Aci-Jel

DESCRIPTION

ACI-JEL Vaginal Jelly is a bland, non-irritating, water-dispersible, buffered acid jelly for intravaginal use. ACI-JEL (vaginal jelly) is classified as a Vaginal Therapeutic Jelly. ACI-JEL (vaginal jelly) contains 0.921% glacial acetic acid (C₂H₄O₂), 0.025% oxyquinoline sulfate (C₁₈H₁₆N₂O₆S), 0.7% ricinoleic acid (C₁₈H₃₄O₃), and 5% glycerin (C₃H₈O₃) compounded withtragacanth,acacia, propylparaben,potassiumhydroxide, stannous chloride, eggalbumen, potassium bitartrate, perfume and purified water. ACI-JEL (vaginal jelly) is formulated to pH 3.9-4.1.

INDICATIONS

ACI-JEL (vaginal jelly) is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.

DOSAGE AND ADMINISTRATION

The usual dose is one applicatorful, administered intravaginally, morning and evening. Duration of treatment may be determined by the patient's response to therapy.

HOW SUPPLIED

85g Tube (NDC 0062-5421-01) with ORTHO® Measured-Dose Applicator.

SIDE EFFECTS

Occasional cases of local stinging and burning have been reported.

药物的相互作用

No incidence of drug interactions have been reported with concomitant use of ACI-JEL (vaginal jelly) and any other medications.Laboratory Tests:The monitoring of vaginal acidity (pH) may be helpful in following the patient's response. (The normal vaginal pH has been shown to be in the range of 4.0 to 5.0.)

警告

No serious adverse reactions or potential safety hazards have been reported with the use of ACI-JEL (vaginal jelly) .

PRECAUTIONS

General:No special care is required for the safe and effective use of ACI-JEL (vaginal jelly) .Drug Interactions:No incidence of drug interactions have been reported with concomitant use of ACI-JEL (vaginal jelly) and any other medications.Laboratory Tests:The monitoring of vaginal acidity (pH) may be helpful in following the patient's response. (The normal vaginal pH has been shown to be in the range of 4.0 to 5.0.)Carcinogenesis:No long-term studies in animals have been performed to evaluatecarcinogenicpotential.Pregnancy:Pregnancy Category C. Animal reproduction studies have not been conducted with ACI-JEL (vaginal jelly) . It is also not known whether ACI-JEL (vaginal jelly) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ACI-JEL (vaginal jelly) should be given to a pregnant woman only if clearly needed.Nursing Mothers:It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ACI-JEL (vaginal jelly) is administered to a nursing woman.

OVERDOSE

No Information Provided.

CONTRAINDICATIONS

None known.

CLINICAL PHARMACOLOGY

ACI-JEL (vaginal jelly) acts to restore and maintain normal vaginal acidity through its buffer action.

PATIENT INFORMATION

No Information Provided.