Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Itching in the vagina
pain during sexual intercourse
thick, white vaginal discharge with no odor or with a mild odor
Less common
Abdominal or stomach cramping or pain
burning on urination or need to urinate more often
burning or irritation of penis of sexual partner
itching, stinging, or redness of the genital area
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Diarrhea
dizziness or lightheadedness
dryness of the mouth
feeling of a furry tongue
headache
loss of appetite
metallic taste or other change in taste sensation
nausea
vomiting
Amebazole may cause your urine to become dark. This is harmless and will go away when you stop using Amebazole.
After you stop using Amebazole, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
Any vaginal or genital irritation or itching
pain during sexual intercourse
thick, white vaginal discharge not present before treatment, with no odor or with a mild odor
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.
Side effects of Amebazole in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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In two multicenter clinical trials, a total of 270 patients received 750 mg Amebazole tablets orally once daily for 7 days, and 287 were treated with a comparator agent administered intravaginally once daily for 7 days.
Most adverse events were described as being of mild or moderate severity. Among patients taking Amebazole who reported headaches, 10% considered them severe, and less than 2% of reported episodes of nausea were considered severe. Metallic taste was reported by 9% of patients taking Amebazole.
Adverse events reported at ≥ 2% incidence for either treatment group, irrespective of treatment causality, are summarized in the table below.
Adverse Events ( ≥ 2% Incidence Rate)—Irrespective of Treatment Causality
Amebazole 7 days
(N=267)
Vaginal Preparation
(N=285)
Headache
48 (18%)
44 (15%)
Vaginitis
39 (15%)
32 (12%)
Nausea
28 (10%)
8 (3%)
Taste Perversion (metallic taste)
23 (9%)
1 (0%)
Infection Bacterial
19 (7%)
17 (6%)
Influenza-like Symptoms
17 (6%)
20 (7%)
Pruritus Genital
14 (5%)
25 (9%)
Abdominal Pain
10 (4%)
13 (5%)
Dizziness
11 (4%)
3 (1%)
Diarrhea
11 (4%)
3 (1%)
Upper Respiratory Tract Infection
11 (4%)
10 (4%)
Rhinitis
12 (4%)
10 (4%)
Sinusitis
7 (3%)
6 (2%)
Urine Abnormal
7 (3%)
4 (1%)
Pharyngitis
8 (3%)
4 (1%)
Dysmenorrhea
9 (3%)
7 (2%)
Moniliasis
9 (3%)
8 (3%)
Mouth Dry
5 (2%)
2 (1%)
Urinary Tract Infection
6 (2%)
16 (6%)
Vulvovaginal candidiasis is a recognized consequence of treatment with many anti-infective agents. In these multicenter clinical trials, there were no statistically significant differences in the incidence rates of yeast vaginitis for groups of patients treated with Amebazole or the vaginal comparator.
The following reactions have been reported during treatment with Amebazole:
Central Nervous System: The most serious adverse reactions reported in patients treated with Amebazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic 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 Amebazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur. In addition, patients have reported headache, syncope, dizziness, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia.
Gastrointestinal: The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea, sometimes accompanied by headache, anorexia, and occasionally vomiting, diarrhea, epigastric distress; abdominal cramping; and constipation.
Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis, and stomatitis 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.
Hypersensitivity: Urticaria, erythematous rash, Stevens-Johnson Syndrome, toxic epidermal necrolysis, 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 Amebazole 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 “serum sickness.” Rare cases of pancreatitis, which generally abated on withdrawal of the drug, have been reported.
Patients with Crohn's disease 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 Amebazole 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 Amebazole 750 mg tablets.
REFERENCES
5. Integrated clinical and statistical report for the treatment of bacterial vaginosis with Amebazole modified release tablet— a dose duration study. G.D. Searle & Co., Protocol No. N13-95-02-015; Report No. N13-96-06-015, 19 Nov 1996.
6. Integrated clinical and statistical report for the treatment of bacterial vaginosis with Amebazole modified release tablet. G.D. Searle & Co., Protocol No. N13-95-02-017; Report No. N13-96-06-017, 11 Nov 1996.
What is the most important information I should know about Amebazole?
Amebazole capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Amebazole capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or take any products containing alcohol or propylene glycol while you are taking Amebazole capsules and for at least 3 days after the last dose. Drinking alcohol or taking products with alcohol or propylene glycol may cause stomach cramps, nausea, vomiting, headaches, and flushing.
Amebazole capsules only works against bacteria; it does not treat viral infections (eg, the common cold).
Be sure to use Amebazole capsules for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Long-term or repeated use of Amebazole capsules may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Some patients have developed persistent nerve problems (peripheral neuropathy) after taking Amebazole capsules for a long period of time. Tell your doctor right away if you develop signs of nerve problems (eg, numbness; tingling; burning of the arms, hands, legs, feet). Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
Amebazole capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Amebazole capsules.
Lab tests, including liver function and white blood cell counts, may be performed while you use Amebazole capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Amebazole capsules with caution in the ELDERLY; they may be more sensitive to its effects.
Amebazole capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amebazole capsules while you are pregnant. Certain patients should not use Amebazole capsules during the first 3 months of pregnancy. Amebazole capsules is found in breast milk. Do not breast-feed while taking Amebazole capsules.
Amebazole contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Hypersensitivity
Amebazole Capsules 375 mg are contraindicated in patients with a prior history of hypersensitivity to Amebazole or other nitroimidazole derivatives.
In patients with trichomoniasis, Amebazole Capsules 375 mg are contraindicated during the first trimester of pregnancy.
Psychotic Reaction with Disulfiram
Use of oral Amebazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer Amebazole to patients who have taken disulfiram within the last two weeks.
Interaction with Alcohol
Use of oral Amebazole 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 Amebazole.
References
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).
DTP/NCI. "metronidazole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "Metronidazole: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Amebazole 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 Amebazole. 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.
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