Tramadol HCI (Centrafarm) Capsules 50 mg
Generic Name: Tramadol HCI
Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets and capsules are only used by people who are expected to need medication to relieve pain around-the-clock. Tramadol is in a class of medications called opiate (narcotic) analgesics.
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What is Tramadol?
Tramadol is a narcotic-like pain reliever.
Tramadol is used to treat moderate to severe pain.
The extended-release form of Tramadol is for around-the-clock treatment of pain. This form of Tramadol is not for use on an as-needed basis for pain.
Tramadol may also be used for purposes not listed in this medication guide.
Does tramadol make you sleepy?
Tramadol oral tablets may cause drowsiness. You should not drive, use heavy machinery, or perform any dangerous activities until you know how this drug affects you. Tramadol may also cause other side effects.
Is tramadol safe to take?
Tramadol is associated with a wide array of side effects. In many people, tramadol is well-tolerated when used for pain, but tramadol can also cause some common and serious side effects.
Tramadol® (Tramadol hydrochloride) is indicated for the management of moderate to moderately severe pain in adults.
Geriatrics ( > 65 Years of Age)
Healthy elderly subjects aged 65 to 75 years administered Tramadol have plasma concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. Tramadol® should be administered with greater caution in patients older than 75 years, due to the greater potential for adverse events in this population.
Pediatrics ( < 18 Years of Age)
The safety and effectiveness of Tramadol® have not been studied in the pediatric population. Therefore, use of Tramadol® tablets is not recommended in patients under 18 years of age.
How should I use Tramadol?
Use Tramadol orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Tramadol orally disintegrating tablets by mouth with or without food.
- To open the blister pack, peel back the foil on the blister. Do NOT push the tablet through the foil.
- Do NOT chew, break, or split the tablet.
- To take Tramadol orally disintegrating tablets, place the tablet in your mouth. Let it dissolve, and then swallow it with saliva. Tramadol orally disintegrating tablets may be taken with or without water.
- If you miss a dose of Tramadol orally disintegrating tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Tramadol orally disintegrating tablets.
How long does it take for Tramadol to kick in?
You will feel less pain 30 to 60 minutes after taking fast-acting tramadol. The pain relief wears off after 4 to 6 hours. Slow-acting tramadol tablets and capsules can take a day or two to start working but the pain relief will last for longer.
Uses of Tramadol in details
Use: Labeled Indications
Extended release: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Immediate release: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of use: Reserve Tramadol for use in patients for whom alternative treatment options (eg, nonopioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol ER is not indicated as an as-needed analgesic.
Off Label Uses
Data from mostly placebo-controlled clinical trials suggest that Tramadol may be beneficial for the treatment of premature ejaculation.
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Tramadol is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
General Dosing Considerations
Tramadol® is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The capsules must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the capsule could result in the uncontrolled delivery of Tramadol, in overdose and death.
Do not administer Tramadol® at a dose exceeding 300 mg per day. Do not use Tramadol® more than once daily or concomitantly with other Tramadol products.
Patients Not Currently on Tramadol Immediate-Release Products
Initiate treatment with Tramadol® at a dose of 100 mg once daily and titrated up as necessary by 100 mg increments every five days to achieve a balance between relief of pain and tolerability.
Patients Currently on Tramadol Immediate-Release Products
Calculate the 24-hour Tramadol IR dose and initiate a total daily dose of Tramadol® rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Tramadol®, some patients maintained on Tramadol IR products may not be able to convert to Tramadol®.
Patients 65 Years of Age and Older
Initiate dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol® should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
Patients with Renal Impairment
The limited availability of dose strengths and once-daily dosing of Tramadol® do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol® in patients with creatinine clearance less than 30 mL/min.
Patients with Hepatic Impairment
The limited availability of dose strengths and once-daily dosing of Tramadol hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol® in patients with severe hepatic impairment (Child-Pugh Class C).
Discontinuation of Treatment
Withdrawal symptoms may occur if Tramadol® is discontinued abruptly. Clinical experience with Tramadol suggests that withdrawal symptoms may be reduced by tapering Tramadol®.
Tramadol® may be taken without regard to food.
CYP2D6 and CYP3A4 Inhibitors: Concomitant administration of CYP2D6 and/or CYP3A4 inhibitors, such as quinidine, fluoxetine, paroxetine and amitriptyline (CYP2D6 inhibitors), and ketoconazole and erythromycin (CYP3A4 inhibitors), may reduce metabolic clearance of Tramadol increasing the risk for serious adverse events including seizures and serotonin syndrome.
There have been postmarketing reports of serotonin syndrome with use of Tramadol and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when Tramadol is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as SSRIs, MAOIs, triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, or St. John’s Wort. If concomitant treatment of Tramadol with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Based on the mechanism of action of Tramadol and the potential for serotonin syndrome, caution is advised when Tramadol is coadministered with a triptan. If concomitant treatment of Tramadol with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Use With Carbamazepine
Patients taking carbamazepine, a CYP3A4 inducer, may have a significantly reduced analgesic effect of Tramadol. Because carbamazepine increases Tramadol metabolism and because of the seizure risk associated with Tramadol, concomitant administration of Tramadol and carbamazepine is not recommended.
Use With Quinidine
Coadministration of quinidine with Tramadol resulted in a 50-60% increase in Tramadol exposure and a 50-60% decrease in M1 exposure. The clinical consequences of these findings are unknown.
Use With Digoxin and Warfarin
Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times.
Potential for Other Drugs to Affect Tramadol
In vitro drug interaction studies in human liver, microsomes indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of Tramadol.
Administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or inducers, such as rifampin and St. John’s Wort, with Tramadol may affect the metabolism of Tramadol leading to altered Tramadol exposure.
Potential for Tramadol to Affect Other Drugs
In vitro drug interaction studies in human liver, microsomes indicate that Tramadol has no effect on quinidine metabolism. In vitro studies indicate that tramadol is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when administered concomitantly at therapeutic doses. Tramadol is a mild inducer of selected drug metabolism pathways measured in animals.
Tramadol side effects
Adverse Drug Reaction Overview
The most commonly reported adverse reactions are dizziness, nausea, constipation, headache, somnolence and vomiting as presented in Table 1.1.
Clinical Trial Adverse Drug Reactions
Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
Incidence of Adverse Reactions for Tramadol® in Chronic Trials of Non-Malignant Pain (Non-titration Trials)
Tramadol® was administered to 550 patients during the double-blind or open-label extension periods in studies of chronic non-malignant pain. Of these patients, 375 were 65 years old or older. Table 1.1 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. The overall incidence rates of adverse experiences in these trials were similar for Tramadol® and the active control groups, acetaminophen with codeine, and aspirin with codeine; however, the rates of withdrawals due to adverse events appeared to be higher in the Tramadol® group. In the Tramadol treatment groups, 16.8-24.5% of patients withdrew due to an AE, compared to 9.6-11.6% for acetaminophen with codeine and 18.5% for aspirin with codeine.
Table 1.1: Cumulative Incidence of Adverse Reactions for Tramadol® in Chronic Trials of Non-Malignant Pain
Percentage of Patients with Adverse Reaction
N = 427
Up to 7 Days Up to 30 Days Up to 90 Days Dizziness/Vertigo 26% 31% 33% Nausea 24% 34% 40% Constipation 24% 38% 46% Headache 18% 26% 32% Somnolence 16% 23% 25% Vomiting 9% 13% 17% Pruritus 8% 10% 11% “CNS Stimulation” Number of patients with adverse event; numbers shown are all events regardless of relationship to study drug.
Incidence 1% to less than 5% possibly causally related: the following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with Tramadol® exists.
Body as a Whole: Malaise.
Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.
Gastrointestinal: Abdominal pain, Anorexia, Flatulence.
Special Senses: Visual disturbance.
Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention.
Incidence less than 1%, possibly causally related: the following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post-marketing experience.
Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma).
Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.
Central Nervous System: Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure, Tremor.
Skin: Stevens-Johnson syndrome/toxic epidermal necrolysis, Urticaria, Vesicles.
Special Senses: Dysgeusia.
Urogenital: Dysuria, Menstrual disorder.
Other adverse experiences, causal relationship unknown
A variety of other adverse events were reported infrequently in patients taking Tramadol® during clinical trials and/or reported in post-marketing experience. A causal relationship between Tramadol® and these events has not been determined. However, the most significant events are listed below as alerting information to the physician.
Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism.
Central Nervous System: Migraine, Speech disorders.
Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.
Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria.
Sensory: Cataracts, Deafness, Tinnitus.
Other Adverse Experiences Previously Reported in Clinical Trials or Post-Marketing Reports with Tramadol Hydrochloride
Adverse events which have been reported with the use of Tramadol products include allergic reactions (including anaphylaxis, angioneurotic edema and urticaria), bradycardia, convulsions, drug dependence, drug withdrawal (including agitation, anxiety, gastrointestinal symptoms, hyperkinesia, insomnia, nervousness, tremors), hyperactivity, hypoactivity, hypotension, worsening of asthma and respiratory depression. Other adverse events which have been reported with the use of Tramadol products and for which a causal association has not been determined include difficulty concentrating, hepatitis, liver failure, pulmonary edema, Stevens-Johnson syndrome and suicidal tendency.
Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma) has been reported with Tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs. Post-marketing experience with the use of Tramadol-containing products included rare reports of delirium, miosis, mydriasis, and speech disorder, and very rare reports of movement disorder including dyskinesia and dystonia.
Cases of hypoglycemia have been reported in patients taking Tramadol, mostly in patients with pre-disposing risk factors, including diabetes, elderly and renal insufficiency. Caution should be exercised when prescribing Tramadol to diabetic patients. More frequent monitoring of blood glucose levels may be appropriate, including at initiation or dose increase.
Drug Abuse, Addiction, And Dependence
Tramadol may induce psychic and physical dependence of the morphine-type (μ-opioid). Dependence and abuse, including drug-seeking behaviour and taking illicit actions to obtain the drug are not limited to those patients with a prior history of opioid dependence. The risk in patients with substance abuse has been observed to be higher. Tramadol is associated with craving and tolerance development.
A Risk Management program to support the safe and effective use of Tramadol® has been established. The following are considered to be the essential components of the Risk Management program:
- Commitment to not emphasize or highlight the scheduling status of Tramadol® (i.e., not listed under a schedule to the CDSA) in its advertising or promotional activities.
- Inclusion of a PAAB-approved fair balance statement in all Tramadol® advertising and promotional materials.
- Assurance that health-care education activities on pain management with Tramadol® include balanced, evidence-based and current information. Commitment to take reasonable actions to inform health-care professionals that there is Health Canada-approved patient information on benefits and risks, and to ensure that this information can be readily accessed through electronic and/or hard copy sources.
Withdrawal symptoms may occur if Tramadol® is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Other symptoms that have been seen less frequently with Tramadol® discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be relieved by reinstitution of opioid therapy followed by a gradual, tapered dose reduction of the medication combined with symptomatic support.
You should not take Tramadol if you are allergic to it, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide. Do not take Tramadol while you are intoxicated (drunk) or taking any of the following: alcohol or street drugs, narcotic pain medicine, sedatives or tranquilizers, or medicine for depression, anxiety, or mental illness.
Seizures (convulsions) have occurred in some people taking Tramadol. Tramadol may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting.
Seek emergency medical attention if you think you have used too much of this medicine. A Tramadol overdose can be fatal.
Tramadol may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
Do not crush the Tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.
Active ingredient matches for Tramadol:
Unit description / dosage (Manufacturer)Price, USD Capsule; Oral; Tramadol Hydrochloride 50 mg Tablet, Effervescent; Oral; Tramadol Hydrochloride 50 mg Injectable; Injection; Tramadol Hydrochloride 50 mg / ml Tablet; Oral; Tramadol Hydrochloride 50 mg Drops; Oral; Tramadol Hydrochloride Tablet; Oral; Tramadol Hydrochloride Drops; Oral; Tramadol Hydrochloride 100 mg / ml Suppositories; Rectal; Tramadol Hydrochloride 100 mg Suppositories; Rectal; Tramadol Hydrochloride Capsule; Oral; Tramadol Hydrochloride 100 mg Tablet, Extended Release; Oral; Tramadol Hydrochloride 100 mg Tablet, Extended Release; Oral; Tramadol Hydrochloride 200 mg Tablet, Extended Release; Oral; Tramadol Hydrochloride 300 mg Tablet, Orally Disintegrating; Oral; Tramadol Hydrochloride 50 mg Tablet, Film-Coated; Oral; Tramadol Hydrochloride 50 mg Tablet, Retard; Oral; Tramadol Hydrochloride 100 mg Tablet, Retard; Oral; Tramadol Hydrochloride 150 mg Tablet, Retard; Oral; Tramadol Hydrochloride 200 mg Tablet; Oral; Tramadol Hydrochloride 100 mg Capsule; Oral; Tramadol Hydrochloride Solution; Oral; Tramadol Hydrochloride Capsule, Extended Release; Oral; Tramadol Hydrochloride 100 mg Capsule, Extended Release; Oral; Tramadol Hydrochloride 200 mg Capsule, Extended Release; Oral; Tramadol Hydrochloride 300 mg Injectable; Injection; Tramadol Hydrochloride 100 mg / ml Tramadol hcl powder$ 29.08 Ultram ER 300 mg 24 Hour tablet$ 10.66 Ultram er 300 mg tablet$ 10.25 Ultram ER 200 mg 24 Hour tablet$ 7.64 Ultram er 200 mg tablet$ 7.35 TraMADol HCl 200 mg 24 Hour tablet$ 6.25 Ultram ER 100 mg 24 Hour tablet$ 4.62 Ultram er 100 mg tablet$ 4.44 TraMADol HCl 100 mg 24 Hour tablet$ 3.78 Ultram 50 mg tablet$ 1.99 Tramadol-Acetaminophen 37.5-325 mg tablet$ 1.07 Tramadol hcl 50 mg tablet$ 0.70 Tramadol / S.Y. 50 mg/1 mL x 1 mL Tramadol / S.Y. 50 mg/1 mL x 2 mL Tramadol / U. C. Pharma 100 mg Tramadol 100mg INJ / 2ml Tramadol 50 Stada 50 mg x 100’s Tramadol Stada 100 mg/1 mL x 20 mL x 1’s Tramadol Stada 100 mg/2 mL x 1’s Tramadol 100 Stada 100 mg x 10’s Capsules; Oral; Tramadol Hydrochloride 50 mg Tablets, Effervescent; Oral; Tramadol Hydrochloride 50 mg Tablets; Oral; Tramadol Hydrochloride 50 mg Tablets; Oral; Tramadol Hydrochloride Capsules; Oral; Tramadol Hydrochloride 100 mg Tablets, Extended Release; Oral; Tramadol Hydrochloride 100 mg Tablets, Extended Release; Oral; Tramadol Hydrochloride 200 mg Tablets, Extended Release; Oral; Tramadol Hydrochloride 300 mg Tablets, Orally Disintegrating; Oral; Tramadol Hydrochloride 50 mg Tablets, Film-Coated; Oral; Tramadol Hydrochloride 50 mg Tablets, Retard; Oral; Tramadol Hydrochloride 100 mg Tablets, Retard; Oral; Tramadol Hydrochloride 150 mg Tablets, Retard; Oral; Tramadol Hydrochloride 200 mg Tablets; Oral; Tramadol Hydrochloride 100 mg Capsules; Oral; Tramadol Hydrochloride Capsules, Extended Release; Oral; Tramadol Hydrochloride 100 mg Capsules, Extended Release; Oral; Tramadol Hydrochloride 200 mg Capsules, Extended Release; Oral; Tramadol Hydrochloride 300 mg Tramadol 325+50+10 Tablet$ 0.10 Tramadol 325+100+20 Tablet$ 0.17 Tramadol tablet 50 mg/1 (Accord Healthcare, Inc. (US))
List of Tramadol substitutes (brand and generic names):
Tramadog (United Kingdom) Tramadol + Paracetamol Richter (Portugal) Tramadol – 1 A Pharma (Germany) Tramadol – Salutas Pharma (China) Tramadol 100 Slovakofarma (Lithuania) TRAMADOL 100MG INJECTION TRAMADOL 100MG INJECTION 1 vial / 2 ML injection each (Jan Aushadhi)$ 0.10 Tramadol 100mg Rotexmedica (Israel) Tramadol 1A Pharma 100 mg/ml (Austria) Tramadol 1A Pharma 50 mg (Austria) Tramadol 2care4 (Sweden) TRAMADOL 50 Tramadol 50 Slovakofarma (Lithuania) Tramadol 50 Slovakofarma 50 mg x 10’s$ 7.90 Tramadol 50 Stada (Lithuania) Tramadol 50 Stada 50 mg x 50’s Tramadol 50 Stada/Tramadol Stada/Tramadol 100 Stada (Singapore) Tramadol 50 Stada cap 50 mg 50’s (Stada) Tramadol Stada inj 100 mg/2 mL 5’s (Stada) TRAMADOL 50MG INJCTION TRAMADOL 50MG INJCTION 1 vial / 1 ML injection each (Jan Aushadhi)$ 0.09 TRAMADOL 50MG TABLET TRAMADOL 50MG TABLET 1 strip / 10 tablets each (Jan Aushadhi)$ 0.08 Tramadol AA Pharma (Canada) Tramadol AbZ (Germany) Tramadol acis (Germany) Tramadol ACT (Australia) Tramadol Actavis (Czech Republic, Denmark, France, Sweden) Tramadol Actavis 100 mg/ml (Hungary) Tramadol Actavis 50 mg (Hungary) Tramadol Actavis 50 mg/ml (Hungary) Tramadol AL (Bulgaria, Czech Republic, Germany, Hungary, Romania, Slovakia) Tramadol AL 50 mg (Hungary) Tramadol Alkaloid (Bosnia & Herzegowina) Tramadol Alpharma (Lithuania) Tramadol Alpharma ApS (Singapore) Tramadol Alternova (Denmark, Sweden) Tramadol Amdipharm (United Kingdom) Tramadol Amneal (Australia) Tramadol amriya (Egypt) Tramadol Amsa (Mexico) Tramadol AN (Australia) Tramadol AN SR (Australia) Tramadol Angenerico (Spain) Tramadol Apotex (Spain) Tramadol Arena (Romania) Tramadol Aristo (Spain) See 3449 substitutes for Tramadol
Equivalent to Ultram
- PubChem. “Tramadol”. https://pubchem.ncbi.nlm.nih.gov/
- DrugBank. “Tramadol”. http://www.drugbank.ca/
- MeSH. “Narcotics”. https://www.ncbi.nlm.nih.gov
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