doxycycline hyclate doxyclycline hyclate

Brand Name: doxycycline hyclate

Generic Name: DOXYCLYCLINE HYCLATE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, COATED

Data Current As Of: 2019-12-16

Doxycycline hyclate tablets are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by Rickettsiae.

Doxycycline hyclate tablets are indicated for treatment of the following 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 .

Doxycycline hyclate tablets are indicated for treatment of the following 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 .

Doxycycline hyclate tablets are indicated for treatment of the following 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 hyclate tablets are 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.

Doxycycline hyclate tablets are indicated for treatment of the following 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 .

Doxycycline hyclate tablets are indicated for the treatment of Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Doxycycline hyclate tablets are indicated as an alternative treatment for the following selected infections when penicillin is contraindicated:

• Syphilis caused by Treponema pallidum .
• Yaws caused by Treponema pallidum subspecies pertenue .
• Listeriosis due to Listeria monocytogenes .
• Vincent's infection caused by Fusobacterium fusiforme.
• Actinomycosis caused by Actinomyces israelii .
• Infections caused by Clostridium species.

In acute intestinal amebiasis, doxycycline hyclate tablets may be a useful adjunct to amebicides. In severe acne, doxycycline hyclate tablets may be useful adjunctive therapy.

Doxycycline hyclate tablets are 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 (2.4) and PATIENT COUNSELING INFORMATION (17)].

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets 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.

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

Advise patients taking doxycycline hyclate for malaria prophylaxis:

• 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 day 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.

Advise all patients taking doxycycline hyclate:

• that doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third at the scored lines to provide 100 mg or 50 mg strength doses, respectively.
• 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 hyclate to reduce the risk of esophageal irritation and ulceration [see ADVERSE REACTIONS (6)].
• that the absorption of tetracyclines is reduced when taken with foods, especially those that contain calcium [see DRUG INTERACTIONS (7.3)]. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk [see CLINICAL PHARMACOLOGY (12.3)].
• that if gastric irritation occurs, doxycycline hyclate may be given with food or milk [see CLINICAL PHARMACOLOGY (12.3)].
• 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.

Advise patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterial drugs, 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.

Counsel patients that antibacterial drugs including doxycycline hyclate should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When doxycycline hyclate 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 or other antibacterial drugs in the future.

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Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Nagpur 441 108

INDIA