likmez

Trichomoniasis: Adult Female and Male Patients: One-day treatment: 2 g (20 mL) of LIKMEZ, given either as a single oral dose or in 2 divided oral doses of 1 g (10 mL) each, given on the same day. ( 2.1 ) Seven-day course of treatment: 250 mg (2.5 mL) of LIKMEZ given three times daily for 7 consecutive days. ( 2.1 ) Individualize the dosing regimen. ( 2.1 ) Amebiasis: Adult Patients: For acute intestinal amebiasis (acute amebic dysentery): 750 mg (7.5 mL) orally three times daily for 5 days to 10 days. ( 2.2 ) For amebic liver abscess: 500 mg (5 mL) or 750 mg (7.5 mL) orally three times daily for 5 days to 10 days. ( 2.2 ) Pediatric Patients : 35 mg/kg/24 hours to 50 mg/kg/24 hours, divided into three doses, to a maximum dose of 2,250 mg/24 hours (maximum dose 750 mg/dose or 7.5 mL/dose),orally for 10 days. ( 2.2 ) Anaerobic Bacterial Infections: In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially. ( 2.3 ) Adult Patients: 7.5 mg/kg every six hours (approx. 500 mg (5 mL) for a 70-kg adult) to a maximum dose of 4 g (40 mL) during a 24-hour period, orally for 7 to 10 days. ( 2.3 ) Infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment. ( 2.3 ) Patients with Severe Hepatic Impairment (Child-Pugh C) Reduce the dose of LIKMEZ by 50%. ( 2.4 ) Patients Undergoing…

The following clinically significant adverse reactions are described elsewhere in the labeling: Central and Peripheral Nervous System Effects [ see Warnings and Precautions (5.2) ] Blood Dyscrasias [ see Warnings and Precautions (5.4 )] Common adverse reactions include nausea, headache, anorexia, vomiting, diarrhea, abdominal cramping, epigastric distress, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . 6.1 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 following reactions have been reported during treatment with metronidazole: Central and Peripheral Nervous System: The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole. In addition, headache, syncope, dizziness, vertigo, incoordination,…

Prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives ( 4.1 ) Patients who have used disulfiram within the last two weeks. ( 4.2 , 7.1 ) Patients who consume alcohol or products containing propylene glycol during and for at least three days after LIKMEZ therapy. ( 4.3 , 7.2 ) Patients with Cockayne syndrome ( 4.4 , 6.2 ) 4.1 Hypersensitivity Reactions LIKMEZ is contraindicated in patients with known hypersensitivity to metronidazole or other nitroimidazole derivatives [ see Adverse Reactions (6.1) ] . 4.2 Psychotic Reactions with Disulfiram LIKMEZ is contraindicated in patients who have used disulfiram within the last two weeks. Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently [ see Drug Interactions (7.1) ] . 4.3 Interaction with Alcohol LIKMEZ is contraindicated in patients who consume alcohol or products containing propylene glycol during and for at least three days after LIKMEZ therapy. Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing [ see Drug Interactions (7.2) ] . 4.4 Cockayne Syndrome LIKMEZ is contraindicated in patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome [ see Adverse Reactions (6.2) ] .

General Single oral doses of metronidazole, up to 15 g (7.5 times the maximum recommended single dose), have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia. Metronidazole is dialyzable. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 days to 7 days of doses of 6 g to 10.4 g every other day (3 times to 5.2 times the maximum recommended single dose). Treatment of Overdosage There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Disulfiram: Psychotic reactions can occur in patients who are using LIKMEZ and disulfiram concurrently. ( 4.2 , 7.1 ) Alcohol or Other Products Containing Propylene Glycol: Abdominal cramps, nausea, vomiting, headaches, and flushing can occur in patients who are using LIKMEZ and alcohol or other products containing propylene glycol concurrently. ( 4.3 , 7.2 ) Warfarin and Other Oral Anticoagulants : LIKMEZ can potentiate the anticoagulant effect. Carefully monitor prothrombin time and International Normalized Ratio (INR). ( 7.3 ) Lithium: Increased lithium serum concentrations; measure serum lithium and serum creatinine concentrations during therapy. ( 7.4 ) Busulfan : Increased busulfan serum concentrations; avoid concomitant use, monitor for plasma concentrations and adjust the busulfan dose accordingly. ( 7.5 ) CYP Inducers and CYP Inhibitors : Prolonged or accelerated half-life of metronidazole or concomitant medications. ( 7.6 , 7.7 ) Drugs with the Potential for Prolonging the QT Interval: QT prolongation when used with LIKMEZ ( 7.8 ) Interference with Laboratory Tests: Metronidazole may interfere with certain serum chemistry laboratory values ( 7.9 ) 7.1 Disulfiram Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. LIKMEZ is contraindicated in patients who have taken disulfiram within the last two weeks [ see Contraindications (4.2) ] . 7.2 Alcoholic Beverages LIKMEZ is contraindicated in patients who consume alcohol or products containing propylene glycol during and for at least 3 days after therapy with LIKMEZ. Use of LIKMEZ with alcohol or other products containing propylene glycol is associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) [ see Contraindications (4.3) ] . 7.3 Warfarin and other Oral Anticoagulants Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. When LIKMEZ is prescribed for patients on this type of anticoagulant therapy, prothrombin time and INR should be carefully monitored. 7.4 Lithium In patients stabilized on relatively high doses of lithium, short-term use of LIKMEZ has been associated with elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium. Monitor serum lithium and serum creatinine concentrations for several days after beginning treatment with LIKMEZ to detect any increase that may precede clinical symptoms of lithium toxicity. 7.5 Busulfan Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Do not administer LIKMEZ concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to LIKMEZ are available, and concomitant administration with busulfan is medically needed, monitor for busulfan plasma concentrations and adjust the busulfan dose accordingly. 7.6 Inhibitors of CYP450 Liver Enzymes The simultaneous administration of LIKMEZ and drugs that decrease microsomal liver enzymes, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. 7.7 Inducers of CYP450 Liver Enzymes The simultaneous administration of LIKMEZ and drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole. Impaired clearance of phenytoin has also been reported. 7.8 Drugs that Prolong the QT Interval QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval. 7.9 Drug/Laboratory Test Interactions 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 dinucleotide (NAD + ⇌ NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.