Azigyl Azithromycin Tablets

AZIGYL – 250/500 (Azithromycin Tablets 250/500 mg).

What Azigyl is and what it is used for, Indications for use of Azigyl, Before you use Azigyl, Use Of Other Medicines Products, How to use Azigyl, Usual Dose of Azigyl, Possible undesirable effects, Presentation, Storage, Manufacturer and Marketer of Azigyl Tablet Medicine for Infections.

 

Composition

Each film coated tablet contains:

Azithromycin USP (Dihydrate)

Eq. to Anhydrous Azithromycin 250/500mg

Excipients q.s.

Approved colour used

 

1. What Azigyl is and what it is used for?

Azigyl coated tablet contains Azithromycin, an antibiotic belonging to the group of the macrolides.

Azithromycin is a broad spectrum antibiotic and shows in-vitro effect on most strains of the following micro-organisms:

 

Gram-positive aerobic bacteria

Staphylococcus aureus, Streptococuccos agalactiae, Streptococcus pyogenes, Erythromycin-resistant Gram-positive strains and majority of methicillin-resistant Staphylococcus spp. strains show cross-resistance Azithromycin.

 

Gram-negative aerobic bacteria

Haemophilus ducrei, Haemophilus influenza, Haemophilus parainfluenza, Moraxella catharallis, Neisseria gonorrhoeae, Bordelella pertusis Bodelella parapertusis, legionella pneumophila.

 

Anaerobic bacteria

Bacteriodes bivius, clostridium perfrigens, Peptostreptococcus spp.

 

Other micro-organisms

Chlamydia pneumonia, Chlamydia trachomatis, Mycoplasma pneumonia. Mycoplasma hominis, Urealyticum, Borrelia burgdorferi, Treponema pallidum.

Upon oral administration Azithromycin reaches its maximum concentration in the blood within 2-3 hours. It penetrates into cells where it reaches concentration higher than in the serum. Elimination half life of the drug product is long (2 – 4 days) and tissue wash out is slow.

The drug product is excreted mainly with bile and to a small extent with urine.

 

Indications for use of Azigyl

a) Upper respiratory tract infections: bacterial pharyngitis, tonsillitis, sinusitis, and otitis media

b) Lower respiratory tract infections: bacterial bronchitis, interstitial pneumonia and bronchopneumonia

c) Skin and soft tissue infections: erythema migrans (initial symptoms of lyme borreliosis), erysipelas, impetigo

d) Sexually transmitted diseases (STDs): uncomplicated non-gonoccoccal urethritis, cervicitis.

 

2. Before you use Azigyl

The medicinal product sbould not be administered if you had in the past any allergic reaction to macrolide antibiotics or any other infections caused by resistant micro-organism, especially by fungi. As in the case of treatment with other antibiotics, the risk of occurrence of pseudomembrabeous enteritis caor pharmacist if diarrhea (in particular persistent one) occurs during the treatment with the medicinal product. The doctor or pharmacist may decide to discontinue Azigyl treatment and apply additional treatment with appropriate medicinal products (e.g. administer metronizadole or vancomycin orally). Drugs slowing bowel movement should not be taken. The Azigyl drug product should not be used in patients with pneumonia who are not able to take the medicine properly, their condition is severe, they suffer from cystic fibrosis,acquired hospital infection ot diagnonised /suspected bacteraemia. The drug product should not be used by patients who require hospitalization, by weakened patients, patients with immunological disorders or dysfunction of the spleen (asplenia). The medicine should be used with special care in persons with kidney or liver dysfunction.

 

Pregnancy

There are no sufficient data concerning safety of use of the drug in pregnant women.

 

Lactation

There are  no sufficient data concerning penetration of Azithromycin into the milk of breastfeeding women. A doctor or pharmacist may use the drug product in breastfeeding women if it is believed necessary.

 

Use Of Other Medicines Products

Before you start taking Azigyl tell your doctor or pharmacist if you are taking or have recently taken any medicinal products 1 hour before or 2 hours after administration of a gastric juice neutralizing medicine. Azigyl may have an effect on the action of cyclosporine (drug used for preventing graft injection). If necessary your doctor or pharmacist will order cyclosporine level determination and will establish your individual dosage regime. Macrolide antibiotics may in some patients impair the metabolism of digoxin (drug used in treating heart disorder). Therefore your doctor or pharmacist should take special care in case of concomitant administration of azithromycin and digoxin. Alkaloids of ergot (drug used among others in obstetrics, migraine and hypertension) should not be used concomitantly due to a possible increase in their toxicity under the influence of Azithromycin. In patients taking Azithromycin an increase of theophyline concentration may occur.

 

3. How to use Azigyl

Azigyl should be used according to a doctor’s or pharmacist advice. The medicine should be taken once daily at least before meals or 2 hours after meals.

 

Usual Dose of Azigyl

In adults and children of body weight up to 45kg: Infections of thr lower/upper respiratory tract and skin/soft tissue infections 500mg as a single daily dose administered for 3 days.

 

Sexually transmitted diseases

1g as a single dose in elderly persons change of dose is not necessary in children of body weight up to 45kg: Infections of the lower/upper respiratory tract and skin/soft tissues infections. Entire dose is 30mg/kg body weight i.e. 10mg/kg body weight administered once daily for 3 days. The Azigyl coated tablets may be used only in those children that can swallow tablets. There are no sufficient data concerning the use of the drug product in infants below 6 months of age.

 

If you took more of the drug product than the administered dose

Undesirable symptoms observed after taking dose higher than recommended were similar to those occurring during proper use of Azithromycin.

 

Typical symptoms of macrolide antibiotics overdose are

Temporary hearing loss, severe nausea, vomiting, diarrhea.

 

If you omitted a dose of the drug product

Take the omitted dose as soon as possible and take next dose as prescribed by the doctor or the pharmacist. Do not take a double dose in order to make up for omitted dose.

 

4. Possible undesirable effects

Azithromycin is generally well tolerated, however during the use of Azithromycin cases of the following undesirable effects were observed.

 

Blood and lymphatic system disorders

Thrombocytopenia, transient neutropenia lnfections: vaginitis, candidiasis.

 

Immunologic system disorder

Anaphylaxis metabolism and nutrition disorders: loss of appetite.

 

Mental disorders

Agression, nervousness, agitation, anxiety.

 

Nervous system disorders

Vertigo, convulsions, headache, insomnia.

 

Hearing and balance disorders

Labyrinth vertigo, hearing disorders including hearing impairment, deafness, ear buzzing.dnthvergo,headngdisordersindugheadnguntpaomentteafress,earbuzzing.

 

Gastrointestinal disorders

Nausea, vomiting, loose stool, indigestion, abdominal pain and contractions, constipation, distension with gas.

 

Renal and urinary tract disorders

Interstitial nephritis, acute renal failure.

 

Presentation

1 Blister of 10 Tablets.

 

Storage

Store in a dry place at temperature from 15oC to 30oC.

Protect from light.

Keep all medicines away from children.

 

Manufactured by

Medico Remedies Pvt. Ltd.

Palghar, Maharashtra – 401 404.

INDIA

 

Marketed by

JIL Nig. Ltd.

No. 60A Ajose Street, Off Berliet Bus-stop,

Apapa/Oshodi Expressway,

Lagos, Nigeria.

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