Make A Donation!

Help us cover the cost of running this website and help with the fight against hepatitis C! We appreciate your support!

Magazine - The Hep Factor

The Hep Factor - Thanks to the Hepatitis C Council of Queensland

Web Version | Print Version

Magazine - Hep C Review

The Hep C Review - Thanks to the Hepatitis C Council of NSW

Part 1 | Part 2

Hep C Community News

Hep C Community News - Thanks to the Hepatitis C Council of South Australia

Magazine - Good Liver

Good Liver - Thanks to the Hepatitis C Council of Victoria
APP Pharmaceuticals Receives Final Approval for Nausea Drug PDF Print E-mail
Saturday, 12 July 2008 18:22
APP Pharmaceuticals has received final approval from the FDA for its ANDA to market a generic version of Roche’s Kytril in 1-mg/mL, 1-mL single-dose and 1-mg/mL, 4-mL multiple-dose vials.

The company already markets generic Kytril (granisetron HCl) in 0.1-mg/mL, 1-mL single-dose vials and will start distributing the other vials immediately, APP said.

Kytril is indicated for preventing nausea and vomiting associated with cancer chemotherapy and radiation.

The FDA previously approved generic Kytril ANDAs submitted by Apotex, Barr Pharmaceuticals, Baxter Healthcare, Roxane Laboratories and Watson Pharmaceuticals.

According to IMS data, branded sales of these two dosage forms of granisetron were approximately $72.2 million last year.

http://tinyurl.com/6z56a5

 

What is the most important information I should know about Kytril?
Take each oral dose with a full glass of water.

Kytril can be taken with or without food.

What is Kytril?

Kytril blocks the actions of chemicals in the body that may cause nausea and vomiting.

Kytril is used to prevent and treat nausea and vomiting associated with cancer chemotherapy, radiation therapy, and anesthesia used during surgery.

Kytril may also be used for purposes other than those listed in this medication guide.

 


What should I discuss with my healthcare provider before taking Kytril?

Before taking Kytril, tell your doctor about any other medical conditions that you have and about any other prescription or over-the-counter medicines, including herbal products, that you take. You may need a dosage adjustment or special monitoring during treatment.
Kytril is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take Kytril without first talking to your doctor if you are pregnant or if you are planning a pregnancy. It is not known whether Kytril passes into breast milk. Do not take Kytril without first talking to your doctor if you are breast-feeding a baby.


How should I take Kytril?

Take Kytril exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each oral dose with a full glass of water.

To ensure you get the correct dose, measure the liquid form of Kytril with a dose-measuring spoon, cup, or dropper not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Kytril can be taken with or without food.
Store Kytril at room temperature away from moisture and heat.


What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
What happens if I overdose?
Seek emergency medical attention.

The only known symptom of a Kytril overdose is headache.

 

What should I avoid while taking Kytril?


There are no restrictions on foods, beverages, or activities during treatment with Kytril unless otherwise directed by your doctor.
What are the possible side effects of Kytril?
If you experience any of the following uncommon but serious side effects, stop taking Kytril and seek emergency medical attention or contact your doctor immediately:

*

an allergic reaction (swelling of the lips, tongue, or face, difficulty breathing, closing of the throat, or hives);
*

irregular heartbeats; or
*

muscle cramps or uncontrollable movements.

Other, less serious side effects may be more likely to occur. Continue to take Kytril and talk to your doctor if you experience

*

headache;
*

fatigue, drowsiness, or dizziness;
*

anxiety or agitation; or
*

diarrhea or constipation.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Kytril?

Kytril has not been reported to interact with other medicines. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with Kytril.
Where can I get more information?

* Your pharmacist has more information about Kytril written for health professionals that you may read.

What does my medication look like?

Granisetron is available with a prescription under the brand name Kytril in a tablet, solution, and injectable formulations. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

*

Kytril 1 mg - white, triangular, film-coated tablets
*

Kytril 2 mg/10 mL - clear, orange-colored, orange-flavored liquid

* Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
* Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

http://www.drugs.com/kytril.html

 

Comments (0)add comment

Write comment
smaller | bigger
password
 

busy
Last Updated ( Saturday, 12 July 2008 19:05 )
 

Site, Article & Information Disclaimer

All information and articles provided on our website and forums are to be used as a guideline only. For your own safety, please always consult with a doctor or specialist before making any decisions regarding your health care. By visiting this website you instantly adhere to this policy.