Abridged Prescribing Information (India): AZIWOK

Name of Medicinal Product: Aziwok® Oral Suspension contains Azithromycin. Dosage form and Strength: Each 5 ml contains:
Azithromycin Dihydrate equivalent to Azithromycin IP 100 mg/200 mg. Therapeutic Indications: Azithromycin is indicated for the treatment of infection caused by sensitive organisms: 1. Lower respiratory tract infections: Community acquired pneumonia, acute bacterial exacerbation of chronic obstructive pulmonary disease, acute bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. 2. Upper respiratory tract infections: Ear, nose, and throat infections like tonsillitis, sinusitis, otitis media and pharyngitis 3. Skin/skin structure infections: Furunculosis, pyoderma and impetigo due to Staphylococcus aureus, S.pyogenes or S.agalactiae. Dosage and Administration: In children <12 years: Give 10 mg/kg body weight on day 1 followed by 5 mg/kg body weight per day on days 2 - 5.. OR 10 mg/kg BODY WEIGHT ONCE DAILY FOR 3 DAYS. Avoid administration to children of age less than 6 months. Contraindications: Hypersensitivity to azithromycin, erythromycin or any macrolide antibiotic. Precautions: 1. No dosage adjustment is required in patients with mild renal and mild to moderate hepatic impairment. However due to dearth of data in patients with severe renal and hepatic dysfunction, caution needs to be exercised. 2. Infants: Avoid use of this suspension in children less than 6 months of age. Drug Interactions: Aluminum and magnesium containing antacids reduce the peak serum levels but not to the extent of azithromycin absorption. Concurrent use of macrolides and theophylline has been associated with increase in serum concentrations of theophylline. Concurrent use of macrolides and warfarin has been associated with increased anticoagulant effects. Drug interactions between macrolides and terfenadine have been reported, so it is advisable to avoid co-administration of azithromycin and terfenadine. Adverse reactions: Most side effects are mild to moderate in severity. Diarrhea/loose stools (5%) nausea and abdominal pains (3%) are commonly reported. The following adverse reactions occurred in <1% of patients. Cardiovascular Palpitations; chest pain GI Dyspepsia; flatulence, vomiting, melena, cholestatic, jaundice.

Ref:

  1. e-Poster presentation Evaluation of multimedia dissolution of Aziwok tablet (Azithromycin) OP21 at RACT 2022 (SRM MCH & RC, Kattankulathur) on 27th April 2022
  2. DRL (2020) ‘COA - Certificate Of Analysis Aziwok 500mg Tablet’.

For the use of a registered medical practitioner, hospital or laboratory only.