Names and pronunciation
(me-troe-ni′da-zole) Flagyl, Flagyl ER Flagyl IV , Flagyl IV RTU , Floruzone ER , Novo-Nidazol
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Individual generic drug information
Extracted information for metroNIDAZOLE only.
(me-troe-ni′da-zole) Flagyl, Flagyl ER Flagyl IV , Flagyl IV RTU , Floruzone ER , Novo-Nidazol
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Func. class.: Antiinfective— miscellaneous
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Chem. class.: Nitroimidazole derivative
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Do not confuse: metroNIDAZOLE/metFORMIN
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ACTION: Direct-acting amebicide/ trichomonacide binds and disrupts DNA structure, thereby inhibiting bacterial nucleic acid synthesis
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USES: Intestinal amebiasis, amebic abscess, trichomoniasis, refractory trichomoniasis, bacterial anaerobic infections, giardiasis, septicemia, endo- carditis; bone, joint, lower respiratory tract infections; rosacea
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Unlabeled uses: Giardiasis
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Extracted information for metroNIDAZOLE only.
CONTRAINDICATIONS: Preg- nancy 1st trimester, breastfeeding, hyper- sensitivity to this product Precautions: Pregnancy, geriatric patients, Candida infections, heart failure, fungal infection, dental disease, bone marrow sup- pression, hematologic disease, GI/renal/ hepatic disease, contracted visual or color fields, blood dyscrasias, CNS disorders
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Black Box Warning: New primary ma- lignancy Black Box Warning: New primary malignancy: use only when indicated; avoid unnecessary use • Giardiasis: stool samples before start- ing to confirm diagnosis, then 3-4 week after treatment • Pregnancy/breastfeeding: not to be used in breastfeeding or 1st trimester of pregnancy
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SIDE EFFECTS CNS: Headache, dizziness, confusion, irritability, restlessness, ataxia, depres- sion, fatigue, drowsiness, insomnia, pares- thesia, peripheral neuropathy, seizures, incoordination, depression, encephalopa- thy, aseptic meningitis (IV) CV: Flattening of T waves EENT: Blurred vision, sore throat, retinal edema, dry mouth, metallic taste, furry tongue, glossitis, stomatitis, photophobia, optic neuritis GI: Nausea, vomiting, diarrhea, epigastric distress, anorexia, constipation, abdomi- nal cramps, CDAD, xerostomia, metallic taste, abdominal pain, pancreatitis HEMA: Leukopenia, bone marrow supression, aplasia, thrombocytopenia GU: Genital candida infection INTEG: Rash, pruritus, urticaria, flushing, Stevens-Johnson syndrome, phlebitis at injection site, toxic epidermal necrolysis
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INTERACTIONS • Do not use with aprenavir • Avoid use with zalcitabine, disulfiram, bortezomib, norfloxacin Decrease: metroNIDAZOLE level—cho- lestyramine Increase: disulfiram reaction—alcohol, oral ritonavir, any product with alcohol Increase: busulfan toxicity—busulfan; avoid concurrent use Increase: metroNIDAZOLE level, toxicity—cimetidine Increase: lithium, CYP3A4 substrates Increase: action of warfarin, phenytoin, lithium, fosphenytoin Increase: leukopenia—azaTHIOprine, fluorouracil Drug/Lab Test Altered: AST, ALT, LDH, glucose Decrease: WBC, neutrophils False decrease: triglycerides
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Extracted information for metroNIDAZOLE only.
DOSAGE AND ROUTES Trichomoniasis • Adult: PO 500 mg bid × 7 days or 2 g as single dose; do not repeat treatment for 4-6 wk • Child ≥45 kg (unlabeled): PO 2 g once • Child <45 kg (unlabeled): PO 15 mg/ kg/day in 3 divided doses × 7-10 days • Infant (unlabeled): PO 15 mg/kg/day divided in 3 doses × 7 days Amebic hepatic abscess • Adult: PO 750 mg tid × 7-10 days • Child: PO 35-50 mg/kg/day in 3 di- vided doses × 7-10 days Intestinal amebiasis • Adult: PO 750 mg tid × 7-10 days • Child: PO 35-50 mg/kg/day in 3 divided doses × 7-10 days, then oral iodoquinol Anaerobic bacterial infections • Adult: IV INFUSION 15 mg/kg over 1 hr, then 7.5 mg/kg IV or PO q6hr, not to ex- ceed 4 g/day; 1st maintenance dose should be administered 6 hr after loading dose Bacterial vaginosis (nonpregnant) • Adult: PO regular rel 500 mg bid or 250 mg tid × 7 days; ext rel 750 mg/day × 7 days Giardiasis (unlabeled) • Adult: PO 250-500 mg tid or 500 mg bid × 5-7 days
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Available forms: Tabs 250, 500 mg; ext rel tab (ER) 750 mg; caps 375 mg; injec- tion solution 5 mg/mL
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Administer: • Store in light-resistant container; do not refrigerate PO route • Do not break, crush, or chew ext rel product, give on empty stomach • PO with or after meals to avoid GI symp- toms, metallic taste; crush tabs if needed IV route Intermittent INFUSION (vial 5 mg/mL) • Premixed infusion bags: prediluted, ready to use infusion over 30-60 min • Lyophilized vials: dilute 500 mg with 4.4 mL sterile water, 0.9% NaCl; must be diluted further with ≤8 mg/mL with 0.9% NaCl, D5W, or LR; must neutralize with 5 mEq NaCO3/500 mg; CO2 gas will be gener- ated and may require venting; run over 30- 60 min; primary IV must be discontinued; may be given as cont infusion; do not use aluminum products; IV may require venting • Do not use aluminum needles or other equipment to prepare product Incompatible: aztreonam, some cepha- losporins, penicillin G, sodium lactate 5% wlv, dextrose 10% wlv injection and others
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Extracted information for metroNIDAZOLE only.
Assess: • Infection: WBC, wound symptoms, fever, skin or vaginal secretions; start treatment after C&S is obtained, wait- ing for results is not needed; for op- portunistic fungal infections; superin- fection: fever, monilial growth, fatigue, malaise • Stools during entire treatment; should be clear at end of therapy; stools should be free of parasites for 1 yr before patient considered cured (amebiasis) • Vision by ophthalmic exam during, af- ter therapy; vision problems often occur • Allergic reaction: fever, rash, itch- ing, chills; product should be discon- tinued if these occur, if fever, facial swelling, blisters occur, discontinue immediately • Renal, reproductive dysfunction: dysuria, polyuria, impotence, dyspa- reunia, decreased libido, I&O; weight daily
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Evaluate: • Therapeutic response: decreased symptoms of infection
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That urine may turn dark reddish brown; that product may cause metallic taste; that both are normal • About proper hygiene after bowel movement; handwashing technique • To notify provider about numbness or tingling of extremities • To avoid hazardous activities because dizziness can occur M • About need for compliance with dos- age schedule, duration of treatment; to take extended-release tabs 1 hr before or 2 hr after meals; to take PO with meals to prevent GI upset • To discuss all OTC, Rx, herbals, sup- plements taken with provider • To notify provider immediately of rash, fever, facial swelling, blisters • To use condoms if treatment for trichomoniasis or cross-contamination may occur; to notify prescriber if preg- nant or planning to become pregnant; that treatment of both partners is nec- essary for trichomoniasis • To use frequent sips of water, sugarless gum, candy for dry mouth • Not to drink alcohol or use prepara- tions containing alcohol during use or for 48 hr after use of product; disulfiram- like reaction can occur • To notify if pregnancy is planned or suspected, or if breastfeeding; risk to fe- tus second/third trimester in trichomo- niasis
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Extracted information for metroNIDAZOLE only.
PHARMACOKINETICS Crosses placenta, enters breast milk, metabolized by liver 30%-60%, excreted in urine (60%-80%), half-life 6-8 hr PO: Peak 2 hr, absorbed 80%-85% IV: Onset immediate, peak end of infusion
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Filter the extracted dose blocks for this individual drug.
Trichomoniasis
• Adult: PO 500 mg bid × 7 days or 2 g as single dose; do not repeat treatment for 4-6 wk
Candidate age grouping · source page 882
Trichomoniasis
• Adult: PO 750 mg tid × 7-10 days
Candidate age grouping · source page 882
Trichomoniasis
• Adult: PO 750 mg tid × 7-10 days
Candidate age grouping · source page 882
Trichomoniasis
• Adult: IV INFUSION 15 mg/kg over 1 hr, then 7.5 mg/kg IV or PO q6hr, not to ex- ceed 4 g/day; 1st maintenance dose should be administered 6 hr after loading dose Bacterial vaginosis (nonpregnant)
Candidate age grouping · source page 882
Trichomoniasis
• Adult: PO regular rel 500 mg bid or 250 mg tid × 7 days; ext rel 750 mg/day × 7 days Giardiasis (unlabeled)
Candidate age grouping · source page 882
Trichomoniasis
• Adult: PO 250-500 mg tid or 500 mg bid × 5-7 days
Candidate age grouping · source page 882