Ketoza Overdose

Did you have any side effects with this medicine?
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What happens if I overdose Ketoza?

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.
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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 or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of Ketoza. These medications can make it harder for the Ketoza tablet to dissolve in your stomach.

Avoid drinking alcohol. It may cause unpleasant side effects while you are taking Ketoza.

Ketoza warnings

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.

Hepatotoxicity

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. Co-administration of the following drugs with Ketoza is contraindicated: dofetilide, quinidine, pimozide, and cisapride. 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.

Adrenal Insufficiency

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 - 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.

Hypersensitivity

Anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported.

Enhanced Sedation

Co-administration of Ketoza® Tablets with oral midazolam, oral triazolam or alprazolam has resulted in elevated plasma concentrations of these drugs. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Concomitant administration of Ketoza® Tablets with oral triazolam, oral midazolam, or alprazolam is contraindicated.

Myopathy

Co-administration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with Ketoza® Tablets.

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:

Allergies

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.

Pediatric

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.

Geriatric

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.

Pregnancy

Pregnancy Category Explanation
All Trimesters C 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.

Breast Feeding

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.

Ketoza precautions

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.
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Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Ketoza Shampoo, 2%. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.

Information for Patients

Patients should be advised of the following:

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to assess the carcinogenic potential of Ketoza Shampoo, 2% have not been conducted. A long-term feeding study of Ketoza in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of Ketoza as high as 80 mg/kg were not genotoxic. The Ames Salmonella microsomal activator assay was also negative.

Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Ketoza should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, Ketoza is not detected in plasma after chronic shampooing on the scalp.

Ketoza has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

Nursing Mothers

There are no adequate and well-controlled studies in nursing women. Ketoza is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when Ketoza Shampoo, 2%, is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

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.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


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References

  1. 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).
  2. DrugBank. "ketoconazole". http://www.drugbank.ca/drugs/DB01026 (accessed September 17, 2018).
  3. MeSH. "14-alpha Demethylase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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