Go PLR Content Marketing Cocos (Keeling) Islands: February 2010

Sunday 28 February 2010

Exocorpol

Exocorpol may be available in the countries listed below.

Ingredient matches for Exocorpol

Poloxamer

Poloxamer is reported as an ingredient of Exocorpol in the following countries:

Japan

International Drug Name Search

Saturday 27 February 2010

oprelvekin injectable

Generic Name: oprelvekin (injectable) (oh PERL ve kin)

Brand Names: Neumega

What is oprelvekin?

Oprelvekin is a protein that stimulates production of platelets in the blood. Platelets are important for proper clotting of the blood and for wound healing.

Oprelvekin is used to prevent platelets from becoming dangerously low in certain people receiving chemotherapy that can result in bone marrow suppression or the need for blood platelet transfusions.

Oprelvekin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about oprelvekin?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have congestive heart failure, kidney disease, a heart rhythm disorder, a seizure disorder, or a history of heart disease, stroke, or fluid retention around your liver, heart, or lungs.

Stop using oprelvekin and get emergency medical help if you have any of these signs of an allergic reaction: fever, rash, shortness of breath, chest pain, wheezing, confusion, fainting, hives, or swelling of your face, lips, tongue, or throat. Once you have had an allergic reaction to oprelvekin, you must never use it again. Other serious side effects of oprelvekin include swelling or rapid weight gain, chest pain, uneven heartbeats, sudden numbness or weakness, confusion, problems with speech or balance, and sudden vision loss or pain behind your eyes. Call your doctor at once if you have any of these side effects.

Treatment with oprelvekin is usually started 6 to 24 hours after chemotherapy is completed. Your blood will then need to be tested on a regular basis. Do not miss any scheduled appointments.

It may take up to 21 days of using this medicine before your platelets increase. For best results, keep using the medication as directed.

What should I discuss with my healthcare provider before using oprelvekin?

Do not use this medication if you are allergic to oprelvekin.

Before using oprelvekin, tell your doctor if you are allergic to any drugs, or if you have:

congestive heart failure;

a heart rhythm disorder;

a history of heart disease or stroke;

a history of fluid around your liver, heart, or lungs;

a seizure disorder; or

kidney disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use oprelvekin.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether oprelvekin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use oprelvekin?

Oprelvekin is given as an injection under the skin of your stomach, thigh, hip, or upper arm. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Avoid shaking the medication vial (bottle). You may gently swirl the vial, but vigorous shaking can ruin the medicine.

Use a different skin area each time you give yourself an injection. Do not inject this medicine into the same place on your body twice in a row.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Treatment with oprelvekin is usually started 6 to 24 hours after chemotherapy is completed. Your blood will then need to be tested on a regular basis. Do not miss any scheduled appointments..

It may take up to 21 days of using this medicine before your platelets increase. For best results, keep using the medication as directed.

Oprelvekin must be mixed with a liquid (diluent) before injecting it. Do not draw your dose into a syringe until you are ready to give yourself an injection. The prepared dose must be used within 3 hours after mixing it.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Store unused oprelvekin vials and diluent syringes in the refrigerator. Do not freeze.

A vial of oprelvekin should be used only once. Throw away any medicine still in the vial after mixing your dose.

What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include shortness of breath, swelling, uneven heartbeats, and chest pain.

What should I avoid while using oprelvekin?

Avoid making any changes in your diet while using this medication. Oprelvekin can cause fluid retention and swelling. Your doctor may recommend a low-salt diet to prevent this condition.

Oprelvekin side effects

feeling short of breath, even with mild exertion;

swelling, rapid weight gain;

chest pain, fast or uneven heartbeats;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with speech, or balance;

feeling light-headed, fainting;

fever, chills, tingling, body aches, flu symptoms;

urinating less than usual, or not at all;

dry mouth, increased thirst, drowsiness, confusion, nausea, vomiting, muscle pain or weakness;

sudden vision loss, headache or pain behind your eyes, with vomiting; or

white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

redness of your eyes;

headache, dizziness, sleep problems (insomnia);

nausea, vomiting, diarrhea;

skin redness, pain, or irritation where the medicine was injected; or

runny or stuffy nose, cough, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Oprelvekin Dosing Information

Usual Adult Dose for Thrombocytopenia Drug Induced:

Nonmyeloid malignancy:
50 mcg/kg subcutaneously once daily following myelosuppressive chemotherapy

Usual Pediatric Dose for Thrombocytopenia Drug Induced:

Study-Phase 1, (n=43) - Nonmyeloid malignancy:
25 to 100 mcg/kg/day following myelosuppressive chemotherapy.

What other drugs will affect oprelvekin?

There may be other drugs that can affect oprelvekin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More oprelvekin resources

Oprelvekin Side Effects (in more detail)
Oprelvekin Use in Pregnancy & Breastfeeding
Oprelvekin Drug Interactions
Oprelvekin Support Group
0 Reviews for Oprelvekin - Add your own review/rating

Compare oprelvekin with other medications

Thrombocytopenia Drug Induced

Where can I get more information?

Your pharmacist can provide more information about oprelvekin.

See also: oprelvekin side effects (in more detail)

Saturday 20 February 2010

Daytrana

Generic Name: methylphenidate (Oral route)

meth-il-FEN-i-date

Oral route(Tablet;Tablet, Extended Release;Tablet, Chewable;Solution)

Use cautiously in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, due to abuse potential. Chronic abuse can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior including psychotic episodes. Careful supervision during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked .

Commonly used brand name(s)

In the U.S.

Concerta

Metadate CD

Metadate ER

Methylin

Methylin ER

Ritalin

Ritalin LA

Ritalin-SR

Available Dosage Forms:

Tablet, Extended Release

Capsule, Extended Release

Tablet, Chewable

Solution

Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For Daytrana

Methylphenidate belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Methylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with a doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, methylphenidate may be used in certain patients with the following condition:

Depressive disorder secondary to physical illness in patients who cannot take antidepressant medicines.

Before Using Daytrana

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of Concerta® extended release tablets have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

No information is available on the relationship of age to the effects of Ritalin® and Ritalin LA® in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Brofaromine

Clorgyline

Furazolidone

Iproniazid

Isocarboxazid

Lazabemide

Linezolid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of methylphenidate

This section provides information on the proper use of a number of products that contain methylphenidate. It may not be specific to Daytrana. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you or your child think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

To help prevent trouble with sleeping, take the last dose of the short-acting tablets before 6 p.m., unless your doctor gives you or your child a different time.

If you or your child are taking the long-acting forms of this medicine:

The Concerta® extended release tablets, Ritalin LA® capsules, and Ritalin SR® tablets are to be swallowed whole with water or other liquids. Do not break, open, crush, or chew them before swallowing.

If you or your child are unable to swallow the Ritalin LA® extended-release capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The drug and applesauce mixture can not be stored for future use.

If you are taking the Concerta® extended-release tablets, you may sometimes notice what looks like a tablet in your stool. This is the empty tablet shell that is left after the medicine has been absorbed into your body.

You may take Concerta® extended release tablets with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For attention deficit hyperactivity disorder (ADHD):
- For short-acting oral dosage form (tablets):
  - Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
  - Teenagers and children 6 years of age and older—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached.
  - Children up to 6 years of age—Use and dose must be determined by the doctor.
- For long-acting oral dosage form (extended-release tablets):
  - For patients who have not been treated with Concerta®:
    - Adults—At first, 18 to 36 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
    - Teenagers and children 6 years of age and older—At first, 18 mg once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
    - Children up to 6 years of age—Use and dose must be determined by your doctor.
  - For patients already using Concerta®:
    - Adults, teenagers, and children 6 years of age and older—At first, 18 to 72 milligrams (mg) once a day in the morning, depending on your previous dose of methylphenidate. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
    - Children up to 6 years of age—Use and dose must be determined by your doctor.
- For long-acting oral dosage form (sustained-release tablets):
  - Adults, teenagers, and children 6 years of age and older—The dose must be determined by the doctor.
  - Children up to 6 years of age—Use and dose must be determined by the doctor.
- For the long-acting oral dosage form (extended-release capsules):
  - Adults, teenagers, and children 6 years of age and older—10 to 20 milligrams (mg) once a day, taken in the morning before breakfast. If needed, your doctor may increase the dose once a week by 10 mg a day as needed up to 60 mg a day.
  - Children up to 6 years of age—Use and dose must be determined by the doctor.

For narcolepsy:
- For short-acting oral dosage form (tablets):
  - Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
  - Teenagers and children 6 years of age and older—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.
- For long-acting oral dosage form (sustained-release tablets):
  - Adults and teenagers and children 6 years of age and older—The dose must be determined by the doctor.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Daytrana

Your doctor should check you or your child's progress at regular visits to make sure this medicine is working properly and to decide if you or your child should continue to take it. Blood tests may be needed to check for unwanted effects.

You or your child will also need to have your blood pressure measured before starting this medicine and while you or your child are using it. If you notice any change to you or your child's recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

You or your child should not use this medicine if you have used a drug for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how this medicine affects you.

Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while using this medicine.

Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

Daytrana Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fast heartbeat

Less common

Chest pain

fever

joint pain

skin rash or hives

Rare

Black, tarry stools

blood in the urine or stools

blurred vision or other changes in vision

convulsions

crusting, dryness, or flaking of the skin

muscle cramps

pinpoint red spots on the skin

scaling, severe redness, soreness, or swelling of the skin

uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)

unusual bleeding or bruising

Incidence not known

Confusion

cracks in the skin

delusions (false beliefs)

depersonalization (feeling like surroundings are not real)

depression (severe)

hallucinations (seeing, hearing, or feeling things that are not there)

hives or welts

loss of heat from the body

mood changes

numbness of the hands

painful or difficult urination

pale skin

red, irritated eyes

red, swollen, or scaly skin

severe or sudden headache

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sudden loss of coordination

sudden slurring of speech

swollen glands

troubled breathing with exertion

unusual behavior

unusual tiredness or weakness

weight loss

yellow skin or eyes

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

confusion (severe)

convulsions

dryness of the mouth or mucous membranes

false sense of well-being

fast, pounding, or irregular heartbeat

fever

flushing

hallucinations (seeing, hearing, or feeling things that are not there)

headache (severe)

increased sweating

large pupils

muscle twitching

overactive reflexes

sweating

trembling or shaking

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Loss of appetite

nervousness

sleeplessness

stuffy nose

trouble with sleeping

unable to sleep

unusually warm skin

Less common

Anger

dizziness

drowsiness

fear

headache

irritability

muscle aches

nausea

nervousness

runny nose

scalp hair loss

stomach pain

talking, feeling, and acting with excitement

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Daytrana side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Daytrana resources

Daytrana Side Effects (in more detail)
Daytrana Use in Pregnancy & Breastfeeding
Daytrana Drug Interactions
Daytrana Support Group
27 Reviews for Daytrana - Add your own review/rating

Daytrana Prescribing Information (FDA)

Daytrana Consumer Overview

Daytrana System MedFacts Consumer Leaflet (Wolters Kluwer)

Concerta Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Concerta Consumer Overview

Concerta Prescribing Information (FDA)

Metadate CD Prescribing Information (FDA)

Metadate CD Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Metadate ER Prescribing Information (FDA)

Methylin Prescribing Information (FDA)

Methylin MedFacts Consumer Leaflet (Wolters Kluwer)

Methylin ER Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Methylphenidate Hydrochloride Monograph (AHFS DI)

Ritalin Consumer Overview

Ritalin Prescribing Information (FDA)

Ritalin LA Prescribing Information (FDA)

Ritalin LA Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Daytrana with other medications

ADHD

Atenolol Tarbis

Atenolol Tarbis may be available in the countries listed below.

Ingredient matches for Atenolol Tarbis

Atenolol

Atenolol is reported as an ingredient of Atenolol Tarbis in the following countries:

Spain

International Drug Name Search

Thursday 18 February 2010

Ondansetron Injection

Dosage Form: injection
FULL PRESCRIBING INFORMATION

Indications and Usage for Ondansetron Injection

Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy

Ondansetron Injection USP is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin [see Clinical Studies (14.1)].

Ondansetron hydrochloride, USP is approved for patients aged 6 months and older.

Prevention of Postoperative Nausea and/or Vomiting

Ondansetron Injection USP is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection USP is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection USP and experience nausea and/or vomiting postoperatively, Ondansetron Injection USP may be given to prevent further episodes [see Clinical Studies (14.3)].

Ondansetron hydrochloride, USP is approved for patients aged 1 month and older.

Ondansetron Injection Dosage and Administration

Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

Adults

The recommended adult intravenous dosage of ondansetron hydrochloride is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Efficacy of the 32 mg single dose beyond 24 hours has not been established. The recommended infusion rate should not be exceeded [see Overdosage(10)]. With the three-dose (0.15 mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron hydrochloride.

Pediatrics

For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron hydrochloride is three 0.15 mg/kg doses [see Clinical Studies (14.1) and Clinical Pharmacology (12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron hydrochloride. The drug should be infused intravenously over 15 minutes.

Prevention of Postoperative Nausea and Vomiting

Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

Adults

The recommended adult intravenous dosage of ondansetron hydrochloride is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

Pediatrics

For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron hydrochloride.

Stability and Handling

After dilution, do not use beyond 24 hours. Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

Dosage Adjustment for Patients with Impaired Hepatic Function

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

Dosage Forms and Strengths

Ondansetron Injection, 2 mg/mL is a clear, colorless, nonpyrogenic, sterile solution available as a 20 mL multidose vial.

Contraindications

Ondansetron Injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. Anaphylactic reactions have been reported in patients taking ondansetron [see Adverse Reactions (6.2)].

The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

Electrocardiographic Changes

ECG changes including QT interval prolongation have been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron hydrochloride in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking other medicinal products that lead to QT prolongation.

Masking of Progressive Ileus and Gastric Distension

The use of ondansetron hydrochloride in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and gastric distention.

Effect on Peristalsis

Ondansetron hydrochloride is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following adverse reactions have been reported in clinical trials of adult patients treated with ondansetron, the active ingredient of intravenous ondansetron hydrochloride at a dosage of three 0.15 mg/kg doses or as a single 32 mg dose. A causal relationship to therapy with ondansetron hydrochloride was unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting

Table 1. Adverse Reactions Reported in > 5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15 mg/kg Doses or as a Single 32 mg Dose
	Number of Adult Patients With Reaction
Adverse Reaction	Ondansetron Injection 0.15 mg/kg x 3 n = 419	Ondansetron Injection 32 mg x 1 n = 220	Metoclopramide n = 156	Placebo n = 34
Diarrhea	16%	8%	44%	18%
Headache	17%	25%	7%	15%
Fever	8%	7%	5%	3%

Cardiovascular

Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported.

Gastrointestinal

Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron.

Hepatic

In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur.

Integumentary

Rash has occurred in approximately 1% of patients receiving ondansetron.

Neurological

There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving Ondansetron Injection, and rare cases of grand mal seizure.

Other

Rare cases of hypokalemia have been reported.

Postoperative Nausea and Vomiting

The adverse reactions in Table 2 have been reported in ≥ 2% of adults receiving ondansetron at a dosage of 4 mg intravenous over 2 to 5 minutes in clinical trials.

Table 2. Adverse Reactions Reported in ≥ 2% (and With Greater Frequency than the Placebo Group) of Adult Patients Receiving Ondansetron at a Dosage of 4 mg Intravenous over 2 to 5 Minutes
* Adverse Reactions: Rates of these reactions were not significantly different in the ondansetron and placebo groups † Patients were receiving multiple concomitant perioperative and postoperative medications
Adverse Reaction*,†	Ondansetron Injection 4 mg Intravenous n = 547 patients	Placebo n = 547 patients
Headache	92 (17%)	77 (14%)
Drowsiness/sedation	44 (8%)	37 (7%)
Injection site reaction	21 (4%)	18 (3%)
Fever	10 (2%)	6 (1%)
Cold sensation	9 (2%)	8 (1%)
Pruritus	9 (2%)	3 (< 1%)
Paresthesia	9 (2%)	2 (< 1%)

Pediatric Use

Rates of adverse reactions were similar in both the ondansetron and placebo groups in pediatric patients receiving ondansetron (a single 0.1 mg/kg dose for pediatric patients weighing 40 kg or less, or 4 mg for pediatric patients weighing more than 40 kg) administered intravenously over at least 30 seconds. Diarrhea was seen more frequently in patients taking ondansetron hydrochloride (2%) compared to placebo (< 1%) in the 1 month to 24 month age group. These patients were receiving multiple concomitant perioperative and postoperative medications.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ondansetron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron.

Cardiovascular

Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT/QTc interval prolongation, and ST segment depression), palpitations, and syncope. Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT/QTc interval prolongation have been reported [see Warnings and Precautions (5.2)].

General

Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylatic reactions, angioedema, bronchospasm, cardiopulmonary arrest, hypotension, laryngeal edema, laryngospasm, shock, shortness of breath, stridor) have also been reported. A positive lymphocyte transformation test to ondansetron has been reported, which suggests immunologic sensitivity to ondansetron.

Hepatobiliary

Liver enzyme abnormalities have been reported. Liver failure and death have been reported in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics.

Local Reactions

Pain, redness, and burning at site of injection.

Lower Respiratory

Hiccups

Neurological

Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Transient dizziness during or shortly after intravenous infusion.

Skin

Urticaria

Eye Disorders

Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours. Transient blurred vision, in some cases associated with abnormalities of accommodation, have also been reported.

Drug Interactions

Drugs Affecting Cytochrome P-450 Enzymes

Ondansetron does not appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron [see Clinical Pharmacology (12.3)]. On the basis of limited available data, no dosage adjustment is recommended for patients on these drugs.

Apomorphine

Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of apomorphine with ondansetron is contraindicated [see Contraindications (4)].

Phenytoin, Carbamazepine, and Rifampin

In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs [see Clinical Pharmacology (12.3)].

Tramadol

Although there are no data on pharmacokinetic drug interactions between ondansetron and tramadol, data from two small studies indicate that concomitant use of ondansetron may result in reduced analgesic activity of tramadol. Patients on concomitant ondansetron self administered tramadol more frequently in these studies, leading to an increased cumulative dose in patient controlled administration (PCA) of tramadol.

Chemotherapy

In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron.

In a crossover study in 76 pediatric patients, intravenous ondansetron did not increase blood levels of high-dose methotrexate.

Temazepam

The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.

Alfentanil and Atracurium

Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in pregnant rats and rabbits at intravenous doses up to 4 mg/kg per day (approximately 1 and 2 times the recommended human intravenous dose of 32 mg/day, respectively, based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Ondansetron is excreted in the breast milk of rats. It is not known whether ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ondansetron is administered to a nursing woman.

Pediatric Use

Little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month of age [see Clinical Studies (14.2)]. Little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months of age [see Clinical Studies (14.1) and Dosage and Administration (2)].

The clearance of ondansetron in pediatric patients 1 month to 4 months of age is slower and the half-life is ~2.5 fold longer than patients who are > 4 to 24 months of age. As a precaution, it is recommended that patients less than 4 months of age receiving this drug be closely monitored [see Clinical Pharmacology (12.3)].

Geriatric Use

Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in U.S.- and foreign-controlled clinical trials, 862 were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is not needed in patients over the age of 65 [see Clinical Pharmacology (12.3)].

Hepatic Impairment

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see Clinical Pharmacology (12.3)]. In such patients, a total daily dose of 8 mg should not be exceeded [see Dosage and Administration (2.3)].

Renal Impairment

Although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min), no dosage adjustment is recommended [see Clinical Pharmacology (12.3)].

Drug Abuse and Dependence

Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Overdosage

There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy. Individual intravenous doses as large as 150 mg and total daily intravenous doses as large as 252 mg have been inadvertently administered without significant adverse events. These doses are more than 10 times the recommended daily dose.

In addition to the adverse reactions listed above, the following events have been described in the setting of ondansetron overdose: “Sudden blindness” (amaurosis) of 2 to 3 minutes’ duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in another patient that took 48 mg of ondansetron hydrochloride tablets. Following infusion of 32 mg over only a 4 minute period, a vasovagal episode with transient second-degree heart block was observed. In all instances, the events resolved completely.

Ondansetron Injection Description

The active ingredient of Ondansetron Injection USP is ondansetron hydrochloride, USP, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:

C18H19N3O•HCl•2H2O M.W. 365.9

Ondansetron HCl, USP is a white to off-white powder that is soluble in water and normal saline.

Each 1 mL of aqueous solution in the 20 mL multidose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP.

Ondansetron Injection USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. The pH of the injection solution is 3.3 to 4.

Ondansetron Injection - Clinical Pharmacology

Mechanism of Action

Ondansetron is a selective 5-HT3 receptor antagonist. While ondansetron’s mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.

Pharmacodynamics

In normal volunteers, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time. In another study in six normal male volunteers, a 16 mg dose infused over 5 minutes showed no effect of the drug on cardiac output, heart rate, stroke volume, blood pressure, or electrocardiogram (ECG). However, no thorough QT study has been conducted with ondansetron. Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers. Ondansetron has no effect on plasma prolactin concentrations.

In a gender-balanced pharmacodynamic study (n = 56), ondansetron 4 mg administered intravenously or intramuscularly was dynamically similar in the prevention of nausea and vomiting using the ipecacuanha model of emesis.

Pharmacokinetics

In normal adult volunteers, the following mean pharmacokinetic data have been determined following a single 0.15 mg/kg intravenous dose.

Table 3. Pharmacokinetics in Normal Adult Volunteers
Age-group (years)	n	Peak Plasma Concentration (ng/mL)	Mean Elimination Half-life (h)	Plasma Clearance (L/h/kg)
19 to 40	11	102	3.5	0.381
61 to 74	12	106	4.7	0.319
≥ 75	11	170	5.5	0.262

Absorption

A study was performed in normal volunteers (n = 56) to evaluate the pharmacokinetics of a single 4 mg dose administered as a 5 minute infusion compared to a single intramuscular injection. Systemic exposure as measured by mean AUC were equivalent, with values of 156 [95% CI 136, 180] and 161 [95% CI 137, 190] ng•h/mL for intravenous and intramuscular groups, respectively. Mean peak plasma concentrations were 42.9 [95% CI 33.8, 54.4] ng/mL at 10 minutes after intravenous infusion and 31.9 [95% CI 26.3, 38.6] ng/mL at 41 minutes after intramuscular injection. In normal volunteers (19 to 39 years old, n = 23), the peak plasma concentration was 264 ng/mL following a single 32 mg dose administered as a 15 minute intravenous infusion.

Distribution

Plasma protein binding of ondansetron as measured in vitro was 70% to 76%, over the pharmacologic concentration range of 10 to 500 ng/mL. Circulating drug also distributes into erythrocytes.

Metabolism

Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation.

Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron. The metabolites are observed in the urine.

In vitro metabolism studies have shown that ondansetron is a substrate for multiple human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4. In terms of overall ondansetron turnover, CYP3A4 plays a predominant role while formation of the major in vivo metabolites is apparently mediated by CYP1A2. The role of CYP2D6 in ondansetron in vivo metabolism is relatively minor.

The pharmacokinetics of intravenous ondansetron did not differ between subjects who were poor metabolisers of CYP2D6 and those who were extensive metabolisers of CYP2D6, further supporting the limited role of CYP2D6 in ondansetron disposition in vivo.

Elimination

In normal volunteers (19 to 39 years old, n = 23), following a single 32 mg dose administered as a 15 minute intravenous infusion, the mean elimination half-life was 4.1 hours. Systemic exposure to 32 mg of ondansetron was not proportional to dose as measured by comparing dose-normalized AUC values to an 8 mg dose. This is consistent with a small decrease in systemic clearance with increasing plasma concentrations.

In adult cancer patients, the mean elimination half-life was 4 hours, and there was no difference in the multidose pharmacokinetics over a 4 day period.

Geriatrics

A reduction in clearance and increase in elimination half-life are seen in patients over 75 years of age. In clinical trials with cancer patients, safety and efficacy were similar in patients over 65 years of age and those under 65 years of age; there was an insufficient number of patients over 75 years of age to permit conclusions in that age-group. No dosage adjustment is recommended in the elderly.

Pediatrics

Pharmacokinetic samples were collected from 74 cancer patients 6 to 48 months of age, who received a dose of 0.15 mg/kg of intravenous ondansetron every 4 hours for 3 doses during a safety and efficacy trial. These data were combined with sequential pharmacokinetics data from 41 surgery patients 1 month to 24 months of age, who received a single dose of 0.1 mg/kg of intravenous ondansetron prior to surgery with general anesthesia, and a population pharmacokinetic analysis was performed on the combined data set. The results of this analysis are included in Table 4 and are compared to the pharmacokinetic results in cancer patients 4 to 18 years of age.

Table 4. Pharmacokinetics in Pediatric Cancer Patients 1 Month to 18 Years of Age
* Population PK (Pharmacokinetic) Patients: 64% cancer patients and 36% surgery patients.
Subjects and Age Group	N	CL (L/h/kg)	Vdss (L/kg)	T½ (h)
		Geometric Mean		Mean
Pediatric Cancer Patients 4 to 18 years of age	N = 21	0.599	1.9	2.8
Population PK Patients* 1 month to 48 months of age	N = 115	0.582	3.65	4.9

Based on the population pharmacokinetic analysis, cancer patients 6 to 48 months of age who receive a dose of 0.15 mg/kg of intravenous ondansetron every 4 hours for 3 doses would be expected to achieve a systemic exposure (AUC) consistent with the exposure achieved in previous pediatric studies in cancer patients (4 to 18 years of age) at similar doses.

In a study of 21 pediatric patients (3 to 12 years of age) who were undergoing surgery requiring anesthesia for a duration of 45 minutes to 2 hours, a single intravenous dose of ondansetron, 2 mg (3 to 7 years) or 4 mg (8 to 12 years), was administered immediately prior to anesthesia induction. Mean weight-normalized clearance and volume of distribution values in these pediatric surgical patients were similar to those previously reported for young adults. Mean terminal half-life was slightly reduced in pediatric patients (range, 2.5 to 3 hours) in comparison with adults (range, 3 to 3.5 hours).

In a study of 51 pediatric patients (1 month to 24 months of age) who were undergoing surgery requiring general anesthesia, a single intravenous dose of ondansetron, 0.1 or 0.2 mg/kg, was administered prior to surgery. As shown in Table 5, the 41 patients with pharmacokinetic data were divided into 2 groups, patients 1 month to 4 months of age and patients 5 to 24 months of age, and are compared to pediatric patients 3 to 12 years of age.

Table 5. Pharmacokinetics in Pediatric Surgery Patients 1 Month to 12 Years of Age
Subjects and Age Group	N	CL (L/h/kg)	Vdss (L/kg)	T½ (h)
		Geometric Mean		Mean
Pediatric Surgery Patients 3 to 12 years of age	N = 21	0.439	1.65	2.9
Pediatric Surgery Patients 5 to 24 months of age	N = 22	0.581	2.3	2.9
Pediatric Surgery Patients 1 month to 4 months of age	N = 19	0.401	3.5	6.7

In general, surgical and cancer pediatric patients younger than 18 years tend to have a higher ondansetron clearance compared to adults leading to a shorter half-life in most pediatric patients. In patients 1 month to 4 months of age, a longer half-life was observed due to the higher volume of distribution in this age group.

In a study of 21 pediatric cancer patients (4 to 18 years of age) who received three intravenous doses of 0.15 mg/kg of ondansetron at 4 hour intervals, patients older than 15 years of age exhibited ondansetron pharmacokinetic parameters similar to those of adults.

Renal Impairment

Due to the very small contribution (5%) of renal clearance to the overall clearance, renal impairment was not expected to significantly influence the total clearance of ondansetron. However, ondansetron mean plasma clearance was reduced by about 41% in patients with severe renal impairment (creatinine clearance < 30 mL/min). This reduction in clearance is variable and was not consistent with an increase in half-life. No reduction in dose or dosing frequency in these patients is warranted.

Hepatic Impairment

In patients with mild-to-moderate hepatic impairment, clearance is reduced 2 fold and mean half-life is increased to 11.6 hours compared to 5.7 hours in those without hepatic impairment. In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced 2 fold to 3 fold and apparent volume of distribution is increased with a resultant increase in half-life to 20 hours. In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenic effects were not seen in 2 year studies in rats and mice with oral ondansetron doses up to 10 and 30 mg/kg per day, respectively (approximately 2.5 and 3.8 times the recommended human intravenous dose of 32 mg/day, based on body surface area).

Ondansetron was not mutagenic in standard tests for mutagenicity.

Oral administration of ondansetron up to 15 mg/kg per day (approximately 3.8 times the recommended human intravenous dose, based on body surface area) did not affect fertility or general reproductive performance of male and female rats.

Clinical Studies

The clinical efficacy of ondansetron hydrochloride, the active ingredient of Ondansetron Injection, was assessed in clinical trials as described below.

Chemotherapy-Induced Nausea and Vomiting

Adults

In a double-blind study of three different dosing regimens of Ondansetron Injection, 0.015 mg/kg, 0.15 mg/kg, and 0.30 mg/kg, each given three times during the course of cancer chemotherapy, the 0.15 mg/kg dosing regimen was more effective than the 0.015 mg/kg dosing regimen. The 0.30 mg/kg dosing regimen was not shown to be more effective than the 0.15 mg/kg dosing regimen.

Cisplatin-Based Chemotherapy

In a double-blind study in 28 patients, Ondansetron Injection (three 0.15 mg/kg doses) was significantly more effective than placebo in preventing nausea and vomiting induced by cisplatin-based chemotherapy. Therapeutic response was as shown in Table 6.

Table 6. Therapeutic Response in Prevention of Chemotherapy-Induced Nausea and Vomiting in Single-Day Cisplatin Therapy* in Adults
* Chemotherapy was high dose (100 and 120 mg/m2; Ondansetron Injection n = 6, placebo n = 5) or moderate dose (50 and 80 mg/m2; Ondansetron Injection n = 8, placebo n = 9). Other chemotherapeutic agents included fluorouracil, doxorubicin, and cyclophosphamide. There was no difference between treatments in the types of chemotherapy that would account for differences in response. † Efficacy based on "all patients treated" analysis. ‡ Median undefined since at least 50% of the patients were rescued or had more than five emetic episodes. § Visual analog scale assessment of nausea: 0 = no nausea, 100 = nausea as bad as it can be. ¶ Visual analog scale assessment of satisfaction: 0 = not at all satisfied, 100 = totally satisfied.
	Ondansetron Injection (0.15 mg/kg x 3)	Placebo	P Value †
Number of patients	14	14
Treatment response 0 Emetic episodes 1 to 2 Emetic episodes 3 to 5 Emetic episodes More than 5 emetic episodes/rescued	2 (14%) 8 (57%) 2 (14%) 2 (14%)	0 (0%) 0 (0%) 1 (7%) 13 (93%)	0.001
Median number of emetic episodes	1.5	Undefined‡
Median time to first emetic episode (h)	11.6	2.8	0.001
Median nausea scores (0 to 100)§	3	59	0.034
Global satisfaction with control of nausea and vomiting (0 to 100)¶	96	10.5	0.009

Ondansetron Injection (0.15 mg/kg x 3 doses) was compared with metoclopramide (2 mg/kg x 6 doses) in a single-blind trial in 307 patients receiving cisplatin ≥ 100 mg/m2 with or without other chemotherapeu

Wednesday 17 February 2010

Allopurinolo Teva

Allopurinolo Teva may be available in the countries listed below.

Ingredient matches for Allopurinolo Teva

Allopurinol

Allopurinol is reported as an ingredient of Allopurinolo Teva in the following countries:

Italy

International Drug Name Search

Saturday 13 February 2010

Relacon LAX

Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)

Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children's Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E

What is Relacon LAX (dextromethorphan and guaifenesin)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Relacon LAX (dextromethorphan and guaifenesin)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Relacon LAX (dextromethorphan and guaifenesin)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.

FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Relacon LAX (dextromethorphan and guaifenesin)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking Relacon LAX (dextromethorphan and guaifenesin)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

Relacon LAX (dextromethorphan and guaifenesin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

severe dizziness, anxiety, restless feeling, or nervousness;

confusion, hallucinations; or

slow, shallow breathing.

Less serious side effects may include:

dizziness;

headache;

skin rash or itching; or

nausea, vomiting, or stomach upset.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Relacon LAX (dextromethorphan and guaifenesin)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

celecoxib (Celebrex);

cinacalcet (Sensipar);

darifenacin (Enablex);

imatinib (Gleevec);

quinidine (Quinaglute, Quinidex);

ranolazine (Ranexa);

ritonavir (Norvir);

sibutramine (Meridia);

terbinafine (Lamisil);

medicines to treat high blood pressure; or

an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with dextromethorphan and guaifenesin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Relacon LAX resources

Relacon LAX Side Effects (in more detail)
Relacon LAX Use in Pregnancy & Breastfeeding
Relacon LAX Drug Interactions
Relacon LAX Support Group
0 Reviews for Relacon LAX - Add your own review/rating

Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)

Mucinex DM Prescribing Information (FDA)

Mucinex DM Maximum Strength Prescribing Information (FDA)

Robitussin DM infant drops

Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Tussin DM Prescribing Information (FDA)

Compare Relacon LAX with other medications

Cough
Expectoration

Where can I get more information?

Your pharmacist can provide more information about dextromethorphan and guaifenesin.

See also: Relacon LAX side effects (in more detail)

Sunday 28 February 2010

Ingredient matches for Exocorpol

Saturday 27 February 2010

What is oprelvekin?

What is the most important information I should know about oprelvekin?

What should I discuss with my healthcare provider before using oprelvekin?

How should I use oprelvekin?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using oprelvekin?

Oprelvekin side effects

Oprelvekin Dosing Information

What other drugs will affect oprelvekin?

More oprelvekin resources

Compare oprelvekin with other medications

Where can I get more information?

Saturday 20 February 2010

Commonly used brand name(s)

Uses For Daytrana

Before Using Daytrana

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of methylphenidate

Dosing

Missed Dose

Storage

Precautions While Using Daytrana

Daytrana Side Effects

More Daytrana resources

Compare Daytrana with other medications

Ingredient matches for Atenolol Tarbis

Thursday 18 February 2010

Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy

Prevention of Postoperative Nausea and/or Vomiting

Ondansetron Injection Dosage and Administration

Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

Prevention of Postoperative Nausea and Vomiting

Stability and Handling

Dosage Adjustment for Patients with Impaired Hepatic Function

Dosage Forms and Strengths

Contraindications

Warnings and Precautions

Hypersensitivity Reactions

Electrocardiographic Changes

Masking of Progressive Ileus and Gastric Distension

Effect on Peristalsis

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Drug Interactions

Drugs Affecting Cytochrome P-450 Enzymes

Apomorphine

Phenytoin, Carbamazepine, and Rifampin

Tramadol

Chemotherapy

Temazepam

Alfentanil and Atracurium

USE IN SPECIFIC POPULATIONS

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use

Hepatic Impairment

Renal Impairment

Drug Abuse and Dependence

Overdosage

Ondansetron Injection Description

Ondansetron Injection - Clinical Pharmacology

Mechanism of Action

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Clinical Studies