Azithromycin - AUG Pharma 500 mg 6 tabs

Azithromycin-AUG Pharma Azithromycin 500mg 6 Tablets

Composition:

Film-coated Tablets contain 524.032 mg azithromycin (as dihydrate).

Description:

Azithromycin is first in a sub-class of macrolide antibiotics called azalides and is chemically different from erythromycin. It is chemically derived from the insertion of a nitrogen atom into the lactone ring of the erythromycin A.

Indications:

Treatment of infections caused by azithromycin-susceptible bacteria.

-infections of the upper respiratory tract (sinusitis, tonsillitis, and pharyngitis),

-infections of the lower respiratory tract (including bronchitis and Pneumonia),

-middle ear infections (acute otitis media),

-Odontostomatological infections,

-skin and soft tissue infections,

-non-gonococcal urethritis (caused by Chlamydia trachomatis),

-Soft chancres (caused by Haemophilus ducreyi).

Dosage and method of administration:

Adults

For the treatment of upper and lower respiratory tract infections, skin and soft tissues infections and odontostomatological infections: 500 mg per day taken once daily, for 3 consecutive days.

For the treatment of sexually transmitted diseases caused by susceptible strains of Chlamydia trachomatis and Haemophilus ducreyi: 1,000 mg taken only once in a single oral administration.

Elderly:

The same dosage regimen can be applied to elderly patients.

Since elderly patients are more susceptible to developing cardiac arrhythmia, particular caution is recommended due to the risk of developing cardiac arrhythmia and torsade de pointes.

Pediatric population:

10 mg/kg/day for 3 consecutive days.

For children weighing 45 kg or more, the adult dose can be used (500 mg/day for three consecutive days).

Weight (Kg) < 15: 10 mg/kg/day for 3 days

Weight (Kg)15-25: 200 mg /day for 3 days

Weight (Kg)26-35: 300 mg /day for 3 days

Weight (Kg)36-45: 400 mg /day for 3 days

Weight (Kg)>45: 500 mg/day for 3 days (same dosage as adults)

For Paediatric doses, appropriate other pharmaceutical preparations are used.

For the treatment of acute otitis media in children, the recommended dose is 10 mg/kg/day for 3 consecutive days.

The total maximum dosage recommended for any paediatric treatment is 1,500 mg.

The medicine must always be administered in a single daily dose.

Method of administration:

Azithromycin-AUG Pharma tablets may be taken any time whether on an empty stomach or after meals. Eating before administration of this product may mitigate any adverse gastrointestinal side effects caused by azithromycin.

Contraindications:

Hypersensitivity to the active ingredient, to erythromycin, any other macrolide or ketolide antibiotics, or any other excepients.

Precautions:

Hypersensitivity

If there is an allergic reaction, the administration of the medicinal product must be discontinued and adequate therapy started. Physicians should be aware of the fact that when the symptomatic therapy is suspended allergic symptoms may occur.

Hepatotoxicity

Azithromycin must be used with caution in patients with serious liver disease since its primary route of elimination is the liver.

Ergotamine Derivatives

Co-administration of macrolide antibiotics in patients being treated with ergotamine derivatives has precipitated convulsive ergotism. Due to the theoretical possibility of ergotism, azithromycin and ergotamine must not be co-administered.

Pregnancy:

Azithromycin must only be used during pregnancy if the benefits outweigh the risks.

Breastfeeding:

The limited information available from the published literature, indicates that azithromycin is present in human milk in a highest median daily dose estimated to be between 0.1 and 0.7 mg/kg/day. No side effects have been observed in breast-fed infants.

It must be decided whether to discontinue breastfeeding or  discontinue/refrain from therapy with azithromycin taking into consideration the benefits of breastfeeding for the child and that of therapy for the woman.

Side Effects:

Immune system disorders: Angiooedema, hypersensitivity

Metabolism and nutrition disorders:Anorexia

Psychiatric Disorders: Nervousness, insomnia

Nervous System Disorders: Headache, Dizziness, somnolence, dysgeusia, paraesthesia.

Eye Disorders: Vision impairment

Ear and Labyrinth Disorders: Ear disorders, vertigo, Hearing impairment including deafness and/or tinnitus

Cardiac disorders: Palpitations

Vascular disorders: Hot flashes

Respiratory, Thoracic and Mediastinal Disorders: Dyspnoea, epistaxis

Gastrointestinal disorders: Diarrhoea, Vomiting, abdominal pain, nausea, Constipation, flatulence, dyspepsia, gastritis, dysphagia, abdominal distension, dry mouth, eructation, mouth ulceration, salivary hypersecretion

Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, dermatitis, dry skin, hyperhidrosis

Storage Method:

Store at a temperature not exceeding 30° C, in a dry place.

Package:

Carton box contains 2 strips containing 3 film coated tablets + inner leaflet.