg/mL at the pediatric dose of 10 mg/kg). Similarly, it has been shown in the dog (10 mg/kg dose) at observed Cmax value of 1.5 mcg/mL (seven times greater than the observed same Cmax and drug dose in the studied pediatric population). On a mg/m2 basis, 30 mg/kg dose in the neonatal rat (135 mg/m2) and 10 mg/kg dose in the neonatal dog (79 mg/m2) are approximately 0.5 and 0.3 times, respectively, the recommended dose in the pediatric patients with an average body weight of 25 kg. Phospholipidosis, similar to that seen in the adult animals, is reversible after cessation of azithromycin treatment. The significance of these findings for animals and for humans is unknown.
REFERENCES
id: 5df54f98-5e24-4e25-b631-ad9786d6c6e6
displayName: REFERENCES SECTION
FDA Article Code: 34093-5
- National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically – Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2 (ISBN 1-56238-394-9). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, January 2000.
- National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests – Seventh Edition. Approved Standard NCCLS Document M2-A7, Vol. 20, No. 1 (ISBN 1-56238-393-0). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, January 2000.
- National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Susceptibility Testing – Eleventh Informational Supplement. NCCLS Document M100-S11, Vol. 21, No. 1 (ISBN 1-56238-426-0). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, January 2001.
PATIENT SUMMARY OF INFORMATION ABOUT AZITHROMYCIN FOR ORAL SUSPENSION, USP
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displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0
This summary contains important information about azithromycin for oral suspension, USP. It is not meant to take the place of your child’s doctor’s instructions. Read this information carefully before you give azithromycin for oral suspension, USP to your child. Ask your child’s doctor, nurse, or pharmacist if you do not understand any of this information or if you want to know more about azithromycin for oral suspension, USP.
What is azithromycin for oral suspension, USP?
Azithromycin for oral suspension, USP is an antibiotic medicine that is taken only once a day to treat the following types of infections in children: ear infections, pneumonia, and throat infections.
Can Antibiotics Cure a Cold or Flu?
No. Antibiotics work only on infections caused by bacteria. They do not kill viruses. No antibiotic, including azithromycin for oral suspension, USP, can treat viral infections such as the common cold and the flu.
What to Tell Your Child’s Doctor Before You Start Azithromycin for Oral Suspension, USP
Only your child’s doctor can decide if azithromycin for oral suspension, USP is right for your child. Before you start azithromycin for oral suspension, USP, be sure to tell the doctor if your child:
- is being given any prescription medicines, including those for asthma
- is being given any over-the-counter medicines you can buy without a prescription, including natural/herbal remedies
- has ever had any liver or kidney problems
- has any other medical problems
- is allergic to any medicines
- is allergic to certain antibiotics such as erythromycin
- is allergic to azithromycin or any of the ingredients of azithromycin for oral suspension, USP. Your doctor or pharmacist can give you a list of these ingredients.
Azithromycin for Oral Suspension, USP and Other Medicines
Some medicines can affect how well azithromycin for oral suspension, USP works. Check with your child’s doctor before giving your child any new medicines.
What is the Right Amount of Azithromycin for Oral Suspension, USP to Give to My Child?
Azithromycin for oral suspension, USP gets deep into infected tissue where it is released slowly over time so the medicine keeps fighting bacteria for many days after the last dose is taken. This is why azithromycin for oral suspension, USP may be taken for as short a time as one day.
Your child’s doctor will decide the total amount of azithromycin for oral suspension, USP to give to your child, depending on your child’s weight and on the specific infection your child has. In addition to deciding the total amount of azithromycin for oral suspension, USP to give to your child, the doctor will tell you to give all the medicine to your child in 1 day or to divide it over 3 days or over 5 days.
For Ear Infections
For ear infections, your child’s doctor will tell you to give azithromycin for oral suspension, USP to your child in one of the following ways: the total amount as 1 dose on 1 day, or the total amount divided into 1 dose-per-day for 3 days or the total amount divided into 1 dose-per-day for 5 days, with a double dose on the first day. Whether given all on 1 day, or divided over 3 days or over 5 days, the total amount of azithromycin for oral suspension, USP you give to your child should be the same.
For Pneumonia
For pneumonia, your child’s doctor will tell you to give azithromycin for oral suspension, USP to your child by dividing the total amount into 1 dose-per-day for 5 days, with a double dose on the first day.
For Throat Infections (“strep throat”)
For throat infections, your child’s doctor will tell you to give azithromycin for oral suspension, USP to your child by dividing the total amount into 1 dose-per-day for 5 days. When you give azithromycin for oral suspension, USP for 5 days for throat infections, you do not need to give a double dose on the first day (as you would with ear infections).
If you have questions about how to give azithromycin for oral suspension, USP to your child, please ask your child’s doctor, nurse, or pharmacist.
How and When to Give Azithromycin for Oral Suspension, USP
Azithromycin for oral suspension, USP may be taken with or without food and may be taken at any time of day.
Shake the bottle well just before you give a dose.
Give azithromycin for oral suspension, USP for the full number of days prescribed by the doctor, even if your child feels better before finishing all the medicine as prescribed.
If you forget to give your child a dose, call the doctor.
When Can I Expect My Child to Begin Feeling Better?
Although azithromycin for oral suspension, USP’s dosing is short and you may be able to give all the medicine to your child more easily, you should not expect azithromycin for oral suspension, USP to work faster than other antibiotics which are dosed for up to 10 days.
Your child’s doctor or nurse can advise you when your child should begin feeling better.
Possible Side Effects
Like all medicines, azithromycin for oral suspension, USP may cause side effects in some children that are usually mild to moderate and go away after the medicine is stopped. The most common ones are diarrhea, abdominal (“tummy”) pain, vomiting, and nausea.
As with other antibiotics, if your child develops diarrhea that becomes severe and watery or does not go away, stop taking the medicine and call the doctor or nurse. This could be a sign of a serious medical problem.
Allergic reactions to azithromycin for oral suspension, USP are rare, but these can be very serious if not treated right away by a doctor. If you think your child might be having an allergic reaction to azithromycin for oral suspension, USP, stop the medicine and call the doctor right away. If you cannot reach the doctor, go to the nearest hospital emergency room. Symptoms of a severe allergic reaction may include trouble breathing; swelling of the face, mouth, and neck; or severe skin rash or blisters.
Azithromycin for oral suspension, USP may cause other less common side effects besides those listed here. For a list of all the side effects that have been reported, ask the doctor, nurse, or pharmacist for the azithromycin for oral suspension, USP professional package insert.
What Should I Do if My Child Vomits (Spits Up) the 1 Day Treatment of Azithromycin for Oral Suspension, USP?
If your child vomits within 30 minutes after the 1 day treatment for an ear infection, please call your child’s doctor.
What to Do for an Overdose
In case of accidental overdose, call your child’s doctor right away or go to the nearest emergency room.
How to Store Azithromycin for Oral Suspension, USP
Keep azithromycin for oral suspension, USP out of the reach of children. Azithromycin for oral suspension, USP can be stored at room temperature. You do not have to keep it in the refrigerator. Throw away any medicine that is left over after treatment.
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Repackaged by:
REBEL DISTRIBUTORS CORP.
Thousand Oaks, CA 91320
Iss. 1/2008
Principal Display Panel
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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Principal Display Panel
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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
