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West-ward Doxycycline Hyclate Caps Size: 6-3/4 x 12-3/8 Fold: 1-1/8 x 1-3/8 Type: 5.4 pt Page 1 3/25/08 DC of these patients took medications immediately before going to bed. (See DOSAGE AND ADMIN-
DOXYCYCLINE HYCLATE CAPSULES, USP
ISTRATION.)
Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS.)
Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS.)
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Other: bulging fontanels in infants and intracranial hypertension in adults. (See PRECAUTIONS -
DESCRIPTION
General.)
Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline.
When given over prolonged periods, tetracyclines have been reported to produce brown-black micro- scopic discoloration of the thyroid gland. No abnormalities of thyroid function studies are known to OVERDOSAGE
In case of overdosage, discontinue medication, treat symptomatically and institute supportive mea- sures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of 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 and a molecular weight of 462.46. The chemical IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 designation for doxycycline is 4-(Dimethylamino)- 1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance pentahydroxy-6- methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Doxycycline is a light dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg yellow crystalline powder. Doxycycline hyclate is soluble in water.
Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly In the management of more severe infections (particularly chronic infections of the urinary tract), stable in normal human serum. Doxycycline will not degrade into an epianhydro form. 100 mg every 12 hours is recommended.
Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of For children above eight years of age: The recommended dosage schedule for children weighing 100 doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, fol- lowed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subse- 50 mg capsule shell contains: FD&C Blue #1, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
quent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 mg capsule shell contains: FD&C Blue #1, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
100 lb the usual adult dose should be used.
The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-Butyl The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol and Synthetic Black Iron Oxide.
CLINICAL PHARMACOLOGY
When used in streptococcal infections, therapy should be continued for 10 days.
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irrita- a biologically active form. Doxycycline is virtually completely absorbed after oral administration.
tion and ulceration. (See ADVERSE REACTIONS.)
Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The doxycycline at 2 hours decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by the kid- absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.
ney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 Studies to date have indicated that administration of doxycycline at the usual recommended doses mL/min.). This percentage excretion may fall as low as 1-5%/72 hours in individuals with severe does not lead to excessive accumulation of the antibiotic in patients with renal impairment.
renal insufficiency (creatinine clearance below 10 mL/min.). Studies have shown no significant Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by difference in serum half-life of doxycycline (range 18-22 hours) in individuals with normal and 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. The dose may be administered with food, including milk or car- Hemodialysis does not alter serum half-life.
Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia tra- Microbiology
chomatis: 100 mg by mouth twice a day for 7 days.
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg by mouth 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 organisms. Cross- Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by resistance of these organisms to tetracyclines is common.
Gram-Negative Bacteria
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.
Yersinia pestis (formerly Pasteurella pestis) For the prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over Francisella tularensis (formerly Pasteurelia tularensis) 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis Vibrio cholerae (formerly Vibrio comma) should begin 1 to 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.
Because many strains of the following groups of gram-negative microorganisms have been shown to ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.
be resistant to tetracyclines, culture and susceptibility testing are recommended: CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.
HOW SUPPLIED
Doxycycline Hyclate Capsules USP, equivalent to 50 mg doxycycline: Opaque Blue/White, No. 2 hard gelatin capsule printed “West-ward 3141”.
Acinetobacter species (formerly Mima species and Herellea species) Gram-Positive Bacteria
Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracycline, culture and susceptibility testing are recommended. Up to 44 percent of Doxycycline Hyclate Capsules USP, equivalent to 100 mg doxycycline: Opaque Blue, No. 0 hard strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be gelatin capsule printed “West-ward 3142”.
resistant to tetracycline drugs. Therefore, tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.
Enterococcus group (Streptococcus faecalis and Streptococcus faecium) Alpha-hemolytic streptococci (viridans group) Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Other Microorganisms
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY
Chlamydia psittaci Fusobacterium fusiforme Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the fol- Chlamydia trachomatis Actinomyces species lowing species: in rats by oxytetracycline, doxycycline, tetracycline PO4, and methacycline; in Mycoplasma pneumoniae Bacillus anthracis minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline Ureaplasma urealyticum Propionbacterium acnes and minocycline; in monkeys by minocycline.
Borrelia recurrentis Entamoeba species 4 methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and Treponema pallidum Balantidium coli tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompa- Treponema pertenue Plasmodium falciparum nied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter Doxycycline has been found to be active against the asexual erythrocytic forms of Plasmodium fal- with high radioiodine uptake in rats fed a relatively high iodine diet.
ciparum but not against the gametocytes of P. falciparum. The precise mechanism of action of the Treatment of various animal species with this class of drugs has also resulted in the induction of thy- roid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in Susceptibility tests: Diffusion techniques: Quantitative methods that require measurement of zone
rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated diameters give the most precise estimate of the susceptibility of bacteria to antimicrobial agents.
One such standard procedure1 which has been recommended for use with disks to test susceptibility References
of organisms to doxycycline uses the 30-mcg tetracycline-class disk or the 30-mcg doxycycline disk.
1. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Interpretation involves the correlation of the diameter obtained in the disk test with the minimum Susceptibility Tests, Fourth Edition. Approved Standard NCCLS Document M2- A4, inhibitory concentration (MIC) for tetracycline or doxycycline, respectively.
Vol. 10, No. 7 NCCLS, Villanova, PA, April 1990.
Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30- 2. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial mcg tetracycline-class disk or the 30-mcg doxycycline disk should be interpreted according to the Susceptibility Tests for Bacteria That Grow Aerobically, Second Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8 NCCLS, Villanova, PA, April 1990.
Zone Diameter (mm) Interpretation
3. aFriedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149-195.
bCziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997;89:524- cHorne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable prospective study. Int J Fertil 1980; 25:315-317.
blood levels. A report of “Intermediate” suggests that the organism would be susceptible if a high dHale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing 2000: dosage is used or if the infection is confined to tissues and fluids in which high antimicrobial levels are attained. A report of “Resistant” indicates that achievable concentrations are unlikely to be inhibitory, and other therapy should be selected.
West-ward Pharmaceutical Corp.
Standardized procedures require the use of laboratory control organisms. The 30-mcg tetracycline- class disk or the 30-mcg doxycycline disk should give the following zone diameters: Organism Zone Diameter (mm)
West-ward Doxycycline Hyclate Caps Size: 6-3/4 x 12-3/8 Fold: 1-1/8 x 1-3/8 Type: 5.4 pt Page 2 3/25/08 DC Dilution techniques: Use a standardized dilution method2 (broth, agar, microdilution) or equivalent
appropriate therapy should be instituted.
with tetracycline powder. The MIC values obtained should be interpreted according to the following Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in indi- viduals receiving tetracyclines. These conditions disappeared when the drug was discontinued.
MIC (mcg/mL) Interpretation
Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic Doxycycline offers substantial but not complete suppression of the asexual blood stages of Plasmodium As with standard diffusion techniques, dilution methods require the use of laboratory control organ- Doxycycline does not suppress P. falciparum’s sexual blood stage gametocytes. Subjects completing isms. Standard tetracycline powder should provide the following MIC values: this prophylactic regimen may still transmit the infection to mosquitoes outside endemic areas.
Prescribing doxycycline hyclate capsules in the absence of proven or strongly suspected bacterial Organism MIC (mcg/mL)
infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Information for Patients
Patients taking doxycycline for malaria prophylaxis should be advised: - that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.
INDICATIONS AND USAGE
- to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycyclinehyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used with mosquitoes, especially from dusk to dawn (e.g., staying in well-screened areas, using mosquito only to treat or prevent infections that are proven or strongly suspected to be caused by nets, covering the body with clothing, and using an effective insect repellent).
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 - should begin 1 to 2 days before travel to the malarious area, epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
- should be continued daily while in the malarious area and after leaving the malarious area, Treatment:
- should be continued for 4 further weeks to avoid development of malaria after returning from an Doxycyline 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.
All patients taking doxycycline should be advised: • Respiratory tract infections caused by Mycoplasma pneumoniae.
- to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue • Lymphogranuloma venereum caused by Chlamydia trachomatis. therapy if phototoxicity (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock should be • Psittacosis (ornithosis) caused by Chlamydia psittaci. considered (See WARNINGS.)
• Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always - to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulcera- eliminated as judged by immunofluorescence.
tion. (See ADVERSE REACTIONS.)
• Inclusion conjunctivitis caused by Chlamydia trachomatis. - that the absorption of tetracyclines is reduced when taken with foods, especially those which contain • Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous inges- tion of food or milk. (See Drug Interactions.)
• Nongonococcal urethritis caused by Ureaplasma urealyticum. - that the absorption of tetracyclines is reduced when taking bismuth subsalicylate (See Drug
• Relapsing fever due to Borrelia recurrentis. Interactions.)
Doxycycline is also indicated for the treatment of infections caused by the following gram-neg- - that the use of doxycycline might increase the incidence of vaginal candidiasis.
• Chancroid caused by Haemophilus ducreyi. Patients should be counseled that antibacterial drugs including doxycycline hyclate capsules should • Plague due to Yersinia pestis (formerly Pasteurella pestis).
only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• Tularemia due to Francisella tularensis (formerly Pasteurella tularensis).
When doxycycline hyclate capsules are prescribed to treat a bacterial infection, patients should be • Cholera caused by Vibrio cholerae (formerly Vibrio comma).
told that although it is common to feel better early in the course of therapy, the medication should be • Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus).
taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease • Brucellosis due to Brucella species (in conjunction with streptomycin).
the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop • Bartonellosis due to Bartonella bacilliformis. resistance and will not be treatable by doxycycline hyclate capsules or other antibacterial drugs in the • Granuloma inguinale caused by Calymmatobacterium granulomatis. Because many strains of the following groups of microorganisms have been shown to be Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is resistant to doxycycline, culture and susceptibility testing are recommended.
discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and Doxycycline is indicated for treatment of infections caused by the following gram-negative bloody stools (with or without stomach cramps and fever) even as late as two or more months after microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as • Enterobacter aerogenes (formerly Aerobacter aerogenes).
Shigella species.
Laboratory Tests
Acinetobacter species (formerly Mima species and Herellea species).
In venereal disease, when co-existing syphilis is suspected, dark field examinations should be done • Respiratory tract infections caused by Haemophilus influenzae. before treatment is started and the blood serology repeated monthly for at least 4 months.
• Respiratory tract and urinary tract infections caused by Klebsiella species.
In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, Doxycycline is indicated for treatment of infections caused by the following gram-positive renal, and hepatic studies, should be performed.
microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Drug Interactions
• Upper respiratory infections caused by Streptococcus pneumoniae (formerly Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to incidence or progression of disease following exposure to aerosolized Bacillus anthracis. avoid giving tetracyclines in conjunction with penicillin.
When penicillin is contraindicated, doxycycyline is an alternative drug in the treatment of the Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
Syphilis caused by Treponema pallidum. Absorption of tetracycline is impaired by bismuth subsalicylate.
• Yaws caused by Treponema pertenue. Barbiturates, carbamazepine, and phenytoin decrease the half- life of doxycycline.
• Listeriosis due to Listeria monocytogenes. The concurrent use of tetracycline and Penthrane® (methoxyflurane) has been reported to result in fatal • Vincent’s infection caused by Fusobacterium fusiforme. • Actinomycosis caused by Actinomyces israelii. Concurrent use of tetracycline may render oral contraceptives less effective.
• Infections caused by Clostridium species.
Drug/Laboratory Test Interactions
In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
In severe acne, doxycycline may be useful adjunctive therapy.
Prophylaxis:
Carcinogenesis, Mutagenesis, Impairment of Fertility
Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not been travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains.
conducted. However, there has been evidence of oncogenic activity in rats in studies with the related See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRE-
antibiotics, oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors).
CAUTIONS section.
Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibiotics (tetracycline, oxytetracycline).
CONTRAINDICATIONS
Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
the fertility of female rats. Effect on male fertility has not been studied.
WARNINGS
Pregnancy: Teratogenic Effects. Pregnancy Category D:
THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF There are no adequate and well-controlled studies on the use of doxycycline in pregnant OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT women. The vast majority of reported experience with doxycycline during human pregnancy is DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common short-term, first trimester exposure. There are no human data available to assess the effects during long-term use of the drugs, but it has been observed following repeated short-term courses.
of long-term therapy of doxycycline in pregnant women such as that proposed for treatment of Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE anthrax exposure. An expert review of published data on experiences with doxycycline use dur- USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST- ing pregnancy by TERIS – the Teratogen Information System – concluded that therapeutic EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDI- 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 Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all is no riska. A case-control study (18,515 mothers of infants with congenital anomalies and antibacterial agents, including doxycycline hyclate capsules, and may range in severity from 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statisti- mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the cally significant association with total malformations and use of doxycycline anytime during colon leading to overgrowth of C. difficile. pregnancy. Sixty-three (0.19%) of the controls and fifty-six (0.30%) of the cases were treated C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin with doxycycline. This association was not seen when the analysis was confined to maternal producing strains of C. difficile cause increased morbidity and mortality, as these infections treatment during the period of organogenesis (i.e., in the second and third months of gesta- can be refractory to antimicrobial therapy and may require colectomy. CDAD must be consid- tion) with the exception of a marginal relationship with neural tube defect based on only two ered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration 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 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 supplementa- Nonteratogenic Effects: (See Warnings).
tion, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically Labor and Delivery
The effect of tetracyclines on labor and delivery is unknown.
All tetracyclines form a stable calcium complex in any bone- forming tissue. A decrease in fibula Nursing Mothers
growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 Tetracyclines are excreted in human milk; however, the extent of absorption of tetracyclines, including hours. This reaction was shown to be reversible when the drug was discontinued.
doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not neces- Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and sarily contraindicated; however, the effects of prolonged exposure to doxycycline in breast milk are can have toxic effects on the developing fetus (often related to retardation of skeletal development).
unknownd. Because of the potential for serious adverse reactions in nursing infants from doxycy- Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracy- cline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking cline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient into account the importance of the drug to the mother. (See WARNINGS.)
should be apprised of the potential hazard to the fetus.
Pediatric Use
The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate See WARNINGS and DOSAGE AND ADMINISTRATION.
that this does not occur with the use of doxycycline in patients with impaired renal function.
ADVERSE REACTIONS
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some indi- Due to oral doxycycline’s virtually complete absorption, side effects of the lower bowel, particularly viduals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be diarrhea, have been infrequent. The following adverse reactions have been observed in patients advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and PRECAUTIONS
inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral adminis- As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible tration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class. Most

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