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Methadose Oral Concentrate

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Methadose Oral Concentrate

Methadose Oral Concentrate

Methadose Oral Concentrate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Methadose Oral Concentrate (methadone hydrochloride oral concentrate) is used as a pain reliever and as part of drug addiction detoxification and maintenance programs. It is a narcotic pain reliever, similar to morphine. This medication is available in generic form. Common side effects include nausea, vomiting, constipation, lightheadedness, dizziness, dry mouth, drowsiness, or sweating. Some effects may decrease after you have been using this medication for a while.

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.

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 Oral Concentrate 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 Oral Concentrate (Methadone Hydrochloride) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Methadose Oral Concentrate FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Heroin Withdrawal

During the induction phase of methadone maintenance treatment, patients are being withdrawn from heroin and may therefore show typical withdrawal symptoms, which should be differentiated from methadone-induced side effects.

They may exhibit some or all of the following signs and symptoms associated with acute withdrawal from heroin or other opiates: lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose-flesh, fever, chilliness 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.

Initial Administration

The initial methadone dose should be carefully titrated to the individual. Too rapid titration for the patient's sensitivity is more likely to produce adverse effects.

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: (listed alphabetically under each subsection)

Body as a Whole - asthenia (weakness), edema, headache

Cardiovascular (also 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

Respiratory - pulmonary edema, respiratory depression (see WARNINGS: Respiratory Depression)

Skin and Appendages - pruritis, urticaria, other skin rashes, and rarely, hemorrhagic urticaria

Special Senses - hallucinations, visual disturbances

Urogenital - amenorrhea, antidiuretic effect, reduced libido and/or potency, urinary retention or hesitancy

Maintenance on a Stabilized Dose - During prolonged administration of methadone, as in a methadone maintenance treatment program, there is usually a gradual, yet progressive, disappearance of side effects over a period of several weeks. However, constipation and sweating often persist.

Drug Abuse And Dependence

Methadose contains methadone, a potent 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.

Since Methadose may be diverted for non-medical use, careful record keeping of ordering and dispensing information, including quantity, frequency, and renewal requests 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).

Infants born to mothers physically dependent on opioids may also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms (See PRECAUTIONS; Pregnancy, Labor and Delivery).

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

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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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