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Ultram ER
Overview
What is Ultram ER?
ULTRAM ER (tramadol hydrochloride) is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
The molecular weight of tramadol HCl is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7.
ULTRAM ER tablets contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, polyvinyl alcohol, polyvinyl pyrrolidone, and sodium stearyl fumarate.
What does Ultram ER look like?
What are the available doses of Ultram ER?
Extended-release tablets are available as:
100 mg tablets: Round, convex, white to off-white, non-scored, imprinted with “100” over “ER” on one side in black ink
200 mg tablets: Round, convex, white to off-white, non-scored, imprinted with “200” over “ER” on one side in black ink
300 mg tablets: Round, convex, white to off-white, non-scored, imprinted with “300” over “ER” on one side in black ink
What should I talk to my health care provider before I take Ultram ER?
How should I use Ultram ER?
ULTRAM ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
ULTRAM ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
What interacts with Ultram ER?
Sorry No Records found
What are the warnings of Ultram ER?
Sorry No Records found
What are the precautions of Ultram ER?
Sorry No Records found
What are the side effects of Ultram ER?
Sorry No records found
What should I look out for while using Ultram ER?
• all children younger than 12 years of age
• post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
ULTRAM ER is also contraindicated in patients with:
What might happen if I take too much Ultram ER?
Clinical Presentation
Acute overdosage with ULTRAM ER can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations .
Treatment of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to tramadol overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to tramadol overdose.
While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals, convulsions following the administration of toxic doses of ULTRAM ER could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice.
Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.
Because the duration of opioid reversal is expected to be less than the duration of action of tramadol in ULTRAM ER, carefully monitor the patient until spontaneous respiration is reliably reestablished. ULTRAM ER will continue to release tramadol and add to the tramadol load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle Ultram ER?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].ULTRAM ER (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms: 100 mg tablets (round, convex, white to off-white, non-scored) imprinted with “100” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0653-30200 mg tablets (round, convex, white to off-white, non-scored) imprinted with “200” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0655-30300 mg tablets (round, convex, white to off-white, non-scored) imprinted with “300” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0657-30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature]. ULTRAM ER (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms: 100 mg tablets (round, convex, white to off-white, non-scored) imprinted with “100” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0653-30200 mg tablets (round, convex, white to off-white, non-scored) imprinted with “200” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0655-30300 mg tablets (round, convex, white to off-white, non-scored) imprinted with “300” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0657-30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature]. ULTRAM ER (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms: 100 mg tablets (round, convex, white to off-white, non-scored) imprinted with “100” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0653-30200 mg tablets (round, convex, white to off-white, non-scored) imprinted with “200” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0655-30300 mg tablets (round, convex, white to off-white, non-scored) imprinted with “300” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0657-30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature]. ULTRAM ER (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms: 100 mg tablets (round, convex, white to off-white, non-scored) imprinted with “100” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0653-30200 mg tablets (round, convex, white to off-white, non-scored) imprinted with “200” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0655-30300 mg tablets (round, convex, white to off-white, non-scored) imprinted with “300” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0657-30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature]. ULTRAM ER (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms: 100 mg tablets (round, convex, white to off-white, non-scored) imprinted with “100” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0653-30200 mg tablets (round, convex, white to off-white, non-scored) imprinted with “200” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0655-30300 mg tablets (round, convex, white to off-white, non-scored) imprinted with “300” over “ER” on one side in black inkBottle of 30 tablets – NDC 50458-0657-30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ULTRAM ER contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin. Although the mode of action of tramadol is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin.
Opioid activity of tramadol is due to both low affinity binding of the parent compound and higher affinity binding of the O‑desmethyl metabolite M1 to µ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in µ‑opioid binding. Tramadol-induced analgesia is only partially antagonized by the opioid antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound.
Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin , as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of tramadol.
Apart from analgesia, tramadol administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, tramadol has no effect on heart rate, left-ventricular function, or cardiac index. Orthostatic hypotension has been observed.
Non-Clinical Toxicology
• all children younger than 12 years of age• post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
ULTRAM ER is also contraindicated in patients with:
The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.
ULTRAM ER contains tramadol, a Schedule IV controlled substance. As an opioid, ULTRAM ER exposes users to the risks of addiction, abuse, and misuse. Because extended-release products such as ULTRAM ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of tramadol present
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed ULTRAM ER. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing ULTRAM ER, and monitor all patients receiving ULTRAM ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as ULTRAM ER, but use in such patients necessitates intensive counseling about the risks and proper use of ULTRAM ER along with intensive monitoring for signs of addiction, abuse, and misuse.
Abuse or misuse of ULTRAM ER by cutting, breaking, chewing, crushing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of tramadol and can result in overdose and death
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing ULTRAM ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions are described in greater detail, in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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