Prodrin
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For relief of tension and vascular headaches.*
*Based on a review of this drug (isometheptene mucate), the National Academy of Sciences- National Research Council and/or other information, FDA has classified the other indication as “Possibly” effective in the treatment of migraine headache. Final classification of less than effective indication requires further investigation.
History
There is currently no drug history available for this drug.
Other Information
Each PRODRIN Caplet contains:
Isometheptene Mucate ......................................... 65 mg
Caffeine ............................................................... 20 mg
Acetaminophen .................................................. 325 mg
Isometheptene Mucate is a white crystalline powder having a characteristic aromatic odor and bitter taste. It is an unsaturated aliphatic amine with sympathomimetic properties. Isometheptene mucate has the following structural formula:
Caffeine is 1H-Purine-2,6-dione, 3,7-dyhydro-1,3,7-trimethyl-. It has the following structural formula:
Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is Acetamide, N-(4-hydroxyphenyl)-. It has the following structural formula:
Sources
Prodrin Manufacturers
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Gentex Pharma
![Prodrin (Isometheptene Mucate, Caffeine, And Acetaminophen) Tablet [Gentex Pharma]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Prodrin | Gentex Pharma
FOR RELIEF OF MIGRAINE HEADACHE: The usual adult dosage is one or two caplets at once, followed by one caplet every hour until relieved, up to 5 caplets within a twelve hour period.
FOR RELIEF OF TENSION HEADACHE: The usual adult dosage is one or two caplets every four hours up to 8 caplets a day.
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