Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Ketoza shampoo may be harmful if swallowed.
Proper storage of Ketoza shampoo:
Store Ketoza shampoo at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketoza shampoo out of the reach of children and away from pets.
Overdose of Ketoza 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.
Treatment: There has been no experience of overdosage with Ketoza cream.
To Avoid Aspiration: Gastric lavage or induced emesis should not be performed. It has been reported that Ketoza cannot be removed by hemodialysis.
Specific Treatment: Use general supportive measures and appropriate routine overdose management.
Supportive Care: Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
What should I avoid while taking Ketoza?
Avoid taking antacids, stomach acid reducers, or medicines to treat stomach ulcer or gastroesophageal reflux disease (Axid, Nexium, Pepcid, Prevacid Prilosec, sucralfate, Tagamet, Zantac, and others). These medications can make it harder for your body to absorb Ketoza.
Avoid drinking alcohol. It may increase your risk of liver damage while you are taking Ketoza.
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.
Ketoza Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation, has occurred with the use of oral Ketoza. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity was reported both by patients receiving high doses for short treatment durations and by patients receiving low doses for long durations.
The hepatic injury has usually, but not always, been reversible upon discontinuation of Ketoza Tablets treatment. Cases of hepatitis have been reported in children.
At baseline, obtain laboratory tests (such as SGGT, alkaline phosphatase, ALT, AST, total bilirubin (TBL), Prothrombin Time (PT), International Normalization Ratio (INR), and testing for viral hepatitides). Patients should be advised against alcohol consumption while on treatment. If possible, use of other potentially hepatotoxic drugs should be avoided in patients receiving Ketoza Tablets.
Prompt recognition of liver injury is essential. During the course of treatment, serum ALT should be monitored weekly for the duration of treatment. If ALT values increase to a level above the upper limit of normal or 30 percent above baseline, or if the patient develops symptoms, Ketoza treatment should be interrupted and a full set of liver tests should be obtained. Liver tests should be repeated to ensure normalization of values. Hepatotoxicity has been reported with restarting oral Ketoza (rechallenge). If it is decided to restart oral Ketoza, monitor the patient frequently to detect any recurring liver injury from the drug.
QT Prolongation and Drug Interactions Leading to QT Prolongation
Ketoza can prolong the QT interval. Coadministration of the following drugs with Ketoza is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine. Ketoza can cause elevated plasma concentrations of these drugs which may prolong the QT interval, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes.
Ketoza Tablets decrease adrenal corticosteroid secretion at doses of 400 mg and higher. This effect is not shared with other azoles. The recommended dose of 200 mg to 400 mg daily should not be exceeded.
Adrenal function should be monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients under prolonged periods of stress (major surgery, intensive care, etc.).
Adverse Reactions Associated with Unapproved Uses
Ketoza has been used in high doses for the treatment of advanced prostate cancer and for Cushing’s syndrome when other treatment options have failed. The safety and effectiveness of Ketoza have not been established in these settings and the use of Ketoza for these indications is not approved by FDA.
In a clinical trial involving 350 patients with metastatic prostatic cancer, eleven deaths were reported within two weeks of starting treatment with high doses of Ketoza Tablets (1200 mg/day). It is not possible to ascertain from the information available whether death was related to Ketoza therapy or adrenal insufficiency in these patients with serious underlying disease.
Anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported.
What should I discuss with my healthcare provider before taking Ketoza?
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 Ketoza, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to Ketoza 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.
Appropriate studies have not been performed on the relationship of age to the effects of Ketoza topical in children younger than 12 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ketoza topical in the elderly. However, some elderly patients may be more sensitive to the side effects of Ketoza.
Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
Ketoza Tablets have been demonstrated to lower serum testosterone. Once therapy with Ketoza has been discontinued, serum testosterone levels return to baseline values. Testosterone levels are impaired with doses of 800 mg per day and abolished by 1600 mg per day. Clinical manifestations of decreased testosterone concentrations may include gynecomastia, impotence and oligospermia.
Information for Patients
Patients should be instructed to report any signs and symptoms which may suggest liver dysfunction so that appropriate biochemical testing can be done. Such signs and symptoms may include unusual fatigue, anorexia, nausea and/or vomiting, abdominal pain, jaundice, dark urine or pale stools.
Ketoza is mainly metabolized through CYP3A4. Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of Ketoza. Similarly, Ketoza may modify the pharmacokinetics of other substances that share this metabolic pathway. Ketoza is a potent CYP3A4 inhibitor and a P-glycoprotein inhibitor. When using concomitant medication, the corresponding label should be consulted for information on the route of metabolism and the possible need to adjust dosages.
Interaction studies have only been performed in adults. The relevance of the results from these studies in pediatric patients is unknown.
Drugs that may decrease Ketoza plasma concentrations
Drugs that reduce the gastric acidity (e.g., acid neutralizing medicines such as aluminum hydroxide, or acid secretion suppressors such as H2-receptor antagonists and proton pump inhibitors) impair the absorption of Ketoza from Ketoza Tablets. These drugs should be used with caution when coadministered with Ketoza Tablets:
Ketoza Tablets should be administered with an acidic beverage (such as non-diet cola) upon co-treatment with drugs reducing gastric acidity.
Acid neutralizing medicines (e.g., aluminum hydroxide) should be administered at least 1 hour before or 2 hours after the intake of Ketoza Tablets.
Upon coadministration, the antifungal activity should be monitored and the Ketoza Tablets dose increased as deemed necessary.
Coadministration of Ketoza Tablets with potent enzyme inducers of CYP3A4 may decrease the bioavailability of Ketoza to such an extent that efficacy may be reduced. Examples include:
Antibacterials: isoniazid, rifabutin, rifampicin.
Anticonvulsants: carbamazepine, phenytoin.
Antivirals: efavirenz, nevirapine.
Therefore, administration of potent enzyme inducers of CYP3A4 with Ketoza Tablets is not recommended. The use of these drugs should be avoided from 2 weeks before and during treatment with Ketoza Tablets, unless the benefits outweigh the risk of potentially reduced Ketoza efficacy. Upon coadministration, the antifungal activity should be monitored and the Ketoza Tablets dose increased as deemed necessary.
Drugs that may increase Ketoza plasma concentrations
Potent inhibitors of CYP3A4 (e.g., antivirals such as ritonavir, ritonavir-boosted darunavir and ritonavir-boosted fosamprenavir) may increase the bioavailability of Ketoza. These drugs should be used with caution when coadministered with Ketoza Tablets.
Patients who must take Ketoza Tablets concomitantly with potent inhibitors of CYP3A4 should be monitored closely for signs or symptoms of increased or prolonged pharmacologic effects of Ketoza, and the Ketoza Tablets dose should be decreased as deemed necessary. When appropriate, Ketoza plasma concentrations should be measured.
Drugs that may have their plasma concentrations increased by Ketoza
Ketoza can inhibit the metabolism of drugs metabolized by CYP3A4 and can inhibit the drug transport by P-glycoprotein, which may result in increased plasma concentrations of these drugs and/or their active metabolite(s) when they are administered with Ketoza. These elevated plasma concentrations may increase or prolong both therapeutic and adverse effects of these drugs. CYP3A4-metabolized drugs known to prolong the QT interval may be contraindicated with Ketoza Tablets, since the combination may lead to ventricular tachyarrhythmias, including occurrences of torsade de pointes, a potentially fatal arrhythmia.
Examples of drugs that may have their plasma concentrations increased by Ketoza presented by drug class with advice regarding coadministration with Ketoza Tablets:
Carcinogenesis, Mutagenesis, Impairment of Fertility
Ketoza did not show any signs of mutagenic potential when evaluated using the dominant lethal mutation test or the Ames Salmonella microsomal activator assay. Ketoza was not carcinogenic in an 18 month, oral study in Swiss albino mice or a 24 month oral carcinogenicity study in Wistar rats at dose levels of 5, 20 and 80 mg/kg/day. The high dose in these studies was approximately 1x (mouse) or 2x (rat) the clinical dose in humans based on a mg/m2 comparison.
Pregnancy Category C
Ketoza has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given in the diet at 80 mg/kg/day (2 times the maximum recommended human dose, based on body surface area comparisons). However, these effects may be related to maternal toxicity, evidence of which also was seen at this and higher dose levels.
There are no adequate and well controlled studies in pregnant women. Ketoza Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Ketoza has also been found to be embryotoxic in the rat when given in the diet at doses higher than 80 mg/kg during the first trimester of gestation.
In addition, dystocia (difficult labor) was noted in rats administered oral Ketoza during the third trimester of gestation. This occurred when Ketoza was administered at doses higher than 10 mg/kg (about one fourth the maximum human dose, based on body surface area comparison).
Ketoza has been shown to be excreted in the milk. Mothers who are under treatment with Ketoza Tablets should not breast feed.
Ketoza Tablets have not been systematically studied in children of any age, and essentially no information is available on children under 2 years. Ketoza Tablets should not be used in pediatric patients unless the potential benefit outweighs the risks.
What happens if I miss a dose of Ketoza?
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.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
DailyMed. "KETOCONAZOLE: 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).