What is Zithromax?
Zithromax 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).
This medicine 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, Zithromax is used in certain patients with the following medical condition:
- Trachoma (treatment).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (Zithromax) and other antibacterial drugs, ZITHROMAX (Zithromax) should be used only to treat 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.
ZITHROMAX (Zithromax) for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Community-Acquired Pneumoniadue to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy.
Pelvic Inflammatory Diseasedue 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 for injection should be followed by ZITHROMAX by the oral route as required.
How should I use Zithromax?
Use Zithromax as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zithromax is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Zithromax at home, a health care provider will teach you how to use it. Be sure you understand how to use Zithromax. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Zithromax if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- 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, 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 Zithromax.
Uses of Zithromax in details
Zithromax is an antibiotic used to treat bacterial infections of the nose, throat, lungs, bronchitis, ear, skin, soft tissues, and sexually transmitted genital and urinary infections.
Each capsule contains Azithromycin Injection 262.05 mg equivalent to Zithromax base 250 mg. It also contains anhydrous lactose, maize starch, magnesium stearate and sodium lauryl sulfate as excipients. The capsule shell contains gelatin, titanium dioxide (E171) and up to 1,000 ppm sulfur dioxide.
Each tablet contains Azithromycin Injection 262.05 mg equivalent to Zithromax base 250 mg. It also contains pre-gelatinized starch, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate and sodium lauryl sulfate as excipients. The film-coating contains hydroxypropyl cellulose, triacetin and titanium dioxide (E171).
Each 5 mL of powder for oral suspension contains Azithromycin Injection 209.64 mg equivalent to Zithromax base 200 mg. It also contains sucrose (1.94 g/100 mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors as excipients.
Each sachet contains Azithromycin Injection 100.16 mg equivalent to Zithromax base 100 mg. It also contains sucrose (1.85 g/Zithromax 100-mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors as excipients. It also contains a dry powder which yields, when added to water, a white to off-white suspension, cherry/banana with a slight vanilla odor.
Each vial contains Azithromycin Injection 524.1 mg equivalent to Zithromax base 500 mg. It also contains anhydrous citric acid and sodium hydroxide as excipients. It is supplied in lyophilized form under a vacuum in a 10-mL vial for IV administration. Upon reconstitution, Zithromax powder yields a solution containing the equivalent of Zithromax 100 mg/mL.
Zithromax is 9-deoxy-9a-aza-9a-methyl-9a-homoerythromycin A. The molecular weight is 749.
ZITHROMAX for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. However, increased tolerability has been observed when tablets are taken with food.
Zithromax for oral suspension (single dose 1 g packet) is not for pediatric use. For pediatric suspension see the prescribing information for ZITHROMAX (Zithromax for oral suspension) 100 mg/5 mL and 200 mg/5 mL bottles.
Directions for administration of ZITHROMAX for oral suspension in the single dose packet (1 g): The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to ensure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of Zithromax.
Sexually Transmitted DiseasesThe recommended dose of ZITHROMAX for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is a single 1 gram (1000 mg) dose of ZITHROMAX. This dose can be administered as one single dose packet (1 g).
Mycobacterial Infections Prevention of Disseminated MAC InfectionsThe recommended dose of ZITHROMAX for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of ZITHROMAX may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC InfectionsZITHROMAX should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of Zithromax plus ethambutol at the discretion of the physician or health care provider.
Dosage Forms And StrengthsZITHROMAX 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing Zithromax dihydrate equivalent to 600 mg Zithromax. These are packaged in bottles of 30 tablets.
ZITHROMAX for oral suspension 1000 mg/5 mL is supplied in single-dose packets containing Zithromax dihydrate equivalent to 1 gram of Zithromax.
Storage And HandlingZITHROMAX 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing Zithromax dihydrate equivalent to 600 mg Zithromax. These are packaged in bottles of 30 tablets. ZITHROMAX tablets are supplied as follows:
Bottles of 30 NDC 0069-3080-30
Tablets should be stored at or below 30°C (86°F).
ZITHROMAX for oral suspension is supplied in single-dose packets containing Zithromax dihydrate equivalent to 1 gram of Zithromax as follows:
Boxes of 10 single-dose packets (1 g) NDC 0069-3051-07
Boxes of 3 single-dose packets (1 g) NDC 0069-3051-75
Store single-dose packets between 5° and 30°C (41° and 86°F).
Distributed by: Pfizer Labs Division of Pfizer Inc., NY, NY 10017. Revised: Dec 2015
NelfinavirCo-administration of nelfinavir at steady-state with a single oral dose of Zithromax resulted in increased Zithromax serum concentrations. Although a dose adjustment of Zithromax is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of Zithromax, such as liver enzyme abnormalities and hearing impairment, is warranted.
WarfarinSpontaneous post-marketing reports suggest that concomitant administration of Zithromax may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with Zithromax and warfarin. Prothrombin times should be carefully monitored while patients are receiving Zithromax and oral anticoagulants concomitantly.
Potential Drug-Drug Interaction With MacrolidesInteractions with the following drugs listed below have not been reported in clinical trials with Zithromax; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin or phenytoin are used with Zithromax careful monitoring of patients is advised.
Zithromax side effects
What are the possible side effects of Zithromax?
Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials of intravenous Zithromax for community-acquired pneumonia, in which 2 to 5 IV doses were given, the reported adverse reactions were mild to moderate in severity and were reversible upon discontinuation of the drug. The majority of patients in these trials had one or more comorbid diseases and were receiving concomitant medications. Approximately 1.2% of the patients discontinued intravenous ZITHROMAX therapy, and a total of 2.4% discontinued Zithromax therapy by either the intravenous or oral route because of clinical or laboratory side effects.
In clinical trials conducted in patients with pelvic inflammatory disease, in which 1 to 2 IV doses were given, 2% of women who received monotherapy with Zithromax and 4% who received Zithromax plus metronidazole discontinued therapy due to clinical side effects.
Clinical adverse reactions leading to discontinuations from these studies were gastrointestinal (abdominal pain, nausea, vomiting, diarrhea), and rashes; laboratory side effects leading to discontinuation were increases in transaminase levels and/or alkaline phosphatase levels.
Overall, the most common adverse reactions associated with treatment in adult patients who received IV/Oral ZITHROMAX in studies of community-acquired pneumonia were related to the gastrointestinal system with diarrhea/loose stools (4.3%), nausea (3.9%), abdominal pain (2.7%), and vomiting (1.4%) being the most frequently reported.
Approximately 12% of patients experienced a side effect related to the intravenous infusion; most common were pain at the injection site (6.5%) and local inflammation (3.1%).
The most common adverse reactions associated with treatment in adult women who received IV/Oral ZITHROMAX in trials of pelvic inflammatory disease were related to the gastrointestinal system. Diarrhea (8.5%) and nausea (6.6%) were most commonly reported, followed by vaginitis (2.8%), abdominal pain (1.9%), anorexia (1.9%), rash and pruritus (1.9%). When Zithromax was coadministered with metronidazole in these trials, a higher proportion of women experienced adverse reactions of nausea (10.3%), abdominal pain (3.7%), vomiting (2.8%), infusion site reaction, stomatitis, dizziness, or dyspnea (all at 1.9%).
Adverse reactions that occurred with a frequency of 1% or less included the following:
Gastrointestinal: Dyspepsia, flatulence, mucositis, oral moniliasis, and gastritis.
Nervous system: Headache, somnolence.
Special senses: Taste perversion.
Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of Zithromax. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions reported with Zithromax during the post-marketing period in adult and/or pediatric patients for which a causal relationship may not be established include:
Allergic: Arthralgia, edema, urticaria and angioedema.
Cardiovascular: Arrhythmias including ventricular tachycardia and hypotension. There have been reports of QT prolongation and torsades de pointes.
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and reports of tongue discoloration.
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis (including fatalities).
Genitourinary: Interstitial nephritis and acute renal failure and vaginitis.
Liver/biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure.
Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.
Psychiatric: Aggressive reaction and anxiety.
Skin/appendages: Pruritus, serious skin reactions including, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS.
Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss.
Laboratory AbnormalitiesSignificant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows:
- elevated ALT (SGPT), AST (SGOT), creatinine (4 to 6%)
- elevated LDH, bilirubin (1 to 3%)
- leukopenia, neutropenia, decreased platelet count, and elevated serum alkaline phosphatase (less than 1%)
When follow-up was provided, changes in laboratory tests appeared to be reversible.
In multiple-dose clinical trials involving more than 750 patients treated with ZITHROMAX (IV/Oral), less than 2% of patients discontinued Zithromax therapy because of treatment-related liver enzyme abnormalities.
Zithromax is contraindicated in patients with known hypersensitivity to Zithromax, erythromycin, any macrolide, or ketolide drug.
Zithromax is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of Zithromax.
Active ingredient matches for Zithromax:
Azithromycin Injection in Australia, Austria, Bahrain, Benin, Burkina Faso, Cameroon, Canada, Central African Republic, Chad, Chile, China, Congo, Costa Rica, Cote D’ivoire, Cyprus, Dominican Republic, Egypt, El Salvador, Finland, France, Gabon, Germany, Ghana, Greece, Guatemala, Guinea, Guyana, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Jordan, Kenya, Kuwait, Lebanon, Liberia, Madagascar, Malawi, Malaysia, Mali, Malta, Mauritania, Mauritius, Myanmar, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, Oman, Panama, Philippines, Portugal, Saudi Arabia, Senegal, Sierra Leone, Singapore, South Africa, Sudan, Switzerland, Taiwan, Thailand, Togo, Tunisia, United Arab Emirates, United Kingdom, United States, Vietnam, Zaire.
Azithromycin in Malaysia, Thailand, Singapore, Finland, New Zealand, Israel, Greece, Chile, Philippines, Indonesia, United Kingdom, United States, France, Netherlands, Austria, Australia, Germany, Switzerland, South Africa, Ireland, Canada, Portugal, Hong Kong.
gapore, Finland, New Zealand, Israel, Greece, Chile, Philippines, Indonesia, United Kingdom, United States, France, Netherlands, Austria, Australia, Germany, Switzerland, South Africa, Ireland, Canada, Portugal, Hong Kong.
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