Aci-Jel

What is Aci-Jel and how is it used?

Aci-Jel is a prescription medicine used to help restore and maintain the natural acid balance of the vagina. Aci-Jel may be used alone or with other medications.

Aci-Jel belongs to a class of drugs called Urologics, Other; Vaginal Preparations, Other.

It is not known if Aci-Jel is safe and effective in children.

What are the possible side effects of Aci-Jel?

Aci-Jel may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• abdominal pain, swelling or tenderness,
• vaginal discharge, itching, or odor, and
• vaginal pain

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Aci-Jel include:

• mild vaginal irritation,
• itching, and
• burning

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Aci-Jel. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 (C ₂ H ₄ O ₂ ), 0.025% oxyquinoline sulfate (C ₁₈ H ₁₆ N ₂ O ₆ S), 0.7% ricinoleic acid (C ₁₈ H ₃₄ O ₃ ), and 5% glycerin (C ₃ H ₈ O ₃ ) compounded with tragacanth, acacia, propylparaben, potassium hydroxide, stannous chloride, egg albumen, 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.

 

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.)

WARNINGS

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 evaluate carcinogenic potential. 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.