AZICARE

Generic Name:                   Azithromycin

Therapeutic Category:    Antibiotics

Pharmacological Class:   Macrolides

Composition:                      Each film coated tablet contains Azithromycin Dihydrate USP 500 mg

Pregnancy Category:       B

Presentation:                      Available in the pack size as 6 tablets X 10 blisters

Mechanism of Action

Azithromycin prevents bacteria from growing by interfering with their protein synthesis. It binds to the 50S subunit of the bacterial ribosome, thus inhibiting translation of mRNA. Nucleic acid synthesis is not affected.

Indications 

Mild-to-moderate susceptible infections including:

• acute bacterial exacerbations of COPD*
• acute bacterial sinusitis, acute otitis media
• community-acquired pneumonia 
• pharyngitis/tonsillitis
• uncomplicated skin and skin structure
• urethritis*, cervicitis*, cancroid* in men
• Treatment and prophylaxis of Mycobacterium avium complex (MAC) infection.

Dosage 

 Route of administration: Oral

For bronchitis

Adult dosage (18 years and older): 500 mg once a day for 3 days.

For sinusitis

Adult dosage (18 years and older): 500 mg once a day for 3 days.

Child dosage (6 months to 17 years): 10 mg/kg of body weight once a day for 3 days.

Child dosage (0 to 6 months): This drug should not be used in children who are younger than 6 months.

For skin and skin structure infections

Adult dosage (18 years and older): 500 mg in a single dose on day 1, followed by 250 mg once per day on days 2 through 5.

For urethritis and cervicitis

Adult dosage (18 years and older): 

• If the infection isn’t caused by gonorrhea, single 1-gram dose is given.
• If the symptoms of gonorrhea infection are seen, a single 2-gram dose is given. 

For acute middle ear infection

Child dosage (6 months to 17 years): 10 mg/kg of body weight on day 1, followed by 5 mg/kg per day on days 2 through 5.

Child dosage (0 to 6 months): This drug should not be used in children who are younger than 6 months.

For mycobacterium avium complex disease

Adult dosage (18 years and older): 300-600 mg once per day, taken with the drug ethambutol.

For pharyngitis or tonsillitis

Adult dosage (18 years and older): 500 mg in a single dose on day 1, followed by 250 mg once per day on days 2 through 5.

Child dosage (2 to 17 years): 12 mg/kg of body weight once per day for 5 days.

Child dosage (0 to 2 years): This drug should not be used for this condition in children who are younger than 2 years

For Cancroid (Genital ulcer)

Adult dosage (18 years or older):  1 gm orally once

Taken with or without food.

Pharmacokinetics 

Absorption: Bioavailability is 37% following oral administration

Protein binding: Approximately 51%

Metabolism: Hepatic

Route of elimination: Biliary 

Half-life: 68 hours

Adverse Effects

• Most common adverse effects are diarrhea, nausea, abdominal pain, and vomiting.
• Others: Nervousness, dermatologic reactions, and anaphylaxis
• As with all antimicrobial agents, pseudomembranous colitis can occur during and up to several weeks after azithromycin therapy. 

Contraindications

AZICARE is contraindicated in the following situations:

• Hypersensitivity to the active substance or to any of the excipients.
• Hepatic Dysfunction

Precautions

• Clostridium Difficile-Associated Diarrhea
• QT Prolongation

Drug Interactions

• Nelfinavir: Taking this drug with azithromycin may cause liver or hearing problem.
• Warfarin: Taking this drug with azithromycin may increase bleeding. 

*Terminologies:

COPD: Chronic Obstructive Pulmonary Disease is a common lung disease having two main forms: chronic bronchitis and emphysema.