Hydrocodone/Acetaminophen

Hydrocodone/Acetaminophenis a prescription medication used to treat Moderate to Severe Pain.

• Hydrocodone/Acetaminophenis available under the following different brand names:Vicodin,LorcetHycet,Norco,Lortab Elixir, Anexsia,Vicodin ES,Vicodin HP,Xodol,Zamicet.

Dosages of Hydrocodone/Acetaminophen:

Adult and pediatric dosage

• Tablet: Schedule II
• 2.5mg/325mg
• 5mg/300mg, 5mg/325mg
• 7.5mg/300mg, 7.5mg/325mg
• 10mg/300mg, 10mg/325mg

Oral Solution/Elixir: Schedule II

• (7.5mg/325mg)/15mL
• (10mg/300mg)/15mL, (10mg/325mg)/15mL

Moderate to Severe Pain

Adult dosage

• 1-2 tablets (2.5-10 mg hydrocodone; 300-325 mg acetaminophen) orally every 4-6 hours as needed
• Acetaminophen: Not to exceed 1 g/dose or 4 g/24 hour
• Hydrocodone: Maximum daily dose should not exceed 60 mg/24 hour

Pediatric dosage

• Children younger than 2 years of age: Safety and efficacy not established
• Children 2-12 years of age: 0.135 mg/kg hydrocodone orally every 4-6 hours as needed
• Children 12 years of age: 1-2 tablets (2.5-10 mg hydrocodone; 300-325 mg acetaminophen) orally every 4-6 as needed

Dosage Considerations – Should be Given as Follows:

• See “Dosages”.

Common side effects of Hydrocodone/Acetaminophen include:

• dizziness,
• drowsiness,
• tiredness,
• nausea,
• vomiting,
• stomach pain,
• constipation, and
• headache

Serious side effects of Hydrocodone/Acetaminophen include:

• 荨麻疹,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• breathing that slows with a long pause,
• blue colored lips,
• 很难wake up,
• skin redness or a rash that spreads and causes blistering and peeling,
• noisy breathing,
• sighing,
• shallow breathing that stops,
• lightheadedness,
• nausea,
• upper stomach pain,
• tiredness,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes,
• vomiting,
• loss of appetite,
• dizziness,
• worsening tiredness,
• weakness,
• agitation,
• hallucinations,
• fever,
• sweating,
• shivering,
• fast heart rate,
• muscle stiffness,
• twitching,
• loss of coordination, and
• diarrhea

Rare side effects of Hydrocodone/Acetaminophen include:

• none

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Hydrocodone/Acetaminophen has severe interactions with the following other drugs:
  • alvimopan
• Hydrocodone/Acetaminophen has serious interactions with at least 94 other drugs.
• Hydrocodone/Acetaminophen has moderate interactions with at least 156 other drugs.
• Hydrocodone/Acetaminophen has minor interactions with at least 51 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Significantrespiratory depression
• Acute or severe bronchialasthmain an unmonitored setting or the absence of resuscitative equipment
• Known or suspectedgastrointestinalobstruction, includingparalytic ileus
• Known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to hydrocodone, ibuprofen, or any components of the drug product
• Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Hydrocodone/Acetaminophen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Hydrocodone/Acetaminophen?”

Cautions

• Do not prescribe foracute painor as needed (PRN) pain relief; only for severe chronic pain requiring continuous, around-the-clockopioidanalgesia
• Hydrocodone is an opioidagonist和一个时间表II物质具有高控制potential for abuse similar tofentanyl,methadone,morphine,oxycodone, andoxymorphone
• Coadministration with other CNS depressants may cause profound sedation, respiratory depression, and death; if coadministration is required, consider a dose reduction of 1 or both drugs
• Monitor carefully in elderly,cachectic, debilitated patients, and those with chronic pulmonary disease because of increased risk for life-threatening respiratory depression
• Monitor patients with head injury or increased ICP for sedation and respiratory depression; avoid use in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention
• May cause severehypotension, including orthostatic hypotension andsyncope; added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromisevasomotortone
• Coadministration with CYP3A4 inhibitors may increase hydrocodone systemic exposure and result in toxicity; if coadministration with CYP3A4 is necessary, monitor patients closely who are currently taking, or discontinuing, CYP3A4 inhibitors or inducers; evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved
• Caution must be used with potentially hazardous activities
• Avoid the use of mixed agonist/antagonistanalgesics (ie, pentazocine,nalbuphine,butorphanol) when taking full opioid agonist analgesics
• 深刻sedation, respiratory depression, coma, and death may result from concomitant administration withbenzodiazepinesor other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate
• Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting,anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat withphysiologicreplacement doses of corticosteroids; wean the patient off of the opioid to allow adrenal function to recover and continuecorticosteroidtreatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency
• May cause spasm of the sphincter of Oddi; opioids may cause increases in serumamylase; monitor patients withbiliarytract disease, includingacute pancreatitis, for worsening symptoms
• Cases ofserotoninsyndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected
• Use caution in debilitated patients, drug abuse history, elderly patients,G6PD deficiency, head injury, hepatic dysfunction,hypothyroidism, impaired pulmonary function, increased intracranial pressure, toxicpsychosis, renal dysfunction
• Hydrocodone may obscure the diagnosis or clinical symptoms of acute abdominal conditions
• Acetaminophen is associated with cases of acuteliver failure, at times resulting in liver transplantation or death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)
• Acetaminophen is associated with rare, but serious skin reactions that can be fatal; these reactions includeStevens-Johnson Syndrome(SJS), toxicepidermalnecrolysis (TEN), and acute generalized exanthematouspustulosis(AGEP); symptoms may include skin redness, blisters, and rash
• Caution and awareness are necessary regarding misuse, abuse, or diversion
• Constipation may occur; take measures to prevent constipation, such as, administeringstoolsoftener and increasingfiber
• Chronic alcoholics should limit acetaminophen intake to less than 2 g/day
• Use caution in morbidlyobesepatients
• Use hydrocodone with caution in patients with prostatichyperplasiaand/or urinarystricture
• Use caution in patients with seizure disorders

Patientaccesstonaloxonefor emergency treatment of opioid overdose

• Assess potential need for naloxone; consider prescribing for emergency treatment of opioid overdose
• Consult on availability and ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines
• Educate patients regarding the signs and symptoms of respiratory depression and to call 911 or seek immediate emergency medical help in the event of a known or suspected overdose

Pregnancy and Lactation

• Prolonged use of opioid analgesics during pregnancy can causeneonatalopioid withdrawal syndrome; there is no available data in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association with opioids and major birth defects
• Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in theneonateand neonatal opioid withdrawal syndrome shortly after birth; the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by newborn; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly
• The drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in the earlypostpartumperiod
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy; capsules and any potential adverse effects on the breastfed infant from therapy or underlying maternal condition
• Monitor infants exposed to drugs through breast milk for excess sedation and respiratory depression;withdrawal symptomscan occur in breastfed infants when maternal administration of an opioidanalgesicis stopped, or when breastfeeding is stopped