Details for: CODEINE PHOSPHATE INJECTION USP
Company: SANDOZ CANADA INCORPORATED
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
00544884 | CODEINE PHOSPHATE INJECTION USP | CODEINE PHOSPHATE | 30 MG / 1 ML | LIQUID | INTRAMUSCULAR |
00544884 | CODEINE PHOSPHATE INJECTION USP | CODEINE PHOSPHATE | 30 MG / 1 ML | LIQUID | SUBCUTANEOUS |
Summary Reports
Summary Safety Review -Opioid-containing cough and cold products - Assessing the potential risk of opioid use disorder and related harms in children and adolescents
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Codeine Phosphate Injection USP is an injection containing codeine (an opioid analgesic) used for:
- Pain
- Codeine Phosphate Injection USP is used to manage pain in adults.
- Cough
- Codeine Phosphate Injection USP is used to control cough in adults.
- Codeine Phosphate Injection USP is not for treatment of cough in patients younger than 18 years of age. In patients this age, the risks of life-threatening breathing problems outweigh the benefits of treating the cough with codeine.
What it does
Codeine Phosphate Injection USP is a painkiller and an antitussive belonging to the class of drugs known as opioids. It relieves pain and depresses the cough reflex by acting on specific nerve cells of the spinal cord and brain.
Codeine Phosphate Injection USP is used to treat mild to moderate pain in patients who need an opioid administered by injection and for the control of exhausting, nonproductive cough which does not respond to non-opioid antitussives. This is given under the skin or into the muscle.
When it should not be used
Do not use Codeine Phosphate Injection USP if you:
- your doctor did not prescribe it for you
- are allergic to codeine or any of the other ingredients in Codeine Phosphate Injection USP
- can control your pain by the occasional use of other pain medications. This includes those available without a prescription
- have severe asthma, trouble breathing, or other breathing problems
- have bowel blockage or narrowing of the stomach or intestines
- have severe pain in your abdomen
- have a head injury
- are at risk for having seizures
- suffer from alcoholism
- are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
- are going to have a, or recently had, planned surgery
- have been told by your doctor that you break down codeine rapidly. This can lead to codeine overdose even at the usual adult dose
- are pregnant or planning to become pregnant or you are in labour
- are breastfeeding. The use of codeine-containing products while breast-feeding may harm your baby. If you breastfeed and take Codeine Phosphate Injection USP , seek immediate medical care for your baby if they are overly drowsy, sedated, have difficulty breast-feeding, have breathing difficulties, and are floppy (have decreased muscle tone). This is very serious for the baby and can lead to death. Tell the baby’s doctor that you are breastfeeding and took Codeine Phosphate Injection USP.
- are less than 12 years old
- are less than 18 years old and are having (or have recently had) your tonsils or adenoids removed because of frequent interruption of breathing during sleep
What the medicinal ingredient is
Medicinal ingredients: codeine phosphate
What the non-medicinal ingredients are
Non-medicinal ingredients: hydrochloric acid and/or sodium hydroxide to adjust pH, sodium metabisulfite 0.1% as preservative, and water for injection
What dosage form it comes in
Codeine Phosphate Injection USP (30 mg/mL) is supplied in 1 mL ampoules, boxes of 10.
Warnings and precautions
Serious Warnings and Precautions
- Even if you take Codeine Phosphate Injection 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 Codeine Phosphate Injection USP. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
- You should never give anyone your Codeine Phosphate Injection USP. They could die from taking it. If a person has not been prescribed Codeine Phosphate Injection USP, taking even one dose can cause a fatal overdose. This is especially true for children.
- If you took Codeine Phosphate Injection 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
- Taking Codeine Phosphate Injection 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.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Codeine Phosphate 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 severe kidney, liver or lung disease
- have low blood pressure
- have past or current depression
- suffer from chronic or severe constipation
- have persistent or chronic cough (as occurs with smoking), glaucoma, high blood pressure
- have problems with your thyroid, adrenal or prostate gland
- have, or had in the past hallucinations or other severe mental problems
- suffer from migraines
Other warnings you should know about:
Some people metabolize codeine at a much faster rate than the general population. This may lead to accidental overdose. Stop taking Codeine Phosphate Injection USP and seek immediate medical help if you start feeling confused, have shallow breathing, or extreme sleepiness. If you know that you metabolize codeine at a much faster rate, tell your doctor BEFORE starting this medication.
Stop taking Codeine Phosphate Injection USP and consult with your healthcare professional if:
- you get a high fever, rash or persistent headache while taking Codeine Phosphate Injection USP along with the cough.
- your symptoms or cough worsen or continue for more than 7 days.
These could be signs of a serious condition.
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. As with all opioids, taking codeine may cause you to become dependent on it. Do not take more than the dose prescribed to you by your doctor.
Breathing problems:
- Avoid taking Codeine Phosphate Injection USP if you are under 18 years of age and you are at risk for breathing problems because you:
- have obstructive sleep apnea
- are obese
- have an existing lung problem
Pregnancy, nursing, labour and delivery:Do not use Codeine Phosphate Injection USP while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. Codeine Phosphate Injection USP can then cause life-threatening breathing problems in your unborn baby or nursing infant.
If you are pregnant and are taking Codeine Phosphate 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 doctor will monitor and guide you on how to slowly stop taking Codeine Phosphate Injection USP. This may help avoid serious harm to your unborn baby.
Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Codeine Phosphate Injection USP. Codeine Phosphate Injection 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 Codeine Phosphate Injection USP.
Serotonin Syndrome: Codeine Phosphate Injection USP can cause Serotonin Syndrome, 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 Syndrome if you take Codeine Phosphate 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.
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.
Interactions with this medication
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 Codeine Phosphate Injection USP:
- Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking Codeine Phosphate Injection USP. It can lead to:
- drowsiness
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
- other sedative drugs which may enhance the drowsiness caused by Codeine Phosphate Injection USP
- 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 Codeine Phosphate Injection USP with MAO inhibitors (MAOi) or if you have taken MAOi’s 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
- warfarin (such as coumadin) and other anticoagulants (used for prevention or treatment of blood clots)
- some anti-retroviral drugs (used to treat viral infections)
- some anti-fungal drugs (used to treat fungal infections)
- some antibiotic drugs (used to treat bacterial infections)
- some heart medication (such as beta blockers)
- tranquilizers, sedatives, sedating antihistamines, other depressants
- grapefruit juice
- drugs used to treat migraines (e.g. triptans)
- St. John’s Wort
Proper use of this medication
- Codeine Phosphate Injection USP may be administered by subcutaneous or intramuscular injection.
- Codeine Phosphate Injection USP should not be used in children less than 12 years old.
- Codeine, including Codeine Phosphate Injection USP, should be prescribed at the lowest effective dose for the shortest period of time. Dosing should be as needed every 4 to 6 hours and not on scheduled intervals.
Usual Adult Starting Dose
Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor.
Your doctor will prescribe the lowest dose that works to control your pain. Higher doses and longer use can lead to more side effects and a greater chance of overdose.
Review your pain regularly with your doctor to determine if you still need Codeine Phosphate Injection USP. Be sure to use Codeine Phosphate 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 Codeine Phosphate Injection USP, tell your doctor immediately.
Stopping your Medication
If you have been taking Codeine Phosphate Injection 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 Codeine Phosphate Injection 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
- 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 Codeine Phosphate Injection USP.
Refilling your Prescription for Codeine Phosphate Injection USP:
A new written prescription is required from your doctor each time you need more Codeine Phosphate Injection 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.
Overdose
If you think you have taken too much Codeine Phosphate Injection USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Signs of overdose may include:
- unusually slow or weak breathing
- dizziness
- confusion
- extreme drowsiness
Missed Dose
If you miss one dose, take it as soon as possible. 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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Codeine Phosphate 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
- low sex drive, impotence (erectile dysfunction), infertility
Talk with your doctor or pharmacist about ways to prevent constipation when you start using Codeine Phosphate Injection USP.
Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
Rare | |||
Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone cold and clammy skin | ✔ | ||
Respiratory Depression: Slow, shallow or weak breathing | ✔ | ||
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea | ✔ | ||
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating. | ✔ | ||
Fast, Slow or Irregular Heartbeat: heart palpitations | ✔ | ||
Low Blood Pressure: dizziness, fainting, light-headedness | ✔ | ||
Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea | ✔ |
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.
How to store
Storage:
- Keep unused or expired Codeine Phosphate Injection USP in a secure place to prevent theft, misuse or accidental exposure.
- Keep Codeine Phosphate 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 ingestion by a child is dangerous and may result in death. If a child accidentally takes Codeine Phosphate Injection USP, get emergency help right away.
- Store between 15 and 30°C. Protect from light.
Disposal:
Codeine Phosphate Injection 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.
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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about Codeine Phosphate Injection USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer 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 www.sandoz.ca, or by calling 1-800-361-3062.
This leaflet was prepared by Sandoz Canada Inc.
Last Revised: December 16, 2019