Apparently, I've been jealous of the collection of hospital bracelets everyone in my household has been getting in the last month, so last night I decided to get one of my own. During my Naranon meeting, I was having a weird pain in my lower back that was so intense at times that it was making me vomit. I ended up having a friend bring me to the hospital, where I was diagnosed with a 6 mm kidney stone. They say that that is really large, and it's unlikely that I'll be able to pass it on my own. To make things even more fun, I'm allergic to sulfa drugs, which means I can't take the medicine that would help my urinary tract. Sigh.
I'm proud of myself for speaking up and not suffering in silence, and for going straight to the hospital. (Of course, my original plan was to wait out the meeting and then go home if I was feeling ok.) But I did ask for and accept help.
I'm grateful that my partner is in a good place. She was really present and supportive. I'm a bit nervous about having narcotics in my house, but I'm trying to turn that over. As my sponsor says, if she ends up relapsing, I can trust that God has plans for more research for her.
Showing posts with label prescription narcotic pain medicine. Show all posts
Showing posts with label prescription narcotic pain medicine. Show all posts
Wednesday, December 10, 2008
Sunday, April 20, 2008
Here we go again
My partner brought up the idea again of going back to our former doctor last night. She's actually being very reasonable and accomodating about it and I'm being certifiably crazy. She said that she's ultimately responsible for her medical decisions and that it's her responsiblity to check out what's being prescribed to make sure it's safe for her. She said that she'd like to go together to see the former doc, and that she'd sign a new release allowing me total access to the doctor. IF I didn't trust her, she said I'd have full permission to check things out with him directly. She said that we'd make an agreement up front that she is not to be prescribed narcotics unless it's a last resort. She said that what happened was her fault, since she lied to the doctor and that we didn't give him a fair chance. She said that she really trusts him and that he's a much better doctor than the one we've been going to lately.
Almost all of what she's saying makes sense logically, but I just get completely crazy over the idea of either of us going back to this man. I feel sooooo betrayed by him. Just the idea of him is traumatizing to me at this point. I don't really get why my feelings are sooooooo big around this, but they clearly are.
Yet again, I'm having this huge war within myself. On the one hand,I feel really hurt that she keeps bringing this option up. Every time I get completely triggered and end up a total mess and she tells me she gets it and promises not to go back to him and not to bring it up again, but then she brings it up again and I completely lose it again. At this point, it feels like she keeps retraumatizing me. But then again, I don't want her to keep what she's thinking and feeling from me.
I don't know. It's late. I'm a mess.
Almost all of what she's saying makes sense logically, but I just get completely crazy over the idea of either of us going back to this man. I feel sooooo betrayed by him. Just the idea of him is traumatizing to me at this point. I don't really get why my feelings are sooooooo big around this, but they clearly are.
Yet again, I'm having this huge war within myself. On the one hand,I feel really hurt that she keeps bringing this option up. Every time I get completely triggered and end up a total mess and she tells me she gets it and promises not to go back to him and not to bring it up again, but then she brings it up again and I completely lose it again. At this point, it feels like she keeps retraumatizing me. But then again, I don't want her to keep what she's thinking and feeling from me.
I don't know. It's late. I'm a mess.
Friday, April 18, 2008
Angry
I'm finding myself angrier and angrier at the doctor who prescribed my partner's latest relapse. My partner holds some resposibility. She took the pills, she didn't double check about whether they were narcotics, she took more than prescribed, and she lied about it. But, on the other hand, my program says that the addict has lost all power of choice once they've taken the first drink, pill, or fix. It makes sense that she didn't take them as prescribed and that she lied about it. And she really did try NOT to put herself in that situation in the first place.
Here's what I've read about Tramadol (not Topomax, as I wrongly said first.)It specifically says not to give it to addicts or people at risk for suicide. Says that overdose can cause death within an hour and that there are withdrawal symptoms. DAMN. DAMN. DAMN!!!!!
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Ultram ER
Warnings & Precautions
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WARNINGS
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 (SSRI antidepressants or anorectics),
Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
Other opioids.
Administration of tramadol may enhance the seizure risk in patients taking:
MAO inhibitors (see also WARNINGS - Use with MAO Inhibitors),
Neuroleptics, or
Other drugs that reduce the seizure threshold.
Risk of convulsions 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 ULTRAM ER for patients who are suicidal or addiction-prone.
Prescribe ULTRAM ER with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.
Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.
Tramadol products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. Tramadol should not be taken in doses higher than those recommended by the physician. The judicious prescribing of tramadol is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of tramadol products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, tramadol should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations.
Many of the tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of tramadol alone or in combination with other drugs. Patients taking tramadol should be warned not to exceed the dose recommended by their physician.
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 ULTRAM ER (see CONTRAINDICATIONS).
Respiratory Depression
Administer ULTRAM ER cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. When 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 (see WARNINGS Seizure Risk and OVERDOSE).
Interaction With Central Nervous System (CNS) Depressants
ULTRAM ER should be used 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. ULTRAM ER increases the risk of CNS and respiratory depression in these patients.
Increased Intracranial Pressure or Head Trauma
ULTRAM ER should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving ULTRAM ER. (See WARNINGS - Respiratory Depression.)
Use in Ambulatory Patients
ULTRAM ER may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.
Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors
Use ULTRAM ER with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of ULTRAM ER with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome.
Withdrawal
Withdrawal symptoms may occur if ULTRAM ER 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 ULTRAM ER.
Misuse, Abuse and Diversion of Opioids
Tramadol is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
Tramadol can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ULTRAM ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
ULTRAM ER 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).
Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.
Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Interactions with 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.
Drug Abuse And Addiction
ULTRAM® ER is a mu-agonist opioid. Tramadol, like other opioids used in analgesia, can be abused and is subject to criminal diversion.
Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.
“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
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. ULTRAM ER, 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.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
ULTRAM ER is intended for oral use only. The crushed tablet poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. With parenteral abuse, the tablet excipients can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Risk of Overdosage
Serious potential consequences of overdosage with ULTRAM ER are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (see OVERDOSE).
Use in Renal and Hepatic Disease
Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. ULTRAM ER has not been studied in patients with severe renal impairment (CLcr < 30 mL/min). The limited availability of dose strengths and once daily dosing of ULTRAM ER do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Therefore, ULTRAM ER should not be used in patients with severe renal impairment (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. The pharmacokinetics of ULTRAM ER has not been studied in patients with severe hepatic impairment. The limited availability of dose strengths and once daily dosing of ULTRAM ER do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Therefore, ULTRAM ER should not be used in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
PRECAUTIONS
Acute Abdominal Condition
The administration of ULTRAM ER may complicate the clinical assessment of patients with acute abdominal conditions.
Use in Drug and Alcohol Addiction
ULTRAM ER is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.
Carcinogenesis, Mutagenesis,Impairment Of Fertility
No carcinogenic effect of tramadol was observed in p53(+/–)-heterozygous mice at oral doses up to 150 mg/kg/day (approximately 2-fold maximum daily human dose [MDHD] of 400 mg/day for a 60 kg adult based on body surface conversion) for 26 weeks and in rats at oral doses up to 75 mg/kg/day for males and 100 mg/kg/day for females (approximately 2-fold MDHD) for two years. However, the excessive decrease in body weight gain observed in the rat study might have reduced their sensitivity to any potential carcinogenic effect of the drug.
Tramadol was not mutagenic in the following assays: a bacterial reverse mutation assay using Salmonella and E. coli, a mouse lymphoma assay (in the absence of metabolic activation), and a bone marrow micronucleus test in mice. Mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans.
No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg/day in male and female rats (approximately equivalent to MDHD).
Pregnancy
Teratogenic Effects: Pregnancy Category C
Tramadol was not teratogenic at oral dose levels up to 50 mg/kg/day (approximately equivalent to MDHD) in rats and 100 mg/kg (approximately 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-fold MDHD), 80 mg/kg in rats (2-fold MDHD) or 300 mg/kg in rabbits (approximately 15-fold MDHD).
Non-teratogenic Effects
Tramadol caused a reduction in neonatal body weight and survival at an oral dose of 80 mg/kg (approximately 2-fold MDHD) when rats were treated during late gestation throughout lactation period.
There are no adequate and well-controlled studies in pregnant women. ULTRAM ER should be used 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.
Labor and Delivery
ULTRAM ER 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 (see Drug Abuse And Addiction). 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 treated with tramadol HCl during labor.
The effect of ULTRAM ER, if any, on the later growth, development, and functional maturation of the child is unknown.
Nursing Mothers
ULTRAM ER 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 sixteen hours postdose was 100 µg of tramadol (0.1% of the maternal dose) and 27 µg of M1.
Pediatric Use
The safety and efficacy of ULTRAM ER in patients under 18 years of age have not been established. The use of ULTRAM ER in the pediatric population is not recommended.
Geriatric Use
Nine-hundred-one elderly (65 years of age or older) subjects were exposed to ULTRAM ER in clinical trials. Of those subjects, 156 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: constipation, fatigue, weakness, postural hypotension and dyspepsia. For this reason, ULTRAM ER should be used with great caution in patients older than 75 years of age (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Brand Name: Ultram ER
Generic Name: Tramadol HCl Extended-Release
Next: Ultram ER - Overdosage & Contraindications »
« Previous: Ultram ER - Side Effects & Drug Interactions
Here's what I've read about Tramadol (not Topomax, as I wrongly said first.)It specifically says not to give it to addicts or people at risk for suicide. Says that overdose can cause death within an hour and that there are withdrawal symptoms. DAMN. DAMN. DAMN!!!!!
1
2
3
4
5
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next »
Ultram ER
Warnings & Precautions
font size
A
A
A
WARNINGS
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 (SSRI antidepressants or anorectics),
Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
Other opioids.
Administration of tramadol may enhance the seizure risk in patients taking:
MAO inhibitors (see also WARNINGS - Use with MAO Inhibitors),
Neuroleptics, or
Other drugs that reduce the seizure threshold.
Risk of convulsions 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 ULTRAM ER for patients who are suicidal or addiction-prone.
Prescribe ULTRAM ER with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.
Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.
Tramadol products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. Tramadol should not be taken in doses higher than those recommended by the physician. The judicious prescribing of tramadol is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of tramadol products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, tramadol should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations.
Many of the tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of tramadol alone or in combination with other drugs. Patients taking tramadol should be warned not to exceed the dose recommended by their physician.
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 ULTRAM ER (see CONTRAINDICATIONS).
Respiratory Depression
Administer ULTRAM ER cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. When 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 (see WARNINGS Seizure Risk and OVERDOSE).
Interaction With Central Nervous System (CNS) Depressants
ULTRAM ER should be used 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. ULTRAM ER increases the risk of CNS and respiratory depression in these patients.
Increased Intracranial Pressure or Head Trauma
ULTRAM ER should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving ULTRAM ER. (See WARNINGS - Respiratory Depression.)
Use in Ambulatory Patients
ULTRAM ER may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.
Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors
Use ULTRAM ER with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of ULTRAM ER with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome.
Withdrawal
Withdrawal symptoms may occur if ULTRAM ER 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 ULTRAM ER.
Misuse, Abuse and Diversion of Opioids
Tramadol is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
Tramadol can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ULTRAM ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
ULTRAM ER 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).
Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.
Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Interactions with 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.
Drug Abuse And Addiction
ULTRAM® ER is a mu-agonist opioid. Tramadol, like other opioids used in analgesia, can be abused and is subject to criminal diversion.
Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.
“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
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. ULTRAM ER, 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.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
ULTRAM ER is intended for oral use only. The crushed tablet poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. With parenteral abuse, the tablet excipients can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Risk of Overdosage
Serious potential consequences of overdosage with ULTRAM ER are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (see OVERDOSE).
Use in Renal and Hepatic Disease
Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. ULTRAM ER has not been studied in patients with severe renal impairment (CLcr < 30 mL/min). The limited availability of dose strengths and once daily dosing of ULTRAM ER do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Therefore, ULTRAM ER should not be used in patients with severe renal impairment (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. The pharmacokinetics of ULTRAM ER has not been studied in patients with severe hepatic impairment. The limited availability of dose strengths and once daily dosing of ULTRAM ER do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Therefore, ULTRAM ER should not be used in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
PRECAUTIONS
Acute Abdominal Condition
The administration of ULTRAM ER may complicate the clinical assessment of patients with acute abdominal conditions.
Use in Drug and Alcohol Addiction
ULTRAM ER is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.
Carcinogenesis, Mutagenesis,Impairment Of Fertility
No carcinogenic effect of tramadol was observed in p53(+/–)-heterozygous mice at oral doses up to 150 mg/kg/day (approximately 2-fold maximum daily human dose [MDHD] of 400 mg/day for a 60 kg adult based on body surface conversion) for 26 weeks and in rats at oral doses up to 75 mg/kg/day for males and 100 mg/kg/day for females (approximately 2-fold MDHD) for two years. However, the excessive decrease in body weight gain observed in the rat study might have reduced their sensitivity to any potential carcinogenic effect of the drug.
Tramadol was not mutagenic in the following assays: a bacterial reverse mutation assay using Salmonella and E. coli, a mouse lymphoma assay (in the absence of metabolic activation), and a bone marrow micronucleus test in mice. Mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans.
No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg/day in male and female rats (approximately equivalent to MDHD).
Pregnancy
Teratogenic Effects: Pregnancy Category C
Tramadol was not teratogenic at oral dose levels up to 50 mg/kg/day (approximately equivalent to MDHD) in rats and 100 mg/kg (approximately 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-fold MDHD), 80 mg/kg in rats (2-fold MDHD) or 300 mg/kg in rabbits (approximately 15-fold MDHD).
Non-teratogenic Effects
Tramadol caused a reduction in neonatal body weight and survival at an oral dose of 80 mg/kg (approximately 2-fold MDHD) when rats were treated during late gestation throughout lactation period.
There are no adequate and well-controlled studies in pregnant women. ULTRAM ER should be used 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.
Labor and Delivery
ULTRAM ER 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 (see Drug Abuse And Addiction). 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 treated with tramadol HCl during labor.
The effect of ULTRAM ER, if any, on the later growth, development, and functional maturation of the child is unknown.
Nursing Mothers
ULTRAM ER 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 sixteen hours postdose was 100 µg of tramadol (0.1% of the maternal dose) and 27 µg of M1.
Pediatric Use
The safety and efficacy of ULTRAM ER in patients under 18 years of age have not been established. The use of ULTRAM ER in the pediatric population is not recommended.
Geriatric Use
Nine-hundred-one elderly (65 years of age or older) subjects were exposed to ULTRAM ER in clinical trials. Of those subjects, 156 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: constipation, fatigue, weakness, postural hypotension and dyspepsia. For this reason, ULTRAM ER should be used with great caution in patients older than 75 years of age (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Brand Name: Ultram ER
Generic Name: Tramadol HCl Extended-Release
Next: Ultram ER - Overdosage & Contraindications »
« Previous: Ultram ER - Side Effects & Drug Interactions
Wednesday, September 5, 2007
More Will Be Revealed
Thanks, Scout, for looking out for both me and my partner! I agreed to hold the pills for her, and she decided how much and when to get them. I did my best to stay on my side of the street. She did her best to be open with me about what she was feeling, and to use the medication to alleviate pain but not to get high. I'm really proud of both of us.
We travelled this weekend. That involved trying to find meetings on the road, since she's doing 90 in 90. We tried to hit meetings on the road on the way to and from our destination, but didn't connect with either one. We did find a couple of meetings and attended them together while we were at our destination. On Monday, when the last meeting we tried to find on the road didn't exist, we decided to have our own meeting in the van on the way home. It was a powerful experience.
It's funny. When I first suggested that we could have our own meeting, she said that we'd been having one for hours in the car. It's true that we had been reading and sharing before our official meeting. I had asked her to read to me from her Step Study book to help me prepare to lead last night's Naranon meeting on the 9th step. Then, she wanted to work on her 2nd step, and read the text to me, and then wrote her own answers to the questions privately. I was especially proud of me when she asked for input on one of her questions. She asked me to give her some examples of her behavior, and I instead gave her examples of my own behavior instead of taking her inventory. Yay me!!
Anyway, I told her that we had been sharing about the program, but that if we wanted to do our own meeting, I'd rather follow the suggested format- do the readings and not cross talk. We read the opening literature for both of our meetings, and then read and shared on "more will be revealed" in the NA literature. She did all the reading since I was driving, but we took turns sharing. It was really powerful, I think for both of us.
One thing I came to realize as we were sharing about "more will be revealed" is that more was being revealed for both of us as we moved along in our recovery journey, and interestingly, a lot of it has been around tooth pain. When she first told me about her addiction, the thought of having any kind of narcotics in the house really frightened me. Early in recovery, I shared in my meeting that I had pain and a prescription, but that I hadn't filled it because I was afraid of having the stuff in the house. My naranon friends encouraged me to take care of me and to fill the scrip. I did, but didn't tell her. Weeks later, I was struggling with MY dishonesty of hiding the medicine in the house and obsessing about her having found it and used it. So, we processed through it together and came up with a plan we both thought would work. I got a locked container and put the meds in it. Weeks after that, in a really courageous and honest share, she told me that she had been able to open the container and get to the meds. She hadn't taken them, but she was obsessing about them being there, and her having access. We decided to give the bottle to a friend.
Then came my need for a wisdom tooth to be pulled, which meant narcotics AND my not being in a place to be able to monitor them myself. We came up with another plan. This time, we gave the pills to a neighbor, and just got what I needed at the time. That worked pretty well. All along, though, I've been terrified (actually I think we both have been) about her having significant pain and being prescribed narcotics.
Well, that time came this weekend, and we got through it together. So, more has been revealed to each of us, as we've worked this program. I could not have imagined, even a couple of weeks ago, us both being ok and her using prescription narcotics as prescribed. But, we got through it. Today, she had her root canal. I'm hoping this part of the journey is over. But, if it's not, and her using the meds prompts another relapse, maybe, just maybe, we'll both still be ok.
We travelled this weekend. That involved trying to find meetings on the road, since she's doing 90 in 90. We tried to hit meetings on the road on the way to and from our destination, but didn't connect with either one. We did find a couple of meetings and attended them together while we were at our destination. On Monday, when the last meeting we tried to find on the road didn't exist, we decided to have our own meeting in the van on the way home. It was a powerful experience.
It's funny. When I first suggested that we could have our own meeting, she said that we'd been having one for hours in the car. It's true that we had been reading and sharing before our official meeting. I had asked her to read to me from her Step Study book to help me prepare to lead last night's Naranon meeting on the 9th step. Then, she wanted to work on her 2nd step, and read the text to me, and then wrote her own answers to the questions privately. I was especially proud of me when she asked for input on one of her questions. She asked me to give her some examples of her behavior, and I instead gave her examples of my own behavior instead of taking her inventory. Yay me!!
Anyway, I told her that we had been sharing about the program, but that if we wanted to do our own meeting, I'd rather follow the suggested format- do the readings and not cross talk. We read the opening literature for both of our meetings, and then read and shared on "more will be revealed" in the NA literature. She did all the reading since I was driving, but we took turns sharing. It was really powerful, I think for both of us.
One thing I came to realize as we were sharing about "more will be revealed" is that more was being revealed for both of us as we moved along in our recovery journey, and interestingly, a lot of it has been around tooth pain. When she first told me about her addiction, the thought of having any kind of narcotics in the house really frightened me. Early in recovery, I shared in my meeting that I had pain and a prescription, but that I hadn't filled it because I was afraid of having the stuff in the house. My naranon friends encouraged me to take care of me and to fill the scrip. I did, but didn't tell her. Weeks later, I was struggling with MY dishonesty of hiding the medicine in the house and obsessing about her having found it and used it. So, we processed through it together and came up with a plan we both thought would work. I got a locked container and put the meds in it. Weeks after that, in a really courageous and honest share, she told me that she had been able to open the container and get to the meds. She hadn't taken them, but she was obsessing about them being there, and her having access. We decided to give the bottle to a friend.
Then came my need for a wisdom tooth to be pulled, which meant narcotics AND my not being in a place to be able to monitor them myself. We came up with another plan. This time, we gave the pills to a neighbor, and just got what I needed at the time. That worked pretty well. All along, though, I've been terrified (actually I think we both have been) about her having significant pain and being prescribed narcotics.
Well, that time came this weekend, and we got through it together. So, more has been revealed to each of us, as we've worked this program. I could not have imagined, even a couple of weeks ago, us both being ok and her using prescription narcotics as prescribed. But, we got through it. Today, she had her root canal. I'm hoping this part of the journey is over. But, if it's not, and her using the meds prompts another relapse, maybe, just maybe, we'll both still be ok.
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