Questions and Answers about OxyContin

[Guest guest]

Questions and Answers about OxyContin:

1. What kind of medicine is OxyContin?

OxyContin contains oxycodone, a very strong narcotic pain reliever similar

to morphine. OxyContin is designed so that the oxycodone is slowly released

over time, allowing it to be used twice daily. You should never break, chew,

or crush the OxyContin tablet since this causes a large amount of oxycodone

to be released from the tablet all at once, potentially resulting in a

dangerous or fatal drug overdose.

2. What kind of pain is appropriate to treat with OxyContin?

OxyContin is intended to help relieve pain that is moderate to severe in

intensity, when that pain is present all the time, and expected to continue

for a long time. This level of pain severity may be caused by a variety of

different medical conditions.

3. How do I know if I have the right kind of pain to use OxyContin?

Only a physician can determine if OxyContin is a good choice to manage a

your pain. If you have pain every day that lasts for a large part of the

day, and the pain is moderate or severe in intensity, depending upon other

factors in your medical history, OxyContin may be a good choice for you.

Speak with your physician.

If you feel you only need to take a pain reliever occasionally and this

adequately treats your pain, OxyContin is NOT the right drug for you. If you

only need a pain reliever for a few days, for example following a dental or

surgical procedure, OxyContin is not the right drug for you.

4. Are there any activities that I should not perform while using OxyContin

for pain relief?

OxyContin may interfere with your ability to do certain things that require

your full attention. You should not drive a car, operate heavy machinery, or

do other possibly dangerous activities while taking OxyContin.

5. What should I do if I still have pain after I take the OxyContin?

Because OxyContin is a very strong medication, you should not adjust the

dose without first speaking with your physician.

6. Can I take other medicines while I am using OxyContin for pain relief?

Combining OxyContin with some other types of medication such as sleeping

pills, tranquilizers, and other pain medications may be dangerous due to the

risk of interactions of these medications that can result in injury or

death. You should speak with your physician before taking any other

medicines with OxyContin. You should also tell your physician about all

prescription drugs, over-the-counter drugs, and dietary supplements/herbal

remedies that you are taking before starting OxyContin.

7. Can I drink an alcoholic beverage while I am using OxyContin for pain

relief?

You should not drink any beverage that contains alcohol while you are taking

OxyContin. This includes beer, wine, and all distilled liquors. OxyContin

and alcoholic beverages may have dangerous interactions that can result in

serious injury or death.

8. Will I become addicted to OxyContin if I take it every day?

OxyContin is only intended for moderate to severe pain that is present on a

daily basis and that requires a very strong pain reliever. Patients with

this type of severe pain condition require daily pain treatment. Taking

OxyContin daily can result in physical dependence, a condition in which the

body shows signs of narcotic withdrawal if the OxyContin is stopped

suddenly. This is not the same thing as addiction, which represents a

situation in which people obtain and take narcotics because of a

psychological need, and not just to treat a legitimate painful condition.

Physical dependence can be treated by slowly under the advice of a physician

by slowing decreasing the OxyContin dose when it is no longer needed for the

treatment of pain. Concerns of addiction should not prevent patients with

appropriate pain conditions from using OxyContin or other narcotics for pain

relief.

9. What should I do when I no longer need the OxyContin for pain relief?

When you no longer need OxyContin, the dose should be gradually reduced so

that you do not feel sick with withdrawal symptoms. You should ask your

physician for a plan on how to gradually decrease the dose and when to stop

the OxyContin.

10. Haven't there been press reports about the misuse of OxyContin?

OxyContin is a safe and effective pain medication when properly prescribed

and used as directed. OxyContin has also been used as a drug of abuse. You

should protect your prescription and your medication from theft and never

give OxyContin to anyone else. You should destroy any left over OxyContin

tablets that you may have once your physician instructs you to stop taking

the medication.

11. Can I take OxyContin if I am pregnant, planning to become pregnant, or

planning to nurse my baby?

Your should speak to your physician about the effects of drugs like

OxyContin on an unborn or newborn child.

12. Are there any other special precautions I should take with my OxyContin?

Because there is a large dose of medication in each OxyContin tablet, you

must be very careful to keep OxyContin stored in a secure location, out of

the reach of children. When you no longer need OxyContin for pain relief,

you should flush the unused tablets down the toilet.

FDA STRENGTHENS WARNINGS FOR OXYCONTIN

FDA has strengthened the warnings and precautions sections in the labeling

of OxyContin (oxycodone HCl controlled-release) Tablets, a narcotic drug

approved for the treatment of moderate to severe pain, because of continuing

reports of abuse and diversion.

OxyContin contains oxycodone HCL, an opioid agonist with an addiction

potential similar to that of morphine. Opioid agonists are substances that

act by attaching to specific proteins called opioid receptors, which are

found in the brain, spinal cord, and gastrointestinal tract. When these

drugs attach to certain opioid receptors in the brain and spinal cord they

can effectively block the transmission of pain messages to the brain.

OxyContin is a controlled substance in Schedule II of the Controlled

Substances Act (CSA), which is administered by the Drug Enforcement

Administration (DEA). Schedule II provides the maximum amount of control

possible under the CSA for approved drug products.

In recent months, there have been numerous reports of OxyContin diversion

and abuse in several states. Some of these reported cases have been

associated with serious consequences including death. In an effort to

educate health care providers about these risks, Purdue Pharmaceuticals,

manufacturer of the product, has issued a warning in the form of a " Dear

Healthcare Professional " letter. The " Dear Healthcare Professional " letter

will be distributed widely to physicians, pharmacists, and other healthcare

professionals. The letter explains the changes to the labeling including

proper prescribing information and highlights the problems associated with

the abuse and diversion of OxyContin.

OxyContin, like morphine, has a high potential for abuse. It is supplied in

a controlled-release dosage form and is intended to provide up to 12 hours

of relief from moderate to severe pain. The tablet must be taken whole and

only by mouth. When the tablet is crushed and its contents are injected

intravenously or snorted into the nostrils, the controlled release mechanism

is defeated and a potentially lethal dose of oxycodone is released

immediately.

FDA has worked with Purdue to make specific changes to the OxyContin

labeling. The new labeling is intended to change prescription practices as

well as increase the physicians' focus on the potential for abuse, misuse,

and diversion.

Changes include a " black box warning " , the strongest type of warning for an

FDA-approved drug. The new warnings are intended to lessen the chance that

OxyContin will be prescribed inappropriately for pain of lesser severity

than the approved use or for other disorders or conditions inappropriate for

a Schedule II narcotic.

The FDA-approved indication for OxyContin is for the treatment of patients

with moderate to severe pain who are expected to need continuous opioids for

an extended time. An important factor that must be considered in prescribing

OxyContin is the severity of the pain that is being treated, not simply the

disease causing the painful symptoms.

FDA continues to recommend that appropriate pain control be provided to

patients who are living with severe pain. Although abuse, misuse, and

diversion are potential problems for all opioids, including OxyContin,

opioids are a very important part of the medical armamentarium for the

management of pain when used appropriately under the careful supervision of

a physician.

Because of the ongoing problem of OxyContin abuse and diversion, FDA has met

with DEA, the Substance Abuse and Mental Health Service Agency, the National

Institute on Drug Abuse, Purdue, Inc., and others. FDA will continue to

monitor reports of abuse, misuse, and diversion of OxyContin and other

opioids and will work with other federal agencies and drug manufacturers to

help ensure that these important drugs remain available to appropriate

patients.

Since all opioids are subject to abuse, misuse, and diversion, FDA is

encouraging all manufacturers of opioids sold in the U.S. to review

voluntarily, and revise as necessary, their product's labeling to provide

adequate warnings and precautions regarding these risks and to promote

responsible prescribing practices.

For more information, patients and healthcare providers can call Purdue

Pharmaceuticals at 1-, or go to FDA's website at

www.fda.gov/cder/drug/infopage/oxycontin/.

OXYCONTIN® Drug Label Warnings

(Oxycodone HCl Controlled-Release) Tablets

10 mg 20 mg 40 mg 80 mg* 160 mg*

* 80 mg and 160 mg for use in opioid-tolerant patients only

OT00367

065570-0F-001

WARNING:

OxyContin is an opioid agonist and a Schedule II controlled substance with

an abuse liability similar to morphine.

Oxycodone can be abused in a manner similar to other opioid agonists, legal

or illicit. This should be considered when prescribing or dispensing

OxyContin in situations where the physician or pharmacist is concerned about

an increased risk of misuse, abuse, or diversion.

OxyContin Tablets are a controlled-release oral formulation of oxycodone

hydrochloride indicated for the management of moderate to severe pain when a

continuous, around-the-clock analgesic is needed for an extended period of

time.

OxyContin Tablets are NOT intended for use as a prn analgesic.

OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS

ONLY. These tablet strengths may cause fatal respiratory depression when

administered to patients not previously exposed to opioids.

OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN,

CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS

LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF

OXYCODONE.

[Guest guest]

Thanks so much for this one the Q/A on Oxycontin!

Sincerely, S.

Questions and Answers about OxyContin

> Questions and Answers about OxyContin:

>

> 1. What kind of medicine is OxyContin?

> OxyContin contains oxycodone, a very strong narcotic pain reliever similar

> to morphine. OxyContin is designed so that the oxycodone is slowly

released

> over time, allowing it to be used twice daily. You should never break,

chew,

> or crush the OxyContin tablet since this causes a large amount of

oxycodone

> to be released from the tablet all at once, potentially resulting in a

> dangerous or fatal drug overdose.

>

> 2. What kind of pain is appropriate to treat with OxyContin?

> OxyContin is intended to help relieve pain that is moderate to severe in

> intensity, when that pain is present all the time, and expected to

continue

> for a long time. This level of pain severity may be caused by a variety of

> different medical conditions.

>

> 3. How do I know if I have the right kind of pain to use OxyContin?

> Only a physician can determine if OxyContin is a good choice to manage a

> your pain. If you have pain every day that lasts for a large part of the

> day, and the pain is moderate or severe in intensity, depending upon other

> factors in your medical history, OxyContin may be a good choice for you.

> Speak with your physician.

>

> If you feel you only need to take a pain reliever occasionally and this

> adequately treats your pain, OxyContin is NOT the right drug for you. If

you

> only need a pain reliever for a few days, for example following a dental

or

> surgical procedure, OxyContin is not the right drug for you.

>

> 4. Are there any activities that I should not perform while using

OxyContin

> for pain relief?

> OxyContin may interfere with your ability to do certain things that

require

> your full attention. You should not drive a car, operate heavy machinery,

or

> do other possibly dangerous activities while taking OxyContin.

>

> 5. What should I do if I still have pain after I take the OxyContin?

> Because OxyContin is a very strong medication, you should not adjust the

> dose without first speaking with your physician.

>

> 6. Can I take other medicines while I am using OxyContin for pain relief?

> Combining OxyContin with some other types of medication such as sleeping

> pills, tranquilizers, and other pain medications may be dangerous due to

the

> risk of interactions of these medications that can result in injury or

> death. You should speak with your physician before taking any other

> medicines with OxyContin. You should also tell your physician about all

> prescription drugs, over-the-counter drugs, and dietary supplements/herbal

> remedies that you are taking before starting OxyContin.

>

> 7. Can I drink an alcoholic beverage while I am using OxyContin for pain

> relief?

> You should not drink any beverage that contains alcohol while you are

taking

> OxyContin. This includes beer, wine, and all distilled liquors. OxyContin

> and alcoholic beverages may have dangerous interactions that can result in

> serious injury or death.

>

> 8. Will I become addicted to OxyContin if I take it every day?

>

> OxyContin is only intended for moderate to severe pain that is present on

a

> daily basis and that requires a very strong pain reliever. Patients with

> this type of severe pain condition require daily pain treatment. Taking

> OxyContin daily can result in physical dependence, a condition in which

the

> body shows signs of narcotic withdrawal if the OxyContin is stopped

> suddenly. This is not the same thing as addiction, which represents a

> situation in which people obtain and take narcotics because of a

> psychological need, and not just to treat a legitimate painful condition.

> Physical dependence can be treated by slowly under the advice of a

physician

> by slowing decreasing the OxyContin dose when it is no longer needed for

the

> treatment of pain. Concerns of addiction should not prevent patients with

> appropriate pain conditions from using OxyContin or other narcotics for

pain

> relief.

> 9. What should I do when I no longer need the OxyContin for pain relief?

> When you no longer need OxyContin, the dose should be gradually reduced so

> that you do not feel sick with withdrawal symptoms. You should ask your

> physician for a plan on how to gradually decrease the dose and when to

stop

> the OxyContin.

>

> 10. Haven't there been press reports about the misuse of OxyContin?

> OxyContin is a safe and effective pain medication when properly prescribed

> and used as directed. OxyContin has also been used as a drug of abuse. You

> should protect your prescription and your medication from theft and never

> give OxyContin to anyone else. You should destroy any left over OxyContin

> tablets that you may have once your physician instructs you to stop taking

> the medication.

>

> 11. Can I take OxyContin if I am pregnant, planning to become pregnant, or

> planning to nurse my baby?

> Your should speak to your physician about the effects of drugs like

> OxyContin on an unborn or newborn child.

>

> 12. Are there any other special precautions I should take with my

OxyContin?

> Because there is a large dose of medication in each OxyContin tablet, you

> must be very careful to keep OxyContin stored in a secure location, out of

> the reach of children. When you no longer need OxyContin for pain relief,

> you should flush the unused tablets down the toilet.

>

> FDA STRENGTHENS WARNINGS FOR OXYCONTIN

>

> FDA has strengthened the warnings and precautions sections in the labeling

> of OxyContin (oxycodone HCl controlled-release) Tablets, a narcotic drug

> approved for the treatment of moderate to severe pain, because of

continuing

> reports of abuse and diversion.

>

> OxyContin contains oxycodone HCL, an opioid agonist with an addiction

> potential similar to that of morphine. Opioid agonists are substances that

> act by attaching to specific proteins called opioid receptors, which are

> found in the brain, spinal cord, and gastrointestinal tract. When these

> drugs attach to certain opioid receptors in the brain and spinal cord they

> can effectively block the transmission of pain messages to the brain.

>

> OxyContin is a controlled substance in Schedule II of the Controlled

> Substances Act (CSA), which is administered by the Drug Enforcement

> Administration (DEA). Schedule II provides the maximum amount of control

> possible under the CSA for approved drug products.

>

> In recent months, there have been numerous reports of OxyContin diversion

> and abuse in several states. Some of these reported cases have been

> associated with serious consequences including death. In an effort to

> educate health care providers about these risks, Purdue Pharmaceuticals,

> manufacturer of the product, has issued a warning in the form of a " Dear

> Healthcare Professional " letter. The " Dear Healthcare Professional " letter

> will be distributed widely to physicians, pharmacists, and other

healthcare

> professionals. The letter explains the changes to the labeling including

> proper prescribing information and highlights the problems associated with

> the abuse and diversion of OxyContin.

>

> OxyContin, like morphine, has a high potential for abuse. It is supplied

in

> a controlled-release dosage form and is intended to provide up to 12 hours

> of relief from moderate to severe pain. The tablet must be taken whole and

> only by mouth. When the tablet is crushed and its contents are injected

> intravenously or snorted into the nostrils, the controlled release

mechanism

> is defeated and a potentially lethal dose of oxycodone is released

> immediately.

>

> FDA has worked with Purdue to make specific changes to the OxyContin

> labeling. The new labeling is intended to change prescription practices as

> well as increase the physicians' focus on the potential for abuse, misuse,

> and diversion.

>

> Changes include a " black box warning " , the strongest type of warning for

an

> FDA-approved drug. The new warnings are intended to lessen the chance that

> OxyContin will be prescribed inappropriately for pain of lesser severity

> than the approved use or for other disorders or conditions inappropriate

for

> a Schedule II narcotic.

>

> The FDA-approved indication for OxyContin is for the treatment of patients

> with moderate to severe pain who are expected to need continuous opioids

for

> an extended time. An important factor that must be considered in

prescribing

> OxyContin is the severity of the pain that is being treated, not simply

the

> disease causing the painful symptoms.

>

> FDA continues to recommend that appropriate pain control be provided to

> patients who are living with severe pain. Although abuse, misuse, and

> diversion are potential problems for all opioids, including OxyContin,

> opioids are a very important part of the medical armamentarium for the

> management of pain when used appropriately under the careful supervision

of

> a physician.

>

> Because of the ongoing problem of OxyContin abuse and diversion, FDA has

met

> with DEA, the Substance Abuse and Mental Health Service Agency, the

National

> Institute on Drug Abuse, Purdue, Inc., and others. FDA will continue to

> monitor reports of abuse, misuse, and diversion of OxyContin and other

> opioids and will work with other federal agencies and drug manufacturers

to

> help ensure that these important drugs remain available to appropriate

> patients.

>

> Since all opioids are subject to abuse, misuse, and diversion, FDA is

> encouraging all manufacturers of opioids sold in the U.S. to review

> voluntarily, and revise as necessary, their product's labeling to provide

> adequate warnings and precautions regarding these risks and to promote

> responsible prescribing practices.

>

> For more information, patients and healthcare providers can call Purdue

> Pharmaceuticals at 1-, or go to FDA's website at

> www.fda.gov/cder/drug/infopage/oxycontin/.

>

> OXYCONTIN® Drug Label Warnings

>

> (Oxycodone HCl Controlled-Release) Tablets

> 10 mg 20 mg 40 mg 80 mg* 160 mg*

>

> * 80 mg and 160 mg for use in opioid-tolerant patients only

>

> OT00367

>

> 065570-0F-001

>

> WARNING:

>

> OxyContin is an opioid agonist and a Schedule II controlled substance with

> an abuse liability similar to morphine.

>

> Oxycodone can be abused in a manner similar to other opioid agonists,

legal

> or illicit. This should be considered when prescribing or dispensing

> OxyContin in situations where the physician or pharmacist is concerned

about

> an increased risk of misuse, abuse, or diversion.

>

> OxyContin Tablets are a controlled-release oral formulation of oxycodone

> hydrochloride indicated for the management of moderate to severe pain when

a

> continuous, around-the-clock analgesic is needed for an extended period of

> time.

>

> OxyContin Tablets are NOT intended for use as a prn analgesic.

>

> OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS

> ONLY. These tablet strengths may cause fatal respiratory depression when

> administered to patients not previously exposed to opioids.

>

> OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN,

> CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS

> LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF

> OXYCODONE.

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> To learn more about EDS, visit our website: http://www.ceda.ca

>

>

[Guest guest]

Thanks so much for this one the Q/A on Oxycontin!

Sincerely, S.

Questions and Answers about OxyContin

> Questions and Answers about OxyContin:

>

> 1. What kind of medicine is OxyContin?

> OxyContin contains oxycodone, a very strong narcotic pain reliever similar

> to morphine. OxyContin is designed so that the oxycodone is slowly

released

> over time, allowing it to be used twice daily. You should never break,

chew,

> or crush the OxyContin tablet since this causes a large amount of

oxycodone

> to be released from the tablet all at once, potentially resulting in a

> dangerous or fatal drug overdose.

>

> 2. What kind of pain is appropriate to treat with OxyContin?

> OxyContin is intended to help relieve pain that is moderate to severe in

> intensity, when that pain is present all the time, and expected to

continue

> for a long time. This level of pain severity may be caused by a variety of

> different medical conditions.

>

> 3. How do I know if I have the right kind of pain to use OxyContin?

> Only a physician can determine if OxyContin is a good choice to manage a

> your pain. If you have pain every day that lasts for a large part of the

> day, and the pain is moderate or severe in intensity, depending upon other

> factors in your medical history, OxyContin may be a good choice for you.

> Speak with your physician.

>

> If you feel you only need to take a pain reliever occasionally and this

> adequately treats your pain, OxyContin is NOT the right drug for you. If

you

> only need a pain reliever for a few days, for example following a dental

or

> surgical procedure, OxyContin is not the right drug for you.

>

> 4. Are there any activities that I should not perform while using

OxyContin

> for pain relief?

> OxyContin may interfere with your ability to do certain things that

require

> your full attention. You should not drive a car, operate heavy machinery,

or

> do other possibly dangerous activities while taking OxyContin.

>

> 5. What should I do if I still have pain after I take the OxyContin?

> Because OxyContin is a very strong medication, you should not adjust the

> dose without first speaking with your physician.

>

> 6. Can I take other medicines while I am using OxyContin for pain relief?

> Combining OxyContin with some other types of medication such as sleeping

> pills, tranquilizers, and other pain medications may be dangerous due to

the

> risk of interactions of these medications that can result in injury or

> death. You should speak with your physician before taking any other

> medicines with OxyContin. You should also tell your physician about all

> prescription drugs, over-the-counter drugs, and dietary supplements/herbal

> remedies that you are taking before starting OxyContin.

>

> 7. Can I drink an alcoholic beverage while I am using OxyContin for pain

> relief?

> You should not drink any beverage that contains alcohol while you are

taking

> OxyContin. This includes beer, wine, and all distilled liquors. OxyContin

> and alcoholic beverages may have dangerous interactions that can result in

> serious injury or death.

>

> 8. Will I become addicted to OxyContin if I take it every day?

>

> OxyContin is only intended for moderate to severe pain that is present on

a

> daily basis and that requires a very strong pain reliever. Patients with

> this type of severe pain condition require daily pain treatment. Taking

> OxyContin daily can result in physical dependence, a condition in which

the

> body shows signs of narcotic withdrawal if the OxyContin is stopped

> suddenly. This is not the same thing as addiction, which represents a

> situation in which people obtain and take narcotics because of a

> psychological need, and not just to treat a legitimate painful condition.

> Physical dependence can be treated by slowly under the advice of a

physician

> by slowing decreasing the OxyContin dose when it is no longer needed for

the

> treatment of pain. Concerns of addiction should not prevent patients with

> appropriate pain conditions from using OxyContin or other narcotics for

pain

> relief.

> 9. What should I do when I no longer need the OxyContin for pain relief?

> When you no longer need OxyContin, the dose should be gradually reduced so

> that you do not feel sick with withdrawal symptoms. You should ask your

> physician for a plan on how to gradually decrease the dose and when to

stop

> the OxyContin.

>

> 10. Haven't there been press reports about the misuse of OxyContin?

> OxyContin is a safe and effective pain medication when properly prescribed

> and used as directed. OxyContin has also been used as a drug of abuse. You

> should protect your prescription and your medication from theft and never

> give OxyContin to anyone else. You should destroy any left over OxyContin

> tablets that you may have once your physician instructs you to stop taking

> the medication.

>

> 11. Can I take OxyContin if I am pregnant, planning to become pregnant, or

> planning to nurse my baby?

> Your should speak to your physician about the effects of drugs like

> OxyContin on an unborn or newborn child.

>

> 12. Are there any other special precautions I should take with my

OxyContin?

> Because there is a large dose of medication in each OxyContin tablet, you

> must be very careful to keep OxyContin stored in a secure location, out of

> the reach of children. When you no longer need OxyContin for pain relief,

> you should flush the unused tablets down the toilet.

>

> FDA STRENGTHENS WARNINGS FOR OXYCONTIN

>

> FDA has strengthened the warnings and precautions sections in the labeling

> of OxyContin (oxycodone HCl controlled-release) Tablets, a narcotic drug

> approved for the treatment of moderate to severe pain, because of

continuing

> reports of abuse and diversion.

>

> OxyContin contains oxycodone HCL, an opioid agonist with an addiction

> potential similar to that of morphine. Opioid agonists are substances that

> act by attaching to specific proteins called opioid receptors, which are

> found in the brain, spinal cord, and gastrointestinal tract. When these

> drugs attach to certain opioid receptors in the brain and spinal cord they

> can effectively block the transmission of pain messages to the brain.

>

> OxyContin is a controlled substance in Schedule II of the Controlled

> Substances Act (CSA), which is administered by the Drug Enforcement

> Administration (DEA). Schedule II provides the maximum amount of control

> possible under the CSA for approved drug products.

>

> In recent months, there have been numerous reports of OxyContin diversion

> and abuse in several states. Some of these reported cases have been

> associated with serious consequences including death. In an effort to

> educate health care providers about these risks, Purdue Pharmaceuticals,

> manufacturer of the product, has issued a warning in the form of a " Dear

> Healthcare Professional " letter. The " Dear Healthcare Professional " letter

> will be distributed widely to physicians, pharmacists, and other

healthcare

> professionals. The letter explains the changes to the labeling including

> proper prescribing information and highlights the problems associated with

> the abuse and diversion of OxyContin.

>

> OxyContin, like morphine, has a high potential for abuse. It is supplied

in

> a controlled-release dosage form and is intended to provide up to 12 hours

> of relief from moderate to severe pain. The tablet must be taken whole and

> only by mouth. When the tablet is crushed and its contents are injected

> intravenously or snorted into the nostrils, the controlled release

mechanism

> is defeated and a potentially lethal dose of oxycodone is released

> immediately.

>

> FDA has worked with Purdue to make specific changes to the OxyContin

> labeling. The new labeling is intended to change prescription practices as

> well as increase the physicians' focus on the potential for abuse, misuse,

> and diversion.

>

> Changes include a " black box warning " , the strongest type of warning for

an

> FDA-approved drug. The new warnings are intended to lessen the chance that

> OxyContin will be prescribed inappropriately for pain of lesser severity

> than the approved use or for other disorders or conditions inappropriate

for

> a Schedule II narcotic.

>

> The FDA-approved indication for OxyContin is for the treatment of patients

> with moderate to severe pain who are expected to need continuous opioids

for

> an extended time. An important factor that must be considered in

prescribing

> OxyContin is the severity of the pain that is being treated, not simply

the

> disease causing the painful symptoms.

>

> FDA continues to recommend that appropriate pain control be provided to

> patients who are living with severe pain. Although abuse, misuse, and

> diversion are potential problems for all opioids, including OxyContin,

> opioids are a very important part of the medical armamentarium for the

> management of pain when used appropriately under the careful supervision

of

> a physician.

>

> Because of the ongoing problem of OxyContin abuse and diversion, FDA has

met

> with DEA, the Substance Abuse and Mental Health Service Agency, the

National

> Institute on Drug Abuse, Purdue, Inc., and others. FDA will continue to

> monitor reports of abuse, misuse, and diversion of OxyContin and other

> opioids and will work with other federal agencies and drug manufacturers

to

> help ensure that these important drugs remain available to appropriate

> patients.

>

> Since all opioids are subject to abuse, misuse, and diversion, FDA is

> encouraging all manufacturers of opioids sold in the U.S. to review

> voluntarily, and revise as necessary, their product's labeling to provide

> adequate warnings and precautions regarding these risks and to promote

> responsible prescribing practices.

>

> For more information, patients and healthcare providers can call Purdue

> Pharmaceuticals at 1-, or go to FDA's website at

> www.fda.gov/cder/drug/infopage/oxycontin/.

>

> OXYCONTIN® Drug Label Warnings

>

> (Oxycodone HCl Controlled-Release) Tablets

> 10 mg 20 mg 40 mg 80 mg* 160 mg*

>

> * 80 mg and 160 mg for use in opioid-tolerant patients only

>

> OT00367

>

> 065570-0F-001

>

> WARNING:

>

> OxyContin is an opioid agonist and a Schedule II controlled substance with

> an abuse liability similar to morphine.

>

> Oxycodone can be abused in a manner similar to other opioid agonists,

legal

> or illicit. This should be considered when prescribing or dispensing

> OxyContin in situations where the physician or pharmacist is concerned

about

> an increased risk of misuse, abuse, or diversion.

>

> OxyContin Tablets are a controlled-release oral formulation of oxycodone

> hydrochloride indicated for the management of moderate to severe pain when

a

> continuous, around-the-clock analgesic is needed for an extended period of

> time.

>

> OxyContin Tablets are NOT intended for use as a prn analgesic.

>

> OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS

> ONLY. These tablet strengths may cause fatal respiratory depression when

> administered to patients not previously exposed to opioids.

>

> OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN,

> CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS

> LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF

> OXYCODONE.

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> To learn more about EDS, visit our website: http://www.ceda.ca

>

>

[Guest guest]

Thanks so much for this one the Q/A on Oxycontin!

Sincerely, S.

Questions and Answers about OxyContin

> Questions and Answers about OxyContin:

>

> 1. What kind of medicine is OxyContin?

> OxyContin contains oxycodone, a very strong narcotic pain reliever similar

> to morphine. OxyContin is designed so that the oxycodone is slowly

released

> over time, allowing it to be used twice daily. You should never break,

chew,

> or crush the OxyContin tablet since this causes a large amount of

oxycodone

> to be released from the tablet all at once, potentially resulting in a

> dangerous or fatal drug overdose.

>

> 2. What kind of pain is appropriate to treat with OxyContin?

> OxyContin is intended to help relieve pain that is moderate to severe in

> intensity, when that pain is present all the time, and expected to

continue

> for a long time. This level of pain severity may be caused by a variety of

> different medical conditions.

>

> 3. How do I know if I have the right kind of pain to use OxyContin?

> Only a physician can determine if OxyContin is a good choice to manage a

> your pain. If you have pain every day that lasts for a large part of the

> day, and the pain is moderate or severe in intensity, depending upon other

> factors in your medical history, OxyContin may be a good choice for you.

> Speak with your physician.

>

> If you feel you only need to take a pain reliever occasionally and this

> adequately treats your pain, OxyContin is NOT the right drug for you. If

you

> only need a pain reliever for a few days, for example following a dental

or

> surgical procedure, OxyContin is not the right drug for you.

>

> 4. Are there any activities that I should not perform while using

OxyContin

> for pain relief?

> OxyContin may interfere with your ability to do certain things that

require

> your full attention. You should not drive a car, operate heavy machinery,

or

> do other possibly dangerous activities while taking OxyContin.

>

> 5. What should I do if I still have pain after I take the OxyContin?

> Because OxyContin is a very strong medication, you should not adjust the

> dose without first speaking with your physician.

>

> 6. Can I take other medicines while I am using OxyContin for pain relief?

> Combining OxyContin with some other types of medication such as sleeping

> pills, tranquilizers, and other pain medications may be dangerous due to

the

> risk of interactions of these medications that can result in injury or

> death. You should speak with your physician before taking any other

> medicines with OxyContin. You should also tell your physician about all

> prescription drugs, over-the-counter drugs, and dietary supplements/herbal

> remedies that you are taking before starting OxyContin.

>

> 7. Can I drink an alcoholic beverage while I am using OxyContin for pain

> relief?

> You should not drink any beverage that contains alcohol while you are

taking

> OxyContin. This includes beer, wine, and all distilled liquors. OxyContin

> and alcoholic beverages may have dangerous interactions that can result in

> serious injury or death.

>

> 8. Will I become addicted to OxyContin if I take it every day?

>

> OxyContin is only intended for moderate to severe pain that is present on

a

> daily basis and that requires a very strong pain reliever. Patients with

> this type of severe pain condition require daily pain treatment. Taking

> OxyContin daily can result in physical dependence, a condition in which

the

> body shows signs of narcotic withdrawal if the OxyContin is stopped

> suddenly. This is not the same thing as addiction, which represents a

> situation in which people obtain and take narcotics because of a

> psychological need, and not just to treat a legitimate painful condition.

> Physical dependence can be treated by slowly under the advice of a

physician

> by slowing decreasing the OxyContin dose when it is no longer needed for

the

> treatment of pain. Concerns of addiction should not prevent patients with

> appropriate pain conditions from using OxyContin or other narcotics for

pain

> relief.

> 9. What should I do when I no longer need the OxyContin for pain relief?

> When you no longer need OxyContin, the dose should be gradually reduced so

> that you do not feel sick with withdrawal symptoms. You should ask your

> physician for a plan on how to gradually decrease the dose and when to

stop

> the OxyContin.

>

> 10. Haven't there been press reports about the misuse of OxyContin?

> OxyContin is a safe and effective pain medication when properly prescribed

> and used as directed. OxyContin has also been used as a drug of abuse. You

> should protect your prescription and your medication from theft and never

> give OxyContin to anyone else. You should destroy any left over OxyContin

> tablets that you may have once your physician instructs you to stop taking

> the medication.

>

> 11. Can I take OxyContin if I am pregnant, planning to become pregnant, or

> planning to nurse my baby?

> Your should speak to your physician about the effects of drugs like

> OxyContin on an unborn or newborn child.

>

> 12. Are there any other special precautions I should take with my

OxyContin?

> Because there is a large dose of medication in each OxyContin tablet, you

> must be very careful to keep OxyContin stored in a secure location, out of

> the reach of children. When you no longer need OxyContin for pain relief,

> you should flush the unused tablets down the toilet.

>

> FDA STRENGTHENS WARNINGS FOR OXYCONTIN

>

> FDA has strengthened the warnings and precautions sections in the labeling

> of OxyContin (oxycodone HCl controlled-release) Tablets, a narcotic drug

> approved for the treatment of moderate to severe pain, because of

continuing

> reports of abuse and diversion.

>

> OxyContin contains oxycodone HCL, an opioid agonist with an addiction

> potential similar to that of morphine. Opioid agonists are substances that

> act by attaching to specific proteins called opioid receptors, which are

> found in the brain, spinal cord, and gastrointestinal tract. When these

> drugs attach to certain opioid receptors in the brain and spinal cord they

> can effectively block the transmission of pain messages to the brain.

>

> OxyContin is a controlled substance in Schedule II of the Controlled

> Substances Act (CSA), which is administered by the Drug Enforcement

> Administration (DEA). Schedule II provides the maximum amount of control

> possible under the CSA for approved drug products.

>

> In recent months, there have been numerous reports of OxyContin diversion

> and abuse in several states. Some of these reported cases have been

> associated with serious consequences including death. In an effort to

> educate health care providers about these risks, Purdue Pharmaceuticals,

> manufacturer of the product, has issued a warning in the form of a " Dear

> Healthcare Professional " letter. The " Dear Healthcare Professional " letter

> will be distributed widely to physicians, pharmacists, and other

healthcare

> professionals. The letter explains the changes to the labeling including

> proper prescribing information and highlights the problems associated with

> the abuse and diversion of OxyContin.

>

> OxyContin, like morphine, has a high potential for abuse. It is supplied

in

> a controlled-release dosage form and is intended to provide up to 12 hours

> of relief from moderate to severe pain. The tablet must be taken whole and

> only by mouth. When the tablet is crushed and its contents are injected

> intravenously or snorted into the nostrils, the controlled release

mechanism

> is defeated and a potentially lethal dose of oxycodone is released

> immediately.

>

> FDA has worked with Purdue to make specific changes to the OxyContin

> labeling. The new labeling is intended to change prescription practices as

> well as increase the physicians' focus on the potential for abuse, misuse,

> and diversion.

>

> Changes include a " black box warning " , the strongest type of warning for

an

> FDA-approved drug. The new warnings are intended to lessen the chance that

> OxyContin will be prescribed inappropriately for pain of lesser severity

> than the approved use or for other disorders or conditions inappropriate

for

> a Schedule II narcotic.

>

> The FDA-approved indication for OxyContin is for the treatment of patients

> with moderate to severe pain who are expected to need continuous opioids

for

> an extended time. An important factor that must be considered in

prescribing

> OxyContin is the severity of the pain that is being treated, not simply

the

> disease causing the painful symptoms.

>

> FDA continues to recommend that appropriate pain control be provided to

> patients who are living with severe pain. Although abuse, misuse, and

> diversion are potential problems for all opioids, including OxyContin,

> opioids are a very important part of the medical armamentarium for the

> management of pain when used appropriately under the careful supervision

of

> a physician.

>

> Because of the ongoing problem of OxyContin abuse and diversion, FDA has

met

> with DEA, the Substance Abuse and Mental Health Service Agency, the

National

> Institute on Drug Abuse, Purdue, Inc., and others. FDA will continue to

> monitor reports of abuse, misuse, and diversion of OxyContin and other

> opioids and will work with other federal agencies and drug manufacturers

to

> help ensure that these important drugs remain available to appropriate

> patients.

>

> Since all opioids are subject to abuse, misuse, and diversion, FDA is

> encouraging all manufacturers of opioids sold in the U.S. to review

> voluntarily, and revise as necessary, their product's labeling to provide

> adequate warnings and precautions regarding these risks and to promote

> responsible prescribing practices.

>

> For more information, patients and healthcare providers can call Purdue

> Pharmaceuticals at 1-, or go to FDA's website at

> www.fda.gov/cder/drug/infopage/oxycontin/.

>

> OXYCONTIN® Drug Label Warnings

>

> (Oxycodone HCl Controlled-Release) Tablets

> 10 mg 20 mg 40 mg 80 mg* 160 mg*

>

> * 80 mg and 160 mg for use in opioid-tolerant patients only

>

> OT00367

>

> 065570-0F-001

>

> WARNING:

>

> OxyContin is an opioid agonist and a Schedule II controlled substance with

> an abuse liability similar to morphine.

>

> Oxycodone can be abused in a manner similar to other opioid agonists,

legal

> or illicit. This should be considered when prescribing or dispensing

> OxyContin in situations where the physician or pharmacist is concerned

about

> an increased risk of misuse, abuse, or diversion.

>

> OxyContin Tablets are a controlled-release oral formulation of oxycodone

> hydrochloride indicated for the management of moderate to severe pain when

a

> continuous, around-the-clock analgesic is needed for an extended period of

> time.

>

> OxyContin Tablets are NOT intended for use as a prn analgesic.

>

> OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS

> ONLY. These tablet strengths may cause fatal respiratory depression when

> administered to patients not previously exposed to opioids.

>

> OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN,

> CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS

> LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF

> OXYCODONE.

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> To learn more about EDS, visit our website: http://www.ceda.ca

>

>