DORYX MPC Tablet Ref.[27552] Active ingredients: Doxycycline

Source: FDA, National Drug Code (US)  Revision Year: 2021 

1. Indications and Usage

1.1 Rickettsial Infections

DORYX MPC is indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

1.2 Sexually Transmitted Infections

DORYX MPC is indicated for treatment of the following sexually transmitted infections:

  • Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.
  • Nongonococcal urethritis caused by Ureaplasma urealyticum.
  • Lymphogranuloma venereum caused by Chlamydia trachomatis.
  • Granuloma inguinale caused by Klebsiella granulomatis.
  • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
  • Chancroid caused by Haemophilus ducreyi.

1.3 Respiratory Tract Infections

DORYX MPC is indicated for treatment of the following respiratory tract infections:

  • Respiratory tract infections caused by Mycoplasma pneumoniae.
  • Psittacosis (ornithosis) caused by Chlamydophila psittaci.
  • Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
  • Doxycycline is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
    • Respiratory tract infections caused by Haemophilus influenzae.
    • Respiratory tract infections caused by Klebsiella species.
    • Upper respiratory infections caused by Streptococcus pneumoniae.

1.4 Specific Bacterial Infections

DORYX MPC is indicated for treatment of the following specific bacterial infections:

  • Relapsing fever due to Borrelia recurrentis.
  • Plague due to Yersinia pestis.
  • Tularemia due to Francisella tularensis.
  • Cholera caused by Vibrio cholerae.
  • Campylobacter fetus infections caused by Campylobacter fetus.
  • Brucellosis due to Brucella species (in conjunction with streptomycin).
  • Bartonellosis due to Bartonella bacilliformis.

Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.

DORYX MPC 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

DORYX MPC is indicated for treatment of the following ophthalmic infections:

  • Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
  • Inclusion conjunctivitis caused by Chlamydia trachomatis.

1.6 Anthrax Including Inhalational Anthrax (Post-Exposure)

DORYX MPC is indicated for treatment of Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

1.7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated

DORYX MPC is indicated as an alternative treatment for the following selected infections when penicillin is contraindicated:

  • Syphilis caused by Treponema pallidum.
  • Yaws caused by Treponema pallidum subspecies pertenue.
  • Listeriosis due to Listeria monocytogenes.
  • Vincent’s infection caused by Fusobacterium fusiforme.
  • Actinomycosis caused by Actinomyces israelii.
  • Infections caused by Clostridium species.

1.8 Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne

In acute intestinal amebiasis, DORYX MPC may be a useful adjunct to amebicides.

In severe acne, DORYX MPC may be useful adjunctive therapy.

1.9 Prophylaxis of Malaria

DORYX MPC is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains [see Dosage and Administration (2.2) and Patient Counseling Information (17)].

1.10 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORYX MPC and other antibacterial drugs, DORYX MPC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions

  • DORYX MPC is not substitutable on a mg per mg basis with other oral doxycyclines. To avoid prescribing errors, do not substitute DORYX MPC for other oral doxycyclines on a mg per mg basis because of differing bioavailability.
  • Do not chew or crush tablets.
  • The recommended dosage, frequency of administration and weight-based dosage recommendations of DORYX MPC differ from that of the other tetracyclines [see Dosage and Administration (2.2, 2.3, 2.4)]. Exceeding the recommended dosage may result in an increased incidence of adverse reactions.
  • Administer DORYX MPC with an adequate amount of fluid to wash down the drug and reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].
  • If gastric irritation occurs, DORYX MPC may be given with food or milk [see Clinical Pharmacology (12.3)].

2.2 Switching from DORYX to DORYX MPC

When switching from DORYX to DORYX MPC:

  • A 120 mg dose of DORYX MPC will replace a 100 mg dose of DORYX

2.3 Dosage in Adult Patients

  • The usual dosage of DORYX MPC is 240 mg on the first day of treatment (administered 120 mg every 12 hours) followed by a maintenance dose of 120 mg daily. The maintenance dose may be administered as a single dose.
  • In the management of more severe infections (particularly chronic infections of the urinary tract), 120 mg every 12 hours is recommended.
  • For certain selected specific indications, the recommended duration or dosage and duration of DORYX MPC in adult patients are as follows:
    • Streptococcal infections, therapy should be continued for 10 days.
    • Uncomplicated urethral, endocervical, or rectal infection caused by C. trachomatis: 120 mg, by mouth, twice-a-day for 7 days.
    • Uncomplicated gonococcal infections in adults (except anorectal infections in men): 120 mg, by mouth, twice-a-day for 7 days. As an alternate single visit dose, administer 360 mg followed in one hour by a second 360 mg dose.
    • Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 120 mg, by mouth, twice-a-day for 7 days.
    • Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 120 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 120 mg, by mouth, twice-a-day for 4 weeks.
    • Acute epididymo-orchitis caused by N. gonorrhoeae: 120 mg, by mouth, twice-a-day for at least 10 days.
    • Acute epididymo-orchitis caused by C. trachomatis: 120 mg, by mouth, twice-a-day for at least 10 days

2.4 Dosage in Pediatric Patients

  • For all pediatric patients weighing less than 45 kg with severe or life threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage of DORYX MPC is 2.6 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose [see Warnings and Precautions (5.1)].
  • For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule of DORYX MPC is 5.3 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.6 mg per kg of body weight (given as a single daily dose or divided into twice daily doses). For pediatric patients weighing over 45 kg, the usual adult dose should be used.

2.5 Dosage for Prophylaxis of Malaria

For adults, the recommended dose of DORYX MPC is 120 mg daily.

For pediatric patients 8 years of age and older, the recommended dosage of DORYX MPC is 2.4 mg per kg of body weight administered once daily. Pediatric patients weighing 45 kg or more should receive the adult dose.

Prophylaxis should begin 1 or 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

2.6 Dosage for Inhalational Anthrax (Post-Exposure)

For adults, the recommended dosage is 120 mg, of DORYX MPC, by mouth, twice-a-day for 60 days.

For pediatric patients weighing less than 45 kg, the recommended dosage of DORYX MPC is 2.6 mg per kg of body weight, by mouth, twice-a-day for 60 days. Pediatric patients weighing 45 kg or more should receive the adult dose.

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.

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

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