Conzip should not be used in children under 13 or children 13 to 18 following a tonsillectomy or adenoidectomy or who have any other risk factors that make them susceptible to respiratory depression.
Using Conzip during pregnancy can harm the fetus, potentially causing neonatal opioid withdrawal syndrome after birth.
Certain medications have the potential for complex interactions with tramadol. The use or discontinuation of drugs known as cytochrome P450 3A4 (CYP3A4) inducers, CYP3A4 inhibitors, or 2D6 inhibitors may need to be carefully considered. Additionally, using central nervous system (CNS) depressants, such as benzodiazepines, with tramadol should be avoided, as the combination can induce profound sedation, breathing problems, coma, and death. Be sure to share your use of all prescription and over-the-counter (OTC) medications with your healthcare provider before starting tramadol to prevent serious drug interactions.
Tramadol is thought to work through two complementary mechanisms of action. First, it binds to the mu-opioid receptors in the brain. This blocks certain pain pathways, preventing pain signals from reaching the central nervous system (CNS).
At the same time, it also blocks the reuptake (reabsorption) of norepinephrine and serotonin into the nerve cells that release them. This boosts the levels of these chemicals in the brain, contributing to tramadol’s analgesic (pain-relieving) effects.
Due to its potential for dependence and abuse, Conzip is classified as a schedule IV controlled substance.
Tramadol comes in various dosage forms, including extended-release (ER) and immediate-release (IR) capsules, tablets, and solutions. It is available under the brand names Conzip (ER capsules), Qdolo (solution), Ultram (IR tablet), and generically.
What Is Conzip Used For?
Conzip is prescribed to treat severe chronic pain that requires long-term, around-the-clock treatment. It is often used when other alternative options (e.g., non-opioid analgesics) have proven inadequate at relieving pain. It might also be used in people who cannot take other pain medications, such as non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-2 inhibitors.
Brand Name(s): Conzip
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Analgesic
Available Generically: Yes
Controlled Substance: Schedule IV
Active Ingredient: Tramadol hydrochloride
Dosage Form(s): Capsule (extended-release and immediate-release), tablet (immediate-release), solution
Unlike IR formulations, the ER version of tramadol releases the active drug gradually in the body, allowing once-daily dosing. For this reason, it is helpful for chronic pain that needs constant management. IR formulations are shorter-lasting, so they can treat severe pain as needed and for shorter periods.
Conzip may be used, for example, to treat chronic pain associated with osteoarthritis, lower back pain, or myofascial pain.
How to Take Conzip
Conzip is available as an ER oral capsule. It is meant to be taken by mouth, with or without food. The capsule must be kept intact and swallowed whole; do not break, chew, split, or dissolve the contents to take it. Doing so can release too much of the drug at once, resulting in a potentially fatal dose.
Conzip is designed to be released into the body gradually over an extended time. For this reason, you will only need to take your dose once a day. The IR version of tramadol is faster-acting and has a different dosing schedule. Follow your healthcare provider’s dosage instructions for the formulation prescribed.
When determining your dosage, your healthcare provider will consider factors such as pain severity, treatment response, prior analgesic use, and risks for addiction or misuse.
Again, it is essential to be mindful of your use of this medication, as it can increase your risk for dependence or misuse.
Storage
Store Conzip at a controlled room temperature of about 68 F to 77 F in a safe place. Keep it out of reach of children and pets, as accidental consumption can be fatal. Store it in an area where other family members or visitors cannot take them.
Properly dispose of unwanted or expired medication through recommended methods to prevent abuse and misuse. This includes taking the drug to a local medicine take-back program or medication drop box, often found at police stations or a pharmacy. Do not flush tramadol down the toilet. If you are unsure how to get rid of your medications, ask your healthcare provider or pharmacist.
Because Conzip is a controlled substance, you can only get a maximum of five refills in a six-month period after receiving a prescription. Once you hit that limit or reach the six-month mark, you’ll need a new prescription from your healthcare provider.
What Are the Side Effects of Conzip?
Like most medications, Conzip can cause mild or serious side effects.
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 1-800-FDA-1088.
Common Side Effects
The most common side effects with Conzip include:
Headache Nausea or vomiting Dry mouth Dizziness Sleepiness Constipation
Talk to your healthcare provider or pharmacist if these side effects don’t go away or become more severe.
Severe Side Effects
Call your healthcare provider immediately if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and symptoms can include the following:
Severe allergic reactions: Symptoms may include trouble breathing, hives, or swelling of the tongue, lips, mouth, or throat. Serotonin syndrome: Signs can include mental changes (e. g. , agitation, hallucinations), tachycardia (fast heart rate), hypertension (high blood pressure), muscle rigidity, hyperthermia (dangerously high body temperature), flushed skin, and tremor. Respiratory depression (hypoventilation): Decreased breathing rate Seizures Suicidal thoughts or behavior Adrenal insufficiency: Symptoms include chronic fatigue, muscle weakness, loss of appetite or weight, and stomach pain. Severe hypotension (low blood pressure): Symptoms include dizziness or lightheadedness, nausea, fainting, lack of concentration, and dehydration or unusual thirst.
Dosage: How Much of Conzip Should I Take?
Modifications
Due to the possible effects of this medication, there may be changes to how it is used. Certain factors may affect how you use Conzip, such as:
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For chronic pain: For oral dosage form (extended-release capsules): Adults—At first, 100 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day. Children 12 years of age and older—Use and dose must be determined by your doctor. Children younger than 12 years of age—Should not be used in these patients. For oral dosage form (extended-release tablets): Adults—At first, 100 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day. Children—Use and dose must be determined by your doctor. For moderate to severe pain: For oral dosage form (solution): Adults—At first, 25 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day. Children younger than 12 years of age—Should not be used in these patients. For oral dosage form (tablets): Adults—At first, 25 milligrams (mg) per day, taken every morning. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Older adults over 75 years of age—At first, 25 mg per day, taken every morning. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 300 mg per day. Children 12 years of age and older—Use and dose must be determined by your doctor. Children younger than 12 years of age—Should not be used in these patients.
Older Adults
Adults 65 and older may be at an increased risk of respiratory depression. If you are in this age group, your healthcare provider might start you at a low dose and gradually increase it over time. People 75 and older should be extra cautious if taking this medication.
Pregnancy or Breastfeeding
Chronic use of opioids during pregnancy can cause neonatal opioid withdrawal syndrome. In neonatal opioid withdrawal syndrome, newborn infants experience symptoms related to opioid exposure. These can include severe irritability, difficulty feeding, breathing problems, and seizures.
If prolonged opioid use is necessary, your healthcare provider should inform you of the risks. Your baby will be monitored for signs of neonatal opioid withdrawal syndrome during labor and shortly after birth. The effects of tramadol on the later growth, development, and maturation of the child are unknown.
Due to the potential risks to the breastfed infant, it is not recommended to use tramadol while breastfeeding.
Switching From IR Tramadol
Your healthcare provider will let you know how your dose should be adjusted if you switch from IR tramadol to ER tramadol.
Risk of Abuse or Dependence
You may be at increased risk of becoming dependent on Conzip if you have a personal or family history of substance use disorder or mental illness. However, these risks should not prevent you from receiving adequate pain management. Extra caution and monitoring should be exercised when taking tramadol if you are at a heightened risk of opioid abuse, misuse, or dependence.
Missed Dose
If a dose of Conzip is missed, take the dose as soon as you remember. If it is too close to the next dose then just skip that dose and take the next dose at the regularly scheduled time. Do not take extra to make up for the missed dose. Doing so can increase your risk for side effects.
Overdose: What Happens If I Take Too Much Conzip?
If someone takes too much Conzip, they may experience:
Respiratory depression (slowed breathing)Drowsiness progressing to comaCold or clammy skinHypotensionSkeletal muscle flaccidity
If you’re experiencing an overdose, use naloxone to reverse tramadol’s effects. Naloxone is designed to rapidly reverse an opioid overdose. A friend or loved one might need to administer this to you.
Once naloxone is administered, call 911 as soon as possible. Naloxone can restore normal breathing within two to three minutes of administration. However, for stronger opioid overdoses, more than one dose might be needed.
There are various naloxone products available. Talk with your pharmacist or healthcare provider for detailed directions.
Precautions
What Are Reasons I Shouldn’t Take Conzip?
There are a few reasons your healthcare provider may not choose Conzip as part of your treatment plan.
If someone collapses or isn’t breathing after taking Conzip, call 911 immediately.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
You should not take other medicines that also contain tramadol. This includes Conzip®, Qdolo, Ryzolt™, Ultram®, or Ultracet®. Using these medicines together may increase your chance for more serious side effects.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with tramadol may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Check with your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
Tramadol is highly metabolized in the body. Some people change tramadol to a stronger product ( O-desmethyltramadol) more quickly than others. These individuals are called “ultra-rapid metabolizers of tramadol”. Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an “ultra-rapid metabolizer of tramadol.” As a result, there is too much O-desmethyltramadol in the body and more side effects of O-desmethyltramadol than usual. Children may be especially sensitive to this effect (eg, serious breathing problems, death). Do not give this medicine to:
Children younger than 12 years of age. Children younger than 18 years of age who have had surgery removal of tonsils or adenoids. Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).
If a nursing mother is an ultra-rapid metabolizer of tramadol, it could lead to an overdose in the nursing baby and cause very serious side effects.
For nursing mothers using this medicine:
Talk to your doctor if you have any questions about taking tramadol or about how this medicine may affect your baby. Call your doctor if you become extremely tired and have difficulty caring for your baby. Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time. Check with your doctor, hospital emergency room, or local emergency services (eg, “call 9-1-1”) immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure your doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cough, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, trouble breathing or swallowing, unusual tiredness or weakness, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine may cause some people to become drowsy, dizzy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.
This medicine may cause hyponatremia (low sodium levels in the blood). Check with your doctor right away if you have coma, confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, increased thirst, muscle pain or cramps, nausea or vomiting, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.
Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. These may be symptoms of hypoglycemia (low blood sugar level).
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your doctor or dentist gives you certain medicines without knowing that you have been taking tramadol.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and other medicines to treat an overdose. Signs of an overdose include: seizures, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or trouble breathing.
Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Allergy
A person should not take Conzip if they are allergic to tramadol or any of its other ingredients.
Risk of Abuse or Dependence
Since Conzip is a controlled substance, there is a risk of abuse and physical dependence.
Tell your healthcare provider immediately if you suspect you are becoming dependent on Conzip or taking more than prescribed to achieve the desired effect. You may need to wean off the medication under the guidance of a healthcare provider and use alternative treatments for pain relief.
Pregnancy
Prolonged use of Conzip can cause neonatal opioid withdrawal syndrome in newborn infants. It is best to talk to your healthcare provider if you are pregnant or plan to become pregnant so they can decide the best option for you.
Breastfeeding
Tramadol and its active metabolite are present in human breast milk. The effects of tramadol on a breastfed infant are unknown, but it is recommended to avoid using the drug while breastfeeding due to the potential risks. Talk with your healthcare provider if you are breastfeeding to discuss the best plan for you.
Children and Adolescents
Conzip should not be used in children under 12. Additionally, it should not be prescribed in children 12 to 18 for post-operative management following tonsillectomy or adenoidectomy or in children with other risk factors for respiratory depression.
Use of Monoamine Oxidase Inhibitors (MAOIs)
Do not use Conzip if you are taking MAOIs or have used MAOIs within the last two weeks. MAOIs are a type of antidepressant that include Emsam (selegiline), Marplan (isocarboxazid), and Nardil (phenelzine). Taking these medications together or within 14 days of each other can cause serotonin syndrome.
Other Health Conditions
In certain individuals, the body may handle Conzip differently. A person should inform their healthcare provider if they have:
Respiratory depressionSuicidal thoughtsBrain tumors or head injuriesGastrointestinal obstruction HypotensionAdrenal insufficiency Seizures Signs of serotonin syndrome
What Other Medications Interact With Conzip?
Several medications can interact with Conzip. Before starting Cozip, be sure to tell your healthcare provider about your use of prescription and over-the-counter (OTC) drugs, vitamins, and herbal supplements.
Taking the following medications with tramadol can increase exposure to tramadol, leading to serious adverse effects such as seizures:
Quinidine, which is used to treat heart arrhythmias (irregular heartbeats) Certain antidepressants, such as Prozac (fluoxetine) and Wellbutrin XL (bupropion) MAOIs, such as linezolid, which should not be taken within 14 days of starting tramadol Triptans, such as Reyvow (lasmiditan) and Zomig (zolmitriptan), which are used to treat migraines Macrolide antibiotics, such as erythromycin and Biaxin XL (clarithromycin) Azole-antifungal drugs, such as ketoconazole and Diflucan (fluconazole) Protease inhibitors, such as Norvir (ritonavir)
Taking certain medications called serotonergic drugs with Conzip can also increase the risk of serotonin syndrome. Examples of these medications include:
Amitriptyline, a tricyclic antidepressant Amrix (cyclobenzaprine), a skeletal muscle relaxant Cymbalta (duloxetine), which is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) Trazodone, a serotonin modulator MAOIs Remeron (mirtazapine), an atypical antidepressant
This is not an exhaustive list, and many more medications increase the risk of serotonin syndrome not mentioned here. Please consult your healthcare provider or pharmacist for more information regarding the potential risk of serotonin syndrome with Conzip and your other prescriptions, OTC products, or complementary alternative medications.
These medications can reduce the efficacy of Conzip and possibly signs of opioid withdrawal in people with physical dependence on tramadol:
Rifampin, an antimycobacterial antibiotic used to treat tuberculosis Anticonvulsants, such as Tegretol (carbamazepine) and Dilantin (phenytoin)
Taking benzodiazepines and other CNS depressants with tramadol can cause severely low blood pressure, respiratory depression, and sedation. Other CNS depressants include:
Certain muscle relaxantsOther opioids, such as morphine, hydromorphone, and methadoneAlcohol
Tramadol may reduce how well diuretics work, although the mechanism of this interaction is not fully understood. Diuretics, also known as “water pills”, help rid the body of excess fluid. Examples of diuretics include:
Lasix (furosemide) Microzide (hydrochlorothiazide) Inspra (eplerenone)
Rarely, tramadol can also interact with digoxin and warfarin. Dosage adjustments may be needed if an interaction occurs.
This list does not include all drugs that can interact with Conzip. Ask your healthcare provider or pharmacist for a complete list of potential drug interactions before starting your medication.
What Medications Are Similar?
Conzip is often used to treat severe, chronic pain when other nonopioid alternatives do not work.
Other opioid medications used to treat severe pain include:
Hysingla ER (hydrocodone) Oxaydo, Oxycontin, Roxybond, Xtampza ER (oxycodone) Percocet (acetaminophen and oxycodone) Codeine Morphine Fentanyl
This list is an example of other opioid medications used to treat severe, chronic pain. It is not a list of drugs recommended to take with Conzip. Talk to your healthcare provider or pharmacist if you have questions or concerns about your pain management.
How Can I Stay Healthy While Taking Conzip?
Conzip can be an effective medication for chronic pain management. Although it can be safe when used carefully, it does not come without serious risks.
However, the more common side effects will present milder. These can be headaches, nausea or vomiting, or opioid-induced constipation. Ask your healthcare team for strategies to manage these side effects during treatment.
Ask your healthcare provider about obtaining naloxone to have on hand while you are using Conzip. Naloxone is an effective antidote for reversing opioid overdoses. Ask your healthcare provider for detailed instructions and have a caregiver or loved one learn how to administer it.
Always inform your healthcare provider about your medical history and use of other prescription and OTC drugs, vitamins, and herbal supplements. This will help you and your healthcare provider work together to make the best treatment decisions.
