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Metronidazole tablet
What is this medicine?
METRONIDAZOLE is an antiinfective. This medicine is used to treat many kinds of infections, like respiratory, skin, gastrointestinal, and bone and joint infections. It will not work for colds, flu, or other viral infections.
What should my health care professional know before I take this medicine?
They need to know if you have any of these conditions:
anemia or other blood disorders
disease of the nervous system
fungal or yeast infection
if you drink alcohol containing drinks
liver disease
seizures
an unusual or allergic reaction to metronidazole, or other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding
How should I take this medicine?
Take this medicine by mouth with a full glass of water. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following:
alcohol or any product that contains alcohol
amprenavir oral solution
disulfiram
paclitaxel injection
ritonavir oral solution
sertraline oral solution
sulfamethoxazole-trimethoprim injection
This medicine may also interact with the following:
cimetidine
lithium
phenobarbital
phenytoin
warfarin
This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while taking this medicine?
Tell your doctor or health care professional if your symptoms do not improve or if they get worse.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
Avoid alcoholic drinks while you are taking this medicine and for three days afterward. Alcohol may make you feel dizzy, sick, or flushed.
If you are being treated for a sexually transmitted disease, avoid sexual contact until you have finished your treatment. Your sexual partner may also need treatment.
What side effects may I notice from this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash or hives, swelling of the face, lips, or tongue
confusion, clumsiness
dark or white patches in the mouth
fever, infection
numbness, tingling, pain or weakness in the hands or feet
pain when passing urine
seizures
unusually weak or tired
vaginal irritation or discharge
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
diarrhea
headache
metallic taste
nausea
stomach pain or cramps
This list may not describe all possible side effects.
Where can I keep my medicine?
Keep out of the reach of children.
Store at room temperature below 25 degrees C (77 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.
Metronidazole is indicated for the treatment of:
Bacterial
Bacterial vaginosis, commonly associated with overgrowth of Gardnerella species and coinfective anaerobes (Mobiluncus, Bacteroides), in symptomatic patients
Pelvic inflammatory disease in conjunction with other antibiotics such as ofloxacin, levofloxacin, or ceftriaxone
Anaerobic infections such as Bacteroides fragilis, spp, Fusobacterium spp, Clostridium spp, Peptostreptococcus spp, Prevotella spp, or any other anaerobes in intra-abdominal abscess, peritonitis, diverticulitis, empyema, pneumonia, aspiration pneumonia, lung abscess, diabetic foot ulcer, meningitis and brain abscesses, bone and joint infections, septicemia, endometritis, or endocarditis
Pseudomembranous colitis due to Clostridium difficile
Helicobacter pylori eradication therapy, as part of a multi-drug regimen in peptic ulcer disease
Dental infection of bacterial origin, such as periapical abscess, periodontal abscess, acute pericoronitis of impacted or partially erupted teeth; often used in conjunction with Amoxicillin
Protozoal
Amoebiasis: Infections caused by Entamoeba histolytica.[1]
Giardiasis: infection of the small intestine caused by the ingestion of infective cysts of protozoan Giardia lamblia.[1]
Trichomoniasis: infection caused by Trichomonas vaginalis, which is a common cause of vaginitis and is the most frequently presenting new infection of the common sexually transmitted diseases.[1]
Nonspecific
Prophylaxis for those undergoing potentially contaminated colorectal surgery or appendectomies and may be combined with neomycin[citation needed]
Crohn's disease with colonic or perianal involvement (non-FDA approved) – believed to be more effective in combination with ciprofloxacin[citation needed]
Topical metronidazole is indicated for the treatment of rosacea, and in the treatment of malodorous fungating wounds.
Preterm births
Metronidazole has also been used in women to prevent preterm birth associated with bacterial vaginosis, amongst other risk factors including the presence of cervicovaginal fetal fibronectin (fFN). A randomised controlled trial demonstrated that metronidazole was ineffective in preventing preterm delivery in high-risk pregnant women and, conversely, the incidence of preterm delivery was actually higher in women treated with metronidazole.[4]
In a study it has been found that metronidazole is not the right antibiotic to administer in these circumstances and that it was often administered too late to be of use. Clindamycin administered early in the second trimester to women who test positive for bacterial vaginosis seemed to be more effective.[5]
Veterinary use
Metronidazole is not labeled for animal use but is widely used to treat infections of Giardia in dogs, cats, and other companion animals, although it does not reliably clear infection with this organism and is being supplanted by fenbendazole for this purpose in dogs and cats.[6] Metronidazole or simply "Metro" is used in the aquarium hobby to treat ornamental fish as a wide spectrum treatment for bacterial and protozoan infections. It is also used to treat human enteric (gi) and systemic infections. The U.S. Food and Drug Administration (FDA) prohibits the use of metronidazole in food animals.[7]
Adverse effects
Common adverse drug reactions (≥1% of patients) associated with systemic metronidazole therapy include: nausea, diarrhea, and/or metallic taste in the mouth. Intravenous administration is commonly associated with thrombophlebitis. Infrequent adverse effects include: hypersensitivity reactions (rash, itch, flushing, fever), headache, dizziness, vomiting, glossitis, stomatitis, dark urine, and/or paraesthesia.[3]
High doses and/or long-term systemic treatment with metronidazole is associated with the development of leukopenia, neutropenia, increased risk of peripheral neuropathy and/or CNS toxicity.[3]
Metronidazole is listed by the US National Toxicology Program (NTP) as reasonably anticipated to be a human carcinogen. Although some of the testing methods have been questioned[citation needed], oral exposure has been shown to cause cancer in experimental animals.[8] The relationship between exposure to metronidazole and human cancer is unclear.[8] One study (Beard et al. 1988) found an excess in lung cancer among women (even after adjusting for smoking), while other studies (IARC 1987; Thapa et al. 1998) found either no increased risk, or a statistically insignificant risk.[8] [9] It appears to have a fairly low potential for cancer risk and under most circumstances the benefits of treatment outweigh the risk. Metronidazole is listed as a possible carcinogen according to the WHO International Agency for Research on Cancer (IARC).[10]
Due to its potential carcinogenic properties, metronidazole is banned in the EU and the USA for veterinary use in the feed of animals and is banned for use in any food animals in the USA.[11][12] In the USA, this type of restriction is covered under the Delaney clause.
Earlier studies suggested a relation between metronidazole and various birth defects. Those studies are now considered flawed and more recent studies "do not support a significant increased risk for birth defects or other adverse effects on the fetus."[13]
Common adverse drug reactions associated with topical metronidazole therapy include local redness, dryness, and/or skin irritation; and eye watering (if applied near eyes).[3]
Metronidazole toxicity of the brain
Toxic levels of metronidazole can cause symmetrical lesions in the brain in the corpus callosum and dentate nuclei. Metronidazole toxicity is rare (though the actual incidence is not known with certainty). Patients present with nausea, vomiting, dysarthria, vertigo, and confusion. Other side effects of the metronidazole can include dry mouth, diarrhea, headache, dizziness, or peripheral neuropathy. An examination of a patient reveals that the patient is confused and has dysarthria (difficult or unclear articulation of speech that is otherwise linguistically normal), ataxia (loss of full control of bodily movements), abnormal eye movements including nystagmus and ophthalmoparesis. Magnetic resonance imaging (MRI) most often shows bilateral symmetric fluid-attenuated inversion recovery (FLAIR) hyperintense lesions of the dentate nuclei (which is one of the deep cerebellar nuclei), as well as symmetric lesions of the corpus callosum and basal ganglia. The brain lesions seen on the MRI rarely enhance and may be Diffusion-Weighted Imaging (DWI) hyperintense. It has a subacute to acute course. Most reports have been seen in patients who receive approximately one gram a day of metronidazole for over 30 days.[14][citation needed]
Metronidazole can rarely cause central nervous system toxicity; it does not seem to be a dose- or duration-related phenomenon. Most patients will have MRI abnormalities. Prognosis is excellent with metronidazole cessation.[15][16]
Interaction with alcohol
Consuming ethanol (alcohol) while using metronidazole has long been thought to have a disulfiram-like reaction with effects that can include nausea, vomiting, flushing of the skin, tachycardia (accelerated heart rate), and shortness of breath,[17] however there are studies calling that notion into question.[18] Consumption of alcohol should be avoided by patients during systemic metronidazole therapy and for at least 48 hours after completion of treatment.[3] However, the mechanism of this reaction in the clinical setting has recently been questioned by some authors,[19][20] and a possible central toxic serotonin reaction for the alcohol intolerance suggested.[21]
Stevens–Johnson syndrome with mebendazole
Metronidazole alone rarely causes Stevens–Johnson syndrome but is reported to occur at high rates when combined with mebendazole.[22]
Potentially fatal serotonin syndrome
It is important to note that serotonin syndrome is not fully understood. The complex drug interaction can happen after a couple days or take up to months. The exact mechanism is not known, a theory of serotonin dysfunction helps explain how the syndrome presents and how it is to be treated. Signs and symptoms are muscle rigidity, headache, elevated blood pressure, and changes in blood chemistry. The only direct treatment is to discontinue the offending drugs. Recently, there have been reported cases of SSRI/SNRI antidepressant drugs and metronidazole induced serotonin syndrome,[21][23] this information is not included on the metronidazole patient information leaflet. SSRI and SNRI antidepressants include Prozac, Lexapro, Celexa, Zoloft, Effexor, Cymbalta, etc.
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