Methadose Oral Concentrate
- Generic Name: methadone hydrochloride
- Brand Name: Methadose Oral Concentrate
Methadose Oral Concentrate (Methadone Hydrochloride) side effects drug center
Methadose Oral Concentrate Side Effects Center
What Is Methadose Oral Concentrate?
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.
What Are Side Effects of Methadose Oral Concentrate?
Common side effects of Methadose Oral Concentrate include:
- anxiety,
- nervousness,
- restlessness,
- sleep problems (insomnia),
- weakness,
- nausea,
- vomiting,
- constipation,
- diarrhea,
- lightheadedness,
- loss of appetite,
- dizziness,
- dry mouth,
- drowsiness,
- sweating,
- decreased sex drive,
- impotence, or
- difficulty having an orgasm.
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.
Dosage for Methadose Oral Concentrate
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.
What Drugs, Substances, or Supplements Interact with Methadose Oral Concentrate?
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.
Methadose Oral Concentrate During Pregnancy or Breastfeeding
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.
Additional Information
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.
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, breathing that stops during sleep;
- 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;
- increased sweating; or
- pain, redness, or swelling where the medicine was injected.
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
SIDE 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. 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 (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
Central Nervous System – agitation, confusion, disorientation, dysphoria, euphoria, insomnia, hallucinations, seizures, visual disturbances, congenital oculomotor disorders (nystagmus, strabismus)
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
Respiratory – pulmonary edema, respiratory depression (see WARNINGS, Respiratory Depression)
Skin and Appendages – pruritus, 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
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 INTERACTIONS
Benzodiazepines and Other Central Nervous System (CNS) Depressants | |
Clinical Impact: | Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. |
Intervention: | Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatments (see WARNINGS). If concomitant use is warranted, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all patients in treatment for opioid use disorder (see WARNINGS). |
Examples: | Alcohol, benzodiazepines, and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids. |
Inhibitors of CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 | |
Clinical Impact: | Methadone undergoes hepatic N-demethylation by several cytochrome P450 (CYP) isoforms, including CYP3A4, CYP2B6, CYP2C19, CYP2C9, and CYP2D6. The concomitant use of methadone and CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitors can increase the plasma concentration of methadone, resulting in increased or prolonged opioid effects, and may result in a fatal overdose, particularly when an inhibitor is added after a stable dose of methadone is achieved. These effects may be more pronounced with concomitant use of drugs that inhibit more than one of the CYP enzymes listed above. After stopping a CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitor, as the effects of the inhibitor decline, the methadone plasma concentration can decrease, resulting in decreased opioid efficacy or withdrawal symptoms in patients physically dependent on methadone. |
Intervention: | If concomitant use is necessary, consider dosage reduction of methadone until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitor is discontinued, follow patients for signs of opioid withdrawal and consider increasing the methadone dosage until stable drug effects are achieved. |
Examples: | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), fluconazole, fluvoxamine, some selective serotonin reuptake inhibitors (SSRIs) (e.g., sertraline, fluvoxamine) |
Inducers of CYP3A4, CYP2B6, CYP2C19, or CYP2C9 | |
Clinical Impact: | The concomitant use of methadone and CYP3A4, CYP2B6, CYP2C19, or CYP2C9 inducers can decrease the plasma concentration of methadone, resulting in decreased efficacy or onset of withdrawal symptoms in patients physically dependent on methadone. These effects could be more pronounced with concomitant use of drugs that can induce multiple CYP enzymes. After stopping a CYP3A4, CYP2B6, CYP2C19, or CYP2C9 inducer, as the effects of the inducer decline, the methadone plasma concentration can increase, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression, sedation, or death. |
Intervention: | If concomitant use is necessary, consider increasing the methadone dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4, CYP2B6, CYP2C19, or CYP2C9 inducer is discontinued, consider methadone dosage reduction and monitor for signs of respiratory depression and sedation. |
Examples: | Rifampin, carbamazepine, phenytoin, St. John’s Wort, Phenobarbital |
Potentially Arrhythmogenic Agents | |
Clinical Impact: | Pharmacodynamic interactions may occur with concomitant use of methadone and potentially arrhythmogenic agents or drugs capable of inducing electrolyte disturbances (hypomagnesemia, hypokalemia). |
Intervention: | Monitor patients closely for cardiac conduction changes. |
Examples: | Drugs known to have potential to prolong QT interval: Class I and III antiarrhythmics, some neuroleptics and tricyclic antidepressants, and calcium channel blockers. Drugs capable of inducing electrolyte disturbances: Diuretics, laxatives, and, in rare cases, mineralocortocoid hormones. |
Serotonergic Drugs | |
Clinical Impact: | The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome (see WARNINGS). |
Intervention: | If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue METHADOSE if serotonin syndrome is suspected. |
Examples: | Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
Monoamine Oxidase Inhibitors (MAOIs) | |
Clinical Impact: | MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) (see WARNINGS). |
Intervention: | The use of METHADOSE is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. |
Examples: | phenelzine, tranylcypromine, linezolid |
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics | |
Clinical Impact: | Patients maintained on methadone may experience withdrawal symptoms when given opioid antagonists, mixed agonist/antagonists, and partial agonists. |
Intervention: | Avoid concomitant use. |
Examples: | butorphanol, nalbuphine, pentazocine, buprenorphine |
Muscle Relaxants | |
Clinical Impact: | Methadone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. |
Intervention: | Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of METHADOSE and/or the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, strongly consider prescribing naloxone for the emergency treatment of opioid overdose (see DOSAGE AND ADMINISTRATION). |
Diuretics | |
Clinical Impact: | Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. |
Intervention: | Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. |
Anticholinergic Drugs | |
Clinical Impact: | The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. |
Intervention: | Monitor patients for signs of urinary retention or reduced gastric motility when METHADOSE is used concomitantly with anticholinergic drugs. |
Paradoxical Effects Of Antiretroviral Agents On Methadone
Concurrent use of certain protease inhibitors with CYP3A4 inhibitory activity, alone and in combination, such as abacavir, amprenavir, darunavir+ritonavir, efavirenz, nelfinavir, nevirapine, ritonavir, telaprevir, lopinavir+ritonavir, saquinavir+ritonavir, and tipranvir+ritonavir, has resulted in increased clearance or decreased plasma levels of methadone. This may result in reduced efficacy of METHADOSE and could precipitate a withdrawal syndrome. Monitor patients receiving METHADOSE and any of these antiretroviral therapies closely for evidence of withdrawal effects and adjust the METHADOSE dose accordingly.
Effects Of Methadone On Antiretroviral Agents
Didanosine And Stavudine
Experimental evidence demonstrated that methadone decreased the area under the concentration-time curve (AUC) and peak levels for didanosine and stavudine, with a more significant decrease for didanosine. Methadone disposition was not substantially altered.
Zidovudine
Experimental evidence demonstrated that methadone increased the AUC of zidovudine which could result in toxic effects.
Desipramine
Plasma levels of desipramine have increased with concurrent methadone administration.
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 andfrequencyis 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)
&Copy; 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.