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CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE- clonidine hydrochloride tablet, extended release


  1. Do Not Take Clonidine Hydrochloride Extended-release Tablets If You Are Allergic To Clonidine In Clonidine Hydrochloride Extended-release Tablets. Before You Take Clonidine Hydrochloride Extended-release Tablets, Tell Your Doctor If You:
  2. How Should I Store Clonidine Hydrochloride Extended-release Tablets?
  3. Patient Information
  4. What Are Clonidine Hydrochloride Extended-release Tablets?
  5. Who Should Not Take Clonidine Hydrochloride Extended-release Tablets?
  6. Before You Take Clonidine Hydrochloride Extended-release Tablets, Tell Your Doctor If You:
  7. Especially Tell Your Doctor If You Take:
  8. How Should I Take Clonidine Hydrochloride Extended-release Tablets?
  9. What Should I Avoid While Taking Clonidine Hydrochloride Extended-release Tablets?
  10. What Are Possible Side Effects Of Clonidine Hydrochloride Extended-release Tablets? Clonidine Hydrochloride Extended-release Tablets May Cause Serious Side Effects, Including:
  11. The Most Common Side Effects Of Clonidine Hydrochloride Extended-release Tablets Include:
  12. Manufactured By:

Do Not Take Clonidine Hydrochloride Extended-release Tablets If You Are Allergic To Clonidine In Clonidine Hydrochloride Extended-release Tablets. Before You Take Clonidine Hydrochloride Extended-release Tablets, Tell Your Doctor If You: 

  • have kidney problems
  • have low or high blood pressure
  • have a history of passing out (syncope)
  • have heart problems, including history of heart attack
  • have had a stroke or have stroke symptoms
  • had a skin reaction (such as a rash) after taking clonidine in a transdermal form (skin patch)
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if clonidine hydrochloride extended-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. Clonidine hydrochloride extended-release tablets can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take clonidine hydrochloride extended-release tablets.

Tell your doctor about all of the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Clonidine hydrochloride extended-release tablets and certain other medicines may affect each other causing serious side effects. Sometimes the doses of other medicines may need to be changed while taking clonidine hydrochloride extended-release tablets.

How Should I Store Clonidine Hydrochloride Extended-release Tablets? 

  • Store clonidine hydrochloride extended-release tablets at 20 to 25 C (68 to 77 F) [

    • Active Ingredient: clonidine hydrochloride
    • Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate

    Rxonly

    KAPVAYis a registered trademark of Concordia Pharmaceuticals, Inc. and the brands listed are trademarks of their respective owners.

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8286621/1017OS

Patient Information 

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

Dosage and Administration

Advise patients that clonidine hydrochloride extended-release tablets 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 hydrochloride extended-release tablets, 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 hydrochloride extended-release tablets in any 24-hour period[seeDosage and Administration (2.4)].

Hypotension/BradycardiaAdvise 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 hydrochloride extended-release tablets. Also advise patients to avoid the use of clonidine hydrochloride extended-release tablets with other centrally active depressants and with alcohol [seeWarnings and Precautions (5.2)].

Rebound Hypertension

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

Allergic Reactions

Advise patients to discontinue clonidine hydrochloride extended-release tablets 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)].

What Are Clonidine Hydrochloride Extended-release Tablets? 

Clonidine hydrochloride extended-release tablets are a prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Your doctor may prescribe clonidine hydrochloride extended-release tablets alone or together with certain other ADHD medicines.

  • Clonidine hydrochloride extended-release tablets are not a central nervous system (CNS) stimulant.
  • Clonidine hydrochloride extended-release tablets should be used as part of a total treatment program for ADHD that may include counseling or other therapies.

Who Should Not Take Clonidine Hydrochloride Extended-release Tablets? 

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

Before You Take Clonidine Hydrochloride Extended-release Tablets, Tell Your Doctor If You: 

  • have kidney problems
  • have low or high blood pressure
  • have a history of passing out (syncope)
  • have heart problems, including history of heart attack
  • have had a stroke or have stroke symptoms
  • had a skin reaction (such as a rash) after taking clonidine in a transdermal form (skin patch)
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if clonidine hydrochloride extended-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. Clonidine hydrochloride extended-release tablets can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take clonidine hydrochloride extended-release tablets.

Tell your doctor about all of the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Clonidine hydrochloride extended-release tablets and certain other medicines may affect each other causing serious side effects. Sometimes the doses of other medicines may need to be changed while taking clonidine hydrochloride extended-release tablets.

Especially Tell Your Doctor If You Take: 

  • anti-depression medicines
  • heart or blood pressure medicine
  • other medicines that contain clonidine
  • a medicine that makes you sleepy (sedation)

Ask your doctor or pharmacist for a list of these medicines, if you are not sure if your medicine is listed above.

Know the medicines that you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How Should I Take Clonidine Hydrochloride Extended-release Tablets? 

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

What Should I Avoid While Taking Clonidine Hydrochloride Extended-release Tablets? 

  • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking clonidine hydrochloride extended-release tablets until you talk with your doctor. Clonidine hydrochloride extended-release tablets taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do not drive, operate heavy machinery or do other dangerous activities until you know how clonidine hydrochloride extended-release tablets will affect you.
  • Avoid becoming dehydrated or overheated.

What Are Possible Side Effects Of Clonidine Hydrochloride Extended-release Tablets? Clonidine Hydrochloride Extended-release Tablets 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 hydrochloride extended-release tablets.
  • Sleepiness.
  • Withdrawal symptoms. Suddenly stopping clonidine hydrochloride 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 Hydrochloride 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 hydrochloride 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.

Manufactured By: 

Par Pharmaceutical

Chestnut Ridge, NY 10977

R09/16 OS257A-01-50-04



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