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AZIMUL-500
Product Composition
Packaging Details
Product Description
AZIMUL-500 – Azithromycin 500 mg Tablets
AZIMUL-500 by Amcare Pharmaceuticals is a prescription macrolide antibacterial containing Azithromycin 500 mg per film-coated tablet. The product contains Azithromycin Dihydrate I.P. equivalent to 500 mg of anhydrous Azithromycin, as shown on the product packaging.
Azithromycin is used for selected bacterial infections caused by susceptible organisms. It should be used only when a bacterial infection is proven or strongly suspected and according to the prescribing healthcare professional.
Composition of AZIMUL-500
Each film-coated tablet contains:
- Azithromycin Dihydrate I.P.
- Equivalent to Azithromycin – 500 mg
- Colour: Titanium Dioxide I.P.
AZIMUL-500 Product Details
| Particular | Details |
|---|---|
| Brand Name | AZIMUL-500 |
| Generic Name | Azithromycin |
| Strength | 500 mg |
| Active Ingredient | Azithromycin Dihydrate equivalent to Azithromycin 500 mg |
| Dosage Form | Film-Coated Tablet |
| Route | Oral |
| Therapeutic Category | Macrolide Antibacterial |
| Prescription Status | Rx / Prescription medicine |
| Pack Shown | 10 × 5 Tablets |
| Company | Amcare Pharmaceuticals |
AZIMUL-500 Uses
Azithromycin tablets are indicated for selected mild-to-moderate bacterial infections caused by susceptible organisms. Depending on the patient population and applicable prescribing information, labelled uses include:
- Community-acquired pneumonia
- Acute bacterial sinusitis
- Acute bacterial exacerbations of chronic bronchitis
- Uncomplicated skin and skin-structure infections
- Certain ear infections such as acute otitis media
- Certain pharyngitis and tonsillitis
- Selected bacterial sexually transmitted infections
Community-Acquired Pneumonia
Azithromycin may be prescribed for certain mild-to-moderate community-acquired pneumonia caused by susceptible organisms in patients appropriate for oral therapy.
Acute Bacterial Sinusitis
AZIMUL-500 may be prescribed for selected acute bacterial sinus infections caused by susceptible organisms.
Respiratory Tract Infections
Azithromycin has labelled use in selected bacterial respiratory infections, including acute bacterial exacerbations of chronic bronchitis in adults.
Skin and Skin-Structure Infections
Azithromycin may be used for certain uncomplicated bacterial skin and skin-structure infections caused by susceptible organisms.
Ear and Throat Infections
Depending on age and clinical circumstances, azithromycin is used for selected cases of acute otitis media and pharyngitis/tonsillitis.
Selected Genital Infections
Azithromycin has labelled indications for certain urethritis and cervicitis infections caused by susceptible organisms.
Benefits of AZIMUL-500
- Contains Azithromycin 500 mg.
- Macrolide antibacterial formulation.
- Film-coated tablet for oral administration.
- Convenient solid oral dosage form.
- Used against selected susceptible bacterial infections when appropriately prescribed.
- Available in a 500 mg strength.
How Does AZIMUL-500 Work?
Azithromycin 500 mg
Azithromycin belongs to the macrolide class of antibacterials. It inhibits bacterial protein synthesis, thereby interfering with the growth of susceptible bacteria.
Its effectiveness depends on the susceptibility of the infecting organism. Antibiotics such as azithromycin should not be used for viral infections.
AZIMUL-500 Dosage & Administration
AZIMUL-500 should be taken only in the dose and for the duration prescribed by a qualified healthcare professional.
The appropriate regimen depends on factors including:
- Type of infection
- Severity of infection
- Patient age
- Body weight where applicable
- Medical history
- Liver and other relevant organ function
- Susceptibility of the causative organism
- Other medicines being taken
Do not self-medicate with azithromycin or change the prescribed dose or treatment duration without medical advice.
How to Take AZIMUL-500
- Take the tablet exactly as prescribed.
- Swallow with water unless your healthcare professional advises otherwise.
- Follow the prescribed treatment duration.
- Do not share antibiotics with other people.
- Do not use leftover antibiotics for a subsequent illness.
AZIMUL-500 Side Effects
Possible adverse effects associated with azithromycin include:
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Headache
More serious adverse reactions can include severe allergic or skin reactions, liver injury and heart-rhythm abnormalities.
Seek prompt medical attention if severe allergic symptoms, serious skin reactions, jaundice, fainting, palpitations or other concerning symptoms occur.
AZIMUL-500 Precautions & Warnings
AZIMUL-500 should be used under medical supervision.
- Do not use in patients with known hypersensitivity to azithromycin, erythromycin, other macrolides or ketolide drugs.
- It is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with previous azithromycin use.
- Serious allergic and skin reactions have been reported.
- Severe hepatotoxicity has been reported; treatment should be stopped and medical assessment obtained if symptoms of hepatitis develop.
- Azithromycin can prolong the QT interval and has been associated with torsades de pointes. Particular caution is required in patients with certain cardiac conditions, electrolyte abnormalities or concomitant medicines that prolong the QT interval.
- Antibiotic-associated Clostridioides difficile diarrhea can occur.
- Azithromycin may worsen muscle weakness in people with myasthenia gravis.
- Use antibiotics only when a susceptible bacterial infection is proven or strongly suspected to help reduce antimicrobial resistance.
AZIMUL-500 Drug Interactions
Inform the doctor or pharmacist about all medicines being taken before starting AZIMUL-500.
Particular attention may be required with medicines that:
- Prolong the QT interval
- Affect cardiac rhythm
- Interact with azithromycin metabolism or transport
- Affect coagulation, such as warfarin
The complete medication list should be reviewed by the healthcare professional before treatment.
AZIMUL-500 Storage
Store AZIMUL-500 according to the storage instructions provided on the approved product packaging.
- Keep in a dry place.
- Protect from excessive heat and moisture.
- Protect from direct light.
- Keep out of reach of children.
- Do not use after the expiry date.
Why Choose AZIMUL-500 by Amcare Pharmaceuticals?
AZIMUL-500 provides Azithromycin 500 mg in a convenient film-coated tablet dosage form.