Durante mucho tiempo no había principios uniformes para la Atribución de nombres a los antibióticos https://antibioticos-wiki.es . Más a menudo se les llama por el nombre genérico o especie del producto, con menos frecuencia-de acuerdo con la estructura química. Algunos antibióticos se nombran de acuerdo con el lugar donde se asignó el producto.
Microsoft word - metronidazole final 2007 2-column.doc
METRONIDAZOLE (Veterinary—Systemic)
Some commonly used brand names for human-labeled products are:
ELUS,CANHelicobacter species infections (treatment)EL—Cats and dogs:Apo-Metronidazole; Flagyl; Novonidazol; and PMS-
Although the treatment of Helicobacter pylori in human
gastrointestinal disease has had major clinical impact, the
relationship of Helicobacter species or Helicobacter-like
Note: For a listing of dosage forms and brand names by country
organisms to gastric disease in cats and dogs has not been
availability, see the Dosage Forms section(s).
established. When evidence of infection with these organisms is
found in a patient, a clinician may make a decision to treat with
Category: Antibacterial (systemic); antiprotozoal.
metronidazole, in combination with other drugs, such as bismuth-containing compounds, a proton-pump inhibitor, and another
antibiotic, based on the data available.{R-22-26} Indications
ELUS,CANInfections, bacterial (treatment)EL, including
Note: Metronidazole is not specifically approved for veterinary use. In
ELUS,CANBone and joint infections (treatment)EL;
other USP information monographs the ELUS and ELCAN
ELUS,CANCentral nervous system infections (treatment)EL;
designations refer to uses that are not included in U.S. and
ELUS,CANIntra-abdominal infections (treatment)EL;
Canadian product labeling; however, in this monograph they
ELUS,CANPerioperative infections, colorectal (prophylaxis)EL;
reflect the lack of veterinary products and, therefore, product
ELUS,CANRespiratory tract infections, lower (treatment)EL;
ELUS,CANSepticemia, bacterial (treatment)EL; or
ELUS,CANSkin and soft tissue infections (treatment)EL—Cats, dogs, and
General considerations horses: Although there are insufficient clinical research data to
Metronidazole is effective in the treatment of systemic and enteric
establish efficacy, metronidazole is used in the treatment of many
obligate anaerobic bacterial infections, including Clostridium
types of anaerobic bacterial infections in animals. In human
species, Fusobacterium species,{R-1} and penicillinase-producing
patients, metronidazole is indicated, usually in combination with
strains of Bacteroides.{R-2; 3} Surgical therapy may be necessary to
other antibiotics, in the prevention of perioperative infections
completely resolve isolated infections.{R-3}
during colorectal surgery and in the treatment of bone and joint
Metronidazole is not clinically effective against facultative anaerobes
infections; central nervous system infections; intra-abdominal
or obligate aerobes.{R-1; 4} However, it is often combined with
infections; lower respiratory tract infections, including
another antibiotic or antibiotics effective against aerobes to treat
pleuropneumonia and lung abscess; septicemia; and skin and soft
mixed bacterial infections.{R-2}
tissue infections caused by susceptible species, including
Metronidazole is considered effective in the treatment of some
Bacteroides and Clostridium species.{R-1; 4} There are limited
pharmacokinetic data and case reports available pertaining to the
use of metronidazole in the treatment of these types of infections
Accepted
in animals, when caused by susceptible organisms.{R-8; 9; 12; 14; 16; 19-
ELUS,CANGiardiasis (treatment)EL—Cats and dogs: Metronidazole is used
to eliminate shedding of giardial cysts and treat associated
ELUS,CANPeriodontal infections (treatment)EL—Cats and dogs:
diarrhea in cats and dogs.{R-6; 7; 36} Environmental eradication is
Metronidazole is used in the treatment of periodontal infections in
necessary for effective treatment. The infection may not be
cats and dogs.{R-15; 17; 18} It may be administered for destructive
completely cleared in all animals.{R-7}
periodontal diseases as part of a treatment plan that also includes
one or more of the following: dental scaling, gingival crevicular
Potentially effective
lavage, periodontal surgery, or regular teeth cleaning.{R-17}
ELUS,CANAmebiasis, intestinal (treatment)EL;
ELUS,CANBalantidiasis, intestinal (treatment)EL; or
Regulatory Considerations
ELUS,CANTrichomoniasis, intestinal (treatment)EL—Cats and dogs: In
human patients, metronidazole is used in the treatment of
The Food and Drug Administration has not approved the use of
susceptible Balantidium coli,Entamoeba histolytica, and
me-tronidazole in animals. Federal law prohibits the extra- Trichomonas species.{R-1; 4; 5} Metronidazole is also recommended label use of nitroimidazoles in food-producing animals.{R-
in the treatment of enteric protozoal infections in cats and dogs,
although the relationship between infection and clinical signs can
Metronidazole is not approved for use in food-producing animals.
ELUS,CANBowel disease, inflammatory (treatment)EL—Cats and dogs:
There are no established withdrawal times.
Although there are insufficient data to establish efficacy,
metronidazole is used in the treatment of inflammatory bowel
Chemistry
ELUS,CANColitis, antibiotic-associated (treatment)EL; or
Chemical group: Nitroimidazoles.
ELUS,CANColitis, clostridial (treatment)EL—Horses: Although there are
Chemical name:
insufficient data to establish efficacy, metronidazole is used in the
Metronidazole—1H-Imidazole-1-ethanol, 2-methyl-5-nitro-.{R-29}
treatment of bacterial colitis caused by susceptible organisms,
Metronidazole hydrochloride—1H-Imidazole-1-ethanol, 2-
including Clostridium difficile.{R-10-12}
methyl-5-nitro-, hydrochloride.{R-29}
ELUS,CANEncephalopathy, hepatic (treatment)EL—Cats and dogs:Molecular formula:
Although there are insufficient data to establish efficacy,
Metronidazole—C6H9N3O3.{R-29}
metronidazole is used to reduce gastrointestinal bacterial
Metronidazole hydrochloride—C6H9N3O3·HCl.{R-29}
production of ammonia thought to contribute to clinical signs in
Molecular weight:
Metronidazole—171.15.{R-29}
ELUS,CANEndometritis (treatment)EL—Horses: Although there are
Metronidazole hydrochloride—207.61.{R-29}
insufficient data to establish efficacy, metronidazole is used in
Description: Metronidazole USP—White to pale yellow, odorless
combination with other antibiotics in the treatment of
crystals or crystalline powder. Is stable in air, but darkens on
endometritis, including infections caused by penicillinase-
exposure to light.{R-30}
producing anaerobic bacteria.{R-13} Solubility: Metronidazole USP—Sparingly soluble in water and in
2007 The United States Pharmacopeial Convention All rights reserved.
alcohol; slightly soluble in ether and in chloroform.{R-30} Drug interactions and/or related problems
The following drug interactions and/or related problems have been
selected on the basis of their potential clinical significance
Pharmacology/Pharmacokinetics
(possible mechanism in parentheses where appropriate)—not
Mechanism of action/Effect: Metronidazole is reduced as it enters
the target cell where it interacts with bacterial or protozoal DNA,
Note: Combinations containing any of the following medications,
causing a loss of helical structure and strand breakage in the
depending on the amount present, may also interact with
DNA; these effects inhibit nucleic acid synthesis and cause death
(hepatic metabolism of metronidazole may be decreased when
Absorption: Metronidazole is moderately well absorbed from the
metronidazole and cimetidine are used concurrently, possibly
gastrointestinal tract.{R-21; 33; 37}
resulting in delayed elimination and increased serum
metronidazole concentrations;{R-5} dosage of metronidazole Distribution: Horses—In one pharmacokinetic study of horses, peak
metronidazole concentrations in peritoneal fluid, synovial fluid,
and cerebrospinal fluid were 65%, 92%, and 30% of peak serum
(phenobarbital may induce microsomal liver enzymes,
concentrations.{R-21} With an oral dose of 7.5 mg/kg every 6
increasing metronidazole’s metabolism and resulting in a
hours, endometrial penetration was poor.{R-21}
decrease in half-life and plasma concentration;{R-5} dosage of Biotransformation: Hepatic, metabolized primarily by side-chain Side/Adverse Effects
The following side/adverse effects have been selected on the basis of
Pharmacokinetic data:
their potential clinical significance (possible signs and, for
humans, symptoms in parentheses where appropriate)—not
Those indicating need for medical attention Neurologic disturbances (ataxia, nystagmus, seizures, tremors, Dogs{R-37}
weakness)—usually with high dosage in cats, dogs, and horses,{R-31; 32} although signs have been reported with doses as low as 30 Horses{R-33}
mg/kg.{R-41} Those indicating need for medical attention only if they continue or are bothersome Anorexia; neutropenia; vomiting Those not indicating need for medical attention Reddish brown urine Human side/adverse effects{R-5}
In addition to the above side/adverse effects reported in animals, the
following side/adverse effects have been reported in humans, and
are included in the human monograph Metronidazole (Systemic)
in USP DI Volume I; these side/adverse effects are intended for
Dogs{R-37}
informational purposes only and may or may not be applicable to
Horses{R-33} 25
the use of metronidazole in the treatment of animals:
{R-21}† 15 Central nervous system (CNS) effects; gastrointestinal disturbance
† Two horses with pleuropneumonia yielded similar kinetic results to
Change in taste sensation; CNS toxicity, including ataxia and encephalopathy; dark urine; dryness of mouth; hypersensitivity; leukopenia; pancreatitis; peripheral Precautions to Consider neuropathy—usually with high doses or prolonged use; Carcinogenicity/Mutagenicity seizures—usually with high doses; thrombocytopenia—
Metronidazole has been shown to be a carcinogen in mice and rats
reversible; thrombophlebitis; unpleasant or sharp metallic
with chronic oral administration. It has also been shown to be
taste; urinary tract effects, including frequent or painful
mutagenic in in vitro assays.{R-1; 4} urination and inability to control urine flow; vaginal candidiasis Pregnancy/Reproduction
Pregnancy—Metronidazole readily crosses the placenta and enters the
Overdose
fetal circulation.{R-1} No teratogenic effects were seen in the pups
For information in cases of overdose or unintentional ingestion,
of rats that had received 250 mg per kg of body weight (mg/kg) a
contact the American Society for the Prevention of Cruelty to
day for 1 to 12 days, or 100 mg/kg a day for 40 days. However,
Animals (ASPCA) National Animal Poison Control Center
spermatogenesis in male rats was affected by the administration of
(888-426-4435 or 900-443-0000; a fee may be required for
consultation) and/or the drug manufacturer. Lactation Lethal dose
Metronidazole is distributed into milk at concentrations similar to
Dogs: 250 mg per kg of body weight (mg/kg) a day induced central
plasma concentrations.{R-1; 4} Risk-benefit should be considered
nervous system dysfunction within 4 to 6 days and death within a
carefully when metronidazole is used in nursing animals.
week of onset of signs.{R-32}
2007 The United States Pharmacopeial Convention All rights reserved.Clinical effects of overdose Usual dose: See Metronidazole Capsules.
The following effects have been selected on the basis of their potential
Note: Cats—The typical way to give 15 mg per kg of body weight
clinical significance—not necessarily inclusive:
to an eight- to nine-pound cat is to administer one-fourth of
Dogs, with doses of 65 to 129 mg/kg a day.{R-32} Ataxia; head tilt; nystagmus (spontaneous, positional, vertical); seizures Strength(s) usually available:
Note: Neurologic effects have also been reported with doses as
low as 30 mg/kg.{R-41} Ataxia and nystagmus were noted consistently in a report on
five cases of toxicosis. Signs appeared within 7 to 12 days of
initiating therapy. In dogs that survived complications of
250 mg (base) (Rx) [Flagyl; GENERIC].
neurologic dysfunction, signs gradually resolved over 1 to 2
500 mg (base) (Rx) [Flagyl; GENERIC].
weeks after ending metronidazole administration.{R-32} Oral Dosage Forms
Note: The dosing and strengths of the dosage forms available are
250 mg (base) (Rx) [Apo-Metronidazole; Novonidazol
expressed in terms of metronidazole base.
(scored); PMS-Metronidazole; GENERIC].
Metronidazole is not specifically approved for veterinary use. In
other USP information monographs the ELUS and ELCAN
Packaging and storage: Store below 40 ºC (104 ºF), preferably
designations indicate uses that are not included in U.S. and
between 15 and 30 ºC (59 and 86 ºF), in a well-closed container,
Canadian product labeling; however, in this monograph they
unless otherwise specified by manufacturer. Store in a light-
reflect the lack of veterinary products and, therefore, product
Additional information: For cats, tablets should not be crushed for METRONIDAZOLE CAPSULES
administration, because metronidazole is bitter and often
Usual dose:
ELUS,CANBacterial infections, anaerobicEL; or
USP requirements: Preserve in well-closed, light-resistant Cats and dogs: Oral, 15 mg (base) per kg of body weight
containers. Contain the labeled amount, within ±10%. Meet the
every twelve hours.{R-38}
requirements for Identification, Dissolution (85% in 60 minutes in
Horses: Oral, 15 to 25 mg (base) per kg of body weight every
0.1 N hydrochloric acid in Apparatus 1 at 100 rpm), and
six hours.{R-33}
Uniformity of dosage units.{R-30}
Note: Anorexia may occur in horses treated with the
above dose; therefore, some clinicians recommend
Parenteral Dosage Forms
use of a lower oral dose of 10 mg per kg of body weight every twelve hours.{R-40}
Note: The dosing and strengths of the dosage forms available are
expressed in terms of metronidazole base.
For susceptible gram-negative anaerobic infections in horses, one study recommended an alternative
Metronidazole is not specifically approved for veterinary use. In
dosage regimen of 15 mg per kg of body weight as
other USP information monographs the ELUS and ELCAN
an initial dose, followed by 7.5 mg per kg of body
designations indicate uses that are not included in U.S. and
weight every six hours.{R-21}
Canadian product labeling; however, in this monograph they reflect the lack of veterinary products and, therefore, product
Contents of the capsule can be mixed with molasses
or administered via nasogastric tube.{R-31; 33; 34}
ELUS,CANInflammatory bowel diseaseEL—Cats and dogs: Oral, 7.5
METRONIDAZOLE INJECTION USP
mg (base) per kg of body weight every twelve hours.
Usual dose:
Note: Reliable dosing information is not available for the use of
Strength(s) usually available:
parenteral metronidazole in animals. However, for situations
in which oral administration is not a viable option, injectable
forms are used by following dosing regimens similar to oral
375 mg (base) (Rx) [Flagyl; GENERIC].
Strength(s) usually available:
500 mg (base) (Rx) [Apo-Metronidazole; Flagyl; PMS-
500 mg (base) per 100 mL (Rx) [GENERIC].
Packaging and storage: Store below 40 ºC (104 ºF), preferably
between 15 and 30 ºC (59 and 86 ºF), in a well-closed container,
unless otherwise specified by manufacturer. Store in a light-
500 mg (base) per 100 mL (Rx) [GENERIC].
Withdrawal times: There are no established withdrawal times since USP requirements: Not in USP.{R-30}
metronidazole is not approved for use in food-producing animals.
METRONIDAZOLE TABLETS USP Packaging and storage: Store below 40 ºC (104 ºF), preferably
2007 The United States Pharmacopeial Convention All rights reserved.
between 15 and 30 ºC (59 and 86 ºF), unless otherwise specified
19. Chou S, Richards GK, Brown RA. A new approach to antibiotic
by manufacturer. Protect from light. Protect from freezing.
therapy in colon surgery based on bioassay tissue concentrations.
Incompatibilities: Intravenous admixtures of metronidazole and
20. Piek CJ, Robben JH. Pyothorax in nine dogs. Vet Q 2000 Apr;
other medications are not recommended.{R-35}
21. Specht TE, Brown MP, Gronwall RR, et al. Pharmacokinetics of
Additional information: Metronidazole Injection USP is an
metronidazole and its concentration in body fluids and
isotonic (297 to 310 mOsm per L), ready-to-use solution,
endometrial tissues of mares. Am J Vet Res 1992 Oct; 53(10):
requiring no dilution or buffering prior to administration.{R-35}
22. Neiger R, Seiler G, Schmassmann A. Use of a urea breath test to
USP requirements: Preserve in single-dose containers of Type I or
evaluate short-term treatments for cats naturally infected with
Type II glass, or in suitable plastic containers, protected from
Helicobacter heilmannii. Am J Vet Res 1999 Jul; 60(7): 880-3.
light. A sterile, isotonic, buffered solution of Metronidazole in
23. Perkins SE, Yan LL, Shen Z, et al. Use of PCR and culture to
detect Helicobacter pylori in naturally infected cats following
Water for Injection. Contains the labeled amount, within ±10%.
triple antimicrobial therapy. Antimicrob Agents Chemother 1996
Meets the requirements for Identification, Bacterial endotoxins,
pH (4.5–7.0), and Particulate matter, and for Injections.{R-30}
24. Happonen I, Linden J, Westermarck EJ. Effect of triple therapy on
eradication of canine gastric helicobacters and gastric disease.
Interim revision: 06/05/95; 06/20/96; 05/19/97; 7/21/98
25. Simpson KW, Strauss-Ayali D, McDonough PL, et al. Gastric
function in dogs with naturally acquired gastric Helicobacter spp.
infection. J Vet Intern Med 1999 Nov-Dec; 13(6): 507-15.
References
26. Cornetta AM, Simpson KW, Strauss-Ayali D, et al. Use of a
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[13C]urea breath test for detection of gastric infection with
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Helicobacter spp in dogs. Am J Vet Res 1998 Nov; 59(11): 1364-
2. Boothe DM. Anaerobic infections in small animals. Probl Vet Med
27. Drugs prohibited for extra-label use in animals. In: Code of
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Federal Regulations. Washington, D.C.: US Government Printing
Small Anim Pract 1988 Nov; 18(6): 1167-82.
Office. April 1, 2006. 21 CFR 530.41. Available at
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Available at www.pfizer.com. Accessed on December 4, 2006.
28. Bartlett JG, Louie TJ, Gorbach SL, et al. Therapeutic efficacy of
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29. USP dictionary of USAN and international drug names, 2006 ed.
6. Zimmer JF. Treatment of feline giardiasis with metronidazole.
Rockville, MD: The United States Pharmacopeial Convention,
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30. The United States pharmacopeia. The national formulary. USP
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8. Tisdall PL, Hunt GB, Beck JA, et al. Management of perianal
fistulae in five dogs using azathioprine and metronidazole prior to
surgery. Aust Vet J 1999 Jun; 77(6): 374-8.
32. Dow SW, LeCouteur RA, Poss ML, et al. Central nervous system
9. Carlson GP, O'Brien MA. Anaerobic bacterial pneumonia with
toxicosis associated with metronidazole treatment of dogs: five
septicemia in two racehorses. J Am Vet Med Assoc 1990 Mar 15;
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33. Sweeny RW, Sweeney CR, Soma LR, et al. Pharmacokinetics of
10. Jones RL. Clostridial enterocolitis. Vet Clin North Am Equine
metronidazole given to horses by intravenous and oral routes. Am
11. Weese JS, Parsons DA, Staempfli HR. Association of Clostridium
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13. Ricketts SW, Mackintosh ME. Role of anaerobic bacteria in
equine endometritis. J Reprod Fertil Suppl 1987; 35(2): 343-51.
36. Kirkpatrick CE, Farrell JP. Feline giardiasis: observations on
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15. Heijl L, Lindhe J. Effect of selective antimicrobial therapy on
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kinetics in the dog. J Vet Pharmacol Ther 1981; 4: 121-7.
16. Sweeney RW, Sweeney CR, Weiher J. Clinical use of
metronidazole in horses: 200 cases (1984-1989). J Am Vet Med
39. Steinman A, Gips M, Lavy E, et al. Pharmacokinetics of
metronidazole in horses after intravenous, rectal, and oral
17. Norris JM, Love DN. In vitro antimicrobial susceptibilities of
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of cats to selected antimicrobial agents. Aust Vet J 2000 Aug;
41. Evans J, Levesque D, Knowles K, et al. Diazepam as a treatment
for metronidazole toxicosis in dogs: a retrospective study of 21
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2007 The United States Pharmacopeial Convention All rights reserved.
Jon Geir Høyersten Sinnslidelsenes historie – noen temaer og tablåer Psykiatriens historie er en broket historie med mange beretninger om galskap og melankoli. Folkelige tradisjoner for forståelse og hjelp har gått parallelt med en vitenskapelig tilnærming. Det skyld- og skambelagte omkring psykiske lidelser har gått igjen. Fokuseringen på psykiatrien som en eneste lang histor
Thomas Carr College Medication Policy Date of approval: Date of review: To be reviewed by: College Nurse, Director of Student Services To be ratified by: Medication Policy Policy Statement Thomas Carr College is committed to the provision of medication needs to promote the wellbeing of all students. No student is to be in possession of any med