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>  New form of Clonazepam, Anyone tried it? | Add To Bookmarks
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SharonEG
post Aug 9 2005, 09:11 AM
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I notice that the FDA has just approved an "oral disintregrating" form of Clonazepam (on 3 August).  Has anyone tried it yet? (I know, it was only approved 5 6 days ago!!)   I am assuming that it will work faster than a regular pill.


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Lindsay
post Aug 9 2005, 06:14 PM
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Thanks for the heads up Sharon!  :;):
QUOTE
Par Pharmaceutical Companies, Inc. (PRX) Receives Final Approval To Market Clonazepam Orally Disintegrating Tablets

SPRING VALLEY, N.Y., Aug. 3 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that its wholly-owned subsidiary, Kali Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for clonazepam orally disintegrating tablets (ODT). Par's clonazepam ODT is the first generic version of the anticonvulsant Klonopin® Wafers. Annual U.S. sales of Klonopin® Wafers are approximately $18 million. Par will begin shipping the product immediately.

Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products, the first of which is Megace® ES, for specialty markets. Par currently manufactures, markets or licenses more than 90 prescription drugs. For press release and other company information, visit http://www.parpharm.com.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.

CONTACT: Stephen J. Mock, or Cecelia C. Heer, both of Par PharmaceuticalCompanies, Inc., +1-201-802-4000

Web site: http://www.parpharm.com/

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lonazepam (kloe-NA-ze-pam)

Treats seizures, panic disorder, and anxiety. This medicine is a benzodiazepine.
Brand Name(s):

Klonopin, Klonopin Wafers, Dissolving Tablet
There may be other brand names for this medicine.
When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to clonazepam or to similar medicines (such as Valium®). You should not use this medicine if you are pregnant, or if you have severe liver disease, narrow-angle glaucoma, or untreated open-angle glaucoma.
How to Use This Medicine:

Tablet, Dissolving Tablet

   * Your doctor will tell you how much of this medicine to take and how often. Do not take more medicine or take it more often than your doctor tells you to.
   * You may take this medicine with or without food.
   * To use the disintegrating tablet (dissolving tablet):
         o Make sure your hands are dry before you touch the tablet.
         o Open the pouch, then peel the foil from the back of the blister package. Take the tablet out. Do not push the tablet through the foil.
         o Put the tablet in your mouth. The tablet should melt quickly. If you want to, you can drink some water after the tablet melts.

If a dose is missed:

   * If you miss a dose or forget to take your medicine, take it as soon as you can. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose.
   * Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

   * Store the medicine at room temperature, away from heat, moisture, and direct light.
   * Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
   * Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

   * Make sure your doctor knows if you are also using theophylline, or medicine to treat fungal infections (such as fluconazole, itraconazole, ketoconazole, Diflucan®, Nizoral®, Sporanox®).
   * Do not drink alcohol while taking this medicine.
   * Make sure your doctor knows if you are using any medicines that make you sleepy (such as sleeping pills, cold and allergy medicine, narcotic pain relievers, or sedatives).

Warnings While Using This Medicine:

   * Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
   * Make sure your doctor knows if you are breastfeeding, or if you have glaucoma, breathing problems, kidney disease, or liver disease.
   * Tell your doctor if you have been addicted to alcohol or other drugs, or if you have a history of depression or mental illness.
   * This medicine may be habit-forming. If you feel that the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for instructions.
   * Taking too much of this medicine can cause death. Symptoms of an overdose include: Severe confusion, problems with memory or balance, shortness of breath, slow heartbeat, seizures, severe nausea, vomiting, diarrhea, increased sweating, and cold, clammy skin.
   * This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

   * Lightheadedness or fainting
   * Severe confusion, drowsiness, or muscle weakness
   * Unusual behavior or thoughts of hurting yourself
   * Unusual movements of the eye
   * Worsening seizures

If you notice these less serious side effects, talk with your doctor:

   * Blurred vision, headache
   * Drooling or dry mouth
   * Hangover feeling
   * Mild nausea, vomiting, diarrhea, or constipation
   * Trouble concentrating

If you notice other side effects that you think are caused by this medicine, tell your doctor.

I don't know anyone who has tried the disolving ones yet, Sharon.

Do you think it is like the wafers?


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Be Well....

~Lindsay ♥, Forum Super Administrator
Founder, depressionforums.org


Forum Super Administrator

DF member since Dec 2001

----
"I cannot make my mark for all time...those concepts are mutually exclusive.
"Lasting effect" is a self -contradictory term. Meaning does not exist in the future, nor do I.
Nothing will have meaning, "ultimately."
Nothing will even mean tomorrow what it did today. Meaning changes with the context.
My meaningfulness is in the here and now. It is enough that I may be of value to someone today.
It is enough that I make a difference now." ~Lindsay



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