Nexiclon

Clonidine is a prescription medication used to treat high blood pressure, ADHD, and cancer pain. Clonidine belongs to a group of drugs called centrally acting alpha-agonist hypotensive agents, which work by relaxing the blood vessels and decreasing heart rate. It also prevent pain signals from being sent to the brain. The way it works to treat ADHD is not well understood.

This medication comes in tablet, extended-release tablet, and patch forms. The tablet and extended-release tablet is usually taken twice a day, with or without food. Clonidine also comes as a patch that is placed on the skin once every 7 days.

This medication is also available in an injectable form to be given by a healthcare professional.

Common side effects of clonindine include dry mouth, constipation, and sedation. Clonidine can also cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how this medication will affect you. Alcohol may intensify this side effect.

Clonidine is a prescription medication used to treat high blood pressure, ADHD, and cancer pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• NextWave Pharmaceuticals, Inc.

• Tris Pharma, Inc.

Common side effects of clonidine tablets and extended-release include:

• fatigue
• upper airway tract infection
• irritability
• sore throat
• insomnia
• nightmares
• emotional disorder
• constipation
• nasal congestion
• increased body temperature
• dry mouth
• ear pain

Common side effects of the clonidine patch include:

• dry mouth
• drowsiness
• fatigue
• headache
• insomnia
• dizziness
• dry throat
• constipation
• nausea
• change in taste
• nervousness

Common side effects of clonidine injectable include:

• drop in blood pressure
• dry mouth
• drowsiness
• fatigue
• headache
• insomnia
• dizziness

This is not a complete list of clonidine side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with clonidine. See “Drug Precautions” section.

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

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

• alcohol
• barbiturates such as phenobarbital
• tricyclic antidepressants such as selegiline (Emsam, Eldepryl), amitriptyline (Elavil), or nortriptyline (Aventyl, Pamelor)
• antipsychotics such as haloperidol (Haldol), risperidone (Risperdal), and olanzapine (Zyprexa)
• digoxin (Lanoxin)
• calcium channel blockers such as verapamil (Calan), diltiazem (Cardizem), or amlodipine (Norvasc)
• beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol XL), and atenolol (Tenormin)

This is not a complete list of clonidine drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

Serious side effects have been reported with clonidine including:

• Rash. Use of the clonidine patch may result in a rash, and a switch to clonidine tablets may or may not cause this side effect.
• Hypersensitivity (allergic) reaction. Use of the clonidine patch may result in a rash, and a switch to clonidine tablets may or may not cause this side effect. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • rash
  • itchiness
  • swelling of face or throat
• Skin burns. This side effect has been reported at the patch site in patients wearing the clonidine patch during a magnetic resonance imaging scan (MRI). It is recommended for the physician to have the patch removed before the patient has an MRI done.
• Clonidine can cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how clonidine affects you.
• To avoid withdrawal side effects (e.g. nervousness, headaches, tremors), do not suddenly stop taking clonidine. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.
• Clonidine may worsen pre-existing heart conduction abnormalities, especially if you are taking other drugs similar to the way clonidine works.
• Do not use clonidine hydrochloride extended-release tablets with other medications containing clonidine.
• Do not take clonidine if you have a known hypersensitivity (allergic reaction) to clonidine or to any other component of the tablet or patch forms.

Topical:

• Refer to precautions listed under "Oral" above.
• Talk to your doctor promptly about the possible need to remove the patch if they observe moderate to severe localized erythema and/or vesicle formation at the site of application or generalized skin rash.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of clonidine, there are no specific foods that you must exclude from your diet when receiving clonidine.

Alcohol may intensify some of the side effects of this medication.

Before taking clonidine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• if redness or swelling develops at patch site
• 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.

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

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in clonidine is excreted in human breast milk. The effect of clonidine on the nursing infant is not known.

• Take clonidine exactly as prescribed.
• Clonidine comes as a tablet or a patch.
• To avoid withdrawal side effects (e.g. nervousness, headaches, tremors), do not suddenly stop taking clonidine. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose (tablet), skip the missed dose and take your next dose at the regular time. Do not take two doses of clonidine at the same time.

Oral:

• Clonidine tablet and extended-release tablet are usually taken twice daily, once in the morning and once in the evening, with or without food.

Topical:

• The clonidine patch is applied to the skin once every 7 days. On Day 8, a new patch is applied, and the old patch should be removed. Apply the patch to a hairless area of intact skin (no burns, bruises, or cuts) on the upper outer arm or chest. Each new patch should be applied on a skin site different from the site of the old patch. If the patch loosens during 7-day wearing, the adhesive cover should be applied directly over the patch to ensure good adhesion.
• Discuss with your doctor about what to do if redness or swelling occurs at patch site.

Injectable:

• This medication is also available in an injectable form to be given by a healthcare professional.

Take clonidine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Oral:

• To start therapy, 0.1 mg tablet is given twice daily (morning and bedtime). Elderly patients may need to start from a lower dose. Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. The typical dose range for clonidine tablet is 0.2 to 0.6 mg per day, divided into a morning and an evening dose. Maximum effective dose is 2.4 mg per day, but this dose amount is not commonly used.

Topical:

• To start therapy, the patch dosage should be adjusted according to individual needs, starting with the lowest patch dose (0.1 mg). If after one or two weeks the desired decrease in blood pressure is not achieved, your dose may be increased by your doctor by adding another clonidine 0.1 mg patch or changing to a larger system (0.2 or 0.3 mg).

Injectable:

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

If you take too much clonidine call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If clonidine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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

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