Advanced Consumer Information

Flagyl I.V.

Generic Name: metronidazole (Oral route, Intravenous route)

met-roe-NYE-da-zole

Oral routeTabletTablet, Extended ReleaseCapsule

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. .

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided .

Intravenous routeSolution

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided .

Commonly used brand name(s):

In the U.S.

Flagyl
Flagyl ER
Flagyl I.V.
Flagyl I.V. RTU

Available Dosage Forms:

Tablet, Extended Release
Solution
Tablet
Capsule
Powder for Solution
Suspension

Therapeutic Class: Antibiotic

Chemical Class: Nitroimidazole

Uses For Flagyl I.V.

Metronidazole is used to treat infections. It may also be used for other problems as determined by your doctor. It will not work for colds, flu, or other virus infections.

Metronidazole is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, metronidazole is used in certain patients with the following medical conditions:

Antibiotic-associated colitis
Balantidiasis
Dental infections
Gastritis or ulcer due to Helicobacter pylori
Giardiasis
Inflammatory bowel disease

For patients taking this medicine for giardiasis:

After treatment, it is important that your doctor check whether or not the infection in your intestinal tract has been cleared up completely.

Before Using Flagyl I.V.

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

Metronidazole has been used in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of metronidazole in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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

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.

Amprenavir
Dihydroergotamine
Disulfiram
Ergoloid Mesylates
Ergonovine
Ergotamine
Methylergonovine

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.

Amiodarone
Busulfan
Fluorouracil
Mycophenolate Mofetil
Warfarin

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
Tacrolimus

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 usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of metronidazole

This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Flagyl I.V.. Please read with care.

If this medicine upsets your stomach, it may be taken with meals or a snack. If stomach upset (nausea, vomiting, stomach pain, or diarrhea) continues, check with your doctor. If you are taking the extended–release formulation, you should try to take it an hour before or two hours after your meal.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

In some kinds of infections, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules, tablets):
- For bacterial infections:
  - Adults and teenagers—Dose is based on body weight. The usual dose is 7.5 milligrams (mg) per kilogram (kg) (3.4 mg per pound) of body weight, up to a maximum dose of 1 gram, every six hours for at least seven days.
  - Children—Dose is based on body weight. The usual dose is 7.5 mg per kg (3.4 mg per pound) of body weight every six hours; or 10 mg per kg (4.5 mg per pound) every eight hours.
- For amebiasis infections:
  - Adults and teenagers—500 to 750 mg three times a day for five to ten days.
  - Children—Dose is based on body weight. The usual dose is 11.6 to 16.7 mg per kg (5.3 to 7.6 mg per pound) of body weight three times a day for ten days.
- For trichomoniasis infections:
  - Adults and teenagers—A single dose of 2 grams; or 1 gram two times a day for one day; or 250 mg three times a day for seven days.
  - Children—Dose is based on body weight. The usual dose is 5 mg per kg (2.3 mg per pound) of body weight three times a day for seven days.
For oral dosage form (extended release tablets):
- For bacterial vaginosis:
  - Adults and teenagers—750 mg once a day for seven days.
  - Children—Use and dose must be determined by your doctor.
For injection dosage form:
- For bacterial infections:
  - Adults and children over 1 week of age—Dose is based on body weight. The usual dose is 15 mg per kg (6.8 mg per pound) of body weight one time to start, then 7.5 mg per kg (3.4 mg per pound) of body weight injected into a vein every six hours for at least seven days.
  - Preterm infants—Dose is based on body weight. The usual dose is 15 mg per kg (6.8 mg per pound) of body weight one time to start, then 7.5 mg per kg (3.4 mg per pound) of body weight, injected into a vein, every twelve hours starting forty-eight hours after the first dose.
  - Full-term infants—Dose is based on body weight. The usual dose is 15 mg per kg (6.8 mg per pound) of body weight one time to start, then 7.5 mg per kg (3.4 mg per pound) of body weight, injected into a vein, every twelve hours starting twenty-four hours after the first dose.
- For treatment before and during bowel surgery:
  - Adults and teenagers—Dose is based on body weight. The usual dose is 15 mg per kg (6.8 mg per pound), injected into a vein, one hour before surgery, then 7.5 mg per kg (3.4 mg per pound) of body weight, injected into a vein, six hours and twelve hours after the first dose.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Flagyl I.V.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Drinking alcoholic beverages while taking this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (for example, elixirs, cough syrups, tonics) may also cause problems. These problems may last for at least a day after you stop taking metronidazole. Also, this medicine may cause alcoholic beverages to taste different. Therefore, you should not drink alcoholic beverages or take other alcohol-containing preparations while you are taking this medicine and for at least 3 days after stopping it.

Metronidazole may cause dryness of the mouth, an unpleasant or sharp metallic taste, and a change in taste sensation. For temporary relief of dry mouth, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

This medicine may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

If you are taking this medicine for trichomoniasis (an infection of the sex organs in males and females), your doctor may want to treat your sexual partner at the same time you are being treated, even if he or she has no symptoms. Also, it may be desirable to use a condom (prophylactic) during intercourse. These measures will help keep you from getting the infection back again from your partner. If you have any questions about this, check with your doctor.

Flagyl I.V. Side Effects

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 immediately if any of the following side effects occur:

Less common

Numbness, tingling, pain, or weakness in hands or feet

Rare

Convulsions (seizures)

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Any vaginal irritation, discharge, or dryness not present before use of this medicine
black, tarry stools; blood in urine or stools
clumsiness or unsteadiness
frequent or painful urination
inability to control urine flow
mood or other mental changes
nausea and vomiting; pinpoint red spots on skin
sense of pelvic pressure
skin rash, hives, redness, or itching
sore throat and fever
stomach and back pain (severe)
unusual bleeding or bruising

For injection form

Pain, tenderness, redness, or swelling over vein in which the medicine is given

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:

More common

Diarrhea
dizziness or light–headedness
headache
loss of appetite
nausea or vomiting
stomach pain or cramps

Less common or rare

Change in taste sensation
dryness of mouth
unpleasant or sharp metallic taste

In some patients metronidazole may cause dark urine. This is only temporary and will go away when you stop taking this medicine.

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

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