Part of my Artist Way class involves writing morning pages- 3 pages of free writing in the mornings. I'm supposed to hand write it, and being the rule-bound person I can be, I'm sticking to that, at least for now. It's been meaning that I've put less energy into writing here. But today, I think I'll copy what I wrote. It's a lesson I keep learning and relearning. For this moment, I think I've got it. Maybe if I put it here, I can at least reference it. Anyway, here are today's morning pages:
Here's my discovery of the moment. I AM being controlling, even though it's not my intention.
I wanted A to not go to Dr. P. It makes sense to me that I would have big feelings about this. And I'm relieved that she made the decision that she did. But it ain't up to me. What is up to me is what I do to take care of myself. My actions are my choice. Like, I could choose to turn him in to the medical board. Or I could choose to detach myself completely from her medical stuff. Or I could chose to end the relationship if it's just too painful for me. I do have choices, and sometimes they're really yucky choices. But what she decides to do is really not my choice.
So, it's the same with not going to work. It's just not my choice whether she goes to work or not.
My feelings are valid and real. I get triggered when she doesn't go to work. It makes sense to me that I'd get triggered. It's a loss of income for me. It also reminds me of really yucky times and it's often a precurser to more yucks. There's also usually much more to the story- omission- which is another trigger for me, b/c it makes it hard to trust.
I am completely powerless over her choices about whether to go to work or not. I've been trying to control this choice, and it's just not mine. I can't get her up and get her to work and keep her there all day. I can't get inside her body and determine what's really going on.
But I do have choices. I can go on with my life and find ways to fill it. I can separate finances if the money thing becomes too intolerable for me. And again, if she continues to make choices that are too damaging for me, I could choose to end the relationship. I can release her with love and hope that she and her higher power get things under control before they become too much for me. I can put the focus back on me. How am I feeling? What do I need to do to take really good care of myself? What I don't need to do is keep trying to manipulate her into changing. It just doesn't work. It's time to stop trying to fix her and start trying to take care of me.
Saturday, April 26, 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!!!!!
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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
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Tuesday, April 15, 2008
Relapse?
About a month ago, my partner went to our doctor complaining of headaches, and the doc asked if she needed her to prescribe something for the pain. She refused, and told me about it later. She said she was surprised that the doc would suggest pain meds when she knows that's her drug of choice.
Then, Friday, she went back to the doctor with chest pains. I asked her to ask the doc about the last incident, and she did. The doctor told her that she would have prescribed a non-narcotic. THEN, the doctor offered to write her a scrip for the chest pain, which is apparently the result of an enlarged chest cavity, but NOT heart related. She went home with a prescription for Topomax.
That night, I went researching Topomax, and found out that it's an Opiod, which is the same thing as the Suboxone she had such a hard time coming off of. What I read said that it works the same way and that it can be addictive. So, of course, I started obsessing. I told her what my concerns were, like the difficulty she'd had coming off of her last opiod and the possiblity that taking this would "wake her tiger", and then I really let it go.
Today, she left work early to go home for her pain pills, and then was going to drive to therapy. I asked if she was supposed to drive while taking them. She said that she was supposed to wait to see how they affected her before driving. I told her that impaired people usually don't realize that they're impaired and she decided to go home.
I went to our couple appointment alone. The therapist was concerned about her having the prescription, and suggested that I hold the medication for her and suggest that she talk to her sponsor and her other therapist, who works in drug treatment. He also told me to ask her to count the pills with me. When I told her what the therapist said, she first said that his advice was bad for me because it was feeding my codependency. Then she told me that she has taken more than the prescribed dosage for the last 3 days, by taking 3 pills in the morning instead of 2. She said that she might as well go out and drink, b/c she was gonna have to pick up a white chip. She went through all kinds of rationalization with herself about whether or not it was a relapse, and told me that she knew she was rationalizing. I mostly just let her talk and reflected back for her.
She told me that she would talk to her sponsor, but that she wasn't willing to let me hold the pills. I told her that I'd need to talk to my sponsor and figure out what I needed to do to take care of myself, but that probably I'd find somewhere else to spend the night if she wanted to keep the pills and I'd see her tomorrow. I told her that I could live with one of 3 options- either I'd hold the pills for her and we could talk to her therapist tomorrow or she could call the therapist tonight or I'd find somewhere else to stay the night and she could keep the pills.
The confusing part for me is that she's actually right. Me being involved in her pills is a dangerous place for me to be with MY disease. But the therapist was right, too. I really didn't think that she was already taking more than prescribed, and if I hadn't followed his suggestion, I wouldn't have known about it and it probably would have escalated.
I don't know. Are any or all of us (me/partner/therapist) making a bigger deal of this than it really is? Or are any or all of us minimizing and rationalizing, and it's really a bigger deal? Should I worry about yet another doctor feeding her addiction? Right now, I feel pretty good about where we are with it for now. Stay tuned.
Then, Friday, she went back to the doctor with chest pains. I asked her to ask the doc about the last incident, and she did. The doctor told her that she would have prescribed a non-narcotic. THEN, the doctor offered to write her a scrip for the chest pain, which is apparently the result of an enlarged chest cavity, but NOT heart related. She went home with a prescription for Topomax.
That night, I went researching Topomax, and found out that it's an Opiod, which is the same thing as the Suboxone she had such a hard time coming off of. What I read said that it works the same way and that it can be addictive. So, of course, I started obsessing. I told her what my concerns were, like the difficulty she'd had coming off of her last opiod and the possiblity that taking this would "wake her tiger", and then I really let it go.
Today, she left work early to go home for her pain pills, and then was going to drive to therapy. I asked if she was supposed to drive while taking them. She said that she was supposed to wait to see how they affected her before driving. I told her that impaired people usually don't realize that they're impaired and she decided to go home.
I went to our couple appointment alone. The therapist was concerned about her having the prescription, and suggested that I hold the medication for her and suggest that she talk to her sponsor and her other therapist, who works in drug treatment. He also told me to ask her to count the pills with me. When I told her what the therapist said, she first said that his advice was bad for me because it was feeding my codependency. Then she told me that she has taken more than the prescribed dosage for the last 3 days, by taking 3 pills in the morning instead of 2. She said that she might as well go out and drink, b/c she was gonna have to pick up a white chip. She went through all kinds of rationalization with herself about whether or not it was a relapse, and told me that she knew she was rationalizing. I mostly just let her talk and reflected back for her.
She told me that she would talk to her sponsor, but that she wasn't willing to let me hold the pills. I told her that I'd need to talk to my sponsor and figure out what I needed to do to take care of myself, but that probably I'd find somewhere else to spend the night if she wanted to keep the pills and I'd see her tomorrow. I told her that I could live with one of 3 options- either I'd hold the pills for her and we could talk to her therapist tomorrow or she could call the therapist tonight or I'd find somewhere else to stay the night and she could keep the pills.
The confusing part for me is that she's actually right. Me being involved in her pills is a dangerous place for me to be with MY disease. But the therapist was right, too. I really didn't think that she was already taking more than prescribed, and if I hadn't followed his suggestion, I wouldn't have known about it and it probably would have escalated.
I don't know. Are any or all of us (me/partner/therapist) making a bigger deal of this than it really is? Or are any or all of us minimizing and rationalizing, and it's really a bigger deal? Should I worry about yet another doctor feeding her addiction? Right now, I feel pretty good about where we are with it for now. Stay tuned.
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