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Orlaam Drug Description
Orlaam
(levomethadyl acetate hydrochloride)

Due to its potential for serious and possibly life-threatening, proarrhythmic effects, LAAM should be reserved for use in the treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for opiate addiction, either because of insufficient effectiveness or the inability to achieve effective dose due to intolerable adverse effects from those drugs (see WARNINGS and Contraindications ).
Cases of QT prolongation and serious arrhythmia (torsade de pointes) have been observed during post-marketing treatment with ORLAAM. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of ORLAAM to determine if a prolonged QT interval (QTc greater than 430 [male] or 450 [female] ms) is present. If there is a prolonged QT interval, ORLAAM should NOT be administered. For patients in whom the potential benefit of ORLAAM treatment is felt to outweigh the risks of potentially serious arrhythmias, an ECG should be performed prior to treatment, 12-14 days after initiating treatment, and periodically thereafter, to rule out any alterations in the QT interval.
ORLAAM should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diurectic, cardiac hypertrophy, hypokalemia, or hypomagnesemia).
ORLAAM is metabolized to active metabolites by the cytochrome P450 isoform, CYP3A4. Therefore, the addition of drugs that induce this enzyme (such as rifampin, phenobarbital, and phenytoin) or inhibit this enzyme (such as ketoconazole, erythromycin, and saquinavir) could increase the levels of parent drug or its active metabolites in a patient that was previously at steady-state, and this could potentially precipitate serious arrhythmias, including torsade de pointes (see PRECAUTIONS , Drug Interactions ).

CONDITIONS FOR DISTRIBUTION AND USE OF ORLAAM (42 CFR Part 8)
ORLAAM, used for the treatment of opiate addiction, shall be dispensed only by Opioid Treatment Programs (OTPs) certified by SAMHSA under 42 CFR Part 8, and registered by the Drug Enforcement Administration under 21. U.S.C. 823(g)(1). This does not preclude the maintenance or detoxification treatment of a patient who is hospitalized for medical conditions other than opiate addiction and who requires temporary maintenance for concurrent opiate addiction during the critical period of the patients hospitalization. Failure to abide by these requirements may result in injunction precluding operation of the program, revocation of the program approval, and possible criminal prosecution.
ORLAAM has no recommended uses outside of the treatment of opiate addiction.

DRUG DESCRIPTION
ORLAAM (brand of levomethadyl acetate hydrochloride) is a synthetic opiate agonist. Chemically, it is levo-alpha-6- dimethylamino-4, 4-diphenyl-3-heptyl acetate hydrochloride, C 23 H 31 NO 2 · HCl. It is also known as levo-alpha-acetyl-methadol hydrochloride (LAAM).
The compound is a white crystalline powder, soluble in water (>15 mg/mL), ethanol, and methyl ethyl ketone. The octanol:water partition coefficient of LAAM is 405:1 at physiologic pH. Doses of ORLAAM (LAAM) are always expressed as the weight of the hydrochloride salt (molecular weight 389.95).
ORLAAM is an aqueous solution which is diluted for oral administration. Each one mL of ORLAAM contains: Levomethadyl acetate hydrochloride (LAAM) 10 mg. Inactive ingredients: Methylparaben, propylparaben, hydrochloric acid and water. Last reviewed on RxList: 12/8/2004




Orlaam Drug Description
Orlaam
(levomethadyl acetate hydrochloride)

Due to its potential for serious and possibly life-threatening, proarrhythmic effects, LAAM should be reserved for use in the treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for opiate addiction, either because of insufficient effectiveness or the inability to achieve effective dose due to intolerable adverse effects from those drugs (see WARNINGS and Contraindications ).
Cases of QT prolongation and serious arrhythmia (torsade de pointes) have been observed during post-marketing treatment with ORLAAM. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of ORLAAM to determine if a prolonged QT interval (QTc greater than 430 [male] or 450 [female] ms) is present. If there is a prolonged QT interval, ORLAAM should NOT be administered. For patients in whom the potential benefit of ORLAAM treatment is felt to outweigh the risks of potentially serious arrhythmias, an ECG should be performed prior to treatment, 12-14 days after initiating treatment, and periodically thereafter, to rule out any alterations in the QT interval.
ORLAAM should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diurectic, cardiac hypertrophy, hypokalemia, or hypomagnesemia).
ORLAAM is metabolized to active metabolites by the cytochrome P450 isoform, CYP3A4. Therefore, the addition of drugs that induce this enzyme (such as rifampin, phenobarbital, and phenytoin) or inhibit this enzyme (such as ketoconazole, erythromycin, and saquinavir) could increase the levels of parent drug or its active metabolites in a patient that was previously at steady-state, and this could potentially precipitate serious arrhythmias, including torsade de pointes (see PRECAUTIONS , Drug Interactions ).

CONDITIONS FOR DISTRIBUTION AND USE OF ORLAAM (42 CFR Part 8)
ORLAAM, used for the treatment of opiate addiction, shall be dispensed only by Opioid Treatment Programs (OTPs) certified by SAMHSA under 42 CFR Part 8, and registered by the Drug Enforcement Administration under 21. U.S.C. 823(g)(1). This does not preclude the maintenance or detoxification treatment of a patient who is hospitalized for medical conditions other than opiate addiction and who requires temporary maintenance for concurrent opiate addiction during the critical period of the patients hospitalization. Failure to abide by these requirements may result in injunction precluding operation of the program, revocation of the program approval, and possible criminal prosecution.
ORLAAM has no recommended uses outside of the treatment of opiate addiction.

DRUG DESCRIPTION
ORLAAM (brand of levomethadyl acetate hydrochloride) is a synthetic opiate agonist. Chemically, it is levo-alpha-6- dimethylamino-4, 4-diphenyl-3-heptyl acetate hydrochloride, C 23 H 31 NO 2 · HCl. It is also known as levo-alpha-acetyl-methadol hydrochloride (LAAM).
The compound is a white crystalline powder, soluble in water (>15 mg/mL), ethanol, and methyl ethyl ketone. The octanol:water partition coefficient of LAAM is 405:1 at physiologic pH. Doses of ORLAAM (LAAM) are always expressed as the weight of the hydrochloride salt (molecular weight 389.95).
ORLAAM is an aqueous solution which is diluted for oral administration. Each one mL of ORLAAM contains: Levomethadyl acetate hydrochloride (LAAM) 10 mg. Inactive ingredients: Methylparaben, propylparaben, hydrochloric acid and water. Last reviewed on RxList: 12/8/2004




Orlaam Drug Description
Orlaam
(levomethadyl acetate hydrochloride)

Due to its potential for serious and possibly life-threatening, proarrhythmic effects, LAAM should be reserved for use in the treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for opiate addiction, either because of insufficient effectiveness or the inability to achieve effective dose due to intolerable adverse effects from those drugs (see WARNINGS and Contraindications ).
Cases of QT prolongation and serious arrhythmia (torsade de pointes) have been observed during post-marketing treatment with ORLAAM. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of ORLAAM to determine if a prolonged QT interval (QTc greater than 430 [male] or 450 [female] ms) is present. If there is a prolonged QT interval, ORLAAM should NOT be administered. For patients in whom the potential benefit of ORLAAM treatment is felt to outweigh the risks of potentially serious arrhythmias, an ECG should be performed prior to treatment, 12-14 days after initiating treatment, and periodically thereafter, to rule out any alterations in the QT interval.
ORLAAM should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diurectic, cardiac hypertrophy, hypokalemia, or hypomagnesemia).
ORLAAM is metabolized to active metabolites by the cytochrome P450 isoform, CYP3A4. Therefore, the addition of drugs that induce this enzyme (such as rifampin, phenobarbital, and phenytoin) or inhibit this enzyme (such as ketoconazole, erythromycin, and saquinavir) could increase the levels of parent drug or its active metabolites in a patient that was previously at steady-state, and this could potentially precipitate serious arrhythmias, including torsade de pointes (see PRECAUTIONS , Drug Interactions ).

CONDITIONS FOR DISTRIBUTION AND USE OF ORLAAM (42 CFR Part 8)
ORLAAM, used for the treatment of opiate addiction, shall be dispensed only by Opioid Treatment Programs (OTPs) certified by SAMHSA under 42 CFR Part 8, and registered by the Drug Enforcement Administration under 21. U.S.C. 823(g)(1). This does not preclude the maintenance or detoxification treatment of a patient who is hospitalized for medical conditions other than opiate addiction and who requires temporary maintenance for concurrent opiate addiction during the critical period of the patients hospitalization. Failure to abide by these requirements may result in injunction precluding operation of the program, revocation of the program approval, and possible criminal prosecution.
ORLAAM has no recommended uses outside of the treatment of opiate addiction.

DRUG DESCRIPTION
ORLAAM (brand of levomethadyl acetate hydrochloride) is a synthetic opiate agonist. Chemically, it is levo-alpha-6- dimethylamino-4, 4-diphenyl-3-heptyl acetate hydrochloride, C 23 H 31 NO 2 · HCl. It is also known as levo-alpha-acetyl-methadol hydrochloride (LAAM).
The compound is a white crystalline powder, soluble in water (>15 mg/mL), ethanol, and methyl ethyl ketone. The octanol:water partition coefficient of LAAM is 405:1 at physiologic pH. Doses of ORLAAM (LAAM) are always expressed as the weight of the hydrochloride salt (molecular weight 389.95).
ORLAAM is an aqueous solution which is diluted for oral administration. Each one mL of ORLAAM contains: Levomethadyl acetate hydrochloride (LAAM) 10 mg. Inactive ingredients: Methylparaben, propylparaben, hydrochloric acid and water. Last reviewed on RxList: 12/8/2004




Orlaam Drug Description
Orlaam
(levomethadyl acetate hydrochloride)

Due to its potential for serious and possibly life-threatening, proarrhythmic effects, LAAM should be reserved for use in the treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for opiate addiction, either because of insufficient effectiveness or the inability to achieve effective dose due to intolerable adverse effects from those drugs (see WARNINGS and Contraindications ).
Cases of QT prolongation and serious arrhythmia (torsade de pointes) have been observed during post-marketing treatment with ORLAAM. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of ORLAAM to determine if a prolonged QT interval (QTc greater than 430 [male] or 450 [female] ms) is present. If there is a prolonged QT interval, ORLAAM should NOT be administered. For patients in whom the potential benefit of ORLAAM treatment is felt to outweigh the risks of potentially serious arrhythmias, an ECG should be performed prior to treatment, 12-14 days after initiating treatment, and periodically thereafter, to rule out any alterations in the QT interval.
ORLAAM should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diurectic, cardiac hypertrophy, hypokalemia, or hypomagnesemia).
ORLAAM is metabolized to active metabolites by the cytochrome P450 isoform, CYP3A4. Therefore, the addition of drugs that induce this enzyme (such as rifampin, phenobarbital, and phenytoin) or inhibit this enzyme (such as ketoconazole, erythromycin, and saquinavir) could increase the levels of parent drug or its active metabolites in a patient that was previously at steady-state, and this could potentially precipitate serious arrhythmias, including torsade de pointes (see PRECAUTIONS , Drug Interactions ).

CONDITIONS FOR DISTRIBUTION AND USE OF ORLAAM (42 CFR Part 8)
ORLAAM, used for the treatment of opiate addiction, shall be dispensed only by Opioid Treatment Programs (OTPs) certified by SAMHSA under 42 CFR Part 8, and registered by the Drug Enforcement Administration under 21. U.S.C. 823(g)(1). This does not preclude the maintenance or detoxification treatment of a patient who is hospitalized for medical conditions other than opiate addiction and who requires temporary maintenance for concurrent opiate addiction during the critical period of the patients hospitalization. Failure to abide by these requirements may result in injunction precluding operation of the program, revocation of the program approval, and possible criminal prosecution.
ORLAAM has no recommended uses outside of the treatment of opiate addiction.

DRUG DESCRIPTION
ORLAAM (brand of levomethadyl acetate hydrochloride) is a synthetic opiate agonist. Chemically, it is levo-alpha-6- dimethylamino-4, 4-diphenyl-3-heptyl acetate hydrochloride, C 23 H 31 NO 2 · HCl. It is also known as levo-alpha-acetyl-methadol hydrochloride (LAAM).
The compound is a white crystalline powder, soluble in water (>15 mg/mL), ethanol, and methyl ethyl ketone. The octanol:water partition coefficient of LAAM is 405:1 at physiologic pH. Doses of ORLAAM (LAAM) are always expressed as the weight of the hydrochloride salt (molecular weight 389.95).
ORLAAM is an aqueous solution which is diluted for oral administration. Each one mL of ORLAAM contains: Levomethadyl acetate hydrochloride (LAAM) 10 mg. Inactive ingredients: Methylparaben, propylparaben, hydrochloric acid and water. Last reviewed on RxList: 12/8/2004




Orlaam Drug Description
Orlaam
(levomethadyl acetate hydrochloride)

Due to its potential for serious and possibly life-threatening, proarrhythmic effects, LAAM should be reserved for use in the treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for opiate addiction, either because of insufficient effectiveness or the inability to achieve effective dose due to intolerable adverse effects from those drugs (see WARNINGS and Contraindications ).
Cases of QT prolongation and serious arrhythmia (torsade de pointes) have been observed during post-marketing treatment with ORLAAM. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of ORLAAM to determine if a prolonged QT interval (QTc greater than 430 [male] or 450 [female] ms) is present. If there is a prolonged QT interval, ORLAAM should NOT be administered. For patients in whom the potential benefit of ORLAAM treatment is felt to outweigh the risks of potentially serious arrhythmias, an ECG should be performed prior to treatment, 12-14 days after initiating treatment, and periodically thereafter, to rule out any alterations in the QT interval.
ORLAAM should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diurectic, cardiac hypertrophy, hypokalemia, or hypomagnesemia).
ORLAAM is metabolized to active metabolites by the cytochrome P450 isoform, CYP3A4. Therefore, the addition of drugs that induce this enzyme (such as rifampin, phenobarbital, and phenytoin) or inhibit this enzyme (such as ketoconazole, erythromycin, and saquinavir) could increase the levels of parent drug or its active metabolites in a patient that was previously at steady-state, and this could potentially precipitate serious arrhythmias, including torsade de pointes (see PRECAUTIONS , Drug Interactions ).

CONDITIONS FOR DISTRIBUTION AND USE OF ORLAAM (42 CFR Part 8)
ORLAAM, used for the treatment of opiate addiction, shall be dispensed only by Opioid Treatment Programs (OTPs) certified by SAMHSA under 42 CFR Part 8, and registered by the Drug Enforcement Administration under 21. U.S.C. 823(g)(1). This does not preclude the maintenance or detoxification treatment of a patient who is hospitalized for medical conditions other than opiate addiction and who requires temporary maintenance for concurrent opiate addiction during the critical period of the patients hospitalization. Failure to abide by these requirements may result in injunction precluding operation of the program, revocation of the program approval, and possible criminal prosecution.
ORLAAM has no recommended uses outside of the treatment of opiate addiction.

DRUG DESCRIPTION
ORLAAM (brand of levomethadyl acetate hydrochloride) is a synthetic opiate agonist. Chemically, it is levo-alpha-6- dimethylamino-4, 4-diphenyl-3-heptyl acetate hydrochloride, C 23 H 31 NO 2 · HCl. It is also known as levo-alpha-acetyl-methadol hydrochloride (LAAM).
The compound is a white crystalline powder, soluble in water (>15 mg/mL), ethanol, and methyl ethyl ketone. The octanol:water partition coefficient of LAAM is 405:1 at physiologic pH. Doses of ORLAAM (LAAM) are always expressed as the weight of the hydrochloride salt (molecular weight 389.95).
ORLAAM is an aqueous solution which is diluted for oral administration. Each one mL of ORLAAM contains: Levomethadyl acetate hydrochloride (LAAM) 10 mg. Inactive ingredients: Methylparaben, propylparaben, hydrochloric acid and water. Last reviewed on RxList: 12/8/2004





Other reviews about Orlaam on wordpress

Chronic Pain, Opioids & the War on Drugs: Everyone Suffers
  by kerriesmyres
People with chronic pain often don't have access to painkillers because their doctors won't prescribe opioids. Doctors see plenty of patients who want drugs, not pain relief, and […]


Treatment of Opioid Addiction by the use of opioids
  by methadonewithdrawel
There are many types of drugs currently used today to treat opioid addiction. Although these drugs are themselves addictive, opioid dependency is so severe that it requires a […]



Other reviews about Orlaam on web:

Learn about the prescription medication Orlaam (Levomethadyl Acetate), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Orlaam (Levomethadyl Acetate) Drug Information: Uses, Side Effects ...


Levacetylmethadol , levomethadyl acetate , Orlaam (trade name) or levo-α-acetylmethadol (LAAM) is a synthetic opioid similar in structure to methadone. Levacetylmethadol - Wikipedia, the free encyclopedia


Orlaam (levomethadyl) patient information. Detailed drug information for the consumer, includes dosage, Orlaam side effects and more. Orlaam consumer information from Drugs.com


Roxane Laboratories, Inc. is discontinuing the sale and distribution of ORLAAM, a synthetic opioid agonist solution indicated for the management of opiate dependence, reserved ... Orlaam (levomethadyl acetate hydrochloride)


Find patient medical information for Orlaam Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Orlaam Oral : Uses, Side Effects, Interactions, Pictures, Warnings ...


Orlaam is a drug used in the treatment of individuals suffering from an opiate addiction. Orlaam has been used under other common names, including LAAM, LAM, Orlaam | Addiction


Why It Is Prescribed. Levomethadyl is used in treatment programs for people addicted to narcotics. How It Works. Levomethadyl comes as a liquid to take by mouth. Orlaam


InjuryBoard News: Orlaam - Find trial lawyers and attorneys with experience in lawsuits involving Orlaam. Contact an attorney who can help you protect your legal rights, free of ... Orlaam / Levomethadyl | InjuryBoard.com


** The U.S. Food and Drug Administration (FDA) issued a new warning about health risks associated with levomethadyl acetate HC, a.k.a. Orlaam, a drug used to treat opiate addiction. FDA Warns About Orlaam


What class of treatment is Orlaam (Levomethadyl Acetate)? This treatment is no longer available. Category: Central Nervous System Agents / Analgesics / Narcotic Analgesics Orlaam - Drugs & Treatments - Revolution Health





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