Miconazole 3 Combination Pack by Cardinal Health
Dosage form: kit
Ingredients: MICONAZOLE NITRATE 200mg; MICONAZOLE NITRATE 10mg in 0.5g
Labeler: Cardinal Health
NDC Code: 37205-583
Miconazole nitrate (200 mg in each suppository)
Miconazole nitrate 2% (external cream)
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
For vaginal use only
If you have never had a vaginal yeast infection diagnosed by a doctor
- vaginal itching and discomfort for the first time
- lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
- vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
Taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
- do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur
- symptoms do not get better in 3 days
- symptoms last more than 7 days
- you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
Ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
- before using this product read the enclosed consumer information leaflet for complete directions and information
adults and children 12 years of age and over:
- suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
- external cream: use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
- children under 12 years of age: ask a doctor
- do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
- do not use if seal over tube opening has been punctured or is not visible
- do not purchase if carton is open
- store at room temperature 15( - 30(C (59( - 86(F). Avoid heat (over 30(C- 86(F)
- suppository: hydrogenated vegetable oil
- external cream: benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
Compare to Monistat® 3 active ingredient*
Miconazole Nitrate Vaginal Suppositories USP, 200 mg and Miconazole Nitrate External Vulvar Cream, 2%
Cures most vaginal yeast infections
Relieves associated external itching and irritation
3 Vaginal suppositories with 3 disposable applicators plus external cream
NET WT. 0.32 oz (9 g) tube
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP, 200 mg and
MICONAZOLE NITRATE EXTERNAL VULVAR CREAM, 2%
CURES MOST VAGINAL YEAST INFECTIONS
RELIEVES EXTERNAL VULVAR ITCHING AND IRRITATION ASSOCIATED WITH A YEAST INFECTION
For the treatment of vaginal yeast infections and the relief of external vulvar itching and irritation associated with a yeast infection.
If you have any or all of the symptoms of a vaginal yeast infection (vaginal itching, burning, discharge) accompanied by external vulvar itching and irritation and if at some time in the past your doctor has told you that these symptoms are due to a vaginal yeast infection, then Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate External Vulvar Cream should work for you. If, however, you have never had these symptoms before, you should see your doctor before using these products.
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES and MICONALZOLE NITRATE EXTERNAL VULVAR CREAM ARE FOR THE TREATMENT OF VAGINAL YEAST INFECTIONS AND FOR THE RELIEF OF EXTERNAL VULVAR ITCHING AND IRRITATION ASSOCIATED WITH A YEAST INFECTION. THESE PRODUCTS DO NOT TREAT OTHER INFECTIONS OR EXTERNAL ITCHING AND IRRITATION DUE TO CAUSES OTHER THAN YEAST INFECTIONS. THESE PRODUCTS DO NOT PREVENT PREGNANCY.
WHAT ARE VAGINAL YEAST INFECTIONS (CANDIDIASIS)?
A yeast infection is a common type of vaginal infection. Your doctor may call it candidiasis. This condition is caused by an organism called Candida, which is a type of yeast. Even healthy women usually have this yeast on the skin, in the mouth, in the digestive tract, and in the vagina. At times, the yeast can grow very quickly. In fact, the infection is sometimes called yeast (Candida) “overgrowth”. Some women also experience a yeast infection on the external skin (vulva) associated with the internal vaginal infection.
A yeast infection can occur at almost any time of life. It is most common during the childbearing years. The infection tends to develop most often in some women who are pregnant, diabetic, taking antibiotics, taking birth control pills, or have a damaged immune system.
Various medical conditions can damage the body’s normal defenses against infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV – the virus that causes AIDS). Infection with HIV causes the body to be more susceptible to infections, including vaginal yeast infections. Women with HIV infection may have frequent vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment. If you may have been exposed to HIV and are experiencing either frequently recurring vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment, you should see your doctor promptly. If you wish further information on risk factors for HIV infection, or on the relationship between recurrent or persistent vaginal yeast infections and HIV infection, please contact your doctor or the CDC National AIDS HOTLINE at 1-800-342-AIDS (English), 1-800-344-7432 (Spanish), or 1-800-243-7889 (Hearing Impaired, TDD).
IF YOU EXPERIENCE FREQUENT YEAST INFECTIONS (THEY RECUR WITHIN A TWO MONTH PERIOD) OR IF YOU HAVE YEAST INFECTIONS THAT DO NOT CLEAR UP EASILY WITH PROPER TREATMENT, YOU SHOULD SEE YOUR DOCTOR PROMPTLY TO DETERMINE THE CAUSE AND TO RECEIVE PROPER MEDICAL CARE.
SYMPTOMS OF VAGINAL YEAST INFECTIONS
There are many signs and symptoms of a vaginal yeast infection. They can include:
- Vaginal itching (ranging from mild to intense);
- A clumpy, vaginal discharge that may look like cottage cheese;
- Vaginal soreness, irritation, or burning, especially during vaginal intercourse;
- Rash or redness around the vagina (vulvar irritation).
NOTE: Vaginal discharge that is different from above, for example, a yellow/green discharge or a discharge that smells “fishy”, may indicate that you have something other than a yeast infection. If this is the case, you should consult your doctor before using these products.
- These products are only effective in treating vaginal infection caused by yeast and in relieving vulvar itching and irritation associated with a yeast infection. Do not use in eyes or take by mouth.
Do not use Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate External Vulvar Cream if you have any of the following signs and symptoms. Also, if they occur while using these products, STOP using these products and contact your doctor right away. You may have a more serious illness.
Fever (above 100°F orally)
Pain in the lower abdomen, back or either shoulder
A vaginal discharge that smells bad
- Ask a doctor or pharmacist before use if you are taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur.
- If there is no improvement or if the infection worsens within 3 days, or complete relief is not felt within 7 days, or your symptoms return within two months, then you may have something other than a yeast infection. You should consult your doctor.
- If you may have been exposed to the human immunodeficiency virus (HIV, the virus that causes AIDS) and are now having recurrent vaginal infections, especially infections that don’t clear up easily with proper treatment, see your doctor promptly to determine the cause of your symptoms and to receive proper medical care.
- Hydrogenated vegetable oil may weaken latex in condoms or in diaphragms. These suppositories contain hydrogenated vegetable oil. Do not rely on condoms or diaphragms to prevent sexually transmitted diseases or pregnancy while using Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate External Vulvar Cream.
- Do not use tampons while using this medication.
- Do not use in girls less than 12 years of age.
- If you are pregnant or think you may be, do not use these products except under the advice and supervision of a doctor.
- Keep this and all drugs out of the reach of children.
- In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP: Three vaginal suppositories each containing 200 mg of miconazole nitrate.
MICONAZOLE NITRATE EXTERNAL VULVAR CREAM: One tube of cream for external vulvar use containing miconazole nitrate 2%.
PLASTIC APPLICATORS: Your combination pack contains either one reusable plastic applicator or three disposable plastic applicators.
DIRECTIONS FOR USE
Miconazole Nitrate Vaginal Suppositories
Begin treatment at bedtime. Before going to bed:
- Tear off one suppository from the strip. Separate the plastic wrap at the pointed end with your thumb. With thumb and forefinger of each hand, hold the plastic tabs and pull apart (see picture). Gently remove the suppository from the plastic wrap.
- Place suppository in the top of the applicator as shown.
- Hold the applicator containing the suppository by the opposite end from where the suppository is. Gently insert the applicator into the vagina as far as it will go comfortably. As shown in the pictures, this can be done while standing with your feet spread a few inches apart and your knees bent. Or, you can lie on your back with your knees bent. Once you are ready, push the inside piece of the applicator in and place the suppository as far back in the vagina as possible. Then remove the applicator from the vagina. You should go to bed as soon as possible after inserting the suppository. This will keep leakage to a minimum.
You may want to use deodorant-free mini-pads or pantyshields during the time that you are using miconazole nitrate vaginal suppositories. This is because the suppository can leak. DO NOT USE TAMPONS.
- Be sure to clean the reusable plastic applicator after each use. Pull the two pieces apart. Wash them with soap and warm water. To rejoin, gently push the inside piece into the outside piece as far as it will go.
- Repeat steps 1 through 4 before going to bed on each of the next two evenings.
Miconazole Nitrate External Vulvar cream
Use the cream twice daily if needed as follows:
- Open the tube. To do this, unscrew the cap, turn the cap upside down and place the cap in the end of the tube. Push down firmly until the seal is broken (as shown).
- Squeeze a small amount of cream onto your finger.
- Gently apply the cream onto the skin (vulva) that itches and is irritated.
- Repeat steps 2 and 3 each morning and evening as needed.
ADVERSE REACTIONS (SIDE EFFECTS)
The following side effects have been reported with the use of Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate External Vulvar Cream: a temporary increase in burning, itching, and/or irritation when the suppository is inserted. Abdominal cramping, headaches, hives, and skin rash have also been reported. If any of these occur, stop using these products and consult your doctor.
FOR BEST RESULTS
- Be sure to use all of the suppositories even if your symptoms go away before you have used all the suppositories.
- Use one suppository at bedtime for three nights in a row, even during your menstrual period.
- Wear cotton underwear.
- If your partner has any penile itching, redness, or discomfort, he should consult his doctor and mention that you are treating yourself for a vaginal yeast infection.
- Dry the outside vaginal area thoroughly after a shower, bath or swim. Change out of a wet bathing suit or damp workout clothes as soon as possible. A dry area is less likely to encourage the growth of yeast.
- Wipe from front to rear (away from the vagina) after a bowel movement or urination.
- Do not douche unless your doctor tells you to do so. Douching may disturb the vaginal bacterial balance.
- Do not scratch if you can help it. Scratching can cause more irritation and can spread the infection.
- Discuss with your doctor any medication you are now taking. Certain types of medication can make your vagina more prone to infection.
IF YOU HAVE A QUESTION
1-800-432-8534 (select option #2)
Questions of a medical nature should be taken up with your doctor.
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP - miconazole nitrate (200 mg each suppository).
MICONAZOLE NITRATE EXTERNAL VULVAR CREAM – miconazole nitrate 2%.
Store at room temperature 59( - 86(F (15( - 30(C). Avoid heat (over 86(F or 30(C).
Actavis Mid Atlantic LLC
1877 Kawai Road,
Lincolnton NC 28092 USA
FORM NO. 7310
|MICONAZOLE 3 COMBINATION PACK
miconazole nitrate kit
|Labeler - Cardinal Health (097537435)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.