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Name:Ultram

Generic Name:Tramadol

Shape and Size:Tramadol Capsules are olive and yellow colour capsules imprinted TRM on the capsule cap and 50 on the capsule body, and contain a white powder.

Strength:50 mg,100 mg, 150 mg, 200 mg, and 300 mg strengths.

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Description

Tramadol hydrochloride extended-release capsules (tramadol hydrochloride) capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride.

Indications

Tramadol hydrochloride extended-release capsules is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the clock treatment of their pain for an extended period of time.

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Contraindications

Tramadol hydrochloride extended-release capsules is contraindicated in patients who have previously demonstrated hypersensitivity to tramadol, any other component of tramadol hydrochloride extended-release capsules, or opioids. Reactions range from pruritis to fatal anaphylactoid reactions .
Tramadol hydrochloride extended-release capsules is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment.

Tramadol hydrochloride extended-release capsules is contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the
absence of resuscitative equipment.

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Adverse Effects

Seizure Risk

Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Concomitant use of tramadol increases the seizure risk in patients taking:
• Selective serotonin re uptake inhibitors and serotonin-norepinephrine re uptake inhibitors (SNRIs) antidepressants or anorectics,
• Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.),
• Other opioids,
• MAO inhibitors
• Neuroleptics, or
• Other drugs that reduce the seizure threshold.
Risk of seizures may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).
In tramadol overdose, naloxone administration may increase the risk of seizure.

Suicide Risk

•Do not prescribe tramadol hydrochloride extended-release capsules for patients who are suicidal or addiction-prone. Consideration should be given to the use of non-narcotic analgesics in patients who are suicidal or depressed.
•Prescribe tramadol hydrochloride extended-release capsules with caution for patients with a history of misuse and/or are taking CNS-active drugs including tranquilizers or antidepressant drugs, or alcohol in excess, and patients who suffer from emotional disturbance or depression.
•Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.

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Serotonin Syndrome Risk

The development of a potentially life-threatening serotonin syndrome may occur with use of tramadol products, including tramadol hydrochloride extended-release capsules, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, with drugs which impair metabolism of serotonin (including MAOIs) and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose.

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Anaphylactoid Reactions

Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride extended release capsules.

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Respiratory Depression

Administer tramadol hydrochloride extended-release capsules cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. If large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.

Interaction With Central Nervous System (CNS) Depressants, Including Alcohol and Drugs of Abuse
Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Use tramadol hydrochloride extended-release capsules with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol hydrochloride extended-release capsules increases the risk of CNS and respiratory depression in these patients. Alcohol-containing beverages should not be consumed by patients using tramadol hydrochloride extended release capsules.

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Drug Interactions

Drugs Affecting Seizure Threshold

Concomitant use of tramadol increases the seizure risk in patients taking SSRI/SNRI antidepressants or anorectics, TCA antidepressants and other tricyclic compounds, other opioids, MAOIs, neuroleptics or other drugs that lower the seizure threshold.

CYP2D6 and/or CYP3A4 inhibitors
Tramadol is metabolized by CYP2D6 to form the active metabolite, O-desmethyl tramadol (M1). 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.

Tramadol is also metabolized by CYP3A4 [see Clinical Pharmacology (12.3)]. Administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin with tramadol hydrochloride extended-release capsules may affect the metabolism of tramadol leading to altered tramadol exposure.

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.

Serotonergic Drugs

There have been post-marketing reports of serotonin syndrome with use of tramadol and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when tramadol hydrochloride extended-release capsules is co-administered 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 hydrochloride extended-release capsules 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.

Triptans

Based on the mechanism of action of tramadol and the potential for serotonin syndrome, caution is advised when tramadol hydrochloride extended-release capsules is co-administered with a triptan. If concomitant treatment of tramadol hydrochloride extended-release capsules with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

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Interaction With Central Nervous System (CNS) Depressants

Tramadol hydrochloride extended-release capsules should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol hydrochloride extended-release capsules increases the risk of CNS and respiratory depression in these patients.

Quinidine

Quinidine is a strong inhibitor of CYP2D6. Coadministration of quinidine with an extended-release tramadol product 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. In vitro drug interaction studies in human liver microsomes indicate that tramadol has no effect on quinidine metabolism.

Digoxin and Warfarins

Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times.

CYP3A4 Inducers
Administration of CYP3A4 inducers, such as carbamezepine, rifampin and St. John’s Wort, with tramadol hydrochloride extended-release capsules may affect the metabolism of tramadol leading to reduced tramadol exposure.

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 hydrochloride extended-release capsules and carbamazepine is not recommended.

Pregnancy and Lactation

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Use tramadol hydrochloride extended-release capsules during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing reports with tramadol HCl immediate-release products. Tramadol hydrochloride extended-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Tramadol was not teratogenic at oral dose levels up to 50 mg/kg/day (1.6-fold the maximum daily human dose (MDHD)) in rats and 100 mg/kg (approximately 6.5-fold MDHD) in rabbits during organogenesis. However, embryo-fetal lethality, reductions in fetal weight and skeletal ossification, and increased supernumerary ribs were observed at a maternal toxic dose of 140 mg/kg in mice (approximately 2.3-fold MDHD), 80 mg/kg in rats (2.6-fold MDHD) or 300 mg/kg in rabbits (approximately 19-fold MDHD).

Non-teratogenic Effects

Tramadol caused a reduction in neonatal body weight at a dose of 50 mg/kg (1.6-fold the MDHD) and reduced pup survival at an oral dose of 80 mg/kg (approximately 2.6-fold MDHD) when rats were treated during late gestation throughout lactation period.

Labor and Delivery

Tramadol hydrochloride extended-release capsules should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor.

Nursing Mothers

Tramadol hydrochloride extended-release capsules is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours post-dose was 100 µg of tramadol (0.1% of the maternal dose) and 27 µg of M1. It is not known whether this drug is excreted in human milk following an oral dose.

Pediatric Use

The safety and efficacy of tramadol hydrochloride extended-release capsules in patients under 18 years of age have not been established. The use of tramadol hydrochloride extended-release capsules in the pediatric population is not recommended.

Geriatric Use

In general, caution should be used when selecting the dose for an elderly patient. Usually, dose administration should start 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.

Eight hundred and twelve elderly (65 years of age or older) subjects were exposed to tramadol hydrochloride extended-release capsules in clinical trials. Of those subjects, two hundred and forty were 75 years of age and older. In general, higher incidence rates of adverse events were observed for patients older than 65 years of age compared with patients 65 years and younger, particularly for the following adverse events: nausea, constipation, somnolence, dizziness, dry mouth, vomiting, asthenia, pruritus, anorexia sweating, fatigue, weakness, postural hypotension and dyspepsia. For this reason, tramadol hydrochloride extended-release capsules should be used with great caution in patients older than 75 years of age.

 

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