Tramadol 100 mg Injection
What is Tramadol 100 mg Injection used for?
Tramadol 100MG INJECTION is a narcotic-like pain reliever.
Tramadol 100MG INJECTION is used to treat moderate to severe pain.
The extended-release form of Tramadol 100MG INJECTION is for around-the-clock treatment of pain. This form of Tramadol 100MG INJECTION is not for use on an as-needed basis for pain.
Tramadol 100MG INJECTION may also be used for purposes not listed in this medication guide.
Tramadol 100MG INJECTION indications
AdultsTramadol 100MG INJECTION® (Tramadol 100MG INJECTION hydrochloride) is indicated to manage moderate to moderately severe pain in adults.
Geriatrics ( > 65 Years of Age)Healthy elderly subjects aged 65 to 75 years administered Tramadol 100MG INJECTION have plasma concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. Tramadol 100MG INJECTION® 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 100MG INJECTION® have not been studied in the pediatric population. Therefore, the use of Tramadol 100MG INJECTION® tablets is not recommended in patients under 18 years of age.
How should I use Tramadol 100MG INJECTION?
Use Tramadol 100MG INJECTION orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Tramadol 100MG INJECTION 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 100MG INJECTION orally disintegrating tablets, place the tablet in your mouth. Let it dissolve, and then swallow it with saliva. Tramadol 100MG INJECTION orally disintegrating tablets may be taken with or without water.
- If you miss a dose of Tramadol 100MG INJECTION 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 using Tramadol 100MG INJECTION orally disintegrating tablets.
Uses of Tramadol 100MG INJECTION in details
Tramadol 100MG INJECTION is a painkiller used to treat moderate to severe pain by acting on certain areas of the brain and the nervous system.
Tramadol 100MG INJECTION description
A synthetic opioid that is used as 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 100MG INJECTION 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)
Tramadol 100MG INJECTION dosage
General Dosing Considerations
Tramadol Injections is an extended-release formulation intended for once a day injecting tramadol 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 100MG INJECTION, in overdose and death.
Do not administer Tramadol 100MG INJECTION® at a dose exceeding 300 mg per day. Do not use Tramadol 100MG INJECTION® more than once daily or concomitantly with other Tramadol 100MG INJECTION products.
Patients Not Currently on Tramadol 100MG INJECTION Immediate-Release Products.
Initiate treatment with Tramadol 100MG INJECTION® 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 100MG INJECTION Immediate-Release Products
Calculate the 24-hour Tramadol 100MG INJECTION IR dose and initiate a total daily dose of Tramadol 100MG INJECTION®, 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 100MG INJECTION®, some patients maintained on Tramadol 100MG INJECTION IR products may not be able to convert to Tramadol 100MG INJECTION®.
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 concomitant disease or other drug therapy. Tramadol 100MG INJECTION® 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 100MG INJECTION® do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol 100MG INJECTION® 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 100MG INJECTION hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol 100MG INJECTION® in patients with severe hepatic impairment (Child-Pugh Class C).
Discontinuation of Treatment
Withdrawal symptoms may occur if Tramadol 100MG INJECTION® is discontinued abruptly. Clinical experience with Tramadol 100MG INJECTION suggests that withdrawal symptoms may be reduced by tapering Tramadol 100MG INJECTION®.
Tramadol 100MG INJECTION® may be taken without regard to food.
Tramadol 100MG INJECTION interactions
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 100MG INJECTION, increasing the risk for serious adverse events including seizures and serotonin syndrome.
Serotonergic DrugsThere has been postmarketing reports of serotonin syndrome using Tramadol 100MG INJECTION and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when Tramadol 100MG INJECTION 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 100MG INJECTION 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.
TriptansBased on the mechanism of action of Tramadol 100MG INJECTION and the potential for serotonin syndrome, caution is advised when Tramadol 100MG INJECTION is coadministered with a triptan. If concomitant treatment of Tramadol 100MG INJECTION with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Use With CarbamazepinePatients taking carbamazepine, a CYP3A4 inducer, may significantly reduce the analgesic effect of Tramadol 100MG INJECTION. Because carbamazepine increases Tramadol 100MG INJECTION metabolism and the seizure risk associated with Tramadol 100MG INJECTION, concomitant administration of Tramadol 100MG INJECTION and carbamazepine is not recommended.
Use With QuinidineCoadministration of quinidine with Tramadol 100MG INJECTION resulted in a 50-60% increase in Tramadol 100MG INJECTION exposure and a 50-60% decrease in M1 exposure. The clinical consequences of these findings are unknown.
Use With Digoxin and WarfarinPost-marketing surveillance of Tramadol 100MG INJECTION has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times.
Potential for Other Drugs to Affect Tramadol 100MG INJECTIONIn vitro drug interaction studies in human liver microsomes indicate concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of Tramadol 100MG INJECTION.
Administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or inducers, such as rifampin and St. John’s Wort, with Tramadol 100MG INJECTION, may affect the metabolism of Tramadol 100MG INJECTION leading to altered Tramadol 100MG INJECTION exposure.
Potential for Tramadol 100MG INJECTION to Affect Other DrugsIn vitro drug interaction studies in human liver microsomes indicate that Tramadol 100MG INJECTION does not affect quinidine metabolism. In vitro studies indicate that Tramadol 100MG INJECTION is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when administered concomitantly at therapeutic doses. Tramadol 100MG INJECTION is a mild inducer of selected drug metabolism pathways measured in animals.
Tramadol 100MG INJECTION side effects
Adverse Drug Reaction OverviewThe most commonly reported adverse reactions are dizziness, nausea, constipation, headache, somnolence, and vomiting, as presented in Table 1.1.
Clinical Trial Adverse Drug ReactionsBecause clinical trials are conducted under particular 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 100MG INJECTION® in Chronic Trials of Non-Malignant Pain (Non-titration Trials)Tramadol 100MG INJECTION® 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 100MG INJECTION® 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 100MG INJECTION® group. In the Tramadol 100MG INJECTION 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 100MG INJECTION® in Chronic Trials of Non-Malignant Pain
Percentage of Patients with Adverse ReactionN = 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 100MG INJECTION® 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 100MG INJECTION® during clinical trials and/or reported in post-marketing experience. A causal relationship between Tramadol 100MG INJECTION® 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 100MG INJECTION HydrochlorideAdverse events which have been reported with the use of Tramadol 100MG INJECTION 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 reported using Tramadol 100MG INJECTION products and a causal association that has not been determined include difficulty concentrating, hepatitis, liver failure, pulmonary edema, Stevens-Johnson syndrome, etc., 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 100MG INJECTION when used concomitantly with other serotonergic agents such as SSRIs and MAOIs. Post-marketing experience using Tramadol 100MG INJECTION-containing products included rare reports of delirium, miosis, mydriasis, speech disorder, and scarce reports of movement disorder dyskinesia and dystonia.
Cases of hypoglycemia have been reported in patients taking Tramadol 100MG INJECTION, mostly in patients with pre-disposing risk factors, including diabetes, elderly and renal insufficiency. Caution should be exercised when prescribing Tramadol 100MG INJECTION to diabetic patients. More frequent monitoring of blood glucose levels may be appropriate, including at initiation or dose increase.
Drug Abuse, Addiction, And DependenceTramadol 100MG INJECTION may induce psychic and physical dependence of the morphine-type (μ-opioid). Dependence and abuse, including drug-seeking behavior 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 100MG INJECTION is associated with craving and tolerance development.
A Risk Management program to support the safe and effective use of Tramadol 100MG INJECTION® 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 100MG INJECTION® (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 100MG INJECTION® advertising and promotional materials.
- Assurance that health-care education activities on pain management with Tramadol 100MG INJECTION® include balanced, evidence-based, and current information. Commitment to take reasonable actions to inform healthcare professionals that Health Canada-approved patient information on benefits and risks and ensure that this information can be readily accessed through electronic and/or hard copy sources.
Withdrawal SymptomsWithdrawal symptoms may occur if Tramadol 100MG INJECTION® 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 100MG INJECTION® 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.
Tramadol 100MG INJECTION contraindications
You should not take Tramadol 100MG INJECTION 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 100MG INJECTION 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 100MG INJECTION. Tramadol 100MG INJECTION may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or taking certain medicines such as antidepressants, muscle relaxers, narcotics, or medicine for nausea and vomiting.
Seek emergency medical attention if you think you have used too much of this medicine. A Tramadol 100MG INJECTION overdose can be fatal.
Tramadol 100MG INJECTION 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 100MG INJECTION 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 100MG INJECTION:
Unit description / dosage (Manufacturer)Price, USD TRAMADOL 100MG INJECTION 1 vial / 2 ML injection each (Jan Aushadhi)$ 0.10
List of Tramadol 100MG INJECTION substitutes (brand and generic names):
Tramadol-Zdorovie (Georgia) Tramadolhydrochlorid Actavis (Austria) Tramadolhydrochlorid Actavis 100 mg (Austria) Tramadolhydrochlorid Actavis 150 mg (Austria) Tramadolhydrochlorid Actavis 200 mg (Austria) Tramadolhydrochloride (Netherlands) Tramadolio 5% Endokrininiai preparatai (Lithuania) Tramadolio EP (Lithuania) Tramadolis Sanitas (Lithuania) Tramadolo ABC (Italy) Tramadolo Actavis (Italy) Tramadolo Angenerico (Italy) Tramadolo Dorom (Italy) Tramadolo EG (Italy) Tramadolo Germed (Italy) Tramadolo HCL Sandoz (Italy) Tramadolo Hexal (Italy) Tramadolo Hexal AG (Italy) Tramadolo Mylan (Italy) Tramadolo Ranbaxy (Italy) Tramadolo Sandoz (Italy) Tramadolo Viatris (Italy) Tramadolor (Austria, Estonia, Germany, Hungary, Latvia, Lithuania, Luxembourg, Romania) Capsule; Oral; Tramadol Hydrochloride 50 mg Injectable; Injection; Tramadol Hydrochloride 50 mg / ml Solution; Oral; Tramadol Hydrochloride Suppositories; Rectal; Tramadol Hydrochloride Tablet; Oral; Tramadol Hydrochloride Capsules; Oral; Tramadol Hydrochloride 50 mg Tablets; Oral; Tramadol Hydrochloride Tramadolor 100 ID (Romania) Tramadolor 100 mg (Austria, Hungary) Tramadolor 100 mg/ml (Austria) Tramadolor 150 mg (Hungary) Tramadolor 200 mg (Hungary) Tramadolor 50 mg (Austria, Hungary) Tramadolor Brause Tablet, Effervescent; Oral; Tramadol Hydrochloride 100 mg Tablet, Effervescent; Oral; Tramadol Hydrochloride 50 mg Tablets, Effervescent; Oral; Tramadol Hydrochloride 100 mg Tablets, Effervescent; Oral; Tramadol Hydrochloride 50 mg Tramadolor ID (Estonia, Latvia) Tablet, Retard; Oral; Tramadol Hydrochloride 100 mg Tablet, Retard; Oral; Tramadol Hydrochloride 150 mg Tablet, Retard; Oral; Tramadol Hydrochloride 200 mg See 3461 substitutes for Tramadol 100MG INJECTION.
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