Fioricet with codeine

What is Fioricet with codeine?

Fioricet with codeine is a strong prescription pain medicine that contains an opioid (narcotic) that is indicated for the relief of the symptom complex of tension (or muscle contraction) headache, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them an opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Description

FIORICET with CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) is supplied in capsule form for oral administration. Each capsule contains:

Butalbital, USP………………….50 mg

Acetaminophen, USP…………300 mg

Caffeine, USP…………………..40 mg

Codeine phosphate, USP……….30 mg

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula:

Acetaminophen (4’hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic.  It has the following structural formula:

Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:

Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula:

Inactive Ingredients: FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and titanium dioxide.

Mechanism of Action

Butalbital, a barbiturate, is a GABAA receptor agonist and may inhibit excitatory AMPA receptors.

The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.

Caffeine is a methylxanthine and CNS stimulant. The exact mechanism with respect to the indication is not clear; however, the effects of caffeine may be due to antagonism of adenosine receptors.

Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.

What is the most important information I should know about Fioricet with codeine?

• Get emergency help right away if you take too much Fioricet with codeine (overdose). When you first start taking Fioricet with codeine, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking Fioricet with codeine with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your Fioricet with codeine. They could die from taking it. Store Fioricet with codeine away from children and in a safe place to prevent stealing or abuse. Selling or giving away Fioricet with codeine is against the law.
• Get emergency help right away if you take more than 4,000 mg of acetaminophen in 1 day. Taking Fioricet with codeine with other products that contain acetaminophen can lead to serious liver problems and death.

Important Information Guiding Use in Pediatric Patients:

• Do not give Fioricet with codeine to a child younger than 12 years of age.
• Do not give Fioricet with codeine to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving Fioricet with codeine to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

Who should not take Fioricet with codeine?

Do not take Fioricet with codeine if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

What should I tell my healthcare provider before taking Fioricet with codeine?

Before taking Fioricet with codeine, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.
• Have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines
• liver, kidney, thyroid problems
• pancreas or gallbladder problems

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of Fioricet with codeine, during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended; may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Fioricet with codeine with certain other medicines can cause serious side effects that could lead to death.

How should I take Fioricet with codeine?

When taking Fioricet with codeine:

• Do not change your dose. Take Fioricet with codeine exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose of 1 or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking Fioricet with codeine regularly, do not stop taking Fioricet with codeine without talking to your healthcare provider.
• After you stop taking Fioricet with codeine, dispose the unused Fioricet with codeine in accordance with the local state guidelines and/or regulations.

What should I avoid while taking Fioricet with codeine?

While taking Fioricet with codeine DO NOT:

• Drive or operate heavy machinery, until you know how Fioricet with codeine affects you. Fioricet with codeine can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Fioricet with codeine may cause you to overdose and die.

What are the possible side effects of Fioricet with codeine?

The possible side effects of Fioricet with codeine:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you:

• have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
• are a nursing mother taking Fioricet with codeine, and your breastfeeding baby has increased sleepiness, confusion, difficulty breathing, shallow breathing, limpness, or difficulty breastfeeding.

These are not all the possible side effects of Fioricet with codeine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Fioricet with codeine?

Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Store Fioricet with Codeine securely and dispose of properly .

Keep this and all medication out of the reach of children.

What are the ingredients in Fioricet with codeine?

Active ingredients: butalbital, acetaminophen, caffeine, codeine phosphate

Inactive ingredients: FD&C blue no. 1; FD&C red no. 40; FD&C yellow no. 6; gelatin, unspecified; microcrystalline cellulose; sodium lauryl sulfate; stearic acid; talc; titanium dioxide

Label

PRINCIPAL DISPLAY PANEL