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Zytopic

30/06/10

Generic Name: triamcinolone (Topical application route)

trye-am-SIN-oh-lone a-SEET-oh-nide

Commonly used brand name(s):

In the U.S.

Aristocort A
Cinolar
Kenalog
Triacet
Triamcot
Triderm
Zytopic

In Canada

Aristocort C Concentrate
Aristocort D Dilute
Aristocort R Ointment Regular
Aristocort R Regular
Kenalog Cream
Kenalog Ointment
Kenalog Spray
Triaderm Mild Cream
Triaderm Mild Ointment
Triaderm Regular Cream
Triaderm Regular Ointment
Trianide Mild-Cream

Available Dosage Forms:

Cream
Lotion
Spray
Ointment

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Triamcinolone

Uses For Zytopic

Triamcinolone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Zytopic

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 triamcinolone topical in the pediatric population. However, because of this medicine’s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor’s instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of triamcinolone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Proper Use of triamcinolone

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

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

If you or your child are using the spray form on or near the face, protect your nose to avoid breathing it in and make sure that your eyes are covered.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

Wash your hands with soap and water before and after using this medicine.
Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

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 redness, itching, and swelling of the skin:
- For topical dosage forms (cream, lotion, and ointment):
  - Adults—Apply to the affected area of the skin two to four times per day.
  - Children—Apply to the affected area of the skin two to four times per day.
- For topical dosage form (aerosol spray):
  - Adults—Spray to the affected area of the skin three to four times per day.
  - Children—Spray to the affected area of the skin three to four times per day.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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 Zytopic

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Zytopic 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:

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin
irritation
itching, scaling, severe redness, soreness, or swelling of the skin
redness and scaling around the mouth
thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

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

Acne or pimples
burning and itching of the skin with pinhead-sized red blisters
burning, itching, and pain in hairy areas, or pus at the root of the hair
increased hair growth on the forehead, back, arms, and legs
lightening of normal skin color
lightening of treated areas of dark skin
reddish purple lines on the arms, face, legs, trunk, or groin
softening of the skin

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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Zyrtec Itchy Eye

30/06/10

Generic Name: ketotifen (Ophthalmic route)

kee-toe-TYE-fen

Commonly used brand name(s):

In the U.S.

Alaway
Claritin Eye
Zaditor
Zyrtec Itchy Eye

Available Dosage Forms:

Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Mast Cell Stabilizer

Chemical Class: Piperidine

Uses For Zyrtec Itchy Eye

Ketotifen ophthalmic (eye) solution is used to temporarily prevent itching of the eye caused by a condition known as allergic conjunctivitis. It works by acting on certain cells, called mast cells, to prevent them from releasing substances that cause the allergic reaction.

This medicine is available both over-the-counter (OTC) and with your doctor’s prescription.

Before Using Zyrtec Itchy Eye

Allergies

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ketotifen in children younger than 3 years of age with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic ketotifen in the elderly with use in other age groups.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of ketotifen

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

Do not wear contact lenses if your eyes are red . Also, do not use this medicine to treat irritation related to contact lens use. If you wear contact lenses: Take out your contact lenses before using ketotifen eye drops. Wait at least 10 minutes after putting the eye drops in before putting the contact lenses back in.

To use the eye drops:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 to 2 minutes to allow the medicine to be absorbed by the eye.
If you think you did not get the drop of medicine into your eye properly, use another drop.
To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Dosing

For ophthalmic dosage form (eye drops):
- For prevention of itching of the eye due to allergic conjunctivitis (eye allergy):
  - Adults and children 3 years of age and older—Use one drop in each affected eye every 8 to 12 hours.
  - Children up to 3 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Zyrtec Itchy Eye

If your symptoms do not improve or if your condition becomes worse, check with your doctor.

Zyrtec Itchy Eye Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Eye redness and swelling

Less common

Eye discharge
eye discomfort
eye pain
hives
increased itching of eyes
rash.

More common

Headaches
stuffy or runny nose

Less common

Burning or stinging of eyes
dry eyes
eyelid disorder
eye sensitivity to light
fever, tiredness, achiness, and sore throat
increase in size of pupils
sore throat
tearing.

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.

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Zyprexa Zydis

30/06/10

Generic Name: olanzapine (Oral route)

oh-LAN-za-peen

Intramuscular routePowder for Solution

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Oral routeTabletTablet, Disintegrating

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Intramuscular routePowder for Suspension, Extended Release

Post-Injection Delirium/Sedation Syndrome
- Adverse events with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of olanzapine pamoate. Olanzapine pamoate must be administered in a registered healthcare facility with ready access to emergency response services. After each injection, patients must be observed at the healthcare facility by a healthcare professional for at least 3 hours. Because of this risk, olanzapine pamoate is available only through a restricted distribution program called olanzapine pamoate Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10- week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine pamoate is not approved for the treatment of patients with dementia-related psychosis .

Patients are at risk for severe sedation (including coma) and/or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency response services. Because of this risk, olanzapine pamoate is available only through a restricted distribution program called olanzapine pamoate Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine pamoate is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s):

In the U.S.

Zyprexa
Zyprexa Zydis

Available Dosage Forms:

Tablet
Tablet, Disintegrating

Therapeutic Class: Antipsychotic

Chemical Class: Thienobenzodiazepine

Uses For Zyprexa Zydis

Olanzapine is used to treat nervous, emotional, and mental conditions (e.g., schizophrenia). It may also be used alone or with other medicines (e.g., lithium or valproate) to treat bipolar disorder (manic-depressive illness) or mania that is part of bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer’s disease.

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

Before Using Zyprexa Zydis

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olanzapine in teenagers 13 to 17 years of age. However, safety and efficacy of olanzapine in children younger than 13 years of age have not been established.

Geriatric

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

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

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.

Levomethadyl
Metoclopramide

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.

Clomipramine
Hydromorphone
Lithium
Mirtazapine
Tetrabenazine
Tramadol

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.

Betel Nut
Carbamazepine
Ciprofloxacin
Fluvoxamine
Haloperidol
Valproic Acid

Interactions with Food/Tobacco/Alcohol

Proper Use of olanzapine

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

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

If you are using the orally disintegrating tablet (Zyprexa® Zydis®), make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

You may take this medicine with or without food.

Tell your doctor if you smoke tobacco. You might need a different amount of this medicine if you smoke.

Dosing

For oral dosage form (orally disintegrating tablets, regular tablets):
- For treatment of schizophrenia:
  - Adults—At first, 5 to 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
  - Teenagers and children 13 to 17 years of age—At first, 2.5 or 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
  - Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For treatment of bipolar disorder:
  - Adults—At first, 5 to 15 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
  - Teenagers and children 13 to 17 years of age—At first, 2.5 or 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
  - Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For treatment of mania with bipolar disorder:
  - Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
  - Teenagers and children 13 to 17 years of age—At first, 2.5 or 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
  - Children younger than 13 years of age—Use and dose must be determined by your doctor.

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Zyprexa Zydis

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

For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you or your child have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your or your child’s weight on a regular basis while you are using this medicine.

Stop taking this medicine and check with your doctor right away if you or your child have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you or your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Olanzapine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for allergies or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; medicines for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Zyprexa Zydis Side Effects

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

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

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
change in vision
change in walking and balance
clumsiness or unsteadiness
difficulty with speaking
difficulty with swallowing
drooling
impaired vision
inability to sit still
loss of balance control
mask-like face
muscle trembling, jerking, or stiffness
need to keep moving
rapid weight gain
restlessness
shakiness in the legs, arms, hands, or feet
shuffling walk
slowed movements
slurred speech
stiffness of the arms and legs
tic-like (jerky) movements of the head, face, mouth, and neck
tingling of the hands or feet
trembling or shaking of the fingers, hands, or feet
twisting movements of the body
uncontrolled movements, especially of the face, neck, and back
unusual weight gain or loss

Less common

Bladder pain
bloody or cloudy urine
bruising
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
chest pain
difficult or labored breathing
difficult, burning, or painful urination
dizziness
excessive muscle tone
frequent urge to urinate
headache
inability to move the eyes
increased blinking or spasms of the eyelid
itching of the vagina or genital area
lack of coordination
large, flat, blue, or purplish patches in the skin
loss of bladder control
loss of memory
lower back or side pain
muscle tension or tightness
nervousness
pain during sexual intercourse
pounding in the ears
problems with memory
rhythmic movement of the muscles
shortness of breath
slow, fast, pounding, or irregular heartbeat or pulse
speaking is less clear than usual
sticking out the tongue
thick, white vaginal discharge with no odor or with a mild odor
tightness in the chest
trouble with breathing, speaking, or swallowing
twitching
uncontrolled twisting movements of the neck, trunk, arms, or legs
unusual or incomplete body or facial movements
weakness of the arms and legs
wheezing

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

Symptoms of overdose

Anxiety
attacking, assaulting, or using force
change in consciousness
change in patterns and rhythms of speech
confusion as to time, place, or person
convulsions (seizures)
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
drowsiness
dry mouth
fainting
hallucinations
heart stops beating
high fever
high or low blood pressure
holding false beliefs that cannot be changed by fact
increased sweating
irregular, fast or slow, or shallow breathing
irritability
lightheadedness
loss of consciousness
mood or mental changes
no breathing
no pulse or blood pressure
pale or blue lips, fingernails, or skin
rapid breathing
relaxed and calm
severe muscle stiffness
shaking or trembling
sleepiness
trouble with sleeping
unconscious
unusual excitement, nervousness, or restlessness
unusual tiredness or weakness
unusually pale skin

More common

Acid or sour stomach
back pain
belching
change in personality
difficulty having a bowel movement (stool)
discouragement
feeling sad or empty
fever
heartburn
increased appetite
increased cough
indigestion
lack of appetite
lack or loss of strength
loss of interest or pleasure
runny nose
sleeplessness
sneezing
stomach discomfort, upset, or pain
stuffy nose
thirst
trouble with concentrating
unable to sleep
watering of the mouth
weight gain

Less common

Blemishes on the skin
body aches or pain
chills
cold sweats
congestion
cough
dry skin
dryness or soreness of the throat
false or unusual sense of well-being
joint pain
heavy menstrual bleeding (periods)
hoarseness
lack of feeling or emotion
leg cramps
pain in the arms or legs
pimples
sweating
tender, swollen glands in the neck
uncaring feelings
voice change
vomiting

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

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

Advanced,Z

Comments (0)

Zyprexa IntraMuscular

30/06/10

Generic Name: olanzapine (Intramuscular route)

oh-LAN-za-peen

Intramuscular routePowder for Solution

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Oral routeTabletTablet, Disintegrating

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Intramuscular routePowder for Suspension, Extended Release

Post-Injection Delirium/Sedation Syndrome
- Adverse events with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of olanzapine pamoate. Olanzapine pamoate must be administered in a registered healthcare facility with ready access to emergency response services. After each injection, patients must be observed at the healthcare facility by a healthcare professional for at least 3 hours. Because of this risk, olanzapine pamoate is available only through a restricted distribution program called olanzapine pamoate Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10- week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine pamoate is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s):

In the U.S.

Zyprexa IntraMuscular
Zyprexa Relprevv

Available Dosage Forms:

Powder for Solution
Powder for Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Thienobenzodiazepine

Uses For Zyprexa IntraMuscular

Olanzapine injection is used to treat agitation that occurs with schizophrenia and bipolar mania. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer’s disease.

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

Zyprexa Relprevv® is available only under a special restricted distribution program called Zyprexa Relprevv® patient care program.

Before Using Zyprexa IntraMuscular

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

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

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.

Levomethadyl
Metoclopramide

Clomipramine
Hydromorphone
Lithium
Mirtazapine
Tetrabenazine
Tramadol

Betel Nut
Carbamazepine
Ciprofloxacin
Fluvoxamine
Haloperidol
Valproic Acid

Interactions with Food/Tobacco/Alcohol

Proper Use of olanzapine

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

A nurse or other trained health professional will give you this medicine in a clinic, community health center, or hospital. This medicine is given as a shot into one of your muscles.

Your doctor may give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Tell your doctor if you smoke tobacco. You might need a different amount of this medicine if you smoke.

Precautions While Using Zyprexa IntraMuscular

It is very important that your doctor check your progress while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

Olanzapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Stop using this medicine and check with your doctor right away if you have any of the following symptoms while receiving this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while receiving this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Olanzapine injection may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

This medicine may cause post-injection delirium/sedation syndrome. Tell your doctor right away if you have the following symptoms: convulsions (seizures), dizziness, drowsiness, sleepiness, or confusion as to time, place, or person after receiving the injection.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

You might get overheated while using this medicine. Drink plenty of water during hot weather, while exercising, or while using a hot tub or sauna. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

Avoid drinking alcohol while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Zyprexa IntraMuscular 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 or nurse immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
change in vision
change in walking and balance
clumsiness or unsteadiness
difficulty with speaking
difficulty with swallowing
drooling
impaired vision
inability to sit still
loss of balance control
mask-like face
muscle trembling, jerking, or stiffness
need to keep moving
rapid weight gain
restlessness
shakiness in the legs, arms, hands, or feet
shuffling walk
slowed movements
slurred speech
stiffness of the arms and legs
tic-like (jerky) movements of the head, face, mouth, and neck
tingling of the hands or feet
trembling or shaking of the fingers, hands, or feet
twisting movements of the body
uncontrolled movements, especially of the face, neck, and back
unusual weight gain or loss

Less common

Bladder pain
bloody or cloudy urine
bruising
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
chest pain
difficult or labored breathing
difficult, burning, or painful urination
dizziness
excessive muscle tone
frequent urge to urinate
headache
inability to move the eyes
increased blinking or spasms of the eyelid
itching of the vagina or genital area
lack of coordination
large, flat, blue, or purplish patches in the skin
loss of bladder control
loss of memory
lower back or side pain
muscle tension or tightness
nervousness
pain, redness, and swelling at the site of the injection
pounding in the ears
problems with memory
rhythmic movement of the muscles
shortness of breath
slow, fast, pounding, or irregular heartbeat or pulse
speaking is less clear than usual
sticking out the tongue
thick, white vaginal discharge with no odor or with a mild odor
tightness in the chest
trouble with breathing, speaking, or swallowing
twitching
uncontrolled twisting movements of the neck, trunk, arms, or legs
unusual or incomplete body or facial movements
weakness of the arms and legs
wheezing

More common

Acid or sour stomach
back pain
belching
change in personality
difficulty having a bowel movement (stool)
discouragement
feeling sad or empty
fever
heartburn
increased appetite
increased cough
indigestion
lack of appetite
lack or loss of strength
loss of interest or pleasure
runny nose
sleeplessness
sneezing
stomach discomfort, upset, or pain
stuffy nose
thirst
trouble with concentrating
unable to sleep
watering of the mouth
weight gain

Less common

Body aches or pain
chills
cold sweats
congestion
cough
dry skin
dryness or soreness of the throat
false or unusual sense of well-being
heavy menstrual bleeding
hoarseness
joint pain
lack of feeling or emotion
leg cramps
pain in the arms or legs
sweating
tender, swollen glands in the neck
uncaring feelings
voice change
vomiting

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

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

Advanced,Z

Comments (0)

Zyprexa Relprevv

30/06/10

Generic Name: olanzapine (Intramuscular route)

oh-LAN-za-peen

Intramuscular routePowder for Solution

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Oral routeTabletTablet, Disintegrating

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .

Intramuscular routePowder for Suspension, Extended Release

Post-Injection Delirium/Sedation Syndrome
- Adverse events with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of olanzapine pamoate. Olanzapine pamoate must be administered in a registered healthcare facility with ready access to emergency response services. After each injection, patients must be observed at the healthcare facility by a healthcare professional for at least 3 hours. Because of this risk, olanzapine pamoate is available only through a restricted distribution program called olanzapine pamoate Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10- week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine pamoate is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s):

In the U.S.

Zyprexa IntraMuscular
Zyprexa Relprevv

Available Dosage Forms:

Powder for Solution
Powder for Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Thienobenzodiazepine

Uses For Zyprexa Relprevv

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

Zyprexa Relprevv® is available only under a special restricted distribution program called Zyprexa Relprevv® patient care program.

Before Using Zyprexa Relprevv

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of olanzapine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

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.

Levomethadyl
Metoclopramide

Clomipramine
Hydromorphone
Lithium
Mirtazapine
Tetrabenazine
Tramadol

Betel Nut
Carbamazepine
Ciprofloxacin
Fluvoxamine
Haloperidol
Valproic Acid

Interactions with Food/Tobacco/Alcohol

Proper Use of olanzapine

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

A nurse or other trained health professional will give you this medicine in a clinic, community health center, or hospital. This medicine is given as a shot into one of your muscles.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Tell your doctor if you smoke tobacco. You might need a different amount of this medicine if you smoke.

Precautions While Using Zyprexa Relprevv

It is very important that your doctor check your progress while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Avoid drinking alcohol while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Zyprexa Relprevv 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 or nurse immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
change in vision
change in walking and balance
clumsiness or unsteadiness
difficulty with speaking
difficulty with swallowing
drooling
impaired vision
inability to sit still
loss of balance control
mask-like face
muscle trembling, jerking, or stiffness
need to keep moving
rapid weight gain
restlessness
shakiness in the legs, arms, hands, or feet
shuffling walk
slowed movements
slurred speech
stiffness of the arms and legs
tic-like (jerky) movements of the head, face, mouth, and neck
tingling of the hands or feet
trembling or shaking of the fingers, hands, or feet
twisting movements of the body
uncontrolled movements, especially of the face, neck, and back
unusual weight gain or loss

Less common

Bladder pain
bloody or cloudy urine
bruising
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
chest pain
difficult or labored breathing
difficult, burning, or painful urination
dizziness
excessive muscle tone
frequent urge to urinate
headache
inability to move the eyes
increased blinking or spasms of the eyelid
itching of the vagina or genital area
lack of coordination
large, flat, blue, or purplish patches in the skin
loss of bladder control
loss of memory
lower back or side pain
muscle tension or tightness
nervousness
pain, redness, and swelling at the site of the injection
pounding in the ears
problems with memory
rhythmic movement of the muscles
shortness of breath
slow, fast, pounding, or irregular heartbeat or pulse
speaking is less clear than usual
sticking out the tongue
thick, white vaginal discharge with no odor or with a mild odor
tightness in the chest
trouble with breathing, speaking, or swallowing
twitching
uncontrolled twisting movements of the neck, trunk, arms, or legs
unusual or incomplete body or facial movements
weakness of the arms and legs
wheezing

More common

Acid or sour stomach
back pain
belching
change in personality
difficulty having a bowel movement (stool)
discouragement
feeling sad or empty
fever
heartburn
increased appetite
increased cough
indigestion
lack of appetite
lack or loss of strength
loss of interest or pleasure
runny nose
sleeplessness
sneezing
stomach discomfort, upset, or pain
stuffy nose
thirst
trouble with concentrating
unable to sleep
watering of the mouth
weight gain

Less common

Body aches or pain
chills
cold sweats
congestion
cough
dry skin
dryness or soreness of the throat
false or unusual sense of well-being
heavy menstrual bleeding
hoarseness
joint pain
lack of feeling or emotion
leg cramps
pain in the arms or legs
sweating
tender, swollen glands in the neck
uncaring feelings
voice change
vomiting

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

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

Advanced,Z

Comments (0)

Zosyn

30/06/10

Generic Name: piperacillin and tazobactam (Intravenous route)

pi-per-a-SIL-in SOE-dee-um, taz-oh-BAK-tam SOE-dee-um

Commonly used brand name(s):

In the U.S.

Zosyn

Available Dosage Forms:

Powder for Solution
Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: Piperacillin

Uses For Zosyn

Piperacillin and tazobactam combination is used to treat bacterial infections in many different parts of the body.

Piperacillin and tazobactam combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Zosyn

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of piperacillin and tazobactam combination in children. However, safety and efficacy have not been established in infants below 2 months of age.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Methotrexate
Vecuronium

Interactions with Food/Tobacco/Alcohol

Proper Use of Zosyn

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using Zosyn

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Piperacillin and tazobactam combination may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Zosyn 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 or nurse immediately if any of the following side effects occur:

More common

Diarrhea

Less common

Bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
blurred vision
breakdown of the skin
burning upper abdominal or stomach pain
changes in skin color
chest pain
confusion
decrease in the amount of urine
difficult or labored breathing
difficult, burning, or painful urination
dizziness
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
enlarged abdomen or stomach
fever
frequent urge to urinate
headache
increased sweating
inflammation or swelling at the injection site
irritation and redness of the skin
loss of appetite
loss of bladder control
lower back or side pain
nausea
nervousness
no blood pressure or pulse
noisy, rattling breathing pain
pain, tenderness, or swelling of the foot or leg
pain, warmth, or burning in the fingers, toes, and legs
pounding in the ears
problems with vision or hearing
rapid weight gain
severe pain in the chest
shortness of breath
skin rash
slow or fast heartbeat
stopping of heart
sudden onset of severe breathing difficulty
sweating
tightness in the chest
tingling of the hands or feet
troubled breathing at rest
unconsciousness
unusual tiredness or weakness
unusual weight gain or loss
vomiting
weight gain
wheezing

Rare

Abdominal or stomach cramps, pain, or tenderness
agitation
anxiety
bleeding gums
bloody nose
bloody, black, or tarry stools
blue lips and fingernails
bone pain
bruising
canker sores
chest congestion
chills
cold sweats
coma
convulsions
cool, pale skin
cough
coughing or spitting up blood
coughing that sometimes produces a pink frothy sputum
decrease in the amount of urine
decrease in the frequency of urination
decrease in urine volume
deep or fast breathing with dizziness
depression
diarrhea, watery and severe, which may also be bloody
difficult, fast, or noisy breathing, sometimes with wheezing
difficulty in passing urine (dribbling)
difficulty with swallowing
drowsiness
dry mouth
excessive muscle tone
extra heart beat
eye pain
fainting or loss of consciousness
fast, pounding, or irregular heartbeat or pulse
flushed, dry skin
fruit-like breath odor
general feeling of illness
high blood pressure
hives
hostility
inability to speak
increase in heart rate
increased clear or white vaginal discharge
increased hunger
increased thirst
increased urination
irritability
itching
itching of the vagina or genital area
large, flat, blue, or purplish patches in the skin
lethargy
lightheadedness
muscle pain or cramps
muscle stiffness or twitching
muscle tension or tightness
nightmares
no blood pressure or pulse
numbness or tingling in the hands, feet, or lips
pain during sexual intercourse
pale skin
pinpoint red or purple spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid breathing
rapid heartbeat
restlessness
seizures
severe constipation
severe or sudden headache
severe vomiting
shakiness in the legs, arms, hands, or feet
slurred speech
sore throat
sores, ulcers, or white spots on the lips, tongue, or inside the mouth
sudden shortness of breath or troubled breathing
sunken eyes
swelling of the face, ankles, feet, or lower legs
swelling of the eyes, eyelids, or hands
swelling or inflammation of the mouth
swollen glands
temporary blindness
thick, white vaginal discharge with no odor or with a mild odor
thirst
total body jerking
troubled breathing
troubled breathing with exertion
unconsciousness
unexplained weight loss
unusual bleeding or bruising
unusual weight loss
weakness
weakness in the arm or leg on one side of the body, sudden and severe
wrinkled skin

Incidence not known

Back or leg pain
blistering, peeling, or loosening of the skin
clay-colored stools
dark urine
fever with or without chills
general body swelling
general feeling of tiredness or weakness
greatly decreased frequency of urination or amount of urine
high fever
joint or muscle pain
nosebleeds
red, irritated eyes
red skin lesions, often with a purple center
unexplained bleeding or bruising
unpleasant breath odor
vomiting of blood
weight gain
yellow eyes or skin

More common

Difficulty having a bowel movement (stool)
sleeplessness
trouble sleeping
unable to sleep

Less common

Acid or sour stomach
belching
breakdown of skin
cracks in the skin at the corners of mouth
heartburn
hiccup
indigestion
irritation and redness of the skin
runny nose
sneezing
soreness or redness around the fingernails and toenails
stomach discomfort, upset, or pain
stuffy nose
white patches in the mouth or on the tongue

Rare

Body aches or pain
burning feeling in the chest or stomach
change in color vision
change in taste or bad unusual or unpleasant (after) taste
congestion
continuing ringing or buzzing or other unexplained noise in the ears
decreased awareness or responsiveness
difficulty seeing at night
difficulty with moving
double vision
dry skin
excess air or gas in the stomach or intestines
feeling of constant movement of self or surroundings
feeling of warmth
feeling unusually cold
full feeling
hearing loss
heartburn
increased sensitivity of the eyes to sunlight
itching or pain of the genital area
lack or loss of strength
passing gas
redness of the face, neck, arms, and occasionally, upper chest
redness, swelling, or soreness of the tongue
seeing double
sensation of spinning
severe sleepiness
shivering
sleepiness or unusual drowsiness
stomach upset
tenderness in stomach area
voice changes

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.

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zopiclone (Oral route)

30/06/10

zoe-PIK-lone

Available Dosage Forms:

Tablet

Therapeutic Class: Nonbarbiturate Hypnotic

Uses For zopiclone

Zopiclonebelongs to the group of medicines called central nervous system (CNS) depressants (medicines that make you drowsy or less alert). zopiclone is used to treat insomnia (trouble in sleeping). Zopiclone helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

zopiclone is available only with your doctor’s prescription.

Before Using zopiclone

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 zopiclone, the following should be considered:

Sleep medicines may cause a special type of memory loss or “amnesia”. When this occurs, a person does not remember what has happened during the several hours between use of the medicine and the time when its effects wear off. This is usually not a problem since most people fall asleep after taking the medicine. In most instances, memory problems can be avoided by taking zopiclone only when you are able to get a full night’s sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to zopiclone 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

Studies on zopiclone have been done only in adult patients, and there is no specific information comparing use of zopiclone in children with use in other age groups.

Geriatric

Confusion, lack of coordination, and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zopiclone.

Breast Feeding

Interactions with Medicines

Using zopiclone 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.

Fospropofol

Interactions with Food/Tobacco/Alcohol

Proper Use of zopiclone

Take zopiclone only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

Do not take zopiclone when your schedule does not permit you to get a full night’s sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Dosing

The dose of zopiclone 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 zopiclone. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (tablets):
- For the treatment of insomnia (trouble in sleeping)
  - Adults—5 to 7.5 milligrams (mg) at bedtime.
  - Older adults—3.75 mg at bedtime; dose may be increased to 5 to 7.5 mg as determined by your doctor.
  - Children up to 18 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of zopiclone, 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.

Precautions While Using zopiclone

If you think you need to take zopiclone for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

zopiclone will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using zopiclone.

zopiclone may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zopiclone is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to zopiclone before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking zopiclone, be sure to discuss it with your doctor. Some changes that have occurred in people taking zopiclone are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

If you will be taking zopiclone for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping zopiclone suddenly may cause withdrawal side effects.

After taking zopiclone for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

If you think you or someone else may have taken an overdose of zopiclone, get emergency help at once. Taking an overdose of zopiclone or taking alcohol or other CNS depressants with zopiclone may lead to breathing problems and unconsciousness. Some signs of an overdose are clumsiness or unsteadiness, mental or mood changes, severe drowsiness, or unusual tiredness or weakness.

zopiclone Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

More common

confusion—more common in older adults
clumsiness or unsteadiness—more common in older adults
daytime anxiety and/or restlessness
difficulty with coordination—more common in older adults
mood or mental changes

Less common

Drowsiness (severe)
shortness of breath
difficult or labored breathing
tightness in chest
wheezing
skin rash
aggressiveness
behavior changes

Rare

Memory problems—more common in older patients
behavior or mental changes

Symptoms of overdose

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

Clumsiness
unsteadiness
mental or mood changes
drowsiness (severe)
unusual tiredness or weakness
sluggishness
reduced physical activity
unusual sleepiness
loss of consciousness

More common

Dizziness
Dryness of mouth
heartburn
impaired vision
increased appetite
indigestion
loss of appetite—more common in older adults
stomach upset
difficulty speaking
constipation
decreased muscle tone
weight loss

Less common

Agitation—more common in older adults
chills
fast, irregular, or pounding heartbeat—more common in older adults
feeling of heaviness of arms and legs
increase in the amount of saliva—more common in older adults
increased sweating—more common in older adults
tingling, burning or prickly sensation
trembling and shaking of fingers, hands, arms, feet, or legs—more common in older adults
vomiting—more common in older adults

After you stop using zopiclone, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Abdominal or stomach cramps or pain
nausea
vomiting
more difficulty in sleeping than before treatment
muscle cramps or discomfort
anxiety
nervousness
irritability
restlessness
increased sweating
tremors
seizures

Zopiclone may cause you to have a coated tongue, bad breath, or a bitter taste. These effects are to be expected when you are taking zopiclone.

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.

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zonisamide (Oral route)

30/06/10

zoe-NIS-a-mide

Commonly used brand name(s):

In the U.S.

Zonegran

Available Dosage Forms:

Capsule
Tablet

Therapeutic Class: Anticonvulsant

Chemical Class: Sulfonamide

Uses For zonisamide

Zonisamide is used together with other medicines to control partial seizures (convulsions) in the treatment of epilepsy. zonisamide is an anticonvulsant that works in the brain tissue to stop seizures.

zonisamide is available only with your doctor’s prescription.

Before Using zonisamide

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 zonisamide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to zonisamide 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 have not been performed on the relationship of age to the effects of zonisamide in children below 16 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of zonisamide have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of zonisamide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving zonisamide.

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

Interactions with Medicines

Using zonisamide 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.

Ginkgo

Interactions with Food/Tobacco/Alcohol

Proper Use of zonisamide

Take zonisamide only as directed by your doctor to help your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

zonisamide comes with a medication guide and a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Zonisamide may be taken with or without food, on a full or empty stomach. Swallow the capsule whole. Do not break, crush, or chew it.

It is important that you drink extra water every day while you take zonisamide to help prevent kidney stones.

zonisamide will be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

Dosing

The dose of zonisamide 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 zonisamide. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (capsules):
- For seizures:
  - Adults and teenagers 16 years of age and older—At first, 100 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 mg per day.
  - Children and teenagers younger than 16 years of age—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of zonisamide, 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 zonisamide

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

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for pregnant patients taking a seizure medicine.

zonisamide may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to zonisamide before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

zonisamide will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking zonisamide.

Contact your doctor immediately if you develop a skin rash, fever, sore throat, sores in your mouth, easy bruising, severe muscle pain or weakness, or worsening of your seizures.

Check with your doctor right away if you have sudden back pain, abdominal or stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.

Serious skin reactions can occur with zonisamide. Stop using zonisamide and check with your doctor right away if you have any of the following symptoms while taking zonisamide: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; joint or muscle pain; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

zonisamide may make you sweat less, which causes your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking zonisamide. Overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking zonisamide.

Do not stop taking zonisamide without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount of medicine you are taking before stopping it completely.

zonisamide may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

zonisamide Side Effects

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

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

More common

Discouragement
feeling sad or empty
irritability
lack of appetite
loss of interest or pleasure
mood or mental changes
shakiness or unsteady walking
tiredness
trouble with concentrating
trouble with sleeping

Less common

Agitation
bruising
delusions
hallucinations
large, flat blue or purplish patches on the skin
rash

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

Symptoms of overdose

Difficult or labored breathing
faintness
loss of consciousness
slow or irregular heartbeat

More common

Abdominal or stomach pain
anxiety
difficulty with memory
dizziness
double vision
headache
loss of appetite
nausea
restlessness
sleepiness
sleeplessness
unusual drowsiness
unusual tiredness or weakness

Less common

Aching muscles or joints
acid or sour stomach
bad, unusual, or unpleasant taste in the mouth
belching
change in taste
chills
constipation
diarrhea
difficulty with speaking
difficulty with thinking
dry mouth
fever
general ill feeling
headache
heartburn
indigestion
mental slowness
nervousness
runny or stuffy nose
sneezing
tingling, burning, or prickly feelings on the skin
uncontrolled, back and forth, or rolling eye movements
weight loss

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

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

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Zomig-ZMT

30/06/10

Generic Name: zolmitriptan (Oral route)

zole-mi-TRIP-tan

Commonly used brand name(s):

In the U.S.

Zomig
Zomig-ZMT

Available Dosage Forms:

Tablet
Tablet, Disintegrating

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Uses For Zomig-ZMT

Zolmitriptan is used to treat severe migraine headaches. Many people find that their headaches go away completely after they take zolmitriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Zolmitriptan often relieves symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Zolmitriptan is not an ordinary pain reliever. It should not be used to relieve any kind of pain other than migraine headaches.

Zolmitriptan may cause serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the good that it can do.

Zolmitriptan is available only with your doctor’s prescription.

Before Using Zomig-ZMT

Allergies

Pediatric

There is no specific information comparing use of zolmitriptan in children or teenagers with use in other age groups.

Geriatric

There is no specific information comparing use of zolmitriptan in patients older than 65 years of age with use in younger adults.

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

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.

Almotriptan
Cisapride
Dihydroergotamine
Ergoloid Mesylates
Ergonovine
Ergotamine
Frovatriptan
Isocarboxazid
Levomethadyl
Linezolid
Mesoridazine
Methylergonovine
Methysergide
Naratriptan
Phenelzine
Pimozide
Procarbazine
Rizatriptan
Sumatriptan
Terfenadine
Thioridazine
Tranylcypromine
Ziprasidone

Acecainide
Ajmaline
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Aprindine
Azimilide
Bretylium
Chloroquine
Citalopram
Clarithromycin
Clovoxamine
Desipramine
Desvenlafaxine
Dibenzepin
Disopyramide
Dofetilide
Dolasetron
Doxepin
Droperidol
Duloxetine
Erythromycin
Escitalopram
Femoxetine
Flecainide
Fluconazole
Fluoxetine
Fluvoxamine
Foscarnet
Gemifloxacin
Halofantrine
Haloperidol
Hydroquinidine
Ibutilide
Imipramine
Isradipine
Lidoflazine
Lorcainide
Mefloquine
Milnacipran
Nefazodone
Nortriptyline
Octreotide
Paroxetine
Pentamidine
Pirmenol
Prajmaline
Probucol
Procainamide
Prochlorperazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Reboxetine
Risperidone
Sematilide
Sertindole
Sertraline
Sibutramine
Sotalol
Spiramycin
St John’s Wort
Sultopride
Tapentadol
Tedisamil
Trifluoperazine
Trimipramine
Vasopressin
Venlafaxine
Zimeldine
Zotepine

Cimetidine

Interactions with Food/Tobacco/Alcohol

Proper Use of zolmitriptan

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

Do not use zolmitriptan for a headache that is different from your usual migraines . Instead, check with your doctor.

To relieve your migraine as soon as possible, use zolmitriptan as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using zolmitriptan.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

Ask your doctor ahead of time about other medicine you might take if zolmitriptan does not work. After you take the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by zolmitriptan are sometimes caused by conditions that need other treatment.

If you feel much better after a dose of zolmitriptan, but your headache comes back or gets worse after a while, you may use more zolmitriptan. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much zolmitriptan may increase the chance of side effects.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor’s directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of zolmitriptan or other pain medicines that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

For patients using the oral disintegrating tablet form of this medicine:

Make sure your hands are dry.
Remove tablet from package, and immediately place the tablet on top of your tongue.
The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

Dosing

For oral dosage form (tablets):
- For migraine headaches:
  - Adults—2.5 mg or lower (tablet may be broken in half) as a single dose. If the migraine comes back after being relieved, another dose may be taken two hours after the last dose. Do not take more than 10 mg in any twenty-four-hour period (one day).
  - Children—Use and dose must be determined by your doctor.
For oral dosage form (oral disintegrating tablets):
- For migraine headaches:
  - Adults—2.5 mg placed on top of your tongue. If the migraine comes back after being relieved, another dose may be taken two hours after the last dose. Do not take more than 10 mg in any twenty-four-hour period (one day).
  - Children—Use and dose must be determined by your doctor.

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.

Precautions While Using Zomig-ZMT

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel drowsy or dizzy during or after a migraine, or after taking zolmitriptan to relieve a migraine. As long as you are feeling drowsy or dizzy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Zomig-ZMT 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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

More common

Chest pain (severe)
heaviness, tightness, or pressure in chest and/or neck
sensation of burning, warmth, heat, numbness, tightness, or tingling

Less common or rare

Abdominal pain (severe)
changes in facial skin color
cough or hoarseness
diarrhea
fast or irregular heartbeat
fever or chills
loss of appetite
lower back or side pain
nausea
painful or difficult urination
puffiness or swelling of the eyelids or around the eyes, face, or lips
shortness of breath, troubled breathing, tightness in chest, and/or wheezing
skin rash, hives, and/or itching
weakness

Other side effects may occur that usually do not need medical attention. Some of the following effects, such as nausea, vomiting, drowsiness, dizziness, and general feeling of illness or tiredness, often occur during or after a migraine, even when zolmitriptan has not been used. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Dizziness
nausea
sleepiness
unusual tiredness or muscle weakness

Less common

Agitation
anxiety
depression
discomfort in jaw, mouth, or throat
difficulty in swallowing
dry mouth
fainting
heartburn
itching of the skin
large nonelevated blue or purplish patches in the skin
muscle aches
pounding heartbeat
sudden large increase in frequency and quantity of urine
sweating
swelling of face, fingers, feet and/or lower legs

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.

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Zonalon

30/06/10

Generic Name: doxepin (Topical route)

DOX-e-pin

Oral routeCapsuleSolution

Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin hydrochloride is not approved for use in pediatric patients .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s):

In the U.S.

Prudoxin
Zonalon

Available Dosage Forms:

Cream

Therapeutic Class: Dermatological Agent

Pharmacologic Class: Antidepressant, Tricyclic

Uses For Zonalon

Topical doxepin is used to relieve itching in patients with certain types of eczema. It appears to work by preventing the effects of histamine, which is a substance produced by the body that causes itching.

Doxepin is available only with your doctor’s prescription.

Before Using Zonalon

Allergies

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of doxepin in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of doxepin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

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

Bepridil
Cisapride
Grepafloxacin
Isocarboxazid
Levomethadyl
Linezolid
Mesoridazine
Metoclopramide
Moclobemide
Pimozide
Sparfloxacin
Terfenadine
Thioridazine
Tranylcypromine

Acecainide
Ajmaline
Amiodarone
Amisulpride
Amprenavir
Arsenic Trioxide
Astemizole
Azimilide
Bretylium
Chloroquine
Clarithromycin
Clonidine
Clorgyline
Disopyramide
Dofetilide
Dolasetron
Droperidol
Enflurane
Epinephrine
Erythromycin
Etilefrine
Fluconazole
Fluoxetine
Foscarnet
Gatifloxacin
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Hydroquinidine
Ibutilide
Iproniazid
Isoflurane
Isradipine
Methoxamine
Midodrine
Moxifloxacin
Nefopam
Nialamide
Norepinephrine
Octreotide
Oxilofrine
Pargyline
Pentamidine
Phenelzine
Phenylephrine
Pirmenol
Prajmaline
Procainamide
Procarbazine
Prochlorperazine
Quetiapine
Quinidine
Rasagiline
Risperidone
Selegiline
Sematilide
Sertindole
Sertraline
Sotalol
Spiramycin
Sulfamethoxazole
Sultopride
Tapentadol
Tedisamil
Telithromycin
Toloxatone
Tramadol
Trifluoperazine
Trimethoprim
Vasopressin
Venlafaxine
Ziprasidone
Zolmitriptan
Zotepine

Acenocoumarol
Arbutamine
Atomoxetine
Bethanidine
Cannabis
Carbamazepine
Cimetidine
Dicumarol
Guanethidine
Paroxetine
Phenprocoumon
Phenytoin
Propoxyphene
S-Adenosylmethionine
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of doxepin

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

Topical doxepin is for external use only. Do not use this medicine orally, do not use it on the eyes, or inside of the vagina.

Use this medicine exactly as directed. Do not use more of it, do not use it more often, and do not use it for more than 8 days. Also, do not apply it to an area of skin larger than recommended by your doctor. To do so may increase the chance of side effects.

Apply a thin layer of doxepin cream to only the affected area(s) of the skin and rub in gently.

To help clear up your skin problem it is very important that you keep using topical doxepin for the full time of treatment. Do not miss any doses.

Do not cover with a bandage or otherwise wrap the area of skin being treated. This may increase the amount of medicine that gets into the bloodstream, thereby increasing the chance of side effects.

Dosing

For topical dosage form (cream):
- For itching due to eczema:
  - Adults—Apply a thin layer to the affected area(s) of the skin four times a day. Space the doses or applications at least three or four hours apart. Treatment may be continued for up to eight days.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

Precautions While Using Zonalon

If your skin problem does not improve after 8 days or if it becomes worse, check with your doctor.

This medicine will add to the effects of alcohol (alcoholic beverages or other alcohol-containing preparations [e.g., elixirs, cough syrups, tonics]) and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Topical doxepin may cause some people to become drowsy. Make sure you know how to react to this medicine before you drive, use machines, or do other jobs that require you to be alert. If too much drowsiness occurs, it may be necessary to use less medicine, use it less often, or stop using it completely. However, check with your doctor first before lessening your dose or stopping use of this medicine.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, or melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Zonalon Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Burning, crawling, or tingling sensation of the skin
swelling at the site of application
worsening of eczema and itching

Rare

Fever

Symptoms of overdose

Abdominal pain and swelling
blurring of vision
convulsions (seizures)
decreased awareness or responsiveness
difficulty in breathing
difficulty in passing urine
dizziness, fainting, or lightheadedness
drowsiness
enlarged pupils
excessive dryness of mouth
extremely high fever or body temperature
extremely low body temperature
fast heartbeat
increased or excessive unconscious or jerking movements
incurable constipation
irregular heartbeat
unconsciousness
vomiting
weak pulse

More common

Burning and/or stinging at the site of application
changes in taste
dizziness
drowsiness
dryness and tightness of skin
dryness of mouth and/or lips
emotional changes
headache
thirst
unusual tiredness or weakness

Less common

Anxiety
irritation, tingling, scaling, and cracking of skin
nausea

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.

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