Patient Medication Information: uses, side effects, how to take - Meperidine Hydrochloride Injection USP (Sandoz Canada, 50 mg)
Serious Warnings and Precautions
Seek immediate medical help for your baby.
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What is Meperidine Hydrochloride Injection USP used for?
Meperidine Hydrochloride Injection USP is used in adults to manage short-term (acute) moderate to severe pain. It is NOT used “as needed” to treat pain that you only have once in a while.
How does Meperidine Hydrochloride Injection USP work?
Meperidine Hydrochloride Injection USP is a painkiller belonging to the class of medicines known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
What are the ingredients in Meperidine Hydrochloride Injection USP?
Medicinal ingredient: meperidine hydrochloride.
Non-medicinal ingredients: sodium hydroxide and/or hydrochloric acid to adjust pH, and water for injection.
Meperidine Hydrochloride Injection USP comes in the following dosage forms:
Solution for injection: 50 mg/mL of meperidine hydrochloride.
Do not use Meperidine Hydrochloride Injection USP if:
- your healthcare professional did not prescribe it for you.
- you are allergic to meperidine, other opioids, or any of the other ingredients in Meperidine Hydrochloride Injection.
- you have mild pain that can be controlled by the occasional use of painkillers including those available without a prescription.
- you have severe asthma, trouble breathing, or other lung problems.
- you have any heart problems.
- you have bowel blockage or narrowing of the stomach or intestines.
- you have a condition where the bowel does not work properly (ileus) or have severe pain in your abdomen.
- you have increased pressure in your skull or have a head injury.
- you have epilepsy (seizures) or a history with epilepsy.
you suffer from alcoholism or alcohol withdrawal.
- 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 are going to have a surgery or operation, or have had a surgery in the last 24 hours.
- you have severe central nervous system (CNS) depression (nervous system slows down).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Meperidine Hydrochloride Injection 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 kidney problems.
- have liver problems.
- have been told you are at risk of having heart problems or seizures.
- have low blood pressure.
- have or have had problems with your mood (such as depression or anxiety), hallucinations, or other mental health problems.
- suffer from chronic or severe constipation.
- have problems with your thyroid, adrenal, or prostate gland.
- have, or had in the past hallucinations or other severe mental problems.
- suffer from migraines.
- have a sleep disorder which causes pauses in breathing or shallow breathing while sleeping (sleep apnea).
- are planning on drinking alcohol. Drinking alcohol while taking Meperidine Hydrochloride Injection USP may cause dangerous side effects, including death. Do NOT drink alcohol while taking Meperidine Hydrochloride Injection USP.
- have a condition that causes weakness or frailty.
- are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed.
- have difficulty urinating.
- are 65 years of age and older.
Other warnings you should know about:
Taking Meperidine Hydrochloride Injection USP can cause the following serious side effects:
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 healthcare professional may do tests, give you another medication, and slowly take you off Meperidine Hydrochloride Injection USP.
Serotonin syndrome (also known as serotonin syndrome): Meperidine Hydrochloride Injection 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 Meperidine Hydrochloride Injection USP with certain anti-depressants or migraine medications.
Serotonin Syndrome 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.
- Sleep apnea: Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your healthcare professional if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.
See the Serious side effects and what to do about them table below for more information on these and other serious side effects.
Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your healthcare professional if you have questions or concerns about abuse, addiction or physical dependence.
Pregnancy, nursing, labour and delivery: Opioids can be transferred to your baby through breast milk, or while still in the womb. Meperidine Hydrochloride Injection USP can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your healthcare professional will determine if the benefits of using Meperidine Hydrochloride Injection USP outweigh the risks to your unborn baby or nursing infant.
If you are pregnant and are taking Meperidine Hydrochloride Injection USP, it is important that you don’t stop taking your medication all of a sudden. If you do, it can cause a miscarriage or a still-birth. Your healthcare professional will monitor and guide you on how to slowly stop taking Meperidine Hydrochloride Injection USP. This may help avoid serious harm to your unborn baby.
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.
Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Meperidine Hydrochloride Injection USP. Meperidine Hydrochloride Injection USP can cause:
- drowsiness,
- dizziness, or
- lightheadedness.
This can usually occur after you take your first dose and when your dose is increased.
Worsened pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia) even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your healthcare professional if you notice a change like this in your pain while you are taking Meperidine Hydrochloride Injection USP.
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 Meperidine Hydrochloride Injection USP:
alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking Meperidine Hydrochloride Injection USP. It can lead to:
- drowsiness,
- unusually slow or weak breathing,
- serious side effects, or
- a fatal overdose.
- other sedative medicines that may enhance the drowsiness caused by Meperidine Hydrochloride Injection USP.
- other opioid analgesics, medicines used to treat pain (e.g., morphine, buprenorphine, nalbuphine, or pentazocine).
- general anesthetics, medicines used during surgery.
- medicines used to help you sleep or that help reduce anxiety (e.g., benzodiazepines, tranquilizers, or hypnotics such as barbiturates).
- antidepressants, medicines used to treat depression and mood disorders. Do not take Meperidine Hydrochloride Injection USP with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.
- medicines used to treat serious mental or emotional disorders, such as schizophrenia (e.g., phenothiazines).
- antihistamines, medicines used to treat allergies.
- anti-emetics, medicines used for the prevention of vomiting.
- muscle relaxants, medicines used to treat muscle spasms and back pain (e.g., baclofen).
- anticoagulants, medicines used to prevent or treat blood clots (e.g., warfarin such as coumadin).
- anti-retrovirals and anti-virals, medicines used to treat viral infections (e.g., ritonavir or acyclovir).
- anti-fungal drugs, medicines used to treat fungal infections.
- antibiotic drugs, medicines used to treat bacterial infections.
- medicines used to treat heart problems (e.g., beta blockers).
- medicines used to treat migraines (e.g. triptans).
- antiepileptics, medicines used to prevent and control seizures (e.g., phenytoin, or gabapentinoids such as pregabalin).
- cimetidine, a medicine used to treat ulcers.
- grapefruit juice.
- St. John’s Wort.
How to take Meperidine Hydrochloride Injection USP:
Meperidine Hydrochloride Injection USP is administered by injection. This is given under the skin, into the muscle or into a vein.
Usual Dose:
Your dose is tailored/personalized just for you. Your healthcare professional will prescribe the lowest dose that works to control your pain. It is recommended that you only take Meperidine Hydrochloride Injection USP for up to 7 days. If you need to take Meperidine Hydrochloride Injection USP for longer, your healthcare professional will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose.
Review your pain regularly with your healthcare professional to determine if you still need Meperidine Hydrochloride Injection USP. Be sure to use Meperidine Hydrochloride Injection USP only for the condition for which it was prescribed.
If your pain increases or you develop any side effect as a result of taking Meperidine Hydrochloride Injection USP, tell your healthcare professional immediately.
Stopping your Medication: If you have been taking Meperidine Hydrochloride Injection USP for more than a few days you should not stop taking it all of a sudden. You should check with your healthcare professional for directions on how to slowly stop taking it. 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;
- heart palpitations;
- 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 Meperidine Hydrochloride Injection USP.
Overdose:
Signs of overdose may include:
- unusually slow or weak breathing;
- dizziness;
- confusion;
- toxic leukoencephalopathy (a brain disorder affecting the brain’s white matter);
- extreme drowsiness.
If you think you, or a person you are caring for, have taken too much Meperidine Hydrochloride Injection USP, contact a healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If a dose has been missed, tell your healthcare professional as soon as possible. The next dose should be given to you at the next scheduled time and in the normal amount.
What are possible side effects from using Meperidine Hydrochloride Injection USP?
These are not all the possible side effects you may feel when taking Meperidine Hydrochloride Injection USP. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- drowsiness;
- insomnia;
- dizziness;
- fainting;
- nausea, vomiting, or a poor appetite;
- dry mouth;
- headache;
- problems with vision;
- weakness, uncoordinated muscle movement;
- itching;
- sweating;
- constipation. Talk with your healthcare professional about ways to prevent constipation when you start using Meperidine Hydrochloride Injection USP;
- low sex drive, impotence (erectile dysfunction), infertility.
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 | ||
| RARE | |||
| Allergic reaction: itchy, red, painful, and irritated or swollen skin (rash), outbreak of pale red bumps or welts on the skin that appear suddenly (hives), swelling of the face, lips, tongue or throat, difficulty swallowing, or difficulty breathing. | √ | ||
| Bowel blockage (impaction): abdominal pain, severe constipation, or nausea. | √ | ||
| Fast, slow, or irregular heartbeat: heart palpitations. | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, or light-headedness. | √ | ||
| Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, dizziness, floppy muscles/low muscle tone, or cold and clammy skin. | √ | ||
| Respiratory depression: slow, shallow, or weak breathing. | √ | ||
| Serotonin toxicity (also known as serotonin syndrome): 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. | √ | ||
| Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, or sweating. | √ | ||
| UNKNOWN FREQUENCY | |||
| Disorder of the adrenal gland: nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. | √ | ||
| Sleep apnea: stop breathing for short periods during your normal nightly sleep. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
- Store Meperidine Hydrochloride Injection USP at room temperature (15°C to 30°C). Keep in a dry place and protected from light.
- Keep unused or expired Meperidine Hydrochloride Injection USP in a secure place to prevent theft, misuse or accidental exposure.
- Keep Meperidine Hydrochloride Injection USP under lock, out of sight and reach of children and pets.
- Never take medicine in front of small children as they will want to copy you. Accidental exposure by a child is dangerous and may result in death. If a child accidentally takes Meperidine Hydrochloride Injection USP, get emergency help right away.
If you want more information about Meperidine Hydrochloride Injection USP:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.sandoz.com, or by calling 1-800-361-3062.