Methylphenidate-induced autoimmune hepatitis.

Methylphenidate is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

Hepatic dysfunction due to intravenous abuse of methylphenidate hydrochloride.

Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.


Methylphenidate is a mild central nervous system stimulant.

Multiple organ failure resulting from intravenous abuse of methylphenidate hydrochloride.

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A 19 year old woman who had been abusing methylphenidate developed fatigue, fever and jaundice. She admitted to intravenous injection of methylphenidate tablets that had been dissolved in water. She had no history of liver disease or alcohol abuse. She was not taking other medications. On physical examination, she was jaundiced and had an enlarged, slightly tender liver. There were no peripheral manifestations of cirrhosis or chronic liver disease. Laboratory tests showed elevations in serum bilirubin (13 mg/dL) and AST (4,942 U/L), with minimal increase in alkaline phosphatase (100 U/L) (Table). Tests for hepatitis A and B were negative. Tests for hepatitis C were not available at the time of this report. A liver biopsy showed focal necrosis and portal inflammation with lymphocytes, plasma cells and eosinophils, typical of drug induced liver injury. Rechallenge with 4 injections of 20 mg of methylphenidate over two days led to rapid recurrence with a similar pattern of injury.






Methylphenidate (Oral Route) Description and Brand …

Methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 5 times the maximum recommended human dose on a mg/kg and mg/m basis, respectively.

Methylphenidate | Side Effects, Dosage, Uses, and More

In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 4 times the maximum recommended human dose on a mg/kg and mg/m basis respectively.

Concerta (Methylphenidate Extended-Release Tablets): …

Adequate and well-controlled studies in pregnant women have not been conducted. Methylphenidate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Common Side Effects of Ritalin (Methylphenidate Hcl) …

Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe methylphenidate should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.

Concerta (methylphenidate) Side Effects and Warnings

It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Methylphenidate Hydrochloride Tablets are administered to a nursing woman.