Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Miconazole liquid may be harmful if swallowed.
Proper storage of Miconazole liquid:
Store Miconazole liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Miconazole liquid out of the reach of children and away from pets.
Overdose of Miconazole in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
An overdose of Miconazole topical is unlikely to occur. If the patient suspects that a much larger than normal dose has been used or that Miconazole topical has been ingested, contact an emergency room or a poison control center. Overdosage or toxic effects are unlikely to occur after the ingestion of a small amount of active ingredients contained in a tube of cream. However, in the event of accidental ingestion, an appropriate method of gastric emptying may be used if considered appropriate. Excessive topical application can result in skin irritation and erythema. This adverse experience can be stopped by an interruption of treatment or a reduction in the frequency of application.
In case of any overdose, contact the physician.
What should I avoid while taking Miconazole?
Avoid getting this medication in your eyes, nose, or mouth.
Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Before using Miconazole:
tell your doctor and pharmacist if you are allergic to Miconazole or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Miconazole, call your doctor. Before using Miconazole, tell your doctor if you are using a diaphragm or condom for birth control and are being treated for a vaginal infection. Miconazole vaginal cream and suppositories can interact with the latex in diaphragms and condoms, so use another method of birth control.
Keep all appointments with your doctor. Miconazole is for external use only. Do not let Miconazole get into your eyes, nose, or mouth, and do not swallow it. Do not apply dressings, bandages, cosmetics, lotions, or other skin medications to the area being treated unless your doctor tells you.
If you obtained the topical form of Miconazole without a prescription and your symptoms do not improve within 4 weeks (2 weeks for jock itch), stop using it and talk to a pharmacist or doctor.
If this is the first time you have had vaginal itching and discomfort, talk to a doctor before using Miconazole. If a doctor has told you before that you had a yeast infection and you have the same symptoms again, use the vaginal cream or suppositories as directed on the package.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
If you still have symptoms of infection after you finish the Miconazole, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
What should I discuss with my healthcare provider before taking Miconazole?
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 Miconazole, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to Miconazole 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.
Although there is no specific information comparing use of topical Miconazole in children with use in other age groups, Miconazole is not expected to cause different side effects or problems in children than it does in adults.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical Miconazole in the elderly with use in other age groups, Miconazole is not expected to cause different side effects or problems in older people than it does in younger adults.
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 Miconazole, 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 Miconazole 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.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of Miconazole products, including Miconazole. DiscontinueORAVIG immediately at the first sign of hypersensitivity.
There is no information regarding cross-hypersensitivity between Miconazole and otherazole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.
Patient Counseling Information
Instructions for Use
The tablet should be used immediately after removal from the bottle.
Instruct patients not to crush, chew, or swallow the tablet.
The rounded side of the tablet should be applied to the upper gum above the incisor tooth in the morning, after brushing the teeth.
The tablet should be held in place for 30 seconds with a slight pressure of the finger over the upper lip to make the tablet stick to the gum.
The tablet may be used if it sticks to the cheek, inside of the lip or the gum.
If the tablet does not adhere, it should be repositioned.
As the Miconazole tablet absorbs moisture from the mouth, it will slowly dissolve over time and should be left in place – there is no need to remove the tablet.
Subsequent applications of Miconazole should be made to alternate sides of the gum.
If Miconazole does not stick or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet does not adhere, a new tablet should be placed.
If Miconazole is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied only once.
If Miconazole falls off or is swallowed after it was in place for 6 hours or more, a new tablet should not be applied until the next regularly scheduled dose.
Patients should avoid situations that could interfere with the sticking of the tabletincluding:
touching or pressing the tablet after placement
wearing upper denture
hitting tablet when brushing teeth
rinsing mouth too vigorously
Hypersensitivity and Other Adverse Reactions
Patients who develop hives, skin rash, or other symptoms of an allergic reaction, and patients who develop swelling or pain, at the tablet application site should stop ORAVIGand contact a healthcare provider. Patients may experience other adverse reactionsincluding diarrhea, headache, nausea, and change in taste.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with Miconazole have not been conducted.
Miconazole was not genotoxic when tested in vitroin a bacterial reverse mutation (Ames) assay or in an in vivo mouse bone marrow micronucleus test. Intraperitoneal injections of Miconazole to mice induced chromosomal aberrations in spermatocytes andbone marrow cells, and morphologic abnormalities in sperm at doses similar to or belowclinical doses. However, no impairment of fertility was observed in intravenous studieswith Miconazole at 40 mg/kg/day in rats or 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIGbuccal tablet, based on body surface area comparisons.
Use In Specific Populations
Pregnancy Category C
There are no adequate and well-controlled clinical trials of Miconazole in pregnant women. Miconazole should not be used during pregnancy unless the potential benefit to the motheroutweighs the potential risk to the fetus.
Miconazole administered orally at doses of 80 mg/kg/day or higher to pregnantrats or rabbits crossed the placenta and resulted in embryo- and fetotoxicity, including increased fetal resorptions. These doses also resulted in prolonged gestation and dystocia in rats, but not in rabbits. Embryofetotoxicity was not observed in intravenous studies with Miconazole at lower doses of 40 mg/kg/day in rats and 20 mg/kg/day in rabbits,which are approximately 8 times higher than the dose a patient would receive if she swallowed an Miconazole buccal tablet, based on body surface area comparisons. Teratogenicitywas not reported in any animal study with Miconazole.
It is not known whether this drug is excreted in human milk. Because many drugs areexcreted in human milk, caution should be exercised when Miconazole is administered to a nursing woman.
Safety and effectiveness of Miconazole in pediatric patients below the age of 16 years have not been established. The ability of pediatric patients to comply with the applicationinstructions has not been evaluated. Use in younger children is not recommended due topotential risk of choking
Clinical studies of Miconazole did not include sufficient numbers of subjects aged 65 andover to determine whether they respond differently from younger subjects.
Miconazole is metabolized by the liver. While Miconazole systemic exposure is minimal following the application of Miconazole, Miconazole should be administered with caution inpatients with hepatic impairment.
Less than 1% of Miconazole is excreted as unchanged drug in the urine; therefore, noadjustment to therapy is necessary in patients with renal impairment.
What happens if I miss a dose of Miconazole?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
DailyMed. "MICONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).