DOXYCYCLINE HYCLATE tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Doxycycline Hyclate (UNII: 19XTS3T51U) (Doxycycline Anhydrous - UNII:334895S862)
Available from:
Apotex Corp.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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, cultur
Product summary:
How Supplied Doxycycline hyclate tablets, USP 75 mg are light teal, round, biconvex film-coated tablets. Engraved "APO" on one side, "D75" on the other side. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate, USP equivalent to 75 mg of doxycycline. Bottles of 60 tablets: NDC 60505-4382-6 Bottles of 100 tablets: NDC 60505-4382-1 Bottles of 500 tablets: NDC 60505-4382-5 Doxycycline hyclate tablets, USP 150 mg are mossy green, capsule shaped, biconvex film-coated tablets. Engraved "A" bisect "P" bisect "O" on one side, "1" bisect "5" bisect "0" on the other side. Each side of the functionally scored tablet has two parallel score lines for splitting into 3 equal portions. Each 150 mg tablet contains 173.1 mg of doxycycline hyclate, USP equivalent to 150 mg of doxycycline. Bottles of 60 tablets: NDC 60505-4384-6 Bottles of 100 tablets: NDC 60505-4384-1 Bottles of 500 tablets: NDC 60505-4384-5 Storage Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Authorization status:
Abbreviated New Drug Application
Authorization number:
60505-4382-1, 60505-4382-5, 60505-4382-6, 60505-4384-1, 60505-4384-5, 60505-4384-6

DOXYCYCLINE HYCLATE- doxycycline hyclate tablet, coated

Apotex Corp.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DOXYCYCLINE HYCLATE TABLETS safely

and effectively. See full prescribing information for DOXYCYCLINE HYCLATE TABLETS.

DOXYCYCLINE HYCLATE tablets, for oral use

Initial U.S. Approval: 1967

INDICATIONS AND USAGE

Doxycycline hyclate tablets are tetracycline class drugs 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 for 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 tablets should be used only to treat or prevent infections that are proven or

strongly suspected to be caused by bacteria. (1.10)

DOSAGE AND ADMINISTRATION

Important Administration Instructions for Doxycycline Hyclate Tablets

Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 50 mg and 100 mg

strength, respectively. (2.1)

Dosage in Adults for Doxycycline Hyclate Tablets

The usual dosage is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a

maintenance dose of 100 mg daily. (2.1)

In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12

hours is recommended. (2.1)

Dosage in Pediatric Patients for Doxycycline Hyclate Tablets:

For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Rocky

Mountain spotted fever), the recommended dose is 2.2 mg per kg of body weight administered every 12 hours.

Pediatric patients weighing 45 kg or more should receive the adult dose. (2.3)

For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the

recommended dose is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by

a maintenance dose of 2.2 mg per kg of body weight given as a single daily dose or divided into two doses. For

pediatric patients weighing over 45 kg, the usual adult dose should be used. (2.3)

See Full Prescribing Information for additional indication specific dosage information and important administration

instructions for doxycycline hyclate tablets. (2.1, 2.4, 2.5)

DOSAGE FORMS AND STRENGTHS

Tablets, 75 mg and 150 mg (functionally scored) (3)

CONTRAINDICATIONS

Doxycycline is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. (4)

WARNINGS AND PRECAUTIONS

The use of doxycycline hyclate tablets 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) and enamel hypoplasia. Advise the

patient of the potential risk to the fetus during pregnancy (2.2, 5.1, 8.1, 8.4)

The use of Doxycycline Hyclate tablets during the second and third-trimester of pregnancy, infancy and childhood up to

the age of 8 years of age may cause reversible inhibition of bone growth. Advise the patient of the potential risk to the

fetus during pregnancy. (5.2,8.1, 8.4)

Clostridioides difficile-associated diarrhea (CDAD) has been reported. Evaluate patients if diarrhea occurs. (5.3)

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking

tetracyclines. Limit sun exposure. (5.3)

Overgrowth of non-susceptible organisms, including fungi, may occur. If such infections occur, discontinue use and

institute appropriate therapy. (5.10)

ADVERSE REACTIONS

Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash,

photosensitivity, urticaria, and hemolytic anemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575, or FDA at 1-800-FDA-

1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. (7.1)

Avoid co-administration of tetracyclines with penicillin. (7.2)

Absorption of tetracyclines, including doxycycline is impaired by antacids containing aluminum, calcium, or magnesium,

bismuth subsalicylate and iron-containing preparations. (7.3)

Concurrent use of tetracyclines, including doxycycline may render oral contraceptives less effective. (7.4)

Barbiturates, carbamazepine and phenytoin decrease the half-life of doxycycline. (7.5)

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding is not recommended. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 5/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Rickettsial Infections

1.2 Sexually Transmitted Infections

1.3 Respiratory Tract Infections

1.4 Specific Bacterial Infections

1.5 Ophthalmic Infections

1.6 Anthrax Including Inhalational Anthrax (Post-Exposure)

1.7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated

1.8 Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne

1.9 Prophylaxis of Malaria

1.10 Usage

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 Dosage in Adult Patients

2.3 Dosage in Pediatric Patients

2.4 Dosage for Prophylaxis of Malaria

2.5 Dosage for Inhalational Anthrax (Post-Exposure)

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Tooth Development

5.2 Inhibition of Bone Growth

5.3 Clostridioides difficile Associated Diarrhea

5.4 Photosensitivity

5.5 Severe Skin Reactions

5.6 Intracranial Hypertension

5.7 Antianabolic Action

5.8 Incomplete Suppression of Malaria

5.9 Development of Drug-Resistant Bacteria

5.10 Potential for Microbial Overgrowth

5.11 Laboratory Monitoring for Long-Term Therapy

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.1 Anticoagulant Drugs

7.2 Penicillin

7.3 Antacids and Iron Preparations

7.4 Oral Contraceptives

7.5 Barbiturates and Anti-Epileptics

7.6 Penthrane

7.7 Drug and Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Rickettsial Infections

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.

1.2 Sexually Transmitted Infections

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.

Sections or subsections omitted from the full prescribing information are not listed.

Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.

Chancroid caused by Haemophilus ducreyi.

1.3 Respiratory Tract Infections

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.

1.4 Specific Bacterial Infections

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.

1.5 Ophthalmic Infections

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.

1.6 Anthrax Including Inhalational Anthrax (Post-Exposure)

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.

1.7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated

Doxycycline hyclate tablets are indicated as an alternative treatment for the following selected

infections when penicillin is contraindicated:

Syphilis caused by Treponema pallidum.

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.

1.8 Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne

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.

1.9 Prophylaxis of Malaria

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)].

1.10 Usage

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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

The usual dosage and frequency of administration of doxycycline hyclate tablets differs from that of

the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of

adverse reactions.

Administer doxycycline hyclate tablets with adequate amounts of fluid to wash down the drugs and

reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].

If gastric irritation occurs, doxycycline hyclate tablets may be given with food or milk [see Clinical

Pharmacology (12.3)]

Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 100 mg

and 50 mg strength, respectively [see FDA-approved patient labeling].

2.2 Dosage in Adult Patients

The usual dosage of doxycycline hyclate tablets is 200 mg on the first day of treatment

(administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily. The

maintenance dose may be administered as a single dose or as 50 mg every 12 hours.

In the management of more severe infections (particularly chronic infections of the urinary tract),

100 mg every 12 hours is recommended.

For certain selected specific indications, the recommended duration or dosage and duration of

doxycycline hyclate tablets in adult patients are as follows:

1. Streptococcal infections, therapy should be continued for 10 days.

2. Uncomplicated urethral, endocervical, or rectal infection caused by Chlamydia trachomatis: 100 mg

by mouth twice-a-day for 7 days.

3. Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by

mouth, twice-a-day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one

hour by a second 300 mg dose.

4. Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg by mouth

twice-a-day for 7 days.

5. Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by

mouth twice-a-day for 2 weeks.

6. Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated

with doxycycline 100 mg by mouth twice-a-day for 4 weeks.

7. Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg by mouth, twice-a-day for at least 10

days.

8. Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice-a-day for at least 10

days.

2.3 Dosage in Pediatric Patients

For all pediatric patients weighing less than 45 kg with severe or life threatening infections (e.g.,

anthrax, Rocky Mountain spotted fever), the recommended dosage of doxycycline hyclate tablets is

2.2 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or

more should receive the adult dose [see Warnings and Precautions (5.1)].

For pediatric patients with less severe disease (greater than 8 years of age and weighing less than

45 kg), the recommended dosage schedule of doxycycline hyclate tablets is 4.4 mg per kg of body

weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2

mg per kg of body weight (given as a single daily dose or divided into twice daily doses). For

pediatric patients weighing over 45 kg, the usual adult dose should be used.

2.4 Dosage for Prophylaxis of Malaria

For adults, the recommended dose of doxycycline hyclate tablets is 100 mg daily.

For pediatric patients 8 years of age and older, the recommended dosage of doxycycline hyclate tablets

is 2 mg per kg of body weight administered once daily. Pediatric patients weighing 45 kg or more

should receive the adult dose. Prophylaxis should begin 1 or 2 days before travel to the malarious area.

Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the

traveler leaves the malarious area.

2.5 Dosage for Inhalational Anthrax (Post-Exposure)

For adults, the recommended dosage is 100 mg, of doxycycline hyclate tablets, by mouth, twice-a-day

for 60 days.

For pediatric patients weighing less than 45 kg, the recommended dosage of doxycycline hyclate tablets

is 2.2 mg per kg of body weight, by mouth, twice-a-day for 60 days. Pediatric patients weighing 45 kg

or more should receive the adult dose.

3 DOSAGE FORMS AND STRENGTHS

Doxycycline hyclate tablets, USP 75 mg are light teal, round, biconvex film-coated tablets. Engraved

"APO" on one side, "D75" on the other side.

Doxycycline hyclate tablets, USP 150 mg are mossy green, capsule shaped, biconvex film-coated

tablets. Engraved "A" bisect "P" bisect "O" on one side, "1" bisect "5" bisect "0" on the other side.

Each side of the functionally scored tablet has two parallel score lines for splitting into 3 equal

portions.

4 CONTRAINDICATIONS

Doxycycline hyclate tablets are contraindicated in persons who have shown hypersensitivity to any of

the tetracyclines.

5 WARNINGS AND PRECAUTIONS

5.1 Tooth Development

The use of doxycycline hyclate tablets 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 of the tetracycline-class, but

it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported

with drugs of the tetracycline-class.Advise the patient of the potential risk to the fetus if doxycycline

hyclate tablets if used during pregnancy [see Use in Specific Populations (8.1,8.4)]. Use doxycycline

hyclate tablets in pediatric patients 8 years of age or less only when the potential benefits are expected

to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted

fever), particularly when there are no alternative therapies.

5.2 Inhibition of Bone Growth

The use of doxycycline hyclate tablets during the second and third trimester of pregnancy, infancy and

childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines

form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been

observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction

was shown to be reversible when the drug was discontinued. Advise the patient of the potential risk to

the fetus if doxycycline hyclate tablets is used during pregnancy [see Use in Specific Populations (8.1,

8.4)].

5.3 Clostridioides difficile Associated Diarrhea

Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial

agents, including doxycycline, 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 antibacterial therapy and may require colectomy. CDAD must be considered in all patients

who present with diarrhea following antibacterial use. 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 antibacterial use 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.

5.4 Photosensitivity

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.

5.5 Severe Skin Reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome,

toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have

been reported in patients receiving doxycycline [See Adverse Reactions (6)]. If severe skin reactions

occur, doxycycline should be discontinued immediately and appropriate therapy should be instituted.

occur, doxycycline should be discontinued immediately and appropriate therapy should be instituted.

5.6 Intracranial Hypertension

Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines

including doxycycline. 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 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.

5.7 Antianabolic Action

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.

5.8 Incomplete Suppression of Malaria

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.

5.9 Development of Drug-Resistant Bacteria

Prescribing doxycycline in the absence of a 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.

5.10 Potential for Microbial Overgrowth

Doxycycline tabs and doxycycline caps may result in overgrowth of non-susceptible organisms,

including fungi. If such infections occur, discontinue use and institute appropriate therapy.

5.11 Laboratory Monitoring for Long-Term Therapy

In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, renal

and hepatic studies should be performed.

6 ADVERSE REACTIONS

The following adverse reactions have been identified during clinical trials or post-approval use of

tetracycline-class drugs, including doxycycline. Because these reactions are reported voluntarily from

a population of uncertain size, it is not always possible to reliably estimate their frequency or establish

a causal relationship to drug exposure.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory

lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. Hepatotoxicity has been

reported. These reactions have been caused by both the oral and parenteral administration of

tetracyclines. Superficial discoloration of the adult permanent dentition, reversible upon

drug discontinuation and professional dental cleaning has been reported. Permanent tooth discoloration

and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth

development [See Warnings and Precautions (5.1)]. Instances of esophagitis and esophageal ulcerations

have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline-class.

Most of these patients took medications immediately before going to bed [see Dosage and

Administration (2.1)].

Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis,

exfoliative dermatitis, and erythema multiforme have been reported. Photosensitivity has been reported

[see Warnings and Precautions (5.4)].

Renal: Rise in BUN has been reported and is apparently dose-related [see Warnings and Precautions

(5.7)].

Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum

sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with

eosinophilia and systemic symptoms (DRESS).

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Intracranial Hypertension: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with

the use of tetracyclines [see Warnings and Precautions (5.6)].

Thyroid Gland Changes: When given over prolonged periods, tetracyclines have been reported to

produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid

function are known to occur.

7 DRUG INTERACTIONS

7.1 Anticoagulant Drugs

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on

anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

7.2 Penicillin

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to

avoid giving tetracyclines, including doxycycline in conjunction with penicillin.

7.3 Antacids and Iron Preparations

Absorption of tetracyclines, including doxycycline is impaired by antacids containing aluminum,

calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.

7.4 Oral Contraceptives

Concurrent use of tetracyclines, including doxycycline may render oral contraceptives less effective.

7.5 Barbiturates and Anti-Epileptics

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

7.6 Penthrane

The concurrent use of tetracycline and Penthrane

(methoxyflurane) has been reported to result in fatal

renal toxicity.

7.7 Drug and Laboratory Test Interactions

False elevations of urinary catecholamines may occur due to interference with the fluorescence test.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

®

Risk Summary

Doxycycline hyclate tablets, like other tetracycline-class antibacterial drugs, may cause discoloration

deciduous teeth, and reversible inhibition of bone growth when administered during the second and

third trimester of pregnancy [see Warnings and Precautions (5.1) and (5.2)]. Available data from

published studies over decades have not shown a difference in major birth defect risk compared to

unexposed pregnancies with doxycycline exposure in the first trimester of pregnancy (see Data). There

are no available data on the risk of miscarriage following exposure to doxycycline in pregnancy.

Advise the patient of the potential risk to the fetus if Doxycycline hyclate tablets is used during

pregnancy.

The estimated background risk of major birth defects and miscarriage for the indicated population is

unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In

the U.S. general population, the estimated background risk of major birth defects and miscarriage in

clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Human Data

A retrospective cohort study of 1,690 pregnant patients who received doxycycline prescriptions in the

first trimester of pregnancy compared to an unexposed pregnant cohort showed no difference in the

major malformation rate. There is no information on the dose or duration of treatment, or if the patients

actually ingested the doxycycline that was prescribed.

Other published studies on exposure to doxycycline in the first trimester of pregnancy have small

sample sizes; however, these studies have not shown an increased risk of major malformations.

The use of tetracyclines during tooth development (second and third trimester of pregnancy) may cause

permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common

during long-term use of the drug but has been observed following repeated short-term courses. [see

Warnings and Precautions (5.1,5.2)].

Animal Data

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 also has been noted in animals treated early in pregnancy.

8.2 Lactation

Risk Summary

Based on available published data, doxycycline is present in human milk. There are no data that inform

the levels of doxycycline in breastmilk, the effects on the breastfed infant, or the effects on milk

production. Because of the potential for serious adverse reactions, including tooth discoloration and

inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with

Doxycycline hylcate tablets and for 5 days after the last dose.

8.3 Females and Males of Reproductive Potential

Infertility

Based on findings from a fertility study in animals, doxycycline may impair female and male fertility.

The reversibility of this finding is unclear. [see Nonclinical Toxicology (13.1)].

8.4 Pediatric Use

Because of the effects of drugs of the tetracycline-class on tooth development and growth, use

doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to

outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted

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