NDC 42291-156 Doxycycline

Doxycycline

NDC Product Code 42291-156

NDC Code: 42291-156

Proprietary Name: Doxycycline Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Doxycycline Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
YELLOW (C48330)
Shape: OVAL (C48345)
Size(s):
13 MM
Imprint(s):
LCI;1338
Score: 1

Code Structure
  • 42291 - Avkare, Inc.
    • 42291-156 - Doxycycline

NDC 42291-156-05

Package Description: 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC 42291-156-25

Package Description: 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Doxycycline with NDC 42291-156 is a a human prescription drug product labeled by Avkare, Inc.. The generic name of Doxycycline is doxycycline. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Avkare, Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Doxycycline Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DOXYCYCLINE 100 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ALUMINUM OXIDE (UNII: LMI26O6933)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Tetracycline-class Drug - [EPC] (Established Pharmacologic Class)
  • Tetracyclines - [CS]

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Avkare, Inc.
Labeler Code: 42291
FDA Application Number: ANDA065285 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-15-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Doxycycline Product Label Images

Doxycycline Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline Tablets USP, 150 mg, 100 mg, 75 mg and 50 mg, contain doxycycline monohydrate equivalent to 150 mg, 100 mg, 75 mg, and 50 mg of doxycycline for oral administration. Inactive ingredients include microcrystalline cellulose, anhydrous lactose, corn starch, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, D&C yellow #10 aluminum lake, and FD&C yellow #6 aluminum lake. The chemical designation of the light-yellow crystalline powder 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.Structural formula:Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.

Clinical Pharmacology

Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.Following a 200 mg dose of doxycycline monohydrate, 24 normal adult volunteers averaged the following serum concentration values: Time (hr): 0.5 1.0 1.5 2.0 3.0 4.0 8.0 12.0 24.0 48.0 72.0 Conc. (mcg/mL): 1.02 2.26 2.67 3.01 3.16 3.03 2.03 1.62 0.95 0.37 0.15Average Observed Values         Maximum Concentration 3.61 mcg/mL (± 0.9 sd)     Time of Maximum Concentration 2.60 hr (± 1.10 sd)     Elimination Rate Constant 0.049 per hr (± 0.030 sd)     Half-Life 16.33 hr (± 4.53 sd)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 to 22 hours) in individuals with normal and severely impaired renal function.Hemodialysis does not alter serum half-life.

Microbiology

Mechanism of ActionDoxycycline 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. Cross resistance with other tetracyclines is common. ResistanceCross resistance with other tetracyclines is common. Antimicrobial ActivityDoxycycline has been shown to be active against most isolates of the following microorganisms, both


in vitro and in clinical infections (see


INDICATIONS AND USAGE).


Gram-Negative Bacteria:Acinetobacter species


Bartonella bacilliformis


Brucella


species


Campylobacter


fetus


Enterobacter aerogenes


Escherichia coli


Francisella tularensis


Haemophilus ducreyi


Haemophilus


influenzaKlebsiella granulomatis


Klebsiella


species


Neisseria gonorrhoeae


Shigella


species


Vibrio cholerae


Yersinia pestis


Gram-Positive Bacteria:Bacillus anthracis


Listeria monocytogenes


Streptococcus pneumoniae


Anaerobes:Clostridium species


Fusobacterium fusiforme


Propionibacterium acnes


Other Bacteria:Nocardiae and other


Actinomyces species


Borrelia recurrentis


Chlamydophila psittaci


Chlamydia trachomatis


Mycoplasma pneumoniae


Rickettsiae


Treponema pallidum


Treponema


pallidum subspecies


pertenue Ureaplasma urealyticum


Parasites Balantidium coli


Entamoeba


species


Susceptibility Testing MethodsFor 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.

Indications And Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets, USP and other antibacterial drugs, doxycycline tablets, 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.Doxycycline Tablets, USP are 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 Tablets, USP are 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 Tablets, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, 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 Tablets, USP are 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 subspecies


pertenue.


   


 Yaws caused by


Treponema 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.

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, including doxycycline, 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 of 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 antibiotic 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 antibiotic use not directed against


C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic 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 tablets. 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 tablets 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 the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six 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 embryo toxicity has been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, 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 preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, doxycycline tablets should be discontinued and appropriate therapy instituted.


Incision and drainage or other surgical procedures should be performed in conjunction with antibacterial therapy when indicated.Prescribing doxycycline tablets 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.

Information For Patients

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 eruptions, 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.


)


    -not to use outdated or poorly stored doxycycline.     -that the use of doxycycline might increase the incidence of vaginal candidiasis.Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.Patients should be counseled that antibacterial drugs including doxycycline tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When doxycycline tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by doxycycline tablets or other antibacterial drugs in the future.

Laboratory Tests

In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months.In long-term therapy, periodic laboratory evaluations 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.Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.The concurrent use of tetracycline and 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 the carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with related antibacterial, 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 (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.

Teratogenic Effects

Pregnancy Category DThere are no adequate and well-controlled  studies on the use of doxycycline in pregnant 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.


1A 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 56 (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

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 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 life-threatening conditions (e.g., anthrax, Rocky mountain spotted fever), particularly when there are no alternative therapies


(See


WARNINGS and


DOSAGE AND ADMINISTRATION).

Adverse Reactions

Due to oral doxycycline's virtually complete absorption, side effects to 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, and 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. Rare 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.
)
Skin: Maculopapular and erythematous rashes. Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme have been reported. 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.)
Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported with tetracyclines.
Other: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines. (See
PRECAUTIONS – General.)
When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. No abnormalities of thyroid function are known to occur.To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life, and it would not be of benefit in treating cases of overdosage.

Dosage And Administration

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 or 50 mg every 6 hours) followed by a maintenance dose of 100 mg/day. 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.


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.


Acute epididymo-orchitis caused by


N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.


Primary and secondary syphilis: 300 mg a day in divided doses for at least 10 days.


Uncomplicated urethral, endocervical, or rectal infection in adults caused by


Chlamydia trachomatis: 100 mg, by mouth, twice a day for at least 7 days.


Nongonococcal urethritis caused by


C. trachomatis and


U. urealyticum: 100 mg, by mouth, twice a day for at least 7 days.


Acute epididymo-orchitis caused by


C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.


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. 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, doxycycline may be given with food. Ingestion of a high fat meal has been shown to delay the time to peak plasma concentrations by an average of one hour and 20 minutes. However, in the same study, food enhanced the average peak concentration by 7.5% and the area under the curve by 5.7%.

How Supplied

Doxycycline Tablets USP, 50 mg are yellow, round, film coated, tablets, debossed "LCI" on one face and "1335" on the other face. Each tablet contains doxycycline monohydrate equivalent to 50 mg of doxycycline.Doxycycline Tablets USP, 75 mg are yellow, round, film coated, tablets, debossed "LCI" on one face and "1535" on the other face. Each tablet contains doxycycline monohydrate equivalent to 75 mg of doxycycline.Doxycycline Tablets USP, 100 mg are yellow, film coated, caplets, debossed "LCI" on one face and "1338" on the other face. Each tablet contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows:Bottles of 50 NDC 42291-156-05

Bottles of 250 NDC 42291-156-25
Doxycycline Tablets USP, 150 mg are yellow, round, film coated, tablets, debossed "LCI" on one face and "1537" on the other face. Each tablet contains doxycycline monohydrate equivalent to 150 mg of doxycycline.Dispense in a tight light-resistant container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].PROTECT FROM LIGHT.

Animal Pharmacology And Animal Toxicology

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO


4, and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO


4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.


Minocycline, tetracycline PO


4, 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.

References

  • 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 prospective study.
  • Int J Fertil 1980; 25:315-317.
  • Hale T.
  • Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing 2000; 225-226.

Other

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478
Mfg. Rev. 09/18

AV 02/19 (P)

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