What happens if I overdose Norofulvin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Norofulvin microsize oral suspension:
Store Norofulvin microsize oral suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Norofulvin microsize oral suspension out of the reach of children and away from pets.
Overdose of Norofulvin in details
There is limited experience on overdose with Norofulvin. In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required.
What should I avoid while taking Norofulvin?
Avoid exposure to sunlight or tanning beds. Norofulvin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Drinking alcohol while taking Norofulvin can cause unpleasant side effects.
Norofulvin warnings
Prophylactic Usage: Safety and efficacy of prophylactic use of this drug has not been established.
Chronic feeding of Norofulvin, at levels ranging from 0.5-2.5% of the diet, resulted in the development of liver tumors in several strains of mice, particularly in males. Smaller particle sizes result in an enhanced effect. Lower oral dosage levels have not been tested. Subcutaneous administration of relatively small doses of Norofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice. Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusions in this regard.
In subacute toxicity studies, orally administered Norofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species. Disturbances in porphyrin metabolism have been reported in Norofulvin-treated laboratory animals. Norofulvin has been reported to have a colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals.
Reports of animal studies in the Soviet literature state that a Norofulvin preparation was found to be embryotoxic and teratogenic on oral administration to pregnant Wistar rats. Rat reproduction studies done in the United States and Great Britain were inconclusive in this regard. Pups with abnormalities have been reported in the litters of a few bitches treated with Norofulvin. Because the potential for adverse effects on the human fetus cannot be ruled out, additional contraceptive precautions should be taken during treatment with Norofulvin and for a month after termination of treatment. Norofulvin (Norofulvin microsize) should not be prescribed to women intending to become pregnant within one month following cessation of therapy.
Suppression of spermatogenesis has been reported to occur in rats but investigation in man failed to confirm this. Norofulvin interferes with chromosomal distribution during cell division, causing aneuploidy in plant and mammalian cells. These effects have been demonstrated in vitro at concentrations that may be achieved in the serum with the recommended therapeutic dosage.
Since Norofulvin has demonstrated harmful effects in vitro on the genotype in bacteria, plants, and fungi, males should wait at least six months after completing Norofulvin therapy before fathering a child.
What should I discuss with my healthcare provider before taking Norofulvin?
Some medical conditions may interact with Norofulvin microsize oral suspension. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin antibiotic (eg, amoxicillin)
- if you have liver disease or lupus
Some MEDICINES MAY INTERACT with Norofulvin microsize oral suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Barbiturates (eg, phenobarbital) because they may decrease Norofulvin microsize oral suspension's effectiveness
- Anticoagulants (eg, warfarin), cabazitaxel, cyclosporine, oral contraceptives (birth control pills), or ulipristal because their effectiveness may be decreased by Norofulvin microsize oral suspension
This may not be a complete list of all interactions that may occur. Ask your health care provider if Norofulvin microsize oral suspension 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.
Norofulvin precautions
- Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic and hematopoietic, should be done. Since Norofulvin is derived from species of Penicillium, the possibility of cross sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty. Since a photosensitivity reaction is occasionally associated with Norofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. Occasionally slight abnormalities in liver enzymes (irrespective of drug relationship) were reported with an incidence of less than 1%, specifically elevated ALT and/orAST. The majority of subjects with elevated liver enzymes also had concomitant medical conditions and were taking other drugs that may have increased the propensity for elevated values. When follow-up was provided, changes in elevated liver enzymes appeared to be reversible. Lupus erythematosus or lupus-like syndromes have been reported in patients receiving Norofulvin. Norofulvin decreases the activity of warfarin-type anticoagulants so that patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulant during and after Norofulvin therapy. Barbiturates usually depress Norofulvin activity and concomitant administration may require a dosage adjustment of the antifungal agent. There have been reports in the literature of possible interactions between Norofulvin and oral contraceptives. The effect of alcohol may be potentiated by Norofulvin, producing such effects as tachycardia and flush.
What happens if I miss a dose of Norofulvin?
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. "GRISEOFULVIN, ULTRAMICROSIZE: 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. "griseofulvin". http://www.drugbank.ca/drugs/DB00400 (accessed September 17, 2018).
- MeSH. "Antifungal Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
