US Pharm. 2010;35(9):14-23.
Vaginal fungal infections, also known as vulvovaginal candidiasis (VVC) or yeast infections, are common and often frequently recurring female genital problems.1 For a variety of reasons, many patients do not wish to see a prescriber. Instead, they attempt self-treatment with nonprescription products. However, vaginal antifungals are not the simple products they seem to be. Prior to use, the patient must understand proper application, contraindications, and whether use of the product is appropriate at all.2
Prevalence of Infection
Vaginitis is the presenting complaint in over 10 million physician visits annually.2 Three-fourths of women will experience one or more incidents of VVC in their lifetime, and an estimated 40% to 45% will have two or more episodes.1,3
Epidemiology
Several factors predispose women to VVC.2,4 Age is predictive, in that the incidence rises rapidly after menarche, but drops precipitously after menopause.2 Medications can be causal or contributory. Antibiotics alter the normal vaginal microenvironment, giving candidal organisms an advantage. Estrogens, whether administered for postmenopausal replacement or as oral contraceptives, enhance vaginal cell glycogen production, facilitating adherence by candidal organisms. Impaired cell-mediated immunity (e.g., HIV/AIDS, high-dose corticosteroids, other immunosuppressants) hinders the patient in combating infection, thus increasing risk.5 Patients with diabetes are also more prone to experience VVC.6 Women must be taught to cleanse correctly following bowel movements. If they cleanse from the bottom forward, they may carry fecal candida to the vagina, thus increasing the risk of VVC.
Etiology
While there are other causes of vaginitis (e.g., Trichomonas, contact dermatitis, irritant dermatitis), the most common cause is fungal.7 The prime offender is Candida albicans, the causal organism in 80% of cases.2,8 It is a normal commensal opportunistic resident of the genital and gastrointestinal tracts, being found in 20% to 25% of females who are asymptomatic.1,9-11 Its high incidence is due to the fact that it is fully viable under a wide range of temperatures and pH levels. Other Candida species may also be causal. They include Candida glabrata, Candida parapsilosis, Candida tropicalis, and Candida krusei.2,10,12
Manifestations
Manifestations of VVC include vulvar pruritus, vaginal discomfort ranging from soreness to overt pain, inflammation, erythema, dyspareunia, external discomfort when urinating, fissuring and/or excoriation of the affected area, and an abnormal vaginal discharge.1,2,11,13 The discharge ranges from a scant, thin, whitish discharge to a thick, white material that resembles cottage cheese due to clumping.1,11,14
Nonprescription Treatment of Vaginal Fungal Infections
The FDA approval for the Rx-to-OTC switch of vaginal antifungals at the beginning of the 1990s was a groundbreaking event in self-care for females. Pharmacists who were practicing at that time may recall the national shortages of Gyne-Lotrimin 7 in late 1990 and of Monistat 7 in early 1991. The manufacturers did not anticipate the overwhelming female desire to self-treat VVC without the intervention of a physician. As a result, pharmacists were bombarded with patients wishing to know when the next shipment would arrive. Many patients purchased two or three packages at a time, knowing that the problem was recurrent and preparing for future episodes.
The products carry numerous sophisticated instructions, warnings, and contraindications that are best explained by the pharmacist.1,2,11 Nevertheless, when the products were switched to OTC status, they could be sold in any gas station or convenience store. A pharmacist’s presence at the point of sale adds value in helping patients understand the labeling.
Patients must first understand that they should only use the product if they have had a prior, physician-diagnosed vaginal fungal infection.11 The FDA assumed that VVC symptoms are so consistent that any woman who has had the initial diagnosis is competent to self-diagnose for the rest of her life.2,15 The CDC was not convinced, however. They stated, “Women whose condition has previously been diagnosed with VVC are not necessarily more likely to be able to diagnose themselves.”1 The pharmacist can point out additional labeling that helps the patient somewhat, such as a warning not to use the products if this is the first time she has had vaginal itching and discomfort, or if she has a foul-smelling vaginal discharge.1
Patients should be instructed that products are available for 1-day, 3-day, and the original 7-day therapy. With the 7-day therapy, symptoms are often absent by the end of therapy.1 One-day and 3-day products were introduced for convenience and to help compliance. However, patients should be advised that symptoms are seldom absent after use of the 1- and 3-day products, and that it may take 5 to 7 days for relief of symptoms.1 Patients should not purchase additional 3-day or 1-day products, but should wait a few additional days. If symptoms persist for more than 7 days after use of any product, patients should see a physician to rule out the presence of resistant candidal organisms or nonfungal pathogens.
Pharmacists should ask the patient the length of time since the last recurrence. If it has been 2 months or less since the previous episode, she should be urged to see a physician.2 Recurrent VVC may signal diabetes, pregnancy, HIV/AIDS, or other immunodeficiency diseases.
The patient may choose among suppositories (i.e., ovules or tablets), ointments, and creams. She may ask the pharmacist which is preferable. Both are fully effective, so the choice is up to the patient. Past satisfaction or dissatisfaction with that dosage form is a vital predictor of which product the patient will wish to purchase. She should be advised to insert products at night to increase contact time with vaginal mucosa and reduce the risk of accidental ejection of the suppository or leakage of the cream.2 One product, Monistat 1 Day or Night Combination Pack, claims that its vaginal insert stays in place whenever it is used.2
The products do not stain clothing, but a sanitary pad can help absorb leakage and discharge and will protect the clothing. Avoid using the product with a tampon, as it will absorb the antifungal, compromising its efficacy.
Some multiday products come with reusable applicators that must be refilled before each use (e.g., Gyne-Lotrimin 7 Vaginal Cream).2 The patient should be advised to wash the applicator thoroughly between applications and be sure that it dries to prevent growth of organisms. In order to increase convenience, most companies market their multiday products with disposable, prefilled applicators. Multiday products should be used for 3 or 7 days in a row.11 The patient should continue using the product even if menstrual flow begins. She should not douche during treatment to prevent washout of the product. Patients should avoid intercourse during use and should refrain from using spermicides and any other vaginal product.
Vaginal antifungal products may be formulated with ingredients that can damage latex contraceptives (e.g., petrolatum, mineral oil).1,2 Patients who rely on condoms, diaphragms, or the cervical cap should read the labels of products prior to purchase. Unless the product carries a specific statement ensuring compatibility when used concomitantly with these latex products, it should be avoided. Latex products should not be used within 72 hours of an incompatible antifungal. Alternatively, the patient may choose nonlatex condoms, such as those made of polyisoprene (e.g., Skyn) or polyurethane (e.g., Trojan Supra).
Vaginal antifungals should not be sold to any patient who is under the age of 12 years.2 The patient must be referred to rule out such serious issues as sexual abuse, bacterial vaginosis, chemical irritation, or childish insertion of a foreign object that remains lodged in the vagina.
The patient should be referred if she exhibits any sign of a sexually transmitted disease. This includes fever, chills, nausea, vomiting, rash, lower abdominal pain, back pain, foul-smelling discharge, or pain in either shoulder.2
Products proven safe and effective include imidazoles, capable of curing 85% to 90% of VVC, and causing mild reactions only occasionally (e.g., contact dermatitis, irritant dermatitis). If a woman taking warfarin uses vaginal miconazole, it may increase her prothrombin time.16
One-day products include Vagistat-1 Ointment (6.5% tioconazole), Monistat 1-Day Treatment (6.5% tioconazole), Monistat 1 Combination Pack (1,200 mg miconazole in an insert and miconazole nitrate 2% cream for external pruritus), and Monistat 1 Day or Night Combination Pack (1,200 mg miconazole ovule and 2% miconazole cream).2 Three-day products include Gyne-Lotrimin 3 Vaginal Cream (2% clotrimazole cream in a tube with 3 disposable applicators), Vagistat-3 Combination Pack (3 vaginal suppositories containing 2% miconazole, 3 disposable applicators, and 2% miconazole external cream), and Monistat 3 Cream (3 applicators prefilled with 4% miconazole). Seven-day products include Gyne-Lotrimin 7 Cream (1% clotrimazole with a single, reusable applicator) and Monistat 7 Combination Pack (7 applicators prefilled with 2% miconazole cream and a small tube of miconazole 2% for external use).2
Products to Avoid
There are numerous safe and effective vaginal antifungal products. For this reason, it is unwise for the pharmacist to either stock or recommend any of the unproven herbal, probiotic, or homeopathic products that claim to treat vaginal infections without proof of their safety or efficacy. For instance, a popular oral homeopathic product advertised as “natural relief” for vaginitis purports to contain C albicans, “kreosotum” (apparently wood tar), phenol, and table salt—all highly diluted so that the tablets contain only lactose.17 The dilution factor is irrelevant, however, as none of the ingredients is known to be effective for vaginitis in any case, and ingesting Candida for a candidal infection is wholly irrational. Stocking and selling unproven products such as this in lieu of products proven safe and effective is not in the best interests of the patients who place their trust in pharmacists.
What Are the Symptoms of an Infection?
One of the hallmark symptoms of a vaginal fungal infection is the discharge. With this type of infection, the discharge may be watery and white or thick, whitish, and clumpy. In the latter case, it resembles cottage cheese in consistency. The woman may also notice that intercourse is uncomfortable or even painful. It may hurt to pass urine, too. The outer genital area (vulva) may be red or swollen, and the vagina and surrounding area may itch or burn.
Is This a Sexually Transmitted Disease?
Some women worry that the infection was contracted through sexual intercourse, but it is not common for a woman to catch this from a man. However, a male can develop the infection after contact with an infected female. If he does, he may notice itching or a rash on the penis. He should see a physician for care, as no OTC product is proven safe or effective for treating this problem in men.
What Help Is Available?
You may choose from one of several nonprescription antifungals that are proven safe and effective in curing vaginal fungal infections when used according to all of the directions on the label. These products contain one of three proven ingredients: clotrimazole, miconazole, or tioconazole. They are available as ointments, creams, or suppositories for 1-, 3-, or 7-day therapy. Trade names include Gyne-Lotrimin, Monistat, and Vagistat.
Avoid products labeled as “natural,” “homeopathic,” or “probiotic,” as they are not FDA approved as safe or effective and could possibly allow the infection to worsen. These unproven products carry such trade names as Azo Yeast, Nature’s Cure, YeastGard, Yeastaway, Hyland’s Vaginitis, NatraBio Candida Yeast Relief, and VH Essentials.
Who Should Use Antifungals?
The only women who can safely use nonprescription products for vaginal fungal infections are those who have already had a candidal (fungal) vaginal infection and for whom it was diagnosed as such by a physician. Once you have had this diagnosis, you can safely recognize these infections for the rest of your life.
However, if you have never had such an infection, you may be mistaken about what it is, and could have another problem that will not be helped by the OTC products, such as a trichomonal or bacterial vaginal infection. If you use the products in these cases, you delay proper treatment and the condition will only worsen.
You should not use OTC antifungals if you are under the age of 12 years, if you are pregnant, or if you have signs of a sexually transmitted disease, such as fever, chills, nausea, vomiting, rash, lower abdominal pain, back pain, a foul-smelling discharge, or pain in the shoulder(s).
Further, if your vaginal fungal infection comes back within 2 months, this could be a sign of pregnancy, diabetes, or even HIV/AIDS. You should check with your physician rather than attempt self-treatment.
Remember, if you have questions, Consult Your Pharmacist.
REFERENCES
1. Sexually transmitted diseases treatment guidelines 2006. Diseases characterized by vaginal discharge. CDC. www.cdc.gov/std/treatment/
2. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
3. Weissenbacher TM, Witkin SS, Gingelmaier A, et al. Relationship between recurrent vulvovaginal candidiasis and immune mediators in vaginal fluid. Eur J Obstet Gynecol Reprod Biol. 2009;144:59-63.
4. Hof H. Mycoses in the elderly. Eur J Clin Microbiol Inf Dis. 2010;29:5-13.
5. Richardson M, Rautemaa R. How the host fights against Candida infections. Front Biosci. 2009;14:4363-4375.
6. Antony G, Saralaya V, Gopalkrishna Bhat K, et al. Effect of phenotypic switching on expression of virulence factors by Candida albicans causing candidiasis in diabetic patients. Rev Iberoam Micol. 2009;26:202-205.
7. Al-Awadhi R, Al-Ramadan BA, George SS, et al. Gynecologic infections seen in cervical smears in Kuwait. Acta Cytol. 2010;54:50-54.
8. Babic M, Hukic M. Candida albicans and non-albicans species as etiological agent of vaginitis in pregnant and non-pregnant women. Bosn J Basic Med Sci. 2010;10:89-97.
9. Hay RJ, Jones RM. New molecular tools in the diagnosis of superficial fungal infections. Clin Dermatol. 2010;28:190-196.
10. Hettiarachchi N, Ashbee HR, Wilson JD. Prevalence and management of non-albicans vaginal candidiasis. Sex Transm Infect. 2010;86:99-100.
11. Vaginal yeast infection. MedlinePlus. www.nlm.nih.gov/medlineplus/
12. Sivasubramanian G, Sobel JD. Refractor urinary tract and vulvovaginal infection caused by Candida krusei. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:1379-1381.
13. Marot-Leblond A, Nail-Billaud S, Pilon F, et al. Efficient diagnosis of vulvovaginal candidiasis by use of a new rapid immunochromatography test. J Clin Microbiol. 2009;47:3821-3825.
14. Lowe NK, Neal JL, Ryan-Wenger NA. Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard. Obstet Gynecol. 2009;113:89-95.
15. Ryan-Wenger NA, Neal JL, Jones AS, et al. Accuracy of vaginal symptom self-diagnosis algorithms for deployed military women. Nurs Res. 2010;59:2-10.
16. Miconazole. Safety information. FDA. www.fda.gov/Safety/Medwatch/
17. Hyland’s Products: Vaginitis. Hyland’s Homeopathic. www.hylands.com/products/
18. Monistat Coolwipes. McNeil-PPC, Inc. www.monistat.com/soothing-
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