What happens if I overdose Sporadal?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Sporadal tablets:
Store Sporadal tablets at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sporadal tablets out of the reach of children and away from pets.
Overdose of Sporadal in details
Sporadal is not removed by dialysis.
There are limited data on the outcomes of patients ingesting high doses of Sporadal. In patients taking either 1000 mg of Sporadal® (Sporadal)
Oral Solution or up to 3000 mg of Sporadal® (Sporadal injection) Capsules, or b.i.d. dosing for four days with Sporadal® (Sporadal injection) Injection, the adverse event profile was similar to that observed at recommended doses.
What should I avoid while taking Sporadal?
This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid taking antacids within 1 hour before or 2 hours after you take Sporadal. Some antacids can make it harder for your body to absorb Sporadal.
Sporadal warnings
Sporadal® (Sporadal) Injection contains the excipient hydroxypropylβ-cyclodextrin which produced pancreatic adenocarcinomas in a rat carcinogenicity study. These findings were not observed in a similar mouse carcinogenicity study. The clinical relevance of these findings is unknown.
Hepatic Effects
Sporadal® (Sporadal injection) has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition, and some of these cases developed within the first week of treatment. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. Continued Sporadal® (Sporadal injection) use or reinstitution of treatment with Sporadal® (Sporadal injection) is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk.
Cardiac Dysrhythmias
Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), or quinidine concomitantly with Sporadal® (Sporadal injection) and/or other CYP3A4 inhibitors. Concomitant administration of these drugs with Sporadal® is contraindicated.
Cardiac Disease
Sporadal® (Sporadal injection) Injection should not be used in patients with evidence of ventricular dysfunction unless the benefit clearly outweighs the risk. For patients with risk factors for congestive heart failure, physicians should carefully review the risks and benefits of Sporadal® (Sporadal injection) therapy. These risk factors include cardiac disease such as ischemic and valvular disease; significant pulmonary disease such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of CHF, should be treated with caution, and should be monitored for signs and symptoms of CHF during treatment. If signs or symptoms of CHF appear during administration of Sporadal® (Sporadal injection) Injection, monitor carefully and consider other treatment alternatives which may include discontinuation of Sporadal® Injection administration.
Sporadal has been shown to have a negative inotropic effect. When Sporadal was administered intravenously to anesthetized dogs, a dose-related negative inotropic effect was documented. In a healthy volunteer study of Sporadal® (Sporadal injection) Injection (intravenous infusion), transient, asymptomatic decreases in left ventricular ejection fraction were observed using gated SPECT imaging; these resolved before the next infusion, 12 hours later.
Sporadal® (Sporadal injection) has been associated with reports of congestive heart failure. In post-marketing experience, heart failure was more frequently reported in patients receiving a total daily dose of 400 mg although there were also cases reported among those receiving lower total daily doses.
Calcium channel blockers can have negative inotropic effects which may be additive to those of Sporadal. In addition, Sporadal can inhibit the metabolism of calcium channel blockers. Therefore, caution should be used when co-administering Sporadal and calcium channel blockers due to an increased risk of CHF. Concomitant administration of Sporadal® (Sporadal injection) and nisoldipine is contraindicated.
Cases of CHF, peripheral edema, and pulmonary edema have been reported in the post-marketing period among patients being treated for onychomycosis and/or systemic fungal infections.
What should I discuss with my healthcare provider before taking Sporadal?
For all uses of Sporadal (Sporadal capsules (Sporadal)):
- If you have an allergy to Sporadal or any other part of Sporadal (Sporadal capsules (Sporadal)).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
Nail fungal infections:
- If you are pregnant or may be pregnant. Do not take Sporadal (Sporadal capsules (Sporadal)) if you are pregnant.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Sporadal (Sporadal capsules (Sporadal)) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Sporadal precautions
In a healthy volunteer study with Sporadal IV, a transient asymptomatic decrease of the left ventricular ejection fraction was observed; this resolved before the next infusion. The clinical relevance of these findings to the oral formulations is unknown.
Sporadal has been shown to have a negative inotropic effect and Sporadal has been associated with reports of congestive heart failure. Sporadal should not be used in patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk. This individual benefit/risk assessment should take into consideration factors eg, the severity of the indication, the dosing regimen, and individual risk factors for congestive heart failure. These risk factors include cardiac disease eg, ischemic and valvular disease; significant pulmonary disease eg, chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of congestive heart failure, should be treated with caution, and should be monitored for signs and symptoms of congestive heart failure during treatment; if such signs or symptoms do occur during treatment, Sporadal should be discontinued.
Calcium-channel blockers can have negative inotropic effects which may be additive to those of Sporadal; Sporadal can inhibit the metabolism of calcium-channel blockers. Therefore, caution should be used when co-administering Sporadal and calcium-channel blockers.
Sporadal has a potential for clinically important drug interactions.
It is advisable to monitor liver function in patients receiving continuous treatment of >1 month and promptly in patients developing symptoms suggestive of hepatitis eg, anorexia, nausea, vomiting, fatigue, abdominal pain or dark urine. If abnormal, treatment should be stopped. In patients with raised liver enzymes or an active liver disease, or who have experienced liver toxicity with other drugs, treatment should not be started unless the expected benefit exceeds the risk of hepatic injury. In such cases, liver enzyme monitoring is necessary.
Decreased Gastric Acidity: Absorption of Sporadal from Sporadal capsules is impaired when the gastric acidity is decreased. In patients also receiving acid neutralizing medicines (eg, aluminum hydroxide), these should be administered at least 2 hrs after the intake of Sporadal capsules. In patients with achlorhydria eg, certain AIDS patients and patients on acid secretion suppressors (eg, H2-antagonists, proton-pump inhibitors), it is advisable to administer Sporadal capsules with a cola beverage.
Hepatic Impairment: Sporadal is predominantly metabolized in the liver. The terminal half-life of Sporadal in cirrhotic patients is somewhat prolonged. The oral bioavailability in cirrhotic patients is somewhat decreased. It is advised to monitor the Sporadal plasma concentrations and to adapt the dose when necessary.
Renal Impairment: The bioavailability of Sporadal may be lower in patients with renal insufficiency. Monitoring of the Sporadal plasma concentrations and a dose adaptation is advisable.
If neuropathy occurs that may be attributable to Sporadal, the treatment should be discontinued.
There is no information regarding cross-hypersensitivity between Sporadal and other azole antifungal agents. Caution should be used in prescribing Sporadal to patients with hypersensitivity to other azoles.
Effects on the Ability to Drive or Operate Machinery: No effects have been observed.
Use in pregnancy & lactation: When administered at high doses to pregnant rats (≥40 mg/kg/day) and mice (≥80 mg/kg/day), Sporadal was shown to increase the incidence of foetal abnormalities and did produce adverse effects on the embryo.
Studies of the use of Sporadal in pregnant women are not available. Therefore, Sporadal should only be given in life-threatening cases of systemic mycosis and when in these cases, the potential benefit outweighs the potential harm to the foetus.
A very small amount of Sporadal is excreted in human milk. The expected benefits of Sporadal therapy should therefore be weighed against the potential risk of breastfeeding. In case of doubt, the patient should not breastfeed.
Use in children: Since clinical data of the use of Sporadal in paediatric patients is limited, it should not be used in these patients unless the potential benefit outweighs the potential risks.
Use in the
Elderly: Since the clinical data on the use of Sporadal in elderly patients is limited, it is advised to use Sporadal in these patients only if the potential benefit outweighs the potential risks.
What happens if I miss a dose of Sporadal?
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. "ITRACONAZOLE: 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. "itraconazole". http://www.drugbank.ca/drugs/DB01167 (accessed September 17, 2018).
- MeSH. "14-alpha Demethylase 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
