Metrogel-Vaginal

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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

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.

Do not use metronidazole vaginal if you have ever had an allergic reaction to it.

Before using metronidazole vaginal, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• a seizure disorder; or
• problems with circulation (such as Raynaud's syndrome).

If you have any of these conditions, you may need a dose adjustment or special tests to safely use metronidazole vaginal.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Metronidazole vaginal may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about MetroGel Vaginal (metronidazole vaginal gel), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about MetroGel Vaginal. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using MetroGel Vaginal.

Review Date: October 4, 2017

MetroGel-Vaginal®
(metronidazole vaginal gel)
0.75% Vaginal Gel

DIRECTIONS FOR USE

1.  Filling the applicator

• Remove cap and puncture metal seal on tube with the pointed tip of cap. (See Figure 1) • Screw end of applicator onto tube. (See Figure 2) • Gently squeeze the tube from the bottom to fill applicator. Plunger will stop when the applicator is full. (See Figure 3) • Unscrew applicator and replace cap on tube.

2.  Inserting the applicator

  The applicator may be inserted while lying on your back with your knees bent or in any comfortable position.   Hold filled applicator by barrel, and gently insert into vagina as far as it will comfortably go. (See Figure 4)   Slowly press the plunger until it stops to deposit gel into vagina and then withdraw the applicator.

3. Care of the applicator

If physician prescribes twice-a-day dosing:

  After use, pull the plunger out of the barrel. (See Figure 5)   Wash both plunger and barrel in warm soapy water and rinse thoroughly.   To reassemble applicator, gently push plunger back into barrel.

IMPORTANT
For once-a-day dosing, apply one applicator full at bedtime. For twice-a-day dosing, apply one applicator full each morning and evening for five days, or as directed by physician.

WARNINGS

  If significant irritation develops from the use of this medication, discontinue use and consult your physician.   Do not use during pregnancy except under the supervision of a physician.   Keep this and all medications out of reach of children.   For vaginal use only. Not for use in the eyes, on the skin or in the mouth.

Store at room temperature. Avoid exposure to extreme heat or cold.
See end of carton and bottom of tube for lot number and expiration date.

US patent #s 4,837,378; 5,536,743
Other patents pending

Manufactured for:
Graceway Pharmaceuticals, LLC
Bristol, TN 37620
By:
DPT Laboratories, Inc.
San Antonio, TX 78215

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to metronidazole, or if:

• you are allergic to parabens or polyethylene glycol;

• you recently drank alcohol; or

• you took disulfiram (Antabuse) within the past 14 days.

To make sure metronidazole vaginal is safe for you, tell your doctor if you have:

• a seizure disorder;

• a blood cell disorder (such as anemia, or low platelets); or

• peripheral vascular disease such as Raynaud's syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

Metronidazole vaginal can pass into breast milk and may harm a nursing baby. Do not breast-feed within 24 hours after using this medicine. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Metronidazole vaginal is not approved for use by anyone younger than 18 years old.

In the U.S.

• Metrogel-Vaginal
• Vandazole

In Canada

• Flagyl
• Neo-Metric
• Nidagel

Available Dosage Forms:

• Suppository
• Gel/Jelly
• Cream

Therapeutic Class: Antibacterial

Chemical Class: Nitroimidazole

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.

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