MS CONTIN® CII Rx
(Morphine Sulfate Controlled-Release) Tablets 15 mg 30 mg 60 mg 100 mg* 200 mg*

*100 and 200 mg for use in opioid-tolerant patients only

WARNING:

MS CONTIN contains morphine sulfate, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Morphine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing MS CONTIN in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

MS CONTIN Tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

MS CONTIN Tablets are NOT intended for use as a prn analgesic. MS CONTIN 100 and 200 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.

MS CONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MS CONTIN TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

DESCRIPTION

Chemically, morphine sulfate is 7,8-didehydro-4,5a-epoxy-17-methylmorphinan-3,6a-diol sulfate (2:1) (salt) pentahydrate.

MS CONTIN® (morphine sulfate controlled-release) Tablets are opiate analgesics supplied in 15, 30, 60, 100 and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). MS CONTIN® Controlled-release Tablets 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg contain the following inactive ingredients: cetostearyl alcohol, hydroxyethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, talc and titanium dioxide.

MS CONTIN Controlled-release Tablets 15 mg also contains FD&C Blue No. 2, lactose and polysorbate 80.

MS CONTIN Controlled-release Tablets 30 mg also contains D&C Red No. 7, FD&C Blue No. 1,
lactose and polysorbate 80.

MS CONTIN Controlled-release Tablets 60 mg also contains D&C Red No. 30, D&C Yellow No. 10,
hydroxypropyl cellulose, and lactose.

MS CONTIN Controlled-release Tablets 100 mg also contains black iron oxide.

MS CONTIN Controlled-release Tablets 200 mg also contains D&C Yellow No. 10, FD&C Blue No.
1, and hydroxypropyl cellulose.

Special Populations

Renal Impairment
Morphine pharmacokinetics are altered in patients with renal failure. Clearance is decreased and the metabolites, M3G and M6G, may accumulate to much higher plasma levels in these patients as compared to patients with normal renal function.

WARNINGS

MS CONTIN (MORPHINE SULFATE CONTROLLED-RELEASE) TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MS CONTIN® TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

MS CONTIN 100 AND 200 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.

MS CONTIN 100 AND 200 mg Tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. Care should be taken in the prescribing of these tablet strengths. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

MS CONTIN is intended for oral use only as an intact tablet. Abuse of the crushed tablet poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. Due to the presence of talc as one of the excipients in tablets, parenteral abuse 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.

Interactions with Alcohol and Drugs of Abuse

Morphine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, hypotension, and profound sedation or coma may result. (See WARNINGS: Interactions with other CNS Depressants.)

Information for Patients/Caregivers

If clinically advisable, patients receiving MS CONTIN® or their caregivers should be given the following information by the physician, nurse, or pharmacist. Therefore, you are instructed as follows:

Patients should be advised that MS CONTIN Tablets contain morphine and should be taken only as directed.

Patients should be advised that MS CONTIN Tablets were designed to work properly only if swallowed whole. MS CONTIN Tablets will release all of their morphine if split, divided, broken, chewed, dissolved, or crushed resulting in the risk of a fatal overdose.

Patients should be advised not to change the dose of MS CONTIN without consulting their physician.

Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.

MS CONTIN may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on MS CONTIN or whose dose has been changed should refrain from dangerous activity until it is established that they are not adversely affected.

MS CONTIN should not be taken with alcohol or other CNS depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician because dangerous additive effects may occur resulting in serious injury or death.

Women of childbearing potential who become or are planning to become pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.

Patients should be advised that if they have been receiving treatment with MS CONTIN for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the MS CONTIN dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.

MS CONTIN 100 mg and 200 mg Tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. Special care must be taken to avoid accidental ingestion or the use by individuals (including children) other than the patient for whom it was originally prescribed, as such unsupervised use may have severe, even fatal, consequences.

Patients should be advised that MS CONTIN® is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

Patients should be advised that they may pass empty matrix "ghosts" (tablets) via colostomy or in the stool, and that this is of no concern since the active medication has already been absorbed.

Patients should be instructed to keep MS CONTIN in a secure place out of the reach of children. When MS CONTIN is no longer needed, the unused tablets should be destroyed by flushing down the toilet.

MS CONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO OTHER OPIOID AGONISTS. MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION.

MS CONTIN TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MS CONTIN TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

You have been given Oxycodone as part of your peri- and postoperative pain management. Please read the following instructions and ask your physician if you have any questions.

DESCRIPTION

All strengths of OXYCODONE also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake.

Information for Patients/Caregivers:

You need to know the following information prior to using OXYCODONE tablets.

Patients should be aware that OXYCODONE tablets contain oxycodone, which is a morphine-like substance.

Patients should be instructed to keep OXYCODONE tablets in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.

When OXYCODONE tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.

Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.

Patients should be advised that OXYCODONE tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).

Patients should not combine OXYCODONE tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, OXYCODONE tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.

The safe use of OXYCODONE tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking OXYCODONE tablets.

Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue OXYCODONE tablets because of the potential for serious adverse reactions to nursing infants.

Patients who are treated with OXYCODONE tablets for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.

Patients should be advised that OXYCODONE tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

OXYCONTIN® CII Rx
(OXYCODONE HCI CONTROLLED-RELEASE) TABLETS
10 mg 15 mg 20 mg 30 mg 40 mg 60 mg* 80 mg* 160 mg*

[Purdue Pharma L.P.]

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

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 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of 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.

Special Populations

Elderly

The plasma concentrations of oxycodone are only nominally affected by age, being 15% greater in elderly as compared to young subjects.

Gender

Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on a body weight adjusted basis. The reason for this difference is unknown.

Renal Impairment

Data from a pharmacokinetic study involving 13 patients with mild to severe renal dysfunction (creatinine clearance <60 mL/min) show peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher, respectively, and AUC values for oxycodone, noroxycodone, and oxymorphone 60%, 50%, and 40% higher than normal subjects, respectively. This is accompanied by an increase in sedation, but not by differences in respiratory rate, pupillary constriction, or several other measures of drug effect. There was an increase in t½ of elimination for oxycodone of only 1 hour (see PRECAUTIONS).

Hepatic Impairment

Data from a study involving 24 patients with mild to moderate hepatic dysfunction show peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher, respectively, than normal subjects. AUC values are 95% and 65% higher, respectively. Oxymorphone peak plasma concentrations and AUC values are lower by 30% and 40%. These differences are accompanied by increases in some, but not other, drug effects. The t½ elimination for oxycodone increased by 2.3 hours (see PRECAUTIONS).

WARNINGS

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.

OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

You as the patients are instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

Ambulatory Surgery and Postoperative Use

OxyContin is not indicated for pre-emptive analgesia (administration pre-operatively for the management of postoperative pain).

OxyContin is not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.

OxyContin is not indicated for pain in the postoperative period if the pain is mild or not expected to persist for an extended period of time.

OxyContin is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (See American Pain Society guidelines).

Patients who are already receiving OxyContin® Tablets as part of ongoing analgesic therapy may be safely continued on the drug if appropriate dosage adjustments are made considering the procedure, other drugs given, and the temporary changes in physiology caused by the surgical intervention (see DOSAGE AND ADMINISTRATION).

OxyContin and other morphine-like opioids have been shown to decrease bowel motility. Ileus is a common postoperative complication, especially after intra-abdominal surgery with opioid analgesia. Caution should be taken to monitor for decreased bowel motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented.

Information for Patients/Caregivers

If clinically advisable, patients receiving OxyContin Tablets or their caregivers should be given the following information by the physician, nurse, pharmacist, or caregiver. Therefore, you are instructed that:

Patients should be aware that OxyContin Tablets contain oxycodone, which is a morphine-like substance.

Patients should be advised that OxyContin Tablets were designed to work properly only if swallowed whole. OxyContin Tablets will release all their contents at once if broken, chewed, or crushed, resulting in a risk of fatal overdose.

Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.

Patients should be advised not to adjust the dose of OxyContin® without consulting the prescribing professional.

Patients should be advised that OxyContin may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).

Patients should not combine OxyContin with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.

Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.

Patients should be advised that OxyContin is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

Patients should be advised that they may pass empty matrix "ghosts" (tablets) via colostomy or in the stool, and that this is of no concern since the active medication has already been absorbed.

Patients should be advised that if they have been receiving treatment with OxyContin for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the OxyContin dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.

Patients should be instructed to keep OxyContin in a secure place out of the reach of children. When OxyContin is no longer needed, the unused tablets should be destroyed by flushing down the toilet.

Patients should not combine OXYCONTIN tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, OXYCONTIN tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.

The safe use of OXYCONTIN tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking OXYCONTIN tablets.

Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue OXYCONTIN tablets because of the potential for serious adverse reactions to nursing infants.

Patients who are treated with OXYCONTIN tablets for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.

Patients should be advised that OXYCONTIN tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

DESCRIPTION

All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg and the 7.5 mg/500 mg strengths contain FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg and 10 mg/650 mg strengths contain D&C Yellow No. 10 Aluminum Lake.

Information for Patients/Caregivers:

You need to know the following information prior to using PERCOCET tablets.

Patients should be aware that PERCOCET tablets contain oxycodone, which is a morphine-like substance.

Patients should be instructed to keep PERCOCET tablets in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.

When PERCOCET tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.

Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.

Patients should be advised that PERCOCET tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).

Patients should not combine PERCOCET tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, PERCOCET tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.

The safe use of PERCOCET tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking PERCOCET tablets.

Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue PERCOCET tablets because of the potential for serious adverse reactions to nursing infants.

Patients who are treated with PERCOCET tablets for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.

Patients should be advised that PERCOCET tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

DESCRIPTION

Valium (diazepam) is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13CIN20 and the molecular weight is 284.75. The structural formula is as follows:

Valium is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate with the following dyes: 5-mg tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; 10-mg tablets contain FD&C Blue No. 1. Valium 2-mg tablets contain no dye.

Information for Patients

To assure the safe and effective use of benzodiazepines, benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug. The risk of dependence increases with duration of treatment; it is also greater in patients with a history of alcohol or drug abuse.

Patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during Valium therapy. As is true of most CNS-acting drugs, patients receiving Valium should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.

Patients should be instructed to keep VALIUM tablets in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.

When VALIUM tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.

Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.

Patients should be advised that VALIUM tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).

Patients should not combine VALIUM tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, VALIUM tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.

The safe use of VALIUM tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking VALIUM tablets.

Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue VALIUM tablets because of the potential for serious adverse reactions to nursing infants.

Patients who are treated with VALIUM tablets for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.

Patients should be advised that VALIUM tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

VICODIN ES® CIII Rx
(hydrocodone bitartrate and
acetaminophen tablets, USP)
7.5 mg/750 mg
Rx only

DESCRIPTION:

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is:

4,5a-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5).

It has the following structural formula:
Each VICODIN ES Tablet contains:
Hydrocodone Bitartrate 7.5 mg
Acetaminophen 750 mg
In addition, each tablet contains the following inactive ingredients: Colloidal silicon dioxide, pregelatinized starch, magnesium stearate, croscarmellose sodium, povidone, and stearic acid.

INDICATIONS AND USAGE:

VICODIN ES Tablets are indicated for the relief of moderate to moderately severe pain.

CONTRAINDICATIONS:

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.
Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

WARNINGS:

Respiratory Depression

At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Misuse, Abuse, and Diversion of Opioids

VICODIN ES contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

VICODIN ES can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing VICODIN ES in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).

Information for Patients/Caregivers

If clinically advisable, patients receiving VICODIN® or their caregivers should be given the following information by the physician, nurse, or pharmacist. Therefore, you are instructed as follows:

Patients should be advised that VICODIN Tablets contain morphine and should be taken only as directed.

Patients should be advised that VICODIN Tablets were designed to work properly only if swallowed whole. VICODIN Tablets will release all of their medication if split, divided, broken, chewed, dissolved, or crushed resulting in the risk of a fatal overdose.

Patients should be advised not to change the dose of VICODIN without consulting their physician.

Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.

VICODIN may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on VICODIN or whose dose has been changed should refrain from dangerous activity until it is established that they are not adversely affected.

VICODIN should not be taken with alcohol or other CNS depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician because dangerous additive effects may occur resulting in serious injury or death.

Women of childbearing potential who become or are planning to become pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.

Patients should be advised that if they have been receiving treatment with VICODIN for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the VICODIN dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.

Patients should be advised that Vicodin® is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
Patients should be advised that they may pass empty matrix "ghosts" (tablets) via colostomy or in the stool, and that this is of no concern since the active medication has already been absorbed.

Patients should be instructed to keep VICODIN in a secure place out of the reach of children.

When VICOOIN is no longer needed, the unused tablets should be destroyed by flushing down the toilet.

Disclosure On The Impact Of Health Care Reform On Your Care

I hereby ACKNOWLEDGE that my doctor will make every attempt to deliver the best care possible in the context of the dynamically changing health care environment. where there is an increasing amount of regulation and rules as to appropriateness and medical necessity of procedures and surgeries.   In fact, your doctor is subject to such Medical Necessity and Appropriateness of Procedure Rules imposed by insurance companies, hospitals and surgery centers, where providers at the Center For Advanced Spine Care are currently performing procedures and surgeries at.   As a result, the treatment recommendation that your doctor/surgeon may make could be affected by these rules and may not be necessarily the most appropriate or preferred treatment in his or her clinical judgement.   In addition, procedures and surgeries may not be authorized and your doctor may simply not be able to perform certain procedures on you.  With the transition of our local health care system from a Clinical Guidelines based system to a Rules based system, your doctor may not be able to provide the preferred recommended care given those newly imposed constraints.