Doxycycline Hyclate

Doxycycline Hyclate

Doxycycline Hyclate Recall

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Questions & Answers

Side Effects & Adverse Reactions

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline hyclate capsules, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following the use of antibacterial drugs. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline hyclate capsules. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and doxycycline hyclate capsules should be avoided because isotretinoin is also known to cause pseudotumor cerebri.

Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation, patients should be monitored until they stabilize.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules, USP and other antibacterial drugs, Doxycycline Hyclate Capsules, 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.

Treatment

Doxycycline is indicated for the treatment of the following infections:

• Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. • Respiratory tract infections caused by Mycoplasma pneumoniae. • Lymphogranuloma venereum caused by Chlamydia trachomatis. • Psittacosis (ornithosis) caused by Chlamydophila psittaci. • Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. • Inclusion conjunctivitis caused by Chlamydia trachomatis. • Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. • Nongonococcal urethritis caused by Ureaplasma urealyticum. • Relapsing fever due to Borrelia recurrentis.

Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:

• Chancroid caused by Haemophilus ducreyi. • 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. • Granuloma inguinale caused by Klebsiella granulomatis.

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 bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:

Escherichia coli.Enterobacter aerogenes. • Shigella species. • Acinetobacter species. • Respiratory tract infections caused by Haemophilus influenzae. • Respiratory tract and urinary tract infections caused by Klebsiella species.

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

• Upper respiratory infections caused by Streptococcus pneumoniae. • Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

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

• Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. • 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 may be a useful adjunct to amebicides.

In severe acne, doxycycline may be useful adjunctive therapy.

Prophylaxis

Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section).

History

There is currently no drug history available for this drug.

Other Information

Doxycycline Hyclate Capsules, USP, are an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline monohydrate is

Chemical Structure-doxycyline hyclate

with a molecular formula of C22H24N2O8•H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8•HCl)2•C2H6O•H2O and the molecular weight is 1025.89. Doxycycline is a light yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water.

Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.

Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

The 50 mg and 100 mg capsule shells contain: gelatin, diacetylated monoglycerides, sucrose fatty acid esters, glacial acetic acid, sodium lauryl sulfate, colloidal silicon dioxide, FD&C Blue #1 and titanium dioxide. The printing ink may contain: Shellac Glaze, Iron  Oxide Black, N-Butyl Alcohol, Propylene Glycol, SDA 3A Alcohol, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, D&C Yellow #10.

Doxycycline Hyclate Manufacturers


  • Golden State Medical Supply, Inc.
    Doxycycline Hyclate Capsule, Gelatin Coated [Golden State Medical Supply, Inc.]
  • American Health Packaging
    Doxycycline Hyclate Capsule [American Health Packaging]
  • Preferred Pharmaceuticals, Inc.
    Doxycycline Hyclate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • American Health Packaging
    Doxycycline Hyclate Capsule [American Health Packaging]
  • Blenheim Pharmacal, Inc.
    Doxycycline Hyclate Capsule [Blenheim Pharmacal, Inc.]
  • Direct Rx
    Doxycycline Hyclate Capsule [Direct Rx]
  • Putney, Inc.
    Doxycycline Hyclate Tablet [Putney, Inc.]
  • A-s Medication Solutions Llc
    Doxycycline Hyclate Capsule, Gelatin Coated [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Doxycycline Hyclate Capsule, Gelatin Coated [A-s Medication Solutions Llc]
  • State Of Florida Doh Central Pharmacy
    Doxycycline Hyclate Capsule [State Of Florida Doh Central Pharmacy]
  • Mhc Pharma, Llc
    Doxycycline Hyclate Tablet, Film Coated [Mhc Pharma, Llc]
  • Mhc Pharma, Llc
    Doxycycline Hyclate Capsule [Mhc Pharma, Llc]
  • Cipla Usa, Inc.
    Doxycycline Hyclate Capsule [Cipla Usa, Inc.]
  • Cipla Usa, Inc.
    Doxycycline Hyclate Tablet, Film Coated [Cipla Usa, Inc.]
  • Hikma Pharmaceutical
    Doxycycline Hyclate Capsules (Doxycycline Hyclate) Capsule [Hikma Pharmaceutical]
  • Apace Packaging Llc
    Doxycycline Hyclate Capsule, Gelatin Coated [Apace Packaging Llc]
  • Contract Pharmacy Services-pa
    Doxycycline Hyclate Capsule [Contract Pharmacy Services-pa]
  • State Of Florida Doh Central Pharmacy
    Doxycycline Hyclate Capsule [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Doxycycline Hyclate Capsule [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Doxycycline Hyclate Capsule [State Of Florida Doh Central Pharmacy]
  • Blenheim Pharmacal, Inc.
    Doxycycline Hyclate Capsule [Blenheim Pharmacal, Inc.]
  • Rebel Distributors Corp
    Doxycycline Hyclate Capsule [Rebel Distributors Corp]
  • Larken Laboratories, Inc.
    Doxycycline Hyclate Tablet [Larken Laboratories, Inc.]
  • Legacy Pharmaceutical Packaging
    Doxycycline Hyclate Tablet, Film Coated [Legacy Pharmaceutical Packaging]
  • Bryant Ranch Prepack
    Doxycycline Hyclate Capsule [Bryant Ranch Prepack]
  • Apothecary Shop Wholesale Inc.
    Doxycycline Hyclate Tablet, Film Coated [Apothecary Shop Wholesale Inc.]
  • Aphena Pharma Solutions (Formerly Testpak)
    Doxycycline Hyclate Tablet [Aphena Pharma Solutions (Formerly Testpak)]
  • Safecor Health, Llc
    Doxycycline Hyclate Tablet, Film Coated [Safecor Health, Llc]
  • H.j. Harkins Company, Inc.
    Doxycycline Hyclate Capsule [H.j. Harkins Company, Inc.]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • Life Line Home Care Services, Inc.
    Doxycycline Hyclate Capsule [Life Line Home Care Services, Inc.]
  • Hhs/program Support Center/supply Service Center
    Doxycycline Hyclate Tablet, Film Coated [Hhs/program Support Center/supply Service Center]
  • Hhs/program Support Center/supply Service Center
    Doxycycline Hyclate Tablet, Coated [Hhs/program Support Center/supply Service Center]
  • Hhs/program Support Center/supply Service Center
    Doxycycline Hyclate Tablet, Film Coated [Hhs/program Support Center/supply Service Center]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • Physicians Total Care, Inc.
    Doxycycline Hyclate Tablet, Film Coated [Physicians Total Care, Inc.]
  • Rebel Distributors Corp
    Doxycycline Hyclate Capsule [Rebel Distributors Corp]
  • Pd-rx Pharmaceuticals, Inc.
    Doxycycline Hyclate Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Lannett Company, Inc.
    Doxycycline Hyclate Tablet, Film Coated [Lannett Company, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Doxycycline Hyclate Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Corepharma, Llc
    Doxycycline Hyclate Tablet, Film Coated [Corepharma, Llc]
  • Versapharm Incorporated
    Doxycycline Hyclate Capsule [Versapharm Incorporated]
  • Stat Rx Usa Llc
    Doxycycline Hyclate Capsule [Stat Rx Usa Llc]
  • Aidarex Pharmaceuticals Llc
    Doxycycline Hyclate Tablet, Film Coated [Aidarex Pharmaceuticals Llc]
  • Aidarex Pharmaceuticals Llc
    Doxycycline Hyclate Capsule [Aidarex Pharmaceuticals Llc]
  • Aidarex Pharmaceuticals Llc
    Doxycycline Hyclate Capsule [Aidarex Pharmaceuticals Llc]
  • Dispensing Solutions, Inc.
    Doxycycline Hyclate Capsule [Dispensing Solutions, Inc.]
  • Liberty Pharmaceuticals, Inc.
    Doxycycline Hyclate Capsule [Liberty Pharmaceuticals, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Doxycycline Hyclate Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • Major Pharmaceuticals
    Doxycycline Hyclate Capsule, Gelatin Coated [Major Pharmaceuticals]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • Unit Dose Services
    Doxycycline Hyclate Tablet [Unit Dose Services]
  • Pd-rx Pharmaceuticals, Inc.
    Doxycycline Hyclate (Doxycycline Hyclate) Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • Blenheim Pharmacal, Inc.
    Doxycycline Hyclate Capsule [Blenheim Pharmacal, Inc.]
  • Remedyrepack Inc.
    Doxycycline Hyclate Capsule [Remedyrepack Inc. ]
  • C.o. Truxton, Inc.
    Doxycycline Hyclate Capsule [C.o. Truxton, Inc.]
  • A-s Medication Solutions Llc
    Doxycycline Hyclate Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Doxycycline Hyclate Tablet [A-s Medication Solutions Llc]
  • Major Pharmaceuticals
    Doxycycline Hyclate Capsule [Major Pharmaceuticals]
  • Medvantx, Inc.
    Doxycycline Hyclate Tablet, Film Coated [Medvantx, Inc.]
  • Mayne Pharma International Pty Ltd
    Doxycycline Hyclate Tablet, Delayed Release [Mayne Pharma International Pty Ltd]
  • Mayne Pharma International Pty Ltd
    Doxycycline Hyclate Tablet, Delayed Release [Mayne Pharma International Pty Ltd]
  • Clinical Solutions Wholesale
    Doxycycline Hyclate Capsule [Clinical Solutions Wholesale]
  • Preferred Pharmaceuticals, Inc.
    Doxycycline Hyclate Capsule [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Doxycycline Hyclate Tablet [Preferred Pharmaceuticals, Inc.]
  • Mylan Pharmaceuticals Inc.
    Doxycycline Hyclate Tablet, Delayed Release [Mylan Pharmaceuticals Inc.]
  • Midlothian Laboratories
    Doxycycline Hyclate Tablet, Delayed Release [Midlothian Laboratories]
  • Compound One Pharmaceuticals Inc
    Doxycycline Hyclate Powder [Compound One Pharmaceuticals Inc]
  • Global Pharmaceuticals, Division Of Impax Laboratories, Inc.
    Doxycycline Hyclate Tablet, Delayed Release [Global Pharmaceuticals, Division Of Impax Laboratories, Inc.]
  • C.o. Truxton, Inc.
    Doxycycline Hyclate Tablet [C.o. Truxton, Inc.]
  • Avkare, Inc.
    Doxycycline Hyclate (Doxycycline Hyclate) Tablet, Film Coated Doxycycline Hyclate (Doxycycline Hyclate) Capsule [Avkare, Inc.]
  • Dava Pharmaceuticals, Inc.
    Doxycycline Hyclate Tablet [Dava Pharmaceuticals, Inc.]
  • Aphena Pharma Solutions – Tennessee, Llc
    Doxycycline Hyclate Tablet, Film Coated [Aphena Pharma Solutions – Tennessee, Llc]
  • State Of Florida Doh Central Pharmacy
    Doxycycline Hyclate Capsule [State Of Florida Doh Central Pharmacy]
  • Aphena Pharma Solutions – New Jersey, Llc
    Doxycycline Hyclate Tablet, Film Coated [Aphena Pharma Solutions – New Jersey, Llc]
  • Golden State Medical Supply, Inc.
    Doxycycline Hyclate Tablet [Golden State Medical Supply, Inc.]
  • Dava Pharmaceuticals, Inc.
    Doxycycline Hyclate Capsule [Dava Pharmaceuticals, Inc.]
  • Mylan Pharmaceuticals Inc.
    Doxycycline Hyclate Tablet, Delayed Release [Mylan Pharmaceuticals Inc.]
  • Blu Pharmaceuticals, Llc
    Doxycycline Hyclate Tablet [Blu Pharmaceuticals, Llc]
  • Chartwell Governmental & Specialty Rx Llc
    Doxycycline Hyclate Tablet, Film Coated [Chartwell Governmental & Specialty Rx Llc]
  • Mylan Pharmaceuticals Inc.
    Doxycycline Hyclate (Doxycycline) Capsule Doxycycline Hyclate (Doxycycline) Tablet [Mylan Pharmaceuticals Inc.]
  • Chartwell Governmental And Specialty Rx Llc
    Doxycycline Hyclate Capsule [Chartwell Governmental And Specialty Rx Llc]
  • Chartwell Rx Llc
    Doxycycline Hyclate Tablet, Film Coated [Chartwell Rx Llc]
  • Chartwell Rx Llc
    Doxycycline Hyclate Capsule [Chartwell Rx Llc]
  • Carilion Materials Management
    Doxycycline Hyclate Capsule [Carilion Materials Management]
  • Actavis Elizabeth Llc
    Doxycycline Hyclate Tablet, Delayed Release [Actavis Elizabeth Llc]
  • Harris Pharmaceutical, Inc
    Doxycycline Hyclate Tablet, Film Coated [Harris Pharmaceutical, Inc]
  • Harris Pharmaceutical, Inc
    Doxycycline Hyclate Capsule [Harris Pharmaceutical, Inc]
  • Mutual Pharmaceutical Company, Inc.
    Doxycycline Hyclate Tablet, Film Coated [Mutual Pharmaceutical Company, Inc.]
  • Citron Pharma Llc
    Doxycycline Hyclate Capsule [Citron Pharma Llc]
  • Citron Pharma Llc
    Doxycycline Hyclate Tablet, Film Coated [Citron Pharma Llc]
  • West-ward Pharmaceutical Corp
    Doxycycline Hyclate Capsule [West-ward Pharmaceutical Corp]
  • Avpak
    Doxycycline Hyclate (Doxycycline Hyclate) Capsule Doxycycline Hyclate (Doxycycline Hyclate) Tablet, Film Coated [Avpak]
  • Burke Therapeutics, Llc
    Doxycycline Hyclate Tablet, Film Coated [Burke Therapeutics, Llc]
  • Preferred Pharmaceuticals Inc.
    Doxycycline Hyclate Tablet, Film Coated [Preferred Pharmaceuticals Inc.]
  • Medsource Pharmaceuticals
    Doxycycline Hyclate Capsule [Medsource Pharmaceuticals]

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