Drug Profiles:
oxycodone HCl, controlled-release
OxyContin®

CAUTION: Federal law prohibits dispensing without prescription.

Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For narcotic analgesics, the following should be considered:

Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to any of the narcotic analgesics. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy-
FDA pregnancy category B. This means that it is unlikely to cause birth defects. However, oxycodone may cause addiction and withdrawal symptoms, difficulty breathing, as well as other harmful effects in a newborn baby when taken during pregnancy. Do not take oxycodone without first talking to your doctor if you are pregnant.

Breast-feeding-
Oxycodone may cause addiction and withdrawal symptoms, difficulty breathing, and sedation in a nursing infant. Do not take oxycodone without first talking to your doctor if you are breast-feeding a baby.

Children-
Breathing problems may be especially likely to occur in children younger than 2 years of age. These children are usually more sensitive than adults to the effects of narcotic analgesics. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines.

Older adults-
Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects, especially breathing problems, during treatment.

Other medicines-
Oxycodone may increase the effects of other drugs that cause drowsiness. Dangerous sedation, dizziness, or drowsiness may occur if oxycodone is taken with any of these medications, including:

• antidepressants
• antihistamines
• pain relievers
• anxiety medicines
• seizure medicines
• muscle relaxants.

Other medical problems-
Oxycodone is habit forming and should only be used under close supervision by patients with an alcohol or drug addiction. Be sure to tell your doctor if you have:

• kidney disease
• liver disease
• asthma
• urinary retention
• an enlarged prostate
• hypothyroidism
• seizures or epilepsy
• gallbladder disease
• head injury
• Addison's disease

Proper Use of This Medicine
It is important to use this medicine properly:

• Take oxycodone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Oxycodone can be taken with food or milk if stomach upset occurs.
• Never take more oxycodone than is prescribed for you. Taking too much oxycodone could result in serious side effects, even death. If your pain is not being adequately treated, talk to your doctor.
• Do not crush, chew, or break controlled-release forms of oxycodone such as Oxycontin. Swallow them whole. They are specially formulated to release oxycodone slowly into your system. Breaking them would cause too much drug to be released into the blood at one time leading to a potentially fatal dose of oxycodone.
• Occasionally, empty Oxycontin tablets may be passed out in the stool. This is not a problem. The active medication has been absorbed in the body and the empty tablet shell may appear in the stool.
• To ensure that you get a correct dose, measure the liquid form of oxycodone with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
• Do not stop taking oxycodone suddenly if you have been taking it continuously for more than 5 to 7 days. Stopping suddenly could cause withdrawal symptoms and make you uncomfortable. Your doctor may want to gradually reduce the dose.
• Increasing the amount of fiber and water (six to eight full glasses) in your diet may alleviate constipation.
• Do not share this medication with anyone else.

Dosing-
The dose of citalopram will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of citalopram. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• Adults—Your doctor will determine the dose according to your individual needs. To be helpful, these medicines need to be taken two times a day at regularly scheduled times.
• Children—Use and dose must be determined by your doctor.

Missed Dose-
Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking the next dose.

Storage-
To store this medicine:

• Keep out of the reach of children. Overdose is very dangerous in young children.
• Store away from heat and direct light.
• Do not store tablets or capsules in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

• If you will be taking this medicine for a long time (for example, for several months at a time), your doctor should check your progress at regular visits.
• Narcotic analgesics will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicines including other narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.
• This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
• Dizziness, light-headedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
• Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or light-headedness, that may occur.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.
• Narcotic analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
• If you have been taking this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, in order to lessen the chance of withdrawal side effects.
• If you think you or someone else may have taken an overdose, get emergency help at once .

Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

• Cold, clammy skin; confusion; convulsions (seizures); dizziness (severe); drowsiness (severe); low blood pressure; nervousness or restlessness (severe); pinpoint pupils of eyes; slow heartbeat; slow or troubled breathing; weakness (severe)

Also, check with your doctor as soon as possible if any of the following side effects occur:

• Less common or rare: fast, slow, or pounding heartbeat; feelings of unreality; hallucinations (seeing, hearing, or feeling things that are not there); hives, itching, or skin rash; increased sweating; irregular breathing; mental depression or other mood or mental changes; ringing or buzzing in the ears; shortness of breath, wheezing, or troubled breathing; swelling of face; trembling or uncontrolled muscle movements; unusual excitement or restlessness (especially in children)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common: Dizziness, light-headedness, or feeling faint; drowsiness; nausea or vomiting
• Less common: Blurred or double vision or other changes in vision; constipation (more common with long-term use and with codeine); decrease in amount of urine; difficult or painful urination; dry mouth; false sense of well-being; frequent urge to urinate; general feeling of discomfort or illness; headache; loss of appetite; nervousness or restlessness; nightmares or unusual dreams; stomach cramps or pain; trouble in sleeping; unusual tiredness or weakness

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Body aches; diarrhea; fast heartbeat; fever, runny nose, or sneezing; gooseflesh; increased sweating; increased yawning; loss of appetite ; nausea or vomiting; nervousness, restlessness, or irritability; shivering or trembling; stomach cramps; trouble in sleeping; unusually large pupils of eyes; weakness

Brand Names-

U.S. and Canada: OxyContin®