Flagyl Vaginal

It is important that your doctor check your progress after you finish using this medicine. This is to make sure that the infection is cleared up.

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

You should not use this medicine if you have taken disulfiram (Antabuse®) within the last 2 weeks. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Alcohol-containing medicines (e.g., elixirs, cough syrups, tonics) may also cause problems. The chance of these problems occurring may continue for at least a day after you stop using metronidazole. You should not drink alcoholic beverages or take other alcohol-containing medicines while you are using this medicine and for at least 3 days after stopping it.

Stop using this medicine and 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 brain condition called encephalopathy.

Stop using this medicine and 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 aseptic meningitis.

Stop using this medicine and 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.

This medicine may 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.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a mini-pad or sanitary napkin. Do not use tampons (like those used for menstrual periods) since they may soak up the medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

• Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (e.g., nylon or rayon) panties.
• Wear only freshly washed panties daily.

Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may keep the medicine from working properly. Also, oils in the cream and vaginal tablets (but not the vaginal gel) may damage latex (rubber) contraceptive devices (e.g., cervical caps, condoms, or diaphragms), causing them to leak, wear out sooner, or not work properly.

Avoid using douches or other vaginal products unless your doctor tells you to.

Many vaginal infections (e.g., trichomoniasis) are spread by having sexual intercourse. You can give the infection to your sexual partner, and the infection could be given back to you. Your partner may also need to be treated for some infections. Until you are sure that the infection is completely cleared up after your treatment with this medicine, your partner should wear a condom during sexual intercourse . If you have any questions about this, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using 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.

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:

• Itching in the vagina
• pain during sexual intercourse
• thick, white vaginal discharge with no odor or with a mild odor

• Abdominal or stomach cramping or pain
• burning on urination or need to urinate more often
• burning or irritation of penis of sexual partner
• itching, stinging, or redness of the genital area

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
• dryness of the mouth
• feeling of a furry tongue
• headache
• loss of appetite
• metallic taste or other change in taste sensation
• nausea
• vomiting

Metronidazole may cause your urine to become dark. This is harmless and will go away when you stop using this medicine.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Any vaginal or genital irritation or itching
• pain during sexual intercourse
• thick, white vaginal discharge not present before treatment, with no odor or with a mild odor

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.

More frequently reported side effects include: cervical candidiasis and vaginitis. See below for a comprehensive list of adverse effects.

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 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:

• 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
• nausea
• tingling or numbness of arms, legs, hands, or feet

Applies to metronidazole topical: topical cream, topical gel, topical kit, topical lotion, vaginal gel with applicator

General

Topical: The most frequently reported side effects were nasopharyngitis, upper respiratory tract infection, and headache.

Vaginal: The most frequently reported side effects were fungal infection, vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, metrorrhagia, breast pain, infection, rash, pharyngitis, abdominal pain, pruritus, and dysmenorrhea.[Ref]

Local

Very common (10% or more): Mild dryness (17.1%), mild scaling (16.2%)
Common (1% to 10%): Moderate dryness, moderate scaling, mild pruritus, moderate pruritus, severe pruritus, mild stinging/burning, moderate stinging/burning, severe stinging/burning, local allergic reaction
Uncommon (0.1% to 1%): Severe dryness, severe scaling
Frequency not reported: Application site reaction, condition aggravated, transient redness[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, breast pain, metrorrhagia, vulvovaginal candidiasis, vulvovaginal pruritus, urinary tract infection, vaginal itching/irritation/burning/numbness, pelvic discomfort, vaginal discharge
Uncommon (0.1% to 1%): Vaginal mycosis, urine discolored, vulva edema, menstrual discomfort/irregularities, vaginal spotting/bleeding
Frequency not reported: Breast enlargement, dysuria, female lactation, labial edema, leucorrhoea, menorrhagia, salpingitis, urinary frequency, vaginitis, vulvovaginal disorder[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, diarrhea, gastritis, tooth disorder, gastrointestinal discomfort, abdominal cramps, vomiting
Uncommon (0.1% to 1%): Constipation, dry mouth, abdominal bloating/noise
Frequency not reported: Dyspepsia, flatulence, gingivitis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Tingling/numb extremities, taste metallic, dysgeusia, paresthesia, hypothesia
Frequency not reported: Peripheral neuropathy, ataxia
Postmarketing reports: Taste perversion[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, bronchitis, nasopharyngitis, sinusitis, upper respiratory tract infection, nasal congestion
Frequency not reported: Asthma, rhinitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, contact dermatitis, dry skin, skin discomfort, burning/stinging, erythema, worsening of rosacea, skin irritation
Frequency not reported: Acne, sweating, urticaria, skin exfoliation, facial edema, zoster lesion, nose pustule, vesicular bullous eruption
Postmarketing reports: Hyperpigmentation, pigmentation disorder, hypertrichosis[Ref]

Other

Very common (10% or more): Fungal infection (12%), flu syndrome (up to 11%)
Common (1% to 10%): Infection, influenza, abscess, pain
Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Mucous membrane disorder[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, difficult sleep, irritability
Frequency not reported: Insomnia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, cramp[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma
Frequency not reported: Skin cancer[Ref]

Ocular

Frequency not reported: Eye irritation, watery eye
Postmarketing reports: Eyelid edema[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Immunologic

Frequency not reported: Allergic reaction[Ref]

Metabolic

Common (1% to 10%): Appetite decreased
Frequency not reported: Anorexia, hypomagnesemia[Ref]

Renal

Frequency not reported: Pyelonephritis[Ref]

Some side effects of metronidazole topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

1% Topical Cream or Gel: Apply and rub in a thin film to the affected area(s) once a day

0.75% Topical Cream, Gel, or Lotion: Apply and rub in a thin layer to affected area(s) twice a day in the morning and evening

Comments:
-A gentle cleaner should be used prior to application.
-Cosmetics may be applied following application.

Use: For the topical treatment of inflammatory lesions and erythema of rosacea