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Clotrimazole (topical): Drug information

Clotrimazole (topical): Drug information
(For additional information see "Clotrimazole (topical): Patient drug information" and see "Clotrimazole (topical): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • 3 Day Vaginal [OTC];
  • Alevazol [OTC];
  • Antifungal (Clotrimazole) [OTC];
  • Antifungal Clotrimazole [OTC];
  • Clotrimazole 3 Day [OTC];
  • Clotrimazole Anti-Fungal [OTC];
  • Clotrimazole GRx [OTC] [DSC];
  • Desenex [OTC];
  • GoodSense Athletes Foot [OTC];
  • Gyne-Lotrimin 3 [OTC];
  • Gyne-Lotrimin [OTC];
  • Micotrin AC [OTC];
  • Mycozyl AC [OTC];
  • Pro-Ex Antifungal [OTC];
  • Shopko Athletes Foot [OTC] [DSC]
Pharmacologic Category
  • Antifungal Agent, Imidazole Derivative;
  • Antifungal Agent, Oral Nonabsorbed/Partially Absorbed;
  • Antifungal Agent, Topical;
  • Antifungal Agent, Vaginal
Dosing: Adult
Candidiasis, vulvovaginal

Candidiasis, vulvovaginal: Note: A longer duration of up to 14 days may be necessary in patients with complicated infection (ie, recurrent or severe infection, infection with non-albicans Candida, or infection in an immunocompromised host) (CDC [Workowski 2021]; HHS [OI adult 2020]). Not effective against Candida glabrata (IDSA [Pappas 2016]).

Cream 1%: Intravaginal: Insert 1 applicatorful (~5 g) once daily (at bedtime) for 7 days (CDC [Workowski 2021]). May also apply externally twice daily for 7 days, as needed, for itching and irritation.

Canesten 6-day intravaginal cream 1% [Canadian product]: Intravaginal: Insert 1 applicatorful (~5 g) once daily (at bedtime) for 6 days.

Cream 2%: Intravaginal: Insert 1 applicatorful (~5 g) once daily (at bedtime) for 3 days (CDC [Workowski 2021]). May also apply externally twice daily for 7 days, as needed, for itching and irritation.

Cream 10% [Canadian product]: Intravaginal: Insert 1 applicatorful (~5 g) as a single dose (at bedtime).

Tablet [Canadian product]: Note: When tablets are used in conjunction with an external cream, apply cream over the irritated area 1 to 2 times/day, as needed, for up to 7 days.

200 mg tablet: Intravaginal: Insert 1 vaginal tablet once daily for 3 days (at bedtime).

500 mg tablet: Intravaginal: Insert 1 vaginal tablet as a single dose (at bedtime).

Cutaneous candidiasis

Cutaneous candidiasis: Topical:

Cream 1%, solution 1%: Apply to affected area twice daily; if no improvement occurs after 4 weeks of therapy, re-evaluate diagnosis.

Ointment 1% (OTC labeling): Apply to affected area twice daily for 2 weeks.

Otomycosis

Otomycosis (off-label use): Topical: Solution 1%: Instill 4 to 5 drops into the affected ear(s) twice daily for 10 to 14 days (Chander 1996; de la Paz Cota 2018; Goguen 2019); application should begin after thorough cleansing of the ear canal by the provider. Reassess after completion of therapy; if fungal elements are still present, repeat cleansing of the ear canal followed by another 10- to 14-day course of clotrimazole and reassessment. Several cycles of ear cleansing followed by topical therapy and reassessment may be required; persistent otomycosis should be managed by an otolaryngologist (Goguen 2019).

Tinea infections

Tinea infections:

Tinea corporis/tinea cruris (OTC labeling): Topical: Cream 1%, ointment 1%, solution 1%: Apply to affected and surrounding area(s) twice daily until clinical resolution, typically 1 to 4 weeks (Goldstein 2021; van Zuuren 2015; Weinstein 2002; manufacturer's labeling).

Tinea pedis (OTC labeling)/tinea manuum (off-label use): Topical: Cream 1%, ointment 1%, solution 1%: Apply to affected and surrounding area(s) twice daily until 1 week after clinical resolution, typically for 4 weeks total (Goldstein 2021; Gupta 2008; Weinstein 2002; manufacturer's labeling).

Tinea versicolor: Topical: Cream 1%, solution 1%: Apply to affected area(s) and immediate surrounding skin twice daily for 2 weeks (Dehghan 2010; manufacturer’s labeling).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Pediatric

(For additional information see "Clotrimazole (topical): Pediatric drug information")

Cutaneous candidiasis

Cutaneous candidiasis: Topical ointment: Children ≥2 years and Adolescents: Topical: Apply twice daily (morning and night) for 2 weeks.

Tinea corporis, tinea cruris, and tinea pedis

Tinea corporis, tinea cruris, and tinea pedis: Topical cream, ointment, or solution: Children ≥2 years and Adolescents: Topical: Apply twice daily (morning and night). Duration: 2 weeks for tinea cruris; 4 weeks for tinea corporis and tinea pedis

Vulvovaginal candidiasis

Vulvovaginal candidiasis: Children ≥12 years and Adolescents: Intravaginal:

Cream (1%): Insert 1 applicatorful of 1% vaginal cream daily (preferably at bedtime) for 7 consecutive days; some patients may require 14 days (CDC [Workowski 2015]). May also apply externally twice daily for 7 days as needed for itching and irritation.

Cream (2%): Insert 1 applicatorful of 2% vaginal cream daily (preferably at bedtime) for 3 consecutive days. May also apply externally twice daily for 7 days as needed for itching and irritation.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Antifungal (Clotrimazole): 1% (14.2 g, 28.4 g) [contains cetostearyl alcohol, methylparaben, propylene glycol, propylparaben]

Antifungal Clotrimazole: 1% (14 g, 28 g) [contains cetyl alcohol, edetate (edta) trisodium, isopropyl alcohol, methylparaben, propylparaben, trolamine (triethanolamine)]

Clotrimazole Anti-Fungal: 1% (15 g, 30 g) [contains benzyl alcohol, cetostearyl alcohol]

Clotrimazole Anti-Fungal: 1% (45 g) [contains ethylparaben]

Clotrimazole GRx: 1% (14 g [DSC]) [contains benzyl alcohol, cetyl alcohol, polysorbate 80]

Desenex: 1% (30 g)

GoodSense Athletes Foot: 1% (14 g) [contains cetyl alcohol, edetate (edta) trisodium, isopropyl alcohol, methylparaben, propylparaben, trolamine (triethanolamine)]

Micotrin AC: 1% (85 g) [contains cetearyl alcohol, disodium edta, propylene glycol]

Mycozyl AC: 1% (85 g) [contains cetostearyl alcohol, disodium edta, glycerin (soy), propylene glycol]

Pro-Ex Antifungal: 1% (42 g) [contains cetyl alcohol, edetate (edta) trisodium, methylparaben, trolamine (triethanolamine)]

Shopko Athletes Foot: 1% (28.4 g [DSC]) [contains benzyl alcohol, cetostearyl alcohol]

Generic: 1% (15 g, 28 g, 30 g, 45 g)

Cream, Vaginal:

3 Day Vaginal: 2% (21 g) [contains benzyl alcohol, cetyl alcohol]

Clotrimazole 3 Day: 2% (22.2 g)

Gyne-Lotrimin: 1% (45 g) [contains benzyl alcohol]

Gyne-Lotrimin 3: 2% (21 g) [contains benzyl alcohol, cetyl alcohol]

Generic: 1% (45 g)

Ointment, External:

Alevazol: 1% (56.7 g)

Solution, External:

Generic: 1% (10 mL, 29.57 mL, 30 mL)

Generic Equivalent Available: US

Yes

Administration: Adult

Intravaginal: For vaginal use only

Cream: May also be applied externally for itching and irritation of surrounding areas. Do not use tampons, douches, spermicides, or other vaginal products or have vaginal intercourse during treatment.

Vaginal tablet [Canadian product]: Should be inserted deep into the vagina to ensure tablet dissolves completely. If tablet does not dissolve completely within one night, consider use of a vaginal cream.

Topical: For external use only; avoid contact with eyes and application to severely cracked or irritated areas. Cleanse and thoroughly dry area prior to application. Apply a thin layer to affected area. For treatment of athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once a day.

Administration: Pediatric

Topical: For external use only. Apply sparingly and rub gently into the cleansed, affected area; do not apply to the eye. For tinea pedis, also apply to spaces between the toes. Children under 12 years should be supervised during use.

Vaginal: Wash hands before using. Insert full applicator into vagina gently and expel cream into vagina. Wash applicator with soap and water following use. Remain lying down for 30 minutes following administration.

Use: Labeled Indications

Topical cream and solution: Topical treatment of candidiasis due to Candida albicans and tinea versicolor caused by Malassezia furfur

OTC labeling: Topical treatment of tinea pedis, tinea cruris, and tinea corporis

Topical ointment: OTC labeling: Topical treatment of tinea cruris, C. albicans, tinea corporis, and tinea pedis

Vaginal cream: Treatment of vaginal yeast infections and relief of associated external vulvar itching and irritation

Vaginal tablet [Canadian product]: Treatment of vaginal candidiasis

Use: Off-Label: Adult

Otomycosis; Tinea manuum

Medication Safety Issues
Sound-alike/look-alike issues:

Clotrimazole may be confused with co-trimoxazole

Lotrimin may be confused with Lotrisone

International issues:

Cloderm: Brand name for clotrimazole [Germany], but also brand name for alclomethasone [Indonesia]; clobetasol [China, India, Malaysia, Singapore, Thailand]; clocortolone [US, Canada]

Canesten: Brand name for clotrimazole [multiple international markets] may be confused with Canesten Bifonazol Comp brand name for bifonazole/urea [Austria]; Canesten Extra brand name for bifonazole [China, Germany]; Canesten Extra Nagelset brand name for bifonazole/urea [Denmark]; Canesten Fluconazole brand name for fluconazole [New Zealand]; Canesten Oasis brand name for sodium citrate [Great Britain]; Canesten Once Daily brand name for bifonazole [Australia]; Canesten Oral brand name for fluconazole [United Kingdom]; Cenestin brand name for estrogens (conjugated A/synthetic) [US, Canada]

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Vaginal:

1% to 10%: Genitourinary: Vulvovaginal burning

<1% (Limited to important or life-threatening): Burning sensation of the penis (of sexual partner), polyuria, pruritus vulvae, vaginal discharge, vulvar pain, vulvar swelling

Contraindications

Hypersensitivity to clotrimazole or any component of the formulation.

OTC labeling: When used for self-medication, do not use vaginal cream if you have never had a vaginal yeast infection diagnosed by a doctor.

Documentation of allergenic cross-reactivity for imidazole antifungals is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Local irritation: If irritation/sensitivity develops, discontinue therapy and institute appropriate alternative therapy.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: Topical: For external use only; avoid contact with the eyes. Not effective for treatment of scalp or nails. When used for self-medication, discontinue use and contact a healthcare provider if there is no improvement in 2 weeks (jock itch) or 4 weeks (athlete's foot, ringworm).

• Self-medication (OTC use): Vaginal: When used for self-medication (OTC), consult a health care provider before use if experiencing vaginal itching and discomfort for the first time, frequent vaginal yeast infections (eg, monthly, 3 in 6 months), or exposure to HIV. A mild increase in vaginal itching, burning, or irritation may occur with use; a health care provider should be consulted before switching to another agent if patient does not experience complete relief. Discontinue use and contact a health care provider if symptoms do not improve in 3 days or last more than 7 days, or if symptoms of a more serious condition occur (eg, abdominal pain, back/shoulder pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge). For vaginal use only; do not use tampons, douches, spermicides, or other vaginal products or have vaginal intercourse during treatment.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: Avoid combination

Sirolimus (Conventional): Clotrimazole (Topical) may increase the serum concentration of Sirolimus (Conventional). Risk C: Monitor therapy

Tacrolimus (Systemic): Clotrimazole (Topical) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Reproductive Considerations

Vaginal products may weaken latex condoms and diaphragms (CDC [Workowski 2021]).

Pregnancy Considerations

Clotrimazole is minimally absorbed following topical or vaginal administration.

Based on available data, vaginal use of clotrimazole is not associated with an increased risk of adverse pregnancy outcomes (Czeizel 1999; Czeizel 2004; Daniel 2018; Farr 2021; Rotem 2018).

Topical azole therapies with 7-day regimens are recommended in pregnant patients with vulvovaginal candidiasis (CDC [Workowski 2021]). Shorter courses of topical azoles are less effective (Young 2001).

Breastfeeding Considerations

It is not known if clotrimazole is present in breast milk; however, clotrimazole is minimally absorbed following topical or vaginal administration.

Clotrimazole ointment or cream may be used for the topical treatment of nipple or breast candidiasis (ABM [Berens 2016]).

Mechanism of Action

Binds to phospholipids in the fungal cell membrane altering cell wall permeability resulting in loss of essential intracellular elements

Pharmacokinetics

Absorption: Topical: Negligible through intact skin; Intravaginal: 3% to 10% of dose is absorbed

Time to peak, serum: Vaginal cream: ~24 hours

Pricing: US

Cream (Clotrimazole External)

1% (per gram): $0.11 - $1.16

Cream (Clotrimazole Vaginal)

1% (per gram): $0.11 - $0.27

Cream (Desenex External)

1% (per gram): $0.26

Cream (Gyne-Lotrimin 3 Vaginal)

2% (per gram): $0.43

Cream (Gyne-Lotrimin Vaginal)

1% (per gram): $0.16

Cream (Micotrin AC External)

1% (per gram): $23.47

Cream (Mycozyl AC External)

1% (per gram): $23.47

Solution (Clotrimazole External)

1% (per mL): $1.64 - $4.51

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Agisten (IL);
  • Aristen (HK);
  • Axasol (CL);
  • Canagyn (LB);
  • Canazol (TH);
  • Candazole (ET, HK, ID, MY, SG, TH);
  • Candexin (PH);
  • Candibene (CZ, UA);
  • Candid (BF, BJ, CI, ET, GH, GM, GN, KE, LK, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UA, UG, VE, ZM, ZW);
  • Candid Mouth Paint (TH);
  • Candid-V3 (TH);
  • Candidex (LK);
  • Candistan (EG);
  • Candiva (PH);
  • Candizole (ZA);
  • Canesten (AE, AT, AU, BF, BG, BH, BJ, BO, BR, CH, CI, CL, CO, CY, CZ, DK, EC, EE, EG, ES, ET, FI, GB, GH, GM, GN, GR, HK, HR, IE, IN, IQ, IR, IS, IT, JO, KE, KR, KW, LB, LR, LT, LY, MA, ML, MR, MT, MU, MW, NE, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, SY, TH, TN, TR, TZ, UA, UG, UY, VE, VN, YE, ZA, ZM, ZW);
  • Canesten 1 (KR);
  • Canestene (BE);
  • Canestene Derm (LU);
  • Canifug (DE, LV);
  • Canison (PH);
  • Chingazol (TH);
  • Cloderm (DE);
  • Clomazol (EC, NZ);
  • Clonea (AU);
  • Clonitia (ID);
  • Closcript (ZW);
  • Clothree (IL);
  • Clotrasone (CN);
  • Clotrex (CR, DO, GT, HN, NI, PA, QA, SV);
  • Clotriderm (ZW);
  • Clotriderm V.T. (HK);
  • Clotrikam-V (HK);
  • Clotrim (BD, BH, JO);
  • Clotrimaderm (IL);
  • Clotrine (ET);
  • Clotrizole (LK);
  • Clovacare (PH);
  • Clozole (QA);
  • Cotren (TH);
  • Covospor (ZA);
  • Dermason (BD);
  • Dermatin (AE, CY, EG, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE);
  • Dermazole (JO);
  • Dermizole (TH);
  • Empecid (AR, PY);
  • Endid (LK);
  • Epicort (CO);
  • Factodin (GR);
  • Fungicare (IL);
  • Fungicide (TW);
  • Fungiderm (TH);
  • Ginet (PE);
  • Gyno Canesten (CN);
  • Imazol (DE, EE, UA, VE);
  • Kamicin (HK);
  • Klotrimasool (EE);
  • Krema-Rosa (AE, CY, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE);
  • Lotramina (PE);
  • Lotremin (MY);
  • Mycocid (IN);
  • Mycohermal (AE);
  • Mycoril (BH, ET, SG, TW);
  • Mycozole (TH);
  • Opizole (BH, QA);
  • Pan-Fungex (PT);
  • SD-Hermal (DE);
  • Taraten (TH);
  • Triderm (LK);
  • Trimaze (ZA);
  • Vagizol (PH);
  • Vanesten (TH);
  • Yeastazol (PH);
  • Zema (TH)


For country code abbreviations (show table)
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  2. Alevazol (clotrimazole) [prescribing information]. Powell, OH: Capital Pharmaceuticals LLC; June 2016.
  3. Berens P, Eglash A, Malloy M, Steube AM. ABM clinical protocol #26: persistent pain with breastfeeding. Breastfeed Med. 2016;11(2):46-53. doi:10.1089/bfm.2016.29002.pjb [PubMed 26881962]
  4. Canesten (clotrimazole) [product monograph]. Mississauga, Ontario, Canada: Bayer Inc; October 2018.
  5. Centers for Disease Control and Prevention (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm. [PubMed 6810084]
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  9. Clotrimazole 3 day vaginal cream [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals U.S.A. Inc; October 2016.
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  11. Czeizel AE, Fladung B, Vargha P. Preterm birth reduction after clotrimazole treatment during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2004;116(2):157-163. doi:10.1016/j.ejogrb.2004.02.011 [PubMed 15358456]
  12. Czeizel AE, Tóth M, Rockenbauer M. No teratogenic effect after clotrimazole therapy during pregnancy. Epidemiology. 1999;10(4):437-440. doi:10.1097/00001648-199907000-00013 [PubMed 10401880]
  13. Daniel S, Rotem R, Koren G, Lunenfeld E, Levy A. Vaginal antimycotics and the risk for spontaneous abortions. Am J Obstet Gynecol. 2018;218(6):601.e1-601.e7. doi:10.1016/j.ajog.2018.02.013 [PubMed 29510088]
  14. Dehghan M, Akbari N, Alborzi N, Sadani S, Keshtkar AA. Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: a double-blind randomized controlled trial. J Dermatol. 2010;37(8):699-702. doi:10.1111/j.1346-8138.2010.00908.x [PubMed 20649710]
  15. de la Paz Cota BR, Cepero Vega PP, Matus Navarrete JJ, et al. Efficacy and safety of eberconazole 1% otic solution compared to clotrimazole 1% solution in patients with otomycosis. Am J Otolaryngol. 2018;39(3):307-312. doi: 10.1016/j.amjoto.2018.03.017. [PubMed 29551350]
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  18. Goldstein AO, Goldstein BG. Dermatophyte (tinea) infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 24, 2021.
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  20. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  21. Khan F, Muhammad R, Khan MR, et al. Efficacy of topical clotrimazole in treatment of otomycosis. J Ayub Med Coll Abbottabad. 2013;25(1-2):78–80. [PubMed 25098061]
  22. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;62(4):e1-e50. doi:10.1093/cid/civ933 [PubMed 26679628]
  23. Paulose KO, Al Khalifa S, Shenoy P, Sharma RK. Mycotic infection of the ear (otomycosis): a prospective study. J Laryngol Otol. 1989;103(1):30–35. doi: 10.1017/s0022215100107960. [PubMed 2921549]
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  25. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Accessed May 6, 2020.
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