Dolophine is a brand name medication containing the active ingredient methadone hydrochloride. Dolophine is used in the treatment of severe pain or in the maintenance treatment of opioid dependence as part of a comprehensive treatment program alongside appropriate social support and medical services.
What Is Dolophine?
Dolophine (methadone hydrochloride) is an opioid agonist. As an agonist, it turns on opioid receptors in the brain. Dolophine activates the body’s natural opioid system, decreasing the perception of pain. Dolophine also helps reduce the craving and withdrawal symptoms associated with heavy opioid use.
FDA Approved Uses
Initially approved by the U.S. Food and Drug Administration in 1947, Dolophine has been used for many years.
Currently, Dolophine is approved for the treatment of:
- Severe pain
- Opioid abuse detoxification
Maintenance treatment of opiate dependence
Dolophine Prescribing Information
Dolophine can only be dispensed via specialized treatment programs, certified by the Substance Abuse and Mental Health Services Administration. Newly prescribed patients should be monitored closely for respiratory depression. Attention should be paid most closely to the first 24–72 hours of initiating therapy. Seek emergency help immediately if excess Dolophine is consumed. Never give anyone your Dolophine. Keep the medication away from children.
Dolophine Use in Opioid Withdrawal Treatment
Many studies have demonstrated the beneficial use of methadone in treating opioid dependence. One study showed methadone was overall superior to buprenorphine in maintaining abstinence and equally effective in decreasing opioid use.
Dolophine tablets are available in 5mg and 10mg formulations. The dosing schedule depends on the particular condition and individual being treated. Always discuss specific dosing regimens with your healthcare provider.
2.5 mg orally every 8–12 hours.
As a pain-reliever, Dolophine can be used temporarily to reduce the suffering associated with severe pain. As the pain becomes tolerable, the dose should be reduced gradually over a period of days or weeks to avoid precipitating symptoms of opioid withdrawal.
Detoxification with Dolophine is always done under clinical supervision and when no signs of opioid intoxication exist. This is done to decrease the risk of overdose. If the withdrawal symptoms persist for four hours after the initial dose, an additional 5–10 mg may be prescribed. The initial daily dose of Dolophine should never exceed 40 mg.
The dose is slowly titrated up over a period of days or weeks until clinical stability is obtained. Normally, a dose between 80–120 mg a day is effective after gradually titrating up.
Dolophine Side Effects
Methadone, the active ingredient in Dolophine, has undergone significant safety assessment since its initial approval in 1947. Long-term methadone maintenance therapy is a safe treatment option for people struggling with opioid dependence.
Some individuals may experience minor side effects, most pronounced during the initial adjustment phase.
Some of the most common side effects of Dolophine are:
- Abdominal pain
More serious side effects of Dolophine use may include:
- Respiratory depression
- Systemic hypotension (significantly low blood pressure)
- Cardiac arrest
- Dependence and addiction
Methadone is a Schedule II controlled substance. Dolophine carries the risk of addiction, abuse and misuse. The long-acting mechanism of Dolophine further increases the risk of overdose and death.
- Overdose: Life-threatening respiratory depression may occur as a result of using Dolophine inappropriately or incorrectly. The respiratory depressant effect of methadone starts much later and lasts much longer than the pain-relieving properties. This is important in those taking repeated doses. People taking the medication should allow for a minimum of six to eight hours between each dose. Always be aware of the potential for overdose with this medication.
- Dependence: The specific risk of developing dependence while taking Dolophine is unknown and varies from person to person. Dolophine should be taken with caution, because even patients taking the medication appropriately may become dependent.
- Neonatal Opioid Withdrawal: The development of neonatal opioid withdrawal as a result of methadone use during pregnancy is well-documented. Regular use of Dolophine during pregnancy is associated with newborn withdrawal symptoms upon delivery. This is a potentially life-threatening condition that must be dealt with accordingly and addressed by certified health care providers.
- Life-threatening QT Prolongation: There have been cases of serious heart arrhythmia described in people who use methadone. Known as QT interval prolongation or Torsades de Pointes, follow-up studies have confirmed the ability of methadone to inhibit cardiac ion channels, affecting their ability to pump correctly. The QT abnormalities were most often observed at high methadone concentrations.
- Seizures: Dolophine may increase the frequency of seizures in patients with a previous history of seizure disorder. Individuals with a known seizure disorder taking Dolophine should be monitored closely for any signs of worsening seizure activity.
- Drug/Medication Interactions: Methadone may interact with other medications. It is broken down by a set of enzymes (CYP enzymes) that are also responsible for the metabolism of many other medications. Speak with your healthcare provider about potential drug interactions.
Some medications that may interact with Dolophine include:
- Monoamine oxidase inhibitors (MAOIs), such as hydralazine
- Antiretroviral agents used in the treatment of HIV, such as zidovudine
- Other opioid treatment medications, such as buprenorphine
- Some heart medications that can affect the QT interval, such as verapamil
- Benzodiazepines, such as lorazepam (Ativan)
- CYP enzyme modulators such as rifampin, carbamazepine, phenytoin, St. John’s wort or phenobarbital
- Other Precautions: Those with any pulmonary diseases or severe asthma should exercise use increased caution if taking Dolophine due to the increased risk of respiratory depression. Dolophine may impair mental clarity, so it is recommended that patients taking Dolophine do not drive or operate heavy machinery. Do not drink alcohol while taking Dolophine — doing so may result in overdose or death.
Dolophine and Pregnancy
The FDA categorizes methadone as a Category C pregnancy medication. Tell your health care provider if you become pregnant while taking Dolophine. Taking Dolophine while pregnant may cause significant harm to the developing baby. Additionally, the baby could be born with neonatal opioid withdrawal syndrome, a potentially lethal situation when not addressed correctly.
If a patient decides to continue taking methadone during pregnancy despite the risks, the dosage may need to be adjusted, as pregnancy may increase the clearance rate of the medication. Methadone should only be used during pregnancy if the potential benefit outweighs the potential risk of harm to the developing fetus.
Although methadone has been detected in human milk, the concentrations are minimal. It is now recommended that infants born to methadone-prescribed mothers should continue breastfeeding as per the usual guidelines. Infants of breastfeeding mothers taking Dolophine should be monitored closely. The benefits and risks associated with methadone use should be discussed with your health care provider.
Key Points: Maintenance Treatment & Your Recovery
Some important points to remember about Dolophine include:
- Dolophine is approved as a strong analgesic (pain reliever), used for severe pain, easing withdrawal symptoms during detoxification treatment and maintenance treatment of opioid dependence
- Because Dolophine contains an opioid, it carries an inherent risk of addiction and misuse
- When used correctly, Dolophine is a safe and effective alternative for the treatment of opioid dependence
- Dolophine carries a serious risk for overdose or death if misused
- Dolophine may cause significant respiratory depression, which can lead to coma or death
- Dolophine is transferred from the mother to the baby if taken during pregnancy, which places the baby at risk for neonatal opioid withdrawal
U.S. Food and Drug Administration. “Dolophine (Methadone Hydrochloride) Tablets”. February 2018. Accessed 26 July 2019
U.S. Food and Drug Administration. “Methadose (Methadone Hydrochloride Oral Concentrate)”. February 2018. Accessed 26 July 2019
Dryden, C.; Young, D.; et al. “Maternal Methadone Use in Pregnancy: Factors Associated with the Development of Neonatal Abstinence Syndrome and Implications for Healthcare Resources”. International Journal of Obstetrics and Gynaecology, March 11, 2009. Accessed July 26, 2019
Joseph, Herman,; et alStancliff, Sharon; Langrod, John. “Methadone Maintenance Treatment: A Review of Historical and Clinical Issues”. The Mount Sinai Journal of Medicine, October/November 2000. Accessed 27 July 2019.
Mattick, Richard,et al. “Buprenorphine Maintenance Versus Placebo or Methadone Maintenance for Opioid Dependence”. Cochrane Systematic Review, 06 February 6, 2014. Accessed 27 July 2019
Pearson, Ellen, et al; “QT Prolongation and Torsades de Pointes Among Methadone Users: Reports to the FDA Spontaneous Reporting system”. Pharamcoepidemiology & Drug Safety, 25 May 25, 2005. Accessed 27 July 27, 2019