Medical Editor: John P. Cunha, DO, FACOEP
What Is Metrogel Vaginal?
Metrogel vaginal (metronidazole) is an antibiotic used to treat bacterial vaginosis.
What Are Side Effects of Metrogel Vaginal?
Side effects of Metrogel vaginal may include:
- burning or stinging when the medicine is applied,
- numbness,
- pelvic pain or cramping,
- loss of appetite,
- constipation,
- upset stomach,
- vomiting,
- dizziness,
- sleep problems (insomnia),
- runny nose,
- urinating more than usual,
- acne,
- increased sweating,
- breast discharge or enlargement, or
- rarely, seizures.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Metrogel Vaginal
The recommended dose is:
- one applicator full of Metrogel vaginal (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days.
What Drugs, Substances, or Supplements Interact with Metrogel Vaginal?
Metrogel vaginal may interact with other vaginal creams or douches used at the same time, disulfiram cimetidine, lithium, or blood thinners. Tell your doctor all medications and supplements you use.
Metrogel Vaginal During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant during treatment with Metrogel vaginal. Metrogel vaginal is not expected to be harmful to a fetus. Metrogel vaginal may pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.
Additional Information
Our Metrogel vaginal Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
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Get emergency medical help if you have signs of an allergic reaction (hives, itching, warmth or tingling; fever, joint pain; dry mouth, dry vagina; stuffy nose, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Rare but serious side effects may include:
- seizure (convulsions); or
- numbness, burning, pain, or tingly feeling in your hands or feet.
Call your doctor at once if you have new or worsening vaginal symptoms.
Common side effects may include:
- vaginal itching or discharge;
- menstrual pain, heavy bleeding;
- breast pain;
- headache;
- rash, itching;
- stomach pain, nausea, diarrhea; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Pelvic Pain: What's Causing Your Pelvic Pain? See SlideshowSIDE EFFECTS
Adverse Events
Clinical Trials
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 METROGELVAGINAL 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%:
Reproductive
Vaginal discharge (12%),
Symptomatic Candida cervicitis/vaginitis (10%),
Vulva/vaginal irritative symptoms (9%),
Pelvic discomfort (3%).
Gastrointestinal
Gastrointestinal discomfort (7%),
Nausea and/or vomiting (4%),
Unusual taste (2%),
Diarrhea/loose stools (1%),
Decreased appetite (1%),
Abdominal bloating/gas; thirsty, dry mouth.
Neurologic
Headache (5%),
Dizziness (2%),
Depression.
Dermatologic
Generalized itching or rash.
Other
Unspecified cramping (1%),
Fatigue,
Darkened urine.
In previous clinical trials submitted for approved labeling of METROGEL-VAGINAL the following was also reported:
Laboratory
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 metronidazole 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, &ldqou;furry&rdqou; 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.
Read the entire FDA prescribing information for Metrogel Vaginal (Metronidazole)
© Metrogel Vaginal Patient Information is supplied by Cerner Multum, Inc. and Metrogel Vaginal Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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