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Therapeutic Category
- ANTIBACTERIALS
- ANTI-INFECTIVE DRUGS
- Pharmaceutical Form : Dry Powder for oral suspension
- Composition : Azithromycin (Dihydrate)200 mg / 5 mL
- Active Substance : Azithromycin
INDICATIONS
Azithromycin – Medico (azithromycin) is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
Adults:
Lower Respiratory Tract:
Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
Patients with cystic fibrosis, Patients with nosocomially acquired infections, Patients with known or suspected bacteremia, Patients requiring hospitalization,
elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia(.
Upper Respiratory Tract
Streptococal Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy (penicillin).
Uncomplicated Skin and Skin Structure infections
Due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage.
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid)
Pediatric Patients:
Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
NOTE: Azithromycin should not be used in pediatric patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
Patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
CONTRA INDICATIONS
Azithromycin – Medico is contraindicated in patients with known hypersensitivity to Azithromycin – Medico or any of the macrolide antibiotics
SIDE EFFECTS
Acute Otitis Media: For the recommended total dosage regimen of 30 mg/kg, the most frequent side effects (≥1%) attributed to treatment were diarrhea, abdominal pain, nausea, vomiting and rash.
Community-Acquired Pneumonia
For the recommended dosage regimen of 10 mg/kg on Day 1 followed by 5 mg/kg on Days 2–5, the most frequent side effects attributed to treatment were diarrhea/loose stools, abdominal pain, vomiting, nausea and rash.
Pharyngitis/tonsillitis
For the recommended dosage regimen of 12 mg/kg on Days 1–5, the most frequent side effects attributed to treatment were diarrhea, vomiting, abdominal pain, nausea and headache.
Side effects that occurred with a frequency of 1% or less included the following:
Cardiovascular: Chest pain.
Gastrointestinal: Dyspepsia, constipation, anorexia, enteritis, flatulence, gastritis, jaundice, loose stools and oral moniliasis.
Hematologic and Lymphatic: Anemia and leukopenia.
Nervous System: Headache (otitis media dosage), hyperkinesia, dizziness, agitation, nervousness and insomnia.
General: Fever, face edema, fatigue, fungal infection, malaise and pain.
Allergic: Rash and allergic reaction.
Respiratory: Cough, pharyngitis, pleural effusion and rhinitis.
Skin and Appendages: Eczema, fungal dermatitis, pruritus, sweating, urticaria and vesiculobullous rash.
Special Senses: Conjunctivitis.
WARNINGS:
Hypersensitivity:
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Hepatotoxicity
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
Clostridium Difficile-associated diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Azithromycin – Medico, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
PRECAUTIONS
General
Because azithromycin is principally eliminated via the liver, caution should be exercised when azithromycin is administered to patients with impaired hepatic function. Due to the limited data in subjects with GFR <10 mL/min, caution should be exercised when prescribing azithromycin in these patients.
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides. A similar effect with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization.
Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
Prescribing Azithromycin – Medico (azithromycin) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
INFORMATION FOR PATIENTS
Azithromycin – Medico tablets and oral suspension can be taken with or without food.
Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.
The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.
Patients should be counseled that antibacterial drugs including Azithromycin – Medico (azithromycin) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When Azithromycin – Medico (azithromycin) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may:
(1) decrease the effectiveness of the treatment
(2) Increase the likelihood that bacteria will develop resistance and will not be treatable by Azithromycin – Medico (azithromycin) or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible
Pregnancy, Pregnancy Category B: Azithromycin should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether Azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azithromycin is administered to a nursing woman.
DRUGS INTERACTIONS:
Drug interaction studies were performed with azithromycin and other drugs likely to be co-administered.
Co-administration of azithromycin at therapeutic doses had a modest effect on the pharmacokinetics of the following drugs :
Atorvastatin – Carbamazepine – Cetirizine – Didanosine- Efavirenz – Fluconazole –Indinavir -Midazolam – fluconazole – Rifabutin – Sildenafil Theophylline – Triazolam – Trimethoprim/Sulfamethoxazole – Zidovudine
No dosage adjustment of these drugs is recommended when co-administered with azithromycin.
Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted.
Warfarin: post-marketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants
Interactions with the drugs listed below have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction. Nonetheless, they have been observed with macrolide products.
Until further data are developed regarding drug interactions when azithromycin and these drugs are used concomitantly, careful monitoring of patients is advised:
– Digoxin: elevated digoxin concentrations.
– Ergotamine or dihydroergotamine: acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.
– Terfenadine, cyclosporine, hexobarbital and phenytoin concentrations.
DOSES\INDICATIONS
Azithromycin – Medico capsules should be given at least 1 hour before or 2 hours after a meal. Azithromycin – Medico capsules should not be mixed with or taken with food.
The recommended dose of Azithromycin – Medico or the treatment of individuals 16 years of age and older with mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease, pneumonia, pharyngitis/tonsillitis (as second line therapy), and uncomplicated skin and skin structure infections due to the indicated organisms is: 500 mg as a single dose on the first day followed by 250 mg once daily on Days 2 through 5 for a total dose of 1.5 grams of Azithromycin – Medico
The recommended dose of Azithromycin – Medico for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) dose of Azithromycin – Medico. This dose can be administered as four 250 mg capsules
Pediatric Patients:
Azithromycin – Medico for oral suspension can be taken with or without food.
Acute Otitis Media
The recommended dose of Azithromycin – Medico for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5.
Acute Bacterial Sinusitis
The recommended dose of Azithromycin – Medico for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.
Community-Acquired Pneumonia
The recommended dose of Azithromycin – Medico for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5.
Pharyngitis/Tonsillitis
The recommended dose of Azithromycin – Medico for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days.
| OTITIS MEDIA: (1-Day Regimen) | OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen) | OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA (5-Day Regimen | weight | |
| One day | Days
(1-3) |
Days
(2-5) |
Day 1 | |
| 3.75 mL
0.75) tsp) |
5 kg | |||
| 7.5 mL
(1.5 tsp) |
10 kg | |||
| 15 mL
(1.5 tsp) |
5 mL
(1 tsp) |
2.5 mL
(0.5 tsp) |
5 mL
(1 tsp) |
20 kg |
| 22.5 mL
(4.5 tsp) |
7.5 mL
(1.5 tsp) |
3.75 mL
0.75) tsp) |
7.5 mL
(1.5 tsp) |
30 kg |
| 30 mL
(6 tsp) |
10 mL
(2 tsp) |
5 mL
(1 tsp) |
10 mL
(2 tsp) |
40 kg |
| 37.5mL
(7.5 tsp) |
12.5 mL
(2.5 tsp) |
6.25 mL
(1.25 tsp) |
12.5 mL
(2.5 tsp) |
50 kg or above |
| Pharyngitis/tonsillitis
(5 days regimen) |
weight |
| 2.5 mL (0.5 tsp) | 8 kg |
| 5 mL (1 tsp) | 17 kg |
| 7.5 mL (1.5 tsp) | 25 kg |
| 10 mL (2 tsp) | 33 kg |
| 12.5 mL (2.5 tsp) | 40 kg |
STORAGE CONDITIONS
Store dry powder below 30°C
Store constituted suspension between 5° to 30°C and discard when full dosing is completed.
PACKING
Bottle of 15 – 30 mL