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Why it's used

Tramadol is used for the management of moderate to severe pain in adults. This medicine works by changing the way of chemicals in the brain which generates pain signals in the body.
Opioid Agonist
Tramadol is a prescription medicine that belongs to a class of medicines called Opioid Agonist. Opioid agonists are medicines used for the treatment of addiction to opioid drugs such as heroin, fentanyl, oxycodone, hydromorphone, and percocet. These medications work to prevent withdrawal and decrease cravings for opioid drugs.

How to use

Read the directions on the product label, patient guide, or medicine guide provided by the medicine company or your pharmacist before starting to use Tramadol. If you have any questions related to this medicine, ask your doctor or pharmacist. Use this medicine as recommended by your doctor.
Tramadol is used with or without food. Swallow the whole tablet with liquid. Tramadol tablets should not be cut, broken, crushed, chewed and dissolved before use otherwise it can cause overdose or fatal.
The typical dose of Tramadol is 50-100 mg twice daily if pain does not relieve increase dose up to 150-200 mg twice daily. The maximum adult dose of Tramadol is 300 mg per day in a day. Tramadol is commonly used at the same time every day. Take your prescribed dose once a day at the same time every day. Do not take more than your prescribed dose. Although this medicine helps people, it may sometimes cause addiction. You may be at higher risk if you have a substance use disorder, such as an addiction to drugs, or to alcohol. To reduce your risk of addiction, take this medicine exactly as prescribed by your doctor.
This medicine is to be used for longer periods of time. Tramadol is used for the treatment of severe pain.
Talk to your doctor if you develop new symptoms. Tell your doctor if sleepiness, difficulty falling asleep or staying asleep, headache, nervousness, uncontrollable shaking of a part of the body, muscle tightness, changes in mood, heartburn or indigestion, and dry mouth. If you have any kidney disease, in such patients the dosage interval should be prolonged as per the patient requirement. If you have issues with the health of your liver, in such patients the dosage interval should be prolonged as per the patient requirement. You should consult with your doctor before stopping the use of Tramadol.
Your doctor may recommend a lower initial dose of this medicine to see the impact of this medicine on the body. Please follow your doctor's directions. Taking a higher dose of this medicine may increase the risk of side-effects. A lower dose of this medicine may be recommended to reduce the risk of side-effects. Older patients may see an increase in the incidence of side-effects with this medicine. As a result, a lower dose may be recommended for older patients.
When stopping this medicine, you may experience withdrawal symptoms such as extreme emotional disturbance (agitation), nervousness, insomnia, excessive abnormal movements (hyperkinesia), tremor, gastrointestinal symptoms, panic attacks, hallucinations, abnormal sensations in the body, tinnitus, unusual CNS symptoms (confusion, delusions, depersonalization, derealization, paranoia), restlessness, shedding tears (lacrimation), mucus discharge from nose (rhinorrhea), yawning, sweating, chills, muscle pain, dilation of the pupil of the eye, irritability, backache, joint pain, weakness, abdominal cramps, nausea, loss of hunger (anorexia), vomiting, diarrhea, increased blood pressure, increased breathing, and increased heart rate. You may need to gradually decrease the dose of this medicine before stopping. The effectiveness of this medicine may reduce if it is used for long periods of time.
The safety and effectiveness of using Tramadol in children has not been established. This medicine may increase the risk of slow and ineffective breathing and fatal in the children.
If using the delayed-release form of this medicine, do not crush or chew the medicine, unless indicated on the package. Crushing or chewing of the medicine can result in unpleasant taste resulting in patients not following the medicine schedule. Crushing or chewing can also release all of the medicine at once, resulting in a decrease of effectiveness and a possible increase in side-effects.
To decrease the possibility of side-effects, you might be recommended to use the extended-release form of this medicine by your doctor. The extended-release medicine helps in maintaining a steady level of the medicine in your body for a longer period of time. Do not crush or chew the medicine, unless indicated on the package or by your doctor.
If using the orally-disintegrating form of this medicine, make sure you do not consume any food or fluid 5 minutes before or after taking this medicine. Before taking the medicine out of the package, wash your hands thoroughly. Place the medicine on the tongue. Make sure you do not chew or swallow the medicine. You do not need to drink water after consuming the medicine. In certain cases, the medicine can taste slightly bitter. Also, ensure that you do not break or split the medicine.
The Tramadol parenteral injection can be intended to use intramuscularly (into the muscle), intravenously (into the blood veins) and slow infusion.
Avoid the consumption of alcohol with Tramadol.
You should store Tramadol at 15°C to 30°C (59°F to 86°F) for tablet and, and away from moisture. Store the medicine away from the reach of children and pets.
Medicines may be prescribed for uses other than those listed in the medicine guide. Do not use Tramadol for conditions for which it was not prescribed. Do not give Tramadol to other people who might have the same conditions or symptoms that you have. Self-medication may harm them.
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How to take Tramadol

Your dose may depend on several personal factors. You should consult with your doctor to find out the dose that is best for you. The dose of Tramadol depends on the following factors:
  • patient's age
  • patient's health
  • the health of the patient's liver
  • the health of the patient's kidneys
  • response to treatment

Tramadol Dosage

Dosage for moderate to severe pain

Adult (adults and children above the age of 12 years)
  • Initial: 50-100 mg twice daily in the morning and evening, if the pain does not relieve increase the dose up to 150-200 mg twice daily
  • Maximum: 300 mg/day

Minimum Age

12 years

Forms

Tablet, orally disintegrating
Strength: 50 mg
Tablet, film coated
Strength: 50 mg
Tablet, extended release
Strength: 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 300 mg
Tablet, coated
Strength: 50 mg
Tablet
Strength: 50 mg, 100 mg
Capsule
Strength: 150 mg
Capsule, extended release
Strength: 150 mg

Special Instructions

Capsule
Tramadol capsule must be swallowed whole, do not be split, chewed, dissolved or crushed and may be taken without regards to the meal.
Tramadol parenteral infusion
The infusion should be prepared immediately before use. The Prepared infusion should be used immediately and store under sterilized conditions at 2 to 8°C for not more than 24 hours.

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued. Avoid taking a repeated dose to make up for a missed dose.

Overdose

What to do if you overdose on Tramadol?
In case of overdose, keep open the respiratory tract (aspiration). Provide other life supports like oxygen and blood pressure rising agents to manage sudden decrease in the blood flow to the body organs (circulatory shock) and build up of fluid in the lungs. Provide advanced life supports (open airway and adequate ventilation or breathing) in case of loss of heart functions (cardiac arrest) and abnormal heart rate (arrhythmia). Use opioid antagonists medicines like naloxone or nalmefene in the situation of slow and ineffective breathing and physical dependence. To prevent harmful effects of Tramadol, immediate stomach emptying should be performed (gastric lavage) or decontamination of the stomach with charcoal is performed within 2 hours after Tramadol intake.
Symptoms of an overdose of Tramadol
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
  • abnormal heartbeat
  • build up of fluid in the lungs
  • cold and clammy skin
  • coma
  • fatal
  • low blood pressure
  • narrowing of the pupils
  • noisy breathing during sleep (atypical snoring)
  • partial or complete airway obstruction
  • skeletal muscle weakness
  • slow and ineffective breathing
  • slow heart rate
If you think you have overdosed on Tramadol, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Tramadol

Before you use Tramadol, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Discuss with your doctor if you are allergic to opioids.
Before you use Tramadol, tell your doctor of your medical history including head injury, seizures, liver problems, kidney problems, thyroid problems, urinating problems, pancreas problems, gallbladder problems, abuse of prescription drugs, alcohol addiction, mental health problems (depression), history of currently taking central nervous system active drugs, circulatory shock, slow and ineffective breathing, rise in pressure around the brain (increased intracranial pressure), brain tumors, stomach or intestinal obstruction, head trauma, metabolic disorders, alcohol or drug withdrawal, or central nervous system infection. The patients using Tramadol may experience decrease respiratory function which may further increase intracranial pressure. It also increases the risk of drug abuse, addiction, or misuse in patients with the history of substance abuse or mental health problems. Patients with alcohol withdrawal, metabolic disorders, head trauma, drug withdrawal, central nervous system infection or with a history of epilepsy may experience an increased risk of seizure when using Tramadol. Using Tramadol in patients taking central nervous system active drugs are at increased risk of suicide. Using Tramadol in patients with a history of shock may cause vasodilation which may lead to decreased heart function and blood pressure. Before having any surgery, discuss with your doctor and dentist about medicines you use including prescription medicines, non-prescription medicines, and herbal supplements.
The use of Tramadol may change blood amylase. Using Tramadol may cause an increase in the blood amylase and obstruction in the flow of digestive juice (spasm of the sphincter of Oddi). Patients with stomach and intestinal conditions such as biliary tract disease, acute pancreatitis should be monitored for worsening of symptoms.
The use of this medicine may change intracranial pressure. Patients more prone to intracranial effects of CO2 retention may experience decreased respiratory function which may lead to a further increase in intracranial pressure. Patients should be monitored for the signs of slow and ineffective breathing and sedation when starting Tramadol therapy.
The use of Tramadol may change blood pressure. Patients using Tramadol may experience a decrease in blood pressure and loss of consciousness. Such patients should be monitored for the signs of low blood pressure after starting the therapy or during dosage adjustment of Tramadol.
Tramadol is not safe for use in women who are pregnant. If you are pregnant or planning to become pregnant, you should discuss the impact on the fetus with your doctor before you start using this medicine. There is no sufficient data available for drug-associated risk for miscarriage, birth defects, growth, and for functional maturation of the child. Prolonged use of Tramadol during pregnancy may cause fetal harm such as slow and ineffective breathing, physical dependence, opioid withdrawal syndrome, and mental (psycho-physiologic) effects. Neonatal opioid withdrawal syndrome includes vomiting, tremor, irritability, abnormal sleep pattern, hyperactivity, diarrhea, high pitched cry, and failure to gain weight. Tramadol should not be used during or before labor when the use of other analgesic medicines is more appropriate. Tramadol may prolong the labor which temporarily decreases the duration, frequency, and strength of uterine contractions. During labor, neonates should be monitored for the sign of sedation and slow and ineffective breathing. Tramadol is not safe for use in women who are breastfeeding. If you are breastfeeding, discuss with your doctor if you should either discontinue breastfeeding, or stop using this medicine during this period. There is no sufficient and adequate data available for safety in breastfeeding. Tramadol may pass into breast milk which may cause serious harmful effects such as sedation, withdrawal symptoms and slow and ineffective breathing in infants. Tramadol should be used while conceiving only when required. The long-term use of Tramadol may reduce fertility. It is unknown whether these effects are reversible.
Avoid drinking alcohol with Tramadol. Consumption of alcohol may cause sedation, slow and ineffective breathing, coma, fatal, seizures, low blood pressure, severe drowsiness, decreased awareness, and breathing problems.
Tramadol can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with Tramadol can worsen the sleepiness. Tramadol may cause seizures in some people. Hence, you should discuss with your doctor before performing any activities where a loss of consciousness may cause harm to you or others.
Older patients may have a higher incidence of side-effects when using Tramadol. Elderly patients may see an increased risk of constipation, fatigue, weakness, low blood pressure on quickly standing up, indigestion (dyspepsia), and slow and ineffective breathing.
Younger patients may have a higher incidence of side-effects with Tramadol. Younger patients may see an increased risk of life-threatening slow and ineffective breathing, fatal, neonatal seizures, and neonatal withdrawal syndrome.
Patients using Tramadol for longer duration may experience tolerance, physical and psychic dependence. Long-term use of Tramadol in pregnant women may cause neonatal withdrawal syndrome.

Tramadol Side-effects

The following side-effects may commonly occur when using Tramadol. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Tramadol. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Tramadol may cause the following side-effects:
  • abnormal coordination
  • abnormal dreams
  • back pain
  • blood in the urine (hematuria)
  • bruise (contusion)
  • clamminess
  • cold (nasopharyngitis)
  • cough
  • decreased appetite
  • decreased weight
  • deficiency of male sex hormones (androgen deficiency)
  • depersonalization
  • derealisation
  • difficulty in expelling urine from the bladder (micturition)
  • dilatation of blood vessels (vasodilatation)
  • dilation of the pupil of the eye
  • disturbance in attention
  • disturbance of the sensory organs (perception disorders)
  • ear infection
  • excessive constriction of the pupil of the eye (miosis)
  • extreme happiness and feeling of excitement (euphoric mood)
  • fainting
  • feeling hot
  • feeling jittery
  • feeling of discomfort
  • feeling unhappy (dysphoria)
  • fever
  • flatulence
  • goosebumps (piloerection)
  • hives
  • indigestion (dyspepsia)
  • inflammation of the bronchial tubes (bronchitis)
  • inflammation of the gallbladder (cholecystitis)
  • influenza like illness
  • insufficient blood flow to the brain and other organs (heart collapse)
  • intestinal infection (gastroenteritis viral)
  • involuntary muscle contractions
  • irritability
  • irritation of the throat (sore throat)
  • itchy inflammation of the skin (dermatitis)
  • joint pain (arthralgia)
  • joint sprain
  • joint stiffness
  • joint swelling
  • life-threatening drug-induced skin reaction (harmful epidermal necrolysis)
  • life-threatening skin reaction (Stevens-Johnson Syndrome)
  • loss of sensitivity (hypoesthesia)
  • loss of sex drive (libido)
  • lower limb swelling (peripheral swelling)
  • muscle cramps
  • muscle injury
  • muscle pain
  • muscle spasms
  • muscle twitching
  • muscle weakness (motorial weakness)
  • neck pain
  • nervousness
  • night sweats
  • nightmares
  • pain
  • pain in limb
  • painful swelling and inflammation of the joint (osteoarthritis)
  • painful urination
  • palpitations
  • panic attacks
  • paranoia
  • rash
  • restlessness
  • ringing in the ears (tinnitus)
  • runny nose (rhinorrhea)
  • sedation
  • serious mental illness (delusion)
  • severe headache (migraine)
  • shivering
  • sleep disturbance
  • sneezing
  • speech disorders
  • stomach (abdominal) pain
  • stomach and intestinal discomfort (gastrointestinal discomfort)
  • stone in the gallbladder (cholelithiasis)
  • stuffy nose (nasal congestion/sinus congestion)
  • sudden feeling of cold with shivering (rigors)
  • tingling sensation
  • toothache
  • tremor
  • urinary frequency
  • vertigo
  • viral infection
  • weakness
  • yawning
The following severe side-effects may also occur when using Tramadol:
  • respiratory disorder (respiratory arrest and possibly fatal)
    Symptoms: life-threatening slow and ineffective breathing, difficulty in breathing (dyspnea), upper respiratory tract infection, inflammation of the lungs (pneumonia) inflammation within the nasal passage (sinusitis)
    Management of slow and ineffective breathing may include supportive measures, close observation, and use of opioid antagonists, depending upon the clinical status of the patient. Closely monitor the patients for slow and ineffective breathing, primarily within the first 24-72 hours of starting therapy.
  • neonatal opioid withdrawal syndrome (symptoms occur in a newborn due to addictive opiate drugs while in the pregnancy) (fetal death and loss of a baby during or before delivery (stillbirth))
    Symptoms: irritability, hyperactivity, abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, failure to gain weight neonatal seizures
    Observe and manage the signs of neonatal opioid withdrawal syndrome in newborns. Advise should be taken in pregnant women who are receiving long-term opioids therapy for the increased chances of neonatal opioid withdrawal syndrome.
  • serotonin-inducing symptoms (serotonin syndrome) (life-threatening condition)
    Symptoms: agitation, hallucinations, coma, increased heart rate, changes in the blood pressure, fever, nausea, vomiting, diarrhea, over-responsive reflexes (hyperreflexia), incoordination rigidity
    Treatment with Tramadol should be discontinued if serotonin syndrome occurs.
  • insufficient production of adrenal hormones (adrenal insufficiency) (life-threatening condition)
    Symptoms: nausea, vomiting, eating disorder (anorexia), fatigue, weakness, dizziness low blood pressure
    Confirm the diagnosis of adrenal insufficiency by proper diagnostic testing as soon as possible and use physiological replacement doses of corticosteroids until adrenal function recovers.
  • immune system disorder such as an allergic reaction (possibly fatal)
    Symptoms: life-threatening allergic reaction, severe itching of the skin, hives, tightening of the lungs' muscles (bronchospasm), swelling of the skin, life-threatening skin reaction (Stevens-Johnson Syndrome), life-threatening drug-induced skin reaction, difficulty in breathing (dyspnea), wheezing swelling of the skin due to an allergic reaction
    Use of Tramadol should be discontinued if life-threatening allergic reactions or other allergic reactions occur and patients should get immediate medical attention.
  • eye disorder
    Symptoms: blurred vision
  • stomach and intestinal disorders
    Symptoms: inflammation of the appendix (appendicitis) inflammation in the pancreas (pancreatitis)
    Patients should be monitored for worsening symptoms and inflammation in the pancreas.
  • Symptoms: bacterial serious skin inflammation (cellulitis)
  • metabolism and nutrition disorder
    Symptoms: low blood sugar (hypoglycaemia)
Your doctor has prescribed this medicine because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious cases of side-effects. This page does not contain a complete list of all possible side-effects.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

History of mental illness or substance abuse

Patients with a history of mental illness or substance abuse are at an increased risk when using this medicine. Such patients are at an increased risk of addiction, misuse or abuse of Tramadol, which may lead to overdose and fatal. These patients should be monitored for the risk and development of addiction, misuse or abuse before using Tramadol. To reduce these risks, a small dose medicine should be prescribed and patients should be advised to dispose off the remaining unused drug.

Life-threatening slow and ineffective breathing

Patients undergoing Tramadol therapy are at increased risk when using this medicine. These patients are at an increased risk of serious, life-threatening, or fatal slow and ineffective breathing during starting or increasing dose of Tramadol. It can be possibly fatal in patients when converting from another opioid to Tramadol due to overdose with the first dose. Patients should be monitored for slow and ineffective breathing within 24-72 hours of starting or increased dose of Tramadol therapy. Proper dosing is recommended to reduce the risk of slow and ineffective breathing. Management of slow and ineffective breathing includes supportive measures (oxygen and vasopressors), close observation and use of opioid antagonists if needed. Patients are advised to swallow the whole tablet of Tramadol to avoid patient's exposure to a harmful dose.

Children taking Tramadol

Children younger than 12 years, children under 18 years with a history of organ removal surgery and children under 12- 18 years with risk factors such as obesity, serious sleep disease (obstructive sleep apnea), neuromuscular disease, severe pulmonary disease, and combined use of other medicines are at increased risk when using this medicine. Such patients are at an increased risk of life-threatening slow or ineffective breathing and it can be possibly fatal. Avoid the use of Tramadol in such patients.

Breastfeeding mother taking Tramadol

Infants who are breastfeeding from mother taking Tramadol are at an increased risk. Infants are at an increased risk of slow and ineffective breathing when a mother is using this medicine. Tramadol should not be used during breastfeeding.

Ultra-rapid metabolizers taking Tramadol

Patients who rapidly convert Tramadol into O-desmethyltramadol are at increased risk. These patients are at increased risk of fatal and life-threatening slow or ineffective breathing or experience signs of overdose such as confusion, extreme sleepiness, or shallow breathing when using this medicine. Tramadol should not be used in such patients.

Prolonged use of Tramadol in pregnant women

Infants are at an increased risk when pregnant women use this medicine for long-term. Infants are at increased risk of neonatal opioid withdrawal syndrome (symptoms occur in a newborn due to addictive opiate drugs while in the pregnancy) when pregnant women use this medicine for a long duration which can be life-threatening. The newborn should be observed for the withdrawal syndrome and should be treated as needed. Pregnant women using Tramadol for longer duration should be informed about the risk of neonatal opioid withdrawal syndrome, and provide treatment accordingly.

Use of cytochrome P450 2D6 inhibitors

Patients using Tramadol with cytochrome P450 2D6 inhibitors such as amiodarone, quinidine, which are used to treat irregular heartbeat are at increased risk when using this medicine. Patients using Tramadol with P450 2D6 inhibitors may result in an increased level of Tramadol and decreased metabolite levels in the blood. It may result in an increased risk of serious harmful effects such as seizures, serotonin syndrome, and withdrawal (after stopping or reducing intake of a drug) syndrome in patients who have the physical dependence on Tramadol. In the case of discontinuation of the combined use of CYP2D6 inhibitors with Tramadol, results in decreased levels of Tramadol and increased metabolite levels in the blood which may increase the harmful effect of opioid and fatal slow and ineffective breathing. These patients should also be monitored for seizures, serotonin syndrome, harmful effects of opioids and signs or symptoms of opioid withdrawal.

Use of CYP3A4 inhibitors and cytochrome P450 3A4 inducers

Patients using CYP3A4 inhibitors such as erythromycin, ritonavir and ketoconazole, which are used to treat bacterial, and fungal infections respectively or cytochrome P450 3A4 inducer such as carbamazepine, rifampin and phenytoin, which are used to treat seizures are at increased risk when using this medicine. When using Tramadol with cytochrome P450 3A4 inhibitors or discontinuing cytochrome P450 3A4 inducer may experience an increase in the level of Tramadol in the blood which may result in increased serious harmful effects including seizures, serotonin syndrome (serotonin-inducing symptoms), and may cause potentially slow or ineffective breathing. The use of Tramadol with cytochrome P450 3A4 inducers or discontinuing cytochrome P450 3A4 inhibitors may decrease the level of Tramadol in the blood that results in sign and symptoms of opioid withdrawal. These patients should also be monitored for signs and symptoms of opioid withdrawal.

Using benzodiazepines or other central nervous system depressants with Tramadol

Patients using benzodiazepines or other central nervous system depressants (anxiolytics, tranquilizers, muscle relaxants, general anaesthetics, antipsychotics, other opioids, alcohol, non-benzodiazepine sedative/hypnotics) are at increased risk when using this medicine. These patients may experience extreme sedation, slow and ineffective breathing, coma, and possibly fatal when using Tramadol with central nervous system depressants. When Tramadol is used with benzodiazepine or other CNS depressant, treatment should be started with the lowest effective dose for the shortest duration. Patients should be monitored for the signs of slow or ineffective breathing and sedation. Patients are also advised not to drive or operate heavy machinery when using benzodiazepines or other CNS depressants in combination. Examine the patients for the risk of drug abuse and inform them for risk of overdose and fatality.

Use of serotonergic drugs therapy

Patients undergoing serotonergic drugs therapy such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), triptans, serotonin and norepinephrine reuptake inhibitors (SNRIs), 5-HT3 receptor antagonists, MAO inhibitors which are used to treat depression, are at increased risk when using this medicine. Patients using Tramadol with serotonergic drugs are at increased risk of seizures and serotonin syndrome. Symptoms of serotonin syndrome may occur within several hours to a few days, which may include incoordination, blood pressure, hallucinations, anxiety, nausea, coma, increased heartbeat, increased body temperature, overresponsive reflexes (hyperreflexia), rigidity, vomiting, and diarrhea. Patients should stop using Tramadol if serotonin syndrome occurs.

Use of tricyclic compounds, monoamine oxidase inhibitors, or neuroleptics which are used to treat neurological disorders

Patients taking tricyclic compounds (cyclobenzaprine, promethazine), monoamine oxidase inhibtors or neuroleptics are at an increased risk when using this medicine. Patients using Tramadol with tricyclic compounds, monoamine oxidase inhibtors or neuroleptics are at increased risk of seizures. Tramadol should not be used in patients taking MAOIs and within 14 days of stopping the MAOI therapy.

Patients with epilepsy, seizures and conditions which increase the risk of seizures

Patients with epilepsy, seizures or conditions which increase the risk of seizures such as head trauma, metabolic disorders, alcohol, drug withdrawal and central nervous system infections are at increased risk when using this medicine. These patients are at an increased risk of seizures.

Suicidal behaviour or addiction-prone patients

Patients with addiction-prone or suicidal behaviour are at an increased risk when using this medicine. These patients are at increased risk of suicide when using this medicine. Tramadol should not be used in such patients. Use of non-narcotic analgesics should be considered in such patients. Patients are advised not to use more than the recommended dose and not to drink excess alcohol.

Patients with a history of misuse or currently taking central nervous system-active drugs, emotional disturbance, excess alcohol, or depression

Patients with a history of misuse, emotional disturbance, excess alcohol use, depression or currently taking central nervous system-active drugs such as antidepressant drugs or tranquilizers are at increased risk. These patients are at an increased risk of suicide when using this medicine. Precaution should be taken when using Tramadol in such patients. Patients are advised not to use more than the recommended dose and not to drink excess alcohol.

Patients with stomach and intestine problems

Patients with stomach and intestine problems such as intestinal paralysis (paralytic ileus) should not use this medicine. These patients may experience disturbances in the flow of bile juices and an increase in blood amylase. Patients with biliary tract disease such as inflammation in the pancreas (acute pancreatitis) should be monitored for worsening of symptoms.

Interactions with Tramadol

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
Tramadol interacts with CYP3A4 inducers such as carbamazepine, phenytoin, and rifampin, which are used to treat seizures and bacterial infections. The use of Tramadol with CYP3A4 inducers may decrease the level of Tramadol in the blood which further results in reduced drug efficacy or withdrawal syndrome in patients who have the physical dependence on Tramadol. In case of discontinuation of the combined use of CYP3A4 inducer with Tramadol, it may increase the level of Tramadol in the blood, which leads to increase the harmful effect of opioid and may cause seizures, serotonin syndrome, and fatal slow or ineffective breathing. The patient taking carbamazepine may decrease the pain-relieving (analgesic) effect of Tramadol which leads to increase Tramadol metabolism and risk of seizure. If the use of Tramadol with the CYP3A4 inducer is necessary, the dose of Tramadol should be increased until the stable effects of the drug are achieved. Follow the patients for the signs of opioid withdrawal. If CYP3A4 inducer is discontinued, the dose of Tramadol should be reduced. Patients should be monitored for the signs of seizures, serotonin syndrome (serotonin-inducing symptoms), slow or ineffective breathing, and sedation. The use of carbamazepine with Tramadol should be avoided if the seizure occurs.
There may be an interaction of Tramadol with CYP3A4 inhibitors such as macrolide antibiotics (erythromycin), azole-antifungal agents (ketoconazole), protease inhibitors (ritonavir), which are used to treat bacterial, fungal and viral infections respectively. The use of Tramadol with CYP3A4 inhibitors may increase the level of Tramadol in the blood which results in increased metabolite levels. Patients should be monitored for serious harmful effects including seizures, serotonin syndrome (serotonin-inducing symptoms), and fatal slow or ineffective breathing, especially when the CYP3A4 inhibitors are added after a stable dose of Tramadol is achieved. In the case of discontinuation of the combined use of CYP3A4 inhibitors with Tramadol, it may decrease the level of Tramadol in the blood which further results in reduced drug efficacy or withdrawal syndrome in patients who have the physical dependence on Tramadol. If the use of Tramadol with the CYP3A4 inhibitors is necessary, the dose of Tramadol should be reduced until the stable effects of the drug are achieved. If CYP3A4 inhibitors are discontinued, the dose of Tramadol should be increased. Patients should be monitored for the signs of opioid withdrawal syndrome.
Tramadol may interact with CYP2D6 inhibitors such as quinidine, fluoxetine, paroxetine and bupropion, which are used to treat heart disease and depression. The use of Tramadol with CYP2D6 inhibitors may result in an increased level of Tramadol and decreased metabolite levels in the blood, especially when the CYP2D6 inhibitors are added after a stable dose of Tramadol is achieved. It results in decreased the effectiveness of Tramadol and may increase the risk of serious harmful effects such as seizures, serotonin syndrome, and withdrawal (after stopping or reducing intake of a drug) syndrome in patients who have the physical dependence on Tramadol. In the case of discontinuation of the combined use of CYP2D6 inhibitors with Tramadol, it may decrease the level of Tramadol and increased metabolite levels in the blood which may increase the harmful effect of opioid and increase the risk of fatal slow and ineffective breathing. If the use of Tramadol with the CYP2D6 inhibitors is necessary, patients should be monitored for the signs of seizures, serotonin syndrome and opioid withdrawal. If CYP2D6 inhibitors are discontinued, the dose of Tramadol should be reduced until the stable effects of the drug are achieved, and such patients should be monitored for signs of slow or ineffective breathing and sedation.
Your doctor's guidelines may need to be followed while taking this medicine along with serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), serotonin and norepinephrine reuptake inhibitors (SNRIs), 5-HT3 receptor antagonists (mirtazapine, trazodone, tramadol), triptans, which are used to treat depression. The use of Tramadol with serotonergic drugs may cause serotonin syndrome (serotonin-inducing symptoms). If the use of Tramadol with serotonergic drugs is necessary, then the patient should be carefully observed while starting treatment and during dose adjustment. Treatment with Tramadol should be discontinued if serotonin syndrome occurs.
Special instructions need to be followed while taking this medicine along with central nervous system depressants such as benzodiazepines and other sedatives/hypnotics, antipsychotics, tranquilizers, anxiolytics, general anesthetics, muscle relaxants, other opioids, which are used to treat depression, anxiety and muscle spasms. The use of Tramadol with benzodiazepines or other CNS depressants may increase the risk of low blood pressure, slow or ineffective breathing, profound sedation, coma, and possibly fatal. Patients should be monitored for the signs of slow or ineffective breathing or sedation. Limit the dosage or minimize the duration in such patients.
Your doctor's guidelines may need to be followed while taking this medicine along with diuretics, which are used to treat blood pressure. The use of opioids may reduce the effectiveness of diuretics by releasing the antidiuretic hormone. Patients should be monitored for the reduced diuresis (overproduction of urine) effects on blood pressure and the dose of diuretic should be increased as needed.
Special instructions need to be followed while taking this medicine along with muscle relaxants, which are used to treat muscle spasms. Tramadol may increase the neuromuscular (muscle functioning) blocking effect of muscle relaxants and enhance the risk of slow or ineffective breathing. Patients should be monitored for the signs of slow and ineffective breathing and decrease the dose of Tramadol or muscle relaxants as needed.
Tramadol interacts with mixed agonist/antagonist and partial agonist opioid analgesics such as butorphanol, nalbuphine, pentazocine, buprenorphine, which are used to treat moderate to severe pain. The use of Tramadol with mixed agonist/antagonist and partial agonist opioid analgesics may reduce the pain-relieving (analgesic) effects of Tramadol and cause withdrawal symptoms. Patients should avoid the use of both medicines together.
There may be an interaction of Tramadol with monoamine oxidase inhibitors (MAOIs) such as phenelzine, tranylcypromine, linezolid, which are used to treat depression. The use of Tramadol with monoamine oxidase inhibitors may cause serotonin syndrome (serotonin-inducing symptoms) and increase the harmful effect of opioid such as coma and slow or ineffective breathing. Tramadol should not be used in patients taking MAOIs and within 14 days of stopping the MAOI therapy.
Tramadol may interact with warfarin, which is used to treat blood clots. The use of Tramadol with warfarin may increase prothrombin time (blood clotting parameter) and ecchymose (bleeding beneath the skin). Patients should take necessary precaution while using Tramadol with warfarin. Dosage adjustment of warfarin and regular monitoring of the prothrombin time should be needed in such patients.
There may be an interaction of Tramadol with digoxin, which is used to treat heart conditions. The use of Tramadol with digoxin may increase the harmful effects of digoxin. Patients should be monitored for the signs of harmful effects of digoxin and adjust the dose of digoxin as required.
Tramadol may interact with anticholinergic drugs, which are used to treat asthma, motion sickness, and diarrhea. The use of Tramadol with anticholinergic drugs may increase the risk of severe constipation, and inability to empty the bladder, which may cause intestinal paralysis (paralytic ileus). Patients should be monitored for the signs of reduced stomach muscle contractions (reduced gastric motility) and inability to empty the bladder when Tramadol is used with anticholinergic drugs.
This page does not contain all the possible interactions of Tramadol. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Tramadol is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.

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