Rianest Cream  is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

Usual Adult Dose for Cutaneous Candidiasis

Apply Rianest topical cream or in a quantity sufficient to cover the affected area and immediately surrounding skin 2 to 4 times a day.
Therapy should be continued for 2 to 8 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Cutaneous Candidiasis

Apply Rianest topical cream in a quantity sufficient to cover the affected area and immediately surrounding skin 2 to 4 times a day.
Therapy should be continued for 2 to 8 weeks, depending on the nature and severity of the infection.

General 

Rianest skin Cream 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.

Information for Patients 

Patients using this medication should receive the following information and instructions:

1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.
2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Laboratory Tests 

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

None

Pregnancy:

Teratogenic Effects:

Pregnancy 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

None.

The frequency of adverse events reported in patients using Rianest Skin Cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application

To report any side effects

- National Pharmacovigilance and Drug Safety Center (NPC)

• Fax: +966-11-205-7662
• To call the executive management of vigilance and crisis management: +966-11-2038222 ext.: 2353 – 2356 – 2317 – 2354 – 2334 – 2340
• Toll-free: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc

None

Nystatin is an antibiotic which is both fungistatic and fungicidal against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Rianest Skin Cream is not absorbed from intact skin or mucous membrane.

There are no findings in the preclinical testing which are of relevance to the prescriber.

Cetostearyl Alcohol (BP)

Cetomacrogol Emulsifying Wax (ISP)

Liquid Paraffin (BP)

Methyl Hydroxybenzoate (BP)

Propyl Hydroxybenzoate (BP)

Glycerol (BP)

Propylene Glycol (BP)

Water for Injection (EP

None.

Do Not store Above  30°C ,

Keep in the original pack to protect from heat.

once the pack has been opened should be used within 1 month

Don not Allow to freeze

15 gram Aluminum tube with plastic screw cap

None