Isometheptene, caffeine and acetaminophen

{{DrugProjectFormSinglePage |authorTag=Alberto Plate [1] |genericName=Isometheptene, caffeine and acetaminophen |aOrAn=an |drugClass=analgesic |indicationType=treatment |indication=tension and vascular headaches |hasBlackBoxWarning=Yes |adverseReactions=hepatotoxicity |blackBoxWarningTitle=Warning |blackBoxWarningBody=Hepatotoxicity: Isometheptene, Caffeine, and Acetaminophen Tablets contain acetaminophen, isometheptene mucate and caffeine. Acetaminophen has been associated with cases of acute liver failure at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often in combination with other acetaminophen-containing products. |fdaLIADAdult=====Migraine Headache====

• Dosage: The usual adult dosage is two tablets at once, followed by one tablet every hour until relieved, up to 5 tablets within a twelve hour period.

Tensional Headache

• Dosage: The usual adult dosage is one or two tablets every four hours up to 8 tablets a day.

|offLabelAdultGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Isometheptene, caffeine and acetaminophen in adult patients. |offLabelAdultNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Isometheptene, caffeine and acetaminophen in adult patients. |offLabelPedGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Isometheptene, caffeine and acetaminophen in pediatric patients. |offLabelPedNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Isometheptene, caffeine and acetaminophen in pediatric patients. |contraindications=This Product is contraindicated in Glaucoma and/or severe cases of renal disease, hypertension, organic heart disease, hepatic disease, and in those patients who are on monoamine oxidase inhibitor (MAOI) therapy. |warnings=====Hepatotoxicity====

• Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
• Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/Anaphylaxis

• There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Isometheptene, Caffeine, and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Isometheptene, Caffeine, and Acetaminophen Tablets for patients with acetaminophen allergy.

|clinicalTrials=*Hypersensitive patients have shown [[rash] and transient dizziness, this can be eliminated by reducing dosage. |overdose=====Following an acute overdosage, toxicity may result====

• Acetaminophen – In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

|howSupplied=Isometheptene, Caffeine, and Acetaminophen Tablets are supplied as white tablets debossed “130” on one side, and scored on the opposite side. Available in bottles of 50 tablets, NDC 50967-620-50. |storage=Store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Avoid exposure to heat.

|alcohol=Alcohol-Isometheptene, caffeine and acetaminophen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. }}