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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Able Laboratories Receives FDA Approval for the Generic Version of Esgic Plus Tablets
From Business Wire, 7/25/01

Business Editors/Health & Medical Writers

SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--July 25, 2001

Generic Version of Esgic Plus(R) With Estimated

Generic Market of $16 Million

Able Laboratories, Inc. (OTCBB:ABRX), today announced it has received Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophene, Caffeine Tablets USP, 50mg/500mg/40mg. The approval followed the FDA's Division of Bioequivalence's determination that Able's Butalbital, Acetaminophene, Caffeine Tablets USP, 50mg/500mg/40mg are bioequivalent and, therefore, therapeutically equivalent to the Esgic Plus(R) tablets of Mikart, Inc. The generic market for Able's newly approved drug, an analgesic tablet used as a pain reliever and relaxant for the treatment of tension and muscle contraction headaches, is estimated to be $16 million by IMS Data.

"These are very exciting times for us. Yesterday, we announced we had received FDA approval for our generic equivalent of Fioricet(R)," commented Jay Wadekar, President and Chief Operating Officer of Able Laboratories, Inc. "I am extremely pleased to announce this second approval today. We have now received four FDA approval in July alone with a total of nine since November 2000. Additionally, we currently have six ANDAs pending approval and our R&D efforts are continuing to feed our new product pipeline."

"I would like to congratulate our employees for all their hard work and the resulting nine FDA approvals we have received in less than eight months," stated C. Robert Cusick, Chairman and Chief Executive Officer of Able Laboratories, Inc. "It is our strategy to focus our continuing R&D efforts on areas of the generic market where we believe we can utilize our expertise and skill. These areas include suppositories and extended release formulations. We also are searching out niche areas with little competition or that will add breadth to our rapidly growing product line."

Able Laboratories (OTCBB:ABRX) is a rapidly growing developer and manufacturer of generic pharmaceuticals. Able's focus is to develop products that offer attractive market opportunities within selected niche markets of the generic drug industry. Able has recently completed its transition to focus the company's activities primarily on generic drug development, manufacturing and sales.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking Statements. Certain information included in this news release (as well as information included in oral statements or other written statements made or to be made by Able Laboratories, Inc. f/k/a DynaGen, Inc.) contain statements that are forward-looking, such statements relate to anticipated future revenues of the company success of current product offerings, research and development efforts and the timeliness of Food and Drug Administration (FDA) filings and approvals. There is no assurance that the company will achieve the sales levels that will make the operation profitable or that FDA filings and approvals will be completed as anticipated. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future and accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Able Laboratories, Inc. f/k/a DynaGen, Inc. For a description of additional risks, and uncertainties, please refer to Able Laboratories, Inc. f/k/a DynaGen, Inc. filings with the Securities and Exchange Commission, including Forms 10 -KSB and 10-Q.

Esgic Plus is a registered trademark of Mikart, Inc.

COPYRIGHT 2001 Business Wire
COPYRIGHT 2001 Gale Group

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