Azee Tablets (Generic Azithromycin Dihydrate Tablets)

Warnings

Serious (including fatal) allergic and skin reactions: Discontinue Azee tablets in case reaction occurs.

Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported, Discontinue Azee tablets immediately if signs and symptoms of hepatitis occur.

Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of Azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.

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Warnings

Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval.

Clostridium difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs.

Azee tablets may exacerbate muscle weakness in persons with myasthenia gravis.

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Azee Tablets (Generic Azithromycin Dihydrate Tablets)

Azee Tablets Side Effects

Most common side effects of Azithromycin (Azee Tablets) are diarrhea (5% to 14%), nausea (3% to 18%), abdominal pain (3% to 7%), or vomiting (2 to 7%). The common side effects of Azee tablets are nausea, vomiting, diarrhea, or abdominal pain.

Rarely occuring side effects are Palpitations, chest pain, Dyspepsia, flatulence, vomiting, melena and cholestatic jaundice, Monilia, vaginitis and nephritis, Dizziness, headache, vertigo and somnolence, Fatigue, Rash, pruritus, photosensitivity and angioedema.

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Overdose

Adverse reactions observed in patients that were administered higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting. In the case of overdosage, general symptomatic and supportive measures are indicated as required.

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Azee Tablets (Generic Azithromycin Dihydrate Tablets)

Azee Tablets During Pregnancy

Azithromycin Dihydrate (Azee tablets) has been classified by the US FDA as Pregnancy Category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin was observed. There are, however, no adequate and well-controlled studies conducted in pregnant women.

Due to the fact that animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if clearly needed. Azithromycin has been reported to be excreted in human breast milk in small amounts. Caution should be exercised when Generic Azithromycin tablets are administered to a nursing mother.

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