Nystatin Oral
Nystatin Oral Uses, Dosage, Side Effects, Food Interaction and all others data.
Nystatin Oral has fungistatic or fungicidal activity against variety of pathogenic and nonpathogenic yeast and fungi, including Candida albicans. Nystatin Oral exerts its antifungal activity by binding to sterols in the fungal cell membrane. As a result of binding, the membrane is no longer able to function as a selective barrier, and potassium and other cellular constituents are lost. It is poorly absorbed from the gastrointestinal tract.
Nystatin Oral is an antifungal that is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It exerts its antifungal effects via disruption of the fungal cell membrane. Resistance to nystatin is minimal in Candida albicans, but tends to develop in other species of Candida. Nystatin Oral carries no significant activity against bacteria, protozoa, or viruses. It carries significant systemic toxicity and is currently unavailable in a formula appropriate for systemic use - its efficacy is currently restricted, therefore, to topical, oral, and gastrointestinal infections.
Trade Name | Nystatin Oral |
Availability | Prescription only |
Generic | Nystatin |
Nystatin Other Names | Nistatina, Nystatin, Nystatine, Nystatinum |
Related Drugs | fluconazole, clotrimazole, Diflucan, itraconazole, miconazole, Mycostatin, Nilstat |
Weight | 100,000 I.u/ml |
Type | Suspension |
Formula | C47H75NO17 |
Weight | Average: 926.107 Monoisotopic: 925.503499959 |
Protein binding | Nystatin is not absorbed into the systemic circulation and is therefore not subject to plasma protein binding. |
Groups | Approved, Vet approved |
Therapeutic Class | Drugs for subcutaneous and systemic mycoses, Drugs used in Vaginal and Vulval condition |
Manufacturer | Unijules Life Sciences Limited |
Available Country | India, Nigeria |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Nystatin Oral Cream is used for the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not used for systemic, oral, intravaginal or ophthalmic use.
Nystatin Oral tablet is an antifungal antibiotic active against a wide range of yeasts and yeast like fungi including Candida albicans. It is used for the prevention and treatment of Candida infections of oral cavity, esophagus and intestinal tract. It provides effective prophylaxis against oral candidiasis in those born of mothers with vaginal candidiasis. It is used for the prophylaxis of Candida overgrowth during courses of broadspectrum antibiotics
Nystatin Oral is also used to associated treatment for these conditions: Anal candidiasis, Candidiasis, Invasive, Intestinal Candidiasis, Mixed Vaginal Infections caused by Trichomonas Vaginalis, candida albicans, Oral Candidiasis, Pruritus Ani, Pruritus Vulvae, Skin candida, Trichomonas Vaginitis, Vaginal Candidiasis, Vulvovaginal Candidiasis, Corticosteroid-responsive dermatoses, Cutaneous candidiasis
How Nystatin Oral works
Nystatin Oral is a channel-forming ionophore, meaning it exerts its therapeutic effect via formation of a membrane-spanning pore in the fungal plasma membrane. The formation of this pore results in a change in membrane permeability that allows for leakage of intracellular contents and the subsequent disruption of electrochemical gradients necessary for proper cell function. Selectivity for fungal cells over mammalian cells is due to nystatin’s greater binding affinity for ergosterol, a key sterol found in fungal cell walls, as opposed to its mammalian counterpart, cholesterol.
Dosage
Nystatin Oral dosage
Children:
- In intestinal and oral candidiasis (thrush): 1,00,000 units (1 ml) should be dropped into the mouth four times daily.The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.
- For prophylaxis in the newborn:The suggested dose is 1,00,000 units (1 ml) once daily or as prescribed by the physician.
Adult:
- For the treatment of intestinal or esophageal candidiasis: 5,00,000 units (5 ml) by mouth 3 or 4 times daily. The dose may be doubled, if required.
- For prophylaxis of intestinal candidiasis in adults: 10,00,000 units (10 ml) daily.
- For prophylaxis to suppress the over growth of Candida albicans in patients receiving broad spectrum antibiotic therapy: 10,00,000 units (10 ml) daily.
- For the treatment of dental sores and oral infection: 1,00,000 units (1 ml) suspension should be dropped into the mouth four times daily.
Elderly: Older people with intestinal candidiasis who are unable to swallow tablets should be given 5,00,000 units (5 ml) suspension four times daily.
Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
Pediatric Use: Safety and effectiveness have been established in the pediatric population from birth to 16 years.
Geriatric Use: Clinical studies with nystatin cream 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.
Side Effects
Nystatin Oral cream: The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application.
Nystatin Oral tablet: Nausea, vomiting and diarrhoea have occasionally been reported with high doses of Nystatin Oral. No systemic effects or allergic reactions have been associated with its oral dose.
Toxicity
The oral LD50 in rats is 10 g/kg. There have been no reports of serious toxic effects following overdosage of nystatin - doses in excess of five million units daily have resulted in nausea and gastrointestinal upset with no other associated effects.
Precaution
Nystatin Oral 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.
Absorption from the gastrointestinal tract is negligible, therefore no special precaution is required to apply in pregnancy and lactation
Food Interaction
No interactions found.Volume of Distribution
Nystatin Oral is not absorbed into the systemic circulation and thus does not undergo distribution.
Elimination Route
Systemic absorption of nystatin is minimal following oral administration, and no detectable plasma concentrations are attained following topical or vaginal administration.
Elimination Route
The majority of orally administered nystatin is eliminated unchanged in the feces.
Pregnancy & Breastfeeding use
Pregnancy Category C. Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin Oral cream 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.
Mouth/Throat/PO/Topical: Pregnancy catagory C
Vaginal: Pregnancy catagory A
Contraindication
Nystatin Oral cream is contraindicated in patients with a history of hypersensitivity to any of its components.
There is no known contraindication to the use of Nystatin Oral oral.
Storage Condition
Store at 20° to 25°C. Avoid freezing.
Innovators Monograph
You find simplified version here Nystatin Oral
Nystatin Oral contains Nystatin see full prescribing information from innovator Nystatin Oral Monograph, Nystatin Oral MSDS, Nystatin Oral FDA label
FAQ
What is Nystatin Oral used to treat?
Nystatin Oral is an antifungal medicine. It's used to treat or prevent infections caused by a fungus.
How safe is Nystatin Oral?
Nystatin Oral is generally very safe. Taking too much is unlikely to harm you or your child. If you're worried, speak to your pharmacist or doctor.
How does Nystatin Oral work?
Nystatin Oral work by kills the fungus and treats the infection. If you're taking Nystatin Oral to prevent an infection, the medicine kills any fungus as it starts to appear.
What are the common side effects of Nystatin Oral?
Common side effects of Nystatin Oral may include: mouth irritation; upset stomach, nausea, vomiting, diarrhea; skin rash.
Is Nystatin Oral safe during pregnancy?
Topical Nystatin Oral is a safe alternative to azole anti-fungals that has been extensively studied in the first trimester of pregnancy. As Nystatin Oral has negligible systemic absorption, no associated risk of major malformations has been observed in numerous trials.
Is Nystatin Oral safe during breastfeeding?
It's usually safe to take Nystatin Oral liquid while you're breastfeeding.
Can I drink alcohol with Nystatin Oral?
Avoid drinking alcohol while taking this drug and for at least 1 day after the last dose. Drinking alcohol or taking products that have alcohol may cause flushing, throwing up, or fast heartbeat. Have blood work checked as you have been told by the doctor.
How many days does it take for Nystatin Oral to work?
Nystatin Oral usually starts to work after 2 days. It's important to continue to take or use Nystatin Oral for 2 days after your condition is better. This will help to stop it coming back again.
When is the best time to take Nystatin Oral?
You usually take Nystatin Oral liquid 4 times a day after meals and before bedtime. It's important not to eat or drink for 30 minutes after taking the liquid.
Do I take Nystatin Oral with food or without food?
You can take Nystatin Oral with or without food.
What does Nystatin Oral do for thrush?
Nystatin Oral is also quite common for young babies to have oral thrush.Nystatin Oral suspension (drops) are an option for the treatment of oral thrush.
Can I take Nystatin Oral for a long time?
People usually only take Nystatin Oral for around a week to clear the infection. If you're using a Nystatin Oral cream or ointment mixed with other ingredients, only use for longer than 7 days if your doctor tells you to.
How long can I stay on Nystatin Oral?
Most doctors recommend that you continue to use the drops for two days after your symptoms have gone a typical course of treatment will last around seven days.
Who should not take Nystatin Oral?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
What are the contraindications for Nystatin Oral?
Nystatin Oral tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
Is Nystatin Oral safe for adults?
Most adults and children, including babies, can take nystatin liquid or use nystatin cream and ointments.
Can Nystatin Oral cause liver damage?
Nystatin Oral is considered very safe and is unlikely to cause hepatic injury.
Can Nystatin Oral cause stomach pain?
Nystatin Oral can causes stomach pain also with other side effects.
What happen If I missed Nystatin Oral?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I take too much Nystatin Oral?
Nystatin Oral is generally very safe. Taking too much is unlikely to harm you or your child. If you're worried, speak to your pharmacist or doctor.
Can Nystatin Oral cure yeast infection?
Nystatin Oral topical (for the skin) is used to treat skin infections caused by yeast.Nystatin Oral topical is not for use to treat a vaginal yeast infection.