Yes

Analgesic, Narcotic

Dental: Management of postoperative pain

Medical: Management of mild to moderate pain that requires relaxation

C-III

B/D (if used for prolonged periods or in high doses at term)

Hypersensitivity to dihydrocodeine or any component

Use 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 liver or renal insufficiency; some preparations contain sulfites which may cause allergic reactions; dextromethorphan has equivalent antitussive activity but has much lower toxicity in accidental overdose; tolerance of drug dependence may result from extended use

>10%:

Central nervous system: Lightheadedness, dizziness, drowsiness, sedation

Dermatologic: Pruritus, skin reactions

Gastrointestinal: Nausea, vomiting, constipation

1% to 10%:

Cardiovascular: Hypotension, palpitations, bradycardia, peripheral vasodilation

Central nervous system: Increased intracranial pressure

Endocrine & metabolic: Antidiuretic hormone release

Gastrointestinal: Biliary tract spasm

Genitourinary: Urinary tract spasm

Ocular: Miosis

Respiratory: Respiratory depression

Miscellaneous: Histamine release, physical and psychological dependence with prolonged use

Naloxone 2 mg I.V. (0.01 mg/kg for children) with repeat administration as necessary up to a total of 10 mg

CYP2D6 enzyme substrate

Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; causes cough suppression by direct central action in the medulla; produces generalized CNS depression

Onset of action: 10-30 minutes

Duration: Oral: 4-6 hours

Serum half-life: 3.8 hours

Time to peak serum concentration: 30-60 minutes

Adults: Oral: 1-2 capsules every 4-6 hours as needed for pain

Alcohol: Additive CNS effects, avoid use

Sedation is common

Concurrent use with MAOIs may produce additive side effects

No information available to require special precautions

Use with caution in patients with platelet and bleeding disorders, renal dysfunction, erosive gastritis, or peptic ulcer disease, previous nonreaction does not guarantee future safe taking of medication; use with caution in impaired hepatic function; do not use aspirin in children <16 years of age for chickenpox or flu symptoms due to the association with Reye's syndrome

Elderly are a high-risk population for adverse effects from nonsteroidal anti-inflammatory agents. As much as 60% of elderly with GI complications to NSAIDs can develop peptic ulceration and/or hemorrhage asymptomatically. Also, concomitant disease and drug use contribute to the risk for GI adverse effects. Use lowest effective dose for shortest period possible. Consider renal function decline with age. Use with caution in patients with history of asthma

If self-administered, use exactly as directed (do not increase dose or frequency); may cause physical and/or psychological dependence. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). May cause dizziness, drowsiness, impaired coordination, or blurred vision (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing or when engaging in tasks requiring alertness until response to drug is known); nausea or vomiting (frequent mouth care, small frequent meals, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help - if constipation remains an unresolved problem, consult prescriber about use of stool softeners). Report chest pain or rapid heartbeat; acute headache; swelling of extremities or unusual weight gain; changes in urinary elimination; acute headache; back or flank pain or spasms; or other adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Observe patient for excessive sedation, respiratory depression; implement safety measures, assist with ambulation

Capsule:

Synalgos®-DC: Dihydrocodeine bitartrate 16 mg, aspirin 356.4 mg, and caffeine 30 mg

"Drugs for Pain," Med Lett Drugs Ther, 1998, 40(1033):79-84.