Azitop 500 Azithromycin Dihydrate USP Tablet

AZITOP-500 TABLET
Azithromycin USP 500mg

 

COMPOSITION

Each Film Coated Tablet Contains:

Azithromycin Dihydrate USP

Eq. to Azithromycin Anhydrous 500 mg

Excipients q.s.

Colour: Erythrosine and Titanium Dioxide BP

 

PHARMACOLOGICAL CLASSIFICATION

Medium and broad spectrum antibiotics.

 

PHARMACOLOGICAL ACTION

Azithromycin is a macrolide (azalide) antibiotic with bactericidal activity. These agents inhibit RNA-depencient protein synthesis by binding reversibly to the 50S ribosomal subunit of the 70S ribosome of sensitive micro-organisms. In vitro Azithromycin demonstrates activity against a wide range of gram-negative and gram-positive organisms, such as: Staphylococcus aureus.

Pharmacokinetics

Azithromycin is rapidly absorbed following oral administration. Bioavailabillty is approximately 37% and is not significantly decreased if Azithromycin tablets are taken with a meal. Peak plasma concentration is achieved 2 to 3 hours after the initial dose. Protein binding is low (51%) and appears to be concentration dependent, with a decrease in protein binding with increasing concentrations. Following absorption, Azithromycin is widely distributed throughout the body. It concentrates intracellularly. Approximately 35% of the Azithromycin dose is metabolised by the liver to inactive metabolites and excreted in bile. More than 50% of the dose is eliminated unchanged via bile and approximately 6.5% of the dose is excreted unchanged in the urine. The elimination half-life of Azithromycin closely reflects the tissue depletion half-life, which ranges between 2 to 4 days.

 

INDICATIONS

Azithromycin is indicated for the following conditions in adults and children one year or older who weigh 45 kg or more: Lower respiratory tract infections, such as bronchitis and pneumonia caused by sensitive Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus or Streptococcus pneumoniae. Upper respiratory tract infections, such as sinusitis or pharyngitis caused by sensitive Haemophilus influenzae, Staphylococcus aureus or Streptococcus pneumoniae. Uncomplicated skin and soft tissue infections caused by sensitive Staphylococcus aureus. Uncomplicated genital tract infections caused by sensitive. Chlamydia trachomatis.

For children 1 year and older who weigh 45 kg or more and who are able to swallow tablets Azithromycin is indicated for the treatment of pharyngitis/tonsillitis and otitis media caused by susceptible organisms.

 

CONTRA-INDICATIONS

With hypersensitivity to Azithromycin or any of the macrolide antibiotics.

With hepatic impairment as elimination occurs mainly through biliary excretion.

Who are using ergot derivatives due to the possibility of ergotism.

Who are younger than 1 year, since safety and efficacy have not been established.

 

WARNINGS

Caution should be exercised when Azithromycin is prescribed to patients with renal impairment, as no data regarding the use of Azithromycin in these patients are available. Serious allergic reactions such as anaphylaxis, angioedema, fever, eosinophilia and skin eruptions have been reported less frequently in patients taking Azithromycin. These patients require prolonged periods of observation and symptomatic treatment as allergic symptoms have recurred in some patients despite successful symptomatic therapy and discontinuation of Azithromycin. Pseudomembranous colitis, ranging in severity from mild to life-threatening, may occur following administration of Azithromycin. It is important to consider the possibility of pseudomembranous colitis in patients that develop diarrhoea subsequent to the administration of Azithromycin.

Ergotism is possible; therefore Azithromycin should not be administered with ergot derivatives.

 

PREGNANCY AND LACTATION

Safety and efficacy in pregnancy and lactation have not been established.

 

DOSAGE AND DIRECTIONS FOR USE

The safety and efficacy of Azithrornycin in children younger than 1 year have not been established. The tablet is not a suitable formulation for children under 45 kg in weight.

The tablets should be swallowed whole with some water. Azithromydn may be taken without regard to meals. Susceptible bacterial infections except sexually transmitted diseases:

Oral: Adults and children over 45 kg in weight: 500 mg once daily for three days.

Five days dosage regimen:

Day 1, 500mg, and then 250mg daily on days 2 – 5.

In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.

Sexually transmitted disease caused by Chlamydia trachomatis: Adults: 1 g given as a single dose. The normal adult dose is recommended for use in the elderly patient.

 

SIDE-EFFECTS

Immune system disorders: Allergic reactions (difficulty in breathing, swelling of face, mouth, neck, hands and feet, arthralgia, urticaria, photosensitivity, skin rash, anaphylaxis).

Blood and lymphatic system disorders: Neutropenia.

Psychiatric disorders: Somnolence, asthenia.

Nervous system disorders: Dizziness and headache. Convulsions, vertigo, paraesthesiae, and taste changes.

Ear and labyrinth disorders: Hearing loss, tinnitus and vertigo.

Cardiac disorders: Chest pain, palpitations, dysrhythmias, including ventricular tachycardia.

Gastrointestinal system disorders: Pseudomembranous colitis (abdominal cramps or pain, tenderness, severe watery diarrhoea which may be bloody, fever), abdominal pain, diarrhoea, nausea and vomiting. Anorexia, abdominal discomfort, flatulence, loose stools, constipation, dyspepsia.

Hepatobiliary system disorders: Transient elevations in liver enzymes, hepatitis, and cholestatic jaundice.

Skin and subcutaneous tissue disorders: Erythemamultiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Renal and urinary disorders: Acute interstitial nephritis, Acute renal failure.

Reproductive system and breast disorders: Vaginitis.

General disorders: Fatigue.

 

Special Precautions

Signs of superinfection with non-susceptible organisms, including fungal infections, should always be kept in mind and monitored when using MEDPRO-Azithromycin. Appropriate measures should be taken to prevent or treat such superinfection.

 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

No data is available on overdosage with Azithromycin. Following overdosage with macrolide antibiotics, typical symptoms may include severe nausea, vomiting and diarrhoea, and hearing loss.

Gastric lavage is indicated. Treatment is symptomatic and supportive.

 

PRESENTATION

AZITOP-500 TABLET: Each strip contains 10 tablets.

 

STORAGE

Store in cool, dry place, below 30oC.

Keep the medicine out of reach of children.

NAFDAC REG. NO.: A4-7377

Mfg. Lic. No.: G/28/1442

 

Manufactured by

Kesar Pharma Pvt. Ltd.

Plot No. 50-P/2, at Bileshwarpura, Chhatral,

Tal-Kalol, Dist.: Gandhinagar-382729,

Gujarat State, INDIA.

 

Marketed by

TOPIX PHARM NIGERIA LTD.

No.7A, Niger Street, Kano, Nigeria.

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