flagyl i.v. rtu in plastic container
Flagyl I.V. Rtu in Plastic Container (Metronidazole) is a nitroimidazole antimicrobial used to treat Abscess, Amebiasis, Bacteroides Infections, Bacterial Endocarditis.
Metronidazole · by Baxter Hlthcare
Available as a generic: Metronidazole
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Key facts
- Active ingredient
- Metronidazole
- Drug class
- Nitroimidazole Antimicrobial
- Form
- Injectable
- Strength
- Metronidazole 500MG/100ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- abscess, amebiasis, bacteroides infections
- Manufacturer
- Baxter Hlthcare
- Half-life
- about 8 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.10 per gm — not your price
- FDA application
- NDA018657
- FDA boxed warning
- Yes — see the boxed warning
What is Flagyl I.V. Rtu in Plastic Container?
From the FDA label:Metronidazole Injection, USP, is a parenteral formulation of the synthetic nitroimidazole antibacterial agent 2-methyl-5-nitro-1 H -imidazole-1-ethanol. Metronidazole Injection, USP, in 100 mL VIAFLEX Plus single dose plastic container, is a sterile, nonpyrogenic, iso-osmotic, buffered solution of 500 mg Metronidazole, USP, 790 mg Sodium Chloride, USP, 47.6 mg Dibasic Sodium Phosphate Dried, USP and 22.9 mg Citric Acid Anhydrous, USP. Metronidazole Injection, USP has an osmolarity of 310 mOsmol/L (calc) and a pH of 5.5 (4.5 to 7.0). Each container contains 14 mEq of sodium. The plastic container is fabricated from a specially formulated polyvinyl chloride plastic. Water can permeate from inside the container into the overwrap in amounts insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. , di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Metronidazole, USP Structural Formula
How to use
Dosage, rate of administration, and duration of treatment are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition and concomitant treatment, and on the patient’s clinical and laboratory response to the treatment. Recommended Dosage for the Treatment of Anaerobic Bacterial Infections The recommended dosage schedule for adults for the treatment of anaerobic infections is presented in the Table 1 : Table 1. Recommended Dosage Schedule for the Treatment of Anaerobic Bacterial Infections in Adults Loading Dose 15 mg/kg infused intravenously over one hour (approximately 1 gram for a 70-kg adult). Maintenance Dosage 7.5 mg/kg infused intravenously over one hour every six hours (approximately 500 mg for a 70-kg adult). The first maintenance dose should be instituted six hours following the initiation of the loading dose. Parenteral therapy may be changed to oral metronidazole therapy when conditions warrant, based upon the severity of the disease and the response of the patient to treatment with Metronidazole Injection. The usual adult oral dosage is 7.5 mg/kg every six hours (approximately 500 mg for a 70-kg adult). A maximum of 4 grams should not be exceeded during a 24-hour period. The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract and endocardium may require longer…
Side effects
The following reactions have been reported during treatment with metronidazole formulations: INFECTIONS AND INFESTATIONS: Vaginal candidiasis BLOOD AND LYMPHATIC SYSTEM DISORDERS: Agranulocytosis, Leukopenia, Neutropenia, Thrombocytopenia, Eosinophilia IMMUNE SYSTEM DISORDERS: Anaphylactic reaction, Hypersensitivity METABOLISM AND NUTRITION DISORDERS: Decreased appetite PSYCHIATRIC DISORDERS: Confusional state, Depression, Insomnia, Decreased libido NERVOUS SYSTEM DISORDERS: Encephalopathy, Seizure, Neuropathy peripheral, Ataxia, Dizziness, Hypoesthesia, Paresthesia, Dysgeusia, Headache, Nystagmus, Aseptic meningitis, Somnolence, Dysarthria, Numbness, Syncope EYE DISORDERS: Optic neuropathy, Saccadic eye movement EAR AND LABYRINTH DISORDERS: Vertigo, tinnitus, hearing impairment, hearing loss CARDIAC DISORDERS: QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval. Flattening of the T-wave may be seen in electrocardiographic tracings, Tachycardia, Palpitation RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Dyspnea GASTROINTESTINAL DISORDERS: Pancreatitis, Abdominal pain, Diarrhea, Nausea, Vomiting, Asthenia, Proctitis HEPATOBILIARY DISORDERS: Hepatotoxicity/Liver Failure in patients with Cockayne syndrome (see CONTRAINDICATIONS ), Jaundice SKIN AND SUBCUTANEOUS DISORDERS: Toxic…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below.
Warnings
Important safety information
Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of metronidazole. Symptoms can be serious and potentially life threatening. If symptoms or signs of SCARs develop, discontinue Metronidazole injection immediately and institute appropriate therapy. Central and Peripheral Nervous System Effects Severe neurological disturbances, including encephalopathy, cerebellar symptoms, convulsive seizures, peripheral neuropathy, optic neuropathy, and aseptic meningitis, have been reported in patients treated with metronidazole. Encephalopathy associated with metronidazole may manifest as confusion or decreased level of consciousness, and is associated with widespread lesions on magnetic resonance imaging (MRI) of the brain. Cerebellar toxicity associated with metronidazole may manifest as ataxia, dizziness, dysarthria, nystagmus and saccadic pursuit and is accompanied by T2 flair lesions within the dentate nuclei seen on MRI. Cerebellar toxicity may concurrently occur with encephalopathy, peripheral neuropathy or seizures. CNS symptoms and CNS lesions are generally reversible within days to weeks upon discontinuation of Metronidazole Injection. Peripheral neuropathy, usually symmetric and mainly of sensory type is characterized by numbness or paresthesia of an extremity. Symptoms may be prolonged after drug discontinuation. Aseptic meningitis may occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued (see ADVERSE REACTIONS ). Advise patients to report neurologic symptoms that occur during metronidazole administration. Discontinue metronidazole treatment if any abnormal neurologic symptoms occur such as ataxia, dizziness, confusion or any other CNS adverse reaction (see ADVERSE REACTIONS ).
Who should not take Flagyl I.V. Rtu in Plastic Container
Hypersensitivity Metronidazole Injection is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. • Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see PRECAUTIONS-Drug Interactions ). • Interaction with Alcohol Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see PRECAUTIONS-Drug Interactions ). • Cockayne Syndrome Metronidazole Injection 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 ).
Overdose — what happens if you take too much
Signs and symptoms of an overdose may include: nausea, vomiting, and neurotoxic effects, including ataxia, confusion, disorientation, seizures, and peripheral neuropathy. Treatment of Overdosage Symptomatic treatment is recommended. There is no specific antidote for an overdose of metronidazole. Discontinue metronidazole administration in the event of an overdose. Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation.
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.
Interactions
Disulfiram Psychotic reactions and confusion have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Do not administer Metronidazole Injection to patients who have taken disulfiram within the last two weeks (see CONTRAINDICATIONS ). • Alcoholic Beverages Abdominal cramps, nausea, vomiting, headaches, tachycardia and flushing may occur if alcoholic beverages or products containing propylene glycol are consumed during or following metronidazole therapy. Discontinue consumption of alcohol or products containing propylene glycol before, during and up to 72 hours after therapy with Metronidazole Injection (see CONTRAINDICATIONS ). • 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 and increased risk of hemorrhages. When Metronidazole Injection is prescribed for patients on this type of anticoagulant therapy, prothrombin time and international normalized ratio (INR) should be carefully monitored and their anticoagulant dose adjusted accordingly. Monitor patients for signs and symptoms of bleeding. • Lithium In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Lithium toxicity may lead to renal damage. Frequent monitoring of serum lithium and serum creatinine levels is necessary. • Busulfan Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity such as sinusoidal obstruction syndrome, gastrointestinal mucositis, and hepatic veno-occlusive disease. Metronidazole Injection should not be administered concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to metronidazole are available, and concomitant administration with busulfan is medically needed, frequent monitoring of busulfan plasma concentration should be performed and the busulfan dose should be adjusted accordingly. • Drugs that Inhibit CYP450 Enzymes The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may decrease metabolism and reduce plasma clearance of metronidazole which may result in metronidazole toxicity. • Drugs that Induce CYP450 Enzymes The simultaneous administration of drugs that induce microsomal liver enzyme activity, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole and therefore decrease its efficacy. • Cytochrome P450 3A4 (CYP3A4) substrates Concomitant use of Metronidazole Injection and CYP3A4 substrates (e.g., amiodarone, tacrolimus, cyclosporine, carbamazepine, phenytoin, and quinidine) may increase respective CYP3A4-substrate plasma levels. Monitoring of plasma concentrations of CYP3A4 substrates may be necessary. • 5-Fluorouracil Metronidazole Injection decreases the clearance of 5-fluorouracil and may therefore cause 5-fluorouracil toxicity. • Vecuronium Metronidazole Injection may potentiate the effects of vecuronium. • 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. • 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. Metronidazole causes an increase in ultraviolet absorbance at 340 nm resulting in falsely decreased values.
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
Alcohol
Watch out for: beer, wine, spirits, and other products containing alcohol.
Combining alcohol with this antibiotic can cause a disulfiram-like reaction — flushing, nausea, vomiting, headache, and a fast heartbeat.
What to do: Avoid alcohol while taking it and for a few days after your last dose, as your prescriber or the label directs. Alcohol can hide in some liquid medicines and mouthwashes.
Source: Metronidazole — MedlinePlus (U.S. National Library of Medicine)
How long does Metronidazole stay in your body?
The elimination half-life of metronidazole is about 8 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the average for healthy adults with normal kidney and liver function; the half-life is much longer in newborns (roughly 22 to 109 hours, longer the more premature the baby). Metronidazole has an active metabolite (hydroxy-metronidazole) whose levels build up in older adults (40-80% higher) and in severe kidney disease, though the label does not give a separate half-life for it.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: FLAGYL (metronidazole) label, DailyMed.
Drug class
How this class works, per Metronidazole - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- abscess
- amebiasis
- bacteroides infections
- bacterial endocarditis
- pseudomembranous enterocolitis
- giardiasis
See how Flagyl I.V. Rtu in Plastic Container ranks — best-rated nitroimidazole antimicrobial for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Flagyl I.V. Rtu in Plastic Container treat?
- Flagyl I.V. Rtu in Plastic Container (Metronidazole) may be used to treat abscess, amebiasis, bacteroides infections, bacterial endocarditis, pseudomembranous enterocolitis, giardiasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Flagyl I.V. Rtu in Plastic Container work?
- Flagyl I.V. Rtu in Plastic Container is a nitroimidazole antimicrobial. Nitroimidazole antibiotics (such as metronidazole) are activated inside oxygen-free bacteria and parasites, where they turn into reactive forms that break and destabilize the microbe's DNA. This kills the germ while largely sparing the body's own cells.
- How much does Flagyl I.V. Rtu in Plastic Container cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.10 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Flagyl I.V. Rtu in Plastic Container?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Flagyl I.V. Rtu in Plastic Container. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Flagyl I.V. Rtu in Plastic Container?
- Flagyl I.V. Rtu in Plastic Container is marketed by Baxter Hlthcare. You can see Baxter Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Flagyl I.V. Rtu in Plastic Container a brand-name or generic drug?
- Flagyl I.V. Rtu in Plastic Container is a brand-name product with the active ingredient Metronidazole. Lower-cost generic equivalents containing Metronidazole are available — ask your pharmacist.
- Is Flagyl I.V. Rtu in Plastic Container available over the counter?
- No. Flagyl I.V. Rtu in Plastic Container is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Flagyl I.V. Rtu in Plastic Container come in?
- Flagyl I.V. Rtu in Plastic Container is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Flagyl I.V. Rtu in Plastic Container?
- Flagyl I.V. Rtu in Plastic Container is classified as nitroimidazole antimicrobial, per the FDA's Established Pharmacologic Class.
- Is Flagyl I.V. Rtu in Plastic Container FDA-registered?
- Flagyl I.V. Rtu in Plastic Container is on record with the U.S. FDA under application number NDA018657. You can verify this on its official FDA label.
- Is Flagyl I.V. Rtu in Plastic Container safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Flagyl I.V. Rtu in Plastic Container. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Flagyl I.V. Rtu in Plastic Container?
- Flagyl I.V. Rtu in Plastic Container's side effects are taken directly from its FDA label. From the label: The following reactions have been reported during treatment with metronidazole formulations: INFECTIONS AND INFESTATIONS: Vaginal candidiasis BLOOD AND LYMPHATIC SYSTEM DISORDERS: Agranulocytosis, Leukopenia, Neutropenia, Thrombocytopenia,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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