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What else should I know about metronidazole gel?
Metronidazolle gel, cream, and lotion are available as:
- Topical gel (0.75%, 1%)
- Cream or lotion (0.75%)
- Vaginal gel (0.75%, 1.3%)
Topical forms of metronidazole should be stored at room temperature, 15 C - 30 C (59 F - 86 F).
Metronidazole was approved by the FDA in 1963.
METROGEL-VAGINAL is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).
NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a &ldqou;fishy&rdqou; amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.
Following a single, intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole) to 12 normal subjects, a mean maximum serum metronidazole concentration of 237 ng/mL was reported (range: 152 to 368 ng/mL). This is approximately 2% of the mean maximum serum metronidazole concentration reported in the same subjects administered a single, oral 500 mg dose of metronidazole (mean Cmax = 12,785 ng/mL, range: 10,013 to 17,400 ng/mL). These peak concentrations were obtained in 6 to 12 hours after dosing with metronidazole vaginal gel and 1 to 3 hours after dosing with oral metronidazole.
The extent of exposure [area under the curve (AUC)] of metronidazole, when administered as a single intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole), was approximately 4% of the AUC of a single oral 500 mg dose of metronidazole (4977 ng-hr/mL and approximately 125,000 ng-hr/mL, respectively).
Dose-adjusted comparisons of AUCs demonstrated that, on a mg to mg comparison basis, the absorption of metronidazole, when administered vaginally, was approximately half that of an equivalent oral dosage.
Patients With Bacterial Vaginosis
Following single and multiple 5 gram doses of metronidazole vaginal gel to 4 patients with bacterial vaginosis, a mean maximum serum metronidazole concentration of 214 ng/mL on day 1 and 294 ng/mL (range: 228 to 349 ng/mL) on day five were reported. Steady state metronidazole serum concentrations following oral dosages of 400 to 500 mg BID have been reported to range from 6,000 to 20,000 ng/mL.
The intracellular targets of action of metronidazole on anaerobes are largely unknown. The 5-nitro group of metronidazole is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of metronidazole on anaerobic organisms.
Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis. (See INDICATIONS AND USAGE.)
Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis, Mobiluncus spp., and Mycoplasma hominis, has not been defined. Nonetheless, metronidazole is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:
In a randomized, single-blind clinical trial of non-pregnant women with bacterial vaginosis who received METROGEL-VAGINAL daily for 5 days, the clinical cure rates for evaluable patients determined at 4 weeks after completion of therapy for the QD and BID regimens were 98/185 (53%) and 109/190 (57%), respectively.
How is this medicine (MetroGel Vaginal) best taken?
Use MetroGel Vaginal as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Follow how to take this medicine as you have been told by your doctor. Do not use more than you were told to use.
- Wash your hands before and after use.
- To gain the most benefit, do not miss doses.
- Use as you have been told, even if your signs get better.
- Do not take MetroGel Vaginal by mouth. For vaginal use only. Keep out of your mouth, nose, and eyes (may burn).
- Some products are to be used at bedtime. For some products it does not matter. Check with the pharmacist about how to use this medicine.
- Do not have vaginal sex while using MetroGel Vaginal.
- Do not use longer than you have been told. A second infection may happen.
What do I do if I miss a dose?
- Use a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not use 2 doses or extra doses.
Convulsive Seizures and Peripheral Neuropathy:
Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole vaginal gel therapy. Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases.
Psychotic reactions have been reported in alcoholic patients who were using oral metronidazole and disulfiram ‑concurrently. Metronidazole vaginal gel should not be administered to patients who have taken disulfiram within the last two weeks.
METROGEL-VAGINAL affords minimal peak serum levels and systemic exposure (AUCs) of metronidazole compared to 500 mg oral metro‑nidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing metronidazole administered orally to metronidazole administered vaginally are not available.
Patients with severe hepatic disease metabolize metronidazole slowly. This results in the accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, metronidazole vaginal gel should be administered cautiously.
Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with metronidazole vaginal gel. Approximately 6-10% of patients treated with METROGEL-VAGINAL developed symptomatic Candida vaginitis during or immediately after therapy.
Disulfiram-like reaction to alcohol has been reported with oral metronidazole, thus the possibility of such a reaction occurring while on metronidazole vaginal gel therapy cannot be excluded.
METROGEL-VAGINAL contains ingredients that may cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.
Information for the Patient:
The patient should be cautioned about drinking alcohol while being treated with metronidazole vaginal gel. While blood levels are signifi‑cantly lower with METROGEL-VAGINAL than with usual doses of oral metronidazole, a possible interaction with alcohol cannot be excluded.
The patient should be instructed not to engage in vaginal intercourse during treatment with this product.
Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anti‑coagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when metronidazole vaginal gel is prescribed for patients on this type of anticoagulant therapy.
In patients stabilized on relatively high doses of lithium, short-term oral metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.
Use of cimetidine with oral metronidazole may prolong the half-life and decrease plasma clearance of metronidazole.
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. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide-adenine dinucleotides (NAD + NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic oral administration in mice and rats. Prominent among the effects in the mouse was the promotion of pulmonary tumorigenesis. This has been observed in all six reported studies in that species, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). At very high dose levels (approximately 500 mg/kg/day), there was a statistically significant increase in the incidence of malignant liver tumors in males. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lymphomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. All these effects are statistically significant. Several long-term oral dosing studies in the rat have been completed. There were statistically significant increases in the incidence of various neoplasms, particularly in mammary and hepatic tumors, among female rats administered metronidazole over those noted in the concurrent female control groups. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.
These studies have not been conducted with 0.75% metronidazole vaginal gel, which would result in significantly lower systemic blood levels than those obtained with oral formulations.
Although metronidazole has shown mutagenic activity in a number of in vitro assay systems, studies in mammals (in vivo) have failed to demonstrate a potential for genetic damage.
Fertility studies have been performed in mice up to six times the recommended human oral dose (based on mg/m2) and have revealed no evidence of impaired fertility.
Pregnancy: Teratogenic Effects:Pregnancy Category B
There has been no experience to date with the use of METROGEL-VAGINAL in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant mice at six times the recommended human dose (based on mg/m2); however, in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. The relationship of these findings to the drug is unknown.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.
Specific studies of metronidazole levels in human milk following intravaginally administered metronidazole have not been performed. However, metronidazole is secreted in human milk in concentrations similar to those found in plasma following oral administration of metronidazole.
Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in children have not been established.
There were no deaths or serious adverse events related to drug therapy in clinical trials involving 800 non-pregnant women who received METROGEL-VAGINAL.
In a randomized, single-blind clinical trial of 505 non-pregnant women who received METROGEL-VAGINAL once or twice a day, 2 patients (one from each regimen) discontinued therapy early due to drug-related adverse events. One patient discontinued drug because of moderate abdominal cramping and loose stools, while the other patient discontinued drug because of mild vaginal burning. These symptoms resolved after discontinuation of drug.
Medical events judged to be related, probably related, or possibly related to administration of METROGEL-VAGINAL once or twice a day were reported for 195/505 (39%) patients. The incidence of individual adverse reactions were not significantly different between the two regimens. Unless percentages are otherwise stipulated, the incidence of individual adverse reactions listed below was less than 1%:
Vaginal discharge (12%),
Symptomatic Candida cervicitis/vaginitis (10%),
Vulva/vaginal irritative symptoms (9%),
Pelvic discomfort (3%).
Gastrointestinal discomfort (7%),
Nausea and/or vomiting (4%),
Unusual taste (2%),
Diarrhea/loose stools (1%),
Decreased appetite (1%),
Abdominal bloating/gas; thirsty, dry mouth.
Generalized itching or rash.
Unspecified cramping (1%),
In previous clinical trials submitted for approved labeling of METROGEL-VAGINAL the following was also reported:
Increased/decreased white blood cell counts (1.7%).
Other Metronidazole Formulations:
Other effects that have been reported in association with the use of topical (dermal) formulations of metronidazole include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse events exceeded an ‑incidence of 2% of patients
METROGEL-VAGINAL affords minimal peak serum levels and systemic exposure (AUC) of metronidazole compared to 500 mg oral metro‑nidazole dosing. Although these lower levels of exposure are less likely to produce the common ‑reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently.
The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of metronidazole:
Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.
Central Nervous System: (See WARNINGS.) Headache, dizziness, syncope, ataxia, confusion, convulsive seizures, peripheral neuropathy, vertigo, incoordination, irritability, depression, weakness, insomnia.
Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, “furry” tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages.
Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctitis.
Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.
Hypersensitivity Reactions: Urticaria; erythematous rash; flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.
Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine.
What is MetroGel-Vaginal (metronidazole vaginal)?
Metronidazole is an antibiotic that fights bacteria in the body.
Metronidazole vaginal (for use in the vagina) is used to treat vaginal infections caused by bacteria.
Metronidazole vaginal may also be used for purposes not listed in this medication guide.
Before Using Metrogel-Vaginal
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:
In deciding whether to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For vaginal metronidazole, the following should be considered:
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.
Appropriate studies on the relationship of age to the effects of metronidazole vaginal gel have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for bacterial vaginosis in teenage females but should not be used before the start of menstruation.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole vaginal gel in the elderly.
|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.|
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 taking 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.
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.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Cholera Vaccine, Live
- Mycophenolate Mofetil
- Mycophenolic Acid
- Papaverine Hydrochloride
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
- 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.
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:
- Aseptic meningitis, history of or
- Encephalopathy (brain disorder), history of or
- Leukopenia (low white blood cells), history of or
- Optic neuropathy (eye disease with vision changes), history of or
- Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or
- Seizures or epilepsy, history of—Use with caution. May make these conditions worse.
- Liver disease, severe—Patients with severe liver disease may have an increase in side effects.
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 Metrogel-Vaginal. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine is to be used only in the vagina. Use it at bedtime, unless your doctor tells you otherwise.
Do not get it in your eyes, nose, mouth, or skin. If this medicine does get into your eyes, wash them out right away with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.
This medicine usually come with patient directions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Wash your hands with soap and water before and after using this medicine.
Metronidazole vaginal gel is in a tube. You will use an applicator to put the gel into your vagina. The applicator has a plastic tube called a barrel that is open at one end and has a plunger (another piece of plastic that can move inside the barrel) at the other end.
- To fill the applicator:
- For cream or gel dosage forms:
- Break the metal seal at the opening of the tube by using the point on the top of the cap.
- Screw the applicator onto the tube.
- Squeeze the medicine into the applicator slowly until it is full.
- Remove the applicator from the tube. Replace the cap on the tube.
- For vaginal tablet dosage form:
- Place the vaginal tablet into the applicator. Wet the vaginal tablet with water for a few seconds.
- For cream or gel dosage forms:
- To insert vaginal metronidazole using the applicator
- For all dosage forms:
- Relax while lying on your back with your knees bent (or in any position that you feel comfortable).
- Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable.
- Slowly press the plunger until it stops.
- Withdraw the applicator. The medicine will be left behind in the vagina.
- Remove the applicator from your vagina. Use each applicator only once, and then throw it away.
- For all dosage forms:
To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment.
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 bacterial vaginal infections:
- For vaginal dosage form (cream):
- Adults and teenagers—One applicatorful (500 milligrams [mg]), inserted into the vagina. Use the medicine one or two times a day for 10 or 20 days.
- Children—Use and dose must be determined by your doctor.
- For vaginal dosage form (gel):
- Adults and teenagers—One applicatorful (5000 milligrams [mg]) inserted into the vagina once a day (at bedtime) for 5 days. Each applicatorful contains 37.5 mg of metronidazole.
- Children—Use and dose must be determined by your doctor.
- For vaginal dosage form (tablets):
- Adults and teenagers—One 500 milligram (mg) tablet, inserted high into the vagina. Use the medicine once a day in the evening for 10 or 20 days.
- Children—Use and dose must be determined by your doctor.
- For vaginal dosage form (cream):
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.
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.
For the Consumer
Applies to metronidazole topical: topical cream, topical emulsion, topical gel/jelly, topical lotion
Other dosage forms:
- vaginal cream, vaginal gel/jelly, vaginal suppository
Along with its needed effects, metronidazole topical (the active ingredient contained in MetroGel-Vaginal) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects of metronidazole topical 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:Less common
- Dry skin
- redness or other signs of skin irritation not present before use of this medicine
- stinging or burning of the skin
- watering of eyes
- Metallic taste in the mouth
- tingling or numbness of arms, legs, hands, or feet