Flagyl I.V.

Generic Name: metronidazole (Oral route, Intravenous route)

met-roe-NYE-da-zole

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
• Capsule
• Tablet
• Solution
• Powder for Solution
• Suspension

Therapeutic Class: Antibiotic

Chemical Class: Nitroimidazole

Uses For Flagyl I.V.

Metronidazole is used to treat bacterial infections in many different parts of the body.

Metronidazole injection is also used to prevent infections in the intestines before and after surgery in some patients.

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine 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

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

No information is available on the relationship of age to the effects of metronidazole injection in geriatric patients.

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

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

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 (e.g., blood dyscrasia, leukopenia), history of or
• Edema (too much fluid in the body) or
• Oral thrush or vaginal yeast infection or
• Seizures, history of—May make these conditions worse.

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

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 continues (nausea, vomiting, stomach pain, or diarrhea), 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 using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop using this medicine too soon, your symptoms may return.

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 per 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 doctor.

If you are using the injection form of this medicine: A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 1 hour.

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 or tablets):
  • For bacterial infections:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) 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 and must be determined by your doctor. The dose is usually 7.5 mg per kg of body weight every six hours; or 10 mg per kg every eight hours.
  • For amebiasis infections:
    • Adults and teenagers—500 to 750 milligrams (mg) three times per day for five to ten days.
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 11.6 to 16.7 mg per kilogram (kg) of body weight three times per day for ten days.
  • For trichomoniasis infections:
    • Adults and teenagers—A single dose of 2 grams; or 1 gram two times per day for one day; or 250 milligrams (mg) three times per day for seven days.
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight three times per day for seven days.
• For oral dosage form (extended-release tablets):
  • For bacterial vaginosis:
    • Adults and teenagers—750 milligrams (mg) once a day for seven days.
    • 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (e.g., elixirs, cough syrups, tonics) may also cause problems. These problems may last for at least a day after you stop using 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 using 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 not alert. If these reactions are especially bothersome, check with your doctor.

If you are using 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.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious condition called encephalopathy.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called meningitis.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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

• Pain, tenderness, redness, or swelling at the site of the injection

• Convulsions (seizures)

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:

• Diarrhea
• dizziness or lightheadedness
• headache
• loss of appetite
• nausea or vomiting
• stomach pain or cramps

• Change in taste sensation
• dryness of the 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.

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

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