Generic Fioricet (50/40/325)
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Esgic

Fioricet and Esgic are brand name drugs made from a combination of acetaminophen (325 mg), butalbital (a barbiturate, 50 mg), and caffeine (40 mg). They are usually used to treat tension headaches and migraine headaches. more...

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Usage and Dosage

Fioricet is usually perscribed for difficult to treat tension headaches as well as migraine. The common dosing schedule is to take 1 - 2 tablets every 4 hours as needed, being careful not to exceed 12 tablets in 24 hours, both to avoid an overdose on the Butalbital and Caffeine, but also because an exceess of 4 grams of Acetaminophen per day causes a serious risk of liver damage.

This usage and dosing info is for informational purposes only and should not be used in place of the instructions of your doctor.

Side Effects

Side effects for any drug are difficult to predict, but commonly reported side effects for Fioricet include:

  • Abdominal pain
  • Dizziness
  • Drowsiness
  • Intoxicated feeling
  • Light-headedness
  • Nausea
  • Sedation
  • Addiction

There are other potential side-effects, this list should not be considered all-inclusive.

Dangers and Risks

Fioricet contains acetaminophen, which has been shown to cause Liver damage at higher dosages. Care should be excersized when using Fioricet to prevent possible liver damage. Fioricet also contains Butalbital, which is an addictive, mind (and behavior) altering barbituate. Fioricet can be habit forming. Fioricet should not be mixed with Alcohol, both due to the possibility of exacerbating liver damage in combination with the APAP, and due to increased risk of intoxication in combination with the Butalbital.

There are other potential risks, this list should not be considered all-inclusive.

Read more at Wikipedia.org


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Unapproved analgesic sales stopped - Esgic with Codeine
From FDA Consumer, 4/1/90 by Dale Blumenthal

The federal government has told a drug manufacturer to stop selling a prescription painkiller because it is an unapproved new drug.

The analgesic, Esgic with Codeine, manufactured by Forest Pharmaceuticals, Inc., St. Louis, Mo., contains acetaminophen, caffeine, codeine, and butalbital (a barbiturate). Although FDA has approved each of these drugs individually, their combination in one product constitutes a new drug. Under FDA regulations, a new drug can't be marketed until the company submits-and FDA approves-a new drug application.

Forest Pharmaceuticals never sought or received approval for Esgic with Codeine, which the company began selling on April 15, 1987.

FDA immediately advised Forest to take Esgic with Codeine off the market. When Forest didn't comply, the agency considered requesting permission from federal court to seize the product, but delayed acting pending the outcome of a similar case involving the drug Fiorinal with Codeine No. 3. Manufactured by Sandoz Pharmaceuticals, Inc., East Hanover, N.J., Fiorinal with Codeine No. 3 contains the same ingredients as Esgic with Codeine except that it contains aspirin instead of acetaminophen.

In May 1988, the U.S. District Court for the Southern District of Ohio ruled that Fiorinal with Codeine No. 3 is an unapproved new drug. FDA then determined that Forest was still selling Esgic with Codeine and requested permission for seizure from the U.S. District Court for the Eastern District of Missouri. The court granted permission, and U.S. marshals seized approximately 750,000 capsules valued at over $20,000 on Aug. 1, 1988.

On July 10, 1989, the court ordered Forest to stop distributing Esgic with Codeine until the drug is approved by FDA. Forest appealed the court's decision on Oct. 26, 1989. As of this writing, Forest's appeal is being considered by the U.S. Court of Appeals for the 8th Circuit. Both the District Court and the Appeals Court have denied Forest's request to allow the drug to stay on the market during the appeal.

COPYRIGHT 1990 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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