MetroNIDAZOLE (Systemic)

Name: MetroNIDAZOLE (Systemic)

Special Populations Renal Function Impairment

CrCl ≤65 mL/minute: Half-life: 18-32 hours (hydroxy metabolite [active]) (Lamp, 1999)

Use Labeled Indications

Amebiasis: Oral immediate-release tablet and capsule: Treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess

Limitations of use (oral immediate-release tablet, capsule and injection): When used for amebic liver abscess, may be used concurrently with percutaneous needle aspiration when it is clinically indicated.

Anaerobic bacterial infections (caused by Bacteroides spp., including the B. fragilis group): Oral immediate-release tablet, capsule, and injection:

Bacterial septicemia: Treatment of bacterial septicemia (also caused by Clostridium spp.)

Bone and joint infections: Treatment (adjunctive therapy) of bone and joint infections

CNS Infections: Treatment of CNS infections, including meningitis and brain abscess

Endocarditis: Treatment of endocarditis

Gynecologic infections: Treatment of gynecologic infections including endometritis, endomyometritis, tubo-ovarian abscess, or postsurgical vaginal cuff infection (also caused by Clostridium spp., Peptococcus spp., Peptostreptococcus spp., and Fusobacterium spp.)

Intra-abdominal infections: Treatment of intra-abdominal infections, including peritonitis, intra-abdominal abscess and liver abscess (also caused by Clostridium spp., Eubacterium spp., Peptococcus spp., and Peptostreptococcus spp.)

Lower respiratory tract infections: Treatment of lower respiratory tract infections, including pneumonia, empyema and lung abscess

Skin and skin structure infections: Treatment of skin and skin structure infections (also caused by Clostridium spp., Peptococcus spp., Peptostreptococcus spp., and Fusobacterium spp.)

Bacterial vaginosis: Oral extended-release tablet: Treatment of bacterial vaginosis in nonpregnant women

Surgical prophylaxis (colorectal surgery): Injection: Preoperative, intraoperative, and postoperative prophylaxis to reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery classified as contaminated or potentially contaminated

Trichomoniasis: Oral immediate-release tablet, capsule, and injection: Treatment of infections caused by Trichomonas vaginalis, including treatment of asymptomatic sexual partners

Contraindications

Hypersensitivity to metronidazole, nitroimidazole derivatives, or any component of the formulation; pregnant patients (first trimester) with trichomoniasis; use of disulfiram within the past 2 weeks; use of alcohol or propylene glycol-containing products during therapy or within 3 days of therapy discontinuation

Canadian labeling: Additional contraindications (not in the US labeling): Active neurological disorders; history of blood dyscrasia; hypothyroidism; hypoadrenalism

Dosing Geriatric

Refer to adult dosing.

Adverse Reactions

>10%:

Central nervous system: Headache (18%)

Gastrointestinal: Nausea (10% to 12%)

Genitourinary: Vaginitis (15%)

1% to 10%:

Central nervous system: Metallic taste (9%), dizziness (4%)

Dermatologic: Genital pruritus (5%)

Gastrointestinal: Abdominal pain (4%), diarrhea (4%), xerostomia (2%)

Genitourinary: Dysmenorrhea (3%), urine abnormality (3%), urinary tract infection (2%)

Infection: Bacterial infection (7%), candidiasis (3%)

Respiratory: Flu-like symptoms (6%), upper respiratory tract infection (4%), pharyngitis (3%), sinusitis (3%)

Frequency not defined:

Cardiovascular: Flattened T-wave on ECG, flushing, syncope

Central nervous system: Aseptic meningitis, ataxia, brain disease, confusion, convulsions, depression, disulfiram-like reaction (with alcohol), dysarthria, insomnia, irritability, peripheral neuropathy, psychosis, seizure, sensation of pelvic pressure, vertigo

Dermatologic: Erythematous rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Endrocrine & metabolic: Decreased libido

Gastrointestinal: Abdominal cramps, abdominal distress, anorexia, constipation, dyspareunia, epigastric distress, glossitis, hairy tongue, hiccups, pancreatitis (rare), proctitis, stomatitis, vomiting

Genitourinary: Cystitis, dark urine (rare), dysuria, urinary incontinence, vaginal dryness, vulvovaginal candidiasis

Hematologic & oncologic: Neutropenia (reversible), thrombocytopenia (reversible, rare)

Immunologic: Serum sickness-like reaction (joint pains)

Local: Inflammation at injection site (IV)

Neuromuscular & skeletal: Arthralgia, weakness

Ophthalmic: Optic neuropathy

Renal: Polyuria

Respiratory: Nasal congestion, rhinitis

Miscellaneous: Fever, lesion (central nervous system, reversible)

Monitoring Parameters

Monitor CBC with differential at baseline, during, and after prolonged or repeated courses of therapy. Closely monitor elderly patients and patients with severe hepatic impairment or ESRD for adverse reactions. Observe patients carefully if neurologic symptoms occur and consider discontinuation of therapy.

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