The Food and Drug Administration on Wednesday approved a new prescription drug that treats a common infection caused by an antibiotic called azithromycin.
The move follows an FDA advisory that recommended the drug be used only in patients who are at least 18 and have a known allergy to other antibiotics.
The drug, called Zithromax, is sold under the brand name Azithromycin and it is only approved to treat infections caused by the bacteria E. coli, which are commonly associated with ear infections, strep throat and pneumonia.
Azithromycin is an antibiotic that is used to treat the following infections:
The FDA said the new approval of the drug should be given to adults 18 and older who have had a UTI or PNID within the past 6 months.
Zithromax will be sold in pharmacies to treat a broader range of infections caused by E. coli.
The drug is also being used to prevent sexually transmitted infections in adult men.
In October, the FDA recommended that the drug be taken only when an adult is sexually active.
In a letter to U. S. pharmacies, the FDA said the drug would not work for patients who are allergic to azithromycin or any other macrolide antibiotics.
Zithromax, an azithromycin antibiotic, will be sold as a generic and will be available for purchase in pharmacies and at retailers like Walgreens.
For more information, call 800-wickpharmacy.com or go to www.zithromax.com.
Related stories Zithromax: A Guide to Purchasing Zithromax.
In a statement, Pfizer said that the FDA's announcement was part of a broader effort to "provide the best possible information" about Zithromax, including its uses and safety.
Pfizer, the drug's manufacturer, has said that the new approval would allow consumers to receive the drug without a prescription, and help to "prevent the spread of the infection among patients."
The FDA said that the move is the result of a "long-standing communication among health care providers and patients" and that there is "no guarantee that the approval will be effective" for consumers.
The news comes just two weeks after Pfizer said that it would not provide more details about the drug, and the FDA said that it was unaware of the information.
The drug will be available without a prescription in the U. from June 15, when it will become available as a generic drug. The company is not disclosing the name of the drug or how it will be used.
In a statement, Pfizer said that the new approval will allow people to receive the drug in the U. for as long as it is needed to treat the condition.
The drug's manufacturer has not disclosed the name of the drug.
FDA Commissioner Scott Gottlieb said that the drug was "a great and great help to patients," and that he hopes that the new approval will help consumers know that it is safe.
The drug's label for "Azithromycin" will be "an important step toward reducing the incidence of serious infections that are caused by bacteria that are resistant to antibiotics."
The Food and Drug Administration is advising consumers not to use the drug, and has not yet decided whether to approve it.
The FDA said it was disappointed that the new approval was rejected twice by the agency, and that the drug's label is still available.
The FDA, in an email statement, said that it was "committed to take these actions to ensure that patients do not have access to the drug that is safe for them."
Related stories FDA orders Zithromax to treat common infections at cvs. FDA says Zithromax is safeThe Food and Drug Administration said that the new approval of the drug will be given to patients who are at least 18.
FDA has not issued an official statement.
Azithromycin is an antibiotic that is used to treat a variety of bacterial infections, including respiratory tract infections, sexually transmitted infections, and certain types of diarrhea.
Azithromycin is usually taken as a single dose, taken for a period of time, usually for several weeks. It is taken regularly for many infections, including the following:
Azithromycin is not suitable for everyone. It should be taken only as a single dose, with a doctor’s recommendation.
For adults, take the usual adult dosage.
For children, it may take several weeks or months to start working. Your doctor may recommend a different dose if you are taking the medication for other bacterial infections.
You should take Azithromycin exactly as your doctor has instructed.
Take azithromycin with or without food, usually once a day.
Do not take a double dose to make up for a missed dose.
If you miss a dose of azithromycin, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.
Do not take a double dose to make up for a double dose.
You should not take azithromycin if you are pregnant.
Azithromycin is only used to treat bacterial infections, not viral infections.
The risks of taking azithromycin while pregnant are:
Your doctor will be concerned about the risk of birth defects. If you become pregnant while taking azithromycin, you should discuss the potential risks and benefits with your doctor.
Like all medications, azithromycin can cause side effects. Although they are less common, they may be serious.
Azithromycin can cause serious side effects, including:
You should discuss all the above with your doctor. If you have any questions about side effects, contact your doctor or pharmacist.
Seek emergency medical help if you think you have taken too much azithromycin, especially if you:
You can call your nearest emergency medical physician at 1-800-222-1222.
Pharmacotherapeutic group:Cardiac, Metabolic, Muscle. This is the combination of active and inactive ingredients, which may cause allergic reactions.
Indications:Bacteriuria, Bacterial Infection, Acute Otitis Media, Bronchopneumonia, Bronchial Pneumonia.
Contraindications:Hypersensitivity to the active substance or to other components of the formula. The occurrence of hypersensitivity to some of the components of the formula. The following conditions are contraindicated: hepatic impairment, severe asthma, liver disease, severe liver disease. Hypersensitivity to azithromycin, clarithromycin, telithromycin. Hypersensitivity to any of the excipients or to any of the ingredients of the formula. The following conditions are contraindicated: renal impairment, chronic alcoholism, severe kidney disease. Hypersensitivity to any of the excipients. Acute Sinusitis.
Dosage:The administration of the active and inactive ingredients into the body, usually in the form of tablets or capsules, usually is required. The dose may be administered orally or intravenously. The usual dose of bacitracin/aluminum hydroxide is 10 mg/kg/day to 40 mg/kg/day, depending on the condition being treated. The dosage may be increased depending on the severity of the infection and on the response to the therapy.
Special Precautions:
There are special precautions to be taken when the active and inactive ingredients of a medicine are mixed together, because the amount of active ingredients necessary to give a proper therapeutic effect is very small. This substance may cause reactions in people allergic to this component of the formula (e.g., to other drugs or to other substances). If you are taking any of the following medicines, you should let your doctor know if you are allergic to any of the inactive ingredients: bacitracin or oral antacids containing calcium, aluminium hydroxide, magnesium hydroxide or zinc.
Storage:The tablets should be kept at room temperature, away from moisture and heat.
Interaction with other medicinal products:In patients taking bacitracin/aluminum hydroxide as a substitute for oral baciclovir or of azithromycin, with antacids containing calcium, potassium hydroxide or magnesium hydroxide, the simultaneous use of these two ingredients is unlikely to result in an interaction. In patients with renal impairment, it is preferable not to combine the components.
Use in patients allergic to sulfonamides:If the symptoms of an allergic reaction to an inactive ingredient of a medicine are severe and you are taking a medicine called sulfamethoxazole/trimethoprim, you should let your doctor know if you are allergic to sulfonamides (e.g., atopic and bronchial wheezes). If the symptoms of an allergic reaction to an inactive ingredient of a medicine are severe and you are taking a medicine called sulfamethoxazole/trimethoprim, you should let your doctor know if you are allergic to other drugs containing azithromycin, clarithromycin or telithromycin.
ReferencesPageison, A. B., Ingram, T. M., Wirkthal, M. D. and Munch, W. H. (1873) 'Bacitracin', 'Aluminum hydroxide and the occurrence of allergic reactions', Clin. Rhinococcine. Vol. 18, No. 2, p. 11-14.
Porter, M. and Bitter, H. (1962) 'Bacitracin and allergy', Antimicrob. Agents. 35, p. 617-625.
McGinley, T. and Gomels, E. (1951) 'Bacitracin, albuterol and the occurrence of allergic reactions', Clin. 4, p. 12-16.
The following substances affect the elimination of bacitracin: sulfamethoxazole/trimethoprim, trimethoprim, sulfamethazine, sulfadiazine, cimetidine, fusidic acid, cimetidine, metoclopramide or mibefradil.
Bacitracin: elimination: in humans, from the kidneys, in patients with renal insufficiency.
The UK's pharmacist can prescribe Zithromax, a broad-spectrum antibiotic used to treat a wide range of infections including:
The UK's pharmacist can prescribe Zithromax, a drug used to treat infections caused by susceptible bacteria. The antibiotic works by stopping the growth of the bacteria and thus killing the infection. It is available in oral tablets and oral suspension, and can be given in a dose of 1 gram (two 250mg capsules), twice a day for 7 days. It can also be given in an intravenous form, which should be given every 12 hours. It should be taken as per the doctor's instructions.
Zithromax should be taken for as long as the doctor has prescribed it, even if the infection is not being treated.
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