Acetic Acid; Glycerin; Oxyquinoline Sulfate; Ricinoleic Acid (3478)
[ a-cee'-tic as'-id; glyc'-er-in; ox-y-kwin'-oh-lin sul'-fate; ris-in-oh-lay'-ik as'-id ]
| Ingredients: |
Acetic Acid; Glycerin; Oxyquinoline Sulfate; Ricinoleic Acid |
| Indications: |
Alkalosis, vaginal |
| Pregnancy Category: |
C |
| FDA Approved: |
2000- 01- 01 |
| Brand Names: |
Acidic Vaginal Jelly
-
US
;
Acid Jelly
-
US
;
Aci-Jel
-
US
;
Fem pH
-
US
;
Relagard
-
US
;
|
| DEA schedules: |
(none)
|
DESCRIPTION
|
| |
Acid Jelly is a bland, non- irritating, water- dispersible, buffered acid jelly for intravaginal use. Acid Jelly is classified
as a Vaginal Therapeutic Jelly. Acid Jelly 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 albumen, potassium bitartrate,
perfume and purified water. Acid Jelly is formulated to pH 3.9- 4.1.
|
CLINICAL PHARMACOLOGY
|
| |
Acid Jelly acts to restore and maintain normal vaginal acidity through its buffer action.
|
INDICATIONS AND USAGE
|
| |
Acid Jelly is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.
|
CONTRAINDICATIONS
|
| |
None known.
|
WARNINGS
|
| |
No serious adverse reactions or potential safety hazards have been reported with the use of Acid Jelly.
|
PRECAUTIONS
|
| |
General: No special care is required for the safe and effective use of Acid Jelly.
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 3.8- 4.2.)
Carcinogenesis: No long- term studies in animals have been performed to evaluate carcinogenic potential.
Pregnancy Category C: Animal reproduction studies have not been conducted with Acid Jelly. It is also not known whether Acid Jelly can cause fetal
harm when administered to a pregnant woman or can affect reproductive capacity. Acid 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 Acid Jelly is administered to a nursing woman.
|
DRUG INTERACTIONS
|
| |
No incidence of drug interactions have been reported with concomitant use of Acid Jelly and any other medications.
|
ADVERSE REACTIONS
|
| |
Occasional cases of local stinging and burning have been reported.
|
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
|
| |
Storage: Store at controlled room temperature 15- 30°C (59- 86°F).
|
PRODUCT IDENTIFICATION
|
| |
None Available |
PRODUCT LISTING - EQUIVALENTS NOT AVAILABLE
|
| |
| gel - vaginal - 0.92% -
|
| 50.0 gm |
$21.94 |
Fem pH
Pharmics Inc
|
00813079955 |
| 50.0 gm |
$21.95 |
Relagard
Blansett Pharmacal Company Inc
|
51674013005 |
| 85.0 gm |
$25.02 |
Aci- Jel
Allscripts Healthcare Solutions
|
54569125200 |
| 85.0 gm |
$27.05 |
Acidic Vaginal Jelly
Qualitest Pharmaceuticals Inc
|
00603770192 |
| 85.0 gm |
$31.50 |
Acid Jelly
Hope Pharmaceuticals
|
60267012585 |
| 85.0 gm |
$34.68 |
Aci- Jel
Janssen Pharmaceuticals
|
00062542101 |
| 85.0 gm |
$34.90 |
Aci- Jel
Physicians Total Care
|
54868037700 |
|
|