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NYSTADERM oral gel, oral cavity, oral thrush

DERMAPHARM AG

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NYSTADERM oral gel, oral cavity, oral thrush

Nystaderm® oral gel

Active ingredient: nystatin.

Application areas:
Nystatin-sensitive yeast infections of the oral cavity (oral thrush).
 
Warning: Contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and sucrose (sugar).
For use in infections in the oral cavity.

active NYSTADERM oral gel, oral cavity, oral thrush ingredients

  • 100000 IU nystatin

NYSTADERM oral gel, oral cavity, oral thrush excipients

  • 1.8 mg methyl 4-hydroxybenzoate
  • 0.2 mg propyl 4-hydroxybenzoate
  • Glycerol 85%
  • sucrose
  • Hyetellosis
  • Raspberry Flavor
  • water, purified
  • Raspberry flavor containing propylene glycol
  • cinnamaldehyde
  • 5.4 mg propylene glycol
  • geraniol
  • citronellol
  • linalool
  • water, purified

Indication/ NYSTADERM oral gel, oral cavity, oral thrush Application

  • The drug is a yeast-specific antifungal.
  • It is suitable for the treatment of nystatin-sensitive yeast infections of the oral cavity (oral thrush).

NYSTADERM oral gel, oral cavity, oral thrush dosage

  • Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • The recommended dose is:
    • Babies and toddlers between 4 - 24 months:
      • For babies and small children (4 - 24 months), it makes sense to put 1/2 - 1 measuring spoon (1/2 - 1 gram) in the oral cavity before and after a meal. This can optimize the effect of nystatin in the oral cavity. The gel should not be applied to the back of the mouth to avoid possible aspiration. In the case of infants and small children, too, it is desirable for the gel to remain in the oral cavity for as long as possible.
    • Children (>/= 2 years) and adults
      • Take the preparation 3 - 6 times a day, in severe cases every 2 hours, in each case 1g of gel (1 measuring spoon).

 

  • duration of use
    • During the treatment of oral thrush, a significant improvement occurs within a few days. However, treatment should be continued for at least 2 days after the symptoms have subsided.
    • The duration of treatment should not exceed 28 days.

 

  • If you take more than you should
    • Very little information is available on overdose with oral nystatin. Since absorption from the gastrointestinal tract into the body after oral administration is negligible, even at high doses, side effects of nystatin on the organism are not to be expected, even in the event of an overdose. If necessary, the usual measures for the removal of drugs from the gastrointestinal tract should be taken.

 

  • If you forgot the application
    • Do not take a double dose to make up for a forgotten dose.

 

  • If you cancel the application
    • You could jeopardize the success of the treatment. Please talk to your doctor or pharmacist before stopping treatment.

 

  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

NYSTADERM oral gel, oral cavity, oral thrush way

  • For use in the oral cavity.
  • The medicine is taken, left in the mouth for a few minutes, and then swallowed.
  • For the treatment of yeast infections in the oral cavity, it has proven useful to also apply a cotton swab to which the preparation has been applied to the affected areas. Due to its adhesiveness, the gel is suitable for treatment in the oral cavity.
  • The tube thread is to be cleaned after use and the tube to be closed tightly.

side NYSTADERM oral gel, oral cavity, oral thrush effects

  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • Common (may affect up to 1 in 10 people)
    • Gastrointestinal complaints, nausea, vomiting and diarrhea
  • Uncommon (may affect up to 1 in 100 people)
    • Exanthema (rashes), urticaria (hives)
  • Rare (may affect up to 1 in 1,000 people)
    • Stevens-Johnson syndrome (fever and painful blistering of the skin and mucous membranes)
  • special instructions
    • If a hypersensitivity reaction occurs, the medicinal product should be discontinued and, if necessary, appropriate treatment should be carried out by a doctor.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

NYSTADERM oral gel, oral cavity, oral thrush interactions

  • Use together with other medicines
    • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
    • Interactions with other drugs have not yet become known.

NYSTADERM oral gel, oral cavity, oral thrush Contraindications

  • The drug must not be used
    • if you are allergic to nystatin or any of the other ingredients of this medicine.
    • in infants under 4 months and children whose swallowing reflex is not yet fully developed.
  • There is no experience of using it in patients who are being treated with cytostatics.

pregnancy NYSTADERM oral gel, oral cavity, oral thrush and breast feeding period

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
  • pregnancy
    • In therapeutic doses, nystatin is hardly absorbed after oral administration through the intact skin or through the mucous membranes.
  • lactation
    • Nystatin does not cross the placenta and is not expected to be excreted in breast milk.
  • The preparation can be used during pregnancy and lactation after benefit/risk assessment.

patient NYSTADERM oral gel, oral cavity, oral thrush notes

  • Warnings and Precautions
    • Please talk to your doctor or pharmacist before using the preparation.
    • children
      • Due to the high osmolarity of nystatin, its use in very underweight and immature preterm infants is not recommended.
      • It is important to consider the variability in maturation of infant swallowing function, particularly when the drug is given to infants 4 to 6 months of age.
      • In the case of premature infants or children with delayed neuromuscular development, the lower age limit should be increased to 5 to 6 months.
    • Aspiration in infants and young children
      • Especially with infants and young children (4 months to 2 years), care must be taken so that the gel does not block the throat. Therefore, the gel should not be used at the back of the throat. Each dose should be divided into small individual portions and applied in the mouth with a clean finger. Babies and small children should therefore also be observed after use. Also because of the risk of choking, the gel for use in infants should not be applied to the nipples of a breastfeeding woman.

 

  • Ability to drive and use machines
    • There is no experience of impairment of the ability to drive and use machines.