Acetaminophen, Caffeine, Dihydrocodeine Bitartrate

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Overview

What is Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules are supplied incapsule form for oral administration.Each red capsule contains:Acetaminophen ............................................. 320.5 mgCaffeine ........................................................... 30 mgDihydrocodeine bitartrate ................................... 16 mg

*Warning: may be habit-forming.

Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder or white glistening needles, is a central nervous system stimulant. It has the following structural formula:

Dihydrocodeine Bitartrate (4,5 a-epoxy-3-methoxy-17-methylmorphinan-6 a-ol(+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:

In addition, each capsule contains the following inactive ingredients: crospovidone, magnesium stearate, povidone, pregelatinized corn 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.

What does Acetaminophen, Caffeine, Dihydrocodeine Bitartrate look like?

What are the available doses of Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

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What should I talk to my health care provider before I take Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

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How should I use Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules are indicated for the relief of moderate to moderately severe pain.

The usual adult dosage is two (2) Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than two (2) capsules should be taken in a 4-hour period. No more than five (5) doses, or ten (10) capsules should be taken in a 24-hour period.

What interacts with Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

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What are the warnings of Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

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What are the precautions of Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

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What are the side effects of Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

Dihydrocodeine:

Acetaminophen:

Caffeine:

What should I look out for while using Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

Dihydrocodeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.

This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.

Hepatotoxicity:

Serious Skin Reactions

Death Related to Ultra-Rapid Metabolism of Codeine to Morphine:

Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert dihydrocodeine into its active metabolite, dihydromorphine, more rapidly andcompletely than other people. This rapid conversion results in higher than expected serum dihydromorphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) [see Overdosage].

Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Dihydrocodeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy [see Contraindications].

When prescribing dihydrocodeine-containing products, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose [see Overdosage].

Hypersensitivity/Anaphylaxis:

Usage in Ambulatory Patients:

Respiratory Depression:

Head Injury:

Hypotensive Effect:

Drug Dependence:

What might happen if I take too much Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

Following an acute overdosage with Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, toxicity may result from the dihydrocodeine or the acetaminophen. Toxicity due to the caffeine is less likely, due to the relatively small amounts in this formulation.

Signs and Symptoms:

Treatment

How should I store and handle Acetaminophen, Caffeine, Dihydrocodeine Bitartrate?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine* bitartrate 16 mg (*Warning: May be habit-forming), are supplied in bottles of 100 capsules (NDC #42195-840-10).Capsules are imprinted “TREZIX” on the red cap in white ink.Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture.Rx OnlyManufactured for:Physician’s Desk Reference is the registered trademark of Thomson Healthcare, Inc.Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine* bitartrate 16 mg (*Warning: May be habit-forming), are supplied in bottles of 100 capsules (NDC #42195-840-10).Capsules are imprinted “TREZIX” on the red cap in white ink.Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture.Rx OnlyManufactured for:Physician’s Desk Reference is the registered trademark of Thomson Healthcare, Inc.Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine* bitartrate 16 mg (*Warning: May be habit-forming), are supplied in bottles of 100 capsules (NDC #42195-840-10).Capsules are imprinted “TREZIX” on the red cap in white ink.Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture.Rx OnlyManufactured for:Physician’s Desk Reference is the registered trademark of Thomson Healthcare, Inc.Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine* bitartrate 16 mg (*Warning: May be habit-forming), are supplied in bottles of 100 capsules (NDC #42195-840-10).Capsules are imprinted “TREZIX” on the red cap in white ink.Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture.Rx OnlyManufactured for:Physician’s Desk Reference is the registered trademark of Thomson Healthcare, Inc.Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine* bitartrate 16 mg (*Warning: May be habit-forming), are supplied in bottles of 100 capsules (NDC #42195-840-10).Capsules are imprinted “TREZIX” on the red cap in white ink.Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture.Rx OnlyManufactured for:Physician’s Desk Reference is the registered trademark of Thomson Healthcare, Inc.Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine* bitartrate 16 mg (*Warning: May be habit-forming), are supplied in bottles of 100 capsules (NDC #42195-840-10).Capsules are imprinted “TREZIX” on the red cap in white ink.Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture.Rx OnlyManufactured for:Physician’s Desk Reference is the registered trademark of Thomson Healthcare, Inc.Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine* bitartrate 16 mg (*Warning: May be habit-forming), are supplied in bottles of 100 capsules (NDC #42195-840-10).Capsules are imprinted “TREZIX” on the red cap in white ink.Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture.Rx OnlyManufactured for:Physician’s Desk Reference is the registered trademark of Thomson Healthcare, Inc.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules contain dihydrocodeine which is a semi-synthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components. The principal action of therapeutic value is analgesia.

Non-Clinical Toxicology

Dihydrocodeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.

This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.

Hepatotoxicity:

Serious Skin Reactions

Death Related to Ultra-Rapid Metabolism of Codeine to Morphine:

Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert dihydrocodeine into its active metabolite, dihydromorphine, more rapidly andcompletely than other people. This rapid conversion results in higher than expected serum dihydromorphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) [see Overdosage].

Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Dihydrocodeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy [see Contraindications].

When prescribing dihydrocodeine-containing products, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose [see Overdosage].

Hypersensitivity/Anaphylaxis:

Usage in Ambulatory Patients:

Respiratory Depression:

Head Injury:

Hypotensive Effect:

Drug Dependence:

General:

Drug Interactions:

Dihydrocodeine with Monoamine Oxidase Inhibitors:Dihydrocodeine, like all opioid analgesics, interacts with monoamine oxidase inhibitors causing central nervous system excitation and hypertension.

Information for Patients/Caregivers:

Advise patients that some people have a genetic variation that results in dihydrocodeine changing into dihydromorphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid dihydrocodeine metabolizer or not. These higher-than-normal levels of dihydromorphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine aftertonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. Dihydrocodeine-containing products are contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving dihydrocodeine-containing products for other reasons to monitor for signs of respiratory depression.

Advise patients that nursing mothers taking dihydrocodeine can also have higher dihydromorphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of dihydromorphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Advise nursing mothers to watch for signs of dihydromorphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby’s doctor immediately if theynotice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

Pregnancy:

Teratogenic Effects – Pregnancy Category C.

Labor and Delivery:

Nursing Mothers:

The risk of infant exposure to dihydrocodeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when dihydrocodeine is administered to a nursing woman. If a dihydrocodeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using dihydrocodeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of dihydrocodeine-containing products during breastfeeding (See Warnings).

Pediatric Use:

Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Dihydrocodeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy [see CONTRAINDICATIONS].

Geriatric Use:

Hepatic Impairment:

Renal Impairment:

Pancreatic/Biliary Tract Disease:

Dihydrocodeine:

Acetaminophen:

Caffeine:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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