Label: DOXYCYCLINE HYCLATE- doxycycline hyclate tablet, delayed release 

  • NDC Code(s): 0378-4531-05, 0378-4531-91, 0378-4532-01, 0378-4532-05
  • Packager: Mylan Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 12/13

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use doxycycline hyclate delayed-release tablets safely and effectively. See full prescribing information for doxycycline hyclate delayed-release tablets.

    DOXYCYCLINE hyclate delayed-release tablets USP, 75 mg and 100 mg for oral use.
    Initial U.S. Approval: 1967

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)

    RECENT MAJOR CHANGES

    Dosage and Administration (2.1)     04/2013

    INDICATIONS AND USAGE

    Doxycycline hyclate delayed-release tablets are a tetracycline-class antimicrobial 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 in acute intestinal amebiasis and severe acne ( 1.8)
    Prophylaxis of malaria ( 1.9)

    DOSAGE AND ADMINISTRATION

    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 daily. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. ( 2.1)
    For children above 8 years of age: The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by 2.2 mg/kg of body weight given as a single daily dose or divided into two doses on subsequent days. For more severe infections up to 4.4 mg/kg of body weight may be used. For children over 45 kg, the usual adult dose should be used. ( 2.1)

    DOSAGE FORMS AND STRENGTHS

    Tablets: 75 mg and 100 mg (3)

    CONTRAINDICATIONS

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

    WARNINGS AND PRECAUTIONS

    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). ( 5.1)
    Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs. ( 5.2)
    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. Reevaluate therapy if superinfection occurs. ( 5.4)

    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 Mylan Pharmaceuticals Inc. Toll free at 1-877-446-3679 (1-877-4-INFO-RX) 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 coadministration of tetracyclines with penicillin ( 7.2)
    Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron-containing preparations ( 7.3)
    Concurrent use of tetracycline may render oral contraceptives less effective ( 7.4)
    Barbiturates, carbamazepine and phenytoin decrease the half-life of doxycycline ( 7.5)

    USE IN SPECIFIC POPULATIONS

    Pregnancy Category D ( 8.1)
    Tetracyclines are excreted in human milk; however, the extent of absorption of doxycycline in the breastfed infant is not known. Doxycycline use during nursing should be avoided if possible. ( 8.3)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 12/2013

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  • 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

    2 DOSAGE AND ADMINISTRATION

    2.1 Usual Dosage and Administration

    2.2 For Prophylaxis of Malaria

    2.3 Inhalational Anthrax (Post-Exposure)

    2.4 Sprinkling the Tablet over Applesauce

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    5 WARNINGS AND PRECAUTIONS

    5.1 Tooth Development

    5.2 Clostridium difficile-Associated Diarrhea

    5.3 Photosensitivity

    5.4 Superinfection

    5.5 Benign Intracranial Hypertension

    5.6 Skeletal Development

    5.7 Antianabolic Action

    5.8 Malaria

    5.9 Development of Drug-Resistant Bacteria

    5.10 Laboratory Monitoring for Long-Term Therapy

    6 ADVERSE REACTIONS

    6.2 Post-Marketing Experience

    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/Laboratory Test Interactions

    8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.3 Nursing Mothers

    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

    *
    Sections or subsections omitted from the full prescribing information are not listed.
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  • 1 INDICATIONS AND USAGE

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release 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.

    Doxycycline is a tetracycline-class antimicrobial indicated in the following conditions or diseases:

    1.1 Rickettsial Infections

    Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

    1.2 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 Calymmatobacterium granulomatis.

    Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.

    Chancroid caused by Haemophilus ducreyi.

    1.3 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

    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 is 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

    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)

    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

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

    Syphilis caused by Treponema pallidum.

    Yaws caused by Treponema pertenue.

    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 may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.

    1.9 Prophylaxis of Malaria

    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 (2.2) and Patient Counseling Information (17)].

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  • 2 DOSAGE AND ADMINISTRATION

    2.1 Usual 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) 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 Pediatric Patients Above 8 Years of Age

    The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by 2.2 mg/kg of body weight given as a single daily dose or divided into two doses on subsequent days. For more severe infections up to 4.4 mg/kg of body weight may be used. For children over 45 kg, the usual adult dose should be used.

    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 (6)].

    If gastric irritation occurs, doxycycline may be given with food or milk [see Clinical Pharmacology (12)].

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

    Uncomplicated Urethral, Endocervical, or Rectal Infection Caused by Chlamydia trachomatis

    100 mg by mouth twice a day for 7 days.

    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.

    Nongonococcal Urethritis (NGU) Caused by 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 C. trachomatis

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

    2.2 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 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.

    2.3 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.

    2.4 Sprinkling the Tablet over Applesauce

    Doxycycline hyclate delayed-release tablets may also be administered by carefully breaking up the tablet and sprinkling the tablet contents (delayed-release beads) on a spoonful of applesauce. The delayed-release beads must not be crushed or damaged when breaking up the tablet. Any loss of beads in the transfer would prevent using the dose. The applesauce/doxycycline mixture should be swallowed immediately without chewing and may be followed by a glass of water if desired. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. In the event that a prepared dose of applesauce/doxycycline cannot be taken immediately, the mixture should be discarded and not stored for later use.

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  • 3 DOSAGE FORMS AND STRENGTHS

    Doxycycline hyclate delayed-release tablets, 75 mg are white, round, scored tablets containing yellow beads debossed with M on one side of the tablet and D to the left of the score and 31 to the right of the score on the other side. Each tablet contains specially coated beads of doxycycline hyclate, USP equivalent to 75 mg of doxycycline.

    Doxycycline hyclate delayed-release tablets, 100 mg are white, round, scored tablets containing yellow beads debossed with M on one side of the tablet and D to the left of the score and 32 to the right of the score on the other side. Each tablet contains specially coated beads of doxycycline hyclate, USP equivalent to 100 mg of doxycycline.

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  • 4 CONTRAINDICATIONS

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

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  • 5 WARNINGS AND PRECAUTIONS

    5.1 Tooth Development

    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. Doxycycline should not be used in this age group, except for anthrax, including inhalational anthrax (post-exposure), unless other drugs are not likely to be effective or are contraindicated.

    5.2 Clostridium difficile-Associated Diarrhea

    Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline hyclate delayed-release tablets, 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 antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 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.

    5.3 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.

    5.4 Superinfection

    As with other antibacterial preparations, use of doxycycline may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibacterial should be discontinued and appropriate therapy instituted.

    5.5 Benign Intracranial Hypertension

    Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued.

    5.6 Skeletal Development

    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 also 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.

    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 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 hyclate delayed-release 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.

    5.10 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.

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  • 6 ADVERSE REACTIONS

    6.2 Post-Marketing Experience

    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. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. 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 is discussed above [see Warnings and Precautions (5.3)].

    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, and exacerbation of systemic lupus erythematosus.

    Blood

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

    Benign Intracranial Hypertension

    Bulging fontanels in infants and benign intracranial hypertension in adults [see Warnings and Precautions (5.5)].

    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.

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  • 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 in conjunction with penicillin.

    7.3 Antacids and Iron Preparations

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

    7.4 Oral Contraceptives

    Concurrent use of tetracycline 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/Laboratory Test Interactions

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

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  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Teratogenic Effects. Pregnancy Category D

    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 the 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 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 (that is, 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 one year of age.3

    Nonteratogenic Effects

    [See Warnings and Precautions (5.1, 5.6).]

    8.3 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. 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 and Precautions (5.1, 5.6)].

    8.4 Pediatric Use

    Because of the effects of drugs of the tetracycline class on tooth development and growth, doxycycline should not be used in pediatric patients to the age of 8 years, unless the potential benefits are expected to outweigh the risks such as for anthrax, or when other drugs are not likely to be effective or are contraindicated [see Warnings and Precautions (5.1, 5.6) and Dosage and Administration (2.1, 2.3)].

    8.5 Geriatric Use

    Clinical studies of doxycycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

    Doxycycline hyclate delayed-release 75 mg tablets contain 2.15 mg (0.09 mEq) of sodium.

    Doxycycline hyclate delayed-release 100 mg tablets contain 2.86 mg (0.12 mEq) of sodium.

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  • 10 OVERDOSAGE

    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.

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  • 11 DESCRIPTION

    Doxycycline hyclate delayed-release tablets, USP, for oral administration, contain specially coated beads of doxycycline hyclate, a broad spectrum antibacterial synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.

    The structural formula for doxycycline hyclate is:

    Structural Formula

    with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical designation for doxycycline hyclate 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 monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow to light yellow crystalline powder, freely soluble in water and methanol, slightly soluble in alcohol, soluble in solutions of alkali hydroxides and carbonates, and practically insoluble in chloroform and in ether. 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. Inactive ingredients in the tablet formulation are: anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose phthalate, lactose monohydrate, povidone, pregelatinized starch (corn), sodium chloride, sodium lauryl sulfate, stearic acid, talc, and triethyl citrate.

    Meets USP Dissolution Test 3.

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  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Doxycycline is an antimicrobial drug [see Clinical Pharmacology (12.4)].

    12.3 Pharmacokinetics

    Doxycycline is virtually completely absorbed after oral administration. The mean Cmax and AUC0-∞ of doxycycline are 24% and 13% lower, respectively, following single dose administration of doxycycline hyclate delayed-release tablets, 100 mg with a high fat meal (including milk) compared to fasted conditions. The mean Cmax of doxycycline is 19% lower and the AUC0-∞ is unchanged following single dose administration of doxycycline hyclate delayed-release tablets, 150 mg with a high fat meal (including milk) compared to fasted conditions. The clinical significance of these decreases is unknown.

    When doxycycline hyclate delayed-release tablets are sprinkled over applesauce and taken with or without water, the extent of doxycycline absorption is unchanged, but the rate of absorption is increased slightly.

    Tetracyclines are concentrated in bile by the liver and excreted in the urine and feces at high concentrations and in a biologically active form. Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with a creatinine clearance of about 75 mL/min. This percentage may fall as low as 1% to 5%/72 hours in individuals with a creatinine clearance below 10 mL/min.

    Studies have shown no significant difference in the serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severely impaired renal function. Hemodialysis does not alter the serum half-life.

    12.4 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. Cross-resistance between tetracyclines is common.

    Doxycycline has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for doxycycline hyclate delayed-release tablets.

    Gram-Negative Bacteria

    Acinetobacter species
    Bartonella bacilliformis
    Brucella species
    Calymmatobacterium granulomatis
    Campylobacter fetus
    Enterobacter aerogenes
    Escherichia coli
    Francisella tularensis
    Haemophilus ducreyi
    Haemophilus influenzae
    Klebsiella species
    Neisseria gonorrhoeae
    Shigella species
    Vibrio cholerae
    Yersinia pestis

    Gram-Positive Bacteria

    Bacillus anthracis
    Streptococcus pneumoniae

    Anaerobic Bacteria

    Clostridium species
    Fusobacterium fusiforme
    Propionibacterium acnes

    Other Bacteria

    Actinomyces species
    Borrelia recurrentis
    Chlamydophila psittaci
    Chlamydia trachomatis
    Mycoplasma pneumoniae
    Rickettsiae
    Treponema pallidum
    Treponema pertenue
    Ureaplasma urealyticum

    Parasites

    Balantidium coli
    Entamoeba species
    Plasmodium falciparum*

    *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 Test Methods

    When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drugs used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.

    Dilution Techniques

    Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method (broth and/or agar)5,6,8. The MIC values should be interpreted according to the criteria provided in Table 1.

    Diffusion Techniques

    Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. Zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standard test method5,7,8. This procedure uses paper disks impregnated with 30 mcg doxycycline to test the susceptibility of bacteria to doxycycline. The disk diffusion interpretive criteria are provided in Table 1.

    Anaerobic Techniques

    For anaerobic bacteria, the susceptibility to doxycycline can be determined by a standardized test method9. The MIC values obtained should be interpreted according to the criteria provided in Table 1.

    Table 1: Susceptibility Test Interpretive Criteria for Doxycycline and Tetracycline
    *
    Organisms susceptible to tetracycline are also considered susceptible to doxycycline. However, some organisms that are intermediate or resistant to tetracycline may be susceptible to doxycycline.
    The current absence of resistance isolates precludes defining any results other than “Susceptible”. If isolates yielding MIC results other than susceptible, they should be submitted to a reference laboratory for further testing.
    Gonococci with 30 mcg tetracycline disk zone diameters of less than 19 mm usually indicate a plasmid-mediated tetracycline resistant Neisseria gonorrhoeae isolate. Resistance in these strains should be confirmed by a dilution test (MIC greater than or equal to 16 mcg/mL).

    Bacteria*

    Minimal Inhibitory Concentration

    (mcg/mL)

    Zone

    Diameter

    (mm)

    Agar

    Dilution

    (mcg/mL)

    S

    I

    R

    S

    I

    R

    S

    I

    R

    Acinetobacter spp.

         Doxycycline

    ≤ 4

    8

    ≥ 16

    ≥ 13

    10 to 12

    ≤ 9

    -

    -

    -

         Tetracycline

    ≤ 4

    8

    ≥ 16

    ≥ 15

    12 to 14

    ≤ 11

    -

    -

    -

    Anaerobes

         Tetracycline

    -

    -

    -

    -

    -

    -

    ≤ 4

    8

    ≥ 16

    Bacillus anthracis*

         Doxycycline

    ≤ 1

    -

    -

    -

    -

    -

    -

    -

    -

         Tetracycline

    ≤ 1

    -

    -

    -

    -

    -

    -

    -

    -

    Brucella species*

         Doxycycline

    ≤ 1

    -

    -

    -

    -

    -

    -

    -

    -

         Tetracycline

    ≤ 1

    -

    -

    -

    -

    -

    -

    -

    -

    Enterobacteriacea

         Doxycycline

    ≤ 4

    8

    ≥ 16

    ≥ 14

    11 to 13

    ≤ 10

    -

    -

    -

         Tetracycline

    ≤ 4

    8

    ≥ 16

    ≥ 15

    12 to 14

    ≤ 11

    -

    -

    -

    Franciscella tularensis*

         Doxycycline

    ≤ 4

    -

    -

    -

    -

    -

    -

    -

    -

         Tetracycline

    ≤ 4

    -

    -

    -

    -

    -

    -

    -

    -

    Haemophilus influenzae

         Tetracycline

    ≤ 2

    4

    ≥ 8

    ≥ 29

    26 to 28

    ≤ 25

    -

    -

    -

    Mycoplasma pneumoniae

         Tetracycline

    -

    -

    -

    -

    -

    -

    ≤ 2

    -

    -

    Nocardiae and other aerobic Actinomyces species*

         Doxycycline

    ≤ 1

    2 to 4

    ≥ 8

    Neisseria gonorrhoeae

         Tetracycline

    -

    -

    -

    ≥ 38

    31 to 37

    ≤ 30

    ≤ 0.25

    0.5 to 1

    ≥ 2

    Streptococcus pneumoniae

         Tetracycline

    ≤ 2

    4

    ≥ 8

    ≥ 23

    19 to 22

    ≤ 18

    -

    -

    -

    Vibrio cholerae

         Doxycycline

    ≤ 4

    8

    ≥ 16

    -

    -

    -

    -

    -

    -

         Tetracycline

    ≤ 4

    8

    ≥ 16

    -

    -

    -

    -

    -

    -

    Yersinia pestis

         Doxycycline

    ≤ 4

    8

    ≥ 16

    -

    -

    -

    -

    -

    -

         Tetracycline

    ≤ 4

    8

    ≥ 16

    -

    -

    -

    -

    -

    -

    Ureaplasma urealyticum

         Tetracycline

    -

    -

    -

    -

    -

    -

    ≤ 1

    ≥ 2

    A report of Susceptible (S) indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations at the infection site necessary to inhibit growth of the pathogen. A report of Intermediate (I) indicates that the result should be considered equivocal, and, if the bacteria is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial is not likely to be inhibited growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.

    Quality Control

    Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test.5,6,7,8,9,10,11 Standard doxycycline and tetracycline powders should provide the following range of MIC values noted in Table 2. For the diffusion technique using the 30 mcg doxycycline disk the criteria noted in Table 2 should be achieved.

    Table 2: Acceptable Quality Control Ranges for Susceptibility Testing for Doxycycline and Tetracycline

    QC Strain

    Minimal

    Inhibitory

    Concentration

    (mcg/mL)

    Zone

    Diameter

    (mm)

    Agar

    Dilution

    (mcg/mL)

    Enterococcus faecalis ATCC 29212

         Doxycycline

    2 to 8

    -

    -

         Tetracycline

    8 to 32

    -

    -

    Escherichia coli ATCC 25922

         Doxycycline

    0.5 to 2

    18 to 24

    -

         Tetracycline

    0.5 to 2

    18 to 25

    -

    Haemophilus influenzae ATCC 49247

         Tetracycline

    4 to 32

    14 to 22

    -

    Neisseria gonorrhoeae ATCC 49226

         Tetracycline

    -

    30 to 42

    0.25 to 1

    Staphylococcus aureus ATCC 25923

         Doxycycline

    -

    23 to 29

    -

         Tetracycline

    -

    24 to 30

    -

    Staphylococcus aureus ATCC 29213

         Doxycycline

    0.12 to 0.5

    -

         Tetracycline

    0.12 to 1

    -

    Staphylococcus pneumoniae ATCC 49619

         Doxycycline

    0.015 to 0.12

    25 to 34

    -

         Tetracycline

    0.06 to 0.5

    27 to 31

    -

    Bacteroides fragilis ATCC 25285

         Tetracycline

    -

    -

    0.125 to 0.5

    Bacteroides thetaiotaomicron ATCC 29741

         Tetracycline

    -

    -

    8 to 32

    Mycoplasma pneumoniae ATCC 29342

         Tetracycline

    0.06 to 0.5

    -

    0.06 to 0.5

    Ureaplasma urealyticum ATCC 33175

         Tetracycline

    -

    -

    ≥ 8

    Close
  • 13 NONCLINICAL TOXICOLOGY

    13.1 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 antibiotics, 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 antibacterials (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.

    13.2 Animal Toxicology and/or Pharmacology

    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 hydrochloride, and tetracycline hydrochloride, 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.

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

    Close
  • 15 REFERENCES

    Friedman JM, 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.
    Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement, CLSI document M100-S23. CLSI document M100S23, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2013.
    Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Ninth Edition. CLSI document M07-A9, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2012.
    Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2012.
    Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline – Second Edition CLSI document M45-A2, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2010.
    Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard – Eighth Edition. CLSI document M11-A8, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2012.
    Clinical and Laboratory Standards Institute (CLSI). Methods for Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard – Second Edition. CLSI document M24-A2, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2011.
    Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI document M43-A, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2011.
    Close
  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Doxycycline Hyclate Delayed-release Tablets, USP are available containing delayed-release beads of doxycycline hyclate, USP equivalent to 75 mg or 100 mg of doxycycline.

    The 75 mg tablets are white, round, scored tablets containing yellow beads debossed with M on one side of the tablet and D to the left of the score and 31 to the right of the score on the other side. They are available as follows:

    NDC 0378-4531-91
    bottles of 60 tablets

    NDC 0378-4531-05
    bottles of 500 tablets

    The 100 mg tablets are white, round, scored tablets containing yellow beads debossed with M on one side of the tablet and D to the left of the score and 32 to the right of the score on the other side. They are available as follows:

    NDC 0378-4532-01
    bottles of 100 tablets

    NDC 0378-4532-05
    bottles of 500 tablets

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

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

    Close
  • 17 PATIENT COUNSELING INFORMATION

    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 (for example, 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 to 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 (for example, skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered [see Warnings and Precautions (5.3)].
    to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].
    that the absorption of tetracyclines is reduced when taken with foods, especially those that contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk [see Drug Interactions (7.3)].
    that the absorption of tetracyclines is reduced when taken with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations [see Drug Interactions (7.3)].
    that the use of doxycycline might increase the incidence of vaginal candidiasis.

    Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of antibacterial. If this occurs, patients should contact their physician as soon as possible.

    Patients should be counseled that antibacterial drugs including doxycycline hyclate delayed-release tablets should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When doxycycline hyclate delayed-release 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 hyclate delayed-release tablets or other antibacterial drugs in the future.

    The brands listed are trademarks of their respective owners.

    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    REVISED DECEMBER 2013
    DXYDR:R5

    Close
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 75 mg

    NDC 0378-4531-91

    Doxycycline
    Hyclate
    Delayed-release
    Tablets, USP
    75 mg*

    Rx only 60 Tablets

    *Each tablet contains delayed-release
    beads of doxycycline hyclate, USP
    equivalent to 75 mg of doxycycline.

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

    Keep container tightly closed.

    Keep this and all medication
    out of the reach of children.

    Store at 20° to 25°C (68° to 77°F).
    [See USP Controlled Room
    Temperature.]

    Usual Adult Dosage: See
    accompanying prescribing
    information.

    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Mylan.com

    RM4531D3

    Doxycycline Hyclate Delayed-Release Tablets 75 mg Bottle Labels
    Close
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 100 mg

    NDC 0378-4532-01

    Doxycycline
    Hyclate
    Delayed-release
    Tablets, USP
    100 mg*

    Rx only 100 Tablets

    *Each tablet contains delayed-release
    beads of doxycycline hyclate, USP
    equivalent to 100 mg of doxycycline.

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

    Keep container tightly closed.

    Keep this and all medication
    out of the reach of children.

    Store at 20° to 25°C (68° to 77°F).
    [See USP Controlled Room
    Temperature.]

    Usual Adult Dosage: See
    accompanying prescribing
    information.

    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Mylan.com

    RM4532A3

    Doxycycline Hyclate Delayed-Release Tablets 100 mg Bottle Labels
    Close
  • INGREDIENTS AND APPEARANCE
    DOXYCYCLINE HYCLATE 
    doxycycline hyclate tablet, delayed release
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0378-4531
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 75 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    SILICON DIOXIDE  
    CROSPOVIDONE  
    LACTOSE MONOHYDRATE  
    POVIDONES  
    STARCH, CORN  
    SODIUM CHLORIDE  
    SODIUM LAURYL SULFATE  
    STEARIC ACID  
    TALC  
    TRIETHYL CITRATE  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code M;D;31
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0378-4531-91 60 in 1 BOTTLE, PLASTIC
    2 NDC:0378-4531-05 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090431 12/30/2010
    DOXYCYCLINE HYCLATE 
    doxycycline hyclate tablet, delayed release
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0378-4532
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    SILICON DIOXIDE  
    CROSPOVIDONE  
    LACTOSE MONOHYDRATE  
    POVIDONES  
    STARCH, CORN  
    SODIUM CHLORIDE  
    SODIUM LAURYL SULFATE  
    STEARIC ACID  
    TALC  
    TRIETHYL CITRATE  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 11mm
    Flavor Imprint Code M;D;32
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0378-4532-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:0378-4532-05 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090431 12/30/2010
    Labeler - Mylan Pharmaceuticals Inc. (059295980)
    Close