Doxycycline Hyclate Delayed release doxycycline hyclate

Get an overview of DOXYCYCLINE HYCLATE DELAYED RELEASE (doxycycline hyclate tablet, delayed release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Doxycycline Hyclate Delayed release can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Doxycycline Hyclate Delayed release.

Drug Basics

Brand Name: Doxycycline Hyclate Delayed release

Generic Name: DOXYCYCLINE HYCLATE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, DELAYED RELEASE

Data Current As Of: 2020-03-30

indications & usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets, USP and other antibacterial drugs, doxycycline hyclate delayed-release tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or diseases:

Doxycycline hyclate delayed-release tablets, USP are a tetracycline-class drug indicated for:

  • Rickettsial infections (1.1)
  • Sexually transmitted infections (1.2)
  • Respiratory tract infections (1.3)
  • Specific bacterial infections (1.4)
  • Ophthalmic infections (1.5)
  • Anthrax, including inhalational anthrax (post-exposure) (1.6)
  • Alternative treatment for selected infections when penicillin is contraindicated (1.7)
  • Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8)
  • Prophylaxis of malaria (1.9)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)

rickettsial infections

Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

sexually transmitted infections

Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis.

Nongonococcal urethritis caused by Ureaplasma urealyticum.

Lymphogranuloma venereum caused by Chlamydia trachomatis.

Granuloma inguinale caused by Klebsiella granulomatis.

Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.

Chancroid caused by Haemophilus ducreyi.

respiratory tract infections

Respiratory tract infections caused by Mycoplasma pneumoniae.

Psittacosis (ornithosis) caused by Chlamydophila psittaci.

Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.

Doxycycline is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:

Respiratory tract infections caused by Haemophilus influenzae .

Respiratory tract infections caused by Klebsiella species.

Upper respiratory infections caused by Streptococcus pneumoniae .

specific bacterial infections

Relapsing fever due to Borrelia recurrentis.

Plague due to Yersinia pestis.

Tularemia due to Francisella tularensis.

Cholera caused by Vibrio cholerae.

Campylobacter fetus infections caused by Campylobacter fetus.

Brucellosis due to Brucella species (in conjunction with streptomycin).

Bartonellosis due to Bartonella bacilliformis.

Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.

Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:

Escherichia coli

Enterobacter aerogenes

Shigella species

Acinetobacter species

Urinary tract infections caused by Klebsiella species.

ophthalmic infections

Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.

Inclusion conjunctivitis caused by Chlamydia trachomatis.

anthrax, including inhalational anthrax (post-exposure)

Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

alternative treatment for selected infections when penicillin is contraindicated

When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:

Syphilis caused by Treponema pallidum.

Yaws caused by Treponema pallidum subspecies pertenue.

Vincent's infection caused by Fusobacterium fusiforme.

Actinomycosis caused by Actinomyces israelii.

Infections caused by Clostridium species.

adjunctive therapy for acute intestinal amebiasis & severe acne

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

In severe acne, doxycycline may be useful adjunctive therapy.

prophylaxis of malaria

Doxycycline is indicated 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 [see Dosage and Administration (2.2) and Patient Counseling Information (17)].

patient counseling information

Patients taking doxycycline for malaria prophylaxis should be advised:

  • that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.
  • to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (for example, staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent).
  • that doxycycline prophylaxis:
  • should begin 1 to 2 days before travel to the malarious area,
  • should be continued daily while in the malarious area and after leaving the malarious area,
  • should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area,
  • should not exceed 4 months.

All patients taking doxycycline should be advised:

  • to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (for example, skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered [see Warnings and Precautions (5.3) ] .
  • to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6.1) ].
  • that the absorption of tetracyclines is reduced when taken with foods, especially those that contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk [see Drug Interactions (7.3) ].
  • that the absorption of tetracyclines is reduced when taken with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations [see Drug Interactions (7.3) ].
  • that the use of doxycycline might increase the incidence of vaginal candidiasis.

Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of antibacterial. If this occurs, patients should contact their physician as soon as possible.

Patients should be counseled that antibacterial drugs including doxycycline hyclate delayed-release tablets should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When doxycycline hyclate delayed-release tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by doxycycline hyclate delayed-release tablets or other antibacterial drugs in the future.

instructions for breaking the 150 mg doxycycline hyclate delayed-release dual-scored tablet

The tablet is marked with separation lines (score lines) and may be broken at these score lines to provide any of the following doses.

To break the tablet, the tablet is held between the thumbs and index fingers close to the appropriate score line. Then, with the score line facing the patient, enough pressure is applied to snap the tablet segments apart (segments that do not break along the score line should not be used).

FDA-Approved Patient Labeling

Doxycycline hyclate delayed-release tablets, USP 75 mg, 100 mg, 150 mg and 200 mg

Instructions for Breaking the 150 mg Doxycycline Hyclate Delayed-Release Dual-Scored Tablet

Your doctor may find it necessary to adjust your dosage of doxycycline hyclate delayed-release tablets, USP to obtain the proper treatment response. The tablet is marked with separation lines (score lines) and may be broken at these score lines to provide any of the following doses.

If your doctor prescribed:

To break the tablet, hold the tablet between your thumbs and index fingers close to the appropriate score line. Then, with the score line facing you, apply enough pressure to snap the tablet segments apart (do not use segments that do not break along the score line).

Rx only

Manufactured by:

USV Private Limited

Daman – 396210, India

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

Revised: 02/2020

package label.principal display panel

Doxycycline Hyclate Delayed-Release Tablets, USP

75 mg

NDC 23155-141-01

100 Tablets

Rx Only

Doxycycline Hyclate Delayed-Release Tablets, USP

100 mg

NDC 23155-142-01

100 Tablets

Rx Only

Doxycycline Hyclate Delayed-Release Tablets, USP

150 mg

NDC 23155-143-01

100 Tablets

Rx Only

Doxycycline Hyclate Delayed-Release Tablets, USP 200 mg

NDC 23155-611-06

60 Tablets

Rx only

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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