dihydrocodeine/aspirin/caffeine (Rx)

Brand and Other Names:Synalgos-DC
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

dihydrocodeine/aspirin/caffeine

capsule: Schedule V

  • 16mg/356.4mg/30mg
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Moderate-to-Severe Pain

2 capsules PO q4hr prn

Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

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
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Warnings

Black Box Warnings

Postoperative pain in children

  • Deaths have occurred in children with obstructive sleep apnea who receive codeine for postoperative pain following tonsillectomy and/or adenoidectomy
  • Codeine is converted to morphine by the liver; these children had evidence of being ultra-rapid metabolizers (via CYP2D6) of codeine, which is an inherited (genetic) ability that causes codeine to be converted rapidly into life-threatening or fatal amounts of morphine (see Pharmacology)

Contraindications

Hypersensitivity

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

Postoperative use in children following tonsillectomy and/or adenoidectomy (see Black Box Warnings)

Cautions

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

May cause respiratory depression

Caution is used with head injury or increased ICP

May cause hypotension

Dihydrocodeine can produce drug dependence

Caution in elderly or debilitated patients, or in patients with following conditions: adrenocortical insufficiency (Addison disease), asthma, central nervous system depression or coma, chronic obstructive pulmonary disease, decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis), delirium tremens, head injury, hypotension, increased intracranial pressure, myxedema or hypothyroidism, prostatic hypertrophy or urethral stricture, and toxic psychosis

Use opioids with caution with MAOIs

Caution with a history of drug abuse

Gastrointestinal bleeding; particular caution in patients with history of GI bleed, alcoholism, or bleeding disorders

Avoid with active peptic ulcer disease

Avoid in severe renal impairment (ie, CrCl <10 mL/min)

Avoid in severe hepatic impairment

Caffeine may produce CNS/CV stimulation and GI irritation

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Pregnancy & Lactation

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

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

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Dihydrocodeine: Semisynthetic opioid agonist analgesic related to codeine

Aspirin: Acts on hypothalamus to produce antipyresis; anti-inflammatory properties attributed to prostaglandin synthetase inhibition resulting in decreased formation of thromboxane A2

Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches

Pharmacogenomics

10% of codeine is metabolized to morphine by CYP2D6; the active morphine metabolite has a higher affinity for opioid receptors

CYP2D6 poor metabolizers may not achieve adequate analgesia

Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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