A non-irritating, water-dispersible acid gel for vaginal use. The drug is a combination product containing oxyquinoline sulfate 0.025% and sodium lauryl sulfate 0.01% that is adjusted to a pH of 4 (slightly lower than the normal vaginal pH of roughly 4.3). This vaginal gel is used as adjunctive therapy to restore and maintain vaginal acidity; this action helps reduce odor causing bacteria. Some advantages to using the vaginal gel are: it will not stain skin or natural fabrics, it helps to eliminate odors, and it can be used during menstruation. Oxyquinoline; sodium lauryl sulfate vaginal gel is a prescription product that was first marketed in 1977.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Intravaginal Administration
-Oxyquinoline; sodium lauryl sulfate vaginal gel is administered intravaginally.
-Instruct patient on proper administration and treatment course.
-Counsel the patient not to use tampons, douches, or spermicides during the treatment course; the patient should also be instructed to abstain from sexual activity during treatment if an active infection is present. It is possible that oxyquinoline; sodium lauryl sulfate vaginal gel may damage condoms, diaphragms, vaginal rings and cervical caps and cause them to fail.
Vaginal Administration:
-Ensure that any Inflat-o-ball or Cube Pessary is removed prior to insertion of oxyquinoline; sodium lauryl sulfate vaginal gel.
-Wash hands before and after use. Use universal precautions (i.e., gloves) for application if needed.
-Pierce end of tube with top of cap (a small amount of gel may escape when top of tube is pierced). Attach threaded end of the jel-jector to gel tube.
-While holding tube with attached jel-jector, squeeze tube from bottom until gel reaches specified dosage level. Detach jel-jector from tube
-Gently insert jel-jector approximately one-half inch into the vagina. Squeeze bulb vigorously once to dispense gel. Keep bulb compressed until the jel-jector is removed from the vagina. Clean the jel-jector immediately after use by flushing the jector (compressing bulb) several times, holding jel-jector under water. The "pin" hole at the top of the bulb is an air release hole. Do NOT tape over this hole or otherwise block this hole. This "pin" hole is not a defect in the bulb.
-After each use, wipe threads of tube and inside of cap. Recap tightly.
-To avoid spreading infection, the product is for use by only 1 patient. Do not share this product with others.
No serious adverse reactions or potential safety hazards have been reported with the use of oxyquinoline; sodium lauryl sulfate vaginal gel. In general, oxyquinoline; sodium lauryl sulfate vaginal gel is well tolerated. Occasional cases of transient vaginal irritation (local stinging and burning) have been reported.
Oxyquinoline; sodium lauryl sulfate vaginal gel preparations are acidic with a pH of roughly 4.0. The concurrent use of oxyquinoline; sodium lauryl sulfate vaginal gel with contraceptive devices (e.g., latex condoms, vaginal contraceptive diaphragms, vaginal rings, or cervical caps) may potentially alter the composition of the latex or rubber product, leading to contraceptive failure. Specific data detailing the interaction between these products are not available. Concurrent use of these contraceptive devices with oxyquinoline; sodium lauryl sulfate vaginal gel preparations is not recommended. An alternative method of birth control should be employed.
Oxyquinoline; sodium lauryl sulfate vaginal gel has not been tested for use during pregnancy and is not recommended for use in pregnant patients. In patients desiring pregnancy, do not use oxyquinoline; sodium lauryl sulfate vaginal gel or any other personal hygiene product vaginally (douches, vaginal sprays, jellies or suppositories), for 6 hours prior to or following intercourse. Any product used within this time period could interfere with conception.
It is not known if oxyquinoline; sodium lauryl sulfate vaginal gel is excreted into human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For vaginal acidification:
Intravaginal dosage:
Adult females: For new pessary wearers, insert one-half of an applicatorful of gel intravaginally 3 times weekly during the first week after original insertion of pessary. Then one-half an applicatorful of gel intravaginally twice weekly thereafter.
Maximum Dosage Limits:
-Adults
No maximum dosage information is available.
-Geriatric
No maximum dosage information is available.
-Adolescents
Use not recommended.
-Children
Use not recommended.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Oxyquinoline; Sodium Lauryl Sulfate products.
Oxyquinoline; sodium lauryl sulfate vaginal gel acts to restore and maintain normal vaginal acidity through it's local buffering action. Vaginal pH is typically in the range of 4 to 5. The pH of the vagina may become more alkaline due to alterations in normal microflora, presence of blood, mucous or cellular material. Maintaining a normal pH may help to prevent overgrowth of candidiasis or other abnormal organisms.
Oxyquinoline; sodium lauryl sulfate vaginal gel is administered intravaginally. There are no specific pharmacokinetic data describing oxyquinoline; sodium lauryl sulfate vaginal gel.
-Route-Specific Pharmacokinetics
Other Route(s)
Vaginal Route
There are no specific pharmacokinetic data describing oxyquinoline; sodium lauryl sulfate vaginal gel.