Amrizol is used to treat bacterial infections in different areas of the body. The extended-release tablets are used to treat women with vaginal infections (bacterial vaginosis).
Amrizol belongs to the class of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, Amrizol will not work for colds, flu, or other virus infections.
Amrizol is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Amrizol is used in certain patients with the following medical conditions:
Clostridium difficile diarrhea or colitis (antibiotic-associated colitis).
Crohn's disease (inflammatory bowel disease).
Gastritis or stomach ulcers due to Helicobacter pylori.
Giardiasis (parasite infection in the intestines).
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Amrizol is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of thetrichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).
Amrizol is indicated in the treatment of asymptomatic females when the organism is associated with endocervi-citis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.
Treatment of Asymptomatic Consorts.
T. vagi-nalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with Amrizol in cases of reinfection.
Amrizol is indicated in the treatment of acute intestinal amebiasis (amebic dysen-tery)and amebic liver abscess.
In amebic liver abscess, Amrizol therapy does not obviate the need for aspiration or drainage of pus.
Anaerobic Bacterial Infections
Amrizol is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Amrizol therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Amrizol.
In the treatment of most serious anaerobic infections, Amrizol I.V. (Amrizol hydrochloride) or Amrizol I.V. RTU® (Amrizol) is usually administered initially. This may be followed by oral ther-apy with Amrizol at the discretion of the physician.
INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostrid-ium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species.
SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger,Peptostreptococcus species, and Fusobacte-rium species.
GYNECOLOGIC INFECTIONS, including endo-metritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcusniger, and Pepto-streptococcus species.
BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clos-tridium species.
BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group.
CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B.fragilis group.
LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group.
ENDOCARDITIS caused by Bacteroides species including the B.fragilis group.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amrizol and other antibacterial drugs, Amrizol 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 selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
How should I use Amrizol?
Use Amrizol gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Amrizol gel. Talk to your pharmacist if you have questions about this information.
If you are using Amrizol gel once daily, use it at bedtime.
Remove the cap from the tube and break the metal seal on the tube with the pointed tip of the cap. Screw the end of the applicator onto the tube. Slowly squeeze gel out of the tube and into the applicator. The plunger will stop when the applicator is full. Unscrew applicator and replace the cap on the tube.
You may insert Amrizol gel lying on your back with your knees bent or in any comfortable position. Hold the filled applicator by the barrel, and gently insert into the vagina as far as it will comfortably go. Slowly press the plunger until it stops, and then remove the applicator.
If you will be using Amrizol gel twice daily, you will need to clean the applicator after your first dose of the day and use it again for your second dose. To clean the applicator, pull the plunger out of the barrel. Wash both the plunger and barrel in warm, soapy water and rinse well. To put the applicator back together, gently push the plunger back into the barrel.
Wash your hands immediately after using Amrizol gel.
When you throw the applicator away, be sure that it is out of the reach of children and pets.
Using Amrizol gel at the same time each day will help you remember to use it.
To clear up your infection completely, use Amrizol gel for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Amrizol gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Amrizol gel.
Uses of Amrizol in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Amebiasis: Treatment of acute intestinal amebiasis (amebic dysentery) and extraintestinal amebiasis (liver abscess)
Limitations of use: When used for amebic liver abscess, may be used concurrently with percutaneous needle aspiration when clinically indicated.
Anaerobic bacterial infections (caused by Bacteroides spp., including the B. fragilis group):
Bacterial septicemia: Treatment of bacterial septicemia (also caused by Clostridium spp.)
Bone and joint infections: Treatment (adjunctive therapy) of bone and joint infections
CNS Infections: Treatment of CNS infections, including meningitis and brain abscess
Endocarditis: Treatment of endocarditis
Gynecologic infections: Treatment of gynecologic infections including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection (also caused by Clostridium spp., Peptococcus spp., Peptostreptococcus spp., and Fusobacterium spp.)
Intra-abdominal infections: Treatment of intra-abdominal infections, including peritonitis, intra-abdominal abscess, and liver abscess (also caused by Clostridium spp., Eubacterium spp., Peptococcus spp., and Peptostreptococcus spp.)
Lower respiratory tract infections: Treatment of lower respiratory tract infections, including pneumonia, empyema, and lung abscess
Skin and skin structure infections: Treatment of skin and skin structure infections (also caused by Clostridium spp., Peptococcus spp., Peptostreptococcus spp., and Fusobacterium spp.)
Surgical prophylaxis (colorectal surgery): Injection: Preoperative, intraoperative, and postoperative prophylaxis to reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery classified as contaminated or potentially contaminated
Trichomoniasis: Treatment of infections caused by Trichomonas vaginalis, including treatment of asymptomatic sexual partners
Off Label Uses
Data from a single case report of one immunocompromised patient with pulmonary infection treated with Amrizol suggest that Amrizol may be beneficial for the treatment of balantidiasis.
Each 100 mL contains Metronidazole USP 500 mg, sodium chloride USP 0.72% w/v, water for injection USP as needed.
Amrizol injection, USP is a parenteral dosage form of the synthetic antibacterial agent 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole. The empirical formula is C6H9N3O3 and the molecular weight is 171.15.
Amrizol injection, USP in 100 mL is a sterile, nonpyrogenic, iso-osmotic, buffered solution of 500 mg Amrizol, USP, 790 mg sodium chloride, USP, 47.6 mg dried dibasic sodium phosphate, USP and 22.9 mg anhydrous citric acid, USP. Amrizol injection, USP has an osmolarity of 310 mOsmol/L (calc) and a pH of 5.5 (4.5 to 7).
Usual Adult Dose for Acne Rosacea
Amrizol topical 1% gel or cream: Apply a thin film to the affected area once a day.
Amrizol topical 0.75% gel, cream, or lotion: Apply a thin film to the affected area twice a day.
Usual Adult Dose for Bacterial Vaginosis
Insert one applicatorful of Amrizol topical 0.75% vaginal gel intravaginally once (at bedtime) or twice a day for 5 consecutive days.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Gel, cream, lotion: Data not available
Vaginal gel: The manufacturer recommends caution when administering this drug to patients with severe hepatic disease.
The duration of topical therapy is 4 to 10 weeks depending on the nature and severity of the condition.
Patients should be advised to use Amrizol topical less frequently or discontinue use if a reaction suggesting local irritation occurs.
Convulsive seizures and peripheral neuropathy have been reported in patients receiving oral or IV Amrizol. If abnormal neurologic signs appear, Amrizol topical vaginal gel should be discontinued at once. The use of Amrizol topical 1% gel should be reevaluated at once if abnormal neurologic signs appear. Amrizol topical should be used with caution in patients with central nervous system diseases.
Amrizol topical should be used with caution in patients with evidence of, or history of blood dyscrasia.
Although disulfiram-like reactions have not been reported in patients receiving vaginal Amrizol, the manufacturer recommends that alcohol be avoided. Amrizol topical vaginal gel should not be used in patients who have taken disulfiram within the last 2 weeks.
Safety and efficacy have not been established in pediatric patients (less than 18 years of age).
Data not available
Amrizol topical may cause eye irritation if applied too close to the eyes. Contact with the eyes should be avoided.
Topical areas to be treated should be washed with a mild cleanser prior to application.
The manufacturer recommends avoidance of vaginal intercourse during treatment with Amrizol topical vaginal gel.
Psychotic reactions have been reported in alcoholic patients who are using Amrizol and disulfiram concurrently. Amrizol should not be given to patients who have taken disulfiram within the last two weeks.
Abdominal cramps, nausea, vomiting, headaches, and flushing may occur if alcoholic beverages or products containing propylene glycol are consumed during or following Amrizol therapy.
Warfarin And Other
Amrizol has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. When Amrizol is prescribed for patients on this type of anticoagulant therapy, prothrombin time and INR should be carefully monitored.
In patients stabilized on relatively high doses of lithium, short-term Amrizol therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning Amrizol to detect any increase that may precede clinical symptoms of lithium intoxication.
Amrizol has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Amrizol should not be administered concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to Amrizol are available, and concomitant administration with busulfan is medically needed, frequent monitoring of busulfan plasma concentration should be performed and the busulfan dose should be adjusted accordingly.
Drugs That Inhibit CYP450 Enzymes
The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of Amrizol.
Drugs That Induce CYP450 Enzymes
The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of Amrizol, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported.
Drug/Laboratory Test Interactions
Amrizol may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD- NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and Amrizol (322 nm) at pH 7.
Two serious adverse reactions reported in patients treated with Amrizol have been convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of Amrizol, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neu-rologic symptoms occur.
The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea reported by about 12% of patients, sometimes accompanied by headache, anorexia, and occasionally vomiting; diarrhea; epi-gastric distress; and abdominal cramping. Constipation has also been reported.
The following reactions have also been reported during treatment with Amrizol:
Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis, and sto-matitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy.
Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.
Central Nervous System: Convulsive seizures, peripheral neuropathy, dizziness, vertigo, incoordination, ataxia, confusion, irritability, depression, weakness, and insomnia.
Hypersensitivity: Urticaria, erythematous rash, flushing, nasal congestion, dryness of the mouth (or vagina or vulva), and fever.
Renal: Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure. Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of Amrizol and seems to have no clinical significance.
Other: Proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint pains sometimes resembling &ldquoserum sickness.” If patients receiving Amrizol drink alcoholic beverages, they may experience abdominal distress, nausea, vomiting, flushing, or headache. A modification of the taste of alcoholic beverages has also been reported. Rare cases of pan-creatitis, which generally abated on withdrawal of the drug, have been reported.
Crohn’s disease patients are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn’s disease patients who have been treated with Amrizol at high doses for extended periods of time. A cause and effect relationship has not been established. Crohn’s disease is not an approved indication for Amrizol.
Amrizol Capsules 375 mg are contraindicated in patients with a prior history of hypersensitivity to Amrizol or other nitroimidazole derivatives.
In patients with trichomoniasis, Amrizol Capsules 375 mg are contraindicated during the first trimester of pregnancy.
Psychotic Reaction with Disulfiram
Use of oral Amrizol is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer Amrizol to patients who have taken disulfiram within the last two weeks.
Interaction with Alcohol
Use of oral Amrizol is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with Amrizol.
DailyMed. "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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