Mikostat Suspension 30 ml

Product Description:

• The oral suspension is intended for oral administration of Nystatin in infants, young children and subjects with significant oral and pharyngeal candidiasis.
• Treatment of digestive candidiasis excluding esophageal candidiasis of The immunocompromised.
• Complementary Treatment of vaginal and cutaneous candidiasis, with The aim of obtaining sterilization of associated intestinal candidiasis.
• Prevention of candidiasis in high-risk subjects: premature babies, immunocompromised, patients subjected to antineoplastic chemotherapy.

How to use:

Oral Candidiasis:

Infants (1 month to 2 years):

• 1ml should be dropped into the mouth four times daily.

Children (> 2 years) and adults:

• For the treatment of denture sores, and oral infections in children (> 2 years) and adults caused by candida Albicans.
• 1ml of the suspension should be dropped into the mouth four times daily; it should be kept in contact with the affected areas as long as possible.

Intestinal candidiasis:

Infants (1 month to 2 years):

• 1ml should be dropped into the mouth four times daily.

Adults:

For the treatment of intestinal candidosis:

• 5ml of the suspension should be dropped into the mouth four times daily.

Paediatric population (> 2 years):

• 1ml Should Be Dropped Into The Mouth Four Times A Day.
• For prophylaxis a total daily dosage of 1 million units has been found to suppress the overgrowth of candida Albicans in patients receiving broad-spectrum antibiotic therapy.
• For prophylaxis in the newborn the suggested dose is 1ml once daily.
• The longer the suspension is kept in contact with the affected area in the mouth before swallowing, the greater its effect will be.
• Administration should be continued for 48 hours after clinical cure to prevent relapse.

Older people:

• No specific dosage recommendations or precautions.
• If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered.
• Very moist lesions are best treated with topical dusting powder.

Caution & Warnings:

• Nystatin, topical preparations should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.
• If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated.
• It is recommended that KOH smears, cultures or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.
• Pregnancy: Teratogenic Effects
• Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation.
• It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity.
• Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

• It is not known whether nystatin is excreted in human milk.
• Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use:

• Safety and effectiveness have been established in the pediatric population from birth to 16 years.

Geriatric Use:

• Clinical studies with Mikostat (Nystatin) Cream and Mikostat (Nystatin) Topical Powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.
• Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Ingredients:

• NYSTATIN