Acetaminophen-Caffeine-Dihydrocodeine

Acetaminophen-Caffeine-Dihydrocodeine is a combination medicine used for the relief of moderate to severe pain.

• Acetaminophen-Caffeine-Dihydrocodeine is available under the following different brand names: Trezix.

Common side effects of Acetaminophen-Caffeine-Dihydrocodeine include:

• nausea
• vomiting
• constipation
• lightheadedness
• dizziness
• drowsiness
• headache
• increased urination
• trouble sleeping

Serious side effects of Acetaminophen-Caffeine-Dihydrocodeine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• interrupted breathing during sleep (sleep apnea)
• mood changes
• irritability
• nervousness
• anxiety
• hallucinations
• fast or irregular heartbeat
• stomach pain
• difficulty urinating
• vision changes
• shaking
• tremors
• loss of appetite
• unusual tiredness
• weight loss
• fainting
• seizures
• severe dizziness

Rare side effects of Acetaminophen-Caffeine-Dihydrocodeine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats, fluttering in the chest, shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because 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.

Adult dosage

Capsule: Schedule III

• 320.5 mg/30 mg/16 mg

Moderate to severe pain

Adult dosage

• 2 capsules orally every 4-6 hours as necessary; not to exceed 5 doses/24 hours (ie, 10 capsules/24 hours)
• Adjust the dose according to pain severity and patient response

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

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, healthcare provider, or pharmacist first.

• Acetaminophen-Caffeine-Dihydrocodeine has no noted severe interactions with any other drugs.
• Acetaminophen-Caffeine-Dihydrocodeine has no noted serious interactions with any other drugs.
• Acetaminophen-Caffeine-Dihydrocodeine has no noted moderate interactions with any other drugs.
• Acetaminophen-Caffeine-Dihydrocodeine has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about 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 healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitation equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Acetaminophen-Caffeine-Dihydrocodeine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Acetaminophen-Caffeine-Dihydrocodeine?”

Cautions

• May impair mental/physical abilities required for hazardous tasks (eg, driving, operating machinery)
• May cause respiratory depression
• Should be used cautiously in case of head injury or increased intracranial pressure (ICP)
• May cause hypotension
• Dihydrocodeine can produce drug dependence
• Caution in elderly or debilitated patients, or patients with the following conditions: adrenocortical insufficiency (Addison disease), asthma, central nervous system depression or coma, chronic obstructive pulmonary disease, decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis), delirium tremens, head injury, hypotension, increased ICP, myxedema or hypothyroidism, prostatic hypertrophy or urethral stricture, and toxic psychosis
• Use opioids with caution with MAOIs
• Acetaminophen is associated with cases of acute liver failure, at times resulting in liver transplant and death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product
• Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis; symptoms may include skin redness, blisters, and rash
• Caution required for patients with a history of drug abuse
• Caffeine may produce CNS/CV stimulation and GI irritation

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • Distributed in breast milk in small amounts, caution advised