Flagyl I.V. RTU Intravenous

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of metronidazole injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole injection in the elderly. However, elderly patients are more likely to have unwanted effects and age-related liver problems, which may require caution and an adjustment in the dose for patients receiving metronidazole injection.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Amprenavir
• Bepridil
• Cisapride
• Disulfiram
• Dronabinol
• Dronedarone
• Mesoridazine
• Pimozide
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bupropion
• Buserelin
• Busulfan
• Capecitabine
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxifluridine
• Droperidol
• Ebastine
• Efavirenz
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluconazole
• Fluorouracil
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lumefantrine
• Mebendazole
• Mefloquine
• Methadone
• Mifepristone
• Mizolastine
• Moxifloxacin
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Paliperidone
• Panobinostat
• Papaverine Hydrochloride
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pipamperone
• Pitolisant
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Risperidone
• Ritonavir
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tegafur
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Warfarin
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Cholestyramine
• Cyclosporine
• Lithium
• Milk Thistle

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems, or history of or
• Brain disease (eg, aseptic meningitis, encephalopathy) or
• Edema (too much fluid in the body) or
• Leukopenia (low white blood cells), history of or
• Optic neuropathy (eye disease with vision changes), history of or
• Oral thrush (Candida infection) or
• Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or
• Seizures, history of or
• Vaginal yeast infection (Candida infection)—Use with caution. May make these conditions worse.

• Kidney disease, end-stage or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Agitation
• back pain
• blindness
• blurred vision
• burning, numbness, tingling, or painful sensations in the hands or feet
• confusion
• decreased vision
• dizziness
• drowsiness
• eye pain
• fever
• hallucinations
• headache
• irritability
• mood or mental changes
• nausea
• seizures (convulsions)
• stiff neck or back
• unsteadiness or awkwardness
• unusual tiredness or weakness
• vomiting
• weakness in the arms, hands, legs, or feet

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• changes in skin color
• changes in speech patterns
• chest pain
• chills
• cough
• diarrhea
• fainting
• feeling of warmth
• itching
• joint or muscle pain
• lower back or side pain
• pain, tenderness, or swelling of the foot or leg
• painful or difficult urination
• pale skin
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the face, neck, arms, and occasionally, upper chest
• shakiness and unsteady walk
• shortness of breath
• slurred speech
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• trouble with speaking
• ulcers, sores, or white spots in the mouth
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach discomfort
• dry mouth
• hives or welts
• redness of the skin
• skin rash
• stuffy nose
• unpleasant metallic taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

You should not use metronidazole if you are allergic to it, or if you have taken disulfiram (Antabuse) within the past 2 weeks.

Do not drink alcohol or consume foods or medicines that contain propylene glycol while you are taking metronidazole and for at least 3 days after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

This medicine will not treat a viral infection such as the common cold or flu.

In animal studies, this medicine caused certain types of cancers or tumors. It is not known whether these effects would occur in people using this medicine. Ask your doctor about your risk.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, dizziness, loss of balance or coordination, numbness and tingling, or seizures (convulsions).

IV:
-Loading dose: 15 mg/kg IV once infused over 1 hour
-Maintenance dose: 7.5 mg/kg IV infused over 1 hour every 6 hours
-Maximum dose: 4 g per day
-Duration of therapy: 7 to 10 days

ORAL:
Immediate-release Capsules and Tablets: 7.5 mg/kg orally every 6 hours
-Maximum dose: 4 g per day
-Duration of therapy: 7 to 10 days

Comments:
-The first IV maintenance dose should be started 6 hours after the start of the loading dose.
-IV therapy may be changed to oral when conditions warrant, based upon severity of disease and response of the patient.
-Infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.

Uses: For the treatment of serious infections due to susceptible anaerobic bacteria including:
-Gynecologic infections, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species
-Bacterial septicemia caused by Bacteroides species including the B fragilis group and Clostridium species
-Central nervous system (CNS) infections, including meningitis and brain abscess, caused by Bacteroides species including the B fragilis group
-Lower respiratory tract infections, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B fragilis group
-Endocarditis caused by Bacteroides species including the B fragilis group

Infectious Diseases Society of America (IDSA) recommendations:
Surgical Site Infections: 500 mg IV every 8 hours in combination with ceftriaxone, ciprofloxacin, or levofloxacin

Uses: For the treatment of infections following operations on the axilla, gastrointestinal tract, perineum, or female genital tract

Immediate-release Capsules: 375 mg orally twice a day for 7 consecutive days

Immediate-release Tablets:
-One-day regimen: 2 g orally as a single dose or 1 g twice given in the same day
-Seven-day regimen: 250 mg orally 3 times a day for 7 consecutive days

Comments:
-Single-dose regimens can assure compliance, however, a 7-day course may minimize reinfection by protecting the patient long enough for the sexual contact to be treated.
-The dose regimen should be individualized in females and males; some patients may tolerate 1 regimen more than the other.
-The patient's sexual partner(s) should also be evaluated/treated.
-If repeat courses are required, an interval of 4 to 6 weeks should elapse between courses and the presence of the trichomonad be reconfirmed by appropriate laboratory testing.
-Pregnant patients should not be treated during the first trimester; if alternative therapy was not adequate in a pregnant patient, the 1-day regimen is not recommended (results in higher serum levels which can reach fetal circulation).

Uses:
-Symptomatic trichomoniasis: For the treatment of Trichomonas vaginalis infection in females and males when confirmed by appropriate laboratory procedures (wet smears and/or cultures)
-Asymptomatic trichomoniasis: For the treatment of asymptomatic T vaginalis infection in females when associated with endocervicitis, cervicitis, or cervical erosion
-Treatment of asymptomatic sexual partners: For the simultaneous treatment of asymptomatic sexual partners of treated patients if T vaginalis is present to prevent reinfection of the partner

US CDC recommendations:
Immediate-release Tablets:
-Recommended regimen: 2 g orally as a single dose
-Alternative regimen: 500 mg orally twice a day for 7 days

Trichomoniasis in HIV-infected women:
-Immediate-release tablets: 500 mg orally twice a day for 7 days

Treatment failure with single-dose therapy and reinfection is excluded:
-Immediate-release tablets: 500 mg orally twice a day for 7 days; for patients failing this regimen, 2 g orally once a day for 7 days should be considered

Comments:
-Sexual partner(s) should be treated simultaneously with the same dose; appropriate treatment of sexual partner(s) may increase reported cure rates.
-Women can be treated with 2 g orally as a single dose at any stage of pregnancy.
-Current guidelines should be consulted for additional information.

IV:
-Loading dose: 15 mg/kg IV once infused over 1 hour
-Maintenance dose: 7.5 mg/kg IV infused over 1 hour every 6 hours
-Maximum dose: 4 g per day
-Duration of therapy: 7 to 10 days

ORAL:
Immediate-release capsules and tablets: 7.5 mg/kg orally every 6 hours
-Maximum dose: 4 g per day
-Duration of therapy: 7 to 10 days

Comments:
-The first IV maintenance dose should be started 6 hours after the start of the loading dose.
-IV therapy may be changed to oral when conditions warrant, based upon severity of disease and response of the patient.
-Infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.

Uses: For the treatment of intraabdominal infections, including intra-abdominal abscess and liver abscess, caused by Bacteroides species including the B fragilis group (B fragilis, B distasonis, B ovatus, B thetaiotaomicron, B vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species

IDSA and SIS recommendations:
-Immediate-release tablets: 500 mg IV every 8 to 12 hours or 1500 mg IV every 24 hours

Use: For empiric treatment of complicated intraabdominal infection

Some experts recommend: 250 mg orally 3 times a day for 5 to 7 days

US CDC recommendations:
-Immediate-release tablets: 500 to 750 mg orally 3 times a day for 10 days

AAP recommendations:
Children less than 45 kg: 45 mg/kg/day orally in 3 divided doses for 7 days
-Maximum dose: 2 g per day

Adolescent vulvovaginitis: 500 mg orally twice a day for 7 days

Comments:
-All women with symptoms should be treated.
-Current guidelines should be consulted for additional information.

AAP recommendations: 35 to 50 mg/kg/day orally in 3 divided doses for 5 days
-Maximum dose: 750 mg/dose

Mild to moderate liver dysfunction: No adjustment recommended.

Severe liver dysfunction (Child-Pugh C):
Immediate-release tablet, capsule, and IV formulations: Dose should be reduced by 50%

Indication specific adjustments for capsule formulation:
-Amebiasis: 375 mg orally every 8 hours for 5 to 10 days
-Trichomoniasis: 375 mg orally every 24 hours for 7 days

Extended-release tablets: Should not be used unless benefits considered to outweigh risks