What happens if I overdose Axcel Metronidazole?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Axcel Metronidazole emulsion may be harmful if swallowed.
Proper storage of Axcel Metronidazole emulsion:
Store Axcel Metronidazole 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 Axcel Metronidazole emulsion out of the reach of children and away from pets.
Overdose of Axcel Metronidazole in details
Use of dosages of intravenous Axcel Metronidazole 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 Axcel Metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported included nausea, vomiting and ataxia.
Oral Axcel Metronidazole 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 Axcel Metronidazole?
Do not drink alcohol while you are taking Axcel Metronidazole 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 Axcel Metronidazole and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Axcel Metronidazole warnings
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 Axcel Metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of Axcel Metronidazole (Axcel Metronidazole) therapy. Axcel Metronidazole should be administered with caution to patients with central nervous system diseases.
Patients with severe hepatic disease metabolize Axcel Metronidazole slowly, with resultant accumulation of Axcel Metronidazole 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 Axcel Metronidazole (Axcel Metronidazole) and requires treatment with a candidacidal agent.
Prescribing Axcel Metronidazole 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
Axcel Metronidazole (Axcel Metronidazole) 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
Axcel Metronidazole 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 Axcel Metronidazole 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. Axcel Metronidazole 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 Axcel Metronidazole. No fetotoxicity was observed when Axcel Metronidazole 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 Axcel Metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.
Use of Axcel Metronidazole for trichomoniasis during pregnancy should be restricted to those in whom alternative treatment has been inadequate. Use of Axcel Metronidazole (Axcel Metronidazole) for trichomoniasis in pregnancy should be carefully evaluated because Axcel Metronidazole 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 Axcel Metronidazole 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. Axcel Metronidazole 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 Axcel Metronidazole 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 Axcel Metronidazole?
Some medical conditions may interact with Axcel Metronidazole capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of nerve, brain, or blood problems; Crohn disease; liver or kidney problems; or seizures
Some MEDICINES MAY INTERACT with Axcel Metronidazole capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Disulfiram because side effects, such as mental or mood changes, may occur
- Cimetidine because it may increase the risk of Axcel Metronidazole capsules's side effects
- Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Axcel Metronidazole capsules's effectiveness
- Anticoagulants (eg, warfarin), busulfan, or lithium because the risk of their side effects may be increased by Axcel Metronidazole capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Axcel Metronidazole capsules 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.
Axcel Metronidazole precautions
Axcel Metronidazole Vaginal Gel affords minimal peak serum levels and systemic exposure (AUCs) of Axcel Metronidazole compared to 500 mg oral Axcel Metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral Axcel Metronidazole, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing Axcel Metronidazole administered orally to Axcel Metronidazole administered vaginally are not available.
General:
Patients with severe hepatic disease metabolize Axcel Metronidazole slowly. This results in the accumulation of Axcel Metronidazole and its metabolites in the plasma. Accordingly, for such patients, Axcel Metronidazole Vaginal Gel should be administered cautiously.
Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with Axcel Metronidazole Vaginal Gel. Approximately 6-10% of patients treated with Axcel Metronidazole Vaginal Gel developed symptomatic Candida vaginitis during or immediately after therapy.
Disulfiram-like reaction to alcohol has been reported with oral Axcel Metronidazole, thus the possibility of such a reaction occurring while on Axcel Metronidazole Vaginal Gel therapy cannot be excluded.
Axcel Metronidazole 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 Axcel Metronidazole Vaginal Gel. While blood levels are significantly lower with Axcel Metronidazole Vaginal Gel than with usual doses of oral Axcel Metronidazole, 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 Axcel Metronidazole 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 Axcel Metronidazole Vaginal Gel is prescribed for patients on this type of anticoagulant therapy.
In patients stabilized on relatively high doses of lithium, short-term oral Axcel Metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.
Use of cimetidine with oral Axcel Metronidazole may prolong the half-life and decrease plasma clearance of Axcel Metronidazole.
Drug/Laboratory Test Interactions:
Axcel Metronidazole 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 Axcel Metronidazole (322 nm) at pH 7.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Axcel Metronidazole 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 Axcel Metronidazole 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% Axcel Metronidazole Vaginal Gel, which would result in significantly lower systemic blood levels than those obtained with oral formulations.
Although Axcel Metronidazole 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 Axcel Metronidazole Vaginal Gel in pregnant patients. Axcel Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity or teratogenicity was observed when Axcel Metronidazole 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 Axcel Metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers:
Specific studies of Axcel Metronidazole levels in human milk following intravaginally administered Axcel Metronidazole have not been performed. However, Axcel Metronidazole is secreted in human milk in concentrations similar to those found in plasma following oral administration of Axcel Metronidazole.
Because of the potential for tumorigenicity shown for Axcel Metronidazole 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 Axcel Metronidazole?
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
- 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).
- DrugBank. "metronidazole". http://www.drugbank.ca/drugs/DB00916 (accessed September 17, 2018).
- MeSH. "Anti-Infective Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
