Drug Interactions between Jentadueto XR and mitotane

MetFORMIN should be taken with meals, and excessive alcohol intake (either short-term binge drinking or frequent consumption) should be avoided during treatment. Taking metFORMIN with alcohol may increase the risk of a rare but serious and potentially life-threatening condition known as lactic acidosis, which is a buildup of lactic acid in the blood that can occasionally occur during treatment with metformin-containing products. Lactic acidosis is more likely to occur if you have kidney or liver disease, acute or unstable congestive heart failure, or dehydration. You should seek immediate medical attention if you develop potential signs and symptoms of lactic acidosis such as fatigue, weakness, muscle pain, increasing drowsiness, abdominal pain or discomfort, slow or irregular heartbeat, breathing difficulty, chills, and other unusual symptoms. Alcohol may also affect blood glucose levels in patients with diabetes. Both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) may occur, depending on how much and how often you drink. You should avoid using alcohol if your diabetes is not well controlled or if you have high triglycerides, neuropathy (nerve damage), or pancreatitis. Moderate alcohol consumption generally does not affect blood glucose levels if your diabetes is under control. However, you should limit your alcohol intake due to the risk of lactic acidosis with metformin. Avoid drinking alcohol on an empty stomach or following exercise, as it may increase the risk of hypoglycemia. Talk to your doctor or pharmacist if you have any questions or concerns about metformin.

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ADJUST DOSING INTERVAL: Fat-rich food enhances the absorption of mitotane. One study evaluated blood levels of mitotane (o,p'-DDD) after subjects ingested a single dose of 2 g administered using various delivery vehicles (e.g., tablets, granules, milk, chocolate or oil emulsion). Mitotane plasma levels were significantly higher for milk, chocolate, and oil emulsion when compared to those who received tablets or granules alone. In the same study, mitotane levels were evaluated in subjects following long-term treatment (total dose of 200 g over 30 to 60 days) in tablet, oil emulsion, or milk formulations. Significantly higher mean plasma levels were recorded in subjects who received mitotane as an oil emulsion or mixed in milk, when compared to tablets alone. Additionally, the recovery of o,p'-DDD from the feces was about 5 times higher in subjects who received tablets alone, suggesting absorption was reduced when compared to subjects who received mitotane mixed with a fat-rich vehicle (e.g., oil emulsion or milk).

GENERALLY AVOID: Concomitant use of mitotane with central nervous system (CNS) depressants, including alcohol, may potentiate adverse effects such as somnolence and sedation.

MANAGEMENT: According to product labeling, mitotane tablets should be taken during meals containing fat-rich food (e.g., milk, chocolate, or oil) and with a full glass of water. Patients should be advised to avoid or limit consumption of alcohol and to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them.

Alcohol may affect blood glucose levels in patients with diabetes. Both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) may occur, depending on how much and how often you drink. You should avoid using alcohol if your diabetes is not well controlled or if you have high triglycerides, neuropathy (nerve damage), or pancreatitis. Moderate alcohol consumption generally does not affect blood glucose levels if your diabetes is under control. However, it may be best to limit alcohol intake to one drink daily for women and two drinks daily for men (1 drink = 5 oz wine, 12 oz beer, or 1.5 oz distilled spirits) in conjunction with your normal meal plan. Avoid drinking alcohol on an empty stomach or following exercise, as it may increase the risk of hypoglycemia. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

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