Acetic Acid; Oxyquinoline Sulfate (0091)
| Ingredients: |
Acetic Acid; Oxyquinoline Sulfate |
| Indications: |
Vaginitis, adjunct |
| Pregnancy Category: |
C |
| FDA Approved: |
pre- 1938 |
| Brand Names: |
|
| DEA schedules: |
(none)
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DESCRIPTION
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Aci- Jel Vaginal Jelly is a bland, non- irritating, water- dispersible, buffered acid jelly for intravaginal use. Aci- Jel
is classified as a Vaginal Therapeutic Jelly.
Aci- Jel contains 0.921% glacial acetic acid (C2 H4 O2 ), 0.025% oxyquinoline sulfate (C18 H16 N2 O6 S), 0.7% ricinoleic acid (C18 H34 O3 ), and 5% glycerin (C3 H8 O3 ) compounded with tragacanth, acacia, propylparaben, potassium hydroxide, stannous chloride, egg albumin, potassium bitartrate,
perfume and purified water. Aci- Jel is formulated to pH 3.9- 4.1
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CLINICAL PHARMACOLOGY
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Acetic acid and oxyquinoline sulfate acts to restore and maintain normal vaginal acidity through its buffer action.
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INDICATIONS AND USAGE
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Acetic acid and oxyquinoline sulfate is indicated as adjunctive therapy in those case where restoration and maintenance of
vaginal acidity is desirable.
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CONTRAINDICATIONS
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None known.
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WARNINGS
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No serious adverse reactions or potential safety hazards have been reported with the use of acetic acid and oxyquinoline sulfate.
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PRECAUTIONS
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General
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No special care is required for the safe and effective use of acetic acid and oxyquinoline sulfate.
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Laboratory Tests
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The monitoring of vaginal acidity (pH) may be helpful in following the patients response. (The normal vaginal pH has been
shown to be in the range of 4.0- 5.0)
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Carcinogenesis
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No long- term studies in animals have been performed to evaluate carcinogenic potential.
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Pregnancy Category C
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Animal reproduction studies have not been conducted with acetic acid and oxyquinoline sulfate. It is also not known whether
acetic acid and oxyquinoline sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Acetic acid and oxyquinoline sulfate should be given to a pregnant woman only if clearly needed.
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Nursing Mothers
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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 acetic acid and oxyquinoline sulfate is administered to a nursing woman.
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DRUG INTERACTIONS
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No incidence of drug interactions have been reported with concomitant use of acetic acid and oxyquinoline sulfate and any
other medications.
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ADVERSE REACTIONS
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Occasional cases of local stinging and burning have been reported.
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DOSAGE AND ADMINISTRATION
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The usual dose is one applicatorful, administered intravaginally, morning and evening. Duration of treatment may be determined
by the patients response to therapy.
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PRODUCT IDENTIFICATION
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None Available |
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