DOXYCYCLINE HYCLATE tablet, film 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:
direct rx
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline 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 el
Product summary:
Doxycycline Hyclate Capsules, USP 50 mg are available as a blue and white capsule filled with yellow powder, imprinted with "2984", containing doxycycline hyclate, equivalent to 50 mg doxycycline; 100 mg are available as a light blue capsule filled with yellow powder imprinted with "2985"containing doxycycline hyclate, equivalent to 100 mg of doxycycline. Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Round, orange film-coated tablet engraved with "3626" on one side, and plain on the other side. Doxycycline for Oral Suspension USP is available as a raspberry-flavored, pink dry powder for oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline in a 2 oz (60 mL) bottle. Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)
Authorization status:
Abbreviated New Drug Application
Authorization number:
72189-127-14, 72189-127-20

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DOXYCYCLINE HYCLATE- doxycycline hyclate tablet, film coated

direct rx

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DOXYCYCLINE HYCLATE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline and

other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven

or strongly suspected to be caused by bacteria.

Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as

Doxycycline Hyclate Tablets and Capsules and Doxycycline for Oral Suspension; for oral

administration.

The structural formula of doxycycline monohydrate is

[Chemical Structure]

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.

Inactive ingredients in the capsule formulations are: colloidal silicon dioxide, lactose anhydrous,

magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch

glycolate, and stearic acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10,

titanium dioxide and gelatin. 100 mg gelatin capsule shell contains: FD&C Blue #1, titanium dioxide and

gelatin. Black ink contains shellac glaze in SD-45, black iron oxide, propylene glycol, FD&C Blue #2,

FD&C Red # 40, FD&C Blue # 1, D&C Yellow # 10, butyl alcohol, denatured alcohol. Each capsule,

for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline.

Inactive ingredients for the oral suspension formulation are: confectioner's sugar, D&C red #27

aluminum lake, ethyl acetate, maltodextrin, methylparaben, microcrystalline cellulose/ sodium

carboxymethylcellulose, modified cornstarch, natural flavoring; propylparaben, simethicone and

sucrose. When reconstituted, each teaspoonful (5 mL) doxycycline suspension, for oral administration,

contains doxycycline monohydrate equivalent to 25 mg of doxycycline.

Inactive ingredients for the tablet formulation are: anhydrous lactose, colloidal silicon dioxide, FD&C

Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose,

microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium

dioxide. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg

doxycycline.

Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are

concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in a

biologically active form. Doxycycline is virtually completely absorbed after oral administration.

Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of

doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by the kidney

is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min.). This

percentage excretion may fall as low as 1 to 5%/72 hours in individuals with severe renal insufficiency

(creatinine clearance below 10 mL/min.). Studies have shown no significant difference in serum half-

life of doxycycline (range 18–22 hours) in individuals with normal and severely impaired renal function.

Hemodialysis does not alter serum half-life.

Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues.

Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following

standard of care intravenous and oral dosing in 44 pediatric patients (2 to18 years of age) showed that

allometrically -scaled clearance (CL) of doxycycline in pediatric patients ≥2 to ≤8 years of age (median

[range] 3.58 [2.27 to 10.82] L/h/70 kg, N =11) did not differ significantly from pediatric patients >8 to

18 years of age (3.27 [1.11 to 8.12] L/h/70 kg, N=33). For pediatric patients weighing ≤45 kg, body

weight normalized doxycycline CL in those ≥2 to ≤8 years of age (median [range] 0.071 [0 .041 to

0.202] L/kg/h, N=10) did not differ significantly from those >8 to 18 years of age (0.081 [0.035 to

0.126] L/kg/h, N=8). In pediatric patients weighing >45 kg, no clinically significant differences in body

weight normalized doxycycline CL were observed between those ≥2 to ≤8 years (0.050 L/kg/h, N=l)

and those >8 to 18 years of age (0.044 [0.014 to 0.121] L/kg/h, N=25). No clinically significant

difference in CL between oral and IV dosing was observed in the small cohort of pediatric patients who

received the oral (N=19) or IV (N=2l) formulation alone.

Microbiology

Mechanism of Action

Doxycycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Doxycycline

has bacteriostatic activity against a broad range of Gram-positive and Gram-negative bacteria.

Resistance

Cross resistance with other tetracyclines is common.

Antimicrobial Activity

Doxycycline has been shown to be active against most isolates of the following microorganisms, both

in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the

package insert.

Gram-Negative Bacteria

Acinetobacter species

Bartonella bacilliformis

Brucella species

Klebsiella species

Klebsiella granulomatis

Campylobacter fetus

Enterobacter aerogenes

Escherichia coli

Francisella tularensis

Haemophilus ducreyi

Haemophilus influenzae

Neisseria gonorrhoeae

Shigella species

Vibrio cholerae

Yersinia pestis

Gram-Positive Bacteria

Bacillus anthracis

Listeria monocytogenes Streptococcus pneumoniae

Anaerobic Bacteria

Clostridium species

Fusobacterium fusiforme

Propionibacterium acnes

Other Bacteria

Nocardiae and other aerobic Actinomyces species

Borrelia recurrentis

Chlamydophila psittaci

Chlamydia trachomatis

Mycoplasma pneumoniae

Rickettsiae

Treponema pallidum

Treponema pallidum subspecies pertenue

Ureaplasma urealyticum

Parasites

Balantidium coli

Entamoeba species

Plasmodium falciparum1

Doxycycline has been found to be active against the asexual erythrocytic forms of Plasmodium

falciparum, but not against the gametocytes of P. falciparum. The precise mechanism of action of the

drug is not known.

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods

and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and

other antibacterial drugs, doxycycline 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.)

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

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. 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 fever), particularly

when there are no alternative therapies.

Clostridium 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 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.

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.) If severe skin

reactions occur, doxycycline should be discontinued immediately and appropriate therapy should be

instituted.

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.

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.

General

As with other antibacterial drugs, use of doxycycline may result in overgrowth of nonsusceptible

organisms, including fungi. If superinfection occurs, doxycycline should be discontinued and

appropriate therapy instituted.

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 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.

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 should only be used to treat

bacterial infections. They do not treat viral infections (e.g., the common cold). When doxycycline 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

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.

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.

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.

Pregnancy

Teratogenic Effects

There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The

vast majority of reported experience with doxycycline during human pregnancy is short-term, first

trimester exposure. There are no human data available to assess the effects of long-term therapy of

doxycycline in pregnant women, such as that proposed for treatment of anthrax exposure. An expert

review of published data on experiences with doxycycline use during pregnancy by TERIS – the

Teratogen Information System – concluded that therapeutic doses during pregnancy are unlikely to pose

a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the

data are insufficient to state that there is no risk.1 A case-control study (18,515 mothers of infants with

congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but

marginally statistically significant association with total malformations and use of doxycycline anytime

during pregnancy. Sixty-three (0.19%) of the controls and fifty-six (0.30%) of the cases were treated

with doxycycline. This association was not seen when the analysis was confined to maternal treatment

during the period of organogenesis (i.e., in the second and third months of gestation) with the exception

of a marginal relationship with neural tube defect based on only two exposed cases.2

A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days with

doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1

year of age.3

Nonteratogenic Effects

(See WARNINGS.)

Labor and Delivery

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers

Tetracyclines are excreted in human milk; however, the extent of absorption of tetracyclines, including

doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily

contraindicated; however, the effects of prolonged exposure to doxycycline in breast milk are

unknown.4 Because of the potential for serious adverse reactions in nursing infants from doxycycline, a

decision should be made whether to discontinue nursing or to discontinue the drug, taking into account

the importance of the drug to the mother. (See WARNINGS.)

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

fever), particularly when there are no alternative therapies. (See WARNINGS and DOSAGE AND

ADMINISTRATION.)

Due to oral doxycycline's virtually complete absorption, side effects of the lower bowel, particularly

diarrhea, have been infrequent. The following adverse reactions have been observed in patients

receiving tetracyclines:

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

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

reported rarely. 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.) Rare instances of esophagitis and esophageal ulcerations have been reported in

patients receiving capsule and tablet forms of the drugs in the tetracycline class. Most of these patients

took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION).

Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, skin

hyperpigmentation, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but

is uncommon. Photosensitivity is discussed above. (See WARNINGS.)

Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS.)

Immune: Hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid

purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, drug reaction with

eosinophilia and systemic symptoms (DRESS), and Jarisch-Herxheimer reaction has been reported in

the setting of spirochete infections treated with doxycycline.

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

Other: Bulging fontanels in infants and intracranial hypertension in adults. (See WARNINGS).

When given over prolonged periods, tetracyclines have been reported to produce brown-black

microscopic discoloration of the thyroid gland. No abnormalities of thyroid function studies are known

to occur.

To report suspected ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or the

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures.

Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.

The usual dosage and frequency of administration of doxycycline differs from that of the other

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

Adults:

The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every

12 hours) followed by a maintenance dose of 100 mg/day. In the management of more severe infections

(particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

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 is 2.2 mg/kg of body weight

administered every 12 hours. Children weighing 45 kg or more should receive the adult dose. (See

WARNINGS and PRECAUTIONS.)

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

kg), the recommended dosage schedule is 4.4 mg/kg of body weight divided into two doses on the first

day of treatment, followed by a maintenance dose of 2.2 mg/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.

The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended

dosage.

When used in streptococcal infections, therapy should be continued for 10 days.

Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the

tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation

and ulceration. (See ADVERSE REACTIONS.)

If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The

absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

Studies to date have indicated that administration of doxycycline at the usual recommended doses does

not lead to excessive accumulation of doxycycline in patients with renal impairment.

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. The dose may be administered with food, including milk or carbonated

beverage, as required.

Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis:

100 mg, by mouth twice a day for 7 days.

Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth, twice a

day for 7 days.

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

mouth, twice a day for 2 weeks.

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.

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

days.

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

For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8

years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis

should begin 1–2 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.

Inhalational anthrax (post-exposure):

ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days

CHILDREN: weighing less than 45 kg; 2.2 mg/kg of body weight by mouth, twice a day for 60 days.

Children weighing 45 kg or more should receive the adult dose.

Doxycycline for Oral Suspension Mixing Directions

Tap bottle lightly to loosen powder. Add 47.6 mL of water to the bottle to make a total volume of 60

mL. Shake well. This prescription, when in suspension, will maintain its potency for two weeks when

kept at room temperature.

Discard Unused Portion After Two Weeks.

Doxycycline Hyclate Capsules, USP 50 mg are available as a blue and white capsule filled with yellow

powder, imprinted with "2984", containing doxycycline hyclate, equivalent to 50 mg doxycycline; 100

mg are available as a light blue capsule filled with yellow powder imprinted with "2985"containing

doxycycline hyclate, equivalent to 100 mg of doxycycline.

Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Round, orange film-coated tablet

engraved with "3626" on one side, and plain on the other side.

Doxycycline for Oral Suspension USP is available as a raspberry-flavored, pink dry powder for oral

suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent

to 25 mg of doxycycline in a 2 oz (60 mL) bottle.

Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as

required).

Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the

following species: in rats by oxytetracycline, doxycycline, tetracycline PO4, and methacycline; in

minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and

minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and

tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was

accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large

goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of

thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and

in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated

with oxytetracycline.

Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS).

Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.

Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–

528.

Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a

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