Agisten V Vaginal Tablets

/ Perrigo

On retiring, the vaginal tablet should be inserted as deep as possible into the vagina, using the applicator provided. This is best achieved when lying back with the legs bent up.
Agisten vaginal tablets need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the vaginal tablet might crumble out of the vagina. To prevent this it is important to insert the medication as deeply as possible into the vagina at bedtime. Should the vaginal tablet not dissolve completely within one night the use of a vaginal cream should be
considered.
3-day treatment of Agisten 3 Vaginal Tablets (0.2 g): 1 vaginal tablet to be introduced each evening on 3 succesive days.
Single-dose treatment with Agisten 1 Vaginal Tablet (0.5 g): One vaginal tablet to be introduced in the evening.
See prescribing information for full details.

For the local treatment of vaginal infections (Vaginitis ) due to Candida species (particularly Candida albicans), trichomonas vaginalis, as well as mycotic infections complicated by other micro-organisms sensitive to the drug.

Hypersensitivity to clotrimazole or any of the excipients in this product.

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
Before using Agisten vaginal tablets, medical advice must be sought if any of the following are applicable:
– more than two infections of candidal vaginitis in the last six months.
– previous history of sexsually transmitted disease or exposure to partner with sexually transmitted disease.
– pregnancy or suspected pregnancy
– aged under 16 or over 60 years
– known hypersensitivity to imidazoles or other vaginal anti-fungal products
Agisten vaginal tablets should not be used if the patient has any of the following
symptoms whereupon medical advice should be sought:
– irregular vaginal bleeding
– abnormal vaginal bleeding or a blood-stained discharge
– vulval or vaginal ulcers, blisters or sores
– lower abdominal pain or dysuria
– any adverse events such as redness, irritation or swelling associated with the treatment
– fever (temperature of 38°C or above) or chills
– nausea or vomiting
– diarrhea
– foul smelling vaginal discharge
Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Agisten tablets. The tablets can be used again if the candidal infection returns after 7 days. However, if the candidal infection occurs more than twice within six months, patients should be advised to consult their physician.

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.
Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus)
Reproductive system and breast disorders: genital peeling, pruritus, rash, edema, discomfort, burning, irritation, pelvic pain
Gastrointestinal disorders: abdominal pain

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently, the effectiveness of such contraceptives may be reduced.
Patients should be advised to use alternative precautions for at least five days after using this product.
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506;
immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be closely monitored for signs and symptoms of tacrolimus overdosage, if necessary by determination of the respective plasma levels.

While controlled clinical studies in pregnant women do not exist epidemiological investigations give no indication that harmful effects on the mother and child should be anticipated when Agisten is used during pregnancy. However, as with all medicine in the first 3 months of pregnancy, clotrimazole should only be used after first consulting a doctor.
Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy.
During pregnancy the treatment should be carried out with Agisten vaginal tablets, since these can be inserted without using an applicator.