Duraclon

Patients should be instructed about the risks of rebound hypertension and warned not to discontinue clonidine except under the supervision of a physician. Patients should notify their physician immediately if clonidine administration is inadvertently interrupted for any reason. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of the potential sedative and hypotensive effects of epidural clonidine. They should also be informed that sedative effects may be increased by CNS-depressing drugs such as alcohol and barbiturates, and that hypotensive effects may be increased by opiates.

Before receiving Duraclon, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of heart problems
• have hypertension due to pheochromocytoma (tumor of the adrenal glands)
• are planning to undergo surgery
• have kidney problems
• have liver problems
• wear contact lenses
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Duraclon falls into category C. No adequate studies have been done in pregnant women. Animal study results do not always equal that of human response. Duraclon should be used during pregnancy only if clearly needed. It is not known if Duraclon will harm your unborn baby.

The recommended starting dose of Duraclon (clonidine) for epidural infusion is 30 mcg/hour. Dosage may be increased or decreased depending on pain relief and occurrence of side effects.

The 500 mcg/mL injectable strength product must be diluted prior to use in an appropriate solution.

NOTE: Duraclon injection (epidural clonidine) is not recommended for obstetrical, postpartum, or perioperative pain management. The risk of hemodynamic instability, especially hypotension and bradycardia, from epidural Duraclon may be unacceptable in these patients. However, in a rare obstetrical, postpartum or perioperative patient, potential benefits may outweigh the possible risks.

In the U.S.

• Duraclon

Available Dosage Forms:

• Solution
• Injectable

Therapeutic Class: Analgesic

Pharmacologic Class: Alpha-2 Adrenergic Agonist

Clonidine is given continuously as an epidural infusion (run around the spinal cord) using an infusion pump. The pump and its tube should be checked regularly to make sure the clonidine flow has not stopped accidentally. The injection or catheter site should also be checked regularly for signs of infection.

If you are using this medicine at home, make sure you understand exactly how to use it.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For pain:
    • Adults—30 mcg per hour given as a continuous infusion.
    • Children—Dosage is based on body weight and must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Tell your doctor immediately if you think the clonidine has stopped for any reason.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

Check with your doctor as soon as possible if any of the following side effects occur:

• Dizziness, light-headedness, or fainting
• slow heartbeat

• Chest pain
• extremely shallow or slow breathing
• fast heartbeat
• fever
• hallucinations (seeing, feeling, or hearing things that are not there)
• mental depression
• sleepiness (excessive)
• vomiting

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Anxiety
• confusion
• dry mouth
• nausea
• sleepiness

• Constipation
• ringing, buzzing, or other unexplained noises in the ears
• sweating, unusual
• weakness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Agitation
• headache
• nervousness
• pounding heartbeat
• shaking or trembling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Duraclon affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• If you are taking this medicine and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help with dry mouth. See a dentist often.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• If you are 65 or older, use Duraclon with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Applies to clonidine: oral suspension extended release, oral tablet, oral tablet extended release

Other dosage forms:

• epidural injectable, epidural solution
• transdermal patch extended release

Along with its needed effects, clonidine (the active ingredient contained in Duraclon) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clonidine:

• Mental depression
• swelling of the feet and lower legs

• Anxiety
• blistering, burning, crusting, dryness, or flaking of the skin
• chest pain or discomfort
• confusion as to time, place, or person
• decreased urine output
• dilated neck veins
• drowsiness
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• fever
• general feeling of discomfort or illness
• holding false beliefs that cannot be changed by fact
• hyperventilation
• irregular breathing
• irritability
• itching, scaling, severe redness, soreness, or swelling of the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness, dizziness, or fainting
• mental depression
• paleness or cold feeling in the fingertips and toes
• pounding, slow heartbeat
• problems in urination or increase in the amount of urine
• raised red swellings on the skin, lips, tongue, or in the throat
• restlessness
• seeing or hearing things that are not there
• shaking
• shortness of breath
• skin rash
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• tingling or pain in the fingers or toes when exposed to cold
• trouble with sleeping
• troubled breathing
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vivid dreams or nightmares
• weight gain
• wheezing

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

• Dizziness (extreme) or faintness
• feeling cold
• pinpoint pupils of the eyes
• unusual tiredness or weakness (extreme)

Some side effects of clonidine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation

• Darkening of the skin
• decreased sexual ability
• dry, itching, or burning eyes
• loss of appetite
• nausea or vomiting

• Blurred vision
• decreased interest in sexual intercourse
• hair loss or thinning of the hair
• inability to have or keep an erection
• leg cramps
• loss in sexual ability, desire, drive, or performance
• muscle or joint pain
• pale skin
• swelling of the breasts or breast soreness in both females and males
• weakness