Nexiclon XR™ (clonidine)
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Hypertension

What is it, and why do I need to control it?

What is Blood Pressure?1

The pressure of blood pushing against the walls of your arteries is blood pressure. Your arteries carry blood from your heart to the other parts of your body.

Blood pressure is measured using two numbers: the pressure in your arteries when your heart beats (systolic) and the pressure in your arteries when your heart is between beats (diastolic). The resulting measure is reported as “systolic/diastolic mmHg.”

Less than 120/80 mmHg is considered normal blood pressure.

What is Hypertension?

Hypertension is higher than normal blood pressure. Hypertension affects almost 65 million adults in the United States.2

The American College of Cardiology/American Heart Association Guidelines diagnose patients with high blood pressure if their blood pressure is consistently 130/80 mmHg or higher.3

What are the Risks?

Uncontrolled high blood pressure can lead to complications such as heart attack or stroke, aneurysm, heart failure and kidney problems, among other illnesses.

How do I know if I have High Blood Pressure?

The best way to know if you have high blood pressure is to have your blood pressure checked by your doctor or healthcare provider. High blood pressure is known as “the silent killer,” because there are often no symptoms until damage has been done. That is why you should have your blood pressure checked regularly.

How is High Blood Pressure Controlled?2

There is no cure for high blood pressure. However, it can be controlled in a number of ways. Your doctor can tell you the best way to control your high blood pressure. Only your doctor can tell you if you need to take medicines for hypertension.

You should:

  • Check your blood pressure often
  • If prescribed, take your high blood pressure medicine exactly as your doctor instructs
  • Exercise
  • Eat foods low in salt
  • Keep your weight at a healthy level
  • Don’t smoke
  • Limit alcohol intake
  • Talk to your healthcare professional about your blood pressure

Additional Patient Resources

Additional support and information about hypertension and heart health can be found here.

American Heart Association: https://www.heart.org

Million Hearts: https://millionhearts.hhs.gov/

Centers for Disease Control: https://www.cdc.gov/heartdisease/index.htm

References:

  1. Centers for Disease Control and Prevention. “High Blood Pressure Symptoms and Causes.” https://www.cdc.gov/bloodpressure/about.htm. Accessed March 16, 2021.
  2. United States Food & Drug Administration. “High Blood Pressure (Hypertension).” https://www.fda.gov/consumers/women/high-blood-pressure-hypertension. Accessed March 16, 2021
  3. Whelton PK, Carey RM, Aronow, WS, Casey DE, Collins KJ, Himmelfarb CD, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines external icon. J Am Coll Cardiol. 2018;71(19):e127–e248.
  4. https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/symptoms-causes/syc-20373410. Accessed March 16, 2021.

Important Safety Information

NEXICLON™ XR (clonidine) Extended-Release Tablets is indicated in the treatment of hypertension. NEXICLON XR may be employed alone or concomitantly with other antihypertensive agents.

IMPORTANT SAFETY CONSIDERATIONS

Contraindications

NEXICLON XR should not be used in patients with known hypersensitivity to clonidine (rash, angioedema, hives).

Warnings and Precautions

Patients should not discontinue therapy without consulting a physician. Dose reduction should be performed gradually over a 2- to 4-day period to avoid withdrawal symptomatology. Rare instances of hypertensive encephalopathy, cerebrovascular accidents, and death have been reported after clonidine withdrawal.

Monitor carefully and titrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure.

Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine.

In perioperative use, NEXICLON XR may be administered up to 28 hours prior to surgery and resumed the following day.

Adverse Reactions

There is very little experience with NEXICLON XR in controlled trials. Based on this limited experience, the adverse event profile of NEXICLON XR appears similar to that of immediate release clonidine formulation. The most commonly expected adverse reactions are dry mouth, drowsiness, and dizziness.

Drug Interactions

No drug interaction studies have been conducted with NEXICLON XR; however the following have been reported with other oral formulations of clonidine:

  • Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs.
  • Tricyclic antidepressants may reduce the hypotensive effect of clonidine, necessitating an increase in clonidine dose.
  • Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Use in Specific Populations

  • Pregnancy Category C. Clonidine is secreted in human milk.
  • Safety and effectiveness in pediatric patients have not been established.
  • Dose may need adjustment in patients with renal impairment.
  • Elderly patients may benefit from a lower initial dose.

Please see Full Prescribing Information for additional product information.

You are encouraged to report negative side effects of prescription drugs to Athena Bioscience, LLC at 1-833-874-2664 or to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.