Acetaminophen, caffeine, and dihydrocodeine

Name: Acetaminophen, caffeine, and dihydrocodeine

Uses For acetaminophen, caffeine, and dihydrocodeine

Acetaminophen, caffeine, and dihydrocodeine combination is used to relieve severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage. Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Dihydrocodeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When dihydrocodeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

acetaminophen, caffeine, and dihydrocodeine is available only with your doctor's prescription.

Before Using acetaminophen, caffeine, and dihydrocodeine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For acetaminophen, caffeine, and dihydrocodeine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to acetaminophen, caffeine, and dihydrocodeine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Trezix™ in the pediatric population. Safety and efficacy have not been established.

Trezix™ should not be used to relieve pain after surgery removal of tonsils and/or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acetaminophen, caffeine, and dihydrocodeine combination in the elderly. However, elderly patients are more likely to have age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving acetaminophen, caffeine, and dihydrocodeine combination in order to avoid potentially serious side effects.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking acetaminophen, caffeine, and dihydrocodeine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using acetaminophen, caffeine, and dihydrocodeine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Nalmefene
  • Naltrexone
  • Riociguat
  • Safinamide

Using acetaminophen, caffeine, and dihydrocodeine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acepromazine
  • Alfentanil
  • Almotriptan
  • Amineptine
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Anileridine
  • Aripiprazole
  • Asenapine
  • Baclofen
  • Benperidol
  • Benzphetamine
  • Bromazepam
  • Bromopride
  • Brompheniramine
  • Buspirone
  • Butabarbital
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Citalopram
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Cocaine
  • Codeine
  • Cyclobenzaprine
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Difenoxin
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Doxylamine
  • Droperidol
  • Duloxetine
  • Eletriptan
  • Enflurane
  • Escitalopram
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Fentanyl
  • Flibanserin
  • Fluoxetine
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fospropofol
  • Frovatriptan
  • Furazolidone
  • Granisetron
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Imatinib
  • Imipramine
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Isoniazid
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Levomilnacipran
  • Levorphanol
  • Linezolid
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lorazepam
  • Lorcaserin
  • Loxapine
  • Meclizine
  • Melitracen
  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Moclobemide
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Naratriptan
  • Nefazodone
  • Nialamide
  • Nicomorphine
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Peginterferon Alfa-2b
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Pimozide
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Pixantrone
  • Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Rasagiline
  • Regadenoson
  • Remifentanil
  • Remoxipride
  • Rizatriptan
  • Secobarbital
  • Selegiline
  • Sertindole
  • Sertraline
  • Sibutramine
  • Sildenafil
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sumatriptan
  • Suvorexant
  • Tapentadol
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Thiothixene
  • Tianeptine
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Trazodone
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Tryptophan
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

Using acetaminophen, caffeine, and dihydrocodeine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Carbamazepine
  • Fosphenytoin
  • Lixisenatide
  • Phenytoin
  • Warfarin
  • Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using acetaminophen, caffeine, and dihydrocodeine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use acetaminophen, caffeine, and dihydrocodeine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Tobacco

Using acetaminophen, caffeine, and dihydrocodeine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use acetaminophen, caffeine, and dihydrocodeine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Cabbage

Other Medical Problems

The presence of other medical problems may affect the use of acetaminophen, caffeine, and dihydrocodeine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison's disease (adrenal gland problem) or
  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Breathing problems (eg, COPD, sleep apnea, respiratory depression) or
  • Cor pulmonale (serious heart condition) or
  • Depression, history of or
  • Drug dependence, especially with narcotics, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Head injuries, history of or
  • Hypothyroidism (an underactive thyroid) or
  • Increased pressure in the head or
  • Mental health problems, history of or
  • Problems with passing urine or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Lung disease or breathing problems, severe or
  • Stomach or bowel blockage—Should not be used in patients with these conditions.

What do I need to tell my doctor BEFORE I take Acetaminophen, Caffeine, and Dihydrocodeine?

  • If you have an allergy to acetaminophen, caffeine, dihydrocodeine, or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking acetaminophen, caffeine, and dihydrocodeine within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with acetaminophen, caffeine, and dihydrocodeine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Acetaminophen, Caffeine, and Dihydrocodeine) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Do not take more than what your doctor told you to take. Liver problems may happen.
  • Do not take acetaminophen, caffeine, and dihydrocodeine with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
  • Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with acetaminophen, caffeine, and dihydrocodeine may cause nervousness, shakiness, and a fast heartbeat.
  • You will be watched closely to make sure you do not misuse, abuse, or become addicted to this medicine.

What do I do if I miss a dose?

  • If you take acetaminophen, caffeine, and dihydrocodeine on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some other side effects of Acetaminophen, Caffeine, and Dihydrocodeine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Hard stools (constipation).
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Upset stomach or throwing up.
  • Sweating a lot.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Acetaminophen, Caffeine, and Dihydrocodeine?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Pharmacologic Category

  • Analgesic Combination (Opioid)
  • Analgesic, Opioid

Dosing Adult

Pain management: Oral:

Capsule (acetaminophen 320.5 mg, caffeine 30 mg, and dihydrocodeine bitartrate 16 mg): Two capsules every 4 hours as needed; adjust dose based on severity of pain (maximum dose: 10 capsules [acetaminophen 3,205 mg/caffeine 300 mg/dihydrocodeine 160 mg] per 24 hours)

Tablet (acetaminophen 712.8 mg, caffeine 60 mg, and dihydrocodeine bitartrate 32 mg): One tablet every 4 hours as needed; adjust dose based on severity of pain (maximum dose: 5 tablets [acetaminophen 3,564 mg/caffeine 300 mg/dihydrocodeine 160 mg] per 24 hours)

Discontinuation of therapy: Decrease dose by 25% to 50% every 2 to 4 days; monitor carefully for signs/symptoms of withdrawal. If patient displays withdrawal symptoms, increase dose to previous dose and then reduce dose more slowly by increasing interval between dose reductions, decreasing amount of daily dose reduction, or both.

Dosing Renal Impairment

There are no specific dosage adjustments provided in the manufacturer’s labeling; use with caution and at a reduced dose.

(web3)