Did you have any side effects with this medicine?
What is Amrizol?
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).
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
Amrizol is an antibiotic that is used to treat a wide variety of infections. It works by stopping the growth of certain bacteria and parasites.
This antibiotic treats only certain bacterial and parasitic infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
Amrizol may also be used with other medications to treat certain stomach/intestinal ulcers caused by a bacteria (H. pylori).
How to use Amrizol
Take this medication by mouth as directed by your doctor. To prevent stomach upset, take this medication with food or a full glass of water or milk. The dosage is based on your medical condition and response to treatment.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Take this drug at evenly spaced intervals.
Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.
Tell your doctor if your condition lasts or gets worse.
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.
The intravaginal administration of a single 5 gram dose of Amrizol results in relatively lower mean systemic exposure to Amrizol that is approximately 2% to 5% of that achieved following a 500 mg oral dose of Amrizol. The following drug interactions were reported for oral Amrizol.
Use of oral Amrizol has been associated with psychotic reactions in alcoholic patients who are using disulfiram concurrently. Amrizol (Amrizol vaginal gel) should not be used by patients who have taken disulfiram within the last two weeks.
Use of oral Amrizol has been associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) to alcohol. Alcoholic beverages and preparations containing ethanol or propylene glycol should not be consumed during and for at least three days after Amrizol therapy.
Coumarin and Other
Use of oral Amrizol has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when Amrizol (Amrizol vaginal gel) is prescribed for patients on this type of anticoagulant therapy. In patients on oral anticoagulants, consider monitoring prothrombin time, international normalized ratio (INR), and other coagulation parameters while on Amrizol.
Short-term use of oral Amrizol has been associated with elevation of serum lithium concentrations and, in a few cases signs of lithium toxicity, in patients stabilized on relatively high doses of lithium. Use Amrizol (Amrizol vaginal gel) with caution in patients treated with lithium and consider monitoring lithium serum concentrations while on Amrizol.
Use of oral Amrizol with cimetidine may prolong the half-life and decrease plasma clearance of Amrizol. No dose adjustment of Amrizol (Amrizol vaginal gel) is necessary.
Amrizol side effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Amrizol compared to another formulation of vaginal Amrizol in 220 women in a single trial. The population was non-pregnant females (age range 18 to 72 years, the mean was 33 years +/- 11 years) with bacterial vaginosis. The racial demographic of those enrolled was 71 (32%) of White, 143 (65%) of Black, 3 (1%) of Hispanic, 2 (1%) of Asian, and 1 (0%) of other. Patients administered an applicator full of Amrizol (Amrizol vaginal gel) intravaginally once daily at bedtime for 5 days.
There were no deaths or serious adverse reactions related to drug therapy in the clinical trial. Amrizol (Amrizol vaginal gel) was discontinued in 5 patients (2.3%) due to adverse reactions.
The incidence of all adverse reactions in Amrizol (Amrizol vaginal gel) -treated patients was 42% (92/220). Adverse reactions occurring in ≥ 1% of patients were: fungal infection* (12%), headache (7%), pruritus (6%), abdominal pain (5%), nausea (3%), dysmenorrhea (3%), pharyngitis (2%), rash (1%), infection (1%), diarrhea (1%), breast pain (1%), and metrorrhagia (1%).
* Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with Amrizol (Amrizol vaginal gel). Approximately 10% of patients treated with Amrizol (Amrizol vaginal gel) developed Candida vaginitis during or immediately after therapy.
Additional uncommon events, reported by < 1% of those women treated with Amrizol (Amrizol vaginal gel) included:
General: allergic reaction, back pain, flu syndrome, mucous membrane disorder, pain
Gastrointestinal: anorexia, constipation, dyspepsia, flatulence, gingivitis, vomiting
Nervous System: depression, dizziness, insomnia
Respiratory System: asthma, rhinitis
Skin and Appendages: acne, sweating, urticaria
Urogenital System: breast enlargement, dysuria, female lactation, labial edema, leucorrhea, menorrhagia, pyleonephritis, salpingitis, urinary frequency, urinary tract infection, vaginitis, vulvovaginal disorder
Other Amrizol Formulations
Other Vaginal Formulations
Other reactions that have been reported in association with the use of other formulations of Amrizol vaginal gel include: unusual taste and decreased appetite.
Topical (Dermal) Formulations
Other reactions that have been reported in association with the use of topical (dermal) formulations of Amrizol include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse reactions exceeded an incidence of 2% of patients.
The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of Amrizol:
Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.
Nervous System: The most serious adverse reactions reported in patients treated with Amrizol have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. In addition, patients have reported syncope, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia.
Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, “furry” tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages.
Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctitis.
Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.
Hypersensitivity Reactions: Urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.
Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine.
The use of Amrizol (Amrizol vaginal gel) is contraindicated in patients with a history of hypersensitivity to Amrizol, other nitroimidazole derivatives, or parabens. Reported reactions include urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.
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 (Amrizol vaginal gel) 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 alcohol consumption during and for at least three days after therapy with Amrizol (Amrizol vaginal gel).
Active ingredient matches for Amrizol:
List of Amrizol substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|Amotrex DS (Bangladesh)|
|Amrizole (Bahrain, Ethiopia, Oman, Peru)|
|Amyda 0.75 % x 1 g|
|Amyda 0.75 % x 10 g|
|Amyda 0.75 % x 20 g|
|Anabact (United Kingdom)|
|Anaerobex 0.5% (Austria)|
|Anaerobyl (South Africa)|
|1 mg x 10's (United Biotech)|
|Anazol 1mg TAB / 10 (United Biotech)|
|ANAZOL tab 1 mg x 10's (United Biotech)||$ 8.32|
|Anegyn 500 mg/100 mL x 1's|
|Anerobizol 5 mg/1 mL x 100 mL x 1's (Marck Biosciences)|
|Anerobizol infusion 5 mg/mL 100 mL x 1's (Marck Biosciences)|
|200 mg x 5 mL x 60ml (Raptakos)||$ 0.14|
|200 mg x 10's (Raptakos)||$ 0.08|
|Antamebin 200mg x 5mL SUSP / 60ml (Raptakos)||$ 0.14|
|Antamebin 200mg TAB / 10 (Raptakos)||$ 0.08|
|ANTAMEBIN oral susp 200 mg x 5 mL x 60ml (Raptakos)||$ 0.14|
|ANTAMEBIN tab 200 mg x 10's (Raptakos)||$ 0.08|
|Antamebin 200mg x 5mL SUSP / 60ml (Raptakos)||$ 0.14|
|Antamebin 200mg TAB / 10 (Raptakos)||$ 0.08|
|Antimonas 250 mg|
|Antizoal infusion 5 mg/mL / PP1 100 mL x 1's (Shijiazhuang No. 4)|
|Ao Ke An (China)|
|Apo-Metronidazole (Canada, Estonia, Singapore)|
|Apo-Metronidazole 250 mg x 1 Bottle 100 Tablet|
|Apo-Metronidazole 250 mg x 1 Bottle 500 Tablet|
|Apo-Metronidazole 250 mg x 1 Bottle 1000 Tablet|
|Apo-Metronidazole 250 mg x 500's|
|Tablets; Oral; Metronidazole 250 mg|
|Apo-metronidazole tablet 250 mg (Apotex Inc (Canada))|
|Apo-metronidazole capsule 500 mg (Apotex Inc (Canada))|
- 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).
- PubChem. "metronidazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "metronidazole". http://www.drugbank.ca/drugs/DB00916 (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Amrizol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Amrizol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
Consumer reported time for resultsNo survey data has been collected yet
1 consumer reported age
There are no reviews yet. Be the first to write one!
Information checked by Dr. Sachin Kumar, MD Pharmacology