Medical  Explorer

Custom Search

Drugs A to Z  :  A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  R  S  T  U  V  W  X  Y  Z
Medicinal Ingredients : A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

Beauty Products : A  B  C  D  E  F  G  I  M  N  O  P  R  S  T  V

Aging      Allergies     Alzheimer's      Arthritis    Asthma      Bacteria   new Cancer    Chickenpox     Colds     Constipation      Diabetes      Epilepsy     Fatigue     Fever     Genetics       Haemorrhoids       newHeadaches      Hepatitis    Immunity      Infection      Insomnia       Leprosy       Menopause      Obesity      Osteoporosis     Other Diseases    Pain      PMS     Parasites     Sinusitis     newStroke     Toxicology    Urology




Arthritis medications
Acupuncture
Alcohol
Patients
newGeneral Health
Medicinal food
Chinese medicine
Nutrients
Smoking
Vitamins
OTC Drugs
Health Products
Therapy
Symptom
Parasitology
 
 

zithromaxZithromax

Azithromycin

 

1. TRADE NAME OF THE MEDICINAL PRODUCT

Zithromax

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Powder for Oral Suspension: Azithromycin dihydrate 209.64 mg/5ml equivalent to 200mg/5ml of azithromycin base.

Film-Coated Tablet 250 mg: Azithromycin dihydrate 262.05 mg equivalent to 250 mg azithromycin base.

Film-Coated Tablet 500 mg: Azithromycin dihydrate 524.10 mg equivalent to 500 mg azithromycin base.

Film-Coated Tablet 600 mg: Azithromycin dihydrate 628.93 mg equivalent to 600 mg azithromycin base.

Powder for Intravenous Solution (IV): Azithromycin dihydrate 524.1 mg equivalent to 500 mg azithromycin base.

 

3. PHARMACEUTICAL FORM

Powder for Oral Suspension: Azithromycin powder for oral suspension is presented as a dry powder which yields, on reconstitution with water, a white to off-white suspension containing the equivalent of 200 mg azithromycin per 5 ml.

Film-Coated Tablets: Azithromycin film-coated tablets are capsular shaped and contain azithromycin dihydrate equivalent to 250 mg, 500 mg, or 600 mg of azithromycin and engraved with either "ZTM 250," "ZTM 500," or "ZTM 600,".

Intravenous: Azithromycin powder for solution for infusion is a white to off-white caked powder supplied in lyophilized form under a vacuum in a 10 ml vial equivalent to 500 mg azithromycin for intravenous administration.

Upon reconstitution, azithromycin powder yields a solution containing the equivalent of 100 mg azithromycin per 1 ml.

 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Azithromycin is indicated for infections caused by susceptible organisms; in lower respiratory tract infections including bronchitis and pneumonia, in skin and soft tissue infections, in acute otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis. (Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin is generally effective in the eradication of streptococci from the oropharynx, however, data establishing the efficacy of azithromycin and the subsequent prevention of rheumatic fever are not available at present.)

 

In sexually transmitted diseases in men and women, azithromycin is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis. It is also indicated in the treatment of chancroid due to Haemophilus ducreyr, and uncomplicated genital infection due to non-multiresistant Neisseria gonorrhoea, concurrent infection with Treponema pallidum should be excluded.

 

Azithromycin is indicated, either alone or in combination with rifabutin, for prophylaxis against Mycobacterium aviumintracellulare complex (MAC) infection, an opportunistic infection prevalent in patients with advanced human immunodeficiency virus (HIV).

 

Azithromycin is indicated in combination with ethambutol for the treatment of disseminated MAC (DMAC) infection in patients with advanced HIV infection.

 

Azithromycin intravenous (IV) is indicated for the treatment of community acquired pneumonia (CAP) caused by susceptible organisms, including Legionella pneumophila, in patients who require initial intravenous therapy.

 

Azithromycin intravenous (IV) is indicated for the treatment of pelvic inflammatory disease (PID) caused by susceptible organisms (Chlamydia trachomatis, Neisseria gonorrhoea, Mycoplasma hominis), in patients who require initial intravenous therapy.

 

4.2 Posology and method of administration

Oral azithromycin should be administered as a single daily dose. The period of dosing with regard to infection is given below.

Azithromycin tablets and powder for oral suspension can be taken with or without food.

In Adults:

For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus ducreyi, or susceptible Neisseria gonorrhoea, the dose is 1000 mg as a single oral dose.

For prophylaxis against MAC infections in patients infected with the human immunodeficiency virus (HIV), the dose is 1200 mg once per week.

For the treatment of DMAC infections in patients with advanced HIV infection, the recommended dose is 600 mg once a day. Azithromycin should be administered in combination with other antimycobacterial agents that have shown in vitro activity against MAC, such as ethambutol at the approved dose.

For the treatment of adult patients with CAP due to the indicated organisms, the recommended dose of intravenous azithromycin is 500 mg as a single daily dose by the IV route for at least two days. Intravenous therapy should be followed by oral azithromycin as a single daily dose of 500 mg to complete a 7 to 10 day course of therapy. The timing of the conversion to oral therapy should be done at the discretion of the physician and in accordance with clinical response.

For the treatment of adult patients with PID due to the indicated organisms, the recommended dose of intravenous azithromycin is 500 mg as a single dose by the IV route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy. The timing of the conversion to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial anaerobic agent may be administered in combination with azithromycin. For all other indications in which the oral formulation is administered, the total dosage of 1500 mg should be given as 500 mg daily for 3 days. As an alternative, the same total dose can be given over 5 days with 500 mg given on day 1, then 250 mg daily on days 2 to 5.

Intravenous Administration: After reconstitution and dilution, the recommended route of administration for intravenous azithromycin is by IV infusion only. Do not administer as an intravenous bolus or an intramuscular injection (see Section 4.4 Special Warnings and Special Precautions for use and section 6.6 Instruction for Use and Handling, and Disposal).

The infusate concentration and rate of infusion for azithromycin intravenous (IV) should be either 1 mg/ml over 3 hours or 2 mg/ml over 1 hour. An intravenous dose of 500 mg azithromycin should be infused for a minimum duration of one (1) hour

 

In Children:

The maximum recommended total dose for any treatment is 1500 mg for children.

In general, the total dose in children is 30 mg/kg. Treatment for pediatric streptococcal pharyngitis should be dosed at a different regimen (see below).

The total dose of 30 mg/kg should be given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, then 5 mg/kg on days 2-5.

As an alternative to the above dosing, treatment for children with acute otitis media can be given as a single dose of 30 mg/kg.

For pediatric streptococcal pharyngitis, azithromycin given as a single dose of 10 mg/kg or 20 mg/kg for 3 days has been shown to be effective; however, a daily dose of 500 mg must not be exceeded. In clinical trials comparing these two dosage regimens, similar clinical efficacy was observed but greater bacteriologic eradication was evident at the 20 mg/kg per day dose. However, penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including prophylaxis of rheumatic fever.

For children weighing less than 15 kg, azithromycin suspension should be measured as closely as possible. For children weighing 15 kg or more, azithromycin suspension should be administered according to the guide provided below:

 

AZITHROMYCIN SUSPENSION 30 mg/kg Total Treatment Dose

Weight

(kg)

3-Day Regimen

5-Day Regimen

Bottle Size

(mg)

<15

10 mg/kg once daily

on days 1-3

10 mg/kg on day 1, then 5 mg/kg

once daily on days 2-5

600

15-25

200 mg (5 ml) once daily

on days 1-3

200 mg (5 ml) on day 1, then 100 mg (2.5 ml)

once daily on days 2-5

600

26-35

300 mg (7.5 ml) once

daily on days 1-3

300 mg (7.5 ml) on day 1, then 150 mg (3.75 ml)

once daily on days 2-5

900

36-45

400 mg (10 ml) once

daily on days 1-3

400 mg (10 ml) on day 1, then 200 mg (5 ml)

once daily on days 2-5

1200

>45

Dose as per adults

Dose as per adults

1500

 

Azithromycin tablets should only be administered to children weighing more than 45 kg.

The safety and efficacy of intravenous azithromycin for the treatment of infections in children has not been established. Safety and efficacy for the prevention or treatment of MAC in children have not been established. Based on pediatric pharmacokinetic data, a dose of 20 mg/kg would be similar to the adult dose of 1200 mg but with a higher Cmax.

In the Elderly: The same dosage as in adult patients is used in the elderly.

In Patients with Renal Impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10 - 80 ml/min). Caution should be exercised when azithromycin is administered to patents with severe renal impairment (GFR < 10 ml/min) (see section 4.4 Special Warnings and Special Precautions for Use and Section 5.2 Pharmacokinetic Properties).

In Patients with Hepatic Impairment: The same dosage as in patients with normal hepatic function may be used in patents with mild to moderate hepatic impairment (see section 4.4 Special Warnings and Special Precautions for Use).

 

1    2    3    4    5

Abdomen
Blood
Bone
Breast
Ear

Eye

Face
Hair

Head

Heart
Kidney
Liver
Limbs
Lungs
newMind
Mouth
Muscles
Nails

Neck

newNerves
Nose

Skin

Teeth

Throat

Tongue
 
Health news
 
Cardiovascular Guide
 
Natural Remedies
 
Treatment of Cancer
 
Women's Health
 
Irritable bowel syndrome
 
Common Childhood Illnesses
 
Prescribed Drugs
 
 

     
         
     

 

Disclaimer