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Methadose Oral Concentrate

Last reviewed on RxList: 2/12/2018
Methadose Oral Concentrate Side Effects Center

Last reviewed on RxList 2/12/2018

Methadose Oral Concentrate (methadone hydrochloride oral concentrate) is a narcotic pain reliever, similar to morphine, used as a pain reliever and as part of drug addiction detoxification and maintenance programs. Methadose Oral Concentrate is available in generic form. Common side effects of Methadose Oral Concentrate include:

Some side effects may decrease after you have been using Methadose Oral Concentrate for a while. Tell your doctor if you have serious side effects of Methadose Oral Concentrate including:

  • shallow breathing,
  • hallucinations or confusion,
  • chest pain,
  • dizziness,
  • fainting,
  • fast or pounding heartbeat,
  • trouble breathing,
  • feeling lightheaded, or
  • fainting.

The initial Methadose dose should be administered under supervision when there are no signs of sedation or intoxication, and the patient shows symptoms of withdrawal. Initially, a single dose of 20 to 30 mg of methadone is sufficient to suppress withdrawal symptoms. Dangerous side effects may result if Methadose is taken with other narcotics, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Methadose can also interact with diuretics (water pills), antibiotics, heart or blood pressure medications, HIV medicines, MAO inhibitors, rifampin, or seizure medications. Many other medicines may cause serious medical problems if you take them together with Methadose. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Methadose should be used only when prescribed. Pregnancy may affect the amount of this drug in your body, so tell your doctor right away if you become pregnant. Use near the expected delivery date is not recommended because of possible harm to the fetus. Babies born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor if you notice any symptoms in your newborn. This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop using this medication.

Our Methadose Oral Concentrate (methadone hydrochloride oral concentrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Methadose Oral Concentrate Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • weak or shallow breathing;
  • severe constipation;
  • a light-headed feeling, like you might pass out;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath; or
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • dizziness, drowsiness;
  • nausea, vomiting; or
  • increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Methadose Oral Concentrate (Methadone Hydrochloride)

Methadose Oral Concentrate Professional Information


The major hazards of methadone are respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardiac arrest, and death have occurred.

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients. In such individuals, lower doses are advisable.

Other adverse reactions include the following: (listed alphabetically under each subsection)

Body as a Wholeasthenia (weakness), edema, headache

Cardiovascular (see WARNINGS, Cardiac Conduction Effects) – arrhythmias, bigeminal rhythms, bradycardia, cardiomyopathy, ECG abnormalities, extrasystoles, flushing, heart failure, hypotension, palpitations, phlebitis, QT interval prolongation, syncope, T-wave inversion, tachycardia, torsade de pointes, ventricular fibrillation, ventricular tachycardia

Digestive – abdominal pain, anorexia, biliary tract spasm, constipation, dry mouth, glossitis

Hematologic and Lymphatic – reversible thrombocytopenia has been described in opioid addicts with chronic hepatitis

Metabolic and Nutritional hypokalemia, hypomagnesemia, weight gain

Nervous – agitation, confusion, disorientation, dysphoria, euphoria, insomnia, seizures

Respiratorypulmonary edema, respiratory depression (see WARNINGS, Respiratory Depression)

Skin and Appendagespruritus, urticaria, other skin rashes, and rarely, hemorrhagic urticaria

Special Senses – hallucinations, visual disturbances

Urogenitalamenorrhea, antidiuretic effect, reduced libido and/or potency, urinary retention or hesitancy

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of METHADOSE.

Serotonin syndrome – Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs (see WARNINGS and PRECAUTIONS, DRUG INTERACTIONS).

Adrenal insufficiency – Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use (see WARNINGS).

Anaphylaxis – Anaphylactic reaction has been reported with ingredients contained in METHADOSE (see CONTRAINDICATIONS).

Androgen deficiency – Cases of androgen deficiency have occurred with chronic use of opioids (see CLINICAL PHARMACOLOGY).

Drug Abuse And Dependence

METHADOSE contains methadone, a Schedule II opioid agonist. Schedule II opioid substances, which also include hydromorphone, morphine, oxycodone, and oxymorphone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Methadone, like morphine and other opioids used for analgesia, has the potential for being abused and is subject to criminal diversion.

Abuse of METHADOSE poses a risk of overdose and death. This risk is increased with concurrent abuse of METHADOSE with alcohol and other substances. In addition, parenteral drug abuse is commonly associated with transmission of infectious disease such as hepatitis and HIV.

Because METHADOSE may be diverted for non-medical use, careful record keeping of ordering and dispensing information, including quantity and frequency is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

METHADOSE, when used for the treatment of opioid addiction in detoxification or maintenance programs, may be dispensed only by opioid treatment programs certified by the Substance Abuse and Mental Health Services Administration (and agencies, practitioners or institutions by formal agreement with the program sponsor).

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy (see WARNINGS, Neonatal Opioid Withdrawal Syndrome, and PRECAUTIONS, Pregnancy).

Physical dependence can develop during chronic opioid therapy.

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or significant dose reduction of a drug. Withdrawal is also precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene) or mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Physical dependence is expected during opioid agonist therapy of opioid addiction.

METHADOSE should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION). If METHADOSE is abruptly discontinued in a physically dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate (see DOSAGE AND ADMINISTRATION, Medically Supervised Withdrawal After a Period of Maintenance Treatment).

Read the entire FDA prescribing information for Methadose Oral Concentrate (Methadone Hydrochloride)

Related Resources for Methadose Oral Concentrate

© Methadose Oral Concentrate Patient Information is supplied by Cerner Multum, Inc. and Methadose Oral Concentrate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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