The combination of acetaminophen, butalbital, and caffeine is called Generic fioricet and it is used to treat tension headaches that are caused by muscle contractions. It is also widely used for migraine, cluster headache and all kinds of headache even neck pain.
Actavis debuts new formulations of Fioricet
US generics major Actavis (NYSE: ACT) has launched new formulations of Fioricet (butalbital, acetaminophen and caffeine capsules, USP) and Fioricet with Codeine (butalbital, acetaminophen, caffeine and codeine phosphate, USP) containing a lower dose of acetaminophen, designed to provide a safer treatment option for patients suffering from tension (or muscle contraction) headaches.
Actavis’ new formulations of Fioricet and Fioricet with Codeine reduce the amount of acetaminophen in the products from 325mg to 300mg, following a Food and Drug Administration guideline that recommended manufacturers limit the dose of acetaminophen in all prescription drug products. Neither the total number of pills that may be prescribed, nor the time interval at which they may be prescribed, will change with the new formulations.
Risk of acute liver failure
Acetaminophen is one of the most commonly-used and important medicines in the USA. While rare in the context of its broad usage, overdose of the drug can be toxic and may lead to acute liver failure (ALF). From 1998 to 2003, acetaminophen was the leading cause of ALF in the USA, with 48% of cases related to accidental overdose, and each year, there are an estimated 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths related to overdoses of the drug. In its guidance, the FDA noted that patients had mistakenly taken too many doses of acetaminophen-containing products, some with as high as 750mg per dosage unit.
By reducing the amount of acetaminophen contained in the products, Actavis’ new formulations of Fioricet and Fioricet with Codeine will provide a safer treatment option for patients seeking relief for the symptom complex of tension (or muscle contraction) headaches, the company noted.
Lannett Approved for Generic Fioricet
Lannett Company announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen, and Caffeine Tablets, the generic of Watson‘s Fioricet. It consists of Butalbital 50mg, Acetaminophen 325mg, Caffeine 40mg.
Fioricet tablets are a combination of a barbiturate and an analgesic, and are indicated for tension (or muscle contraction) headaches. Butalbital is a short-acting barbiturate with anticonvulsant and sedative properties. Caffeine is a cranial vasoconstrictor that potentiates analgesia.
The company expects to ship the product next month.
For more information call (215) 333-9000 or visit www.lannett.com.
Butalbital/APAP/Caffeine Tablets – Mayne Pharma
Butalbital / APAP / caffeine tablets are a combination product containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine indicated for the relief of the symptom of tension (or muscle contraction) headaches.
Butalbital / APAP / caffeine tablets are only sold in the USA. For further information, please contact USA Customer Service at 1-800-344-8661.
What is Fioricet and What it is used for ?
Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.
Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.
When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.
Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.
The usual adult dose is 1-2 tablets every four hours as needed, not exceeding six tablets in a 24-hour period.
Generic Fioricet Manufacturers
There are a lot of manufacturers can produce generic fioricet because they are just compound of butalbital, apap, caffeine.
| Generic Fioricet | CAPSULE; ORAL | MIKART | 89007 | |
| CAPSULE; ORAL | NEXGEN PHARMA | 40885 | ||
| CAPSULE; ORAL | WEST WARD | 40261 | ||
| CAPSULE; ORAL | MIKART | 40085 | ||
| SOLUTION; ORAL | MIKART | 40387 | ||
| TABLET; ORAL | CONCORD LABS NJ | 40864 | ||
| TABLET; ORAL | CONCORD LABS NJ | 40883 | ||
| TABLET; ORAL | MALLINCKRODT | 87804 | ||
| TABLET; ORAL | MIKART | 89175 | ||
| TABLET; ORAL | MIKART | 40496 | ||
| TABLET; ORAL | VINTAGE PHARMS | 40511 | ||
| TABLET; ORAL | VINTAGE PHARMS | 40513 | ||
| TABLET; ORAL | WATSON LABS | 40267 | ||
| TABLET; ORAL | WEST WARD | 89718 | ||
| TABLET; ORAL | WEST WARD | 40336 | ||
| TABLET; ORAL | MIKART | 89451 | ||
| TABLET; ORAL | WATSON LABS | 88616 |
Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide. The images of generic fioricet are listed below:
