6-3/4 x 12-3/8

West-Ward Doxycycline Tabs Rev. 06/11 Flat Size: 6-3/4 x 12-3/8 Folded Size: 1-1/8 x 1-3/8 Type: 5 3/4 pt. Page 1 3/31/11 Proof 1 JB DOXYCYCLINE HYCLATE
Dilution techniques: Use a standardized dilution method
TABLETS, USP
equivalent with tetracycline powder. The MIC values obtained should be interpreted accordingto the following criteria: Rev. 06/11
MIC (mcg/mL) Interpretation
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline and other antibacterial drugs, Doxycycline should be used only to treat or prevent As with standard diffusion techniques, dilution methods require the use of laboratory control infections that are proven or strongly suspected to be caused by bacteria.
organisms. Standard tetracycline powder should provide the following MIC values: DESCRIPTION
Organism MIC (mcg/mL)
Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline.
The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro- 3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide mono- hydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water.
INDICATIONS AND USAGE
Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.
hyclate and other antibacterial drugs, doxycycline hyclate 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 selectingor modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Treatment:
Doxycycline is indicated for the treatment of the following infections: • Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.
• Respiratory tract infections caused by Mycoplasma pneumoniae.
• Lymphogranuloma venereum caused by Chlamydia trachomatis.
• Psittacosis (ornithosis) caused by Chlamydia psittaci.
• Trachoma caused by Chlamydia trachomatis, although the infectious agent is not Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of always eliminated as judged by immunofluroescence.
doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, • Inclusion conjunctivitis caused by Chlamydia trachomatis.
Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline • Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide.
• Nongonococcal urethritis caused by Ureaplasma urealyticum.
CLINICAL PHARMACOLOGY
• Relapsing fever due to Borrelia recurrentis.
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They Doxycycline is also indicated for the treatment of infections caused by the following gram- are concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in a biologically active form. Doxycycline is virtually completely absorbed after oral • Chancroid caused by Haemophilus ducreyi.
• Plague due to Yersinia pestis (formerly Pasteurella pestis).
Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL • Tularemia due to Francisella tularensis (formerly Pasteurella tularensis).
of doxycycline at 2 hours decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by • Cholera caused by Vibrio cholerae (formerly Vibrio comma).
the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance • Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus).
about 75 mL/min). This percentage excretion may fall as low as 1-5%/72 hours in individuals • Brucellosis due to Brucella species (in conjunction with streptomycin).
with severe renal insufficiency (creatinine clearance below 10 mL/min). Studies have shown • Bartonellosis due to Bartonella bacilliformis.
no significant difference in serum half-life of doxycycline (range 18-22 hours) in individuals • Granuloma inguinale caused by Calymmatobacterium granulomatis.
with normal and severely impaired renal function.
Because many strains of the following groups of microorganisms have been shown to beresistant to doxycycline, culture and susceptibility testing are recommended.
Hemodialysis does not alter serum half-life.
Doxycycline is indicated for treatment of infections caused by the following gram-negative Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues.
microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Microbiology
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect • Enterobacter aerogenes (formerly Aerobacter aerogenes).
by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative • Acinetobacter species (formerly Mima species and Herellea species).
organisms. Cross-resistance of these organisms to tetracyclines is common.
• Respiratory tract infections caused by Haemophilus influenzae.
Gram-Negative Bacteria
• Respiratory tract and urinary tract infections caused by Klebsiella species.
Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: • Upper respiratory infections caused by Streptococcus pneumoniae (formerly Yersinia pestis (formerly Pasteurella pestis) • Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to Francisella tularensis (formerly Pasteurelia tularensis) reduce the incidence or progression of disease following exposure to aerosolized Vibrio cholerae (formerly Vibrio comma) When penicillin is contraindicated, doxycycyline is an alternative drug in the treatment of the Because many strains of the following groups of gram-negative microorganisms have been • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
shown to be resistant to tetracyclines, culture and susceptibility testing are recommended: • Syphilis caused by Treponema pallidum.
• Yaws caused by Treponema pertenue.
• Listeriosis due to Listeria monocytogenes.
• Vincent’s infection caused by Fusobacterium fusiforme.
• Actinomycosis caused by Actinomyces israelii.
Acinetobacter species (formerly Mima species and Herellea species) • Infections caused by Clostridium species.
In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.
Gram-Positive Bacteria
In severe acne, doxycycline may be useful adjunctive therapy.
Because many strains of the following groups of gram-positive microorganisms have been Prophylaxis:
shown to be resistant to tetracycline, culture and susceptibility testing are recommended. Up Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short- to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis term travelers (<4 months) areas with chloroquine and/or pyrimethamine-sulfadoxine resistant have been found to be resistant to tetracycline drugs. Therefore, tetracycline should not be strains. See DOSAGE AND ADMINISTRATION section and Information for Patients subsection
used for streptococcal disease unless the organism has been demonstrated to be susceptible.
of the PRECAUTIONS section.
CONTRAINDICATIONS
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Enterococcus group (Streptococcus faecalis and Streptococcus faecium) WARNINGS
Alpha-hemolytic streptococci (viridans group) THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST Other Microorganisms
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 Chlamydia psittaci Fusobacterium fusiforme is more common during long-term use of the drugs, but it has been observed following Chlamydia trachomatis Actinomyces species repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE Mycoplasma pneumoniae Bacillus anthracis DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, Ureaplasma urealyticum Propionibacterium acnes INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE Borrelia recurrentis Entamoeba species NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
Treponema pallidum Balantidium coli Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all Treponema Pertenue Plasmodium falciparum antibacterial agents, including Doxycycline, and may range in severity from mild diarrhea to Doxycycline has been found to be active against the asexual erythrocytic forms of fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to Plasmodium falciparum but not against the gametocytes of P. falciparum. The precise mech- anism of action of the drug is not known.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin Susceptibility tests: Diffusion techniques: Quantitative methods that require measurement of
producing strains of C. difficile cause increased morbidity and mortality, as these infections zone diameters give the most precise estimate of the susceptibility of bacteria to antimicrobial can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered agents. One such standard procedure1 which has been recommended for use with disks to in all patients who present with diarrhea following antibiotic use. Careful medical history is test susceptibility of organisms to doxycycline, uses the 30-mcg tetracycline-class disk or necessary since CDAD has been reported to occur over two months after the administration of the 30-mcg doxycycline disk. Interpretation involves the correlation of the diameter obtained in the disk test with the minimum inhibitory concentration (MIC) for tetracycline or doxycycline, If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, Reports from the laboratory giving results of the standard single-disk susceptibility test with a antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
30-mcg tetracycline-class disk the 30-mcg doxycycline disk should be interpreted according 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 Zone Diameter (mm) Interpretation
every 6 hours. This reaction was shown to be reversible when the drug was discontinued.
tetracycline doxycycline
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 has also been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally while taking this drug, the patient should be apprised of the potential hazard to the fetus.
achievable blood levels. A report of “Intermediate” suggests that the organism would be The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate susceptible if a high dosage is used or if the infection is confined to tissues and fluids in that this does not occur with the use of doxycycline in patients with impaired renal function.
which antimicrobial levels are attained. A report of “Resistant” indicates that achievable Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some concentrations are unlikely to be inhibitory, and other therapy should be selected.
individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light Standardized procedures require the use of laboratory control organisms. The 30-mcg tetracycline- should be advised that this reaction can occur with tetracycline drugs, and treatment should class disk or the 30-mcg doxycycline disk should give the following zone diameters: be discontinued at the first evidence of skin erythema.
Organism Zone Diameter (mm)
PRECAUTIONS
tetracycline doxycycline
As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued andappropriate therapy instituted.
West-Ward Doxycycline Tabs Rev. 06/11 Flat Size: 6-3/4 x 12-3/8 Folded Size: 1-1/8 x 1-3/8 Type: 5 3/4 pt. Page 2 5/31/11 Proof 1 JB Bulging fontanels in infants and benign intracranial hypertension in adults have been reported been reported rarely. These reactions have been caused by both the oral and parenteral in individuals receiving tetracyclines. These conditions disappeared when the drug was administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline Incision and drainage or other surgical procedures should be performed in conjunction with class. Most of these patients took medications immediately before going to bed. (See DOSAGE
AND ADMINISTRATION).
Doxycycline offers substantial but not complete suppression of the asexual blood stages of Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, maculo- papular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon.
Doxycycline does not suppress P. falciparum’s sexual blood stage gametocytes. Subjects Photosensitivity is discussed above. (See WARNINGS).
completing this prophylactic regimen may still transmit the infection to mosquitoes outside Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS).
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, Prescribing Doxycycline in the absence of proven or strongly suspected bacterial infection or a serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
development of drug-resistant bacteria.
Other: bulging fontanels in infants and intracranial hypertension in adults. (See PRECAUTIONS
Information for Patients
- General).
Patients taking doxycycline for malaria prophylaxis should be advised: When given over prolonged periods, tetracyclines have been reported to produce brown-black - that no present-day antimalarial agent, including doxycycline, guarantees protection against microscopic discoloration of the thyroid gland. No abnormalities of thyroid function studies - to avoid being bitten by mosquitoes by using personal protective measures that help avoid To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at contact with mosquitoes, especially from dusk to dawn (e.g., staying in well-screened areas, 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
using mosquito nets, covering the body with clothing, and using an effective insect repellent).
OVERDOSAGE
In case of overdosage, discontinue medication, treat symptomatically and institute supportive - should begin 1 to 2 days before travel to the malarious area.
measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating - 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 DOSAGE AND ADMINISTRATION
Other dosage forms of doxycycline may be more appropriate to meet some of the dosing All patients taking doxycycline should be advised: THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS - to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE discontinue therapy if phototoxicity (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
should be considered (see WARNINGS).
- to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered ulceration. (See ADVERSE REACTIONS).
100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. - that the absorption of tetracyclines is reduced when taken with foods, especially those which In the management of more severe infections (particularly chronic infections of the urinary contain calcium. However, the absorption of doxycycline is not markedly influenced by tract), 100 mg every 12 hours is recommended.
simultaneous ingestion of food or milk. (See Drug Interactions.)
For children above eight years of age: The recommended dosage schedule for children weighing - that the absorption of tetracyclines is reduced when taking bismuth subsalicylate (See Drug
100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of Interactions.)
treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two - that the use of doxycycline might increase the incidence of vaginal candidiasis.
doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be Patients should be counseled that antibacterial drugs including doxycycline hyclate should used. For children over 100 Ib the usual adult dose should be used.
only be used to treat bacterial infections. They do not treat viral infections (e.g., the common The therapeutic antibacterial serum activity will usually persist for 24 hours following cold). When Doxycycline is 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 When used in streptococcal infections, therapy should be continued for 10 days.
be taken exactly as directed. Skipping doses or not completing the full course of therapy may Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that the tetracycline class is recommended to wash down the drugs and reduce the risk of bacteria will develop resistance and will not be treatable by doxycycline hyclate or other esophageal irritation and ulceration. (See ADVERSE REACTIONS).
If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.
discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery Studies to date have indicated that administration of doxycycline at the usual recommended and bloody stools (with or without stomach cramps and fever) even as late as two or more doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.
months after having taken the last dose of the antibiotic. If this occurs, patients should contacttheir physician as soon as possible.
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 Laboratory Tests
followed in one hour by a second 300 mg dose. The dose may be administered with food, In venereal disease, when co-existent syphilis is suspected, dark field examinations should be including milk or carbonated beverage, as required.
done before treatment is started and the blood serology repeated monthly for at least 4 months.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia tra- In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, chomatis: 100 mg, by mouth, twice a day for 7 days.
renal, and hepatic studies, should be performed.
Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg, by Drug Interactions
Because tetracyclines have been shown to depress plasma prothrombin activity, patients whoare on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100mg by mouth twice a day for 2 weeks.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisableto avoid giving tetracyclines in conjunction with penicillin.
Syphilis of more than one year’s duration: Patients who are allergic to penicillin should betreated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.
Absorption of tetracycline is impaired by antacids containing aluminum, calcium, or magnesium,and iron-containing preparations.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for atleast 10 days.
Absorption of tetracycline is impaired by bismuth subsalicylate.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
The concurrent use of tetracycline and Penthrane®(methoxyflurane) has been reported to For the 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 Concurrent use of tetracycline may render oral contraceptives less effective.
adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area.
Drug/Laboratory Test Interactions
Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after False elevations of urinary catecholamine levels may occur due to interference with the the traveler leaves the malarious area.
Carcinogenesis, Mutagenesis, Impairment of Fertility
ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.
Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not been CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, conducted. However, there has been evidence of oncogenic activity in rats in studies with the twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.
related antibiotics, oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid HOW SUPPLIED
Doxycycline Hyclate Tablets USP, equivalent to 100 mg doxycycline: Orange Coated, Round, Likewise, although mutagenicity studies of doxycycline have not been conducted, positive Unscored Tablets; Debossed "WW 112".
results in in vitro mammalian cell assays have been reported for related antibiotics (tetracycline, 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.
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and Pregnancy: Teratogenic Effects. Pregnancy Category D:
There are no adequate and well-controlled studies on the use of doxycycline in pregnantwomen. The vast majority of reported experience with doxycycline during human pregnancy Dispense in a tight, light-resistant container as defined in the USP using a child-resistant 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 treatment ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY of anthrax exposure. An expert review of published data on experiences with doxycycline use Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in during pregnancy by TERIS – the Teratogen Information System – concluded that therapeutic the following species: in rats by oxytetracycline, doxycycline, tetracycline P0 and methacycline; doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and in minipigs by doxycycline, minocycline, tetracycline P0 , and methacycline; in dogs by quality of data were assessed as limited to fair), but the data are insufficient to state that there is doxycycline and minocycline; in monkeys by minocycline.
no risk3. A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 Minocycline, tetracycline P0 , methacycline, doxycycline, tetracycline base, oxytetracycline mothers of infants with no congenital anomalies) shows a weak but marginally statistically HCI, and tetracycline HCI were goitrogenic in rats fed a low iodine diet. This goitrogenic effect significant association with total malformations and use of doxycycline anytime during pregnancy.
was accompanied by high radioactive iodine uptake. Administration of minocycline also Sixty-three (0.19%) of the controls and fifty-six (0.30%) of the cases were treated with doxycycline.
produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.
This association was not seen when the analysis was confined to maternal treatment during Treatment of various animal species with this class of drugs has also resulted in the induction the period of organogenesis (i.e., in the second and third months of gestation) with the exception of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetra- of a marginal relationship with neural tube defect based on only two exposed cases4.
cycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days in goats and rats treated with oxytetracycline.
with doxycycline during early first trimester. All mothers reported their exposed infants were References
1. National Committee for Clinical Laboratory Standards, Performance Standards for Nonteratogenic Effects: (See WARNINGS).
Antimicrobial Disk Susceptibility Tests, Fourth Edition. Approved Standard NCCLS Labor and Delivery
Document M2-A4, Vol. 10, No. 7 NCCLS, Villanova, PA, April 1990.
The effect of tetracyclines on labor and delivery is unknown.
2. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Nursing Mothers
Susceptibility Tests for Bacteria That Grow Aerobically, Second Edition. Approved Standard Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines, NCCLS Document M7-A2 Vol. 10, No. 8 NCCLS, Villanova, PA, April 1990.
including doxycycline, by the breastfed infant is not known. Short-term use by lactating 3. Friedman JM and Polifka JE Teratogenic Effects of Drugs. A Resource for Clinicians women is not necessarily contraindicated; however, the effects of prolonged exposure to (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195.
doxycycline in breast milk are unknown6. Because of the potential for adverse reactions in 4. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 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 5. Home HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: WARNINGS).
a prespective study. Int J Fertil 1980; 25:315-317.
Pediatric Use
6. Hale T. Medications and Mothers Milk. 9th, edition. Amarillo, TX. Pharmasoft Publishing See WARNINGS and DOSAGE AND ADMINISTRATION.
ADVERSE REACTIONS
Due to oral doxycycline’s virtually complete absorption, side effects of the lower bowel, West-Ward Pharmaceutical Corp.
particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, andinflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has

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