Dihydrocodeine/Aspirin/Caffeine/

Discontinued

DEA Class;  Rx, schedule III

Common Brand Names; Synalgos-DC 

Analgesics and Opioids combos

Combination of aspirin, ASA; caffeine; dihydrocodeine; for moderate to moderately severe pain; produces a greater analgesic effect than aspirin or opiates alone; may cause fewer adverse reactions than equianalgesic doses of individual agents.

Indicated for the treatment of moderate pain to severe pain (i.e. headache, myalgia, back pain, bone pain, dental pain, dysmenorrhea, or arthralgia).

Because of risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve therapy for use in patients for whom alternative treatment options [e.g., non-opioid analgesics], have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia

Hypersensitivity

Any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitation equipment), and acute or severe bronchial asthma or hypercapnia

Children <12 years

Postoperative management in children <18 years following tonsillectomy and/or adenoidectomy (see Black Box Warnings)

Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

Known or suspected gastrointestinal obstruction, including paralytic ileus

Hemophilia

Reye’s syndrome

Known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)

Syndrome of asthma, rhinitis, and nasal polyps

Dihydrocodeine

Light-headedness

Dizziness

Drowsiness

Headache

Fatigue

Sedation

Confusion

Aspirin

Stomach pain

Heartburn

Nausea

Vomiting

Dyspepsia

Tinnitus (high or chronic dose)

Rash

Caffeine

Insomnia

Restlessness

Nervousness

Tremor

Tinnitus

Irritability

Nausea

May impair mental/physical abilities required for hazardous tasks (eg, driving, operating machinery)

May cause respiratory depression; risk is greatest during initiation of therapy or following a dosage increase; monitor patients closely for respiratory depression, especially within first 24-72 hours of initiating therapy and following dosage increases; to reduce risk, proper dosing and titration are essential; overestimating; dosage when converting patients from another opioid product can result in fatal overdose with first dose

Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia

Pregnancy

Pregnancy Category: D; avoid aspirin during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome; available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

Lactation: Distributed in breast milk in small amounts, caution advised

Adults

8 capsules/24 hours PO.

Geriatric

8 capsules/24 hours PO.

Adolescents

Safety and efficacy have not been established.

Children

12 years: Safety and efficacy have not been established.

1 to 11 years: Use is contraindicated.

Infants

Use is contraindicated.

dihydrocodeine/aspirin/caffeine

Capsule: Schedule V

16mg/356.4mg/30mg