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In addition to requiring new labeling on these prescript"...
Methadose Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Methadose is indicated to relieve moderate to severe pain that has not been relieved by non-narcotic pain relievers. It also is used to prevent withdrawal symptoms in patients who were addicted to opiate drugs and are enrolled in treatment programs. Side effects of Methadose include drowsiness, weakness, dizziness, nausea, vomiting, constipation, lack of appetite, stomach pain, sweating, dry mouth, and flushing.
Methadose comes as a tablet, a dispersible tablet (can be dissolved in liquid), a solution (liquid), and a concentrated solution (liquid that must be diluted before use) to take by mouth. Methadose can be taken with or without food as prescribed by a doctor. Many other drugs can interact with Methadose. Tell your doctor all medications you use. During pregnancy, Methadose should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the fetus. Methadose passes into breast milk and is unlikely to harm a nursing infant. Women who are planning to breastfeed should consult their doctors before doing so. If breastfeeding is suddenly stopped, the nursing infant may experience withdrawal symptoms. Breastfeeding women should discuss a plan for breastfeeding with their doctors. It is not known if Methadose can cause fetal harm when administered to a pregnant or breastfeeding woman. Withdrawal symptoms may occur if you suddenly stop using this medication.
Our Methadose 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Methadose in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing;
- hallucinations or confusion;
- chest pain, dizziness, fainting, fast or pounding heartbeat; or
- trouble breathing, feeling light-headed, or fainting.
Less serious side effects may include:
- feeling anxious, nervous, or restless;
- sleep problems (insomnia);
- feeling weak or drowsy;
- dry mouth, nausea, vomiting, diarrhea, constipation, loss of appetite; or
- decreased sex drive, impotence, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Methadose (Methadone Hydrochloride Tablets) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Methadose FDA Prescribing Information: Side Effects
The following serious adverse reactions and/or conditions are discussed elsewhere in the labeling:
- Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- QT Prolongation [see WARNINGS AND PRECAUTIONS]
- Chronic Pulmonary Disease [see WARNINGS AND PRECAUTIONS]
- Head Injuries and Increased Intracranial Pressure [see WARNINGS AND PRECAUTIONS]
- Interactions with Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Hypotensive Effect [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
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 and in those who are not suffering severe pain. In such individuals, lower doses are advisable.
Other adverse reactions include the following:
Body as a Whole: asthenia (weakness), edema, headache
Cardiovascular: arrhythmias, bigeminal rhythms, bradycardia, cardiomyopathy, ECG abnormalities, extrasystoles, flushing, heart failure, hypotension, palpitations, phlebitis, QT interval prolongation, syncope, T-wave inversion, tachycardia, torsades de pointes, ventricular fibrillation, ventricular tachycardia
Renal: antidiuretic effect, urinary retention or hesitancy
Respiratory: pulmonary edema, respiratory depression
Hypersensitivity: Anaphylaxis has been reported with ingredients contained in Methadose. Advise patients how to recognize such a reaction and when to seek medical attention.
Maintenance on a Stabilized Dose: During prolonged administration of methadone, as in a methadone maintenance treatment program, constipation and sweating often persist and hypogonadism, decreased serum testosterone and reproductive effects are thought to be related to chronic opioid use.
Methadose for the Detoxification and Maintenance Treatment of Opioid Dependence
During the induction phase of methadone maintenance treatment, patients are being withdrawn from illicit opioids and may have opioid withdrawal symptoms. Monitor patients for signs and symptoms including: lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose-flesh, fever, chilling alternating with flushing, restlessness, irritability, weakness, anxiety, depression, dilated pupils, tremors, tachycardia, abdominal cramps, body aches, involuntary twitching and kicking movements, anorexia, nausea, vomiting, diarrhea, intestinal spasms, and weight loss and consider dose adjustment as indicated.
Read the entire FDA prescribing information for Methadose (Methadone Hydrochloride Tablets) »
Additional Methadose Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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