Zithromax Dry Syrup (Azithromycin Dihydrate)

Adult dose

Administer once daily and may be taken without regard to meals. ○ Adults 1) Sexually transmitted infection caused by Chlamydia trachomatis: Administer 25mL [azithromycin 1g (potency)] as a single dose 2) Other indications - 3-day regimen: Administer 12.5mL [azithromycin 500mg (potency)] once daily for 3 days [total dose of azithromycin 1.5g (potency)] - 5-day regimen: Administer 12.5mL [azithromycin 500mg (potency)] once on the first day, followed from the second day by 6.25mL [azithromycin 250mg (potency)] once daily for 4 days [total dose of azithromycin 1.5g (potency)] ○ Elderly patients Administer the same dosage and administration as for adults

Child dose

○ Children Administer azithromycin 10mg (potency)/Kg of body weight once daily for 3 days, or administer 10mg (potency)/Kg of body weight once on the first day, followed from the second day by 5mg (potency)/Kg of body weight once daily for 4 days. For the treatment of pediatric patients with acute otitis media, in addition to the two regimens above, a single dose of 30mg (potency)/Kg of body weight may be administered. For this 1-day regimen, take the dose 1 hour before or 2 hours after a meal. 15～25Kg: 1-day regimen (for acute otitis media) 15mL [azithromycin 600mg (potency)] as a single dose / 3-day regimen 5mL [azithromycin 200mg (potency)] once daily for 3 days / 5-day regimen 5mL [azithromycin 200mg (potency)] once on the first day, followed from the second day by 2.5mL [azithromycin 100mg (potency)] once daily for 4 days 26～35Kg: 1-day regimen (for acute otitis media) 22.5mL [azithromycin 900mg (potency)] as a single dose / 3-day regimen 7.5mL [azithromycin 300mg (potency)] once daily for 3 days / 5-day regimen 7.5mL [azithromycin 300mg (potency)] once on the first day, followed from the second day by 3.75mL [azithromycin 150mg (potency)] once daily for 4 days 36～45Kg: 1-day regimen (for acute otitis media) 30mL [azithromycin 1.2g (potency)] as a single dose / 3-day regimen 10mL [azithromycin 400mg (potency)] once daily for 3 days / 5-day regimen 10mL [azithromycin 400mg (potency)] once on the first day, followed from the second day by 5mL [azithromycin 200mg (potency)] once daily for 4 days Over 45Kg: 1-day regimen (for acute otitis media) 37.5mL [azithromycin 1.5g (potency)] as a single dose / 3-day regimen same as adult dose / 5-day regimen same as adult dose

This drug, being a macrolide antibiotic, may rarely cause serious allergic reactions. If symptoms such as angioedema or anaphylaxis occur, administration should be halted immediately, and appropriate treatment must be sought. This drug may alter the gut flora and can lead to diarrhea caused by Clostridium difficile infection, hence symptoms of diarrhea should be monitored closely. If symptoms are severe, consultation with a physician is necessary. This medication should not be used in patients with hypersensitivity, patients taking certain vasoconstrictors, or patients with fructose intolerance. Particular caution is warranted when administering this drug to patients with severe renal impairment, severe liver dysfunction, or diabetes mellitus. If symptoms of liver dysfunction appear, administration must be halted immediately. Generally, this medication has good tolerability, but side effects such as nausea, vomiting, diarrhea, abdominal discomfort, abdominal distension, mild neutropenia, hearing impairments, tinnitus, aggressive reactions, nervousness, agitation, anxiety, dizziness, convulsions, headaches, hyperactivity, sensory disturbances, drowsiness, sensory loss, fainting, palpitations, ventricular tachycardia, arrhythmia, hypotension, indigestion, constipation, pseudomembranous colitis, pancreatitis, pyloric stenosis, tongue discoloration, itching, rash, phototoxicity have been reported. Rarely, serious adverse effects such as hearing loss or arrhythmia can occur, hence if such symptoms appear, immediate consultation with a physician is advised. Similar to other antibiotics, this medication poses a risk for secondary infections by resistant bacteria; thus, symptoms must be monitored carefully. Patients with heart disease or electrolyte imbalances, as well as those at risk for QT interval prolongation, should have their cardiac status monitored closely when receiving this medication. During pregnancy, since the safety for the fetus has not been entirely established, it should only be used when absolutely necessary, and in breastfeeding cases, considering the medication may pass into breast milk, a decision on usage should be consulted with a physician. Elderly patients may be more sensitive to cardiac side effects than younger individuals and require caution. In cases of overdose, general symptomatic and supportive care is needed, and exact dosing and preparation methods should be understood before use. Finally, this medication should be kept out of reach of children and stored in its original container to prevent misuse and degradation of quality.

Angioedema, anaphylaxis, acute generalized pustular dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, diarrhea, nausea, vomiting, loose stools, abdominal discomfort, abdominal distension, liver function abnormalities, rash, urticaria, candidiasis, vaginitis, thrombocytopenia, leukopenia, agranulocytosis, shock, anaphylactic symptoms, anorexia, aggressive reactions, neurosthenia, agitation, anxiety, dizziness, seizures, headache, hyperactivity, sensory disturbances, drowsiness, sensory loss, syncope, taste/smell distortion and loss, hearing loss, tinnitus, hearing impairment, palpitations, ventricular tachycardia, arrhythmia, QT prolongation, Torsades de pointes, hypotension, dyspepsia, constipation, pseudomembranous colitis, pancreatitis, pyloric stenosis, tongue discoloration, hepatitis, jaundice, cholestatic jaundice, liver necrosis, liver failure, itching, photosensitivity reactions, edema, hives, angioedema, erythema multiforme, arthralgia, rhabdomyolysis, myalgia, malaise, interstitial nephritis, acute renal failure, weakness, fatigue, lethargy, fever, cough, dyspnea, interstitial pneumonia, eosinophilic pneumonia, infantile hypertrophic pyloric stenosis

This medication may be sensitive to air or moisture, hence must be stored in a tightly closed container. It is advisable to store it in a cool room away from direct sunlight.

Appearance

White to off-white powder

Package unit

600mg/bottle X 1, 900mg/bottle X 1