Unizithrine suspension 100 mg/5 ml 30 ml

Unizithrin Azithromycin 100 mg / 5ml Powder for oral suspension 30 ml

Composition:

When reconstituted:

Each 5 ml contains :

Azithromycin dihydrate 104.8 mg equivalent to 100 mg Azithromycin

Indications:

Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms:

- bronchitis

- sinusitis

- otitis media

- skin and soft tissue infections

- community-acquired pneumonia

- pharyngitis/tonsillitis

- uncomplicated genital infections due to Chlamydia trachomatis and Neisseria gonorrhoeae.

Posology and method of administration:

Method of administration:

Unizithin should be given as a single daily dose.

Unizithin Suspension can be taken with or without food Children over 45 kg body weight and adults, including elderly patients: The total dose of azithromycin is 1500 mg which should be given over three days (500 mg once daily). 

In uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000 mg as a single oral dose. 

For susceptible Neisseria gonorrhea the recommended dose is 1000 mg or 2000 mg of azithromycin in combination with 250 mg or 500 mg ceftriaxone according to local clinical treatment guidelines. 

For patients who are allergic to penicillin and/or cephalosporins, prescribers should consult local treatment guidelines.

Paediatric population:

Unizithrin Suspension should be used for children under 45 kg. The dose in children is 10 mg/kg as a single daily dose for 3 days: Up to 15 kg (less than 3 years): Measure the dose as closely as possible using the 10 ml. For children weighing more than 15 kg, Unizithin Suspension should be administered using the measuring cup provided according to the following guidance:

15-25 kg (3-7 years): 10 ml (200 mg) given as 1 x 10 ml, once daily for 3 days.

26-35 kg (8-11 years): 15 ml (300 mg) given as 1 x 15 ml, once daily for 3 days.

36-45 kg (12-14 years): 20 ml (400 mg) given as 1 x 20 ml, once daily for 3 days.

Over 45 kg: Dose as per adults.

Hepatic impairment:

Since azithromycin is metabolized in the liver and excreted in the bile, the drug should not be given to patients suffering from severe liver disease. 

Reconstitution direction:

Add distilled water to 30 ml ( to arrow)

Shake well till you get a suspension

Contraindications:

-Unizithin is contraindicated in patients with a known hypersensitivity to azithromycin or any macrolide or ketolide antibiotics, erythromycin, or to any excipients.

-Unizithin are contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of Unizithin 500mg capsules and Unizithin 600 mg suspension.

Special warnings and precautions for use:

Hypersensitivity

-As with erythromycin and other macrolides, serious allergic reactions including angioneurotic oedema and anaphylaxis (rarely fatal), Acute Generalized Exanthematous Pustulosis (AGEP) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported.

-Hepatotoxicity (Abnormal Liver Function) Hepatitis, Cholestatic Juandice, Hepatic necrosis. And hepatic failure have been reported, some of which have resulted in death. Discontinue (Unizithin capsules and suspension are for oral administration only) immediately if signs and symptoms of. hepatitis occur. 

-because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administrated.

-caution is required when treating patients:

• With congenital or documented QT prolongation.

• Currently receiving treatment with other active substance known to prolong QT interval such as antiarrhythmics of Classes la and III, cisapride and terfenadine

• With electrolyte disturbance, particularly in case of hypokalaemia and hypomagnesemia

• With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.

-Superinfection: As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms including fungi is recommended.

-Clostridium difficult associated diarrhoea: 

Clostridium difficult associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhoea to fatal colitis. 

-Renal impairment: 

In patients with severe renal impairment (GFR <10 ml/min) a 33% increase in systemic exposure to azithromycin was observed Myasthenia gravis: Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving azithromycin therapy.

Pregnancy and lactation:

Pregnancy: Azithromycin should be used during pregnancy only if clearly needed.

Breast-feeding: As many drugs are excreted in human milk, azithromycin should not be used in the treatment of a lactating woman unless the physician feels that the potential benefits justify the potential risks tothe infant.

Side effects:

Liver/ Biliary: adverse reactions related to hepatic dysfunction have 

Uncommon: Candidiasis, oral candidiasis, vaginal infection

Blood and Lymphatic System Disorders

Uncommon: Leukopenia, neutropenia

Immune System Disorders

Angioedema, hypersensitivity

Metabolism and Nutrition Disorders

Common: Anorexia

Psychiatric Disorders

Uncommon: Nervousness

Nervous System Disorders

Common: Dizziness, headache, paraesthesia, dysgeusia

Eye Disorders

Common: Visual impairment

Ear and Labyrinth Disorders

Common: Deafness

Cardiac Disorders

Uncommon: Palpitations

Gastrointestinal Disorders

Very common: Diarrhoea, abdominal pain, nausea, flatulence

Common: Vomiting, dyspepsia

Hepatobiliary Disorders

Uncommon: Hepatitis

Skin and Subcutaneous Tissue Disorders

Common: Pruritus and rash

Uncommon: SUS, photosensitivity reaction, urticaria

Musculoskeletal, Connective Tissue Disorders

Common: Arthralgia

General disorders and Administration Site Conditions

Common: Fatgue

Uncommon: Chest pain, oedema, malaise, asthenia

Storage Method:

- Store at a temperature not exceeding 30 °C

- Used after reconstitution for 5 days

- Keep out of reach of children

Package:

Carton box contains a glass bottle 13.4gm powder for oral suspension + Plastic Measuring Cup and a insert leaflet.