How do I take (generic) Darvocet / Propoxyphene
Generic Name: Dextropropoxyphene / Propoxyphene
Brand Names: Balacet, Darvocet, Darvon, Propacet
Each tablet contains: 65 mg Dextropropoxyphene and 325 mg Paracetamol (Acetaminophen), Dicyclomine 10 mg,
Darvocet (Dextropropoxyphene) is an analgesic in the opioid category. Propoxyphene belongs to a group of drugs called narcotic pain relievers. It is used to treat mild to moderate pain and as an anti-tussive and local anesthetic. It can be used to ease surgical pain both prophylactically and palliatively. Propoxyphene may also be used for purposes other than those listed in this medication guide. It is possible to classify it as a mild opioid pain-killer, however it is considered no more effective than aspirin in treating pain.
Davocet (Dextropropoxyphene) is sometimes combined with paracetamol (acetaminophen) or aspirin. Trade-names include Darvocet-N for dextropropoxyphene and paracetamol and Darvon-N with ASA for dextropropoxyphene and aspirin. It is also sometimes sold in combination with caffeine in order to deter abuse and augment analgesia.
There is no peer-reviewed evidence that this combination is any more effective than paracetamol alone. There is significant anecdotal evidence from patients that Darvocet is more effective than paracetamol, but a third of patients suffering chronic pain report relief from that pain when treated with placebo.
Dextropropoxyphene, like codeine, is a weak opioid, known to cause dependency among recreational users. Codeine is more commonly used; however, as codeine is, in essence, a prodrug that requires in vivo metabolism to the more active opioid morphine for maximum efficacy, it is ineffective for some individuals with the poor metabolizer genotype of the liver Cytochrome P450 enzyme CYP2D6. It is in people with this low-function isoform of the CYP2D6 gene that dextropropoxyphene is particularly useful, as its metabolism does not require CYP2D6.
Restless legs syndrome (RLS)
Propoxyphene has been found to be helpful in relieving the symptoms of restless legs syndrome (RLS).
In pure form, dextropropoxyphene is commonly used to ease the withdrawal symptoms in people addicted to opioids. Being very weak in comparison to the opioids that are commonly abused, dextropropoxyphene can only act as a partial substitute. It does not have much effect on mental cravings; however it can be effective in alleviating physical withdrawal effects, such as muscle cramps.
Dextropropoxyphene is contraindicated in patients allergic to paracetamol (acetaminophen) or dextropropoxyphene, in alcoholics, and in combination with amphetamine, where CNS stimulation is potentiated and fatal convulsions can occur in dextropropoxyphene overdosage. Dextropropoxyphene is not intended for use in patients who are prone to suicide, anxiety, panic, or addiction.
Darvocet overdose is commonly broken into two categories: liver toxicity (from paracetamol poisoning) and dextropropoxyphene overdose.
Many users experience toxic effects from the paracetamol (acetaminophen) in pursuit of the endlessly-increasing dose required for pain relief. They suffer acute liver toxicity, which causes severe stomach pains, nausea, and vomiting (all of which are increased by light or stimulation of the sense of sight).
An overdose of dextropropoxyphene may lead to various systemic effects. Excessive opioid receptor stimulation is responsible for the CNS depression, respiratory depression, miosis, and gastrointestinal effects seen in propoxyphene poisoning. It may also account for mood/thought altering effects.
In addition, both propoxyphene and its metabolite norpropoxyphene, have local anesthetic effects at concentrations about 10 times those necessary for opioid effects. Norpropoxyphene is a more potent local anesthetic than propoxyphene, and they are both more potent than lidocaine. Local anesthetic activity appears to be responsible for the arrhythmias and cardiovascular depression seen in propoxyphene poisoning.
Both propoxyphene and norpropoxyphene are potent blockers of cardiac membrane sodium channels and are more potent than lidocaine, quinidine, and procainamide in this respect. As a result, propoxyphene and norpropoxyphene appear to have the characteristics of a Vaughn-Williams Class Ic antiarrhythmic.
These direct cardiac effects include decreased heart rate (i.e. cardiovascular depression), decreased contractility, and decreased electrical conductivity (i.e., increased PR, AH, HV, and QRS intervals). These effects appear to be due to their local anesthetic activity and are not reversed by naloxone. Widening of the QRS complex appears to be a result of a quinidine-like effect of propoxyphene, and sodium bicarbonate therapy appears to have a positive direct effect on the QRS dysrhythmia.
Seizures may result from either opioid or local anesthetic effects. Pulmonary edema may result from direct pulmonary toxicity, neurogenic/anoxic effects, or cardiovascular depression.
Do not use propoxyphene if you have a history of suicidal thoughts or actions. Propoxyphene should never be taken together with a sedative (such as Valium or Xanax) or an antidepressant if you are also drinking large amounts of alcohol. Propoxyphene may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking propoxyphene. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.
Never take more than your prescribed dose of propoxyphene. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Propoxyphene can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using propoxyphene suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
What should I tell my healthcare provider before taking propoxyphene?
Do not use propoxyphene if you have a history of suicidal thoughts or actions. Propoxyphene should never be taken together with a sedative (such as Valium or Xanax) or an antidepressant if you are also drinking large amounts of alcohol. Propoxyphene may be habit-forming and should be used only by the person it was prescribed for. Propoxyphene should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
Before using propoxyphene, tell your doctor if you are allergic to any drugs, or if you have:
If you have any of these conditions, you may not be able to use propoxyphene, or you may need a dosage adjustment or special tests during treatment.
FDA pregnancy category C. propoxyphene may be harmful to an unborn baby, and could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Propoxyphene passes into breast milk and could harm a nursing baby. Do not use propoxyphene without telling your doctor if you are breast-feeding a baby.
Older adults may be more sensitive to the effects of this medicine.
Propoxyphene was initially introduced as propoxyphene hydrochloride. Shortly before the patent on propoxyphene expired, propoxyphene napsylate form was introduced to the market. Napsylate salt is claimed to be less prone to abuse, because it is almost insoluble in water and therefore cannot be used for injection. Napsylate also gives lower peak blood level. Because of different molecular mass, a dose of 100 mg of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg propoxyphene hydrochloride.
In the United States, dextropropoxyphene HCl is available as a prescription formulation with paracetamol (acetaminophen) in ratio anywhere from 30 mg / 600 mg to 100 mg / 650 mg (or 100 mg / 325 mg in the case of Balacet), respectively. These are usually named Darvocet. On the other hand, Darvon is a pure propoxyphene preparation available in the U.S. that does not contain paracetamol.
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Dextropropoxyphene acts as an mu-opioid receptor agonist. It also acts as a potent, noncompetitive α3β4 neuronal nicotinic acetylcholine receptor antagonist, as well as a weak serotonin reuptake inhibitor.
Propoxyphene was initially introduced as propoxyphene hydrochloride. Shortly before the patent on propoxyphene expired, propoxyphene napsylate form was introduced to the market. Napsylate salt (the salt of naphthalenesulfonic acid) is claimed to be less prone to abuse, because it is almost insoluble in water, so cannot be used for injection. Napsylate also gives lower peak blood level. Because of different molecular mass, a dose of 100 mg of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg of propoxyphene hydrochloride.
Before the FDA-directed recall, dextropropoxyphene HCl was available in the United States as a prescription formulation with paracetamol (acetaminophen) in ratio from 30 mg / 600 mg to 100 mg / 650 mg (or 100 mg / 325 mg in the case of Balacet), respectively. These are usually named Darvocet. Darvon is a pure propoxyphene preparation that does not contain paracetamol.
In Australia, dextropropoxyphene is available on prescription, both as a combined product (32.5 mg dextropropoxyphene per 325 mg paracetamol branded as Di-gesic, Capadex, or Paradex; it is also available in pure form (100 mg capsules) known as Doloxene.
Detectable levels of propoxyphene/dextropropoxyphene may stay in a person's system for up to 9 days after last dose and can be tested for specifically in nonstandard urinalysis, but may remain in the body longer in minuscule amounts. Propoxyphene will not show up on standard opiate/opioid tests because it is not chemically related to opiates as part of the OPI or OPI 2000 panels, which detect morphine and related compounds. It is most closely related to methadone.
Usage controversy and regulation
Trade Name: Doloxene - 100 mg - dextropropoxyphene napsylate
Dextropropoxyphene is subject to some controversy: while many physicians prescribe it for a wide range of mildly to moderately painful symptoms, as well as for treatment of diarrhea, many others refuse to prescribe it, citing limited effectiveness. In addition, the therapeutic index of dextroproxyphene is relatively narrow.
Caution should be used when administering dextropropoxyphene, particularly with children and the elderly and with patients who may be pregnant or breast feeding; other reported problems include kidney, liver or respiratory disorders, and prolonged use. Attention should be paid to concomitant use with tranquillizers, antidepressants or excess alcohol.
Darvon, a dextropropoxyphene formulation made by Eli Lilly, which had been on the market for 25 years, came under heavy fire in 1978 by consumer groups that said it was associated with suicide. Darvon was never withdrawn from the market, until recently. But Lilly has waged a sweeping, and largely successful, campaign among doctors, pharmacists and Darvon users to defend the drug as safe when it is used in proper doses and not mixed with alcohol. On November 19, 2010, the FDA banned all sale of Darvon and Darvocet.
In Australia, both pure dextropropoxyphene capsules (as napsylate, 100 mg), marketed as Doloxene, and combination tablets and capsules (with paracetamol) all containing 32.5 mg dextropropoxyphene HCl with 325 mg paracetamol, which are currently available on prescription were supposed to be withdrawn from 1 March 2012,but Aspen Pharma sought a review in the Administrative Appeals Tribunal which resulted in a stay in the ban until a hearing scheduled for late May. In 2013 the Administrative Appeals Tribunal ruled that the drugs could be sold under strict conditions.
In November 2007, the European Commission requested the European Medicines Agency (EMA) to review the safety and effectiveness of dextropropoxyphene based medicines and on 25 June 2009 the EMA recommended a gradual withdrawal throughout the European Union. The EMA's conclusion was based on evidence that dextropropoxyphene-containing medicines were weak painkillers, the combination of dextropropoxyphene and paracetamol was no more effective than paracetamol on its own, and the difference between the dose needed for treatment and a harmful dose (the "therapeutic index") was too small.
In Sweden, physicians had long been discouraged by the medical products agency to prescribe dextropropoxyphene due to the risk of respiratory depression and even death when taken with alcohol. Physicians have earlier been recommended to prescribe products with only dextropropoxyphene and not to patients with a history of drug abuse, depression or suicidal tendencies. Products with mixed active ingredients were taken off the market and only products with dextropropoxyphene were allowed to be sold. Dextropoxyphene was de facto narcotica labelled. As of March 2011, all products containing the substance are withdrawn because of safety issues after a European Commission decision.
It was discussed at the time that people who abuse alcohol and other substances and take combination dextropoxyphene / acetaminophen (paracetamol) may need to take many combination tablets to reach euphoria, because the amount of dextropropoxyphene per tablet is relatively low (30–40 mg). The ingested paracetamol - the other component - may then reach liver toxic levels. In the case of alcoholics, who often already have damaged livers, even a relatively small overdose with paracetamol may produce hepatotoxicity, liver necrosis and liver failure. This toxicity with the combination of overdosed dextroproxyphene (with its CNS/respiratory depression/vomit with risk for aspiration pneumonia, as well as cardiotoxicity) and paracetamol-induced liver damage can result in death.
In the United Kingdom, preparations containing only dextropropoxyphene were discontinued in 2004.In 2007, the Medicines and Healthcare Products Regulatory Agency removed the licence for co-proxamol, also called distalgesic.From then on in the UK, co-proxamol is only available on a named patient basis, for long-term chronic pain and only to those who have already been prescribed this medicine. Its withdrawal from the UK market is a result of concerns relating to its toxicity in overdose (even small overdoses can be fatal), and dangerous reaction with alcohol. Recreational use in the UK is uncommon. Many patients have been prescribed alternative combinations of drugs as a replacement.
The motivation for the withdrawal of co-proxamol was the reduction in suicides and a key part of the agency's justification of its decision was based upon studies showing co-proxamol was no more effective than paracetamol alone in pain management. Prescribing authorities, such as the Royal College of General Practitioners, unanimously recommended withdrawal, while patients who responded to the agency's request for information tended to want to continue treatment.
The co-proxamol preparations available in the UK contained a subtherapeutic dose of paracetamol, 325 mg per tablet. Patients were warned not to take more than eight tablets in one day, a total dose of 2600 mg paracetamol per day. Despite this reduced level, patients were still at a high risk of overdose; coproxamol was second only to tricyclic antidepressants as the most common prescription drugs used in overdose. Following the reduction in prescribing in 2005–2007, prior to its complete withdrawal, the number of deaths associated with the drug dropped significantly. Additionally, patients have not substituted other drugs as a method of overdose.
The decision to withdraw coproxamol has met with some controversy; it has been brought up in the House of Commons on two occasions, 13 July 2005 and on 17 January 2007. Patients have found alternatives to co-proxamol either too strong, too weak, or with intolerable side effects. During the House of Commons debates, it is quoted that originally some 1,700,000 patients in the UK were prescribed co-proxamol. Following the phased withdrawal, this has eventually been reduced to 70,000. However, it appears this is the residual pool of patients who cannot find alternate analgesia to co-proxamol.
The safety net of prescribing co-proxamol after license withdrawal from 31 December 2007, on a "named patient" basis where doctors agree there is a clinical need, has been rejected by most UK doctors because the wording that "responsibility will fall on the prescriber" is unacceptable to most doctors. Some patients intend to take the case to the European Court of Human Rights. However, the European Medicines Agency has recently backed the agency's decision, and recommended in June 2009 that propoxyphene preparations be withdrawn across the European Union.
In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products, based on its weak pain-killing abilities, addictiveness, association with drug deaths and possible heart problems, including arrhythmia. A subsequent re-evaluation resulted in a July 2009 recommendation to strengthen the boxed warning for propoxyphene to reflect the risk of overdose. Dextropropoxyphene subsequently carried a black box warning in the U.S., stating:
Propoxyphene should be used with extreme caution, if at all, in patients who have a history of substance/drug/alcohol abuse, depression with suicidal tendency, or who already take medications that cause drowsiness (e.g., antidepressants, muscle relaxants, pain relievers, sedatives, tranquilizers). Fatalities have occurred in such patients when propoxyphene was misused.
Because of potential for side effects, this drug is on the list for High Risk Medications in the elderly.
On November 19, 2010, the FDA requested the cessation of all sale of Darvon and Darvocet from the US drug market due to heart arrhythmia in patients who took the drug. The drug Darvocet may also be involved in combined drug intoxication, because it may lead to confusion in patients and physicians. Many doctors are commonly switching to tramadol, because it is more effective than Darvocet yet is believed to be less addictive than stronger hydrocodone based medications.
However, in the same way codeine is a prodrug that requires in vivo metabolism for efficacy, tramadol is as well. So in the same manner as codeine, tramadol can be ineffective for individuals with liver enzyme CYP2D6 deficiencies. This can sometimes make propoxyphene a "last resort" for minor pain relief in people with this condition, as even much stronger opioids such as hydrocodone and oxycodone will also be slightly less effective as much as 10% of these medications will be converted to the much stronger hydromorphone and oxymorphone, respectively, in typical patients. In these cases medications like morphine or tapentadol can be used as they do not require further metabolism to be effective. However, these medications are many times stronger than propoxyphene, and come with their own set of risks, including a much larger risk of overdose and addiction than propoxyphene.
Bulk dextropropoxyphene is a Schedule II controlled substance with a DEA ACSCN of 9273 and a 2013 annual aggregate manufacturing quota of 19 grams.
On December 1, 2010, Health Canada and Paladin Labs Inc. announced the voluntary recall and withdrawal of Darvon-N from the Canadian market and the discontinuation of sale of Darvon-N.
On June 12, 2013, the Indian government suspended the manufacture, sale, and distribution of the drug under Section 26A of the 1940 Drugs and Cosmetic Act.
Use by right-to-die societies
High toxicity and relatively easy availability made propoxyphene a drug of choice for right-to-die societies. It is listed in Dr. Philip Nitschke's The Peaceful Pill Handbook and Dr. Pieter Admiraal's Guide to a Humane Self-Chosen Death. "With the withdrawal of the barbiturate sleeping tablets from the medical prescribing list, propoxyphene has become the most common doctor-prescribed medication used by seriously ill people to end their lives." The slang name for the combination of propoxyphene and other drugs used for suicide is "Darvon cocktail"
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