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HIGHLIGHTS OF PRESCRIBING INFORMATION
The highlights do not include all the information needed to u DORYX ®
(doxycycline hyclate delayed-relea tablets) safely and effectively. See Full Prescribing Information for DORYX Tablets. DORYX ® (doxycycline hyclate delayed-relea tablets), 80 mg, 100 mg, 150 mg, and 200 mg for Oral u. Initial U.S. Approval: 1967 To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, DORYX Tablets should be ud only to treat or prevent infections that are proven or strongly suspected to be caud by bacteria. (1) ----------------RECENT MAJOR CHANGES------- Dosage and Administration (2.1) 04/2013 ---------------INDICATIONS AND USAGE------------------DORYX is 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 lected infections when penicillin is contraindicated (1.7) • Adjunctive therapy in acute intestinal amebiasis and vere acne (1.8) • Prophylaxis of malaria
(1.9) ----------------DOSAGE AND ADMINISTRATION---------- • Adults: the usual do of oral doxycycline is 200 mg on the first day of
treatment (administered 100 mg every 12 hours) followed by a
maintenance do of 100 mg daily. In the management of more vere infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. (2.1) • For children above eight 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 dos on the first day of treatment, followed by 2.2 mg/kg of body weight given as a single daily do or divided into two dos on subquent days. For more vere infections up to 4.4 mg/kg of body weight may be ud. For children over 45 kg, the usual adult do should be ud. (2.1) -----------------DOSAGE FORMS AND STRENGTHS------ Tablets: 80 mg, 100 mg, 150 mg, and 200 mg (3) -----------------CONTRAINDICATIONS-----------------------
Doxycycline is contraindicated in persons who have shown hypernsitivity to any of the tetracyclines. (4 ) -----------------WARNINGS AND PRECAUTIONS---------- • The u of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cau permanent discoloration of the teeth (yellow-gray-brown). (5.1)
• Clostridium difficile -associated diarrhea: Evaluate patients if diarrhea occurs. (5.2) • Photonsitivity manifested by an exaggerated sunburn reaction has been obrved 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---------------------Adver reactions obrved in patients receiving tetracyclines include anorexia, naua, vomiting, diarrhea, rash, photonsitivity, urticaria, and hemolytic anemia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-521-8813 or FDA at 1-800-FDA-1088 or v/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 u of tetracycline may render oral contraceptives less effective (7.4) • Barbiturates, carbamazepine and phenytoin decrea 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 u during nursing should be avoided if possible. (8.3) See 17 for PATIENT COUNSELING INFORM
ATION and FDA-approved Patient Labeling . Revid: 04/2013 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 R ickettsial 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 lected infections when penicillin is
contraindicated
1.8 Adjunctive therapy for acute intestinal amebiasis and vere acne 1.9 Prophylaxis of malaria 2 DOSAGE AND ADMINISTRATION
2.1 Usual Dosage and Administration 2.2 For prophylaxis of malaria 2.3 Inhalation anthrax (post exposure) 2.4 Sprinkling the tablet over applesauce
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
365天
5 WARNINGS AND PRECAUTIONS
5.1 T ooth Development 5.2 Clostridium difficile associated diarrhea 5.3 Photonsitivity 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
6.1 Clinical Trial Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS
7.1 A nticoagulant 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 P regnancy 8.3 Nursing Mothers 8.4 Pediatric U 8.5 Geriatric U 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 14 CLINICAL STUDIES 15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Instructions for breaking the 150 mg Dual-Scored Tablet FDA-Approved Patient Labeling
*Sections or subctions omitted from the Full Prescribing Information are not listed.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORYX and other antibacterial drugs, DORYX should be ud only to treat or prevent infections that are proven or strongly suspected to be caud by susceptible bacteria. When culture and susceptibility information are available, they should be considered in lecting or modifying antibacterial therapy. In the abnce of such data, local epidemiology and susceptibility patterns may contribute to the empiric lection of therapy.
Doxycycline is a tetracycline-class antimicrobial indicated in the following conditions or dias:
1.1 Rickettsial
infections
Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caud by Rickettsiae.
finalize1.2 Sexually transmitted infections
Uncomplicated urethral, endocervical or rectal infections caud by Chlamydia trachomatis.2015年12月六级
Nongonococcal urethritis caud by Ureaplasma urealyticum.
Lymphogranuloma venereum caud by Chlamydia trachomatis.
Granuloma inguinale caud by Calymmatobacterium granulomatis. Uncomplicated gonorrhea caud by Neisria gonorrhoeae.
Chancroid caud by Haemophilus ducreyi.
infections
1.3 Respiratory
tract
Respiratory tract infections caud by Mycoplasma pneumoniae.
Psittacosis (ornithosis) caud by Chlamydophila psittaci.
minglang
Becau 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 caud by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug: Respiratory tract infections caud by Haemophilus influenzae.
Respiratory tract infections caud by Klebsiella species.
Upper respiratory infections caud by Streptococcus pneumoniae.
1.4 Specific bacterial infections
疯子的英文Relapsing fever due to Borrelia recurrentis.
Plague due to Yersinia pestis.
Tularemia due to Francilla tularensis.
Cholera caud by Vibrio cholerae.
Campylobacter fetus infections caud by Campylobacter fetus.
Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis.
Becau 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 caud by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
Escherichia coli
Enterobacter aerogenes
Shigella species
李阳疯狂英语音标
Acinetobacter species
Urinary tract infections caud by Klebsiella species.
infections
1.5 O phthalmic
Trachoma caud by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
Inclusion conjunctivitis caud 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 dia following exposure to aerosolized Bacillus anthracis.
1.7 Alternative treatment for lected infections when penicillin is
contraindicated
When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:
Syphilis caud by Treponema pallidum.
Yaws caud by Treponema pertenue.
秘密英文
Vincent’s infection caud by Fusobacterium fusiforme.
Actinomycosis caud by Actinomyces israelii.
Infections caud by Clostridium species.
1.8 Adjunctive therapy for acute intestinal amebiasis and vere acne
In acute intestinal amebiasis, doxycycline may be a uful adjunct to amebicides.
英文爱情格言In vere acne, doxycycline may be uful adjunctive therapy.
1.9 Prophylaxis of malaria
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 [e Dosage and Administration (2.2) and Patient Counling Information (17)].
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 do of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours), followed by a maintenance do of 100 mg daily. The maintenance do may be administered as a single do or as 50 mg every 12 hours. In the management of more vere 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/kg of body weight divided into two dos on the first day of treatment, followed by 2.2 mg/kg of body weight given as a single daily do or divided into two dos on subquent days. For more vere infections up to 4.4 mg/kg of body weight may be ud. For children over 45 kg, the usual adult do should be ud.
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 [e Adver Reactions (6.1)].
If gastric irritation occurs, doxycycline may be given with food or milk [e Clinical Pharmacology (12)].
When ud in streptococcal infections, therapy should be continued for 10 days.
Uncomplicated urethral, endocervical, or rectal infection caud by Chlamydia trachomatis: 100 mg by mouth twice a day for 7 days. As an alternate dosing regimen for uncomplicated urethral or endocervical infection caud by Chlamydia trachomatis, administer 200 mg by mouth once-a-day for 7 days.
upttingUncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice-a-day for 7 days. As an alternate single visit do, administer 300 mg stat followed in one hour by a cond 300 mg do.
Nongonococcal urethritis (NGU) caud by U. urealyticum: 100 mg by mouth twice-aday 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 wit
h doxycycline 100 mg by mouth twice-a-day for 4 weeks.
Acute epididymo-orchitis caud 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 do is 100 mg daily. For children over 8 years of age, the recommended do is 2 mg/kg given once daily up to the adult do. 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)
get away
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 do.
2.4 Sprinkling the tablet over applesauce
DORYX Tablets may also be administered by carefully breaking up the tablet and sprinkling the tablet contents (delayed-relea pellets) on a spoonful of applesauce. The delayed-relea pellets must not be crushed or damaged when breaking up the tablet. Any loss of pellets in the transfer would prevent using the do. The applesauce/DORYX 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 do of
applesauce/DORYX Tablet cannot be taken immediately, the mixture should be discarded and not stored for later u.
3 DOSAGE FORMS AND STRENGTHS
DORYX (doxycycline hyclate delayed-relea tablets, USP), 80 mg are white, oval scored tablets containing yellow pellets and debosd with “D|8” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 80 mg of doxycycline.
DORYX (doxycycline hyclate delayed-relea tablets, USP), 100 mg are white, oval scored tablets containing yellow pellets and debosd with “D|1” on one face and plain on the other. Each tablet co
ntains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline.
DORYX (doxycycline hyclate delayed-relea tablets, USP), 150 mg are white, rectangular dual-scored tablets containing yellow pellets and debosd with “D|D|D” on one face and dual-scored on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 150 mg of doxycycline.
DORYX (doxycycline hyclate delayed-relea tablets), 200 mg are white, oval scored tablets containing yellow pellets and debosd with “D|D” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 200 mg of doxycycline.
