Amebazole Overdose

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What happens if I overdose Amebazole?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Amebazole emulsion may be harmful if swallowed.

Proper storage of Amebazole emulsion:

Store Amebazole emulsion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amebazole emulsion out of the reach of children and away from pets.

Overdose of Amebazole in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Use of dosages of intravenous Amebazole higher than those recommended has been reported. These include the use of 27 mg/kg three times a day for 20 days, and the use of 75 mg/kg as a single loading dose followed by 7.5 mg/kg maintenance doses. No adverse reactions were reported in either of the two cases.

Single oral dose of Amebazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported included nausea, vomiting and ataxia.

Oral Amebazole has been studied as a radiation sensitizer in the treatment of malignant tumors. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.

Treatment: There is no specific antidote for overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.

What should I avoid while taking Amebazole?

Do not drink alcohol while you are taking Amebazole and for at least 3 days after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

Check the labels of any medicines or food products you use to make sure they do not contain alcohol.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Amebazole and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Amebazole warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Convulsive Seizures and Peripheral Neuropathy

Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with Amebazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of Amebazole (Amebazole) therapy. Amebazole should be administered with caution to patients with central nervous system diseases.

Patients with severe hepatic disease metabolize Amebazole slowly, with resultant accumulation of Amebazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously.

Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with Amebazole (Amebazole) and requires treatment with a candidacidal agent.

Prescribing Amebazole in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Laboratory tests

Amebazole (Amebazole) is a nitro-imidazole and should be used with caution in patients with evidence of or history of blood dys-crasia. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to metro-nidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended before and after therapy for trichomonia-sis and amebiasis, especially if a second course of therapy is necessary, and before and after therapy for anaerobic infections.

Carcinogenesis, mutagenesis, impairment of fertility

Amebazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats.

Prominent among the effects in the mouse was the promotion of pulmonary tumorigenesis. This has been observed in all six reported studies in that species, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). At very high dose levels (approx. 500 mg/kg/day which is approximately 33 times the most frequently recommended human dose for a 50 kg adult based on mg/kg body weight) there was a statistically significant increase in the incidence of malignant liver tumors in males. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lym-phomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. All these effects are statistically significant.

Several long-term, oral-dosing studies in the rat have been completed. There were statistically significant increases in the incidence of various neo-plasms, particularly in mammary and hepatic tumors, among female rats administered metroni-dazole over those noted in the concurrent female control groups.

Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.

Although Amebazole has shown mutagenic activity in a number of in vitro assay systems, studies in mammals (in vivo) have failed to demonstrate a potential for genetic damage.

Fertility studies have been performed in mice at doses up to six times the maximum recommended human dose based on mg/m² and have revealed no evidence of impaired fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category B. Amebazole crosses the placental barrier and enters the fetal circulation rapidly. Reproduction studies have been performed in rats at doses up to five times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Amebazole. No fetotoxicity was observed when Amebazole was administered orally to pregnant mice at 20 mg/kg/day, approximately one and a half times the most frequently recommended human dose (750 mg/day) based on mg/kg body weight; however in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. The relationship of these findings to the drug is unknown. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because Amebazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Use of Amebazole for trichomoniasis during pregnancy should be restricted to those in whom alternative treatment has been inadequate. Use of Amebazole (Amebazole) for trichomoniasis in pregnancy should be carefully evaluated because Amebazole crosses the placental barrier and its effects on the human fetal organogenesis are not known.

Nursing mothers

Because of the potential for tumorigenicity, shown for Amebazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance ofthe drug to the mother. Amebazole is secreted in human milk in concentrations similar to those found in plasma.

Geriatric use

Decreased renal function does not alter the single-dose pharmacokinetics of metroni-dazole. However, plasma clearance of metronida-zole is decreased in patients with decreased liver function. Therefore, in elderly patients, monitoring of serum levels may be necessary to adjust the Amebazole dosage accordingly.

Pediatric use

Safety and effectiveness in pediatric patients have not been established, except for the treatment of amebiasis.

What should I discuss with my healthcare provider before taking Amebazole?

Some medical conditions may interact with Amebazole emulsion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Amebazole emulsion. Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amebazole emulsion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Amebazole precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Amebazole Vaginal Gel affords minimal peak serum levels and systemic exposure (AUCs) of Amebazole compared to 500 mg oral Amebazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral Amebazole, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing Amebazole administered orally to Amebazole administered vaginally are not available.

General:

Patients with severe hepatic disease metabolize Amebazole slowly. This results in the accumulation of Amebazole and its metabolites in the plasma. Accordingly, for such patients, Amebazole Vaginal Gel should be administered cautiously.

Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with Amebazole Vaginal Gel. Approximately 6-10% of patients treated with Amebazole Vaginal Gel developed symptomatic Candida vaginitis during or immediately after therapy.

Disulfiram-like reaction to alcohol has been reported with oral Amebazole, thus the possibility of such a reaction occurring while on Amebazole Vaginal Gel therapy cannot be excluded.

Amebazole Vaginal Gel contains ingredients that may cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.

Information for the Patient:

The patient should be cautioned about drinking alcohol while being treated with Amebazole Vaginal Gel. While blood levels are significantly lower with Amebazole Vaginal Gel than with usual doses of oral Amebazole, a possible interaction with alcohol cannot be excluded.

The patient should be instructed not to engage in vaginal intercourse during treatment with this product.

Drug Interactions:

Oral Amebazole 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 Amebazole Vaginal Gel is prescribed for patients on this type of anticoagulant therapy.

In patients stabilized on relatively high doses of lithium, short-term oral Amebazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.

Use of cimetidine with oral Amebazole may prolong the half-life and decrease plasma clearance of Amebazole.

Drug/Laboratory Test Interactions:

Amebazole 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 dinucleotides (NAD + NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and Amebazole (322 nm) at pH 7.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Amebazole has shown evidence of carcinogenic activity in a number of studies involving chronic oral administration in mice and rats. Prominent among the effects in the mouse was the promotion of pulmonary tumorigenesis. This has been observed in all six reported studies in that species, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). At very high dose levels (approximately 500 mg/kg/day), there was a statistically significant increase in the incidence of malignant liver tumors in males. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lymphomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. All these effects are statistically significant. Several long-term oral dosing studies in the rat have been completed. There were statistically significant increases in the incidence of various neoplasms, particularly in mammary and hepatic tumors, among female rats administered Amebazole over those noted in the concurrent female control groups. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.

These studies have not been conducted with 0.75% Amebazole Vaginal Gel, which would result in significantly lower systemic blood levels than those obtained with oral formulations.

Although Amebazole has shown mutagenic activity in a number of in vitro assay systems, studies in mammals (in vivo) have failed to demonstrate a potential for genetic damage.

Fertility studies have been performed in mice up to six times the recommended human oral dose (based on mg/m2) and have revealed no evidence of impaired fertility.

Pregnancy: Teratogenic Effects:

Pregnancy Category B

There has been no experience to date with the use of Amebazole Vaginal Gel in pregnant patients. Amebazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity or teratogenicity was observed when Amebazole was administered orally to pregnant mice at six times the recommended human dose (based on mg/m2); however, in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. The relationship of these findings to the drug is unknown.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because Amebazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

Specific studies of Amebazole levels in human milk following intravaginally administered Amebazole have not been performed. However, Amebazole is secreted in human milk in concentrations similar to those found in plasma following oral administration of Amebazole.

Because of the potential for tumorigenicity shown for Amebazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in children have not been established.

What happens if I miss a dose of Amebazole?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.



References

  1. 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).
  2. DrugBank. "metronidazole". http://www.drugbank.ca/drugs/DB00916 (accessed September 17, 2018).
  3. MeSH. "Anti-Infective Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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