Trezix™ combines three ingredients that work together to reduce relieve moderate to moderately severe pain:
Dihydrocodeine Bitartrate provides effective opioid pain relief.
Acetaminophen provides effective peripheral pain relief.
Caffeine is an analgesic adjuvant and addresses fatigue and drowsiness, a common side effect of all opioids.
An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Choose a topic below to learn more about Trezix™, but always remember that your healthcare provider is your best resource for any and all questions regarding Trezix™ and pain management in general.
Q. What is Trezix?
A. Trezix is a combination medicine used to relive moderate to severe pain. Trezix may also be used for purposes not listed in this medication guide
Misuse of opioid medicine can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it.
Do not give Trezix to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.
Fatal adverse events can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
Q. How should I take Trezix?
A. Follow the directions on your prescription label and read all medication guides. Never use Trezix in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to take more of this medicine.
Never share opioid medicine with another person, especially with someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, AND DEATH. Keep the medication in a place where others cannot get to it.
DO not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using the medicine.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
Q. What happens if I overdose?
A. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Trezix can be fatal, especially in a child or other person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.
Q. What happens if I miss a dose?
A. 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.
Q. What should I avoid while taking Trezix?
A. Avoid driving or operating machinery until you know how this medicine 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 too much acetaminophen can lead to a fatal overdose.
Q. What are Trezix side effects?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Trezix and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
- chest pain, fast or pounding heartbeats, feeling light-headed, fainting;
- confusion, extreme drowsiness, unusual thoughts or behavior;
- painful or difficult urination;
- severe constipation;
- liver problems–nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- low cortisol levels– nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects include:
- dizziness, drowsiness, tiredness, headache;
- nausea, vomiting, stomach pain, constipation;
- sweating, itching; or
- skin rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Q. What other drugs will affect Trezix?
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
- other narcotic medications–opioid pain medicine or prescription cough medicine.
- a sedative like Valium–diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others.
- drugs that make you sleepy or slow your breathing–a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
- drugs that affect serotonin levels in your body–a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may affect Trezix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
TREZIX™ capsules are supplied in capsule form for oral administration.
Each red capsule contains:
Caffeine ………………………………………………….30 mg
Dihydrocodeine bitartrate ………………………….16 mg
Acetaminophen (4′-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder or white glistening needles, is a central nervous system stimulant.
Dihydrocodeine Bitartrate (4,5 _-epoxy-3-methoxy-17-methylmorphinan-6 _-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic.
In addition, each capsule contains the following inactive ingredients: crospovidone, magnesium stearate, povidone, pregelatinized starch, stearic acid. The capsule is composed of FD&C Red #40, and gelatin. Imprinting ink is composed of ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, pharmaceutical glaze (modified) in SD-45, propylene glycol, simethicone, and titanium dioxide.
INDICATIONS AND USAGE
DRUG ABUSE AND DEPENDENCE
DOSAGE AND ADMINISTRATION
Questions about Trezix™?
Ridgeland MS 39157
Phone (601) 605-0664
Fax (601) 605-0135
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENYME; HEPTATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse and Misuse
TREZIX™ expose patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing TREZIX™, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of TREZIX™. Monitor for respiratory depression, especially during initiation of TREZIX™ or following a dose increase [see WARNINGS].
Accidental ingestion of TREZIX™, especially by children, can result in a fatal overdose of TREZIX™ [see WARNINGS].
Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-threatening Respiratory Depression in Children
Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to CYP2D6 polymorphism [see WARNINGS and PRECAUTIONS]. TREZIXTM is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see CONTRAINDICATIONS]. Avoid the use of TREZIX™ in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of TREZIX™ during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS].
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with TREZIX™ requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine[see WARNINGS and PRECAUTIONS]
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see WARNINGS].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS, PRECAUTIONS; DRUG INTERACTIONS].
- Reserve concomitant prescribing of TREZIX™ and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.