Darvon Compound 65: Uses, Dosage & Side Effects

Introduction to Darvon Compound 65

Darvon Compound 65 is a combination medication used for the treatment of mild to moderate pain. It contains propoxyphene hydrochloride (65 mg), aspirin (389 mg), and caffeine (32.4 mg). Darvon Compound 65 provides pain relief through the analgesic properties of propoxyphene and aspirin, while caffeine enhances their effects. source

Chemical Composition

Darvon Compound 65 contains three active ingredients:

• Propoxyphene Hydrochloride (65 mg) – an opioid analgesic
• Aspirin (389 mg) – an analgesic, anti-inflammatory, and antipyretic
• Caffeine (32.4 mg) – a stimulant that enhances pain relief

The combination of these ingredients provides effective relief from mild to moderate pain. source

Administration and Dosage

The recommended dosage of Darvon Compound 65 is 1-2 capsules every 4 hours as needed for pain, not to exceed 6 capsules per day. It should be taken orally with a full glass of water. Do not crush, chew, or dissolve the capsules. source

Mechanism of Action

Propoxyphene acts as an agonist at the mu-opioid receptors, modulating the perception of pain in the central nervous system. Aspirin inhibits cyclooxygenase enzymes, reducing inflammation and pain. Caffeine is a CNS stimulant that enhances the analgesic effects of propoxyphene and aspirin by increasing their absorption and slowing their metabolism. source

Pharmacokinetics and Pharmacodynamics

Propoxyphene is rapidly absorbed from the GI tract and undergoes extensive first-pass metabolism in the liver. Peak plasma levels occur within 2-3 hours. Aspirin is also rapidly absorbed, with peak levels in 1-2 hours. Caffeine reaches peak concentration in 30-60 minutes. Propoxyphene and aspirin are highly protein-bound and widely distributed in the body. The half-life of propoxyphene is 6-12 hours, while aspirin’s is 4-6 hours. Elimination occurs primarily through hepatic metabolism and renal excretion. source

Side Effects and Adverse Reactions

Common side effects of Darvon Compound 65 include:

• Nervous system: dizziness, sedation, stupor, delirium, somnolence, ataxia, coma, syncope, respiratory depression
• Gastrointestinal: nausea, vomiting, constipation, abdominal pain
• Allergic reactions: skin rash, itching, hives, swelling

Long-term use can lead to physical dependence and withdrawal symptoms upon discontinuation. source source

Contraindications and Precautions

Darvon Compound 65 should be avoided or used with caution in:

• Patients with respiratory depression, asthma, or hypercapnia
• Patients with acute or severe bronchial asthma
• Patients with known hypersensitivity to propoxyphene, aspirin, or caffeine
• Pregnant women (Category C) and breastfeeding mothers
• Children under 12 years of age
• Elderly patients or those with debilitated conditions

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Drug Interactions

Darvon Compound 65 may interact with other medications, including:

• CNS depressants (alcohol, sedatives, tranquilizers): increased risk of respiratory depression, sedation, and hypotension
• Warfarin: increased risk of bleeding
• MAO inhibitors: increased risk of serotonin syndrome
• Phenobarbital: decreased effectiveness of Darvon Compound 65

Consult a healthcare provider before taking Darvon Compound 65 with any other medications. source

Controlled Substance Classification

Darvon Compound 65 is a Schedule 4 controlled substance under the Controlled Substances Act due to its potential for abuse and dependence. It can only be legally obtained with a prescription from a licensed healthcare provider. Possession without a valid prescription is illegal.

Patient Education and Counseling Points

When prescribing Darvon Compound 65, healthcare providers should educate patients on:

• Proper dosing instructions and the importance of not exceeding recommended doses
• Potential side effects and when to seek medical attention
• Risks of physical dependence and withdrawal with long-term use
• Avoidance of alcohol and other CNS depressants while taking Darvon Compound 65
• Proper storage and disposal of the medication

Historical Context and Brand Information

Darvon Compound 65 was first introduced to the market in 1957 by Eli Lilly and Company. It gained widespread popularity as a pain reliever but declined in use following increasing concerns about abuse, addiction, and overdose deaths associated with propoxyphene. Darvon products were eventually phased out and discontinued in 2010.

Alternate Names and Formulations

Propoxyphene was marketed under various brand names, including Darvon, Dolene, SK-65, and Balacet. It was available in different strengths and formulations, with Darvon Compound 65 containing aspirin and caffeine in addition to propoxyphene. Other propoxyphene products included Darvon-N, Darvocet, and Wygesic.

Nursing and Clinical Guidelines

When administering Darvon Compound 65, nurses should follow these guidelines:

• Verify the patient’s identity and check for allergies before administration
• Assess the patient’s pain level and monitor for effectiveness of the medication
• Monitor for signs of respiratory depression, sedation, and other adverse effects
• Educate the patient on proper use, storage, and disposal of the medication
• Document the administration and patient response in the medical record

Source: Davis’s Drug Guide (link not available)

Safety Alerts and FDA Warnings

In 2010, the FDA issued a safety alert recommending against the continued prescribing and use of propoxyphene products, including Darvon Compound 65, due to risks of serious toxicity to the heart, even at therapeutic doses. The FDA concluded that the safety risks outweighed the benefits and requested that manufacturers voluntarily withdraw propoxyphene from the market.

Public and Cultural Impact

Darvon Compound 65 was widely prescribed and used for pain relief during its time on the market. It was often featured in popular media and became a household name. However, its reputation diminished as awareness grew about the risks of abuse, addiction, and overdose associated with propoxyphene. Its eventual withdrawal from the market marked a significant shift in the approach to pain management and opioid prescribing.

Collectible Memorabilia

Vintage Darvon Compound 65 apothecary jars and advertisements are sought after as collectible items representing pharmaceutical and advertising history. The distinct red-and-gray capsules were often featured in these marketing materials. While no longer holding medicinal value, these artifacts offer a glimpse into the cultural impact and medical practices of the past.

Visual Identification

Darvon Compound 65 capsules are easily identifiable by their gray and red coloration. The capsules are imprinted with “LILLY 3111” for distinction. Images of the capsules can be found in pill identification resources and databases.

In summary, Darvon Compound 65 is a combination pain medication containing propoxyphene, aspirin, and caffeine that was widely used for pain relief before its market withdrawal in 2010 due to safety concerns. Understanding its history, properties, and impact provides insight into the evolving landscape of pain management and the delicate balance between effectiveness and risk in pain medication use.