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CLONIDINE HYDROCHLORIDE- clonidine tablet, extended release


  1. Patient Information
  2. Clonidine Hcl Extended-release Tablets?
  3. May Cause Serious Side Effects, Including:
  4. The Most Common Side Effects Of Clonidine Hcl Extended-release Tablets Include:

Patient Information 

Advise the patient to read the FDA-approved Patient Labeling (Patient Information)

Dosage and Administration

Advise patients that clonidine HCl extended-release must be swallowed whole, never crushed, cut, or chewed, and may be taken with or without food. When initiating treatment, provide dosage escalation instructions[seeDosage and Administration (2.1)].

Missed Dose

If patients miss a dose of clonidine HCl extended-release, advise them to skip the dose and take the next dose as scheduled and not to take more than the prescribed total daily amount of clonidine HCl extended-release in any 24-hour period[seeDosage and Administration (2.4)].

Hypotension/Bradycardia

Advise patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, to avoid becoming dehydrated or overheated[seeWarnings and Precautions (5.1)].

Sedation and Somnolence

Instruct patients to use caution when driving a car or operating hazardous machinery until they know how they will respond to treatment with clonidine HCl extended-release. Also advise patients to avoid the use of clonidine HCl extended-release with other centrally active depressants and with alcohol[seeWarnings and Precautions (5.2)].

Rebound Hypertension

Advise patients not to discontinue clonidine HCl extended-release abruptly[seeWarnings and Precautions (5.3)].

Allergic Reactions

Advise patients to discontinue clonidine HCl extended-release and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur, such as generalized rash, urticaria, or angioedema[seeWarnings and Precautions (5.4)].

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Clonidine Hcl Extended-release Tablets? 

  • Do not take clonidine HCl extended-release tablets if you are allergic to clonidine in clonidine HCl extended-release tablets.

    • Take clonidine HCl extended-release tablets exactly as your doctor tells you to take it.
    • Your doctor will tell you how many clonidine HCl extended-release tablets to take and when to take them. Your doctor may change your dose of clonidine HCl extended-release tablets. Do not change your dose of clonidine HCl extended-release tablets without talking to your doctor.
    • Do not stop taking clonidine HCl extended-release tablets without talking to your doctor.
    • Clonidine HCl extended-release tablets can be taken with or without food.
    • Clonidine HCl extended-release tablets should be taken 2 times a day (in the morning and at bedtime).
    • If you miss a dose of clonidine HCl extended-release tablets, skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the same time.
    • Take clonidine HCl extended-release tablets whole. Do not chew, crush or break clonidine HCl extended-release tablets. Tell your doctor if you cannot swallow clonidine HCl extended-release tablets whole. You may need a different medicine.
    • If you take too much clonidine HCl extended-release tablets, call your Poison Control Center (1-800-222-1222) or go to the nearest hospital emergency room right away.

    What should I avoid while taking

May Cause Serious Side Effects, Including: 

  • Low blood pressure and low heart rate.Your doctor should check your heart rate and blood pressure before starting treatment and regularly during treatment with clonidine HCl extended-release tablets.
  • Sleepiness.
  • Withdrawal symptoms. Suddenly stopping clonidine HCl extended-release tablets may cause withdrawal symptoms including: increased blood pressure, headache, increased heart rate, lightheadedness, tightness in your chest and nervousness.

The Most Common Side Effects Of Clonidine Hcl Extended-release Tablets Include: 

  • sleepiness
  • tiredness
  • irritability
  • trouble sleeping (insomnia)
  • nightmare
  • constipation
  • dry mouth
  • decreased appetite
  • dizziness

Tell your doctor if you have any side effects that bother you or that does not go away.

These are not all of the possible side effects of clonidine HCl extended-release tablets. For more information, ask your doctor or pharmacist.

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

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