Author: Alex Thompson

Ultram Uses, Dosage & Side Effects

Tramadol can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. ULTRAM has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving ULTRAM.

See also Warning section.This medication is used to help relieve moderate to moderately severe pain. Tramadol belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed ULTRAM.

The analgesic activity of ULTRAM is due to both parent drug and the M1 metabolite [see CLINICAL PHARMACOLOGY]. Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation. Linear pharmacokinetics have been observed following multiple doses of 50 and 100 mg to steady-state. The effect of oral tramadol on the QTcF interval was evaluated in a double-blind, randomized, four-way crossover, placebo-and positive- (moxifloxacin) controlled study in 68 adult male and female healthy subjects. At a 600 mg/day dose (1.5-foldthe maximum immediate-release daily dose), the study demonstrated no significant effect on the QTcF interval.

1. Call your healthcare provider if you have any of these symptoms and they are severe.
2. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed ULTRAM.
3. Just one dose can cause death in someone using it accidentally or improperly.
4. Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center (where available) to determine the latest recommendations for the management of an overdose.
5. Furthermore, around 71% of people in emergency rooms from tramadol-related complications say they used the drug with other sedatives and painkillers.

An opioidantagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. However, this effect is not consistent andmay be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioidanalgesics during labor for signs of excess sedation and respiratory depression. Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with ULTRAM. Do not abruptly discontinue ULTRAM in a patient physically dependent on opioids. When discontinuing ULTRAM in aphysically dependent patient, gradually taper the dosage.

Ultram overdose has the potential to be fatal if not addressed immediately. If you’re ever with someone exhibiting signs of Tramadol overdose, call 911 directly and seek emergency medical attention. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include Micromedex (updated 3 Mar 2024), Cerner Multum™ (updated 4 Mar 2024), ASHP (updated 12 Feb 2024) and others.

More About Drugs and Medications

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response.

This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription. There’s a limit to the number of refills you can get for this prescription. You or your pharmacy may have to contact your doctor for a new prescription if you need this medication refilled. Your doctor will write the number of refills authorized on your prescription.

Indications and Usage for Ultram

ULTRAM ®(tramadol hydrochloride) 50 mg tablets are white, capsule-shaped, coated, with a functional score. The tablets are imprinted “ULTRAM” on one side and “06 59” on the scored side. ULTRAM (tramadol hydrochloride) 50 mg (equivalent to 43.9 mg of tramadol) tablets are white, capsule-shaped, coated, with a functional score. Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available. Talk with your doctor about other drug options that may work for you. Many insurance companies require a prior authorization for certain forms or brands of this drug.

Although it is an opioid agonist, it has not been classified as a scheduled substance. According to the US Food and Drug Administration’s postmarketing surveillance, the rate of addiction was 1 in 100,000 during the last 18 months period of supervision. Tramadol dependence is very rare but can happen in a patient without a substance abuse history. Never use Ultram in larger amounts, or for longer than prescribed.

In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of ULTRAM beincreased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

9 Increased Risk of Seizure

A class of drugs is a group of medications that work in a similar way. This means it can only be used with a doctor’s close supervision. These types of drugs require a doctor’s close supervision based on their medical use in treatment, potential for misuse, and potential for dependence if misused.

The volume of distribution of tramadol was 2.6 and 2.9 liters/kg in male and female subjects, respectively, following a 100mg intravenous dose. The binding of tramadol to human plasma proteins is approximately 20% and binding also appears tobe independent of concentration up to 10 mcg/mL. Saturation of plasma protein binding occurs only at concentrations outside the clinically relevant range.

The concomitant use of ULTRAM with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in tramadol plasma levels and a decrease in the levels of the active metabolite, M1. A decrease in M1 exposure inpatients who have developed physical dependence to tramadol, may result in signs and symptoms of opioid withdrawal andreduced efficacy. The effect of increased tramadol levels may be an increased risk for serious adverse events including seizures and serotonin syndrome. A decrease in M1 exposure in patients who have developed physical dependence to tramadol, may result in signs and symptoms of opioid withdrawal and reduced efficacy. Tramadol and its metabolite, O-desmethyltramadol (M1), are present in human milk. There is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production.

Drug Interactions

The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see ADVERSE REACTIONS]. Inform patients that anaphylaxis has been reported with ingredients contained in ULTRAM. Advise patients how torecognize such a reaction and when to seek medical attention [see CONTRAINDICATIONS; WARNINGS AND PRECAUTIONS; ADVERSE REACTIONS]. Inform patients that ULTRAM may cause orthostatic hypotension and syncope.

For this reason, breastfeeding is notrecommended during treatment with ULTRAM [see Use In Specific Populations]. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence]. Individually titrate ULTRAM to a dose that provides adequate analgesia and minimizes adverse reactions. Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants,a history of opioid use disorder, or prior opioid overdose. However, the presence of risk factors for overdose should notprevent the proper management of pain in any given patient [see WARNINGS AND PRECAUTIONS].