Conzip 100mg 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; serotonin and norepinephrine reuptake inhibitor
Pregnancy Category
Category C
FDA Approved
Aug 2013
DEA Schedule
Schedule IV
Overview
What is this medicine?
Conzip is an extended-release capsule containing tramadol, a strong pain medicine. It works in your brain to change how your body feels and responds to pain. The extended-release form means it releases the medicine slowly over 24 hours to provide continuous pain relief for chronic 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 trouble breathing and death from overdose.
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 fast pain relief or on an as-needed basis.
* Do not use this medication for pain relief after surgery if you have not been taking similar medications.
If you have difficulty swallowing, discuss this with your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, away from the bathroom. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to secure the medication. 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. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume 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 trouble breathing and death from overdose.
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 fast pain relief or on an as-needed basis.
* Do not use this medication for pain relief after surgery if you have not been taking similar medications.
If you have difficulty swallowing, discuss this with your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, away from the bathroom. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to secure the medication. 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. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not crush, chew, or break the capsule. Swallow it whole.
- Do not drink alcohol while taking this medication, as it can increase the risk of serious side effects.
- Avoid driving or operating heavy machinery until you know how this medicine affects you, as it can cause drowsiness or dizziness.
- Store this medication securely in a place inaccessible to children and pets to prevent accidental ingestion.
- Do not share this medication with anyone else, as it can be dangerous for them.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 100 mg orally once daily. Titrate by 50 mg every 5 days. Max 300 mg once daily.
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
moderateToSevereChronicPain:
Initial 100 mg once daily, titrate by 50 mg every 5 days to a maximum of 300 mg once daily.
Pediatric Dosing
Neonatal:
Not established; contraindicated for pain management in children younger than 12 years.
Infant:
Not established; contraindicated for pain management in children younger than 12 years.
Child:
Not established; contraindicated for pain management in children younger than 12 years; contraindicated in children younger than 18 years following tonsillectomy and/or adenoidectomy.
Adolescent:
Not recommended for patients 12 to 18 years of age who are obese or have underlying respiratory conditions.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for CrCl >30 mL/min.
Moderate:
Not recommended for CrCl <30 mL/min.
Severe:
Not recommended for CrCl <30 mL/min.
Dialysis:
Not recommended.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment.
Moderate:
Use with caution; consider lower doses.
Severe:
Not recommended for severe hepatic impairment (Child-Pugh Class C).
Pharmacology
Mechanism of Action
Tramadol and its active metabolite (M1) bind to mu-opioid receptors in the central nervous system (CNS), causing analgesia. Tramadol also inhibits the reuptake of norepinephrine and serotonin, which contributes to its analgesic effect.
Pharmacokinetics
Absorption:
Bioavailability:
~75%
Tmax:
12 hours (Conzip)
FoodEffect:
Administration with food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
~2.7 L/kg
ProteinBinding:
~20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Tramadol: ~6.3 hours; M1: ~7.4 hours (for immediate release; apparent half-life for ER can be longer due to absorption kinetics)
Clearance:
Not available
ExcretionRoute:
Primarily renal (90%)
Unchanged:
~30% (tramadol), ~6% (M1)
Pharmacodynamics
OnsetOfAction:
Gradual (extended-release formulation)
PeakEffect:
12 hours (Conzip)
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse; Respiratory Depression; Accidental Ingestion; Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children; Neonatal Opioid Withdrawal Syndrome; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants.
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 immediate medical attention:
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
In rare cases, 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, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Severe dizziness or fainting
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Trouble urinating
Frequent urination
Breathing difficulties, such as:
+ Slow breathing
+ 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, may occur, especially when taking certain other medications. Seek medical help immediately if you experience:
+ Agitation
+ Changes 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, may occur. Seek medical help immediately if you experience:
+ 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Feeling dizzy, sleepy, tired, or weak
Constipation, diarrhea, nausea, or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
* Excessive sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 immediate medical attention:
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
In rare cases, 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, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Severe dizziness or fainting
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Trouble urinating
Frequent urination
Breathing difficulties, such as:
+ Slow breathing
+ 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, may occur, especially when taking certain other medications. Seek medical help immediately if you experience:
+ Agitation
+ Changes 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, may occur. Seek medical help immediately if you experience:
+ 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Feeling dizzy, sleepy, tired, or weak
Constipation, diarrhea, nausea, or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
* Excessive sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:
- Difficulty breathing or slow, shallow breathing
- Extreme drowsiness or feeling like you might pass out
- Dizziness or lightheadedness
- Confusion or unusual thoughts
- Seizures
- Severe constipation
- Symptoms of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Signs of an allergic reaction (rash, itching, swelling of the 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 to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Respiratory issues, such as asthma, breathing difficulties, or sleep apnea, as well as high carbon dioxide levels in the blood.
Gastrointestinal problems, including stomach or bowel blockage or narrowing.
Kidney or liver disease.
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 impair your actions, such as phenobarbital or pain relievers like oxycodone.
Current use of carbamazepine or other medications containing the same active ingredient.
Use of specific medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
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 modify any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Respiratory issues, such as asthma, breathing difficulties, or sleep apnea, as well as high carbon dioxide levels in the blood.
Gastrointestinal problems, including stomach or bowel blockage or narrowing.
Kidney or liver disease.
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 impair your actions, such as phenobarbital or pain relievers like oxycodone.
Current use of carbamazepine or other medications containing the same active ingredient.
Use of specific medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
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 modify 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, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose may increase the risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain, contact your doctor immediately. Do not take more than the prescribed dose.
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 dose.
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 dose, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Alcohol Interactions
Do not consume alcohol or products containing alcohol while taking this medication, as it 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, amenorrhea, or ejaculation difficulties, 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, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose may increase the risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain, contact your doctor immediately. Do not take more than the prescribed dose.
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 dose.
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 dose, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Alcohol Interactions
Do not consume alcohol or products containing alcohol while taking this medication, as it 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, amenorrhea, or ejaculation difficulties, 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:
- Pinpoint pupils
- Slow or shallow breathing
- Extreme drowsiness or unresponsiveness
- Limp muscles
- Cold, clammy skin
- Loss of consciousness
- Seizures
- Coma
What to Do:
Seek immediate emergency medical attention. Call 911 or Poison Control (1-800-222-1222). Naloxone may be administered by emergency personnel.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days
- Linezolid
- Methylene blue
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, alcohol, other opioids, sedatives/hypnotics) - increased risk of respiratory depression, profound sedation, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, St. John's Wort, fentanyl, lithium, buspirone) - increased 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 adverse effects.
Moderate Interactions
- CYP2D6 inducers (e.g., rifampin, carbamazepine) - may decrease tramadol exposure and increase M1, potentially increasing toxicity or reducing efficacy.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease tramadol exposure, reducing efficacy.
- Drugs that lower seizure threshold (e.g., bupropion, TCAs, SSRIs, antipsychotics) - increased risk of seizures.
Minor Interactions
- Not specifically categorized as minor, but general caution with drugs affecting GI motility.
Monitoring
Baseline Monitoring
Pain assessment
Rationale: To establish baseline pain intensity, character, and location for efficacy monitoring.
Timing: Prior to initiation
Respiratory rate and depth
Rationale: To assess baseline respiratory function due to risk of respiratory depression.
Timing: Prior to initiation
Level of consciousness/Sedation score
Rationale: To assess baseline mental status and risk of CNS depression.
Timing: Prior to initiation
Bowel function
Rationale: To assess baseline for opioid-induced constipation.
Timing: Prior to initiation
Renal and hepatic function tests
Rationale: To assess organ function and guide dosing adjustments if impairment is present.
Timing: Prior to initiation (if clinically indicated)
Routine Monitoring
Pain relief and adverse effects (e.g., respiratory depression, sedation, constipation, nausea, vomiting, dizziness, seizures, signs of serotonin syndrome)
Frequency: Regularly, especially during titration and dose changes; ongoing throughout therapy.
Target: Adequate pain control with tolerable side effects.
Action Threshold: Significant respiratory depression (RR <10-12 bpm, shallow breathing), excessive sedation (unable to arouse), severe constipation, new-onset seizures, signs of serotonin syndrome (agitation, hyperthermia, muscle rigidity, rapid heart rate).
Signs of abuse, misuse, or addiction
Frequency: Ongoing throughout therapy.
Target: Absence of aberrant drug-taking behaviors.
Action Threshold: Requests for early refills, lost prescriptions, multiple prescribers, escalating doses without clinical justification, selling medication.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or drowsiness
- Dizziness
- Nausea and vomiting
- Severe constipation
- Seizures
- Symptoms of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Not recommended for use during pregnancy. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of birth defects (limited data, but generally avoided).
Second Trimester:
Risk of fetal growth restriction and other adverse outcomes.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate if used near term.
Lactation
Not recommended. Tramadol and its active metabolite (M1) are present in breast milk. Serious adverse reactions, including respiratory depression and sedation, can occur in breastfed infants.
Infant Risk:
High risk of serious adverse effects, including respiratory depression, sedation, and death, especially in infants of mothers who are ultra-rapid metabolizers of tramadol.
Pediatric Use
Contraindicated for pain management in children younger than 12 years. Contraindicated in children younger than 18 years following tonsillectomy and/or adenoidectomy. Not recommended for adolescents 12-18 years of age who are obese or have underlying respiratory conditions due to increased risk of respiratory depression.
Geriatric Use
Use with caution. Start at the lowest effective dose (e.g., 50 mg once daily) and titrate slowly. Increased risk of respiratory depression, falls, and CNS effects (e.g., confusion, dizziness). Consider age-related decreases in renal and hepatic function.
Clinical Information
Clinical Pearls
- Conzip is an extended-release formulation and should not be used for as-needed pain relief. It is intended for chronic pain requiring continuous, around-the-clock opioid analgesia.
- Patients must be instructed not to crush, chew, or dissolve the capsules, as this can lead to rapid release of a potentially fatal dose of tramadol.
- Educate patients and caregivers on the signs of respiratory depression and serotonin syndrome, and when to seek emergency medical attention.
- The risk of seizures is dose-related and increased with concomitant use of other drugs that lower the seizure threshold.
- Due to the risk of addiction, abuse, and misuse, assess patient risk factors before prescribing and monitor for aberrant drug-taking behaviors during therapy.
- Consider the patient's CYP2D6 metabolizer status, as ultra-rapid metabolizers may have increased M1 levels, leading to increased opioid effects, while poor metabolizers may have reduced efficacy.
Alternative Therapies
- Other extended-release opioid analgesics (e.g., oxycodone ER, morphine ER, hydromorphone ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, COX-2 inhibitors)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, duloxetine, tricyclic antidepressants)
- Non-pharmacological therapies (e.g., physical therapy, exercise, cognitive behavioral therapy, interventional pain procedures)
Cost & Coverage
Average Cost:
Highly variable per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (depends on insurance plan formulary)
General Drug Facts
If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. 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 right away. When seeking help, be prepared to provide critical information, including what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. 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 right away. When seeking help, be prepared to provide critical information, including what was taken, the quantity, and the time of the incident.