What happens if I overdose Funtas?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Funtas liquid may be harmful if swallowed.
Proper storage of Funtas liquid:
Store Funtas 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 Funtas liquid out of the reach of children and away from pets.
Overdose of Funtas in details
An overdose of Funtas topical is unlikely to occur. If the patient suspects that a much larger than normal dose has been used or that Funtas 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 Funtas?
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.
Funtas warnings
Before using Funtas:
tell your doctor and pharmacist if you are allergic to Funtas 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 Funtas, call your doctor. Before using Funtas, tell your doctor if you are using a diaphragm or condom for birth control and are being treated for a vaginal infection. Funtas 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. Funtas is for external use only. Do not let Funtas 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 Funtas 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 Funtas. 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 Funtas, 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 Funtas?
Some medical conditions may interact with Funtas suppositories. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have the blood disease porphyria or a history of liver disease, or you have been exposed to HIV
- if you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting
- if this is the first time you have had vaginal itching and discomfort
- if you have vaginal yeast infections often (eg, once a month or 3 in 6 months)
- if you are taking antibiotics
Some MEDICINES MAY INTERACT with Funtas suppositories. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of side effects such as bruising or bleeding may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Funtas suppositories may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Funtas precautions
Hypersensitivity
Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of Funtas products, including Funtas. DiscontinueORAVIG immediately at the first sign of hypersensitivity.
There is no information regarding cross-hypersensitivity between Funtas 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 Funtas 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 Funtas should be made to alternate sides of the gum.
- If Funtas 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 Funtas 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 Funtas 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
- chewing gum
- 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.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with Funtas have not been conducted.
Funtas 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 Funtas 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 Funtas 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
Pregnancy Category C
There are no adequate and well-controlled clinical trials of Funtas in pregnant women. Funtas should not be used during pregnancy unless the potential benefit to the motheroutweighs the potential risk to the fetus.
Funtas 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 Funtas 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 Funtas buccal tablet, based on body surface area comparisons. Teratogenicitywas not reported in any animal study with Funtas.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs areexcreted in human milk, caution should be exercised when Funtas is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of Funtas 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
Geriatric Use
Clinical studies of Funtas did not include sufficient numbers of subjects aged 65 andover to determine whether they respond differently from younger subjects.
Hepatic Impairment
Funtas is metabolized by the liver. While Funtas systemic exposure is minimal following the application of Funtas, Funtas should be administered with caution inpatients with hepatic impairment.
Renal Impairment
Less than 1% of Funtas 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 Funtas?
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.
References
- 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).
- DrugBank. "miconazole". http://www.drugbank.ca/drugs/DB01110 (accessed September 17, 2018).
- MeSH. "Cytochrome P-450 CYP3A Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
