Effective Date

Date of Origin   

04-01-2025           

Acticlate®

(doxycycline hyclate)

Tablet*

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

Adjunctive therapy for acute intestinal amebiasis adjunct to amebicides

Prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains

Adjunctive therapy for severe acne

*generic available

24

Doryx®, Doxycycline Hyclate

Delayed-release tablet*

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

Adjunctive therapy for acute intestinal amebiasis adjunct to amebicides

Prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains

Adjunctive therapy for severe acne

*generic available

3

Doryx® MPC

(doxycycline hyclate)

Delayed-release tablet

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

Adjunctive therapy for acute intestinal amebiasis adjunct to amebicides

Prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains

Adjunctive therapy for severe acne

1

doxycycline hyclate

Capsule*

Delayed-release tablet*

Tablet*

Capsule, Delayed-Release Tablet, Tablet (50mg, 100mg):

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides

For the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains

In severe acne, doxycycline may be useful adjunctive therapy

Tablet (20mg):

For use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis

*generic available

4,7,29

doxycycline monohydrate

Capsule*

Tablet*

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

Adjunctive therapy for acute intestinal amebiasis adjunct to amebicides

Adjunctive therapy for severe acne

*generic available

2,5

Emrosi™

(minocycline hydrochloride)

Extended-release capsule

Treatment of inflammatory lesions (papules and pustules) of rosacea in adults

Limitations of use:

• This formulation of minocycline has not been evaluated in the treatment or prevention of infections
• To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use only as indicated

20

LymePak™

(doxycycline hyclate)

Tablet*

Treatment of early Lyme disease (as evidenced by erythema migrans) due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above

*generic available

33

minocycline hydrochloride

Capsule*

Tablet*

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

Adjunctive therapy for acute intestinal amebiasis adjunct to amebicides

Adjunctive therapy for severe acne

Treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx

• Oral minocycline is not indicated for the treatment of meningococcal infection

*generic available

10,11

minocycline hydrochloride

Extended-release tablet*

Treatment of only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older

Limitations of use:

• Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. 

*generic available

30

Minolira™

(minocycline hydrochloride)

Extended-release tablet

Treatment of only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older

Limitations of Use:

• This formulation of minocycline has not been evaluated in the treatment of infections.

26

Oracea®

(doxycycline)

Delayed-release capsule*

Treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.

Limitations of use:

• This formulation of doxycycline has not been evaluated in the treatment or prevention of infections.
• Oracea has not been evaluated for the treatment of erythematous, telangiectatic, or ocular components of rosacea. 

*generic available

6

Seysara®

(sarecycline hydrochloride)

Tablet

Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age or older

Limitations of Use:

• Efficacy of Seysara beyond 12 weeks and safety beyond 12 months have not been established.
• Seysara has not been evaluated in the treatment of infections.

28

Solodyn®

(minocycline hydrochloride)

Extended-release tablet*

Treatment of only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older 

Limitations of use:

• Solodyn did not demonstrate any effect on non-inflammatory lesions. 
• Safety of Solodyn has not been established beyond 12 weeks of use. 
• This formulation of minocycline has not been evaluated in the treatment of infections. 

*generic available

12

Targadox®

(doxycycline hyclate)

Tablet*

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

Adjunctive therapy for acute intestinal amebiasis adjunct to amebicides

Prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains

Adjunctive therapy for severe acne

*generic available

25

Tetracycline

Capsule*

Tablet

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

Adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica

Adjunctive therapy for severe acne

*generic available

31,32

Vibramycin®

Capsule (doxycycline hyclate)*

Suspension (doxycycline monohydrate)*

Treatment of infections due to susceptible strains of microorganisms (refer to labeling for additional details)

Adjunctive therapy for acute intestinal amebiasis adjunct to amebicides

Prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains

Adjunctive therapy for severe acne

*generic available

8

Ximino®, Minocycline Hydrochloride

Extended-release capsule

To treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older

Limitations of Use:

• Ximino did not demonstrate any effect on non-inflammatory acne lesions. Safety of Ximino has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. 

27

Acne Vulgaris

Acne vulgaris is a common, chronic, inflammatory skin disorder of the pilosebaceous unit. Signs and symptoms include comedones, papules, pustules, or nodules on the face, but may also affect the upper arms, trunk, and back. Acne vulgaris most commonly occurs in adolescents, but it can affect most age groups and can persist into adulthood.(15,16) Topical therapies are the mainstay of acne treatment, and are used alone or in combination with other topical or oral agents. Using a combination of multiple mechanisms of action of topical therapies is recommended as multimodal therapy to optimize efficacy and reduce the risk of antibiotic resistance. Systemic oral antibiotics are typically used to treat moderate to severe acne. (15)

Topical retinoids are vitamin A derivatives and are strongly recommended for the treatment of acne by the American Academy of Dermatology (AAD). Topical retinoid agents include tretinoin, adapalene, tazarotene, and trifarotene. Only modest differences in activity, tolerability, and efficacy have been noted between the different retinoids, and comparative effectiveness data does not suggest superiority of one topical retinoid against another.(15)

BP is strongly recommended by the AAD for the treatment of acne. BP is a topical antimicrobial agent and is available over-the-counter. BP use is limited by concentration and formulation dependent side effects, including burning, stinging, dryness, erythema, and irritation. (15)

Topical antibiotics are strongly recommended by the AAD for the treatment of acne and have both antibacterial and anti-inflammatory effects. Treatment options include erythromycin, clindamycin, minocycline, and dapsone. Topical antibiotic monotherapy is not recommended due to the risk of antibiotic resistance, and they should be used in combination with BP and/or a topical retinoid. There is a lack of evidence to suggest superiority of one topical antibiotic against another.(15)

Fixed dose combination products of topical antibiotics, topical retinoids, and/or BP are strongly recommended by the AAD. Fixed dose combination products assist in treatment regimen adherence and may be less expensive than their individual components separately. When using a combination topical retinoid/antibiotic agent, it is recommended to use concomitant BP to prevent antibiotic resistance. Insufficient evidence is available to recommend topical BP, retinoids, antibiotics, or their combinations over one another.(15)

Clascoterone (Winlevi) is a topical antiandrogen agent. It is conditionally recommended for the treatment of acne by the AAD due to treatment access and cost, despite a high certainty of benefits over risks. Azelaic acid is a topical comedolytic, antibacterial, and anti-inflammatory agent and is also conditionally recommended for the treatment of acne by the AAD. Azelaic acid may be beneficial for patients with sensitive skin or dyspigmentation due to its lightening effects. Insufficient evidence is available to develop a recommendation on the use of topical sodium sulfacetamide for acne even though it is used in practice.(15)

Systemic oral tetracycline-class antibiotics are commonly used to treat moderate to severe acne, and include doxycycline, minocycline, sarecycline, and tetracycline.(15) They are recommended to be used in combination with benzoyl peroxide (BP) and/or a topical retinoid to decrease the risk of antibiotic resistance and limit the duration of systemic antibiotic exposure.(14,15) The use of systemic antibiotics should be limited to the shortest duration possible, typically 3 to 4 months, to reduce the risk of antibiotic resistance or antibiotic associated complications, and should not be used as monotherapy. Treatment endpoints should include the discontinuation of systemic antibiotics and the continuation of topical therapies as maintenance. Oral tetracycline-class antibiotics should be avoided in patients less than 9 years old due to the risk of permanent teeth enamel hypoplasia or discoloration during tooth development. (15)

Oral doxycycline is strongly recommended by the AAD for moderate to severe acne. There is insufficient evidence to recommend a specific dosage over another, but doses as low as 40mg daily (20 mg twice daily or 40 mg extended release daily) have demonstrated efficacy. Oral minocycline is conditionally recommended by the AAD for moderate to severe acne due to concerns of rare potential adverse effects despite moderate certainty of benefits over risks. These adverse effects include vertigo, autoimmune hepatitis, skin hyperpigmentation, drug induced lupus, and hypersensitivity syndrome. Oral sarecycline (Seysara) is conditionally recommended by the AAD for moderate to severe acne due to concerns of high cost that may impact access despite a high certainty of benefits over risks.(15) Oral tetracycline may also be used for the treatment of moderate to severe acne, but doxycycline and minocycline have been found to be more effective.(14) The risks and benefits of treatments should be considered when choosing a treatment option since there is insufficient evidence comparing systemic antibiotics against each other or against topical therapies directly.(15)

Rosacea

Rosacea is a chronic inflammatory disorder that primarily presents as flushing, erythema, papules/pustules, phymas, and telangiectasia on the cheeks, nose, forehead, and chin.  Rosacea may also affect the eyes, which is known as the clinical subtype of ocular rosacea.(9,17) There is no cure for rosacea, but treatment to reduce or control symptoms can be accomplished with topical and oral therapies. Topical and oral therapy are often used in combination initially until a single therapy can be used long-term to maintain remission.(9)

A phenotype approach is used to guide treatment selection in order to target the predominant signs and symptoms that a patient is expressing. Topical therapies are often used to target the erythematotelangiectatic phenotype (persistent erythema) and/or the papulopustular phenotype (papules/pustules).(9,17,18) 

Tetracyclines, macrolides, and isotretinoin are the mainstay oral medications used in the treatment of rosacea.(18) Oral tetracyclines have been found to be most efficacious for the treatment of papulopustular rosacea, but they may also be used to treat erythema, inflamed phymas, and ocular rosacea. Oral tetracyclines used to treat rosacea include doxycycline, minocycline, and tetracycline. Doxycycline and minocycline are considered more efficacious for treating papules/pustules and ocular symptoms over tetracycline, but no superiority has been found for the treatment of erythema or inflamed phymas.(9) The British Association of Dermatologists 2021 rosacea guidelines strongly recommend avoiding minocycline for the treatment of rosacea due to potential side effects.(13)

Efficacy (Oracea)

A double-blind randomized trial compared Oracea 40 mg once daily to doxycycline 100 mg once daily in the treatment of moderate to severe rosacea for 16 weeks. There was no statistically significant difference in the primary efficacy endpoint of the change in total lesion count. There was a higher incidence of GI adverse events related to doxycycline 100 mg versus Oracea (26% vs 5%); however, the discontinuation rate due to adverse events was higher with Oracea versus doxycycline 100 mg (11.4% vs 8.5%).(19)

Safety

Doxycycline, minocycline, and tetracycline are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.(1-8,12,20,24-33)

Minocycline hydrochloride capsules and tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.(10,11)

1

Doryx MPC prescribing information. Mayne Pharma Commercial LLC. April 2024.

2

Doxycycline monohydrate tablet prescribing information. Zydus Pharmaceuticals USA Inc. May 2024.

3

Doryx prescribing information. Mayne Pharma. May 2023.

4

Doxycycline hyclate capsule and tablet prescribing information. Chartwell RX LLC. April 2024.

5

Doxycycline monohydrate capsule prescribing information. Chartwell RX, LLC. October 2023.

6

Oracea prescribing information. Galderma Laboratories, L.P. January 2023.

7

Doxycycline hyclate 20mg tablet prescribing information. Larken Laboratories, Inc. December 2023.

8

Vibramycin prescribing information. Pfizer Inc. January 2024.

9

Thiboutot D, Anderson R, Cook-Bolden F, et al. Standard management options for rosacea: The 2019 update by the National Rosacea Society Expert Committee. Journal of the American Academy of Dermatology. 2020;82(6):1501-1510. doi:10.1016/j.jaad.2020.01.077

10

Minocycline hydrochloride capsule prescribing information. Torrent Pharmaceuticals Limited. January 2024.

11

Minocycline hydrochloride tablet prescribing information. Sun Pharmaceutical Industries, Inc. June 2018.

12

Solodyn prescribing information. Bausch Health US LLC. September 2017.

13

Hampton PJ, Berth‐Jones J, Williamson CED, et al. British Association of Dermatologists guidelines for the management of people with rosacea 2021*. British Journal of Dermatology. 2021;185(4):725-735. doi:10.1111/bjd.20485

14

Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. Journal of the American Academy of Dermatology. 2016;74(5):945-973.e33. doi:10.1016/j.jaad.2015.12.037

15

Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. Journal of the American Academy of Dermatology. 2024;90(5):1006.e1-1006.e30. doi:10.1016/j.jaad.2023.12.017

16

Sutaria AH, Masood S, Saleh HM, Schlessinger J. Acne vulgaris. StatPearls - NCBI Bookshelf. Published August 17, 2023. https://www.ncbi.nlm.nih.gov/books/NBK459173/

17

Sharma A, Kroumpouzos G, Kassir M, et al. Rosacea management: A comprehensive review. Journal of Cosmetic Dermatology. 2022;21(5):1895-1904. doi:10.1111/jocd.14816

18

Nguyen C, Kuceki G, Birdsall M, Sahni DR, Sahni V, Hull CM. Rosacea: Practical guidance and Challenges for Clinical management. Clinical, Cosmetic and Investigational Dermatology. 2024;Volume 17:175-190. doi:10.2147/ccid.s391705

19

Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatology. 2008;7(6): 573-576.

20

Emrosi prescribing information. Journey Medical Corporation. November 2024.

21

Reference no longer used.

22

Reference no longer used.

23

Del Rosso JQ, Tanghetti E, Webster G, Gold LFS, Thiboutot D, Gallo RL. Update on the Management of Rosacea from the American Acne & Rosacea Society (AARS). J Clin Aesthet Dermatol. 2019;12(6):17-24.

24

Acticlate prescribing information. Almirall, LLC. March 2020.

25

Targadox prescribing information. Journey Medical Corporation. August 2020.

26

Minolira prescribing information. EPI Health, Inc. November 2022.

27

Ximino prescribing information. Journey Medical Corporation. January 2021.

28

Seysara prescribing information. Almirall, LLC. November 2023. 

29

Doxycycline hyclate delayed release tablet prescribing information. Alembic Pharmaceuticals Inc. April 2023.

30

Minocycline hydrochloride extended release tablet prescribing information. Ascend Laboratories, LLC. September 2022.

31

Tetracycline capsule prescribing information. Amneal Pharmaceuticals NY LLC. December 2023.

32

Tetracycline tablet prescribing information. Pharmaka Generics Inc. January 2024. 

33

LymePak prescribing information. Chartwell RX, LLC. December 2022.

100 MG ; 150 MG ; 20 MG ; 50 MG ; 75 MG

M ; N ; O

Y

M ; N ; O

Doryx ; Doryx mpc ; Doxycycline hyclate dr

doxycycline hyclate tab delayed release

100 MG ; 120 MG ; 150 MG ; 200 MG ; 50 MG ; 60 MG ; 75 MG ; 80 MG

M ; N ; O ; Y

N ; O ; Y

Emrosi

minocycline hcl micronized (rosacea) capsule er

40 MG

M ; N ; O ; Y

N

Minocin

100 MG ; 50 MG ; 75 MG

M ; N ; O

O ; Y

Minocycline hydrochloride ; Ximino

135 MG ; 45 MG ; 90 MG

M ; N ; O

M

Minolira ; Solodyn

minocycline hcl tab er

105 MG ; 115 MG ; 135 MG ; 45 MG ; 55 MG ; 65 MG ; 80 MG ; 90 MG

M ; N ; O ; Y

N ; O ; Y

Oracea

40 MG

M ; N ; O

O ; Y

Seysara

100 MG ; 150 MG ; 60 MG

M ; N ; O

N

Tetracycline hydrochlorid

tetracycline hcl tab

250 MG ; 500 MG

M ; N ; O ; Y

N

Vibramycin

25 MG/5ML

M ; N ; O

O ; Y

Vibramycin

100 MG

M ; N ; O

O ; Y

100 MG ; 150 MG ; 20 MG ; 50 MG ; 75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Doryx ; Doryx mpc ; Doxycycline hyclate dr

doxycycline hyclate tab delayed release

100 MG ; 120 MG ; 150 MG ; 200 MG ; 50 MG ; 60 MG ; 75 MG ; 80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Emrosi

minocycline hcl micronized (rosacea) capsule er

40 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Minocin

100 MG ; 50 MG ; 75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Minocycline hydrochloride ; Ximino

135 MG ; 45 MG ; 90 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Minolira ; Solodyn

minocycline hcl tab er

105 MG ; 115 MG ; 135 MG ; 45 MG ; 55 MG ; 65 MG ; 80 MG ; 90 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Oracea

40 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Seysara

100 MG ; 150 MG ; 60 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Tetracycline hydrochlorid

tetracycline hcl tab

250 MG ; 500 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Vibramycin

100 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Vibramycin

25 MG/5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Brand and Nonpreferred generic agent(s) will be approved when ONE of the following are met:

1. The requested agent is a doxycycline agent or Seysara AND ONE of the following
   1. The patient's medication history of use in the past 90 days includes a preferred generic doxycycline agent OR
   2. The patient has an intolerance or hypersensitivity to a preferred generic doxycycline agent OR
   3. The patient has an FDA labeled contraindication to ALL preferred generic doxycycline agents OR
2. The requested agent is a minocycline agent AND BOTH of the following:
   1. ONE of the following:
      1. The patient's medication history of use in the past 180 days includes a preferred generic doxycycline agent OR
      2. The patient has an intolerance or hypersensitivity to a preferred generic doxycycline agent OR
      3. The patient has an FDA labeled contraindication to ALL preferred generic doxycycline agents AND
   2. ONE of the following:
      1. The patient's medication history of use in the past 180 days includes a preferred generic minocycline agent OR 
      2. The patient has an intolerance or hypersensitivity to a preferred generic minocycline agent OR
      3. The patient has an FDA labeled contraindication to ALL preferred generic minocycline agents OR
3. The requested agent is a tetracycline agent AND BOTH of the following:
   1. ONE of the following:
      1. The patient's medication history of use in the past 180 days includes a preferred generic doxycycline agent OR
      2. The patient has an intolerance or hypersensitivity to a preferred generic doxycycline agent OR
      3. The patient has an FDA labeled contraindication to ALL preferred generic doxycycline agents AND
   2. ONE of the following:
      1. The patient's medication history of use in the past 180 days includes a preferred generic tetracycline agent OR
      2. The patient has an intolerance or hypersensitivity to a preferred generic tetracycline agent OR
      3. The patient has an FDA labeled contraindication to ALL preferred generic tetracycline agents

Length of Approval:  12 months

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.