Black Box Warning: Pancreatitis, Lactic Acidosis and Hepatomegaly With Steatosis
Fatal and non-fatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naïve and treatment-experienced patients, regardless of the degree of immunosuppression.
Dinex EC capsules should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis (see WARNINGS AND PRECAUTIONS).
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk (see WARNINGS AND PRECAUTIONS).
Side effects of Dinex EC
• Most Common : Inflammation of pancreas, diarrhea, nausea, vomiting, abdominal pain, headache, fatigue, rash, urea in blood, liver failure and blurred vision.
Dosage & When it is to be taken (Indications)
Daily dose is based on body weight.
Adult: PO- As tab/cap: patients with body weight more than 60kg: 400 mg/day. Patients with body weight less than 60 kg: 250 mg/day.
It comes as a tablet to take by mouth, on en empty stomach.
When is Dinex EC not to be taken? (Contraindications)
Warnings and Precautions for Dinex EC
• Caution should be exercised in patients with history of advanced HIV infection (AIDS), kidney, liver problems, gallstones, nerve problems, high blood cholesterol, any allergy, who are taking other medications, elderly, children especially less than 2 yeas old, during pregnancy and breastfeeding.
• Avoid alcohol consumption.
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