Patient Medication Information: uses, side effects, how to take - Methadone Hydrochloride Oral Concentrate USP
Serious Warnings and Precautions
- Even if you take Methadone Hydrochloride Oral Concentrate USP as prescribed, you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
You may get life-threatening breathing problems while taking Methadone Hydrochloride Oral Concentrate USP. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing. This is less likely to happen if you take it as prescribed by your doctor. Because this effect is long-lasting, breathing problems can happen hours after taking your dose. Breathing problems may be most likely when starting Methadone Hydrochloride Oral Concentrate USP and when the dose is increased. Get emergency medical help immediately if you:
- Have trouble breathing, or have slow or shallow breathing;
- Have a slow or irregular heartbeat;
- Have severe sleepiness;
- Have cold, clammy skin;
- Feel faint, dizzy, confused, or cannot think, walk or talk normally;
- Have a seizure;
- Have hallucinations.
Dangerous side effects and death may occur when Methadone Hydrochloride Oral Concentrate USP is used with alcohol or with other medications that may cause drowsiness such as antidepressants, antihistamines, muscle relaxants or sleeping medications.
In some patients, Methadone Hydrochloride Oral Concentrate USP may cause heartbeat problems that can be life- threatening in rare cases. Symptoms may include fainting, palpitations (feeling a rapid, pounding or irregular heartbeat), or loss of consciousness.
- You should never give anyone your Methadone Hydrochloride Oral Concentrate USP. They could die from taking it. If a person has not been prescribed Methadone Hydrochloride Oral Concentrate USP, taking even one dose can cause a fatal overdose. This is especially true for children.
What is Methadone Hydrochloride Oral Concentrate USP used for?
Methadone Hydrochloride Oral Concentrate USP is used in conjunction with appropriate social and medical services as a substitution treatment for opioid drug dependence. Only a qualified doctor can prescribe Methadone Hydrochloride Oral Concentrate USP. Methadone Hydrochloride Oral Concentrate USP needs to be taken under daily supervision of a healthcare professional.
How does Methadone Hydrochloride Oral Concentrate USP work?
Methadone belongs to a class of drugs that is commonly referred to as opioids or narcotics which also includes the illicit drug heroin, and the prescription drugs codeine, fentanyl, hydromorphone and morphine.
Methadone acts to suppress symptoms of opioid withdrawal without producing a “high”, while the long-acting nature of the drug allows for once-a-day maintenance dosing.
What are the ingredients in Methadone Hydrochloride Oral Concentrate USP?
Medicinal ingredients: Methadone hydrochloride
Non-medicinal ingredients: artificial cherry flavour, brilliant blue FCF, citric acid monohydrate, glycerol, hydroxyethylcellulose, purified water, sodium benzoate, xylitol.
Methadone Hydrochloride Oral Concentrate USP comes in the following dosage forms:
Oral concentrate, sugar-free (sweetened with xylitol), cherry flavour: 10 mg/mL
Do not use Methadone Hydrochloride Oral Concentrate USP if:
- you are allergic to methadone hydrochloride or any of the other ingredients in Methadone Hydrochloride Oral Concentrate USP
- If you took Methadone Hydrochloride Oral Concentrate USP while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:
- has changes in their breathing (such as weak, difficult or fast breathing)
- is unusually difficult to comfort
- has tremors (shakiness)
- has increased stools, sneezing, yawning, vomiting, or fever Seek immediate medical help for your baby.
- Taking Methadone Hydrochloride Oral Concentrate USP with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- you have severe asthma, trouble breathing, or other breathing problems
- you are taking or have taken within the past 2 weeks a monoamine oxidase inhibitor (MAOI) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
- you have severe diarrhea caused by antibiotics
- you have bowel blockage or narrowing of the stomach or intestines
- you have severe pain in your abdomen
- you have a head injury
- you are at risk for seizures
- you suffer from alcoholism
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Methadone Hydrochloride Oral Concentrate USP. Talk about any health conditions or problems you may have, including if you:
- have a history of illicit or prescription drug or alcohol abuse
- have severe kidney, liver, lung disease
- have heart disease
- have low blood pressure
- have or had depression
- have problems with your thyroid, adrenal or prostate gland
- suffer from chronic or severe constipation
- have, or had in the past, hallucinations or other severe mental problems
- suffer from migraines
- you are going to have a planned surgery
- you are pregnant or plan to become pregnant
Other warnings you should know about:
Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.
Pregnancy, nursing, labour and delivery: The use of Methadone Hydrochloride Oral Concentrate USP during labour or delivery is not recommended. Opioids can be transferred to your baby through breast milk, or while still in the womb. Methadone Hydrochloride Oral Concentrate USP can then cause life-threatening breathing problems in your unborn baby or nursing infant.
Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Methadone Hydrochloride Oral Concentrate USP. Methadone Hydrochloride Oral Concentrate USP can cause:
- drowsiness
- dizziness or
- lightheadedness
This can usually occur after you take your first dose and when your dose is increased.
Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones.
You may experience symptoms such as:
- nausea, vomiting
- feeling tired, weak or dizzy
- decreased appetite
You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off Methadone Hydrochloride Oral Concentrate USP.
Serotonin toxicity (also known as serotonin syndrome): Methadone Hydrochloride Oral Concentrate USP can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take Methadone Hydrochloride Oral Concentrate USP with certain antidepressants or migraine medications.
Serotonin toxicity symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
Sexual Function/Reproduction: Long-term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.
- You should call your doctor immediately if you feel dizzy, lightheaded, or faint or have palpitations (feeling a rapid, pounding or irregular heartbeat) after taking Methadone Hydrochloride Oral Concentrate USP;
- You should not drink alcohol or take medicines that may cause drowsiness and/or slow, shallow breathing (like sleeping aids or muscle relaxers) when taking Methadone Hydrochloride Oral Concentrate USP;
- If you become pregnant or plan to become pregnant, talk with your doctor about the risks related both to taking Methadone Hydrochloride Oral Concentrate USP during pregnancy, and to stopping Methadone Hydrochloride Oral Concentrate USP;
- Stopping treatment with Methadone Hydrochloride Oral Concentrate USP may result in a return to narcotic drug use;
- If you suddenly stop taking Methadone Hydrochloride Oral Concentrate USP, you may experience withdrawal symptoms. If you and your doctor decide that you should stop taking Methadone Hydrochloride Oral Concentrate USP, consider slowly lowering the dose instead of suddenly stopping the treatment. Your doctor can provide you with an appropriate dosing schedule.
If you are pregnant or breastfeeding, then speak with your doctor about the risks and benefits of breastfeeding while taking Methadone Hydrochloride Oral Concentrate USP such as the following:
- Your baby will receive a small amount of Methadone Hydrochloride Oral Concentrate USP through your breast milk;
- Your baby may experience withdrawal symptoms if you suddenly stop breastfeeding.
- Talk with your doctor about developing a plan to slowly wean your baby;
- You should not drink alcohol or use drugs of abuse while breastfeeding, because doing so will expose your baby to additional risks;
- When starting Methadone Hydrochloride Oral Concentrate USP treatment or increasing the dose while breastfeeding, closely watch your baby for changes in behavior or breathing patterns.
Sleep Apnea: Opioids can cause sleep-related breathing disorders such as sleep apnea syndromes (including central sleep apnea [CSA]) and hypoxia (including sleep-related hypoxia).
Intolerance to certain sugars: Methadone Hydrochloride Oral Concentrate USP contains a sweetener called xylitol. Talk to your doctor before taking this medicine if you have been told that you are intolerant to certain sugars. In some people, xylitol may affect the amount of methadone their body can absorb. In these people, switching between Methadone Hydrochloride Oral Concentrate USP and other methadone-containing products that do not contain xylitol may cause changes in methadone blood levels. This can cause a return of symptoms. If this happens, please contact your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Methadone Hydrochloride Oral Concentrate USP:
Alcohol. This includes prescription and non-prescription medications that contain alcohol.
Do not drink alcohol while you are taking Methadone Hydrochloride Oral Concentrate USP. It can lead to:
- drowsiness
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
- other opioid analgesics (drugs used to treat pain)
- general anesthetics (drugs used during surgery)
- benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
- antidepressants (for depression and mood disorders). Do not take Methadone Hydrochloride Oral Concentrate USP with MAO inhibitors (MAOI) or if you have taken MAOIs in the last 14 days.
- drugs used to treat serious mental or emotional disorders (such as schizophrenia)
- antihistamines (drugs used to treat allergies)
- anti-emetics (drugs used for the prevention of vomiting)
- drugs used to treat muscle spasms and back pain
- drugs used to treat migraines (e.g., triptans)
- anti-epileptic drugs (used to treat seizures)
- anti-retroviral drugs (used to treat HIV)
- anti-fungal drugs (used to treat fungal infections)
- antibiotic drugs (used to treat bacterial infections)
- some heart medication (such as beta-blockers, anti-arrhythmic agents and calcium channel blockers)
- grapefruit juice
- St. John’s wort
Be sure to tell your doctor, dentist, pharmacist and all other health professionals who are treating you that you are taking Methadone Hydrochloride Oral Concentrate USP.
How to take Methadone Hydrochloride Oral Concentrate USP:
Usual Adult Starting Dose
Dosing of Methadone Hydrochloride Oral Concentrate USP is patient-specific and varies based on use and symptoms. Take exactly as directed by your doctor. The dose should be taken all at once, and preferably at the same time every day.
The dose of Methadone Hydrochloride Oral Concentrate USP will “hold” for longer periods of time as your treatment progresses. You should not change your dose of Methadone Hydrochloride Oral Concentrate USP unless you discuss this with your doctor and your doctor recommends a dose change. Taking higher doses can lead to more side effects and a greater chance of overdose.
If you develop any side effect as a result of taking Methadone Hydrochloride Oral Concentrate USP, tell your doctor immediately.
If you have been taking Methadone Hydrochloride Oral Concentrate USP for more than a few days you should not stop taking it all of a sudden.
Your doctor will monitor and guide you on how to slowly stop taking Methadone Hydrochloride Oral Concentrate USP. You should do it slowly to avoid uncomfortable symptoms such as having:
- body aches
- diarrhea
- goosebumps
- loss of appetite
- nausea
- feeling nervous or restless
- runny nose
- sneezing
- tremors or shivering
- stomach cramps
- rapid heart rate (tachycardia)
- having trouble sleeping
- an unusual increase in sweating
- an unexplained fever
- weakness
- yawning
By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking Methadone Hydrochloride Oral Concentrate USP.
Refilling Your Prescription for Methadone Hydrochloride Oral Concentrate USP:
A new written prescription is required from your doctor each time you need more Methadone Hydrochloride Oral Concentrate USP. Therefore, it is important that you contact your doctor before your current supply runs out.
Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for your pain management.
Occasionally, the brand of methadone prescribed by your doctor or dispensed by your pharmacist may change. Should you experience any side effects, discuss with your doctor or pharmacist.
Overdose:
Signs of overdose may include:
- unusually slow or weak breathing
- dizziness
- confusion
- extreme drowsiness
Missed Dose:
It is important that you do not miss any doses. If you miss one dose, take your next dose at your usual time. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once. If you miss several doses in a row, talk to your doctor before restarting your medication.
What are possible side effects from using Methadone Hydrochloride Oral Concentrate USP?
These are not all the possible side effects you may feel when taking Methadone Hydrochloride Oral Concentrate USP. If you experience any side effects not listed here, contact your healthcare professional. Side effects may include:
- Drowsiness
- Insomnia
- Dizziness
- Fainting
If you think you, or a person you are caring for, have taken too much Methadone Hydrochloride Oral Concentrate USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
- Nausea, vomiting, or a poor appetite
- Dry mouth
- Headache
- Problems with vision
- Weakness, uncoordinated muscle movement
- Itching
- Sweating
- Constipation
- Low sex drive, impotence (erectile dysfunction), infertility
Talk with your doctor or pharmacist about ways to prevent constipation when you start using Methadone Hydrochloride Oral Concentrate USP.
Get emergency medical help right away if you have:
- Fast or slow or skipped heartbeat, chest pain, chest tightness, fainting or feel very dizzy;
- Serotonin Syndrome: a combination of most or all of the following symptoms: agitation, confusion, delirium, rapid heart rate and high blood pressure, stiffness, lack of coordination, nausea, vomiting, diarrhea, sweating, fever, shivering, seizure and coma.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Overdose: confusion, hallucinations, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone, cold and clammy skin, low blood sugar | √ | ||
Respiratory Depression: slow, shallow or weak breathing | √ | ||
Serotonin Toxicity: a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (> 38°C), or rigid muscles | √ | ||
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea | √ | ||
Fast, Slow or Irregular Heartbeat: heart palpitations | √ | ||
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating | √ | ||
| Low Blood Pressure: dizziness, fainting, lightheadedness | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Your pharmacist or other health professional will store this product.
In the case of take-home doses:
- You should store Methadone Hydrochloride Oral Concentrate USP, like other opioids, in a locked, secure place and out of the sight and reach of children and pets.
- Never take medicine in front of small children as they may want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidently takes Methadone Hydrochloride Oral Concentrate USP, get emergency help right away.
- Methadone Hydrochloride Oral Concentrate USP is a federally-controlled drug because of the potential for abuse. Protect your Methadone Hydrochloride Oral Concentrate USP from theft or any other access, and never provide your Methadone Hydrochloride Oral Concentrate USP to anyone else.
- Keep unused or expired Methadone Hydrochloride Oral Concentrate USP in a secure place to prevent theft, misuse or accidental exposure.
- Store at room temperature (15 - 30°C). Keep in a dry place. Protected from light and freezing.
Disposal:
Methadone Hydrochloride Oral Concentrate USP should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.
If you want more information about Methadone Hydrochloride Oral Concentrate USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer's website https://sterinova.com/; or by calling Sterinova Inc. at 1-844-329-2939.
Sterinova Inc.
St-Hyacinthe, QC, J2S 0J9
CANADA