Medical term:
Stagesic
hydrocodone bitartrate and acetaminophen
hydrocodone bitartrate and aspirin
hydrocodone bitartrate and ibuprofen
hydrocodone bitartrate and homatropine methyl-bromide
Pharmacologic class: Opioid agonist/nonopioid analgesic combination
Therapeutic class: Opioid analgesic; allergy, cold, and cough remedy (antitussive)
Controlled substance schedule III
Pregnancy risk category C
Action
Blocks release of inhibitory neurotransmitters, altering perception of and emotional response to pain. Hydrocodone/ibuprofen combination raises pain threshold by nonselectively inhibiting cyclooxygenase; prostaglandin synthesis then decreases and anti-inflammatory and analgesic effects occur.
Availability
hydrocodone bitartrate and acetaminophen
Capsules: 5 mg hydrocodone (hyd.)/500 mg acetaminophen (acet.)
Elixir/oral solution: 2.5 mg hyd./167 mg acet./5 ml
Tablets: 2.5 mg hyd./500 mg acet.; 5 mg hyd./325 mg acet.; 5 mg hyd./400 mg acet.; 5 mg hyd./500 mg acet.; 7.5 mg hyd./325 mg acet.; 7.5 mg hyd./400 mg acet.; 7.5 mg hyd./500 mg acet.; 7.5 mg hyd./650 mg acet.; 7.5 mg hyd./750 mg acet.; 10 mg hyd./325 mg acet.; 10 mg hyd./400 mg acet.; 10 mg hyd./500 mg acet.; 10 mg hyd./650 mg acet.; 10 mg hyd./660 mg acet.; 10 mg hyd./750 mg acet.
hydrocodone bitartrate and aspirin
Tablets: 5 mg hyd./500 mg aspirin
hydrocodone bitartrate and ibuprofen
Tablets: 7.5 mg hyd./200 mg ibuprofen
hydrocodone bitartrate and homatropine methylbromide
Syrup: 1.5 mg/5 ml, 5 mg/5 ml
Tablets: 1.5 mg, 5 mg
Indications and dosages
➣ Moderate to severe pain
Adults: 2.5 to 10 mg P.O. q 4 to 6 hours p.r.n. When giving hydrocodone/acetaminophen, don't exceed 60 mg/day; when giving hydrocodone/ibuprofen, don't exceed 37.5 mg/day.
Children: 0.15 to 0.2 mg/kg P.O. q 6 hours
➣ Cough
Adults: One tablet or 5 ml (syrup) q 4 to 6 hours as needed; don't exceed 6 tablets or 30 ml syrup in 24 hours.
Children ages 6 to 12: One-half tablet or 2.5 ml (syrup) q 4 to 6 hours as needed; don't exceed 3 tablets or 15 ml syrup in 24 hours.
Contraindications
• Hypersensitivity to hydrocodone, acetaminophen, aspirin, ibuprofen, or homatropine methylbromide (for corresponding combination products) or to alcohol, aspartame, saccharine, sugar, or tartrazine (with some products)
Precautions
Use cautiously in:
• severe renal, hepatic, or pulmonary disease; increased intracranial pressure; hypothyroidism; adrenal insufficiency; prostatic hypertrophy; thrombocytopenia; alcoholism
• elderly patients
• pregnant or breastfeeding patients.
Administration
☞ In patients receiving concurrent MAO inhibitors, know that hydrocodone may produce severe, unpredictable reactions. Initial dosage may need to be 25% lower than usual dosage.
Adverse reactions
CNS: confusion, drowsiness, sedation, dysphoria, euphoria, floating feeling, hallucinations, headache, anxiety, depression, fatigue, insomnia, lethargy, nervousness, slurred speech, tremor, asthenia, unusual dreams
CV: orthostatic hypotension, bradycardia, peripheral edema, palpitations, arrhythmias
EENT: blurred vision, vision changes, diplopia, miosis, tinnitus, pharyngitis, rhinitis, sinusitis
GI: nausea, vomiting, constipation, dysphagia, esophagitis, dyspepsia, flatulence, gastritis, gastroenteritis, mouth ulcers, dry mouth, anorexia
GU: urinary retention or frequency, erectile dysfunction
Respiratory: respiratory depression, bronchitis, dyspnea
Skin: pruritus, urticaria, diaphoresis, flushing
Other: physical or psychological drug dependence, drug tolerance
Interactions
Drug-drug. Angiotensin-converting enzyme inhibitors: decreased therapeutic effects of these drugs
Antihistamines, sedative-hypnotics: additive CNS depression
Buprenorphine, butorphanol, nalbuphine, pentazocine: precipitation of opioid withdrawal in physically dependent patients
Buprenorphine, pentazocine: decreased analgesia
Lithium: increased lithium blood level (with hydrocodone/ibuprofen only)
MAO inhibitors: severe, unpredictable reactions
Methotrexate: increased methotrexate blood level
Naloxone: withdrawal symptoms
Oral anticoagulants: increased risk of GI bleeding (with hydrocodone/ibuprofen only)
Drug-diagnostic tests. Amylase, lipase: increased levels
Drug-herbs. Chamomile, hops, kava, skullcaps, valerian: increased CNS depression
Drug-behaviors. Alcohol use: increased CNS depression
Patient monitoring
• In prolonged use, monitor for psychological and physical dependence.
• Watch closely for withdrawal symptoms when drug is discontinued.
• Assess elderly patients carefully for adverse reactions.
☞ Monitor for signs and symptoms of drug overdose, including nausea, vomiting, blurred vision, cool and clammy skin, dizziness, confusion, dyspnea, respiratory depression, bradycardia, hearing loss, tinnitus, headache, and mood or behavior changes.
Patient teaching
• Tell patient drug may cause drowsiness. Caution him to avoid driving and other hazardous activities until CNS effects are known.
• Inform patient that prolonged use may lead to physical or psychological dependence.
• Caution patient to avoid alcohol during therapy.
• Instruct patient to move slowly when sitting up or standing, to avoid dizziness from sudden blood pressure decrease.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.
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