Acticlate
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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ACTICLATE and other antibacterial drugs, ACTICLATE 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 antibacterial indicated in the following conditions or diseases:
Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by Rickettsiae.
Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis.
Nongonococcal urethritis caused by Ureaplasma urealyticum.
Lymphogranuloma venereum caused by Chlamydia trachomatis.
Granuloma inguinale caused by Klebsiella granulomatis.
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
Chancroid caused by Haemophilus ducreyi.
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.
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.
Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
Inclusion conjunctivitis caused by Chlamydia trachomatis.
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:
Syphilis caused by Treponema pallidum.
Yaws caused by Treponema pallidum subspecies pertenue.
Listeriosis due to Listeria monocytogenes.
Vincent’s infection caused by Fusobacterium fusiforme.
Actinomycosis caused by Actinomyces israelii.
Infections caused by Clostridium species.
In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.
Doxycycline 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)].
Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by Rickettsiae.
1.2 Sexually Transmitted InfectionsUncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis.
Nongonococcal urethritis caused by Ureaplasma urealyticum.
Lymphogranuloma venereum caused by Chlamydia trachomatis.
Granuloma inguinale caused by Klebsiella granulomatis.
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
Chancroid caused by Haemophilus ducreyi.
1.3 Respiratory Tract InfectionsRespiratory 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 InfectionsRelapsing 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 InfectionsTrachoma 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 ContraindicatedWhen penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:
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 AcneIn acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.
1.9 Prophylaxis of MalariaDoxycycline 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)].
History
There is currently no drug history available for this drug.
Other Information
ACTICLATE™ (doxycycline hyclate USP) Tablets contain doxycycline hyclate, a broad-spectrum antibacterial synthetically derived from oxytetracycline, in an immediate release formulation for oral administration.
The structural formula for doxycycline hyclate is:
with a molecular formula of (C22H24N2O8, HCl)2• C2H6O• H2O and a molecular weight of 1025.87.
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 is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Inactive ingredients in the tablet formulation are: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium and magnesium stearate. Film-coating contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C Blue #1 (75 mg), FD&C Yellow #6 (75 mg), FD&C Blue #2 (150 mg) and yellow iron oxide (150 mg).
Sources
Acticlate Manufacturers
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Aqua Pharmaceuticals
![Acticlate (Doxycycline Hyclate) Tablet, Coated [Aqua Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Acticlate | Aqua Pharmaceuticals
2.1 Usual Dosage and AdministrationThe 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 eight years of age: The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by 2.2 mg per 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 per 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 (6.1)].
If gastric irritation occurs, doxycycline may be given with food or milk [see Clinical Pharmacology (12.3)].
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 C. trachomatis and U. urealyticum: 100 mg by mouth twice-a-day for 7 days.
Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 2 weeks.
Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 4 weeks.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg by mouth, twice-a-day for at least 10 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice-a-day for at least 10 days.
2.2 Prophylaxis of MalariaFor adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg per 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 per kg of body weight, by mouth, twice-a-day for 60 days. Children weighing 45 kg or more should receive the adult dose.
2.1 Usual Dosage and AdministrationThe 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 eight years of age: The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by 2.2 mg per 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 per 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 (6.1)].
If gastric irritation occurs, doxycycline may be given with food or milk [see Clinical Pharmacology (12.3)].
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 C. trachomatis and U. urealyticum: 100 mg by mouth twice-a-day for 7 days.
Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 2 weeks.
Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 4 weeks.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg by mouth, twice-a-day for at least 10 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice-a-day for at least 10 days.
2.2 Prophylaxis of MalariaFor adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg per 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 per kg of body weight, by mouth, twice-a-day for 60 days. Children weighing 45 kg or more should receive the adult dose.
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