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NRS Nasal

30/06/10

Generic Name: oxymetazoline nasal (ox ee me TAZ oh leen)
Brand Names: Afrin, Afrin Nasal Sinus, Allerest 12 Hour Nasal Spray, Duramist Plus, Duration, Four-Way Nasal Spray, Genasal, Neo-Synephrine 12 Hour, Nostrilla, NRS Nasal, NTZ Long Acting Nasal, Oxyfrin, Oxymeta-12, Sinarest Nasal, Sinex Long-Acting, Twice-A-Day

What is NRS Nasal (oxymetazoline nasal)?

Oxymetazoline is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. The nasal formulation acts directly on the blood vessels in your nasal tissues. Constriction of the blood vessels in your nose and sinuses leads to drainage of these areas and a decrease in congestion.

Oxymetazoline nasal is used to treat congestion associated with allergies, hay fever, sinus irritation, and the common cold.

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

What is the most important information I should know about NRS Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Do not use more of this medication than is recommended on the package or by your doctor.

Who should not use NRS Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. This could cause a very dangerous drug interaction with serious side effects.

Before taking this medication, tell your doctor if you have

high blood pressure;
any type of heart disease, hardening of the arteries, or irregular heart beats;
thyroid problems;
diabetes;
glaucoma or increased pressure in the eye;
an enlarged prostate or difficulty urinating; or
liver or kidney disease.

You may not be able to use oxymetazoline nasal, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether oxymetazoline nasal will harm an unborn baby. Do not use oxymetazoline nasal without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of oxymetazoline nasal. Do not use this medication without first talking to your doctor if you are breast-feeding a baby. If you over 60 years of age, you may be more likely to experience side effects from oxymetazoline nasal. You may require a lower dose of this medication.

How should I use NRS Nasal (oxymetazoline nasal)?

Use oxymetazoline nasal exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To apply the nasal spray, keep your head upright, spray, then sniff hard for a few minutes after administering a dose.

To apply the nasal drops, lie on a bed on your back with your head hanging over the edge. Insert the drops and remain in this position for several minutes. Gently turn your head from side to side.

Do not allow the tip of the container to touch the inside of your nose or any other surface. This spreads the infection.

Also, to prevent the spread of infection, do not share this medication with anyone else.

Discard this medication bottle after use. Do not save it for reuse.

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful. Oxymetazoline nasal should not be used more often than twice a day (every 12 hours).

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Store oxymetazoline nasal at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an oxymetazoline nasal overdose include extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.

What should I avoid while taking NRS Nasal (oxymetazoline nasal)?

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful.

NRS Nasal (oxymetazoline nasal) side effects

If you experience any of the following serious side effects, stop using oxymetazoline nasal and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
seizures;
unusual behavior or hallucinations; or
an irregular or fast heartbeat.

More commonly, you may experience some sneezing or burning, stinging, dryness, or irritation of the nose. These side effects are usually mild and temporary.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect NRS Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Although drug interactions between topical nasal decongestants and drugs taken by mouth are not expected, they can occur. Rarely, oxymetazoline nasal may interact with the following medicines:

furazolidone (Furoxone);
guanethidine (Ismelin);
indomethacin (Indocin);
methyldopa (Aldomet);
bromocriptine (Parlodel);
caffeine in cola, tea, coffee, chocolate and other products;
theophylline (Theo-Dur, Theochron, Theolair, others);
tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);
other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);
phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and
other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with oxymetazoline nasal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about oxymetazoline nasal written for health professionals that you may read.

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.

Concise,N

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NRS-Nasal Relief

30/06/10

Generic Name: oxymetazoline (Nasal route)

ox-i-me-TAZ-oh-leen

Commonly used brand name(s):

In the U.S.

4-Way Long Lasting
Afrin
Duramist Plus
Duration
Genasal
Mucinex Full Force
Mucinex Moisture Smart
Nasacon
Nasin
Neo-Synephrine 12 Hour
Nostrilla
NRS-Nasal Relief
Sinarest Nasal
Vicks Sinex 12 Hour

Available Dosage Forms:

Solution
Spray

Therapeutic Class: Decongestant

Chemical Class: Imidazoline

Uses For NRS-Nasal Relief

Oxymetazoline is used for the temporary relief of nasal (of the nose) congestion or stuffiness caused by hay fever or other allergies, colds, or sinus trouble.

This medicine may also be used for other conditions as determined by your doctor.

This medicine is available without a prescription.

Before Using NRS-Nasal Relief

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

Children may be especially sensitive to the effects of oxymetazoline. This may increase the chance of side effects during treatment.

Geriatric

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of oxymetazoline in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 oxymetazoline

This section provides information on the proper use of a number of products that contain oxymetazoline. It may not be specific to NRS-Nasal Relief. Please read with care.

To use the nose drops:

Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:

Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once into each nostril, wait 3 to 5 minutes to allow the medicine to work, then blow the nose gently and thoroughly. Repeat until the complete dose is used.
Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
To avoid spreading the infection, do not use the container for more than one person.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

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 nasal dosage form (nose drops or spray):
- For nasal congestion or stuffiness:
  - Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  - 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.

NRS-Nasal Relief 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 as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body

Blurred vision
fast, irregular, or pounding heartbeat
headache, dizziness, drowsiness, or lightheadedness
high blood pressure
nervousness
trembling
trouble in sleeping
weakness.

Increase in runny or stuffy nose

The above side effects are more likely to occur in children because there is a greater chance in children that too much of this medicine may be absorbed into the body.

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:

Burning, dryness, or stinging inside of nose
increase in nasal discharge
sneezing

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.

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.

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NTZ Long Acting Nasal

30/06/10

What is NTZ Long Acting Nasal (oxymetazoline nasal)?

Oxymetazoline nasal is used to treat congestion associated with allergies, hay fever, sinus irritation, and the common cold.

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

What is the most important information I should know about NTZ Long Acting Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Do not use more of this medication than is recommended on the package or by your doctor.

Who should not use NTZ Long Acting Nasal (oxymetazoline nasal)?

Before taking this medication, tell your doctor if you have

high blood pressure;
any type of heart disease, hardening of the arteries, or irregular heart beats;
thyroid problems;
diabetes;
glaucoma or increased pressure in the eye;
an enlarged prostate or difficulty urinating; or
liver or kidney disease.

You may not be able to use oxymetazoline nasal, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

How should I use NTZ Long Acting Nasal (oxymetazoline nasal)?

To apply the nasal spray, keep your head upright, spray, then sniff hard for a few minutes after administering a dose.

To apply the nasal drops, lie on a bed on your back with your head hanging over the edge. Insert the drops and remain in this position for several minutes. Gently turn your head from side to side.

Do not allow the tip of the container to touch the inside of your nose or any other surface. This spreads the infection.

Also, to prevent the spread of infection, do not share this medication with anyone else.

Discard this medication bottle after use. Do not save it for reuse.

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Store oxymetazoline nasal at room temperature away from moisture and heat.

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an oxymetazoline nasal overdose include extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.

What should I avoid while taking NTZ Long Acting Nasal (oxymetazoline nasal)?

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful.

NTZ Long Acting Nasal (oxymetazoline nasal) side effects

If you experience any of the following serious side effects, stop using oxymetazoline nasal and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
seizures;
unusual behavior or hallucinations; or
an irregular or fast heartbeat.

More commonly, you may experience some sneezing or burning, stinging, dryness, or irritation of the nose. These side effects are usually mild and temporary.

What other drugs will affect NTZ Long Acting Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Although drug interactions between topical nasal decongestants and drugs taken by mouth are not expected, they can occur. Rarely, oxymetazoline nasal may interact with the following medicines:

furazolidone (Furoxone);
guanethidine (Ismelin);
indomethacin (Indocin);
methyldopa (Aldomet);
bromocriptine (Parlodel);
caffeine in cola, tea, coffee, chocolate and other products;
theophylline (Theo-Dur, Theochron, Theolair, others);
tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);
other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);
phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and
other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with oxymetazoline nasal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about oxymetazoline nasal written for health professionals that you may read.

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.

Concise,N

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Nu-Cotrimox

30/06/10

Generic Name: trimethoprim and sulfamethoxazole (Oral route)

sul-fa-meth-OX-a-zole, trye-METH-oh-prim

Commonly used brand name(s):

In the U.S.

Bactrim
Bactrim DS
Septra
Septra DS
Sulfatrim
Sulfatrim Pediatric

In Canada

Apo-Sulfatrim
Novo-Trimel
Nu-Cotrimox
Septa Pediatric
Septra Pediatric Suspension

Available Dosage Forms:

Tablet
Suspension

Therapeutic Class: Sulfonamide Combination

Pharmacologic Class: Folic Acid Antagonist

Chemical Class: Sulfonamide

Uses For Nu-Cotrimox

Sulfamethoxazole and trimethoprim combination is used to treat infections such as urinary tract infections, middle ear infections (otitis media), bronchitis, traveler’s diarrhea, and shigellosis (bacillary dysentery). This medicine is also used to prevent or treat Pneumocystis carinii pneumonia (PCP), a very serious kind of pneumonia. This type of pneumonia occurs more commonly in patients whose immune systems are not working normally, such as cancer patients, transplant patients, and patients with acquired immune deficiency syndrome (AIDS).

Sulfamethoxazole and trimethoprim combination is an antibiotic. It works by eliminating the bacteria that cause many kinds of infections. This medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor’s prescription.

Before Using Nu-Cotrimox

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in children older than 2 months of age. Safety and efficacy have not been established for infants less than 2 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require an adjustment in the dose for patients receiving sulfamethoxazole and trimethoprim combination.

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

Sulfamethoxazole

Trimethoprim

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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.

Bepridil
Cisapride
Dofetilide
Levomethadyl
Mesoridazine
Pimozide
Terfenadine
Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Acenocoumarol
Ajmaline
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Aprindine
Arsenic Trioxide
Astemizole
Azimilide
Bretylium
Chloral Hydrate
Chloroquine
Chlorpromazine
Clarithromycin
Desipramine
Dibenzepin
Disopyramide
Dolasetron
Doxepin
Droperidol
Eltrombopag
Enflurane
Erythromycin
Flecainide
Fluconazole
Fluoxetine
Foscarnet
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Hydroquinidine
Ibutilide
Imipramine
Isoflurane
Isradipine
Lidoflazine
Lorcainide
Mefloquine
Methotrexate
Nortriptyline
Octreotide
Pentamidine
Pirmenol
Prajmaline
Probucol
Procainamide
Prochlorperazine
Propafenone
Pyrimethamine
Quetiapine
Quinidine
Risperidone
Sematilide
Sertindole
Sotalol
Spiramycin
Sultopride
Tedisamil
Telithromycin
Trifluoperazine
Trimipramine
Vasopressin
Warfarin
Zotepine

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.

Acetohexamide
Anisindione
Chlorpropamide
Didanosine
Digoxin
Enalaprilat
Enalapril Maleate
Fosphenytoin
Glipizide
Glyburide
Phenytoin
Quinapril
Repaglinide
Rifabutin
Rosiglitazone
Tolazamide
Tolbutamide

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of trimethoprim and sulfamethoxazole

This section provides information on the proper use of a number of products that contain trimethoprim and sulfamethoxazole. It may not be specific to Nu-Cotrimox. Please read with care.

Sulfamethoxazole and trimethoprim combination is best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects.

For patients taking the oral liquid, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Dosing

For oral dosage forms (liquid or tablets):
- For treatment of bacterial infections:
  - Adults and children 40 kilograms (kg) of body weight or more—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours.
  - Infants 2 months of age and older, and children up to 40 kg of weight—Dose is based on body weight. The usual dose is 40 mg of sulfamethoxazole and 8 mg of trimethoprim per kg of body weight every 12 hours.
  - Infants below 2 months of age—Use and dose must be determined by your doctor.
- For treatment of Pneumocystis carinii pneumonia (PCP):
  - Adults and children 2 months of age and older—Dose is based on body weight. The usual dose is 75 to 100 milligrams (mg) of sulfamethoxazole and 15 to 20 mg of trimethoprim per kilogram (kg) of body weight each day, given in equally divided doses every 6 hours.
  - Infants below 2 months of age—Use and dose must be determined by your doctor.
- For prevention of Pneumocystis carinii pneumonia (PCP):
  - Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim once a day.
  - Children and infants 2 months of age and older—Dose is based on body size and must be determined by your doctor. The usual dosing regimen is 750 mg of sulfamethoxazole and 150 mg of trimethoprim per square meter of body surface each day. This is given in equally divided doses two times a day for three days a week on consecutive days (e.g., Monday, Tuesday, Wednesday).
  - Infants below 2 months of age—Use and dose must be determined by your doctor.

Missed Dose

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 Nu-Cotrimox

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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. Do not breastfeed while using the medicine.

Very rarely, this medicine has caused severe side effects. If you start to have a skin rash, or if you think you are having a severe skin reaction, stop taking this medicine and call your doctor right away. Symptoms of a severe reaction may include a skin rash, skin color that is very pale or yellow, or skin with purple spots, along with a sore throat, fever, muscle pain, cough, and trouble with breathing.

Check with your doctor right away if you have abdominal or stomach cramps; bloating; watery and severe diarrhea, which may also be bloody; nausea or vomiting; or unusual tiredness or weakness. These may be symptoms of a serious intestinal infection.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; shortness of breath; or chest pain after you use the medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Nu-Cotrimox 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:

Rare

Abdominal or stomach pain
black, tarry stools
blistering, peeling, or loosening of skin
changes in skin color
chest pain
chills
cough or hoarseness
dark urine
diarrhea
dizziness
fever with or without chills
general feeling of tiredness or weakness
headache
itching
joint or muscle pain
light-colored stools
loss of appetite
lower back or side pain
nausea
pain, tenderness, or swelling of foot or leg
painful or difficult urination
pale skin
rash
red irritated eyes
red skin lesions, often with a purple center
shortness of breath
sore throat
sores, ulcers, or white spots in mouth or on lips
swollen or painful glands
tightness in chest
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood
wheezing
yellow eyes or skin

Incidence not known

Abdominal tenderness
back, leg, or stomach pains
bleeding gums
bleeding under the skin
blindness or vision changes
blisters hives or itching
bloating
blood in urine or stools
bluish-colored lips, fingernails, palms
burning, crawling, itching, numbness, painful, prickling, “pins and needles”, or tingling feelings
burning of face or mouth
chest pain
clumsiness or unsteadiness
cloudy urine
confusion
constipation
continuing ringing or buzzing or other unexplained noise in ears
convulsions
cracks in the skin
decreased frequency or amount of urine
diarrhea
diarrhea, watery and severe, which may also be bloody
difficulty breathing
difficulty swallowing
fainting spells
general body swelling
general feeling of discomfort or illness
hair loss
hearing loss
hives
increased blood pressure
increased thirst
indigestion
irregular heartbeat
large, flat, blue or purplish patches in the skin
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of heat from the body
muscle or joint pain
nosebleeds
not able to pass urine
numbness or tingling in hands, feet, or lips
pain or burning while urinating
painful knees and ankles
pains in the stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
raised red swellings on the skin, the buttocks, legs, or ankles
rapid heart rate
red, swollen skin
redness of the white part of the eyes
redness, swelling, or soreness of tongue
scaly skin
shakiness and unsteady walk
sores, ulcers, or white spots on lips or in mouth
soreness of muscles
stiff neck or back
swelling of face, hands, legs, and feet
swelling or inflammation of the mouth
trouble breathing
unsteadiness, trembling, or other problems with muscle control or coordination
unusual weight loss
weakness in hands or feet
weakness or heaviness of legs
weight gain

More common

Passing of gas

Incidence not known

Discouragement
feeling of constant movement of self or surroundings
feeling sad or empty
increased sensitivity of skin to sunlight
irritability
lack of feeling or emotion
loss of interest or pleasure
nervousness
redness or other discoloration of skin
seeing, hearing, or feeling things that are not there
sensation of spinning
severe sunburn
sleeplessness
trouble concentrating
trouble sleeping
unable to sleep
uncaring
weight loss

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.

Advanced,N

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NP 27

30/06/10

Generic Name: tolnaftate topical (toll NAF tate)
Brand Names: Absorbine Athletes Foot, Absorbine Jr. Antifungal, Aftate For Athletes Foot, Blis-To-Sol, Desenex Spray, Fungatin, Fungi-Guard, Genaspor, Hongos, NP 27, Podactin, T-Athlete, Tinactin, Tinaspore, Ting

What is NP 27 (tolnaftate topical)?

Tolnaftate topical is an antifungal medication. Tolnaftate topical prevents fungus from growing on the skin.

Tolnaftate topical is used to treat skin infections such as athlete’s foot, jock itch, and ringworm infections. Tolnaftate is also used, along with other antifungals, to treat infections of the nails, scalp, palms, and soles of the feet. The powder and powder aerosol may be used to prevent athlete’s foot.

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

What is the most important information I should know about NP 27 (tolnaftate topical)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in the eyes, nose, or mouth.

What should I discuss with my healthcare provider before using NP 27 (tolnaftate topical)?

Do not use tolnaftate topical if you have had an allergic reaction to it in the past.

It is not known whether tolnaftate topical will be harmful to an unborn baby. Do not use tolnaftate topical without first talking to your doctor if you are pregnant. It is not known whether tolnaftate topical passes into breast milk. Do not use tolnaftate topical without first talking to your doctor if you are breast-feeding a baby.

How should I use NP 27 (tolnaftate topical)?

Use tolnaftate topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the gel, cream, lotion, spray, or powder twice daily as directed for 2 to 6 weeks. Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 10 days or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in the eyes, nose, or mouth. Store tolnaftate topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the dose you missed and apply only the regular amount of tolnaftate topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of tolnaftate topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that tolnaftate topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using NP 27 (tolnaftate topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn’t allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

NP 27 (tolnaftate topical) side effects

Serious side effects of tolnaftate topical use are not expected to occur. Stop using tolnaftate topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

What other drugs will affect NP 27 (tolnaftate topical)?

Other skin medications may affect the absorption or effectiveness of tolnaftate topical. Avoid using other topicals at the same time except under the direction of a doctor.

Where can I get more information?

Your pharmacist has additional information about tolnaftate topical written for health professionals that you may read.

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.

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Nplate

30/06/10

Generic Name: romiplostim (ROM i PLOS tim)
Brand Names: Nplate

What is romiplostim?

Romiplostim is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body.

Romiplostim is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.

Romiplostim is usually given after other medications have been tried without successful treatment of symptoms.

Romiplostim is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

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

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

Romiplostim is available only under a special program called Nplate NEXUS. You must be enrolled in this program and sign all required agreements in order to receive the medication. Read all program brochures and agreements carefully.

Romiplostim is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

Before you use romiplostim, tell your doctor if you have kidney or liver disease.

Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any scheduled visits to your doctor.

It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

After you stop using romiplostim, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 2 weeks after you stop using romiplostim. Your blood will need to be tested weekly during this time.

What should I discuss with my health care provider before receiving romiplostim?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you use romiplostim, tell your doctor if you have kidney or liver disease.

FDA pregnancy category C. It is not known whether romiplostim is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on a pregnancy registry if you become pregnant while receiving romiplostim. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether romiplostim had any effect on the baby

It is not known whether romiplostim 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.

Using romiplostim may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called “preleukemia”). Talk with your doctor if you have concerns about this risk.

How is romiplostim given?

Romiplostim is given as an injection under the skin, usually once per week. Your doctor, nurse, or other healthcare provider will give you this injection.

It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. For best results, keep receiving the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your romiplostim injection.

What happens if I overdose?

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

Overdose can cause signs of a blood clot, including sudden numbness or weakness, sudden headache or confusion, problems with vision or speech, loss of balance, chest pain, sudden cough, wheezing, rapid breathing, fast heart rate, and pain or swelling in one or both legs.

What should I avoid while receiving romiplostim?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using romiplostim.

Romiplostim 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.

Less serious side effects may include:

headache;
dizziness;
joint or muscle pain;
pain in your arms, legs, or shoulder;
numbness or tingly feeling;
sleep problems (insomnia); or
stomach pain or upset.

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.

What other drugs will affect romiplostim?

There may be other drugs that can interact with romiplostim. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about romiplostim.

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.

Concise,N

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Noxafil Suspension

30/06/10

Generic Name: Posaconazole (POE-sa-KON-a-zole)
Brand Name: Noxafil

Noxafil Suspension is used for:

Preventing certain types of fungal infections in patients with severely weakened immune systems. It may be used to treat certain fungal infections of the mouth or throat. It may also be used for other conditions as determined by your doctor.

Noxafil Suspension is an azole antifungal. It works by killing sensitive fungi.

Do NOT use Noxafil Suspension if:

you are allergic to any ingredient in Noxafil Suspension
you are taking a 5-HT₁ receptor agonist (eg, eletriptan), certain H₁ antagonists (eg, astemizole, terfenadine), cisapride, conivaptan, an ergot alkaloid (eg, ergotamine), erythromycin, halofantrine, pimozide, a quinazoline (eg, alfuzosin), quinidine, or sirolimus

Contact your doctor or health care provider right away if any of these apply to you.

Before using Noxafil Suspension:

Some medical conditions may interact with Noxafil Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you are allergic to other azole antifungals (eg, itraconazole)
if you have a history of liver, kidney, or heart problems (eg, irregular heartbeat, abnormal heart function tests)
if you have abnormal blood electrolyte (eg, potassium, magnesium, calcium) levels
if you have severe diarrhea or vomiting

Some MEDICINES MAY INTERACT with Noxafil Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Amiodarone, certain H₁ antagonists (eg, astemizole, terfenadine), cisapride, dofetilide, erythromycin, halofantrine, levomethadyl, pimozide, or quinidine because the risk of severe heart effects, including irregular heartbeat, may be increased
HMG-CoA reductase inhibitors (eg, simvastatin) because the risk of severe muscle problems may be increased
Cimetidine or efavirenz because it may decrease Noxafil Suspension’s effectiveness
Phenytoin or rifabutin because the risk of their side effects may be increased by Noxafil Suspension; they may also decrease Noxafil Suspension’s effectiveness
5-HT₁ receptor agonists (eg, eletriptan), aldosterone blockers (eg, eplerenone), benzodiazepines (eg, midazolam, alprazolam), buspirone, calcium channel blockers (eg, nifedipine), cinacalcet, conivaptan, cyclophosphamide, cyclosporine, digoxin, ergot alkaloids (eg, ergotamine, dihydroergotamine), erlotinib, eszopiclone, gefitinib, HIV protease inhibitors (eg, ritonavir), muscarinic receptor antagonists (eg, tolterodine), narcotic pain medicines (eg, fentanyl), phosphodiesterase inhibitors (eg, sildenafil), quinazolines (eg, alfuzosin), ranolazine, sirolimus, sulfonylureas (eg, glipizide), tacrolimus, tyrosine kinase receptor inhibitors (eg, dasatinib), or vinca alkaloids (eg, vincristine) because the risk of their side effects may be increased by Noxafil Suspension
Hormonal contraceptives (eg, birth control pills) because their effectiveness may be decreased by Noxafil Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Noxafil Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Noxafil Suspension:

Use Noxafil Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Noxafil Suspension by mouth with food.
Shake well before each use.
Use the measuring spoon marked for medicine dosing that comes with Noxafil Suspension. Ask your pharmacist for help if you are unsure of how to measure your dose.
Rinse the measuring spoon with water after each use and before storage.
Take Noxafil Suspension on a regular schedule to get the most benefit from it.
Taking Noxafil Suspension at the same time each day will help you remember to take it.
Continue to take Noxafil Suspension even if you feel well. Do not miss any doses.
If you miss a dose of Noxafil Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Noxafil Suspension.

Important safety information:

Noxafil Suspension may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Noxafil Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Contact your doctor if you experience severe diarrhea or vomiting. The effectiveness of Noxafil Suspension may be decreased.
Noxafil Suspension only works against fungi; it does not treat viral infections (eg, the common cold) or bacterial infections.
Be sure to use Noxafil Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Long-term or repeated use of Noxafil Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Hormonal birth control (eg, birth control pills) may not work as well while you are using Noxafil Suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).
Diabetes patients – Noxafil Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Lab tests, including liver function and heart function tests, may be performed while you use Noxafil Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Noxafil Suspension should be used with extreme caution in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is not known if Noxafil Suspension can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Noxafil Suspension while you are pregnant. It is not known if Noxafil Suspension is found in breast milk. If you are or will be breast-feeding while you use Noxafil Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Noxafil Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; coughing; diarrhea; dizziness; headache; muscle, joint, or back pain; nausea; sore throat; stomach pain or upset; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mouth inflammation; pale stools; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; swelling of the ankles, feet, or hands; tremor; unusual bruising or bleeding; vaginal bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Noxafil Suspension:

Store Noxafil Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Noxafil Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Noxafil Suspension, please talk with your doctor, pharmacist, or other health care provider.
Noxafil Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Noxafil Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

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Novothyrox

30/06/10

N,Professional

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Novox

30/06/10

Generic Name: carprofen tablets
Dosage Form: FOR ANIMAL USE ONLY

Novox® CAPLETS
(carprofen)
Non-steroidal anti-inflammatory drug
For oral use in dogs only

CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Carprofen is a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class that includes ibuprofen, naproxen, and ketoprofen. Carprofen is the nonproprietary designation for a substituted carbazole, 6-chloro-∝-methyl-9H-carbazole-2-acetic acid. The empirical formula is C15H12CIN02 and the molecular weight 273.72. The chemical structure of carprofen is:

Carprofen is a white, crystalline compound. It is freely soluble in ethanol, but practically insoluble in water at 25°C.

CLINICAL PHARMACOLOGY:

Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic activity approximately equipotent to indomethacin in animal models.1

The mechanism of action of carprofen, like that of other NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity. Two unique cyclooxygenases have been described in mammals.2 The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and renal function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in inflammation. Inhibition of COX-I is thought to be associated with gastrointestinal and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. The specificity of a particular NSAID for COX-2 versus COX-1 may vary from species to species.3 In an in vitro study using canine cell cultures, carprofen demonstrated selective inhibition of COX-2 versus COX-1.4 Clinical relevance of these data has not been shown. Carprofen has also been shown to inhibit the release of several prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system) inflammatory reactions.1

Several studies have demonstrated that carprofen has modulatory effects on both humoral and cellular immune responses.5-9 Data also indicate that carprofen inhibits the production of osteoclast-activating factor (OAF), PGE1, and PGE2 by its inhibitory effects on prostaglandin biosynthesis.1

Based upon comparison with data obtained from intravenous administration, carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered orally.10 Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and 25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8 hours) after single oral doses varying from 1-35 mg/kg of body weight. After a 100 mg single intravenous bolus dose, the mean elimination half-life was approximately 11.7 hours in the dog. Carprofen is more than 99% bound to plasma protein and exhibits a very small volume of distribution.

Carprofen is eliminated in the dog primarily by biotransformation in the liver followed by rapid excretion of the resulting metabolites (the ester glucuronide of carprofen and the ether glucuronides of 2 phenolic metabolites, 7-hydroxy-carprofen and 8-hydroxy carprofen) in the feces (70-80%) and urine (10-20%). Some enterohepatic circulation of the drug is observed.

INDICATIONS:

Carprofen is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

CONTRAINDICATIONS:

Carprofen should not be used in dogs exhibiting previous hypersensitivity to carprofen.

PRECAUTIONS:

As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Effects may result from decreased prostaglandin production and inhibition of the enzyme cyclooxygenase which is responsible for the formation of prostaglandins from arachidonic acid.11-14 When NSAIDs inhibit prostaglandins that cause inflammation they may also inhibit those prostaglandins which maintain normal homeostatic function. These anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease more often than in healthy patients.12,14 NSAID therapy could unmask occult disease which has previously been undiagnosed due to the absence of apparent clinical signs. Patients with underlying renal disease for example, may experience exacerbation or decompensation of their renal disease while on NSAID therapy.11-14 The use of parenteral fluids during surgery should be considered to reduce the potential risk of renal complications when using NSAIDs perioperatively.

Carprofen is an NSAID, and as with others in that class, adverse reactions may occur with its use. The most frequently reported effects have been gastrointestinal signs. Events involving suspected renal, hematologic, neurologic, dermatologic, and hepatic effects have also been reported. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be approached cautiously, with appropriate monitoring. Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or gastrointestinal perforations, concomitant use carprofen and other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. If additional pain medication is needed after administration of the total daily dose of carprofen, a non-NSAID or non-corticosteroid class of analgesia should be considered. The use of another NSAID is not recommended. Sensitivity to drug-associated adverse reactions varies with the individual patient. Carprofen treatment was not associated with renal toxicity or gastrointestinal ulceration in well-controlled safety studies of up to ten times the dose in dogs.

Novox® Caplets is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as safety has not been established in dogs with these disorders. The safe use of Novox® Caplets in animals less than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not been established. Studies to determine the activity of carprofen when administered concomitantly with other protein-bound or similarly metabolized drugs have not been conducted.

Drug compatibility should be monitored closely in patients requiring additional therapy. Such drugs commonly used include cardiac, anticonvulsant and behavioral medications. It has been suggested that treatment with carprofen may reduce the level of inhalant anesthetics needed.15

If additional pain medication is warranted after administration of the total daily dose of Novox® Caplets, alternative analgesia should be considered. The use of another NSAID is not recommended. Consider appropriate washout times when switching from one NSAID to another or when switching from corticosteroid use to NSAID use.

WARNINGS:

Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs only. Do not use in cats.

All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse Reactions, Animal Safety and Post-Approval Experience).

INFORMATION FOR DOG OWNERS:

Novox® Caplets, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes.

Serious adverse reactions associated with this drug class can occur without warning and in rare situations result in death (see Adverse Reactions). Owners should be advised to discontinue Novox® Caplets therapy and contact their veterinarian immediately if signs of intolerance are observed.

The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID.

ADVERSE REACTIONS:

During investigational studies of osteoarthritis with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen caplet- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1 %), and constipation (0.3%). The product vehicle served as control.

There were no serious adverse events reported during clinical field studies with once daily oral administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control.

Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study (2 mg/lb once daily)
Observation	carprofen	Placebo
	(n=129)	(n=132)
Inappetence	1.6	1.5
Vomiting	3.1	3.8
Diarrhea/Soft stool	3.1	4.5
Behavior change	0.8	0.8
Dermatitis	0.8	0.8
PU/PD	0.8	–
SAP increase	7.8	8.3
ALT increase	5.4	4.5
AST increase	2.3	0.8
BUN increase	3.1	1.5
Bilirubinuria	16.3	12.1
Ketonuria	14.7	9.1

Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical relevance.

During investigational studies of surgical pain for the caplet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control.

Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily)
*A single dog may have experienced more than one occurrence of an event.
Observation*	carprofen	Placebo
	(n=148)	(n=149)
Vomiting	10.1	13.4
Diarrhea/Soft stoo	6.1	6.0
Ocular disease	2.7	0
Inappetence	1.4	0
Dermatitis/skin lesion	2.0	1.3
Dysrhythmia	0.7	0
Apnea	1.4	0
Oral/periodontal disease	1.4	0
Pyrexia	0.7	1.3
Urinary tract disease	1.4	1.3
Wound drainage	1.4	0

Post-Approval Experience:

Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting. The categories of adverse reactions are listed in decreasing order of frequency by body system.

Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis.

Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinurla, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers.

Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation.

Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria.

Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness.

Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis.

Dermatologic: Pruritis, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis.

Immunologic or hypersensitivity: Facial swelling, hives, erythema.

In rare situations, death has been associated with some of the adverse reactions listed above.

To report a suspected adverse reaction call 1-888-708-3326.

DOSAGE AND ADMINISTRATION:

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprofen and other treatment options before deciding to use Carprofen. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Caplets are scored and dosage should be calculated in half-caplet increments.

EFFECTIVENESS:

Confirmation of the effectiveness of carprofen for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries, was demonstrated in 5 placebo-controlled, masked studies examining the anti-inflammatory and analgesic effectiveness of carprofen in various breeds of dogs.

Separate placebo-controlled, masked, multicenter field studies confirmed the anti-inflammatory and analgesic effectiveness of carprofen when dosed at 2 mg/lb once daily or when divided and administered at 1 mg/lb twice daily. In these two field studies, dogs diagnosed with osteoarthritis showed statistically significant overall improvement based on lameness evaluations by the veterinarian and owner observations when administered carprofen at labeled doses.

Separate placebo-controlled, masked, multicenter field studies confirmed the effectiveness of carprofen for the control of postoperative pain when, dosed at 2 mg/lb once daily in various breeds of dogs. In these studies, dogs presented for ovariohysterectomy, cruciate repair and aural surgeries were administered carprofen preoperatively and for a maximum of 3 days (softtissue) or 4 days (orthopedic) postoperatively. In general, dogs administered carprofen showed statistically significant improvement in pain scores compared to controls.

ANIMAL SAFETY STUDIES:

Laboratory studies in unanesthetized dogs and clinical field studies have demonstrated that carprofen is well tolerated in dogs after oral administration. In target animal safety studies, carprofen was administered orally to healthy Beagle dogs at 1, 3, and 5 mg/lb twice daily (1, 3 and 5 times the recommended total daily dose) for 42 consecutive days with no significant adverse reactions. Serum albumin for a single female dog receiving 5 mg/lb twice daily decreased to 2.1 g/dL after 2 weeks of treatment, returned to the pre-treatment value (2.6 g/dL) after 4 weeks of treatment, and was 2.3 g/dL at the final 6-week evaluation. Over the 6-week treatment period, black or bloody stools were observed in 1 dog (1 incident) treated with 1 mg/lb twice daily and in 1 dog (2 incidents) treated with 3 mg/lb twice daily. Redness of the colonic mucosa was observed in 1 male that received 3 mg/lb twice daily.

Two of 8 dogs receiving 10 mg/lb orally twice daily (10 times the recommended total daily dose) for 14 days exhibited hypoalbuminemia. The mean albumin level in the dogs receiving this dose was lower (2.38 g/dL) than each of 2 placebo control groups (2.88 and 2.93 g/dL, respectively). Three incidents of black or bloody stool were observed in 1 dog. Five of 8 dogs exhibited reddened areas of duodenal mucosa on gross pathologic examination. Histologic examination of these areas revealed no evidence of ulceration, but did show minimal congestion of the lamina propria in 2 of the 5 dogs.

In separate safety studies lasting 13 and 52 weeks, respectively, dogs were administered orally up to 11.4 mg/lb/day (5.7 times the recommended total daily dose of 2 mg/lb) of carprofen. In both studies, the drug was well tolerated clinically by all of the animals. No gross or histologic changes were seen in any of the treated animals. In both studies, dogs receiving the highest doses had average increases in serum L-alanine aminotransferase (ALT) of approximately 20 IU.

In the 52-week study, minor dermatologic changes occurred in dogs in each of the treatment groups but not in the control dogs. The changes were described as slight redness or rash and were diagnosed as non-specific dermatitis. The possibility exists that these mild lesions were treatment related, but no dose relationship was observed.

Clinical field studies were conducted with 549 dogs of different breeds at the recommended oral doses for 14 days (297 dogs were included in a study evaluating 1 mg/lb twice daily and 252 dogs were included in a separate study evaluating 2 mg/lb once daily). In both studies the drug was clinically well tolerated and the incidence of clinical adverse reactions for carprofen-treated animals was no higher than placebo-treated animals (placebo contained inactive ingredients found in carprofen caplets). For animals receiving 1 mg/lb twice daily, the mean post-treatment serum ALT values were 11 IU greater and 9 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. Differences were not statistically significant. For animals receiving 2 mg/lb once daily, the mean post-treatment serum ALT values were 4.5 IU greater and 0.9 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. In the latter study, 3 carprofen-treated dogs developed a 3-fold or greater increase in (ALT) and/or (AST) during the course of therapy. One placebo-treated dog had a greater than 2-fold increase in ALT. None of these animals showed clinical signs associated with the laboratory value changes. Changes in clinical laboratory values (hematology and clinical chemistry) were not considered clinically significant. The 1 mg/lb twice daily course of therapy was repeated as needed at 2-week intervals in 244 dogs, some for as long as 5 years.

Clinical field studies were conducted in 297 dogs of different breeds undergoing orthopedic or soft tissue surgery. Dogs were administered 2 mg/lb of carprofen caplets two hours prior to surgery then once daily, as needed for 2 days (soft tissue surgery) or 3 days (orthopedic surgery). Carprofen was well tolerated when used in conjunction with a variety of anesthetic-related drugs. The type and severity of abnormal health observations in carprofen- and placebo-treated animals were approximately equal and few in number (see Adverse Reactions). The most frequent abnormal health observation was vomiting and was observed at approximately the same frequency in carprofen- and placebo-treated animals. Changes in clinicopathologic indices of hematopoetic, renal, hepatic, and clotting function were not clinically significant. The mean post-treatment serum ALT values were 7.3 IU and 2.5 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. The mean post-treatment AST values were 3.1 IU less for dogs receiving carprofen and 0.2 IU greater for dogs receiving placebo.

STORAGE:

Store at controlled room temperature 15°-30°C (59° – 86°F).

HOW SUPPLIED:

Novox® Caplets are scored, and contain 25 mg, 75 mg, or 100 mg of carprofen per caplet. Each caplet size is packaged in bottles containing 30, 60, or 180 caplets.

REFERENCES:

Baruth H,et al: In Anti-Inflammatory and Anti-Rheumatic Drugs, Vol. II, Newer Anti-Inflammatory Drugs, Rainsford KD, ed. CRC Press, Boca Raton, pp. 33-47,1986.
Vane JR, Botting RM: Mechanism of action of anti-inflammatory drugs. Scand J Rheumatol 25:102, pp. 9-21.
Grossman CJ, Wiseman J, Lucas FS, et al: Inhibition of constitutive and inducible cyclooxygenase activity in human platelets and mononuclear cells by NSAIDs and COX-2 inhibitors. Inflammation Research 44:253-257,1995.
Ricketts AP, Lundy KM, Seibel SB: Evaluation of selective inhibition of canine cyclooxygenase 1 and 2 by carprofen and other nonsteroidal anti-inflammatory drugs. Am J Vet Res 59:11, pp. 1441-1446, November 1998.
Ceuppens JL, et al: Non-steroidal anti-inflammatory agents inhibit the synthesis of IgM rheumatoid factor in vitro. Lancet 1:528,1982.
Ceuppens JL, et al: Endogenous prostaglandin E2 enhances polyclonal immunoglobulin production by ionically inhibiting T suppressor cell activity. Cell Immunol 70:41,1982.
Schleimer RP, et al: The effects of prostaglandin synthesis inhibition on the immune response. Immunopharmacology 3:205, 1981.
Leung KH,et al: Modulation of the development of cell mediated immunity: possible roles of the products of cyclooxygenase and lipoxygenase pathways of arachidonic acid metabolism. Int J Immunopharmacology4:195, 1982.
Veit BC: Immunoregulatory activity of cultured-induced suppressor macrophages. Cell Immunol, 72:14, 1982.
Schmitt M,et al: Biopharmaceutical evaluation of carprofen following single intravenous, oral, and rectal doses in dogs. Biopharm Drug Dispos 11(7):585-94,1990.
Kore AM: Toxicology of nonsteriodal anti-inflammatory drugs. Veterinary Clinics of North America, Small Animal Practice 20, March 1990.
Binns SH: Pathogenesis and pathophysiology of ischemic injury in cases of acute renal failure. Compend for Cont Ed16:1, January 1994.
Boothe DM: Prostaglandins: Physiology and clinical implications. Compend for Cont Ed 6:11, November 1984.
Rubin SI: Nonsteroidal anti-inflammatory drugs, prostaglandins, and the kidney. JAVMA 188:9, May 1986.
Ko CH, Lange DN, Mandsager RE, et al: Effects of butorphanol and carprofen on the minimal alveolar concentration of isoflurane in dogs. JAVMA 217:1025-1028, 2000.

For a copy of the Material Safety Data Sheet (MSDS) or to report adverse reactions call Vedco, Inc. at 1-888-708-3326.

ANADA 200-498, Approved by FDA

TAKE TIME

OBSERVE LABEL DIRECTIONS

Distributed by:
Vedco, Inc.
St. Joseph, MO 64507

®Novox is a registered trademark of Vedco, Inc.

VEDCO

Dog Owner Information about Novox® CAPLETS (carprofen) for Osteoarthritis and Post-Surgical Pain
Generic name: carprofen (“car-prô-fen”)

This summary contains important information about Novox® Caplets. You should read this information before you start giving your dog Novox® Caplets and review it each time the prescription is refilled. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or if you want to know more about Novox® Caplets.

What is Novox® Caplets?

Novox® Caplets is a nonsteroidal anti-inflammatory drug (NSAID) that is used to reduce pain and inflammation (soreness) due to osteoarthritis and pain following surgery in dogs. Novox® Caplets is a prescription drug for dogs. It is available as a caplet and is given to dogs by mouth.

Osteoarthritis (OA) is a painful condition caused by “wear and tear” of cartilage and other parts of the joints that may result in the following changes or signs in your dog:

Limping or lameness
Decreased activity or exercise (reluctance to stand, climb stairs, jump or run, or difficulty in performing these activities)
Stiffness or decreased movement of joints

To control surgical pain (e.g. for surgeries such as spays, ear procedures or orthopedic repairs) your veterinarian may administer Novox® Caplets before the procedure and recommend that your dog be treated for several days after going home.

What kind of results can I expect when my dog is on Novox® Caplets?

While Novox® Caplets is not a cure for osteoarthritis, it can relieve the pain and inflammation of OA and improve your dog’s mobility.

Response varies from dog to dog but can be quite dramatic.
In most dogs, improvement can be seen in a matter of days.
If Novox® Caplets is discontinued or not given as directed, your dog’s pain and inflammation may come back.

Who should not take Novox® Caplets?

Your dog should not be given Novox® Caplets if he/she:

Has had an allergic reaction to carprofen, the active ingredient of Novox® Caplets.
Has had an allergic reaction to aspirin or other NSAIDs (for example deracoxib, etodalac, firocoxib, meloxicam, phenylbutazone ortepoxalin) such as hives, facial swelling, or red or itchy skin.

Novox® Caplets should be given to dogs only. Cats should not be given Novox® Caplets. Call your veterinarian immediately if your cat receives Novox® Caplets. People should not take Novox® Caplets. Keep Novox® Caplets and all medicines out of reach of children. Call your physician immediately if you accidentally take Novox® Caplets.

How to give Novox® Caplets to your dog.

Novox® Caplets should be given according to your veterinarian’s instructions. Your veterinarian will tell you what amount of Novox® Caplets is right for your dog and for how long it should be given. Novox® Caplets should be given by mouth and maybe given with or without food.

What to tell/ask your veterinarian before giving Novox® Caplets.

Talk to your veterinarian about:

The signs of OA you have observed (for example limping, stiffness).
The importance of weight control and exercise in the management of OA.
What tests might be done before Novox® Caplets is prescribed.
How often your dog may need to be examined by your veterinarian.
The risks and benefits of using Novox® Caplets.

Tell your veterinarian if your dog has ever had the following medical problems:

Experienced side effects from Novox® Caplets or other NSAIDs, such as aspirin
Digestive upset (vomiting and/or diarrhea)
Liver disease
Kidney disease
A bleeding disorder (for example, Von Willebrand’s disease)

Tell your veterinarian about:

Any other medical problems or allergies that your dog has now or has had.
All medicines that you are giving your dog or plan to give your dog, including those you can get without a prescription.

Tell your veterinarian if your dog is:

Pregnant, nursing or if you plan to breed your dog.

What are the possible side effects that may occur in my dog during Novox® Caplets therapy?

Novox® Caplets, like other drugs, may cause some side effects. Serious but rare side effects have been reported in dogs taking NSAIDs, including Novox® Caplets. Serious side effects can occur with or without warning and in rare situations result in death.

The most common NSAID-related side effects generally involve the stomach (such as bleeding ulcers), and liver or kidney problems. Look for the following side effects that can indicate your dog may be having a problem with Novox® Caplets or may have another medical problem:

Decrease or increase in appetite
Vomiting
Change in bowel movements (such as diarrhea, or black, tarry or bloody stools)
Change in behavior (such as decreased or increased activity level, incoordination, seizure or aggression)
Yellowing of gums, skin, or whites of the eyes (jaundice)
Change in drinking habits (frequency, amount consumed)
Change in urination habits (frequency, color, or smell)
Change in skin (redness, scabs, or scratching)

It is important to stop therapy and contact your veterinarian immediately if you think your dog has a medical problem or side effect from Novox® Caplets therapy. If you have additional questions about possible side effects, talk to your veterinarian.

Can Novox® Caplets be given with other medicines?

Novox® Caplets should not be given with other NSAIDs (for example aspirin, deracoxib, etodalac, firocoxib, meloxicam, tepoxalin) or steroids (for example cortisone, dexamethasone, prednisone, triamcinolone). Tell your veterinarian about all medicines you have given your dog in the past, and any medicines that you are planning to give with Novox® Caplets. This should include other medicines that you can get without a prescription. Your veterinarian may want to check that all of your dog’s medicines can be given together.

What do I do in case my dog eats more than the prescribed amount of Novox® Caplets?

Contact your veterinarian immediately if your dog eats more than the prescribed amount of Novox® Caplets.

What else should I know about Novox® Caplets?

This sheet provides a summary of information about Novox® Caplets. If you have any questions or concerns about Novox® Caplets, or osteoarthritis, or postoperative pain, talk to your veterinarian.

As with all prescribed medicines, Novox® Caplets should only be given to the dog for which it was prescribed. It should be given to your dog only for the condition for which it was prescribed.

It is important to periodically discuss your dog’s response to Novox® Caplets at regular check ups. Your veterinarian will best determine if your dog is responding as expected and if your dog should continue receiving Novox® Caplets.

To report a suspected adverse reaction call Vedco, Inc. at 1-888-708-3326.

Distributed by:
Vedco, Inc.
St. Joseph, MO 64507
001762101

® Novox is a registered trademark of Vedco, Inc.

VEDCO

Principal Display Panel

Principal Display Panel – Bottle Label – 25 mg

NDC 50989-236-86
Novox® CAPLETS
(carprofen)
Non-steroidal anti-inflammatory drug
For oral use in dogs only
25 MG
180 CAPLETS
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
VEDCO
ANADA #200-498, Approved by FDA

Principal Display Panel

Principal Display Panel – Carton Label – 25 mg

Principal Display Panel

Principal Display Panel – Bottle Label – 75 mg

NDC 50989-238-86
Novox® CAPLETS
(carprofen)
Non-steroidal anti-inflammatory drug
For oral use in dogs only
75 MG
180 CAPLETS
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
VEDCO
ANADA #200-498, Approved by FDA

Principal Display Panel

Principal Display Panel – Carton Label – 75 mg

Principal Display Panel

Principal Display Panel – Bottle Label – 100 mg

NDC 50989-245-86
Novox® CAPLETS
(carprofen)
Non-steroidal anti-inflammatory drug
For oral use in dogs only
100 MG
180 CAPLETS
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
VEDCO
ANADA #200-498, Approved by FDA

Principal Display Panel

Principal Display Panel – Carton Label – 100 mg

Novox
carprofen tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	50989-236
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carprofen (carprofen)	carprofen	25 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	orange (orange)	Score	2 pieces
Shape	OVAL (OVAL)	Size	12mm
Flavor		Imprint Code	25;mg
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50989-236-02	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		30 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-236-02)
2	50989-236-50	1 BOTTLE In 1 CARTON	contains a BOTTLE
2		60 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-236-50)
3	50989-236-86	1 BOTTLE In 1 CARTON	contains a BOTTLE
3		180 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-236-86)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200498	02/01/2010

Novox
carprofen tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	50989-238
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carprofen (carprofen)	carprofen	75 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	orange (orange)	Score	2 pieces
Shape	OVAL (OVAL)	Size	15mm
Flavor		Imprint Code	75;mg
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50989-238-02	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		30 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-238-02)
2	50989-238-50	1 BOTTLE In 1 CARTON	contains a BOTTLE
2		60 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-238-50)
3	50989-238-86	1 BOTTLE In 1 CARTON	contains a BOTTLE
3		180 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-238-86)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200498	02/01/2010

Novox
carprofen tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	50989-245
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carprofen (carprofen)	carprofen	100 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	orange (orange)	Score	2 pieces
Shape	OVAL (OVAL)	Size	19mm
Flavor		Imprint Code	100;mg
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50989-245-02	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		30 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-245-02)
2	50989-245-50	1 BOTTLE In 1 CARTON	contains a BOTTLE
2		60 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-245-50)
3	50989-245-86	1 BOTTLE In 1 CARTON	contains a BOTTLE
3		180 TABLET In 1 BOTTLE	This package is contained within the CARTON (50989-245-86)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200498	02/01/2010

Labeler - Vedco, Inc. (021634266)

Registrant - Norbrook Laboratories Limited (214580029)

Establishment
Name	Address	ID/FEI	Operations
Carnbane Industrial Estate		211218325	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Armagh Road		232880554	ANALYSIS

Revised: 01/2010Vedco, Inc.

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Who should not use NTZ Long Acting Nasal (oxymetazoline nasal)?

How should I use NTZ Long Acting Nasal (oxymetazoline nasal)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking NTZ Long Acting Nasal (oxymetazoline nasal)?

NTZ Long Acting Nasal (oxymetazoline nasal) side effects

What other drugs will affect NTZ Long Acting Nasal (oxymetazoline nasal)?

Where can I get more information?

30/06/10

Uses For Nu-Cotrimox

Before Using Nu-Cotrimox

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of trimethoprim and sulfamethoxazole

Dosing

Missed Dose

Storage

Precautions While Using Nu-Cotrimox

Nu-Cotrimox Side Effects

30/06/10

What is NP 27 (tolnaftate topical)?

What is the most important information I should know about NP 27 (tolnaftate topical)?

What should I discuss with my healthcare provider before using NP 27 (tolnaftate topical)?

How should I use NP 27 (tolnaftate topical)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using NP 27 (tolnaftate topical)?

NP 27 (tolnaftate topical) side effects

What other drugs will affect NP 27 (tolnaftate topical)?

Where can I get more information?

30/06/10

What is romiplostim?

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

What should I discuss with my health care provider before receiving romiplostim?

How is romiplostim given?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving romiplostim?

Romiplostim side effects

What other drugs will affect romiplostim?

Where can I get more information?

30/06/10