
Amotrex200 mg/5 m
ACI Limited

Anamet 200 mg/5 ml is a broad-spectrum antimicrobial agent with potent activity against anaerobic bacteria and protozoa. It is indicated for a wide range of parasitic, protozoal, and anaerobic bacterial infections across multiple organ systems and medical specialties.
Amoebicides / Antiprotozoal Drugs / Anti-diarrhoeal Antimicrobials / Antibacterial Agents (Anaerobes)
Anamet 200 mg/5 ml is a synthetic 5-nitroimidazole antimicrobial agent that belongs to the imidazole class of antibacterial drugs. It is classified therapeutically as both an antiprotozoal agent and an antianaerobic antibacterial. It is unique among antimicrobials in its highly selective activity against obligate anaerobic organisms and certain protozoa — organisms that exist and thrive in low-oxygen or oxygen-free environments.
Anamet 200 mg/5 ml is a prodrug that requires intracellular activation to exert its antimicrobial effect. The activation mechanism is selective for anaerobic or microaerophilic organisms:
Key selectivity: Aerobic mammalian cells cannot reduce Anamet 200 mg/5 ml's nitro group at physiologically normal redox potentials, explaining why the drug is selectively toxic to anaerobes and protozoa while being well tolerated in humans at therapeutic doses.
The dose of Anamet 200 mg/5 ml depends on the indication, formulation, patient age, and weight. Always follow your registered physician's prescribed dose. Do not self-medicate.
The recommended dose for bacterial vaginosis is one applicatorful of Anamet 200 mg/5 ml 0.75% gel (approximately 5 g delivering approximately 37.5 mg Anamet 200 mg/5 ml), administered intravaginally once or twice daily for 5 days. For once-daily dosing, Anamet 200 mg/5 ml vaginal gel should be administered at bedtime to optimize retention and local drug contact time.
Anamet 200 mg/5 ml IV infusion requires no dilution and must not be mixed with any other drug prior to administration. Administer as a separate infusion.
This is the most widely known and practically important drug interaction with Anamet 200 mg/5 ml. Anamet 200 mg/5 ml inhibits the enzyme acetaldehyde dehydrogenase, which is responsible for the second step in alcohol metabolism (conversion of acetaldehyde to acetate). When alcohol is consumed concurrently with Anamet 200 mg/5 ml, acetaldehyde accumulates in the blood, causing a highly unpleasant and potentially dangerous disulfiram-like (Antabuse) reaction, including:
Patients must not consume alcoholic beverages or any medications or preparations containing alcohol (including mouthwashes, cough syrups, and some liquid medications) during Anamet 200 mg/5 ml treatment and for at least 24–48 hours after the last dose.
The concurrent use of Anamet 200 mg/5 ml and Disulfiram (a drug used to treat alcohol dependence) has been associated with psychotic reactions and confusion. This combination is clinically contraindicated. A washout period of at least 2 weeks between disulfiram and Anamet 200 mg/5 ml is recommended.
Anamet 200 mg/5 ml significantly potentiates the anticoagulant effect of warfarin by inhibiting its hepatic catabolism (through CYP2C9 inhibition), leading to increased warfarin plasma levels and a substantially elevated risk of hemorrhagic events. This interaction can lead to life-threatening bleeding if not managed. In patients who must receive both drugs:
Anamet 200 mg/5 ml may increase plasma lithium concentrations, raising the risk of lithium toxicity (tremor, confusion, nausea, polyuria, cardiac arrhythmias). Serum lithium levels should be closely monitored when Anamet 200 mg/5 ml is added to or removed from a lithium regimen.
When co-administration of Anamet 200 mg/5 ml and cyclosporin is necessary, both serum cyclosporin and serum creatinine levels should be closely monitored. Anamet 200 mg/5 ml may increase cyclosporin plasma concentrations, with potential nephrotoxic consequences in transplant recipients.
Phenytoin and phenobarbital are potent inducers of hepatic cytochrome P450 enzymes that metabolize Anamet 200 mg/5 ml. Co-administration results in increased elimination of Anamet 200 mg/5 ml, leading to reduced Anamet 200 mg/5 ml plasma concentrations and potentially insufficient therapeutic drug levels. If concurrent use is necessary, monitor clinical response and consider increasing the Anamet 200 mg/5 ml dose.
Anamet 200 mg/5 ml reduces the clearance of 5-fluorouracil, resulting in increased plasma levels and potentially significantly increased toxicity of 5-FU (myelosuppression, mucositis, diarrhea, nausea). This interaction requires careful dose adjustment and close monitoring when both drugs are used in oncology combination regimens.
Anamet 200 mg/5 ml may increase plasma levels of busulfan (a chemotherapy agent used in conditioning regimens for hematopoietic stem cell transplantation). Elevated busulfan levels can lead to severe busulfan toxicity — including veno-occlusive disease of the liver, seizures, and severe myelosuppression. Co-administration should be avoided; if unavoidable, busulfan plasma levels must be closely monitored.
Anamet 200 mg/5 ml is contraindicated in the following situations:
Anamet 200 mg/5 ml is generally well tolerated at standard doses for usual treatment durations. Most adverse effects are dose-related and more likely with prolonged therapy. The following have been reported:
Important warning: If signs of significant central or peripheral neuropathy develop (ataxia, confusion, convulsions, severe paresthesia), Anamet 200 mg/5 ml should be discontinued immediately and the patient evaluated.
The US FDA Pregnancy Category of Anamet 200 mg/5 ml is Category B. Animal reproduction studies have not demonstrated evidence of fetal harm, teratogenicity, or impaired fertility. However, there are no adequate and well-controlled studies of Anamet 200 mg/5 ml in pregnant women. Because animal reproductive toxicology studies are not always predictive of human outcomes, Anamet 200 mg/5 ml should be used during pregnancy only if clearly needed and when the clinical benefit to the mother outweighs any theoretical risk to the fetus.
First trimester: Use should be avoided unless no suitable alternative exists. Anamet 200 mg/5 ml has been shown to be mutagenic in bacteria and carcinogenic in rodents at high doses — while human carcinogenicity has not been established, caution during organogenesis (first trimester) is prudent.
Second and third trimesters: Anamet 200 mg/5 ml may be used when clinically necessary, particularly for systemic anaerobic infections and trichomoniasis (for which it remains the most effective oral treatment). For trichomoniasis specifically, treatment should be deferred to the second trimester where possible.
Pregnant women with trichomoniasis who receive Anamet 200 mg/5 ml should be advised that the treatment is for symptomatic relief and infection clearance, and that their sexual partner must also be treated to prevent reinfection.
Anamet 200 mg/5 ml is excreted into human breast milk and achieves concentrations similar to maternal plasma levels. The estimated infant dose from breastfeeding is approximately 10–13% of the maternal weight-adjusted dose — which is below the typical therapeutic dose given to infants directly.
While no adverse effects on breastfed infants have been definitively established at the doses used to treat the mother, caution should be exercised when Anamet 200 mg/5 ml is administered to a nursing woman. Options to consider include:
If Anamet 200 mg/5 ml must be administered for longer than the usually recommended treatment duration — due to compelling clinical necessity — the following monitoring is mandatory:
Anamet 200 mg/5 ml is primarily metabolized by hepatic oxidation. In patients with advanced hepatic insufficiency, Anamet 200 mg/5 ml clearance may be substantially impaired, leading to significant drug accumulation. In patients with hepatic encephalopathy, high plasma concentrations of Anamet 200 mg/5 ml may worsen encephalopathic symptoms — creating a particularly dangerous cycle. Therefore:
Patients must be explicitly and clearly warned that they must not consume any alcoholic beverages or alcohol-containing preparations (including certain mouthwashes, cough mixtures, and topical medications) during treatment with Anamet 200 mg/5 ml and for at least 24–48 hours after the final dose. The disulfiram-like reaction can be severe and potentially dangerous.
Patients should be warned that Anamet 200 mg/5 ml may cause their urine to appear dark or brownish in color. This is caused by Anamet 200 mg/5 ml metabolites excreted in the urine and is a harmless and reversible phenomenon — it does not indicate kidney damage or hematuria and requires no clinical action.
In trichomoniasis, treatment of the patient alone is often insufficient to achieve a cure. Both sexual partners must be treated simultaneously to eliminate the infection and prevent reinfection. If the partner is not treated concurrently, reinfection of the treated patient is highly likely.
Anamet 200 mg/5 ml may cause overgrowth of Candida species (oral or vaginal thrush) — particularly with prolonged use. Monitor for signs of candidiasis during extended therapy and treat appropriately with antifungal agents if needed.
Anamet 200 mg/5 ml has been shown to be mutagenic in bacteria (Ames test) and carcinogenic in rodents at doses substantially higher than those used therapeutically in humans. The clinical relevance of these findings to short-course human therapeutic use is uncertain, and no increased incidence of cancer has been definitively established from clinical or epidemiological data in humans. Nevertheless, unnecessary use of Anamet 200 mg/5 ml should be avoided, and prolonged therapy should only be undertaken when clearly indicated and with appropriate clinical monitoring.
Anamet 200 mg/5 ml has a relatively wide safety margin at commonly available doses. The following is known from reported overdose cases:
In the event of suspected Anamet 200 mg/5 ml overdose, contact a poison control center or seek emergency medical care immediately.
Anamet 200 mg/5 ml is primarily metabolized in the liver by oxidative pathways. In patients with advanced hepatic insufficiency or hepatic encephalopathy:
The elimination half-life of Anamet 200 mg/5 ml itself remains essentially unchanged in the presence of renal failure, as the parent drug is primarily eliminated via hepatic metabolism. Therefore, no dose adjustment is required for Anamet 200 mg/5 ml in patients with renal failure based on conventional pharmacokinetic principles.
However, Anamet 200 mg/5 ml metabolites (including the hydroxy-metabolite with residual antibacterial activity) are primarily renally excreted and accumulate in patients with renal failure. The clinical significance of this metabolite accumulation is not fully established, but caution is warranted in severe renal failure.
Hemodialysis: Anamet 200 mg/5 ml and its metabolites are efficiently removed during an 8-hour hemodialysis session. Therefore, Anamet 200 mg/5 ml should be re-administered immediately after each hemodialysis session to restore therapeutic plasma levels.
Peritoneal dialysis (IDP or CAPD): No routine dose adjustment or supplemental dosing is required in patients undergoing either intermittent peritoneal dialysis or continuous ambulatory peritoneal dialysis.
No specific age-based dose adjustment is recommended for elderly patients, as the pharmacokinetics of Anamet 200 mg/5 ml are not significantly altered by aging alone. However, elderly patients are more likely to have reduced hepatic metabolic capacity, and liver function should be considered when prescribing Anamet 200 mg/5 ml in this population. Use the lowest effective dose and be alert for accumulation effects — particularly neurological effects — in elderly patients with hepatic dysfunction.
Anamet 200 mg/5 ml is approved for use in children across a wide range of indications with age-appropriate and weight-based dosing. The suspension formulation is preferred for infants and young children. The safety and efficacy of Anamet 200 mg/5 ml in children under 1 year of age are not as extensively studied — use in neonates and young infants should be under close specialist medical supervision, with awareness of the potential for CNS toxicity due to immature blood-brain barrier function in very young infants.
Amoebicides, Anti-diarrhoeal Antiprotozoal
Anamet 200 mg/5 ml is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Anamet 200 mg/5 ml is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Anamet 200 mg/5 ml.
US FDA Pregnancy Category of Anamet 200 mg/5 ml is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Anamet 200 mg/5 ml have been shown to be excreted in human milk. So, caution should be exercised when Anamet 200 mg/5 ml is administered to a nursing woman.
Hepatic impairment: Anamet 200 mg/5 ml is mainly metabolised by hepatic oxidation. Substantial impairment of Anamet 200 mg/5 ml clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of Anamet 200 mg/5 ml may contribute to the symptoms of the encephalopathy. Anamet 200 mg/5 ml should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that Anamet 200 mg/5 ml may darken urine.Renal impairment: The elimination half-life of Anamet 200 mg/5 ml remains unchanged in the presence of renal failure. The dosage of Anamet 200 mg/5 ml therefore needs no reduction. Such patients however retain the metabolites of Anamet 200 mg/5 ml. The clinical significance of this is not known at present. In patients undergoing haemodialysis Anamet 200 mg/5 ml and metabolites are efficiently removed during an eight hour period of dialysis. Anamet 200 mg/5 ml should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Anamet 200 mg/5 ml need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
What is Anamet 200 mg/5 ml used for?
Anamet 200 mg/5 ml is a broad-spectrum antimicrobial agent with potent activity against anaerobic bacteria and protozoa. It is indicated for a wide range of parasitic, protozoal, and anaerobic bacterial infections across multiple organ systems and medical specialties. Anaerobic Bacterial Infections Surgical Prophylaxis — prevention of postoperative infections due to anaerobic bacteria, particularl…
What is the dosage of Anamet 200 mg/5 ml?
The dose of Anamet 200 mg/5 ml depends on the indication, formulation, patient age, and weight. Always follow your registered physician's prescribed dose. Do not self-medicate. Oral Tablets and Suspension Trichomoniasis Patient Group Dose / Regimen Adults and children over 10 years 200 mg three times daily (t.i.d.) for 7 days, OR 400 mg twice daily (b.i.d.) for 7 days, OR 800 mg in the morning + 1…
What are the side effects of Anamet 200 mg/5 ml?
Anamet 200 mg/5 ml is generally well tolerated at standard doses for usual treatment durations. Most adverse effects are dose-related and more likely with prolonged therapy. The following have been reported: Gastrointestinal Effects (Most Common) Metallic or bitter taste — one of the most frequently reported and characteristic adverse effects; usually mild and transient Nausea — very common; takin…
Who should not take Anamet 200 mg/5 ml?
Anamet 200 mg/5 ml is contraindicated in the following situations: Known hypersensitivity to Anamet 200 mg/5 ml or to any other nitroimidazole derivative (e.g., tinidazole, ornidazole, secnidazole, nimorazole). Cross-sensitivity among nitroimidazoles is possible, and all members of this drug class should be avoided in patients with confirmed nitroimidazole allergy. Concurrent use with disulfiram —…
What precautions should be taken with Anamet 200 mg/5 ml?
Prolonged and High-Dose Therapy — Neurological Monitoring If Anamet 200 mg/5 ml must be administered for longer than the usually recommended treatment duration — due to compelling clinical necessity — the following monitoring is mandatory: Regular hematological monitoring — complete blood count with leucocyte count should be performed periodically, as neutropenia and leukopenia may develop Neurolo…
Is Anamet 200 mg/5 ml safe during pregnancy and breastfeeding?
Pregnancy The US FDA Pregnancy Category of Anamet 200 mg/5 ml is Category B . Animal reproduction studies have not demonstrated evidence of fetal harm, teratogenicity, or impaired fertility. However, there are no adequate and well-controlled studies of Anamet 200 mg/5 ml in pregnant women. Because animal reproductive toxicology studies are not always predictive of human outcomes, Anamet 200 mg/5 m…
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