LABESTEN® (Clotrimazole Vaginal tablets)

Gafacom March 20, 2023

LABESTEN® (Clotrimazole Vaginal tablets)

Clotrimazole vaginal tablets are a medication used to treat vaginal yeast infections. The tablets are inserted into the vagina and release clotrimazole, an antifungal medication that kills the fungus and relieves symptoms such as itching, burning, and discharge.

Clotrimazole works by disrupting the cell membranes of the fungi, which leads to their death. The medication is generally well-tolerated, although it can cause side effects such as irritation, burning, or redness in the vaginal area.

Prescription only medicine (POM)

LABESTEN® vaginal tablets contain clotrimazole, an imidazole antifungal agent which interferes with ergosterol synthesis and therefore alters the permeability of the cell membrane of sensitive fungi. Clotrimazole also has active against some gram-positive bacteria (though not clinically useful), and Trichomonas vaginalis



Dosage, administration and indication

LABESTEN® tablets should be inserted into the vagina, as high as possible, using the applicator provided. This is best achieved when lying back with legs bent up.

Adults

One pessary should be inserted daily (preferably at night) for three consecutive days. A second treatment may be carried out if necessary.

There is no separate dosage schedule for the elderly.

Labesten® tablets need moisture in the vagina in order to dissolve completely; otherwise undissolved pieces of the pessary might crumble out of the vagina. Pieces of undissolved pessary may be noticed by women who experience vaginal dryness. To help prevent this it is important that the pessary is inserted as high as possible in to the vagina at bedtime.

Generally treatment during the menstrual period should not be performed due to the risk of the pessary being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.

Do not use tampons, intravaginal douches, speprmicides or other vaginal products while using this product.

Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.

Children:

Not for use in children under 16

Directions for insertion of vaginal tablets using the applicator

  • Pull back the applicator about 2.5 centimeters (1 inch). Insert the tablet into the cup at the end of the hollow tube (applicator)
  • Lie on your back with your knees drawn up. Insert the applicator into your vagina as far as it will comfortably go. Do not try force it to go further.
  • Be sure the applicator is in the correct position in your vagina before you push the plunger
  • Then, push the plunger to place the tablet in your vagina.
  • Remove the applicator. Wash with mild soap and warm water. Rinse thoroughly and dry

Precautions, warning and side effects

Labesten® vaginal tablets are contraindicated in patients with known hypersensitivity to clotrimazole. Local reactions including irritation and burning sensation

Labesten vaginal tablets should not be used for treatment in patients during the menstruation period.

Pregnant women who are on medication with Labesten vaginal tablets should strictly follow the doctor’s instructions.

Therapeutic category: ATC D01A (Gynaecological anti-infective and antiseptics – imidazole derivatives)

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