Doxycycline Hyclate

Doxycycline Hyclate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Doxycycline Hyclate is an anti-bacterial agent that is FDA approved for the treatment of rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, tick fevers, respiratory tract infections caused by mycoplasma pneumoniae, lymphogranuloma venereum, psittacosis, trachoma, inclusion conjunctivitis, uncomplicated urethral, endocervical, or rectal infections in adults caused by chlamydia trachomatis, nongonococcal urethritis caused by ureaplasma urealyticum, relapsing fever, chancroid, plague, tularemia, cholera, campylobacter fetus infections, brucellosis, bartonellosis, granuloma inguinale. Common adverse reactions include photosensitivity, diarrhea, nasopharyngitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acinetobacter infection

Acne vulgaris; Adjunct

Actinomycotic infection

Amebic infection - Intestinal infectious disease

Anthrax

Bartonellosis

Brucellosis; Adjunct

Chancroid

Chlamydial infection

Cholera

Clostridial infection

Epididymitis

Gonorrhea, Uncomplicated

Granuloma inguinale

Inclusion conjunctivitis

Infection by Campylobacter fetus

Infection due to Enterobacteriaceae

Infection due to Escherichia coli

Inhalational anthrax, Postexposure; Prophylaxis

Late latent syphilis, or latent syphilis of unknown duration; Penicillin allergy

Listeriosis

Lymphogranuloma venereum

Malaria; Prophylaxis

Nongonococcal urethritis

Plague

Psittacosis

Q fever

Relapsing fever

Respiratory tract infection

Rocky Mountain spotted fever

Rosacea, inflammatory lesions (papules and pustules)

Shigellosis

Spotted fevers

Staphylococcal infection of skin

Syphilis, Primary, secondary, or early latent; Penicillin allergy

Tularemia, Postexposure

Typhus group rickettsial disease

Urinary tract infectious disease

Vincent's infection

Yaws

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline Hyclate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxycycline Hyclate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Doxycycline Hyclate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline Hyclate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxycycline Hyclate in pediatric patients.

Contraindications

• This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Warnings

• 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.

• 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.

PRECAUTIONS

General:

• As with other antibacterial drugs, use of Doxycycline may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, Doxycycline Hyclate Capsules should be discontinued and appropriate therapy instituted.

• 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, vision loss, and papilledema. 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, it is possible that permanent visual loss can occur. If visual symptoms develop 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.

• Incision and drainage or other surgical procedures should be performed in conjunction with antibacterial therapy, when indicated.

• Doxycycline offers substantial but not complete suppression of the asexual blood stages of Plasmodium strains.

• Doxycycline does not suppress P. falciparum's sexual blood stage gametocytes. Subjects completing this prophylactic regimen may still transmit the infection to mosquitoes outside endemic areas.

• Prescribing Doxycycline Hyclate Capsules in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Doxycycline Hyclate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Doxycycline Hyclate Postmarketing Experience in the drug label.

Drug Interactions

• Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

• Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.

• Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

• Absorption of tetracyclines is impaired by bismuth subsalicylate.

• Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

• The concurrent use of tetracycline and Penthrane® (methoxyflurane) has been reported to result in fatal renal toxicity.

• Concurrent use of tetracycline may render oral contraceptives less effective.

• Drug/Laboratory Test Interactions:

• False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Doxycycline Hyclate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxycycline Hyclate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Doxycycline Hyclate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Doxycycline Hyclate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Doxycycline Hyclate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Doxycycline Hyclate in geriatric settings.

Gender

There is no FDA guidance on the use of Doxycycline Hyclate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Doxycycline Hyclate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Doxycycline Hyclate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Doxycycline Hyclate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Doxycycline Hyclate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Doxycycline Hyclate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Doxycycline Hyclate Administration in the drug label.

Monitoring

There is limited information regarding Doxycycline Hyclate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Doxycycline Hyclate and IV administrations.

Overdosage

There is limited information regarding Doxycycline Hyclate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Doxycycline Hyclate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Doxycycline Hyclate Mechanism of Action in the drug label.

Structure

There is limited information regarding Doxycycline Hyclate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Doxycycline Hyclate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Doxycycline Hyclate Pharmacokinetics in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

• Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with the related antibacterial drugs, oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors).

• Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibacterial drugs (tetracycline, oxytetracycline).

• Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.

Clinical Studies

There is limited information regarding Doxycycline Hyclate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Doxycycline Hyclate How Supplied in the drug label.

Storage

There is limited information regarding Doxycycline Hyclate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Information For Patients

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 (e.g., staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent).
• that doxycycline prophylaxis:

• should begin 1-2 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 (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock should be considered. (See WARNINGS.)
• to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)
• that the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. (See DRUG INTERACTIONS.)
• that the absorption of tetracyclines is reduced when taking bismuth subsalicylate. (See DRUG INTERACTIONS.)
• that the use of doxycycline might increase the incidence of vaginal candidiasis.

• Patients should be counseled that antibacterial drugs, including Doxycycline Hyclate Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Doxycycline Hyclate Capsules is 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 Capsules or other antibacterial drugs in the future.

• Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterials are 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 the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

• Laboratory Tests:

• In venereal disease, when co-existent syphilis is suspected, dark field examinations should be done before treatment is started and the blood serology repeated monthly for at least 4 months.

• In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic studies, should be performed.

Precautions with Alcohol

Alcohol-Doxycycline Hyclate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Adoxa Adoxa CK Adoxa Pak, Adoxa TT, Monodox, Oracea, Vibramycin Monohydrate, Avidoxy.

Look-Alike Drug Names

There is limited information regarding Doxycycline Hyclate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.