Acetaminophen, Caffeine, and Dihydrocodeine

Pronunciation

(a seet a MIN oh fen, KAF een, & dye hye droe KOE deen)

U.S. Brand Names

Panlor® DC; Panlor® SS

Synonyms

Caffeine, Dihydrocodeine, and Acetaminophen; Dihydrocodeine Bitartrate, Acetaminophen, and Caffeine

Generic Available

Use

Relief of moderate to moderately-severe pain

Restrictions

C-III

Pregnancy Risk Factor

Pregnancy Implications

Reproduction studies have not been conducted with this combination.

Lactation

Enters breast milk/not recommended

Contraindications

Hypersensitivity to acetaminophen, caffeine, dihydrocodeine, codeine, or any component of the formulation; significant respiratory depression (in unmonitored settings); acute or severe bronchial asthma; hypercapnia; paralytic ileus

Warnings/Precautions

Acetaminophen may cause severe hepatotoxicity in acute overdose; limit acetaminophen to <4 g/day; in addition, chronic daily dosing in adults has resulted in liver damage in some patients. Use with caution in patients with alcoholic liver disease; consuming

3 alcoholic drinks/day may increase the risk of liver damage. Use caution in patients with known G6PD deficiency. Caffeine may cause CNS and cardiovascular stimulation as well as GI irritation in high doses. Dihydrocodeine should be used with caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists (morphine, hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone), respiratory diseases including asthma, emphysema, COPD, or severe hepatic or renal insufficiency. Use caution with MAO inhibitors.

This combination should be used with caution in elderly or debilitated patients, hypotension, adrenocortical insufficiency, thyroid disorders, prostatic hyperplasia, urethral stricture, seizure disorder, CNS depression, head injury or increased intracranial pressure. Causes sedation; caution must be used in performing tasks which require alertness (eg, operating machinery or driving). Safety and efficacy in pediatric patients have not been established.

Adverse Reactions

Frequency not defined. Most common reactions with this combination include:

Central nervous system: Dizziness, drowsiness, lightheadedness, sedation

Dermatologic: Pruritus, skin reactions

Gastrointestinal: Constipation, nausea, vomiting

Drug Interactions

Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C8/9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)

Caffeine: Substrate of CYP1A2 (major), 2C8/9 (minor), 2D6 (minor), 2E1 (minor), 3A4 (minor); Inhibits CYP1A2 (weak), 3A4 (moderate)

Dihydrocodeine: Substrate of CYP2D6 (major)

Acetaminophen: See individual monograph for associated interactions.

Caffeine:

CYP1A2 inhibitors: May increase the levels/effects of caffeine. Example inhibitors include amiodarone, fluvoxamine, ketoconazole, and rofecoxib.

CYP3A4 substrates: Caffeine may increase the levels/effects of CYP3A4 substrates. Example substrates include benzodiazepines, calcium channel blockers, ergot derivatives, mirtazapine, nateglinide, nefazodone, tacrolimus, and venlafaxine.

Quinolone antibiotics (specifically ciprofloxacin, norfloxacin, ofloxacin): Quinolones may increase the level/effects of caffeine.

Dihydrocodeine:

CYP2D6 inhibitors: May decrease the effects of dihydrocodeine. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.

Quinidine: Quinidine may decrease the effects of dihydrocodeine.

Ethanol/Nutrition/Herb Interactions

Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced toxicity. Ethanol may also increase CNS depression.

Stability

Store at controlled room temperature of 15°C to 30°C (59°F to 86°F); protect from moisture

Mechanism of Action

Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center.

Caffeine is a CNS stimulant; use with acetaminophen and dihydrocodeine increases the level of analgesia provided by each agent.

Dihydrocodeine binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces generalized CNS depression.

Dosage

Oral: Adults: Relief of pain:

Panlor® DC: 2 capsules every 4 hours as needed; adjust dose based on severity of pain (maximum dose: 10 capsules/24 hours)

Panlor® SS: 1 tablet every 4 hours as needed; adjust dose based on severity of pain (maximum dose: 5 tablets/24 hours)

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause dizziness or drowsiness

Mental Health: Effects on Psychiatric Treatment

May cause nausea and vomiting; combined use with SSRIs, acetylcholinesterase inhibitors, aripiprazole, or ziprasidone may produce additive effects. The effects of benzodiazepines, mirtazapine, nefazodone, and venlafaxine may be enhanced by caffeine (CYP3A4 inhibitor). Use with chlorpromazine, fluoxetine, paroxetine, pergolide, or ropinirole may decrease the effects of dihydrocodeine. Fluvoxamine may increase the effects of caffeine. Reduce caffeine consumption by 50% or choose an alternative SSRI. Barbiturates, carbamazepine, and excessive intake of ethanol may decrease the effectiveness, as well as increase the hepatotoxic potential of acetaminophen. Combined use with psychotropics may produce additive sedative effects.

Dosage Forms

Capsule (Panlor® DC): Acetaminophen 356.4 mg, caffeine 30 mg, and dihydrocodeine bitartrate 16 mg

Tablet (Panlor® SS): Acetaminophen 712.8 mg, caffeine 60 mg, and dihydrocodeine bitartrate 32 mg

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