The Food and Drug Administration (FDA) announced Thursday that a drug that can treat a bacterial infection of the gastrointestinal tract has been approved by the U. S. Food and Drug Administration (FDA) to treat patients infected with the same type of bacteria.
The FDA’s approval of Zithromax, an azithromycin antibiotic, is a “black box” warning that warns that certain types of infections, including those that are caused by bacteria such asLegionellaandStreptococcus, can become severe in children and elderly patients.
The FDA’s “black box” label includes Zithromax as an alternative to antibiotics such as clarithromycin and azithromycin. It says that Zithromax is less likely to cause severe side effects in children and is less likely to be used in patients with known or suspected kidney or liver disease.
FDA spokeswoman Laura Bartlett said in a statement, “Zithromax is an alternative to antibiotics, and has been approved for pediatric patients as part of a larger plan to address the infection.”
Zithromax has been prescribed to more than 1.5 million patients worldwide, including over the age of 65. It was the only azithromycin drug approved to treat pneumonia in children. The FDA approved the drug in 2001 as a treatment for a rare bacterial infection known asChlamydia. The infection, which is caused by, is often caused by bacteria such asEnterococcus
“The FDA has been a great help to patients who are on azithromycin therapy. We are very proud to have this important drug in the same category as all other antibiotics,” said John T. Leinwey, the FDA’s medical director.
The drug’s label says it is not approved for use in children. The drug has also not been approved for use in adults.
The FDA said it has received numerous reports of children taking Zithromax. However, the FDA declined to provide more information about Zithromax use in children.
Zithromax is used to treat infections caused by bacteria. The FDA has not approved this drug, however, because it is not approved to treat any specific condition.
The company said it was pleased to have this approval and that it will continue to evaluate Zithromax’s benefits for children and elderly patients. It will also work to ensure it is used judiciously.
“This is a positive development,” said Dr. John M. Johnson, a pediatric infectious diseases specialist at Children’s Hospital Cleveland.
Johnson said that as a pediatric infectious diseases specialist, he is familiar with the drug’s safety and efficacy in children. The FDA approved it as a treatment option for children ages 5-17 years of age, and has been approved for use in adults. Johnson said the FDA’s drug label advises patients that Zithromax can be used in children and that Zithromax is a non-antibiotic drug.
Zithromax has not been approved for use in adults, and Johnson believes the company is working to address the condition. He said that the FDA has been working with the manufacturers of Zithromax to ensure the drug’s safety and efficacy in children and has a plan to address any concerns and inform patients and caregivers of its benefits.
“These are the things that are important to patients, and they’re important to our patients and to the FDA, and they are important to us as physicians and patients,” said Dr. Robert C. Ritter, the FDA’s medical director.
In a statement, the company said it will continue to work with the manufacturers of Zithromax to ensure that the drug is used judiciously and that the benefits are used in patients.
“We continue to work to ensure that Zithromax is used judiciously and that the benefits are used in patients,” said Dr. John R. Heiman, the FDA’s medical director.
The drug was developed and approved by the drug manufacturer from a proprietary technology platform to be used in pediatric patients ages 5-17 years of age.
The company has developed the drug as a treatment for patients with serious infections of the gastrointestinal tract. The FDA has received several reports of children taking Zithromax.
A: ZITHROMAX 250MG CAPSULE is used to manage mild to moderately susceptible infections caused by bacteria and other microorganisms, which include chest, throat, and nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat, and sinusitis). It is also used to manage ear infections and skin and soft tissue infections (such as an abscess/boil).
A: ZITHROMAX 250MG CAPSULE works by inhibiting bacterial protein synthesis (essential for the bacteria to grow) that results in its destruction, thus managing its growth and spread of infection in affected individuals.
A: The most common side effects of taking ZITHROMAX 250MG CAPSULE are stomach cramps, nausea, vomiting, diarrhea, flatulence, dizziness, headache, and/or skin rash. Consult your doctor if any of the symptoms worsen.
A: Take this medicine as advised by your physician.
For Tablet, Capsule: Swallow ZITHROMAX 250MG CAPSULE with a glass of water. Do not crush or chew the medicine.
For Dispersible Tablet: Disperse ZITHROMAX 250MG CAPSULE in the specified quantity of water as mentioned in the label. Consume the mixture immediately after reconstitution.
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
A: ZITHROMAX 250MG CAPSULE is not recommended for use in patients allergic to Azithromycin, other antibiotics such as erythromycin/clarithromycin (macrolides), and/or ketolides. It is also not recommended for use in patients suffering from liver diseases such as cholestatic jaundice or hepatic dysfunction.
A: ZITHROMAX 250MG CAPSULE is usually available by prescription only. It is important to consult with a healthcare provider before starting management with ZITHROMAX 250MG CAPSULE.
A: ZITHROMAX 250MG CAPSULE can be taken with or without food. However, taking it with food may help reduce the risk of gastrointestinal side effects such as nausea and stomach upset.
A: Drowsiness is not a common side effect of ZITHROMAX 250MG CAPSULE. However, some individuals may experience dizziness or fatigue while taking the medication. If you experience any significant drowsiness or dizziness, avoid driving or operating machinery until you know how the medication affects you.
A: ZITHROMAX 250MG CAPSULE may be prescribed by a healthcare provider to manage certain dental infections caused by bacteria. However, the appropriateness of ZITHROMAX 250MG CAPSULE for dental infections should be determined by a healthcare provider based on the specific circumstances of the infection.
A: No. ZITHROMAX 250MG CAPSULE belongs to antibiotics and are only effective against bacterial infections. They will not work for viral infections such as the common cold or flu.
References: 1. Aciclovir. 2. Azithromycin. 3. Food. 4. ZITHROMAX 250MG CAPSULE.Zithromax (azithromycin) is a *prescription only medication.
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.
WarningsYou should not use Zithromax if you have ever had jaundice or liver problems caused by taking azithromycin.
Before taking this medicine:You should not use Zithromax if you are allergic to azithromycin, or if:
Zithromax side effects:Get emergency medical help if you have signs of an allergic reaction to Zithromax: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling). Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using azithromycin. Call your doctor at once if you have:
Seek medical treatment if you have symptoms of:
Other side effects include:
The side effects caused by this medicine are possibly scarring and usually disappear after a few months or even years after taking this medicine.
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Zithromax (azithromycin) is an antibiotic that fights bacteria. 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.
Zithromax (azithromycin) works by preventing bacteria from producing proteins that are essential to them. Without these proteins the bacteria cannot grow, replicate and increase in numbers. Azithromycin therefore stops the spread of infection and remaining bacteria are killed by the body's immune system or eventually die.
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Brand: PfizerSize: 18 Tablets (6 x 3)Strength: 250 mgNDC: 00069-3060-75UPC: 300693060757
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