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OxyContin tablets are taken every 12 hours. Most pain medications must be taken every three to six hours. 

OxyContin is available in three tablet strengths (10, 20, and 40 mg). 

OxyContin tablets are available by prescription only. The tablets are to be taken whole. Taking broken, chewed, or crushed tablets could lead to the rapid release and absorption of a potentially toxic dose of oxycodone. 

OxyContin is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. OxyContin is contraindicated in any patients who has or is suspected of having paralytic ileus. 

OxyContin, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. OxyContin may produce orthostatic hypotension opioids in ambulatory patients. OxyContin, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. 
GENERAL INFORMATION

OxyContin has been approved for the treatment of moderate to severe pain which requires treatment for more than a few days, such as the pain associated with musculoskeletal conditions.

OxyContin tablets are taken every 12 hours. Most pain medications must be taken every three to six hours.

OxyContin is available in three tablet strengths (10, 20, and 40 mg).

OxyContin tablets
opioids are available by prescription only. The tablets are to be taken whole. Taking broken, chewed, or crushed tablets could lead to the rapid release and absorption of a potentially toxic dose of oxycodone.

OxyContin is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. OxyContin is contraindicated in any patients who has or is suspected of having paralytic ileus.

OxyContin, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. OxyContin may produce orthostatic hypotension in ambulatory patients. OxyContin, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Clinical Results

In clinical trials of OxyContin tablets, involving more than 700 patients, onset of pain relief occurred within one hour for most patients.

Side Effects

The most serious risk associated with opioids, including OxyContin, is respiratory depression. Common opioid side effects are constipation, nausea, sedation, dizziness, vomiting, pruritis, headache, dry mouth, sweating, and weakness.

Additional Information

Among the most common causes of persistent, debilitating pain are arthritis, lower back conditions, injuries, and cancer. For example, more than eight million Americans are permanently disabled by
back pain--with 65,000 new cases diagnosed each year.

In advanced stages of cancer, nearly 75% of cancer patients have pain that is moderate, severe, or very severe. In earlier stages, 30% to 45% of cancer patients experience moderate to severe pain.

DESCRIPTION

OxyContin® (oxycodone hydrochloride controlled-release) tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, 80 mg, and 160 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:
C18H21NO4•HCl MW 351.83

The chemical formula is 4, 5-epoxy-14-hydroxy-3-methoxy- 17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hydroxypropyl methylcellulose, lactose, magnesium stearate, povidone, red iron oxide (20 mg strength tablet only), stearyl alcohol, talc, titanium dioxide, triacetin, yellow iron oxide (40 mg strength tablet only), yellow iron oxide with FD&C blue No. 2 (80 mg strength tablet only), FD&C blue No. 2 (160 mg strength tablet only) and other ingredients.

OxyContin® 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID TOLERANT PATIENTS ONLY.

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COLUMBUS, Ohio (AP) - Sally Royster cried when her orthopedic surgeon said he would no longer prescribe OxyContin for
the chronic back pain that leaves her unable to walk. She was told prescriptions for the drug were under too much scrutiny. 
Sheila Lambert sent the medical history of her degenerative spinal disease to 25 doctors and phoned 100 others but all said they weren't taking new patients or didn't take pain patients.

``If they hear you have been on OxyContin they treat you like an addict,'' said Lambert of Jonesville, Va.

Across the country, chronic pain sufferers like Royster, 50, and Lambert, 41, are finding it increasingly difficult to obtain the powerful prescription painkiller, dubbed ``Hillbilly Heroin'' because of its burgeoning abuse as a narcotic in Appalachia.

They say that abuse - and the response to it by law makers and law enforcers - has made doctors increasingly unwilling to
provide the drug, even to the cancer patients and chronic pain sufferers who need it.

Royster searched seven months before she found a specialist in late September near her Cincinnati-area home that would prescribe OxyContin. Until then, her primary care physician agreed to prescribe the drug, but only on an interim basis, she said.

While most strong pain medicines last only about four hours, OxyContin gives a steady 12-hour release and has fewer side
effects. But to addicts who chew the pill or crush it and snort or inject the powder, OxyContin produces a quick, heroin-like high that can kill.

Since 1998, OxyContin and oxycodone, the narcotic's active ingredient, have been linked to more than 100 deaths nationwide.

The drug's maker, Purdue Pharma, pulled its strongest dosage off the market in May and issued tamperproof prescription pads. But pharmacies are still being robbed for OxyContin and the drug is still being abused. One pharmacy in St. Albans, Vt., stopped stocking the painkiller after thieves broke in four times this summer looking for OxyContin.

The Drug Enforcement Administration (DEA) reports that, in the United States, oxycodone products, including OxyContin, are frequently abused pharmaceuticals. The pharmacological effects of OxyContin make it a suitable substitute for heroin; therefore, it is attractive to the same abuser population. The illegal diversion, distribution, and abuse of oxycodone products, particularly OxyContin, appear to be concentrated most heavily in the East, according to respondents to the National Drug Intelligence Center (NDIC) National Drug Threat Survey 2000 and DEA reporting. OxyContin Tablet, commonly referred to as OxyContin, has become the oxycodone product of choice in Maine, Ohio, and West Virginia, and in portions of eastern Kentucky, Maryland, western Pennsylvania, and rural southwestern Virginia. 

Oxycodone is a central nervous system depressant. Oxycodone's action appears to work through stimulating the opioid receptors found in the central nervous system that activate responses ranging from analgesia to respiratory depression to euphoria. People who take the drug repeatedly can develop a tolerance or resistance to the drug's effects. . OxyContin was developed and patented in 1996 by Purdue Pharma L.P. and was originally available in 10 milligram (mg), 20 mg, 40 mg, and 80 mg tablets. A 160 mg tablet became available in July 2000. By comparison, Percocet and Tylox contain 5 mg of oxycodone and Percodan-Demi contains just 2.25 mg. The strength, duration, and known dosage of OxyContin are the primary reasons the drug is attractive to both abusers and legitimate users.

Several deaths have resulted specifically from the abuse of OxyContin in Kentucky, Ohio, Virginia, and West Virginia. The Pike County, Kentucky, Coroner reported 19 OxyContin-related deaths during calendar year 2000. In December 2000, seven OxyContin overdose deaths were reported in Southeastern Kentucky by two Kentucky State Police posts. The Logan Daily News reported in October 2000 that four Hocking County, Ohio, residents overdosed on OxyContin over an 18-day period. Two of the four died. There have been at least four OxyContin overdose deaths in Pulaski, Virginia, since 1998. In July 2000, The Williamson Daily reported five OxyContin-related overdose deaths in southwestern West Virginia since May 2000.

The illegal use of OxyContin, as well as other prescription drugs, has increased recently. The 1999 National Household Survey on Drug Abuse (NHSDA) showed that approximately 9% of the U.S. population (19.9 million people) have used pain relievers illegally in their lifetime. An estimated 1.6 million Americans used prescription-type pain relievers non-medically for the first time in 1998. This represents a significant increase since the 1980s, when there were generally fewer than 500,000 initiates per year. Among youth age 12–17, the incidence rate increased from 6.3 per 1,000 potential new users in 1990 to 32.4 per 1,000 potential new users in 1998. For young adults age 18–25, there was also an increase in the rate of first use between 1990 and 1998 (from 7.7 to 20.3 per 1,000 potential new users).

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In 1999, an estimated 4 million people, about 2 percent of the population age 12 and older, were non-medically using prescription drugs. Of these, 2.6 million misused pain relievers, 1.3 million misused sedatives and tranquilizers, and 0.9 million misused stimulants.1 While prescription drug abuse affects many Americans, some trends of particular concern can be seen among older adults, adolescents, and women. Data suggest that up to 17 percent of adults age 60 or older may be affected by prescription drug abuse. Older people are prescribed medications about three times more frequently than the general population, and have poorer compliance with directions for use. 
The National Household Survey on Drug Abuse numbers indicate that the sharpest increases in new users of prescription drugs for non-medical purposes occur in 12 to 17 and 18 to 25 year-olds. Among 12 to 14 year-olds, psychotherapeutics (e.g., pain killers, tranquilizers, sedatives, and stimulants) were reported to be one of two primary drugs used.

In the Monitoring the Future Survey of 8th, 10th, and 12th graders nationwide, researchers reported that for barbiturates, tranquilizers, and narcotics other than heroin, general long-term declines in use in the 1980s leveled-off in the early 1990s, with modest increases again in the mid-1990s.

Overall, men and women have roughly similar rates of nonmedical use of prescription drugs, with the exception of 12 to 17 year olds. In this age group, young women are more likely th

an young men to use psychotherapeutic drugs nonmedically. Also, among women and men who use sedatives, anti-anxiety drugs, and hypnotics, women are almost twice as likely to become addicted.3

The Drug Abuse Warning Network, which collects data on drug-related hospital emergency room episodes, reported that mentions of hydrocodone as a cause for visiting an emergency room increased 37 percent among all age groups from 1997 to 1999. Also, mentions of clonazepam increased 102 percent since 1992

Opioids are commonly prescribed because of their effective analgesic or pain relieving properties. Many studies have shown that properly managed medical use of opioid analgesic drugs is safe and rarely causes clinical addiction, which is defined as compulsive, often uncontrollable use. Taken exactly as prescribed, opioids can be used to manage pain effectively. 
Among the drugs that fall within this class - sometimes referred to as narcotics - are morphine, codeine, and related drugs. Morphine is often used before or after surgery to alleviate severe pain. Codeine is used for milder pain. Other examples of opioids that can be prescribed to alleviate pain include oxycodone (OxyContin-an oral, controlled release form of the drug); propoxyphene (Darvon); hydrocodone (Vicodin); hydromorphone (Dilaudid); and meperidine (Demerol), which is used less often because of its side effects. In addition to their effective pain relieving properties, some of these drugs can be used to relieve severe diarrhea (Lomotil, for example, which is diphenoxylate) or severe coughs (codeine).

Opioids 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. In addition to relieving pain, opioid drugs can affect regions of the brain that mediate what we perceive as pleasure, resulting in the initial euphoria that many opioids produce. They can also produce drowsiness, cause constipation, and, depending upon the amount of drug taken, depress breathing. Taking a large single dose could cause severe respiratory depression or be fatal.

Opioids may interact with other drugs and are only safe to use with other drugs under a physician's supervision. Typically, they should not be used with substances such as alcohol, antihistamines, barbiturates, or benzodiazepines. These drugs slow down breathing, and their combined effects could risk life-threatening respiratory depression. Chronic use of opioids can result in tolerance to the drugs so that higher doses must be taken to obtain the same initial effects. Long-term use also can lead to physical dependence - the body adapts to the presence of the drug and withdrawal symptoms occur if use is reduced abruptly.

Symptoms of withdrawal can include restlessness, muscle and bone pain, insomnia, diarrhea, vomiting, cold flashes with goose bumps ("cold turkey"), and involuntary leg movements.
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. 
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.

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, oxy, oxycontin online, oxycodone information. buying oxycontin online.

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.
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