Fiorinal with Codeine Side Effects Center

Last updated on RxList: 5/6/2021
Fiorinal with Codeine Side Effects Center

What Is Fiorinal with Codeine?

Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) is a combination of a pain reliever/anti-inflammatory/fever reducer, a barbiturate, a vasoconstrictor, and a narcotic pain reliever (opiate-type) used to relieve complex tension headaches. Fiorinal with Codeine is available in generic form.

What Are Side Effects of Fiorinal with Codeine?

Common side effects of Fiorinal with Codeine include:

  • nausea,
  • vomiting,
  • stomach upset,
  • heartburn,
  • gas,
  • constipation,
  • diarrhea,
  • shaking (tremor),
  • lightheadedness,
  • dizziness,
  • anxiety,
  • agitation,
  • drowsiness,
  • mood changes,
  • sleep problems (insomnia),
  • sweating,
  • urinating more than usual,
  • ringing in your ears,
  • blurred vision, or
  • dry mouth

Dosage for Fiorinal with Codeine

Dose of Fiorinal with Codeine is 1 or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules.

What Drugs, Substances, or Supplements Interact with Fiorinal with Codeine?

Fiorinal with Codeine may interact with monoamine oxidase inhibitors (MAOIs), antidepressants, alcohol, antihistamines, sedatives, pain relievers, anxiety medicines, muscle relaxants, anticoagulants, probenecid or sulfinpyrazone, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin and other salicylates (forms of aspirin), steroids, or insulin and oral anti-diabetic drugs. Tell your doctor all medications you are taking.

Fiorinal with Codeine During Pregnancy or Breastfeeding

Fiorinal with Codeine is not recommended for use during pregnancy. This drug passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug. Butalbital and codeine are both habit-forming and potentially abusable. Withdrawal symptoms may occur when you stop taking this medication.

Our Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

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Fiorinal with Codeine Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • a slow heart rate or weak pulse;
  • a light-headed feeling, like you might pass out;
  • confusion, unusual thoughts or behavior;
  • easy bruising or bleeding (nosebleeds, bleeding gums);
  • severe constipation;
  • symptoms of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women.

Common side effects include:

  • nausea, vomiting, stomach pain, constipation;
  • headache, dizziness, drowsiness; or
  • feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fiorinal with Codeine (Butalbital Compound With Codeine)

SLIDESHOW

16 Surprising Headache Triggers and Tips for Pain Relief See Slideshow
Fiorinal with Codeine Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
  • Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Severe Hypotension [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Withdrawal [see WARNINGS AND PRECAUTIONS]
  • Coagulation Abnormalities and Bleeding [see WARNINGS AND PRECAUTIONS]
  • Reye’s Syndrome [see WARNINGS AND PRECAUTIONS]
  • Allergy [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Incidence In Controlled Clinical Trials

The following table summarizes the incidence rates of the adverse events reported by at least 1% of the FIORINAL with CODEINE treated patients in controlled clinical trials comparing FIORINAL with CODEINE to placebo, and provides a comparison to the incidence rates reported by the placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.

Adverse Events Reported by at Least 1% of FIORINAL with CODEINE Treated Patients During Placebo Controlled Clinical Trials Incidence Rate of Adverse Events

Body System/Adverse Event FIORINAL with CODEINE
(N=382)
Placebo
(N=377)
Central Nervous
  Drowsiness 2.4% 0.5%
  Dizziness/Lightheadedness 2.6% 0.5%
  Intoxicated Feeling 1.0% 0%
Gastrointestinal
  Nausea/Abdominal Pain 3.7% 0.8%

Other Adverse Events Reported During Controlled Clinical Trials

The listing that follows represents the proportion of the 382 patients exposed to FIORINAL with CODEINE while participating in the controlled clinical trials who reported, on at least one occasion, an adverse event of the type cited. All reported adverse events, except those already presented in the previous table, are included. It is important to emphasize that, although the adverse events reported did occur while the patient was receiving FIORINAL with CODEINE, the adverse events were not necessarily caused by FIORINAL with CODEINE.

Adverse events are classified by body system and frequency. “Frequent” is defined as an adverse event which occurred in at least 1/100 (1%) of the patients; all adverse events listed in the previous table are frequent. “Infrequent” is defined as an adverse event that occurred in less than 1/100 patients but at least 1/1000 patients. All adverse events tabulated below are classified as infrequent.

Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, and sluggishness.

Autonomic Nervous: dry mouth and hyperhidrosis.

Gastrointestinal: vomiting, difficulty swallowing, and heartburn.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain and muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, and tinnitus.

The following adverse drug reactions have been reported with the components of FIORINAL with CODEINE. Potential effects of high dosage are listed in the [OVERDOSE] section of this insert.

Aspirin: occult blood loss, hemolytic anemia, iron deficiency anemia, gastric distress, heartburn, nausea, peptic ulcer, prolonged bleeding time, acute airway obstruction, renal toxicity when taken in high doses for prolonged periods, impaired urate excretion, hepatitis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Codeine: nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of FIORINAL with CODEINE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Central Nervous: abuse, addiction, anxiety, depression, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sedation, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.

Autonomic Nervous: epistaxis, flushing, miosis, salivation.

Gastrointestinal: anorexia, appetite increased, constipation, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasm, hiccup, mouth burning, pyloric ulcer.

Cardiovascular: chest pain, hypotensive reaction, palpitations, syncope.

Skin: erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis.

Urinary: kidney impairment, urinary difficulty.

Miscellaneous: allergic reaction, anaphylactic shock, cholangiocarcinoma, drug interaction with erythromycin (stomach upset), edema.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in FIORINAL with CODEINE.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

DRUG INTERACTIONS

Table 1 includes clinically significant drug interactions with FIORINAL with CODEINE.

Table 1: Clinically Significant Drug Interactions with FIORINAL with CODEINE

Inhibitors of CYP3A4
Clinical Impact: The concomitant use of FIORINAL with CODEINE with CYP3A4 inhibitors may result in an increase in codeine plasma concentrations with subsequently metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fat depression, particularly when an inhibitor is added after a stable dose of FIORINAL with CODEINE is achieved.

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metaboli with resultant lower morphine levels [see CLINICAL PHARMACOLOGY], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who developed physical dependence to codeine.

Intervention: If concomitant use with CYP3A4 inhibitor is necessary, consider dosage reduction of FIORINAL with CODEINE until stable drug effects are achieved. M patients for respiratory depression and sedation at frequent intervals.

If a CYP3A4 inhibitor is discontinued, consider increasing the FIORINAL with CODEINE dosage until stable drug effects are achieved. Monitor for signs withdrawal.

Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir)
CYP3A4 Inducers
Clinical Impact: The concomitant use of FIORINAL with CODEINE and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolis with resultant lower morphine levels [see CLINICAL PHARMACOLOGY], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who developed physical dependence [see WARNINGS AND PRECAUTIONS].

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the codeine plasma concentration may increase with subsequently greater metaboli cytochrome CYP2D6, resulting in greater morphine levels [see CLINICAL PHARMACOLOGY], which could increase or prolong both the therapeutic effect reactions, and may cause serious respiratory depression.

Intervention: If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy and signs of opioid withdrawal and consider increasing the FI with CODEINE dosage as needed.

If a CYP3A4 inducer is discontinued, consider FIORINAL with CODEINE dosage reduction, and monitor for signs of respiratory depression and sedation intervals.

Examples: Rifampin, carbamazepine, phenytoin
Inhibitors of CYP2D6
Clinical Impact: Codeine in FIORINAL with CODEINE is metabolized by CYP2D6 to form morphine. The concomitant use of FIORINAL with CODEINE and CYP2D6 i increase the plasma concentration of codeine, but can decrease the plasma concentrations of active metabolite morphine which could result in reduced anal

efficacy or symptoms of opioid withdrawal, particularly when an inhibitor is added after a stable dose of FIORINAL with CODEINE is achieved [see CLINICAL PHARMACOLOGY].

After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrease but the active metabolite morphin concentration will increase, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression [see CLINICAL PHARMACOLOGY].
Intervention: If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of FI with CODEINE and monitor patients closely at frequent intervals.

If concomitant use with CYP2D6 inhibitors is necessary, follow the patient for reduced efficacy or signs and symptoms of opioid withdrawal and consider the FIORINAL with CODEINE as needed.

After stopping use of a CYP2D6 inhibitor, consider reducing the FIORINAL with CODEINE and monitor the patient for signs and symptoms of respiratory or sedation.
Examples: paroxetine, fluoxetine, bupropion, quinidine
Benzodiazepines and other Central Nervous System (CNS) Depressants
Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of respiratory profound sedation, coma, and death.
Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to th required. Follow patients closely for signs of respiratory depression and sedation [see WARNINGS AND PRECAUTIONS].
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.
Serotonergic Drugs
Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.
Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue FIORINAL with C serotonin syndrome is suspected.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methyle
Monoamine Oxidase Inhibitors (MAOIs)
Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see WARNINGS AND PRECAUTIONS]
Intervention: Do not use FIORINAL with CODEINE in patients taking MAOIs or within 14 days of stopping such treatment.

If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

Examples: phenelzine, tranylcypromine, linezolid
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Clinical Impact: May reduce the analgesic effect of FIORINAL with CODEINE and/or precipitate withdrawal symptoms.
Intervention: Avoid concomitant use.
Intervention: butorphanol, nalbuphine, pentazocine, buprenorphine
Muscle Relaxants
Clinical Impact: Codeine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of FIORINAL with CODEINE an muscle relaxant as necessary.
Diuretics
Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.

The effectiveness of diuretics in patients with underlying renal or cardiovascular disease may be diminished by the concomitant administration of aspirin du inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention.

Anticholinergic Drugs
Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when FIORINAL with CODEINE is used concomitantly with anticholinergic dru
Anticoagulants
Clinical Impact: Aspirin may enhance the effects of anticoagulants. Concurrent use may increase the risk of bleeding. Aspirin can also displace warfarin from protein bindin leading to prolongation of both the prothrombin time and the bleeding time.
Intervention: Monitor patients for signs of bleeding.
Examples: Warfarin, heparin, enoxaparin, clopidogrel, prasugrel, rivaroxaban, apixaban
Uricosuric Agents
Clinical Impact: Aspirin inhibits the uricosuric effects of uricosuric agents.
Intervention: Avoid concomitant use.
Examples: Probenecid
Carbonic Anhydrase Inhibitors
Clinical Impact: Concurrent use with aspirin can lead to high serum concentrations of the carbonic anhydrase inhibitor and cause toxicity due to competition at the renal tub secretion.
Intervention: Consider reducing the dose of the carbonic anhydrase inhibitor and monitor patient for any adverse effects from the carbonic anhydrase inhibitor.
Examples: Acetazolamide, methazolamide
Methotrexate
Clinical Impact: Aspirin may enhance the toxicity of methotrexate by displacing it from its plasma protein binding sites and/or reducing its renal clearance.
Intervention: Use caution if using concomitantly, especially in elderly patients or patients with renal impairment. Monitor patients for methotrexate toxicity.
Nephrotoxic Agents
Clinical Impact: Concomitant use with aspirin may lead to additive nephrotoxicity due to the inhibition of renal prostaglandins by aspirin. Also, the plasma concentration of increased by conditions that reduce the glomerular filtration rate or tubular secretion.
Intervention: Use FIORINAL with CODEINE with caution if used concomitantly with nephrotoxic agents. Closely monitor the renal function of patients
Examples: Aminoglycosides, amphotericin B, systemic bacitracin, cisplatin, cyclosporine, foscarnet, or parenteral vancomycin
Angiotensin Converting Enzyme (ACE) Inhibitors
Clinical Impact: The hyponatremic and hypotensive effects of ACE inhibitors may be diminished by the concomitant administration of aspirin due to its indirect effect on th angiotensin conversion pathway.
Intervention: Use caution if using concomitantly. Monitor the blood pressure and renal function of patients.
Examples: Ramipril, captopril
Beta Blockers
Clinical Impact: The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading renal blood flow, and salt and fluid retention.
Intervention: Use caution if using concomitantly. Monitor the blood pressure and renal function of patients
Examples: Metoprolol, propranolol
Hypoglycemic Agents
Clinical Impact: Aspirin may increase the serum glucose-lowering action of insulin and sulfonylureas leading to hypoglycemia.
Intervention: Patients should be advised to consult a physician if any signs or symptoms of hypoglycemia occur.
Examples: Insulin, glimepiride, glipizide
Anticonvulsants
Clinical Impact: Aspirin can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic levels.
Intervention: Use caution if using concomitantly.
Examples: Phenytoin, valproic acid
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Clinical Impact: Concurrent use with aspirin may increase the risk of bleeding or lead to decreased renal function. Aspirin may enhance serious side effects and toxicity of k displacing it from its plasma protein binding sites and/or reducing its renal clearance.
Intervention: Avoid concomitant use.
Examples: Ketorolac, ibuprofen, naproxen, diclofenac
Corticosteroids
Clinical Impact: In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids e clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Intervention: Avoid concomitant use

Drug Abuse And Dependence

Controlled Substance

FIORINAL with CODEINE contains codeine. Codeine in combination with butalbital, aspirin, and caffeine is a Schedule III controlled substance.

Abuse

FIORINAL with CODEINE contains codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. FIORINAL with CODEINE can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS AND PRECAUTIONS].

All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.

“Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.

FIORINAL with CODEINE, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Risks Specific to Abuse of FIORINAL with CODEINE

FIORINAL with CODEINE is for oral use only. Abuse of FIORINAL with CODEINE poses a risk of overdose and death. The risk is increased with concurrent abuse of FIORINAL with CODEINE with alcohol and other central nervous system depressants.

Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Butalbital

Barbiturates may be habit-forming. Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1,500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than twofold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.

Do not abruptly discontinue FIORINAL with CODEINE in a patient physically dependent on opioids. Rapid tapering of FIORINAL with CODEINE in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.

When discontinuing FIORINAL with CODEINE, gradually taper the dosage using a patient-specific plan that considers the following: the dose of FIORINAL with CODEINE the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use In Specific Populations].

Read the entire FDA prescribing information for Fiorinal with Codeine (Butalbital Compound With Codeine)

© Fiorinal with Codeine Patient Information is supplied by Cerner Multum, Inc. and Fiorinal with Codeine Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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