Vibra-Tabs Film Coated Tablets, Vibramycin Hyclate Capsules, Vibramycin Calcium Oral Suspension Syrup, Vibramycin Monohydrate Oral Suspension(Pfizer)
DESCRIPTION
Vibramycin® antibiotics broad-spectrum syntically derived from oxytetracycline, is available as Vibramycin Monohydrate (doxycycline monohydrate); Vibramycin Hyclate Vibra-Tabs (doxycycline hydrochloride hemiethanolate hemihydrate); Vibramycin Calcium (doxycycline calcium) oral administration.
structural mula of doxycycline monohydrate is
a molecular mula of C 22 H 24 N 2 O 8 ·H 2 O a molecular weight of 462.46. chemical designation doxycycline 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 monohydrate. molecular mula doxycycline hydrochloride hemiethanolate hemihydrate is (C 22 H 24 N 2 O 8 ·HCl) 2 ·C 2 H 6 O·H 2 O molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water.
Doxycycline has a high degree of lipoid solubility a low affinity calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.
Inert ingredients in syrup mulation : apple flavor; butylparaben; calcium chloride; carmine; glycerin; hydrochloric acid; magnesium aluminum silicate; povidone; propylene glycol; propylparaben; raspberry flavor; simethicone emulsion; sodium hydroxide; sodium metabisulfite; sorbitol solution; water.
Inert ingredients in capsule mulations : hard gelatin capsules (which may contain Blue 1 or inert ingredients); magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate.
Inert ingredients oral suspension mulation : carboxymethylcellulose sodium; Blue 1; methylparaben; microcrystalline cellulose; propylparaben; raspberry flavor; Red 28; simethicone emulsion; sucrose.
Inert ingredients tablet mulation : ethylcellulose; hydroxypropyl methylcellulose; magnesium stearate; microcrystalline cellulose; propylene glycol; sodium lauryl sulfate; talc; titanium dioxide; Yellow 6 Lake.
CLINICAL PHARMACOLOGY
Tetracyclines readily absorbed bound to plasma proteins in varying degree. y concentrated by liver in bile, excreted in urine feces at high concentrations in a biologically active m. Doxycycline is virtually completely absorbed after oral adminstration.
Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by kidney is about 40%/72 hours in individuals normal function (creatinine clearance about 75 mL/min.). This percentage excretion may fall as low as 1-5%/72 hours in individuals severe renal insufficiency (creatinine clearance below 10 mL/min.). Studies have shown no significant difference in serum half-life of doxycycline (range 18-22 hours) in individuals normal severely impaired renal function.
Hemodialysis does not alter serum half-life.
Results of animal studies indicate that tetracyclines cross placenta found in fetal tissues.
Microbiology
tetracyclines primarily bacteriostatic thought to exert ir antimicrobial effect by inhibition of protein synsis. tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive gram-negative organisms. Cross-resistance of se organisms to tetracyclines is common.
Gram-Negative Bacteria
Neisseria gonorrhoeae
Calymmatobacterium granulomatis
Haemophilus ducreyi
Haemophilus influenzae
Yersinia pestis (merly Pasteurella pestis )
Francisella tulnsis (merly Pasteurella tulnsis )
Vibrio cholerae (merly Vibrio comma )
Bartonella bacillimis
Brucella species
Because many strains of following groups of gram-negative microorganisms have shown to be resistant to tetracyclines, culture susceptibility testing recommended:
Escherichia coli
Klebsiella species
Enterobacter aerogenes
Shigella species
Acinetobacter species (merly Mima species Herellea species)
Bacteroides species
Gram-Positive Bacteria
Because many strains of following groups of gram-positive microorganisms have shown to be resistant to tetracycline, culture susceptibility testing recommended. Up to 44 percent of strains of Streptococcus pyogenes 74 percent of Streptococcus faecalis have found to be resistant to tetracycline drugs. ree, tetracycline should not be used streptococcal disease unless organism has demonstrated to be susceptible.
Streptococcus pyogenes
Streptococcus pneumoniae
Enterococcus group ( Streptococcus faecalis Streptococcus faecium )
Alpha-hemolytic streptococci (viridans group)
Or Microorganisms
Rickettsiae
Chlamydia psittaci
Chlamydia trachomatis
Mycoplasma pneumoniae
Ureaplasma urealyticum
Borrelia recurrentis
Treponema pallidum
Treponema pertenue
Clostridium species
Fusobacterium fusime
Actinomyces species
Bacillus anthracis
Propionibacterium acnes
Entamoeba species
Balantidium coli
Plasmodium falciparum
Doxycycline has found to be active against asexual erythrocytic ms of Plasmodium falciparum but not against gametocytes of P. falciparum . precise mechanism of action of drug is not known.
Susceptibility tests: Diffusion techniques: Quantitative methods that require measurement of zone diameters give most precise estimate of susceptibility of bacteria to antimicrobial agents. One such stard procedure 1 which has recommended use disks to test susceptibility of organisms to doxycycline uses 30-mcg tetracycline-class disk or 30-mcg doxycycline disk. Interpretation involves correlation of diameter obtained in disk test minimum inhibitory concentration (MIC) tetracycline or doxycycline, respectively.
Reports from laboratory giving results of stard single-disk susceptibility test a 30-mcg tetracycline-class disk or 30-mcg doxycycline disk should be interpreted according to following criteria:
Zone Diameter (mm) Interpretation
tetracycline doxycycline
>/=19 >/=16 Susceptible
15-18 13-15 Intermediate
</=14 </=12 Resistant
A report of "Susceptible" indicates that pathogen is likely to be inhibited by generally achievable blood levels. A report of "Intermediate" suggests that organism would be susceptible if a high dosage is used or if infection is confined to tissues fluids in which high antimicrobial levels attained. A report of "Resistant" indicates that achievable concentrations unlikely to be inhibitory, or rapy should be selected.
Stardized procedures require use of laboratory control organisms. 30-mcg tetracycline-class disk or 30-mcg doxycycline disk should give following zone diameters:
Organism Zone Diameter (mm)
tetracycline doxycycline
E. coli ATCC 25922 18-25 18-24
S. aureus ATCC 25923 19-28 23-29
Dilution techniques: Use a stardized dilution method 2 (broth, agar, microdilution) or equivalent tetracycline powder. MIC values obtained should be interpreted according to following criteria:
MIC (mcg/mL) Interpretation
</=4 Susceptible
8 Intermediate
>/=16 Resistant
As stard diffusion techniques, dilution methods require use of laboratory control organisms. Stard tetracycline powder should provide following MIC values:
Organism MIC (mcg/mL)
E. coli ATCC 25922 1.0-4.0
S. aureus ATCC 29213 0.25-1.0
E. faecalis ATCC 29212 8-32
P. aeruginosa ATCC 27853 8-32
INDICATIONS USAGE
Treatment:
Doxycycline is indicated treatment of following infections:
Rocky Mountain spotted fever, typhus fever typhus group, Q fever, rickettsialpox, 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 infectious agent is not always eliminated as judged by immunofluorescence.
Inclusion conjunctivitis caused by Chlamydia trachomatis .
Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis .
Nongonococcal urethritis caused by Ureaplasma urealyticum .
Relapsing fever due to Borrelia recurrentis .
Doxycycline is also indicated treatment of infections caused by following gram-negative microorganisms:
Chancroid caused by Haemophilus ducreyi.
Plague due to Yersinia pestis (merly Pasteurella pestis ).
Tulmia due to Francisella tulnsis (merly Pasteurella tulnsis ).
Cholera caused by Vibrio cholerae (merly Vibrio comma ).
Campylobacter fetus infections caused by Campylobacter fetus (merly Vibrio fetus ).
Brucellosis due to Brucella species (in conjunction streptomycin).
Bartonellosis due to Bartonella bacillimis.
Granuloma inguinale caused by Calymmatobacterium granulomatis.
Because many strains of following groups of microorganisms have shown to be resistant to doxycycline, culture susceptibility testing recommended.
Doxycycline is indicated treatment of infections caused by following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to drug:
Escherichia coli.
Enterobacter aerogenes (merly Aerobacter aerogenes ).
Shigella species.
Acinetobacter species (merly Mima species Herellea species).
Respiratory tract infections caused by Haemophilus influenzae.
Respiratory tract urinary tract infections caused by Klebsiella species.
Doxycycline is indicated treatment of infections caused by following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to drug:
Upper respiratory infections caused by Streptococcus pneumoniae (merly Diplococcus pneumoniae ).
Anthrax due to Bacillus anthracis , including inhalational anthrax (post-exposure): to reduce incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
When penicillin is contraindicated, doxycycline is an alternative drug in treatment of following infections:
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
Syphilis caused by Treponema pallidum.
Yaws caused by Treponema pertenue.
Listeriosis due to Listeria monocytogenes.
Vincent's infection caused by Fusobacterium fusime.
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 rapy.
Prophylaxis:
Doxycycline is indicated prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to as chloroquine /or pyrimethamine-sulfadoxine resistant strains. See DOSAGE ADMINISTRATION section information Patients subsection of PRECAUTIONS section.
CONTRAINDICATIONS
This drug is contraindicated in persons who have shown hypersensitivity to any of tetracyclines.
WARNINGS
USE OF DRUGS OF TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY CHILDHOOD TO AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of drugs, but it has observed following repeated short-term courses. Enamel hypoplasia has also reported. TETRACYCLINE DRUGS, REE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OR DRUGS NOT LIKELY TO BE EFFECTIVE OR CONTRAINDICATED.
Pseudomembranous colitis has reported nearly all antibacterial agents, including doxycycline, may range in severity from mild to life-threatening. ree, it is important to consider this diagnosis in patients who present diarrhea subsequent to administration of antibacterial agents.
Treatment antibacterial agents alters normal flora of colon may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotics-associated colitis."
After diagnosis of pseudomembranous colitis has established, rapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of drug alone. In moderate to severe cases, consideration should be given to management fluids electrolytes, protein supplementation treatment an antibacterial drug clinically effective against Clostridium difficile colitis.
All tetracyclines m a stable calcium complex in any bone-ming tissue. A decrease in fibula growth rate has observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when drug was discontinued.
Results of animal studies indicate that tetracyclines cross placenta, found in fetal tissues, can have toxic effects on developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if patient becomes pregnant while taking this drug, patient should be apprised of potential hazard to fetus.
antianabolic action of tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur use of doxycycline in patients impaired renal function.
Photosensitivity manifested by an exaggerated sunburn reaction has observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur tetracycline drugs, treatment should be discontinued at first evidence of skin eryma.
Vibramycin Syrup contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms life-threatening or less severe asthmatic episodes in certain susceptible people. overall prevalence of sulfite sensitivity in general population is unknown probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
PRECAUTIONS
General
As or antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, antibiotics should be discontinued appropriate rapy instituted.
Bulging fontanels in infants benign intracranial hypertension in adults have reported in individuals receiving tetracyclines. se conditions disapped when drug was discontinued.
Incision drainage or or surgical procedures should be permed in conjunction antibiotics rapy, when indicated.
Doxycycline offers substantial but not complete suppression of asexual blood stages of Plasmodium strains.
Doxycycline does not suppress P. falciparum's sexual blood stage gametocytes. Subjects completing this prophylactic regimen may still transmit infection to mosquitoes outside endemic as.
information Patients
Patients taking doxycycline malaria prophylaxis should be advised:
that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.
to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact mosquitoes, especially from dusk to dawn (e.g., staying in well-screened as, using mosquito nets, covering body clothing, using an effective insect repellent).
that doxycycline prophylaxis:
should begin 1-2 days bee travel to malarious a,
should be continued daily while in malarious a after leaving malarious a,
should be continued 4 furr weeks to avoid development of malaria after returning from an endemic a,
should not exceed 4 months.
All patients taking doxycycline should be advised:
to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline to discontinue rapy if phototoxicity (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock should be considered (See WARNINGS .)
to drink fluids liberally along doxycycline to reduce risk of esophageal irritation ulceration. (See ADVERSE REACTIONS .)
that absorption of tetracyclines is reduced when taken foods, especially those which contain calcium. However, absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. (See DRUG INTERACTIONS .)
that absorption of tetracyclines is reduced when taking bismuth subsalicylate (See DRUG INTERACTIONS .)
that use of doxycycline might increase incidence of vaginal cidiasis.
Laboratory Tests
In venereal disease, when co-existent syphilis is suspected, dark field examinations should be done bee treatment is started blood serology repeated monthly at least 4 months.
In long-term rapy, periodic laboratory evaluation of organ systems, including hematopoietic, renal, hepatic studies, should be permed.
Drug Interactions
Because tetracyclines have shown to depress plasma prothrombin activity, patients who on anticoagulant rapy may require downward adjustment of ir anticoagulant dosage.
Since bacteriostatic drugs may interfere bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, iron-containing preparations.
Absorption of tetracyclines is impaired by bismuth subsalicylate.
Barbiturates, carbamazepine, phenytoin decrease half-life of doxycycline.
concurrent use of tetracycline Penthrane® (methoxyflurane) has reported to result in fatal renal toxicity.
Concurrent use of tetracycline may render oral contraceptives less effective.
Drug/Laboratory Test Interactions
False elevations of urinary catecholamine levels may occur due to interference fluorescence test.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not conducted. However, re has evidence of oncogenic activity in rats in studies related antibiotics, oxytetracycline (adrenal pituitary tumors), minocycline (thyroid tumors).
Likewise, although mutagenicity studies of doxycycline have not conducted, positive results in in vitro mammalian cell assays have reported related antibiotics (tetracycline, oxytetracycline).
Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no appnt effect on fertility of female rats. Effect on male fertility has not studied.
Pregnancy: Teratogenic Effects. Pregnancy Category D:
re no adequate well-controlled studies on use of doxycycline in pregnant women. vast majority of reported experience doxycycline during human pregnancy is short-term, first trimester exposure. re no human data available to assess effects of long-term rapy of doxycycline in pregnant women such as that proposed treatment of anthrax exposure. An expert review of published data on experiences doxycycline use during pregnancy by TERIS - Teratogen information System - concluded that rapeutic doses during pregnancy unlikely to pose a substantial teratogenic risk ( quantity quality of data were assessed as limited to fair), but data insufficient to state that re is no risk a . A case-control study (18,515 mors of infants congenital anomalies 32,804 mors of infants no congenital anomalies) shows a weak but marginally statistically significant association total malmations use of doxycycline anytime during pregnancy. Sixty-three (0.19%) of controls fifty-six (0.30%) of cases were treated doxycycline. This association was not seen when analysis was confined to maternal treatment during period of organogenesis (i.e., in second third months of gestation) exception of a marginal relationship neural tube defect based on only two exposed cases b .
A small prospective study of 81 pregnancies describes 43 pregnant women treated 10 days doxycycline during early first trimester. All mors reported ir exposed infants were normal at 1 year of age c .
Nonteratogenic effects: (See WARNINGS ).
Labor Delivery
effect of tetracyclines on labor delivery is unknown.
Nursing Mors
Tetracyclines excreted in human milk; however, extent of absorption of tetracyclines, including doxycycline, by breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated; however, effects of prolonged exposure to doxycycline in breast milk unknown d . Because of potential serious adverse reactions in nursing infants from doxycycline, a decision should be made wher to discontinue nursing or to discontinue drug, taking into account importance of drug to mor. (See WARNINGS .)
Pediatric Use
See WARNINGS DOSAGE ADMINISTRATION .
ADVERSE REACTIONS
Due to oral doxycycline's virtually complete absorption, side effects of lower bowel, particularly diarrhea, have infrequent. following adverse reactions have observed in patients receiving tetracyclines:
Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions ( monilial overgrowth) in anogenital region. Hepatotoxicity has reported rly. se reactions have caused by both oral pnteral administration of tetracyclines. R instances of esophagitis esophageal ulcerations have reported in patients receiving capsule tablet ms of drugs in tetracycline class. Most of se patients took medications immediately bee going to bed. ( See DOSAGE ADMINISTRATION .)
Skin: maculopapular erymatous rashes. Exfoliative dermatitis has reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS .)
Renal toxicity: Rise in BUN has reported is appntly dose related. (See WARNINGS .)
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erymatosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia have reported.
Or: bulging fontanels in infants intracranial hypertension in adults. (See PRECAUTIONS - General .)
When given over prolonged periods, tetracyclines have reported to produce brown-black microscopic discoloration of thyroid gl. No abnormalities of thyroid function studies known to occur.
OVERDOSAGE
In case of overdosage, discontinue medication, treat symptomatically institute supportive measures. Dialysis does not alter serum half-life thus would not be of benefit in treating cases of overdosage.
DOSAGE ADMINISTRATION
USUAL DOSAGE FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF OR TETRACYCLINES. EXCEEDING RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: usual dose of oral doxycycline is 200 mg on first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. maintenance dose may be administered as a single dose or as 50 mg every 12 hours.
In management of more severe infections (particularly chronic infections of urinary tract), 100 mg every 12 hours is recommended.
children above eight years of age: recommended dosage schedule children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. more severe infections up to 2 mg/lb of body weight may be used. children over 100 lb usual adult dose should be used.
rapeutic antibacterial serum activity will usually persist 24 hours following recommended dosage.
When used in streptococcal infections, rapy should be continued 10 days.
Administration of adequate amounts of fluid along capsule tablet ms of drugs in tetracycline class is recommended to wash down drugs reduce risk of esophageal irritation ulceration. (See ADVERSE REACTIONS .)
If gastric irritation occurs, it is recommended that doxycycline be given food or milk. absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.
Studies to date have indicated that administration of doxycycline at usual recommended doses does not lead to excessive accumulation of antibiotics in patients renal impairment.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. dose may be administered food, including milk or carbonated beverage, as required.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg by mouth twice a day 7 days.
Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth twice a day 7 days.
Syphilis - early: Patients who allergic to penicillin should be treated doxycycline 100 mg by mouth twice a day 2 weeks.
Syphilis of more than one year's duration: Patients who allergic to penicillin should be treated doxycycline 100 mg by mouth twice a day 4 weeks.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day at least 10 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day at least 10 days.
prophylaxis of malaria: adults, recommended dose is 100 mg daily. children over 8 years of age, recommended dose is 2 mg/kg given once daily up to adult dose. Prophylaxis should begin 1-2 days bee travel to malarious a. Prophylaxis should be continued daily during travel in malarious a 4 weeks after traveler leaves malarious a.
Inhalational anthrax (post-exposure):
ADULTS: 100 mg of doxycycline, by mouth, twice a day 60 days.
CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day 60 days. Children weighing 100 lb or more should receive adult dose.
HOW SUPPLIED
Vibramycin® Hyclate (doxycycline hyclate) is available in capsules containing doxycycline hyclate equivalent to:
50 mg doxycycline
bottles of 50 (NDC 0069-0940-50)
capsules white light blue imprinted "VIBRA" on one half "PFIZER 094" on or half.
100 mg doxycycline
bottles of 50 (NDC 0069-0950-50)
capsules light blue imprinted "VIBRA" on one half "PFIZER 095" on or half.
Vibra-Tabs® (doxycycline hyclate) is available in salmon colored film-coated tablets containing doxycycline hyclate equivalent to:
100 mg doxycycline
bottles of 50 (NDC 0069-0990-50)
tablets imprinted on one side "VIBRA-TABS" "PFIZER 099" on or side.
Vibramycin® Calcium Syrup (doxycycline calcium) oral suspension is available as a raspberry-apple flavored oral suspension. Each teaspoonful (5 mL) contains doxycycline calcium equivalent to 50 mg of doxycycline: 1 pint (473 mL) bottles (NDC 0069-0971-93).
Vibramycin® Monohydrate (doxycycline monohydrate) Oral Suspension is available as a raspberry-flavored, dry powder oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline: 2 oz (60 mL) bottles (NDC 0069-0970-65).
All products to be stored below 86°F (30°C) dispensed in tight, light-resistant containers (USP).
ANIMAL PHARMACOLOGY ANIMAL TOXICOLOGY
Hyperpigmentation of thyroid has produced by members of tetracycline class in following species: in rats by oxytetracycline, doxycycline, tetracycline PO 4 , methacycline; in minipigs by doxycycline, minocycline, tetracycline PO 4 , methacycline; in dogs by doxycycline minocycline; in monkeys by minocycline.
Minocycline, tetracycline PO 4 , methacycline, doxycycline, tetracycline base, oxytetracycline HCl, tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter high radioiodine uptake in rats fed a relatively high iodine diet.
Treatment of various animal species this class of drugs has also resulted in induction of thyroid hyperplasia in following: in rats dogs (minocycline); in chickens (chlortetracycline); in rats mice (oxytetracycline). Adrenal gl hyperplasia has observed in goats rats treated oxytetracycline.
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