Hydrocodone acetaminophen

Hydrocodone acetaminophen

Generic name: acetaminophen and hydrocodone (a SEET a MIN oh fen and hye droe KOE done)

Brand name: Hycet, Lorcet, Norco, Verdrocet, Vicodin, Xodol, Zamicet
Drug class: Narcotic analgesic combinations

What is acetaminophen and hydrocodone?

Acetaminophen and hydrocodone is a combination medicine used to relieve moderate to moderately severe pain.

Hydrocodone is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

Acetaminophen and hydrocodone may also be used for purposes other than those listed in this medication guide.

Warnings

MISUSE OF ACETAMINOPHEN AND HYDROCODONE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Acetaminophen and hydrocodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Stop taking acetaminophen and hydrocodone and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use this medicine if you are allergic to acetaminophen or hydrocodone, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

To make sure acetaminophen or hydrocodone is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• liver disease;

• a drug or alcohol addiction;

• kidney disease;

• a head injury or seizures;

• urination problems; or

• problems with your thyroid, pancreas, or gallbladder.

Hydrocodone acetaminophen Uses:

• Pain management:

  • It is used in the management of pain severe enough to require an opioid analgesic and for which alternative treatments are insufficient.
  • Limitations of use:
    • Generally, 3 days or less of treatment with the lowest effective dose is preferred for acute pain and rarely should use exceed 7 days.
    • For chronic pain, nonpharmacologic and nonopioid pharmacologic treatments are first-line therapy and opioid prescriptions should be accompanied by established goals for pain and function and a discussion with the candidate for risks and benefits.

Hydrocodone acetaminophen Dose in Pain management: Oral:

Note: Pain relief and adverse events should be analyzed frequently. Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions. The use of higher starting doses in patients who are not opioid-tolerant might cause fatal respiratory depression.

• Dosage ranges (based on specific product labeling):

  • Hydrocodone is used as 2.5 to 10 mg every 4 to 6 hours as required with the maximum dose of hydrocodone that can be limited by the acetaminophen content of the specific product.
  • The dose of acetaminophen should be limited to less than 4 g/day.
  • The use of the lowest effective dose is recommended.

• Discontinuation of therapy:

  • When stopping chronic opioid therapy, the dose should be gradually tapered down.
  • An optimal universal tapering schedule for all patients has not been established.
  • The proposed schedules range from slow i.e  10% reductions per week to rapid i.e 25% to 50% reduction every few days.
  • Tapering schedules should be individualized to minimize opioid withdrawal while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered.
  • An even slower taper might be appropriate in patients who have been receiving opioids for a long duration (eg, years), particularly in the final stage of tapering, whereas more rapid tapers might be appropriate in patients experiencing severe adverse events.
  • observe carefully for signs & symptoms of withdrawal.
  • If the patient displays withdrawal symptoms, consider slowing the taper schedule. Alterations might include increasing the interval between the dose reductions, decreasing the amount of daily dose reduction, pausing the taper and reinitiating when the patient is ready, or coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms.
  • Continue to offer nonopioid analgesics as required for pain management during the taper. Consider nonopioid adjunctive treatments for withdrawal symptoms (eg, GI complaints, and muscle spasm) as indicated.

 

It is important to note that doses are based on hydrocodone. Titrate up to appropriate analgesic effect.

Hydrocodone acetaminophen Dose for pain relief in opioid-naive patients:

• Infants, Children, and Adolescents: Limited data available in infants and children <2 years:

The Maximum daily dose of acetaminophen should be limited to less than 75 mg/kg/day in less than or equal to 5 divided doses and not to exceed 4000 mg/day and possibly less in patients with hepatic impairment or ethanol use.

• • Patient weight:

    • <50 kg:
      • It is given orally with the usual initial dose of Hydrocodone 0.1-0.2 mg/kg/dose every 4-6 hours.
      • In infants, reduced doses and close monitoring should be considered due to possible increased sensitivity to respiratory depressant effects. It should be used with caution in infants.
    • ≥50 kg:
      • It is given orally with the usual initial dose of Hydrocodone 5-10 mg every 4-6 hours

 

Pregnancy Risk Factor C

• • • • [US Boxed Warning]: Long-term opioid use during pregnancy can cause neonatal withdrawal syndrome. This condition can be fatal if it is not treated as per the protocols of neonatologists.
      • Pregnant women who are required to use opioids for prolonged periods of time should be informed about the risks of neonatal opioid withdrawal syndrome. They also need to be provided with the necessary treatment.
      • Opioids can cross the placenta.

  Use of hydrocodone or acetaminophen during breastfeeding

  • • Breast milk can secrete hydrocodone and acetaminophen.
    • According to literature, when deciding whether to continue or stop breastfeeding during therapy, it should consider the risks of infant exposure, the benefits to the infant and the benefits to the mother.

• See individual agents.

 

Dose in Kidney Disease:

There are no specific dose adjustments given in the literature. Caution should be exercised. Therapy should be started with lower doses and monitored closely.

 

Dose in Liver disease:

There are no specific dosage adjustments provided in the manufacturer’s labeling. Caution should be exercised. Therapy should be started with lower doses and monitored closely.

 

Side effects of Hydrocodone acetaminophen:

• Cardiovascular:

  • Bradycardia
  • Cardiac Arrest
  • Circulatory Shock
  • Hypotension

• Central Nervous System:

  • Anxiety
  • Clouding Of Consciousness
  • Coma
  • Dizziness
  • Drowsiness
  • Drug Dependence
  • Dysphoria
  • Euphoria
  • Fear
  • Lethargy
  • Malaise
  • Mental Deficiency
  • Mood Changes
  • Sedation
  • Stupor

• Dermatologic:

  • Cold And Clammy Skin
  • Diaphoresis
  • Pruritus
  • Skin Rash

• Endocrine & Metabolic:

  • Hypoglycemic Coma

• Gastrointestinal:

  • Abdominal Pain
  • Constipation
  • Gastric Distress
  • Heartburn
  • Nausea
  • Occult Blood In Stools
  • Peptic Ulcer
  • Vomiting

• Genitourinary:

  • Nephrotoxicity
  • Ureteral Spasm
  • Urinary Retention

• Hematologic & Oncologic:

  • Agranulocytosis
  • Hemolytic Anemia
  • Iron Deficiency Anemia
  • Prolonged Bleeding Time
  • Thrombocytopenia

• Hepatic:

  • Hepatic Necrosis
  • Hepatitis

• Hypersensitivity:

  • Hypersensitivity Reaction

• Neuromuscular & Skeletal:

  • Vesicle Sphincter Spasm

• Otic:

  • Hearing Loss (Chronic Overdose)

• Renal:

  • Renal Tubular Necrosis

• Respiratory:

  • Airway Obstruction
  • Apnea
  • Dyspnea
  • Respiratory Depression (Dose Related)

 

Contraindications to Hydrocodone acetaminophen:

• • • Hypersensitivity reactions, including anaphylaxis of hydrocodone, Acetaminophen or any component, are an absolute contraindication.
    • Respiratory depression is a serious problem.
    • Acute or severe bronchial asthma in an unmonitored setting, or without resuscitative devices.
    • Paralytic ileus, GI obstruction and other gastrointestinal problems are all possible.

It is rare to see evidence of cross-reactivity between opioids and allergenic opioids. Cross-sensitivity is possible due to similarities in pharmacologic reactions. Consider an opioid that comes from an alternate structural class (e.g., phenylpiperidine or diphenylheptane).

Warnings and precautions

• CNS depression:

  • CNS depression can result, which could lead to mental or physical impairments. It is important to warn patients about tasks that require mental alertness, such as driving or operating machinery.

• Constipation

  • Patients with unstable angina or post-myocardial injury may experience constipation from hydrocodone.
  • To reduce constipation, consider preventive measures such as stool softeners or increased fiber.

• Hepatotoxicity: [US Boxed Warning]

  • Acetaminophen has been linked to cases of acute liver disease, sometimes leading to liver transplantation and death.
  • Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed >4 g/day and often involve more than one acetaminophen-containing product.
  • Preexisting liver disease and alcohol consumption are both risk factors that increase greatly.
  • Some patients have suffered liver damage from chronic daily doses of alcohol in their adult lives.

• Hypersensitivity and anaphylactic reactions

  • Acetaminophen has been linked to anaphylactic and hypersensitivity reactions. If you experience symptoms of an allergic reaction or hypersensitivity, stop using Acetaminophen immediately.

• Hypotension

  • Use of it can lead to severe hypotension, orthostatic hypotension, and syncope. Patients with hypovolemia, heart disease (including acute MI), and drugs that can exaggerate hypotensive effects such as phenothiazines and general anesthetics should be cautious.
  • After dose titration or initiation, monitor for hypotension symptoms.
  • Patients with circulatory shock should not use this product.

• Phenanthrene hypersensitivity:

  • Patients with hypersensitivity reactions to other opioid agonists phenanthrene derivatives (codeine/hydromorphone, levorphanol/oxycodone, and oxymorphone) should be cautious.

• Respiratory depression [US Boxed Warning]

  • It is possible to develop severe, life-threatening or fatal respiratory depression.
  • Monitor your respiratory health closely, especially when you are initiating or increasing the dose.
  • The sedating effects of opioids can be exacerbated by carbon dioxide retention due to opioid-induced respiratory depression.

• Reactions to skin:

  • Acetaminophen can cause severe and possibly fatal skin reactions, such as Stevens-Johnson syndrome, acute generalized exanthematous pustulsis, and toxic epidermal necrolysis.
  • If severe reactions occur, you should not treat them.

• Conditions abdominales:

  • It can make it difficult to diagnose or follow the clinical course of acute abdominal conditions.
  • Patients with intestinal motility disorders should be cautious. This could cause constipation, or obstructive intestinal disease.
  • It is not recommended for use in the presence of GI obstruction or paralytic ileus.

• Adrenocortical Insufficiency

  • Patients with adrenocortical impairment, including Addison disease, should be cautious.
  • Long-term opioid abuse can lead to secondary hypogonadism. This could cause infertility, sexual dysfunction, mood disorders, and osteoporosis.

• Insufficiency of the biliary tract:

  • Patients with acute pancreatitis or biliary dysfunction should be cautious. Opioids could cause constriction in the sphincter Oddi.

• CNS depression/coma:

  • Patients with impaired consciousness and coma should not use it. These patients are more susceptible to the intracranial effects CO retention.

• Delirium tremens:

  • Patients with delirium-tremens should be used with caution.

• Use of ethanol:

  • Patients with alcoholic liver disease should be cautious. Drinking more than three alcoholic drinks per week may increase your risk of liver damage.

• G6PD deficiency:

  • Acetaminophen should be used with caution for patients suffering from a G6PD deficiency.

• Head trauma

  • Patients with intracranial injuries, intracranial lesion or elevated intracranial pressure should exercise caution. An exaggerated elevation in ICP could occur.

• Hepatic impairment

  • Patients with hepatic impairment should be cautious.

• Mental health conditions

  • Patients with mental health conditions such as depression, anxiety disorders, and post-traumatic stress disorder should be cautious when using opioids for chronic pain. There is a greater risk of opioid overdose and opioid use disorder. It is important to have regular and strict monitoring.

• Obesity:

  • Patients who are obese or morbidly so should exercise caution.

• Prostatic hyperplasia/urinary restriction:

  • Patients with prostatic hyperplasia or urinary stricture should be cautious.

• Psychosis:

  • Patients with toxic psychosis should be treated with caution.

• Renal impairment

  • Patients with impaired renal function should not use it.

• Respiratory disease

  • Patients with severe chronic obstructive lung disease (or cor pulmonale) should be cautious when using opioids. Also, it is important to monitor for respiratory depression in patients who have a significantly decreased respiratory reserve, hypoxia or hypercapnia or those with preexisting respiratory depression.
  • Even at therapeutic doses, critical respiratory depression can occur.
  • These patients should consider non-opioid alternatives.
  • Patients with severe or acute bronchial asthma should not use it in an unmonitored environment or without resuscitative equipment.

• Seizures:

  • Patients with seizure disorders should be cautious. It may cause or exacerbate seizures.

• Sleep-disordered breathing

  • Patients with sleep-disordered breathing risk factors, such as HF or obesity, should be treated with opioids.
  • Patients with severe or moderate sleep-disordered breathing should avoid opioids

• Thyroid dysfunction:

• Patients with thyroid dysfunction should exercise caution.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and hydrocodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose can also cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

What to avoid

Avoid driving or operating machinery until you know how acetaminophen and hydrocodone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.

 

Monitoring parameters:

• • • It can be used to relieve pain, improve respiratory and mental health, and lower blood pressure.
    • Bowel function.
    • The signs and symptoms of abuse, misuse, or addiction.
    • Signs and symptoms of hypogonadism/hypoadrenalism

Alternate suggestions: Chronic pain is a long-term treatment that does not involve active cancer treatment or end-of life care.

• • Assess the benefits and risks of opioid therapy within one to four weeks after treatment initiation. Dose increases are also considered.
  • Patients at higher risk for overdose or those with opioid addiction should be re-evaluated every three months.
  • Prior to initiating treatment, it is preferable to have your urine tested for drug use. Re-checking should occur at least once a year (includes prescription drugs and illegal drugs of abuse).
  • Clinicians should review the state prescription drug monitoring program data prior to therapy initiation, and every three months thereafter (frequency ranges from every prescription to every 3 month).

 

How to administer Hydrocodone acetaminophen (Lortab, Norco)?

I may be taken without regard to meals.

 

Mechanism of action of Hydrocodone acetaminophen (Lortab, Norco):

Hydrocodone

• • • Binds to the CNS’s opiate receptors, altering pain perception and response. It reduces the symptoms of cough in the medullary centre. It causes generalized CNS depression.

Acetaminophen

• • • The CNS activates descending serotonergic inhibitory channels in the CNS, which are not yet fully understood.
    • Smith 2009 suggests that there may also be interactions with other nociceptive system (Smith 2009). The hypothalamic heat-regulating centre is inhibited, which produces antipyresis.

You can also contact individual agents.

Acetaminophen: Refer to the Acetaminophen monograph.

Hydrocodone:

Metabolism:

• • It is a liver-friendly organism.
  • O-demethylation via primarily CYP2D6 and hydromorphone (major active metabolite having a 10-to 33-fold or more than a 100-fold greater binding affinity for mu-opioid receptors than hydrocodone);
  • N-demethylation via CYP3A4 is to norhydrocodone, the major metabolite; and 40% metabolism/clearance takes place via non-CYP pathways including 6-ketosteroid decrease to 6-alpha-hydrocol or 6-betahydrocol and other elimination pathways (eg fecal and biliary, renal, renal).

Half-life elimination:

• ~4 hours

Time to peak, serum:

• ~1 hour

Excretion:

• Urine (26% of a single dose in 72 hours, with ~12% as unchanged drug, 5% as norhydrocodone, 4% as conjugated hydrocodone, 3% as 6-hydrocodol, and 0.21% as conjugated 6-hydromorphol.

 

International Brands of Hydrocodone acetaminophen:

• Hycet
• Lorcet
• Lorcet HD
• Lorcet Plus
• Lortab
• Norco
• Verdrocet
• Vicodin
• Vicodin ES
• Vicodin HP
• Xodol 10/300
• Xodol 5/300
• Xodol 7.5/300
• Zamicet
• Hycodone
• Kodone
• Sinalgen

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