Conzip 300mg Capsules
WARNING: For all patients taking this drug:This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing.Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life- threatening if not treated.Children:This drug is not approved for use in children. Severe and sometimes deadly breathing problems have happened with tramadol in children. Sometimes, this happened after surgery to remove tonsils or adenoids and in children who were rapid metabolizers of tramadol. Do not give to a child younger than 12 years of age. Do not give to a child younger than 18 years of age who is very overweight, has certain health problems like sleep apnea or other lung or breathing problems, or has had surgery to remove tonsils or adenoids. If your child has been given this drug, ask the doctor about the benefits and risks. @ COMMON USES: It is used to manage pain when daily pain treatment is needed for a long time. It is for use when non-opioid pain drugs do not treat your pain well enough or you cannot take them.
Drug Class
Opioid Analgesic
Pharmacologic Class
Centrally acting synthetic opioid analgesic; mu-opioid receptor agonist; serotonin and norepinephrine reuptake inhibitor
Pregnancy Category
Not available (FDA has moved away from letter categories, now risk summary)
FDA Approved
Jan 1970
DEA Schedule
Schedule IV
Overview
What is this medicine?
Conzip is an extended-release capsule containing tramadol, a pain reliever. It works in your brain to change how your body feels and responds to pain. Because it's extended-release, it's designed to release the medicine slowly over 24 hours, so you usually take it only once a day for ongoing pain.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
Swallow the medication whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.
You can take this medication with or without food. However, some products must be taken consistently, either always with food or always without food. Be sure to understand how to take your specific product in relation to food. If you are unsure, consult your doctor or pharmacist.
Take this medication at the same time every day.
Do not use this medication for rapid pain relief or on an as-needed basis.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
Special Considerations
If you have trouble swallowing, discuss this with your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom.
Keep it in a safe location where children cannot see or reach it, and where others cannot access it. A locked box or area can help keep the medication secure.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist if you have questions about the best disposal method. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and return to your regular schedule.
Do not take two doses at the same time or take extra doses.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
Swallow the medication whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.
You can take this medication with or without food. However, some products must be taken consistently, either always with food or always without food. Be sure to understand how to take your specific product in relation to food. If you are unsure, consult your doctor or pharmacist.
Take this medication at the same time every day.
Do not use this medication for rapid pain relief or on an as-needed basis.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
Special Considerations
If you have trouble swallowing, discuss this with your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom.
Keep it in a safe location where children cannot see or reach it, and where others cannot access it. A locked box or area can help keep the medication secure.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist if you have questions about the best disposal method. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and return to your regular schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not crush, chew, or dissolve the capsule. Swallow it whole.
- Take exactly as prescribed; do not take more or less than directed.
- Do not stop taking this medication suddenly without talking to your doctor, as withdrawal symptoms can occur.
- Avoid alcohol and other sedating medications (e.g., benzodiazepines, sleeping pills) while taking Conzip, as this can increase the risk of serious side effects like severe drowsiness and breathing problems.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Store in a safe place, out of reach of children and pets, to prevent accidental ingestion.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Conzip 300mg is a high dose, typically for patients already tolerant to lower doses of tramadol. Initial dosing for tramadol ER usually starts at 100mg once daily.
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
Chronic Pain:
Initial: 100 mg orally once daily. Titrate by 50 mg increments every 5 days to a maximum of 300 mg once daily. Conzip 300mg is the maximum recommended dose.
Pediatric Dosing
Neonatal:
Not established (Contraindicated due to risk of respiratory depression and neonatal opioid withdrawal syndrome)
Infant:
Not established (Contraindicated due to risk of respiratory depression and neonatal opioid withdrawal syndrome)
Child:
Not established (Contraindicated in children <12 years; contraindicated in children <18 years following tonsillectomy/adenoidectomy)
Adolescent:
Not established (Contraindicated in children <18 years following tonsillectomy/adenoidectomy; use with caution and only if benefits outweigh risks in other adolescents 12-18 years)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for mild impairment (CrCl 50-80 mL/min) for ER formulations, but monitor closely.
Moderate:
Not recommended for use in patients with CrCl <30 mL/min for ER formulations.
Severe:
Not recommended for use in patients with CrCl <30 mL/min for ER formulations.
Dialysis:
Not recommended for use in patients with CrCl <30 mL/min, including those on dialysis, as tramadol is slowly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment, but monitor closely.
Moderate:
Not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
Severe:
Not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
Pharmacology
Mechanism of Action
Tramadol is a centrally acting synthetic opioid analgesic. It binds to mu-opioid receptors, leading to inhibition of pain transmission. Additionally, tramadol inhibits the reuptake of norepinephrine and serotonin, which contributes to its analgesic effects by enhancing descending inhibitory pain pathways.
Pharmacokinetics
Absorption:
Bioavailability:
75% (oral)
Tmax:
12 hours (for extended-release formulations)
FoodEffect:
Food does not significantly affect the extent of absorption but may slightly delay Tmax.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
20%
CnssPenetration:
Yes
Elimination:
HalfLife:
6.3 hours (tramadol); 7.4 hours (M1 metabolite)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (primarily)
Unchanged:
30% (tramadol); 6% (M1 metabolite)
Pharmacodynamics
OnsetOfAction:
Within 1 hour (for immediate release; ER is slower)
PeakEffect:
12 hours (for extended-release formulations)
DurationOfAction:
24 hours (for extended-release formulations)
Safety & Warnings
BLACK BOX WARNING
ADDICTION, ABUSE, AND MISUSE: Tramadol extended-release exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing tramadol extended-release, and monitor all patients receiving tramadol extended-release for the development of these behaviors and conditions.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol extended-release. Monitor for respiratory depression, especially during initiation of tramadol extended-release or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of tramadol extended-release, especially by children, can result in a fatal overdose of tramadol.
ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR OPIOID OVERDOSE IN CHILDREN: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy and were associated with evidence of ultra-rapid metabolism of tramadol to O-desmethyltramadol (an active metabolite of tramadol). Tramadol extended-release is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of tramadol extended-release in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of tramadol extended-release during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES: The concomitant use of tramadol extended-release with all cytochrome P450 3A4 inhibitors may result in an increase in tramadol plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in tramadol plasma concentration. The effects of concomitant use of cytochrome P450 2D6 inhibitors with tramadol extended-release are complex. Concomitant use of tramadol extended-release with cytochrome P450 2D6 inhibitors may result in an increase in tramadol plasma concentration and a decrease in the plasma concentration of the active metabolite O-desmethyltramadol (M1). The clinical effect of concomitant use of CYP2D6 inhibitors with tramadol extended-release is dependent on the patient’s CYP2D6 metabolizer status.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol extended-release. Monitor for respiratory depression, especially during initiation of tramadol extended-release or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of tramadol extended-release, especially by children, can result in a fatal overdose of tramadol.
ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR OPIOID OVERDOSE IN CHILDREN: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy and were associated with evidence of ultra-rapid metabolism of tramadol to O-desmethyltramadol (an active metabolite of tramadol). Tramadol extended-release is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of tramadol extended-release in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of tramadol extended-release during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES: The concomitant use of tramadol extended-release with all cytochrome P450 3A4 inhibitors may result in an increase in tramadol plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in tramadol plasma concentration. The effects of concomitant use of cytochrome P450 2D6 inhibitors with tramadol extended-release are complex. Concomitant use of tramadol extended-release with cytochrome P450 2D6 inhibitors may result in an increase in tramadol plasma concentration and a decrease in the plasma concentration of the active metabolite O-desmethyltramadol (M1). The clinical effect of concomitant use of CYP2D6 inhibitors with tramadol extended-release is dependent on the patient’s CYP2D6 metabolizer status.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Severe dizziness or fainting
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Trouble urinating
Frequent urination
Breathing difficulties, slow breathing, or shallow breathing
Noisy breathing
Sleep apnea (breathing problems during sleep)
Changes in vision
Severe constipation or stomach pain, which may indicate a severe bowel problem
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Severe Skin Reaction
This medication may cause a severe skin reaction, which can lead to serious health problems and even death. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Nausea or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
Excessive sweating
Reporting Side Effects
If you have questions about side effects or want to report any, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Severe dizziness or fainting
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Trouble urinating
Frequent urination
Breathing difficulties, slow breathing, or shallow breathing
Noisy breathing
Sleep apnea (breathing problems during sleep)
Changes in vision
Severe constipation or stomach pain, which may indicate a severe bowel problem
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Severe Skin Reaction
This medication may cause a severe skin reaction, which can lead to serious health problems and even death. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Nausea or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
Excessive sweating
Reporting Side Effects
If you have questions about side effects or want to report any, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or unusual thoughts
- Seizures
- Symptoms of Serotonin Syndrome: agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea
- Severe constipation or abdominal pain
- Signs of an allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Respiratory problems, including asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Stomach or bowel conditions, such as blockages or narrowing.
Kidney or liver disease.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol.
If your doctor has informed you that you are a rapid metabolizer of certain medications.
Recent consumption of large amounts of alcohol or use of medications that may cause drowsiness, such as phenobarbital or pain relievers like oxycodone.
Current or recent use of specific medications, including:
+ Carbamazepine
+ Other medications containing the same active ingredient as this drug
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause a sudden increase in blood pressure
* Breastfeeding, as this medication is not recommended during breastfeeding.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Respiratory problems, including asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Stomach or bowel conditions, such as blockages or narrowing.
Kidney or liver disease.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol.
If your doctor has informed you that you are a rapid metabolizer of certain medications.
Recent consumption of large amounts of alcohol or use of medications that may cause drowsiness, such as phenobarbital or pain relievers like oxycodone.
Current or recent use of specific medications, including:
+ Carbamazepine
+ Other medications containing the same active ingredient as this drug
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause a sudden increase in blood pressure
* Breastfeeding, as this medication is not recommended during breastfeeding.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more than the prescribed amount.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk of seizures with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If the medication becomes less effective, contact your doctor. Do not take more than the prescribed amount.
Low Blood Sugar
This medication may cause low blood sugar, which can be severe enough to require hospitalization. If you experience symptoms such as dizziness, headache, fatigue, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.
Dependence and Withdrawal
Regular use of opioid medications like this one may lead to dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dosage, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Interactions with Alcohol
Do not consume alcohol or products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause decreased sex hormone levels. If you experience reduced libido, fertility problems, irregular menstrual periods, or ejaculation issues, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more than the prescribed amount.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk of seizures with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If the medication becomes less effective, contact your doctor. Do not take more than the prescribed amount.
Low Blood Sugar
This medication may cause low blood sugar, which can be severe enough to require hospitalization. If you experience symptoms such as dizziness, headache, fatigue, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.
Dependence and Withdrawal
Regular use of opioid medications like this one may lead to dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dosage, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Interactions with Alcohol
Do not consume alcohol or products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause decreased sex hormone levels. If you experience reduced libido, fertility problems, irregular menstrual periods, or ejaculation issues, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Loss of consciousness
- Seizures
- Slowed heart rate
- Low blood pressure
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. If available, administer naloxone if the person is unresponsive or has severe breathing problems. Call 1-800-222-1222 (Poison Control Center) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Hypersensitivity to tramadol or any component of the formulation
- Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, linezolid, St. John's Wort, fentanyl, lithium, buspirone) - risk of serotonin syndrome
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may decrease M1 formation, reducing efficacy
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - may increase tramadol exposure, increasing risk of adverse effects
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease tramadol exposure, reducing efficacy
- Naloxone (may precipitate withdrawal)
- Buprenorphine, nalbuphine, pentazocine (partial agonist/antagonist opioids - may reduce analgesic effect and/or precipitate withdrawal)
Moderate Interactions
- Anticoagulants (e.g., warfarin) - increased INR/bleeding risk
- Diuretics (e.g., furosemide, hydrochlorothiazide) - risk of orthostatic hypotension
- Anticholinergic drugs (e.g., atropine, scopolamine) - increased risk of urinary retention and severe constipation
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation of therapy
Mental status (alertness, orientation)
Rationale: To assess baseline neurological function and identify risk for sedation/altered mental status.
Timing: Prior to initiation of therapy
Concomitant medications review
Rationale: To identify potential drug-drug interactions, especially with CNS depressants or serotonergic agents.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (CrCl, LFTs)
Rationale: To assess organ function and determine need for dose adjustment.
Timing: Prior to initiation of therapy, if clinically indicated
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., daily, weekly, monthly depending on stability)
Target: Acceptable pain control with minimal side effects
Action Threshold: Inadequate pain control or worsening pain; consider dose adjustment or alternative therapy
Respiratory rate and depth
Frequency: Regularly, especially during dose titration or initiation of therapy; PRN if sedation observed
Target: 12-20 breaths/min (adults), unlabored
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation; intervene immediately
Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during dose titration or initiation of therapy; PRN if patient appears drowsy
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unarousable; intervene immediately
Bowel function (constipation)
Frequency: Daily to weekly
Target: Regular bowel movements
Action Threshold: No bowel movement for >3 days; initiate bowel regimen
Signs of Serotonin Syndrome
Frequency: Monitor closely, especially when co-administered with serotonergic drugs
Target: Absence of symptoms
Action Threshold: Mental status changes, autonomic instability, neuromuscular abnormalities, GI symptoms; discontinue tramadol and supportive care
Signs of Opioid Use Disorder (OUD)
Frequency: Ongoing assessment during therapy
Target: Absence of aberrant drug-related behaviors
Action Threshold: Drug-seeking behavior, escalating use, loss of control; consider referral for OUD treatment
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Nausea, vomiting, constipation
- Dizziness, lightheadedness
- Seizures (especially with higher doses or predisposing factors)
- Symptoms of Serotonin Syndrome (agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea)
- Symptoms of Adrenal Insufficiency (nausea, vomiting, anorexia, fatigue, weakness, dizziness, low blood pressure)
- Symptoms of Androgen Deficiency (decreased libido, impotence, erectile dysfunction, amenorrhea, infertility)
- Symptoms of Neonatal Opioid Withdrawal Syndrome (NOWS) in infants of mothers using tramadol during pregnancy (irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, poor feeding, sweating, yawning, sneezing, fever)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are limited and conflicting for tramadol specifically. Risk of NOWS if prolonged use continues.
Second Trimester:
Risk of NOWS if prolonged use continues.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used for prolonged periods. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Tramadol and its active metabolite (M1) are present in breast milk. There is a risk of serious adverse reactions in breastfed infants, including excess sedation and respiratory depression, especially in mothers who are ultra-rapid metabolizers of tramadol. Breastfeeding is not recommended for mothers taking tramadol. If breastfeeding is considered, monitor infants closely for signs of sedation, respiratory depression, and poor feeding.
Infant Risk:
Risk of infant sedation, respiratory depression, poor feeding, and potentially death, particularly if the mother is an ultra-rapid metabolizer of tramadol.
Pediatric Use
Contraindicated in children younger than 12 years of age. Contraindicated in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid use in adolescents 12 to 18 years of age who have other risk factors for respiratory depression. Safety and effectiveness have not been established in pediatric patients.
Geriatric Use
Use with caution in elderly patients (≥65 years) due to increased risk of respiratory depression, sedation, and falls. Start with lower doses and titrate slowly. Monitor renal and hepatic function closely, as age-related decline in these functions may necessitate dose adjustments.
Clinical Information
Clinical Pearls
- Conzip 300mg is a high dose of tramadol ER; ensure the patient is opioid-tolerant and has been titrated to this dose.
- Emphasize that extended-release capsules must be swallowed whole and not crushed, chewed, or dissolved, as this can lead to rapid release and potentially fatal overdose.
- Educate patients and caregivers about the signs of respiratory depression and overdose, and the importance of naloxone availability.
- Be vigilant for signs of serotonin syndrome, especially when co-prescribing with other serotonergic agents.
- Tramadol has a dual mechanism of action (opioid and monoamine reuptake inhibition), which contributes to its analgesic profile but also its unique side effect and interaction profile (e.g., seizures, serotonin syndrome).
- Consider the patient's CYP2D6 metabolizer status, as ultra-rapid metabolizers may experience increased opioid effects, while poor metabolizers may have reduced efficacy.
Alternative Therapies
- Other extended-release opioid analgesics (e.g., morphine ER, oxycodone ER, hydromorphone ER, tapentadol ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, duloxetine, tricyclic antidepressants) for chronic pain management, often as part of a multimodal approach.
- Interventional pain procedures
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
Cost & Coverage
Average Cost:
Not available (highly variable by pharmacy, insurance, and specific brand/generic) per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic); Tier 3 or 4 (for brand)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care immediately. When reporting the incident, be prepared to disclose the substance involved, the quantity taken, and the time of the incident to ensure prompt and effective treatment.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care immediately. When reporting the incident, be prepared to disclose the substance involved, the quantity taken, and the time of the incident to ensure prompt and effective treatment.