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For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, ULTRAM® 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day. Use in Renal Impairment For patients maintained on tramadol IR products, calculate the 24-hour tramadol IR dose and initiate a total daily dose of Betram 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 Betram, some patients maintained on tramadol IR products may not be able to convert to Betram. Betram should not be administered at a dose exceeding 300 mg per day. The concomitant use of Betram with other tramadol products is not recommended (see WARNINGS). Individualization Of Dose
Betram SR has not been studied in children. The safety and efficacy of Betram SR has not been established and the product should not be used in children.Serious and rarely, fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol. When these rare reactions 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 ULTRAM® tablets (see CONTRAINDICATIONS). Drug Abuse, Addiction And Dependence If ULTRAM® is used as rescue medication in conjunction with extended-release tramadol tablets, the total daily dose of tramadol should not exceed 400 mg. Fentanyl products should not be used as rescue medication in patients taking ULTRAM®. Missed Dose
Betram could be abused by crushing, chewing, snorting, or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death (see WARNINGS and Drug Abuse And Addiction). Convulsions have been reported in patients receiving Betram at the recommended dose levels. The risk may be increased when doses of Betram hydrochloride exceed the recommended upper daily dose limit (400 mg). In addition, Betram may increase the seizure risk in patients taking other medicinal products that lowers the seizure threshold. Patients with epilepsy or those susceptible to seizures should only be treated with Betram if there are compelling circumstances. ULTRAM® is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. ULTRAM® may worsen central nervous system and respiratory depression in these patients.Ramsay was in overall command of Operation Neptune, the unimaginably complex naval and landing operations of D-Day, as more than 4,000 ships and landing craft, nearly 200,000 men and thousands of aircraft took part in the first wave of Normandy landings.
Withdrawal symptoms may occur if Betram is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Clinical experience suggests that withdrawal symptoms may be reduced by tapering Betram. Misuse, Abuse And Diversion Of OpioidsThe safety and efficacy of Betram in patients under 18 years of age have not been established. The use of Betram in the pediatric population is not recommended. Geriatric Use Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Betram, like other opioids, may be diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
