What happens if I overdose Clomizol?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Clomizol solution may be harmful if swallowed.
Proper storage of Clomizol solution:
Store Clomizol solution at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clomizol solution out of the reach of children and away from pets.
Overdose of Clomizol in details
No reports are available on cases of overdose with Clomizol 1% w/w. There is no specific antidote.
Topical Clomizol is intended for cutaneous use only.
In the case of cutaneous overdose patients should be managed by symptomatic care; patients should wash off the product with water and cleanser, discontinue use, and see the physician so appropriate therapy can be implemented as needed. In the case of ingestion of an overdose, patients should see the physician and be managed by symptomatic and supportive care.
What should I avoid while taking Clomizol?
There are no restrictions on foods, beverages, or activities during treatment with Clomizol unless your doctor directs otherwise.
Clomizol warnings
If irritation or sensitivity develops with the use of Clomizol Cream, treatment should be discontinued and appropriate therapy instituted.
Pregnancy & lactation:
Pregnancy Category B
The disposition of 14C-Clomizol has been studied in humans and animals. Clomizol is very poorly absorbed following dermal application or intravaginal administration to humans.
In clinical trials, use of vaginally applied Clomizol in pregnant women in their second and third trimesters has not been associated with ill effects. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.
Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to Clomizol.
High oral doses of Clomizol in rats and mice ranging from 50 to 120 mg/kg resulted in embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning. However, Clomizol was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively.
Oral absorption in the rat amounts to approximately 90% of the administered dose.
Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.
Nursing Mothers
It is not known whether this drug is excreted in human milk, caution should be exercised when Clomizol is used by a nursing woman.
Pediatric Use
Safety and effectiveness in children have been established for Clomizol when used as indicated and in the recommended dosage.
What should I discuss with my healthcare provider before taking Clomizol?
Some medical conditions may interact with Clomizol inserts. 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 diabetes, or you have been exposed to HIV
- if this is the first time you have had vaginal itching and discomfort
- if you have vaginal yeast infections often (eg, your symptoms return within 2 months) or your symptoms do not clear up with treatment
- if you are taking antibiotics
Some MEDICINES MAY INTERACT with Clomizol inserts. However, no specific interactions with Clomizol inserts are known at this time.
Ask your health care provider if Clomizol inserts 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.
Clomizol precautions
General:
If irritation or sensitivity develops with the use of Clomizol Cream, treatment should be discontinued and appropriate therapy instituted.
Information for Patients :
The patient should be advised to:
- 1.
- Use the medication for the full treatment time even though the symptoms may have improved. Notify the physician if there is no improvement after four weeks of treatment.
- 2.
- Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.
- 3.
- Avoid the use of occlusive wrappings or dressings.
- 4.
- Avoid sources of infection or reinfection.
Laboratory Tests
If there is lack of response to Clomizol Cream, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.
Drug Interactions
Synergism or antagonism between Clomizol and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
Carcinogenesis, Mutagenesis, Impairment of Fertility
An 18-month oral dosing study with Clomizol in rats has not revealed any carcinogenic effect.
In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to Clomizol were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral Clomizol doses of 100 mg/kg body weight. The results of this study showed that Clomizol had no mutagenic effect.
Usage in Pregnancy: Pregnancy Category B
The disposition of 14C-Clomizol has been studied in humans and animals. Clomizol is very poorly absorbed following dermal application or intravaginal administration to humans.
In clinical trials, use of vaginally applied Clomizol in pregnant women in their second and third trimesters has not been associated with ill effects. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.
Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to Clomizol.
High oral doses of Clomizol in rats and mice ranging from 50 to 120 mg/kg resulted in embroyotoxicity (possible secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning. However, Clomizol was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively.
Oral absorption in the rat amounts to approximately 90% of the administered dose.
Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.
Nursing Mothers
It is not known whether this drug is excreted in human milk, caution should be exercised when Clomizol is used by a nursing woman.
Pediatric Use
Safety and effectiveness in children have been established for Clomizol when used as indicated and in the recommended dosage.
What happens if I miss a dose of Clomizol?
Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.
References
- DailyMed. "BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE: 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. "clotrimazole". http://www.drugbank.ca/drugs/DB00257 (accessed September 17, 2018).
- MeSH. "Anti-Infective Agents, Local". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
