Clonidine

What is Clonidine?

• Clonidine (Catapres) is a centrally active alpha-adrenergic agonist used predominantly as an antihypertensive agent, usually in combination with other agents.
• Clonidine Hydrochloride Injection, USP is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone.
• Clonidine extended-release tablets (Kapvay) are used alone or in combination with other medications as part of a treatment program to control symptoms of attention deficit hyperactivity disorder.

Clonidine

Clonidine3D

Clonidine3Dan

What are the uses of this medicine?

• Clonidine (Catapres) is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.
• Clonidine Hydrochloride Injection, USP is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone.
• Kapvay (clonidine hydrochloride) is used for the treatment of attention deficit hyperactivity disorder(ADHD).

How does this medicine work?

• Clonidine (klon' i deen) is an antihypertensive agent which acts by stimulation of the alpha 2A subtype of alpha adrenergic receptors in the brainstem, causing a reduction in the sympathic outflow of the central nervous system.
• Decreases in plasma levels of norepinephrine correlate closely with its antihypertensive effects.
• Clonidine is effective in lowering blood pressure and can be used alone or in combination with other antihypertensive medications.
• Clonidine is also used in several other conditions in which central nervous system sympathetic activity is believed to contribute including neuropathy, smoking and alcohol cessation, attention deficit disorder, vascular headache, menopausal symptoms, diabetic diarrhea, and restless leg syndrome.

Who Should Not Use this medicine ?

This medicine cannot be used:

• in patients with known hypersensitivity to clonidine.

Clonidine hydrochloride injection cannot be used:

• in patients with a history of sensitization or allergic reactions to clonidine.
• in the presence of an injection site infection
• in patients on anticoagulant therapy
• in those with a bleeding diathesis

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antidepressants
• beta blockers such as acebutolol (Sectral), atenolol (Tenormin, in Tenoretic), betaxolol, bisoprolol (Zebeta, in Ziac), carvedilol (Coreg), labetalol , metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), pindolol, propranolol (Inderal, Innopran XL, in Inderide), sotalol (Betapace, Sorine), and timolol
• calcium channel blockers such as amlodipine (in Amturnide, Norvasc, in Amturnide, in Tekamlo, others), diltiazem (Cardizem, Dilacor XR, Dilt-CD, Taztia XT, Tiazac, others), felodipine (Plendil), isradipine, nicardipine (Cardene), nifedipine (Adalat CC, Afeditab CR, Procardia), nimodipine, nisoldipine (Sular), and verapamil (Calan, Covera, Verelan, others, in Tarka)
• digoxin (Lanoxin)
• medications for anxiety, mental illness, or seizures
• sedatives
• sleeping pills
• tranquilizers
• tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), maprotiline, nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)

Is this medicine FDA approved?

• Clonidine was approved for use in the United States in 1974 and continues to be widely used with more than 11 million prescriptions being filled yearly. Current approved indications are for treatment of hypertension, but some preparations are also approved for cancer pain management and treatment of attention deficit disorder.
• Off label uses include treatment of Tourette syndrome, migraine headahces, stress and sleep disorders, and to alleviate symptoms of alcohol, nicotine or narcotic withdrawal.

How should this medicine be used?

Recommended dosage: Adults: The dose of clonidine hydrochloride must be adjusted according to the patient’s individual blood pressure response.

The following is a general guide to its administration: Initial Dose:

• 0.1 mg tablet twice daily (morning and bedtime).

Elderly patients may benefit from a lower initial dose.

Maintenance Dose:

• Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved.
• Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness.
• The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses.

Clonidine HCl Injection:

• The recommended starting dose of clonidine hydrochloride injection for continuous epidural infusion is 30 mcg/hr.

Administration:

• Clonidine comes as a tablet to take by mouth.
• The tablet is usually taken two times a day at evenly spaced intervals.
• Take clonidine at around the same times every day.
• Your doctor may start you on a low dose of clonidine and gradually increase your dose, not more than once every week.
• Clonidine may help to control your condition but will not cure it.
• Continue to take clonidine even if you feel well. Do not stop taking clonidine without talking to your doctor.
• If you suddenly stop taking clonidine, it can cause a rapid rise in your blood pressure and symptoms such as nervousness, headache, and uncontrollable shaking of a part of the body.
• Your doctor will probably decrease your dose gradually over 2 to days for the regular tablet and 3 to 7 days for the extended-release tablet.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As tablets for oral administration
• Clonidine Hydrochloride Injection

This medicine is available in fallowing brand namesː

• Catapres; Jenloga

What side effects can this medication cause?

The most common side effects of this medicine include:

• dry mouth
• drowsiness
• dizziness
• constipation
• sedation

The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride may include: Body As A Whole:

• Weakness
• headache
• withdrawal syndrome
• pallor
• positive Coombs’ test
• increased sensitivity to alcohol
• fever

Cardiovascular:

• Orthostatic symptoms
• palpitations
• tachycardia
• bradycardia
• Syncope
• Raynaud’s phenomenon
• congestive heart failure
• electrocardiographic abnormalities (i.e. sinus node arrest, functional bradycardia, high degree AV block and arrhythmias)
• sinus bradycardia
• atrioventricular block

Central Nervous System:

• Nervousness and agitation
• mental depression
• insomnia
• nightmares
• restlessness
• anxiety
• visual and auditory hallucinations
• delirium

Dermatological:

• Rash
• pruritus
• hives
• angioneurotic edema
• urticaria
• alopecia

Gastrointestinal:

• Nausea and vomiting
• anorexia
• malaise
• hepatitis
• parotitis
• constipation
• pseudo-obstruction
• abdominal pain

Genitourinary:

• Decreased sexual activity
• [[[impotence]] and loss of libido
• nocturia
• micturition
• urinary retention

• Hematologic: Thrombocytopenia
• Metabolic: Weight gain; gynecomastia; transient elevation of blood glucose or serum creatine phosphokinase
• Musculoskeletal: Muscle or joint pain
• Oro-otolaryngeal: Dryness of the nasal mucosa
• Ophthalmological: Dryness of eyes, burning of the eyes and blurred vision

What special precautions should I follow?

• Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. When discontinuing therapy with clonidine hydrochloride, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology.
• Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.
• Talk to your doctor about the risks and benefits of using clonidine if you are 65 years of age or older. Older adults should not usually use clonidine because it is not as safe as other medications that can be used to treat the same condition.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking clonidine.
• You should know that clonidine may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
• Ask your doctor about the safe use of alcohol while you are taking clonidine. Alcohol can make the side effects from clonidine worse.
• You should know that clonidine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking clonidine. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.
• Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes.
• Despite wide scale use for many years, clonidine has not been linked definitively to either serum aminotransferase elevations or clinically apparent

liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis.
• Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure.
• clonidine has produced signs of toxicity in children.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• There is no specific antidote for clonidine overdosage.
• Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended.
• Gastric lavage may be indicated following recent and/or large ingestions.
• Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension.
• Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension.
• Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy.
• Dialysis is not likely to significantly enhance the elimination of clonidine.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• No adequate, well-controlled studies have been conducted in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• clonidine hydrochloride

Inactive ingredients:

• starch, corn
• d&c yellow no. 10
• fd&c yellow no. 6
• lactose monohydrate
• magnesium stearate

Who manufactures and distributes this medicine?

Clonidine hydrochloride tablets: Manufactured by:

• Actavis Elizabeth LLC
• Elizabeth, NJ USA

Clonidine HCl Injection: Manufactured by:

• HIKMA FARMACÊUTICA (PORTUGAL), S.A.
• Estrada do Rio da Mó, 8, 8A e 8B – Fervença
• 2705 – 906 Terrugem SNT
• PORTUGAL

Distributed by:

• Hikma Pharmaceuticals USA Inc.
• Berkeley Heights, NJ

What should I know about storage and disposal of this medication?

Clonidine hydrochloride tablets:

• Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).
• Dispense in a tight, light-resistant container as defined in the USP.

Clonidine HCl Injection:

• Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).
• Preservative Free.
• Discard unused portion.

Antihypertensive agents

• Dailymed label info on Clonidine
• FDA Clonidine

Clonidine Resources
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