Azitel 500 mg (Capsule)

Title

• Azitel 500 mg Capsule

Categories

• Medicine
• Antibiotics
• Macrolides

Description

• Azitel 500 mg Capsule is indicated for various infections in the lower and upper respiratory tracts, otitis media, skin and soft tissue infections, and sexually transmitted diseases.
• It can be administered orally or through intravenous infusion.
• Azithromycin, the active ingredient, acts by binding to the 50S ribosomal subunit of susceptible microorganisms, interfering with microbial protein synthesis, without affecting nucleic acid synthesis.
• Dosage guidelines vary for adults and children, as well as for specific conditions such as typhoid fever and community-acquired pneumonia.
• The medication should be reconstituted by adding boiled and cooled water and shaken until the powder is completely mixed.
• There are several interactions to consider with other medications, including antacids, carbamazepine, cyclosporin, digoxin, ergot derivatives, methylprednisolone, theophylline, warfarin, and terfenadine.
• Azithromycin is contraindicated in patients hypersensitive to azithromycin or any other macrolide antibiotic and in patients with hepatic diseases.
• Common side effects include gastrointestinal discomfort, allergic reactions, reversible elevations in liver transaminases, cholestatic jaundice, and transient mild reductions in neutrophil counts.
• Pregnancy Category of Azithromycin is B, and caution should be exercised when administered to nursing women.
• There are specific precautions and warnings related to rare serious allergic reactions, use in special populations with renal or hepatic impairment, and potential overdose effects.

Color Options

• White

Form

• Capsule

Dimension

• 500 mg

Packaging

• Bottle

Route of Administration

• Oral
• Intravenous

Mode of Action

• Prevents the synthesis of essential proteins required by bacteria to carry out vital functions

Absorption

• Readily absorbed; greater absorption on an empty stomach with a time to peak concentration in adults of 2.1 to 3.2 hours for oral dosage forms

Site of Action

• Phagocytes, with high concentrations released during active phagocytosis that can be over 50 times higher than in plasma due to ion trapping and high lipid solubility

Half-life

• 68 hours with a large single dose maintaining bacteriostatic levels in infected tissue for several days

Excretion

• Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination, with approximately 6% of the administered dose appearing as unchanged drug in urine over the course of a week

Microbiological Activity

• Active against numerous microorganisms, including aerobic and facultative gram-positive and gram-negative microorganisms, and anaerobic microorganisms

Dosage Guidelines

• Specific dosages for adults and children, including recommendations for sexually transmitted diseases and typhoid fever, as well as for intravenous infusion in adult patients with community-acquired pneumonia and pelvic inflammatory disease

Reconstitution Procedure

• Shake the bottle well to loosen the powder, add boiled and cooled water up to the water mark of the bottle label, shake until powder is completely mixed with water

Antacid Interaction

• Azithromycin should be taken at least 1 hour before or 2 hours after the antacid

Cyclosporin Interaction

• Caution should be exercised before co-administration, and cyclosporin levels should be monitored if co-administration is necessary

Digoxin Interaction

• The possibility of raised digoxin levels should be monitored in patients receiving concomitant azithromycin and digoxin

Ergot Derivatives Interaction

• Azithromycin and ergot derivatives should not be co-administered

Methylprednisolone Interaction

• Azithromycin had no significant effect on the pharmacokinetics of methylprednisolone

Theophylline Interaction

• There is no evidence of any pharmacokinetic interaction when azithromycin and theophylline are co-administered

Warfarin Interaction

• Azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers

Terfenadine Interaction

• Azithromycin did not affect the pharmacokinetics of terfenadine administered at the recommended dose of 60 mg every 12 hours

Contraindications

• Hypersensitivity to azithromycin or any other macrolide antibiotic, co-administration of ergot derivatives, and hepatic diseases

Side Effects

• Mild to moderate gastrointestinal discomfort, allergic reactions, reversible elevations in liver transaminases, and rare cases of serious hypersensitivity reactions and cholestatic jaundice

Pregnancy Category

• B

Pregnancy Precautions

• Use during pregnancy only if adequate alternatives are not available

Lactation Precautions

• Caution should be exercised when azithromycin is administered to nursing women

Allergic Reactions

• Rare serious allergic reactions, including angioneurotic edema and anaphylaxis

Renal Impairment

• No dose adjustment is needed in patients with mild renal impairment, but caution should be exercised in patients with more severe renal impairment

Hepatic Impairment

• Not to be used in patients with hepatic disease

Overdose Effects

• Typical symptoms include hearing loss, severe nausea, vomiting, and diarrhea, with gastric lavage and general supportive measures indicated

Storage Conditions

• Keep in a dry place away from light and heat, and out of the reach of children

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