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Northyx

30/06/10

Generic Name: methimazole (me THIM a zole)
Brand Names: Northyx, Tapazole

What is Northyx (methimazole)?

Methimazole prevents the thyroid gland from producing too much thyroid hormone.

Methimazole is used to treat hyperthyroidism (overactive thyroid). It is also used before thyroid surgery or radioactive iodine treatment.

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

What is the most important information I should know about Northyx (methimazole)?

Do not use methimazole if you are pregnant. It could harm the unborn baby. Do not take methimazole if you are breast-feeding a baby. Methimazole can increase your risk of bleeding. If you need to have surgery, tell the surgeon ahead of time that you are using this medication.

Methimazole can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

Do not receive a “live” vaccine while you are being treated with methimazole, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Keep using this medication even if you feel fine or have no symptoms of hyperthyroidism. You may need to keep taking methimazole long term to control your condition. Stopping the medication could cause your symptoms to return.

What should I discuss with my healthcare provider before taking Northyx (methimazole)?

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take this medication:

liver disease;
a blood cell disorder; or
a weak immune system.

FDA pregnancy category D. Do not use methimazole if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Methimazole can pass into breast milk and may harm a nursing baby. Do not use methimazole if you are breast-feeding a baby.

How should I take Northyx (methimazole)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take methimazole with a full glass of water.

Methimazole can be taken with or without food, but you should take it the same way each time.

Methimazole can increase your risk of bleeding. If you need to have any type of surgery, tell the surgeon ahead of time that you are using this medication.

It is important to use methimazole regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Keep using this medication even if you feel fine or have no symptoms of hyperthyroidism. You may need to keep taking methimazole long term to control your condition. Stopping the medication could cause your symptoms to return. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, upset stomach, headache, joint pain, fever, itching, swelling, or pale skin and easy bruising or bleeding.

What should I avoid while taking Northyx (methimazole)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using methimazole, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Northyx (methimazole) side effects

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

fever, chills, sore throat, body aches, flu symptoms;
easy bruising or bleeding, unusual weakness;
blood in your urine or stools;
severe blistering, peeling, and red skin rash; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

headache, drowsiness, dizziness;
mild nausea, vomiting, or stomach upset;
itching, minor skin rash;
muscle, joint, or nerve pain;
swelling; or
hair loss.

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

What other drugs will affect Northyx (methimazole)?

Tell your doctor about all other medicines you use, especially:

theophylline (Theo-Dur, Elixophyllin, Uniphyl, and others);
a blood thinner such as warfarin (Coumadin);
digoxin (digitalis, Lanoxin); or
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and other drugs may interact with methimazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about methimazole.

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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Nortrel

30/06/10

N,Professional

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Nortrel 0.5/35

30/06/10

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Estrostep Fe, Femcon FE, Junel 1.5/30, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin 21 1.5/30, Loestrin 24 Fe, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin FE 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 7/7/7, Nortrel 0.5/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent

What is Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor’s instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke, blood clot, or circulation problems;
a hormone-related cancer such as breast or uterine cancer;
abnormal vaginal bleeding;
liver disease, liver cancer, or a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

high blood pressure or a history of heart disease;
high cholesterol, gallbladder disease, or diabetes;
migraine headaches or a history of depression; or
a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor’s instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor’s instructions.

The 28-day birth control pack contains seven “reminder” pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one “active” pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two “active” pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two “active” pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three “active” pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Nortrel 0.5/35 (ethinyl estradiol and norethindrone) side effects

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

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;
breast pain, tenderness, or swelling;
freckles or darkening of facial skin;
increased hair growth, loss of scalp hair;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge;
changes in your menstrual periods, decreased sex drive; or
headache, nervousness, dizziness.

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 Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);
prednisolone (Orapred);
theophylline (Respbid, Theo-Dur);
St. John’s wort;
an antibiotic;
seizure medication;
a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
HIV or AIDS medications.

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

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

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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Norpramin

30/06/10

Generic Name: desipramine (des IP ra meen)
Brand Names: Norpramin

What is Norpramin (desipramine)?

Desipramine is a tricyclic antidepressant. Desipramine affects chemicals in the brain that may become unbalanced.

Desipramine is used to treat symptoms of depression.

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

What is the most important information I should know about Norpramin (desipramine)?

Do not use this medication if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking Norpramin (desipramine)?

Do not use this medication if you are allergic to desipramine, or if you have recently had a heart attack. Do not use desipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take desipramine before the MAO inhibitor has cleared from your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take desipramine:

heart disease, or a history of heart attack, stroke, or seizures;
a family history of sudden death related to a heart rhythm disorder;
bipolar disorder (manic-depression);
schizophrenia or other mental illness;
liver disease;
overactive thyroid;
diabetes (desipramine may raise or lower blood sugar);
glaucoma; or
problems with urination.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Desipramine may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether desipramine 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.

Older adults may be more likely to have side effects from this medication.

Do not give desipramine to anyone under 18 years old without the advice of a doctor.

How should I take Norpramin (desipramine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking desipramine. You may need to stop using the medicine for a short time.

Do not stop using desipramine without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take a few weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment. Store desipramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of desipramine can be fatal. Symptoms may include uneven heartbeats, extreme drowsiness, vomiting, blurred vision, confusion, hallucinations, muscle stiffness, feeling hot or cold, seizure (convulsions), or coma.

What should I avoid while taking Norpramin (desipramine)?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with desipramine.

Grapefruit and grapefruit juice may interact with desipramine. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Desipramine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Desipramine can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Norpramin (desipramine) 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.

Call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heart rate;
seizure (convulsions);
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, general ill feeling;
sudden numbness or weakness, especially on one side of the body;
sudden headache, problems with vision, speech, or balance;
easy bruising or bleeding, unusual weakness;
tremors, restless muscle movements in your eyes, tongue, jaw, or neck;
very stiff (rigid) muscles, high fever, sweating, confusion, tremors, feeling like you might pass out;
urinating less than usual or not at all;
extreme thirst with headache, nausea, vomiting, and weakness;
skin rash, severe tingling or numbness, pain and muscle weakness; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

vomiting, constipation;
dry mouth, unpleasant taste;
weakness, lack of coordination;
feeling anxious, restless, dizzy, or drowsy;
sleep problems (insomnia), nightmares;
blurred vision, trouble concentrating, headache, ringing in your ears;
breast swelling (in men or women); or
decreased sex drive, impotence, or difficulty having an orgasm.

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

What other drugs will affect Norpramin (desipramine)?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by desipramine. Tell your doctor if you regularly use any of these medicines, or any other antidepressants.

Before taking desipramine, tell your doctor if you have used an “SSRI” antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Tell your doctor about all other medicines you use, especially:

cimetidine (Tagamet); or
heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

This list is not complete and there are many other medicines that can interact with desipramine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about desipramine.

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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Norpace CR Sustained-Release Capsules

30/06/10

Generic Name: Disopyramide (dye-soe-PEER-a-mide)
Brand Name: Norpace CR

Norpace CR Sustained-Release Capsules sometimes produces new irregular heartbeats (arrhythmias). Therefore, it should be used in carefully selected patients. Consult your doctor or pharmacist for more information.

Norpace CR Sustained-Release Capsules are used for:

Correcting or preventing various types of life-threatening irregular heartbeats and heart rhythm disturbances.

Norpace CR Sustained-Release Capsules are an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm (antiarrhythmic effect).

Do NOT use Norpace CR Sustained-Release Capsules if:

you are allergic to any ingredient in Norpace CR Sustained-Release Capsules
you have second- or third-degree heart block and do not have a pacemaker, you were born with an irregular heartbeat due to QT prolongation, or your heart is in shock
you are taking astemizole, cisapride, a class III antiarrhythmic (eg, amiodarone, sotalol), a phenothiazine (eg, thioridazine), pimozide, or a quinolone (eg, grepafloxacin, sparfloxacin), or terfenadine

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

Before using Norpace CR Sustained-Release Capsules:

Some medical conditions may interact with Norpace CR Sustained-Release Capsules. 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 have a history of certain heart conditions or irregular heart rhythms (eg, enlargement or inflammation of the heart, heart block, heart failure, heart attack, Wolff-Parkinson-White syndrome), diabetes, glaucoma, severe muscle weakness, high or low levels of potassium in the blood, or kidney or liver disease
if you have difficulty urinating due to an obstruction of the bladder neck or prostate problems

Some MEDICINES MAY INTERACT with Norpace CR Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Astemizole, beta-blockers (eg, propranolol), cisapride, class III antiarrhythmics (eg, amiodarone, sotalol), dofetilide, droperidol, ketolides (eg, telithromycin), macrolides (eg, erythromycin), phenothiazine (eg, thioridazine), pimozide, quinolones (eg, sparfloxacin, grepafloxacin), terfenadine, verapamil, or ziprasidone because side effects, such as life threatening irregular heartbeats, may be increased
Hydantoins (eg, phenytoin) because the effectiveness of Norpace CR Sustained-Release Capsules may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norpace CR Sustained-Release Capsules 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 Norpace CR Sustained-Release Capsules:

Use Norpace CR Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Norpace CR Sustained-Release Capsules may be taken with or without food.
Swallow Norpace CR Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
Norpace CR Sustained-Release Capsules works best if it is taken at the same time each day.
If you miss a dose of Norpace CR Sustained-Release Capsules, 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 Norpace CR Sustained-Release Capsules.

Important safety information:

Norpace CR Sustained-Release Capsules may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Norpace CR Sustained-Release Capsules.
Do not become overheated in hot weather or during exercise or other activities; heatstroke may occur.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Norpace CR Sustained-Release Capsules.
Use Norpace CR Sustained-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
Use Norpace CR Sustained-Release Capsules with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Norpace CR Sustained-Release Capsules during pregnancy. Norpace CR Sustained-Release Capsules are excreted in breast milk. Do not breast-feed while taking Norpace CR Sustained-Release Capsules.

Possible side effects of Norpace CR Sustained-Release Capsules:

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:

Aches or pain; bloating; blurred vision; constipation; difficulty urinating; dizziness; dryness of the eyes, mouth, nose, or throat; fatigue; frequent and urgent urination; gas; general body discomfort; headache; muscle weakness; nausea; tiredness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or slow heartbeat; fever; lightheadedness; heart rhythm problems; severe difficulty urinating; shortness of breath; sore throat; swelling.

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. Symptoms may include difficulty breathing; change in heart rhythm; loss of consciousness.

Proper storage of Norpace CR Sustained-Release Capsules:

Store Norpace CR Sustained-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Norpace CR Sustained-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Norpace CR Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Norpace CR Sustained-Release Capsules are 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 Norpace CR Sustained-Release Capsules. 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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Norphyl

30/06/10

Generic Name: aminophylline (Oral route)

am-i-NOF-i-lin

Commonly used brand name(s):

In the U.S.

Norphyl
Phyllocontin

In Canada

Quibron-T

Available Dosage Forms:

Tablet, Extended Release
Tablet
Solution

Therapeutic Class: Bronchodilator

Chemical Class: Theophylline

Uses For Norphyl

Aminophylline is used together with other medicine to treat the symptoms of asthma, bronchitis, emphysema, and other lung diseases.

Aminophylline belongs to a group of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

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

Before Using Norphyl

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aminophylline in children. However, children younger than 1 year of age are more likely to have serious side effects, which may require caution and an adjustment in the dose for patients receiving aminophylline.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aminophylline in the elderly. However, elderly patients may be more sensitive to the effects of aminophylline than younger adults, which may require caution and an adjustment in the dose for patients receiving aminophylline.

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

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.

Febuxostat

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.

Bupropion
Cimetidine
Ciprofloxacin
Enoxacin
Erythromycin
Ethinyl Estradiol
Etintidine
Etonogestrel
Fluvoxamine
Halothane
Idrocilamide
Imipenem
Levofloxacin
Mestranol
Mexiletine
Norelgestromin
Norethindrone
Norgestrel
Pefloxacin
Peginterferon Alfa-2a
Rofecoxib
Thiabendazole
Troleandomycin
Zileuton

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.

Adenosine
Adinazolam
Alprazolam
Aminoglutethimide
Amiodarone
Azithromycin
Bromazepam
Brotizolam
Cannabis
Carbamazepine
Chlordiazepoxide
Clobazam
Clonazepam
Clorazepate
Diazepam
Disulfiram
Estazolam
Flunitrazepam
Flurazepam
Fosphenytoin
Halazepam
Interferon Alfa-2a
Ipriflavone
Isoproterenol
Ketazolam
Lorazepam
Lormetazepam
Medazepam
Methotrexate
Midazolam
Nilutamide
Nitrazepam
Oxazepam
Pancuronium
Pentoxifylline
Phenobarbital
Phenytoin
Piperine
Prazepam
Propafenone
Quazepam
Rifampin
Rifapentine
Riluzole
Ritonavir
Secobarbital
St John’s Wort
Tacrine
Tacrolimus
Telithromycin
Temazepam
Ticlopidine
Triazolam
Viloxazine
Zafirlukast

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.

Using this medicine with any of the following may cause an increased risk of certain side effects 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.

Caffeine

Proper Use of aminophylline

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

Take this medicine exactly as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep the blood level constant, take this medicine at the same time each day and do not miss any doses.

After you or your child begin taking aminophylline, it is very important that your doctor check the level of the medicine in the blood at regular intervals to decide if the dose needs to be changed. Keep all appointments for testing the blood level.

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 oral dosage form (tablets):
- To treat symptoms of asthma, bronchitis, and emphysema:
  - Adults, teenagers, and children above 1 year of age weighing more than 45 kilograms (kg)—At first, 380 milligrams (mg) per day, divided and given every 6 to 8 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 760 mg per day.
  - Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 507 milligrams per day, divided and given every 6 to 8 hours.
  - Children and teenagers 1 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 15.2 to 17.7 milligrams (mg) per kg of body weight per day, divided and given every 4 to 6 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 25.3 mg per kg of body weight per day or 760 mg per day.
  - Infants younger than 1 year of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Norphyl

It is very important that your doctor check the progress of you or your child at regular visits, especially for the first few weeks after you begin using this medicine. Blood tests may be needed to check for unwanted effects.

A change in your usual behavior or physical well-being may affect the way this medicine works in your body. Tell your doctor if you or your child:

Have had a fever of 102 degrees F or higher for at least 24 hours or more.
Have started or stopped smoking tobacco or marijuana in the last few weeks.
Have started or stopped taking another medicine in the last few weeks.
Have changed your diet in the last few weeks.

Stop using this medicine and check with your doctor right away if you or your child have the following symptoms while using this medicine: nausea or vomiting that continues, headaches, trouble with sleeping, seizures, or irregular heartbeats.

Do not stop or change the dose of this medicine without checking first with your doctor.

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

This medicine may add to the central nervous system (CNS) stimulant effects of caffeine-containing foods or beverages such as chocolate, cocoa, tea, coffee, and cola drinks. Avoid eating or drinking large amounts of these foods or beverages while using this medicine. If you have questions about this, check with your doctor.

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

Norphyl 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

Cracks in the skin
loss of heat from the body
red, swollen skin
scaly skin
skin rash

Incidence not known

Chest pain or discomfort
dizziness
fainting
fast, slow, or irregular heartbeat
increase in urine volume
lightheadedness
persistent vomiting
pounding or rapid pulse
seizures
shakiness

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

Symptoms of overdose

Abdominal or stomach pain
blurred vision
confusion
confusion about identity, place, and time
dark-colored urine
decrease in frequency of urination
decreased urine
diarrhea
difficulty in passing urine (dribbling)
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
dry mouth
fast, pounding, or irregular heartbeat or pulse
fever
increased thirst
irregular heartbeat
loss of appetite
mood changes
muscle cramps or spasms
muscle pain or stiffness
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
pain or discomfort in the arms, jaw, back, or neck
painful urination
shakiness in the legs, arms, hands, or feet
shortness of breath
sweating
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds

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:

Incidence not known

Headache
irritability
restlessness
sleeplessness
trouble sleeping
unable to sleep

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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Norplant System

30/06/10

Generic Name: levonorgestrel intrauterine system (LEE voe nor JES trel)
Brand Names: Mirena

What is Norplant System (levonorgestrel intrauterine system)?

Levonorgestrel is a female hormone. This hormone can cause changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Levonorgestrel intrauterine system is a plastic device that contains the hormone levonorgestrel. This device is placed in the uterus where it slowly releases the hormone to prevent pregnancy for up to 5 years. Levonorgestrel intrauterine system is meant for use in a woman who has had at least one child and is in a stable sexual relationship with someone who has no other sexual partners.

Levonorgestrel intrauterine system is also used in women who have heavy menstrual bleeding and choose to use an intrauterine form of birth control.

Levonorgestrel is a progestin hormone and does not contain estrogen. The intrauterine device releases levonorgestrel into the uterus, but only small amounts of the hormone reach your blood stream.

Levonorgestrel intrauterine system may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Norplant System (levonorgestrel intrauterine system)?

You should not use this medication if you have abnormal vaginal bleeding, an uncontrolled pelvic infection, a condition that affects the shape of the uterus, past or present breast cancer, a liver problem, cervical or uterine cancer, a weak immune system, if you have recently had a serious pelvic infection following a pregnancy or abortion, or if you already have an intrauterine device (IUD) in place.

You also should not use this medication if you have a history of pelvic inflammatory disease (unless you have had a normal pregnancy after the infection was treated and cleared), a recent abnormal Pap smear that has not yet been diagnosed or treated, or if you do not have an exclusive sexual partner.

Before using the levonorgestrel intrauterine device, tell your doctor if you have diabetes, a bleeding or blood-clotting disorder, a vaginal infection, pelvic infection, or sexually transmitted disease, high blood pressure, heart disease, or a heart valve disorder.

Serious side effects of the intrauterine system include severe cramps or pelvic pain, heavy or ongoing vaginal bleeding, unusual vaginal discharge, pale skin, easy bruising or bleeding, fever, chills, sudden numbness or weakness, severe headaches, or jaundice (yellowing of the skin or eyes). Only your doctor should remove the levonorgestrel intrauterine system. Do not attempt to remove the device yourself.

What should I discuss with my healthcare provider before taking Norplant System (levonorgestrel intrauterine system)?

An intrauterine device can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about your personal risk and about ways to help prevent a pelvic infection.

You should not use this medication if you are allergic to levonorgestrel, silicone, or polyethylene, or if you have:

abnormal vaginal bleeding;
an untreated or uncontrolled pelvic infection (vaginal, uterine, or bladder);
a serious pelvic infection following a pregnancy or abortion within the past 3 months;
a history of pelvic inflammatory disease (PID), unless you have had a normal pregnancy after the infection was treated and cleared;
uterine fibroid tumors or other conditions that affect the shape of the uterus;
past or present breast cancer;
liver disease or liver tumor (benign or malignant);
known or suspected cervical or uterine cancer;
a recent abnormal Pap smear that has not yet been diagnosed or treated;
a disease or condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse;
if you have another intrauterine device (IUD) in place; or
if you do not have an exclusive sexual partner.

You may need special tests to safely use a levonorgestrel intrauterine device if you have:

diabetes;
a bleeding or blood-clotting disorder;
a vaginal infection, pelvic infection, or sexually transmitted disease; or
high blood pressure, heart disease or a heart valve disorder.

Your doctor may ask about your partner’s medical and sexual history before prescribing a levonorgestrel intrauterine device for you.

The levonorgestrel intrauterine system should not be used during pregnancy. This device can cause severe infection, miscarriage, premature birth, or death of the mother if it is left in place during pregnancy. Tell your doctor right away if you become pregnant while using the intrauterine system.

If you choose to continue a pregnancy that occurs while using a levonorgestrel intrauterine system, watch for signs of infection such as fever, chills, flu symptoms, cramps, vaginal bleeding or discharge. Contact your doctor at once if you have any of these symptoms.

If you have recently had a baby and are breast-feeding, wait until your baby is at least 6 weeks old before you start using the intrauterine system.

How is levonorgestrel intrauterine system used?

Levonorgestrel is a T-shaped plastic device that is inserted through the vagina and placed into the uterus. You will receive the device in a clinic setting. Your doctor will place the device into your uterus using a thin plastic tube. The device is usually inserted within 7 days after the start of a menstrual period.

You may feel pain or dizziness during insertion of the intrauterine device. You may also have some vaginal bleeding. These symptoms should last only 30 minutes or less after the device is inserted, especially if you stay in a sitting or lying position during that time. Tell your doctor if you still have these symptoms after 30 minutes have passed.

A pair of strings is attached to the device for removal when you decide to discontinue using it. Your doctor will cut these strings short enough so they do not protrude from your vagina. Do not pull on the strings or attempt to remove the device.

After each menstrual period you should check to make sure you can still feel the removal strings. Wash your hands with soap and water, and insert your clean fingers into the vagina. You should be able to feel the strings deep inside the vagina, at the opening of your cervix. Call your doctor at once if you cannot feel the strings, or if you think the device has slipped lower in your uterus or out of your uterus. A sudden increase in menstrual flow may be a sign that the device has slipped out of place.

If you think the device is not properly in place, use a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy until your doctor is able to replace the levonorgestrel device.

Your doctor will need to see you within 4 and 12 weeks after insertion of the device to make sure it is still in place correctly. Be sure to also have regular annual pelvic exams and Pap smears while you are using the levonorgestrel intrauterine system.

The levonorgestrel intrauterine system should not interfere with sexual intercourse, wearing tampons, or using other vaginal medications recommended by your doctor.

You may have irregular periods during the first 3 to 6 months of using the intrauterine system. Your flow may be lighter or heavier, and you may eventually stop having periods after several months. Contact your doctor if you think you might be pregnant, or if you do not have a menstrual period for 6 weeks in a row.

The levonorgestrel intrauterine system must be removed at the end of the 5-year wearing time. Your doctor can insert a new device at that time if you wish to continue using this form of contraception. Only your doctor should remove the intrauterine system. Do not attempt to remove the device yourself.

Following removal of the levonorgestrel intrauterine device, you may become pregnant right away. Most women who choose to discontinue using the device in order to have a baby will become pregnant within the first year after removal.

What happens if I miss a dose?

Since the intrauterine device continuously releases a low dose of levonorgestrel, missing a dose does not occur when using this form of levonorgestrel.

What happens if I overdose?

An overdose of levonorgestrel released from the intrauterine system is very unlikely to occur.

What should I avoid while using Norplant System (levonorgestrel intrauterine system)?

Avoid having sexual intercourse with more than one partner. Also avoid having sexual intercourse with a partner who has other sexual partners besides you. The intrauterine device can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted disease.

Levonorgestrel intrauterine system will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to help protect yourself from these diseases.

Contact your doctor if your sexual partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

Norplant System (levonorgestrel intrauterine system) side effects

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

The levonorgestrel intrauterine device may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. If the device embeds in or perforates the uterine wall, your doctor may need to surgically remove the device.

Call your doctor at once if you have a serious side effect such as:

severe cramps or pelvic pain;
extreme dizziness, feeling like you might pass out;
heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
severe pain in your side or lower stomach;
pale skin, weakness, easy bruising or bleeding;
fever, chills, or other signs of infection;
pain during sexual intercourse;
sudden numbness or weakness, especially on one side of the body;
sudden or severe headache, confusion, problems with vision, sensitivity to light;
jaundice (yellowing of the skin or eyes); or
signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

irregular menstrual periods, changes in bleeding patterns or flow;
breakthrough bleeding, or heavier menstrual bleeding during the first few weeks after device insertion;
back pain;
headache, nervousness, mild dizziness;
nausea, vomiting, bloating;
breast tenderness or pain;
weight gain, acne, changes in hair growth;
mood changes, loss of interest in sex;
mild itching, skin rash; or
puffiness in your face, hands, ankles, or feet.

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 Norplant System (levonorgestrel intrauterine system)?

Tell your doctor about all other medications you use, especially:

insulin;
a blood thinner such as warfarin (Coumadin); or
steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

This list is not complete and there may be other drugs that can interact with the levonorgestrel intrauterine system. 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 pharmacist can provide more information about the levonorgestrel intrauterine system.

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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Norpace CR

30/06/10

Generic Name: disopyramide (DYE soe PIR a mide)
Brand Names: Norpace, Norpace CR

What is Norpace CR (disopyramide)?

Disopyramide affects the way that your heart beats.

Disopyramide is used to treat seriously irregular heartbeat patterns.

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

What is the most important information I should know about Norpace CR (disopyramide)?

Do not skip doses or change your dosing schedule without talking to your doctor. Changing your schedule could make your condition much worse. Use caution when driving, operating machinery, or performing other hazardous activities. Disopyramide may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities. Do not crush, chew, or break any controlled-release (CR) forms of disopyramide. Swallow them whole. They are specially formulated to release slowly in your body.

What should I discuss with my healthcare provider before taking Norpace CR (disopyramide)?

Before taking disopyramide, tell your doctor if you have

any other type of heart disease or heart problem,
liver disease,
kidney disease,
difficulty urinating or an enlarged prostate,
glaucoma, or
myasthenia gravis.

You may not be able to take disopyramide, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Disopyramide is in the FDA pregnancy category C. This means that it is not known whether disopyramide will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Disopyramide passes into breast milk. It is not known whether disopyramide will affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Norpace CR (disopyramide)?

Take disopyramide exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break any controlled-release (CR) forms of disopyramide. Swallow them whole. They are specially formulated to release slowly in your body. Do not skip doses or change your dosing schedule without talking to your doctor. Changing your schedule could make your condition much worse. Store disopyramide at room temperature away from moisture and heat.

What happens if I miss a dose?

Try not to miss any doses of this medication. Missing doses could be very dangerous.

If you do miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication. A double dose could be dangerous.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a disopyramide overdose include dry mouth and eyes, blurred vision, constipation, difficulty urinating, dizziness, worsening irregular heartbeats, loss of consciousness, and death.

What should I avoid while taking Norpace CR (disopyramide)?

Use caution when driving, operating machinery, or performing other hazardous activities. Disopyramide may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase side effects while you are taking disopyramide.

Follow any other special instructions given by your doctor regarding food, beverages, and activities.

Norpace CR (disopyramide) side effects

If you experience any of the following serious side effects, stop taking disopyramide and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
a new or a worsening irregular heartbeat pattern;
chest pain, chest discomfort, shortness of breath, or swelling of your legs or feet; or
severe dizziness.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

mild dizziness or tiredness,
headache,
blurred vision,
dry mouth,
rash, itching,
muscle aches or pains, or
difficulty urinating.

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

What other drugs will affect Norpace CR (disopyramide)?

Before taking disopyramide, tell your doctor if you are taking any of the following medications:

other medicines used to treat irregular heartbeats such as quinidine (Cardioquin, Quinora, others), amiodarone (Cordarone), bepridil (Vascor), procainamide (Pronestyl, Procan, Procanbid), and others;
a beta-blocker such as acebutolol (Sectral), propranolol (Inderal), metoprolol (Lopressor), carteolol (Cartrol), labetalol (Normodyne, Trandate), pindolol (Visken), nadolol (Corgard), and others;
erythromycin (E-Mycin, E.E.S., Ery-Tab, and others) or clarithromycin (Biaxin);
phenytoin (Dilantin);
phenobarbital (Solfoton, Luminal);
cisapride (Propulsid);
rifampin (Rimactane, Rifadin); or
warfarin (Coumadin).

You may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

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

Where can I get more information?

Your pharmacist can provide more information about disopyramide.

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

Comments (0)

Norpace

30/06/10

Generic Name: disopyramide (DYE soe PIR a mide)
Brand Names: Norpace, Norpace CR

What is Norpace (disopyramide)?

Disopyramide affects the way that your heart beats.

Disopyramide is used to treat seriously irregular heartbeat patterns.

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

What is the most important information I should know about Norpace (disopyramide)?

What should I discuss with my healthcare provider before taking Norpace (disopyramide)?

Before taking disopyramide, tell your doctor if you have

any other type of heart disease or heart problem,
liver disease,
kidney disease,
difficulty urinating or an enlarged prostate,
glaucoma, or
myasthenia gravis.

You may not be able to take disopyramide, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

How should I take Norpace (disopyramide)?

Take disopyramide exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

What happens if I miss a dose?

Try not to miss any doses of this medication. Missing doses could be very dangerous.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a disopyramide overdose include dry mouth and eyes, blurred vision, constipation, difficulty urinating, dizziness, worsening irregular heartbeats, loss of consciousness, and death.

What should I avoid while taking Norpace (disopyramide)?

Follow any other special instructions given by your doctor regarding food, beverages, and activities.

Norpace (disopyramide) side effects

If you experience any of the following serious side effects, stop taking disopyramide and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
a new or a worsening irregular heartbeat pattern;
chest pain, chest discomfort, shortness of breath, or swelling of your legs or feet; or
severe dizziness.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

mild dizziness or tiredness,
headache,
blurred vision,
dry mouth,
rash, itching,
muscle aches or pains, or
difficulty urinating.

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

What other drugs will affect Norpace (disopyramide)?

Before taking disopyramide, tell your doctor if you are taking any of the following medications:

other medicines used to treat irregular heartbeats such as quinidine (Cardioquin, Quinora, others), amiodarone (Cordarone), bepridil (Vascor), procainamide (Pronestyl, Procan, Procanbid), and others;
a beta-blocker such as acebutolol (Sectral), propranolol (Inderal), metoprolol (Lopressor), carteolol (Cartrol), labetalol (Normodyne, Trandate), pindolol (Visken), nadolol (Corgard), and others;
erythromycin (E-Mycin, E.E.S., Ery-Tab, and others) or clarithromycin (Biaxin);
phenytoin (Dilantin);
phenobarbital (Solfoton, Luminal);
cisapride (Propulsid);
rifampin (Rimactane, Rifadin); or
warfarin (Coumadin).

You may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

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

Where can I get more information?

Your pharmacist can provide more information about disopyramide.

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

Comments (0)

Noromectin

30/06/10

Generic Name: ivermectin injection
Dosage Form: FOR ANIMAL USE ONLY

Noromectin® (ivermectin)
Injection for Cattle an Swine
1% Sterile Solution

ANADA 200-437, Approved by the FDA

A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine.

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

INTRODUCTION

Noromectin (ivermectin) Injection is an injectable parasiticide for cattle and swine. One low-volume dose effectively treats and controls the following internal and external parasites that may impair the health of cattle and swine: gastrointestinal roundworms (including inhibited Ostertagia ostertagi in cattle), lungworms, grubs, sucking lice, and mange mites of cattle; and gastrointestinal roundworms, lungworms, lice, and mange mites of swine. Ivermectin’s convenience, broad-spectrum efficacy and safety margin make Noromectin Injection a unique product for parasite control of cattle and swine.

PRODUCT DESCRIPTION

Ivermectin is derived from the avermectins, a family of potent, broad-spectrum antiparasitic agents isolated from fermentation of Streptomyces avermitilis.

Noromectin Injection is a clear, ready-to-use, sterile solution containing 1% ivermectin, 40% glycerol formal, and propylene glycol q.s. ad 100%. Noromectin Injection is formulated to deliver the recommended dose level of 200 mcg ivermectin/kilogram of body weight in cattle when given subcutaneously at the rate of 1 mL/110 lb (50 kg). In Swine, Noromectin Injection is formulated to deliver the recommended dose level of 300 mcg ivermectin/kilogram body weight when given subcutaneously in the neck at the rate of 1 mL per 75 lb (33 kg).

MODE OF ACTION

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

INDICATIONS

Cattle: Noromectin Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice, and mange mites in cattle:

Gastrointestinal Roundworms (adults and fourth-stage larvae):

Ostertagia ostertagi (including inhibited O. ostertagi)

O. lyrata

Haemonchus placei

Trichostrongylus axei

T. colubriformis

Cooperia oncophora

C. punctata

C. pectinata

Oesophagostomum radiatum

Bunostomum phlebotomum

Nematodirus helvetianus (adults only)

N. spathiger (adults only)

Lungworms (adults and fourth-stage larvae):

Dictyocaulus viviparus

Cattle Grubs (parasitic stages):

Hypoderma bovis

H. lineatum

Sucking Lice:

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

Mites (scabies):

Psoroptes ovis (syn. Pcommunis var. bovis)

Sarcoptes scabiei var. bovis

Persistent Activity

Ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection withDictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei and Cooperia oncophora for 14 days after treatment.

Swine: Noromectin Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine:

Gastrointestinal Roundworms:

Large roundworm, Ascaris sum

(adults and fourth-stage larvae)

Red stomach worm,Hyostrongylus rubidus

(adults and fourth-stage larvae)

Nodular worm,Oesophagostomum spp.

(adults and fourth-stage larvae)

Threadworm, Strongyloides ransomi (adults)

Somatic Roundworm Larvae:

Threadworm, Strongyloides ransomi (somatic larvae)

Sows must be treated at least seven days before farrowing to prevent infection in piglets.

Lungworms:

Metastrongylus spp. (adults)

Lice:

Haematopinus suis

Mange Mites:

Sarcoptes scabiei var. suis

DOSAGE

Cattle: Noromectin Injection should be given only by subcutaneous injection under the loose skin in front of or behind the shoulder at the recommended dose level of 200 mcg of ivermectin per kilogram of body weight. Each mL of Noromectin Injection contains 10 mg of ivermectin, sufficient to treat 110 lb (50 kg) of body weight (maximum 10 mL per injection site).

Body Weight (lb)	Dose Volume (mL)
220	2
330	3
440	4
550	5
660	6
770	7
880	8
990	9
1100	10

Swine: Noromectin Injection should be given only by subcutaneous injection in the neck of swine at the recommended dose level of 300 mcg of ivermectin per kilogram (2.2 lb) of body weight. Each mL of Noromectin Injection contains 10 mg of ivermectin, sufficient to treat 75 lb of body weight.

	Body Weight (lb)	Dose Volume (mL)
Growing Pigs	19	1/4
	38	1/2
	75	1
	150	2
Breeding Animals	225	3
(Sows, Gilts, and Boars)	300	4
	375	5
	450	6

ADMINISTRATION

Cattle: Noromectin Injection is to be given subcutaneously only, to reduce risk of potentially fatal clostridial infection of the injection site. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16-gauge, 1/ 2 to 3/4 inch needle is suggested. Inject under the loose skin in front of or behind the shoulder (see illustration).

When using the 250, 500 or 1000 mL pack size, use only automatic syringe equipment.

Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections.

No special handling or protective clothing is necessary.

Swine: Noromectin (ivermectin) Injection is to be given subcutaneously in the neck. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16- or 18-gauge needle is suggested for sows and boars, while an 18- or 20-gauge needle may be appropriate for young animals. Inject under the skin, immediately behind the ear (see illustration).

When using the 100, 250, 500 or 1000 mL pack size, use only automatic syringe equipment. As with any injection, sterile equipment should be used. The injection site should be cleaned and disinfected with alcohol before injection. The rubber stopper should also be disinfected with alcohol to prevent contamination of the contents. Mild and transient pain reactions may be seen in some swine following subcutaneous administration.

Recommended Treatment Program

Swine: At the time of initiating any parasite control program, it is important to treat all breeding animals in the herd. After the initial treatment, use Noromectin Injection regularly as follows:

BREEDING ANIMALS

Sows: Treat prior to farrowing, preferably 7-14 days before, to minimize infection of piglets.

Gilts: Treat 7-14 days prior to breeding.

Treat 7-14 days prior to farrowing.

Boars: Frequency and need for treatments are dependent upon exposure.

Treat at least two times a year.

FEEDER PIGS

(Weaners/Growers/Finishers)

All weaner/feeder pigs should be treated before placement in clean quarters.

Pigs exposed to contaminated soil or pasture may need retreatment if reinfection occurs.

NOTE:

Noromectin Injection has a persistent drug level sufficient to control mite infestations throughout the egg to adult life cycle. However, since the ivermectin effect is not immediate, care must be taken to prevent reinfestation from exposure to untreated animals or contaminated facilities. Generally, pigs should not be moved to clean quarters or exposed to uninfested pigs for approximately one week after treatment. Sows should be treated at least one week before farrowing to minimize transfer of mites to newborn baby pigs.
Louse eggs are unaffected by Noromectin Injection and may require up to three weeks to hatch. Louse infestations developing from hatching eggs may require retreatment.
Consult a veterinarian for aid in the diagnosis and control of internal and external parasites of swine.

Special Minor Use

Reindeer: For the treatment and control of warbles (Oedemagena tarandi) in reindeer, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under ADMINISTRATION.

American Bison: For the treatment and control of grubs (Hypoderma bovis) in American bison, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under ADMINISTRATION.

RESIDUE INFORMATION: Do not treat reindeer or American bison within 8 weeks (56 days) of slaughter.

WARNING
NOT FOR USE IN HUMANS.
Keep this and all drugs out of the reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact Norbrook, Inc. at 1-913-599-5777.

RESIDUE INFORMATION: Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves.
Do not use in calves to be processed for veal.
Do not treat swine within 18 days of slaughter.

PRECAUTIONS

Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment. For cattle, divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction.

Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections.

Observe cattle for injection site reactions. Reactions may be due to clostridial infection and should be aggressively treated with appropriate antibiotics. If injection site infections are suspected, consult your veterinarian.

This product is not for intravenous or intramuscular use. Protect product from light.

Noromectin Injection for Cattle and Swine has been developed specifically for use in cattle, swine, reindeer, and American bison only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

When to Treat Cattle with Grubs

Noromectin Injection effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. Destruction ofHypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities. Killing Hypoderma lineatum when it is in the tissue surrounding the esophagus (gullet) may cause salivation and bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. These reactions are not specific to treatment with Noromectin Injection, but can occur with any successful treatment of grubs. Cattle should be treated either before or after these stages of grub development. Consult your veterinarian concerning the proper time for treatment.

Cattle treated with Noromectin Injection after the end of the heel fly season may be retreated with Noromectin Injection during the winter for internal parasites, mange mites, or sucking lice without danger of grub-related reactions. A planned parasite control program is recommended.

STORAGE

Store at 15 – 30 °C (59 to 86 °F).

ENVIRONMENTAL SAFETY

Studies indicate that when ivermectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit water runoff from feedlots to enter lakes, streams, or ponds. Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

HOW SUPPLIED

Noromectin Injection for Cattle and Swine is available in five ready-to-use pack sizes:

The 50 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 10 head of 550 lb (250 kg) cattle or 100 head of 38 lb (17.3 kg) swine.

The 100 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 20 head of 550 lb (250 kg) cattle or 200 head of 38 lb (17.3 kg) swine.

The 250 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 50 head of 550 lb (250 kg) cattle or 500 head of 38 lb (17.3 kg) swine.

The 500 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle or 1000 head of 38 lb (17.3 kg) swine.

The 1000 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle or 2000 head of 38 lb (17.3 kg) swine.

Restricted Drug – California. Use Only as Directed.

Made in the UK.
Norbrook Laboratories Limited,
Newry, Co. Down, Northern Ireland.
004670I04

Principal Display Panel

Bottle Label – 1000 mL
ANADA 200-437 Approved by the FDA
Noromectin® (ivermectin)
Injection for Cattle and Swine
1% Sterile Solution
1000 mL
Norbrook®

Carton Label – 1000 mL

ANADA 200-437

Approved by the FDA

Noromectin®

(ivermectin)

Injection for Cattle and Swine

1% Sterile Solution

A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine

1000 mL

Norbrook®

Noromectin FOR CATTLE AND SWINE
ivermectin injection, solution

Product Information
Product Type	OTC ANIMAL DRUG	NDC Product Code (Source)	55529-012
Route of Administration	SUBCUTANEOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ivermectin (ivermectin)	ivermectin	10 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
propylene glycol

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	55529-012-01	1 VIAL In 1 CARTON	contains a VIAL, PLASTIC
1		50 mL In 1 VIAL, PLASTIC	This package is contained within the CARTON (55529-012-01)
2	55529-012-02	1 VIAL In 1 CARTON	contains a VIAL, PLASTIC
2		100 mL In 1 VIAL, PLASTIC	This package is contained within the CARTON (55529-012-02)
3	55529-012-04	1 VIAL In 1 CARTON	contains a VIAL, PLASTIC
3		250 mL In 1 VIAL, PLASTIC	This package is contained within the CARTON (55529-012-04)
4	55529-012-05	1 VIAL In 1 CARTON	contains a VIAL, PLASTIC
4		500 mL In 1 VIAL, PLASTIC	This package is contained within the CARTON (55529-012-05)
5	55529-012-06	1 VIAL In 1 CARTON	contains a VIAL, PLASTIC
5		1000 mL In 1 VIAL, PLASTIC	This package is contained within the CARTON (55529-012-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200437	04/01/2007

Labeler - Norbrook Laboratories Limited (214580029)

Establishment
Name	Address	ID/FEI	Operations
Armagh Road		232880554	MANUFACTURE, ANALYSIS

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

Revised: 02/2010Norbrook Laboratories Limited

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