100,000 units/mL Oral Suspension
Antifungal

 

FORMULATION:
Each mL contains Nystatin BP 100,000 units.

 

DESCRIPTION:
Nystatin (Afunginal) is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a variety of yeasts and yeast-like fungi.  It is a polyene antibiotic undetermined structural formula that is obtained from Streptomyces noursei.

 

CLINICAL PHARMACOLOGY:
Nystatin (Afunginal) acts by binding to sterols in the cell membrane of the fungus which interferes in the membrane permeability.  It exhibits no appreciable activity against bacteria or trichomonads.
Following oral administration, Nystatin (Afunginal) is poorly absorbed with no detectable blood levels when given in the recommended doses.  Most of the orally administered Nystatin (Afunginal ) is passed unchanged in the stool.

 

INDICATIONS:
Nystatin Oral Suspension (Afunginal) is indicated for the treatment of candidiasis in the oral cavity.

 

CONTRAINDICATIONS:
The preparation is contraindicated in patients with a history of hypersensitivity to Nystatin (Afunginal).

 

PRECAUTIONS:
Usage in Pregnancy
No adverse or complications have been attributed to Nystatin (Afunginal) in infants born to women treated with Nystatin (Afunginal).

 

ADVERSE DRUG REACTIONS:
Diarrhea, gastrointestinal distress, nauses and vomiting.  Oral irritation & sensitation may occur. Rashes, including urticaria and rarely Stevens-Johnson syndrome have been reported.

 

DOSAGE AND ADMINISTRATION:
Intestinal or Esophageal Candidiasis:
Adult: 500,000 IU (5mL) or 1,000,000 IU (10mL) 4 times a day.
Children: 100,000 IU (1mL) or more may be given 4 times a daily.
Lesions of the mouth: 100,000 IU (1mL) 4 times daily.
Infants born to mothers with vaginal candidiasis: 100,000 IU (1mL) daily.
The preparation should be retained in the mouth as long as possible before swallowing and patients should avoid taking food or drink earlier that 1 hour after a dose or as prescribed by physician.

 

CAUTION:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

 

AVAILABILITY:
12 mL amber glass bottle with calibrated dropper.

 

STORAGE:
Store at a temperatures not exceeding 30°C.  Shake gently before using.

 

Keep all medicines out of reach of children.

 

Manufactured by:
The ACME Laboratories, LTD
Dhulivita, Dhamral
Dhaka, Bangladesh

 

Exclusively Distributed by:

Remed Pharmaceuticals, Inc.
AIC Burgundy Empire Tower
ADB Ave., corner Sapphire & Garnet Road
Ortigas Center, Pasig City 1605