Generic Name: Linezolid (lin-AYZ-oh-lid)
Brand Name: Zyvox

Zyvox Suspension is used for:

Treating adults with certain serious bacterial infections that are often resistant to other antibiotics.

Zyvox Suspension is an oxazolidinone antibiotic. It works by interfering with the production of proteins needed by bacteria to grow.

Do NOT use Zyvox Suspension if:

• you are allergic to any ingredient in Zyvox Suspension
• you are taking an amphetamine (eg, dextroamphetamine), certain anorexiants (eg, phentermine), buspirone, a catechol-O-methyltransferase (COMT) inhibitor (eg, entacapone), levodopa, meperidine, a sympathomimetic (eg, albuterol, dopamine, epinephrine, pseudoephedrine), tetrabenazine, or a triptan (eg, sumatriptan)
• you are taking or have taken certain anorexiants (eg, sibutramine), apraclonidine, bupropion, cyclobenzaprine, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), a norepinephrine reuptake inhibitor (eg, atomoxetine), a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, duloxetine), a serotonin reuptake inhibitor (eg, paroxetine), a tetracyclic antidepressant (eg, maprotiline), or a tricyclic antidepressant (eg, amitriptyline) within the past 14 days

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

Before using Zyvox Suspension:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of high blood pressure, kidney problems, eye or vision problems, bone marrow problems, low blood cell or platelet levels, an adrenal gland tumor (pheochromocytoma), carcinoid syndrome, severe liver problems, seizures, an overactive thyroid, or phenylketonuria
• if you have a prolonged infection that has been previously treated with another antibiotic medicine
• if you are taking any medicine for depression

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

• Amphetamines (eg, dextroamphetamine), certain anorexiants (eg, phentermine, sibutramine), apraclonidine, ginseng, meperidine, sympathomimetics (eg, albuterol, dopamine, epinephrine, pseudoephedrine), or tryptophan because the risk of serious side effects, including severe headache, fever, or high blood pressure, may be increased
• Bupropion, busporine, catechol-O-methyltransfirase (COMT) inhibitors (eg, entacapone), levodopa, MAOIs (eg, phenelzine), norepinephrine reuptake inhibitors (eg, atomoxetine), propoxyphene, SNRIs (eg, duloxetine ), tetrabenazine, tetracyclic antidepressants (eg, maprotiline), tricyclic antidepressants (eg, amitriptyline), or triptans (eg, sumatriptan) because the risk of serious side effects, including severe fever, mental or mood changes, or muscle problems, may be increased
• Carbamazepine, barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifamycins (eg, rifampin) because they may decrease Zyvox Suspension’s effectiveness

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

How to use Zyvox Suspension:

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

• Take Zyvox Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Gently mix before each dose by turning the bottle upside-down 3 to 5 times. Do not shake Zyvox Suspension.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• To clear up your infection completely, take Zyvox Suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
• If you miss a dose of Zyvox Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Zyvox Suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Zyvox Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Be sure to use Zyvox Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Zyvox Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use an MAOI may cause severe high blood pressure. This could occur for up to 2 weeks after you stop taking an MAOI. Do not eat foods high in tyramine while you take Zyvox Suspension. Ask your health care provider for a complete list of foods you should avoid. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.
• Zyvox Suspension may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Zyvox Suspension only works against bacteria; it does not treat viral infections (eg, the common cold).
• Lactic acidosis has occurred with the use of Zyvox Suspension. Contact your doctor if you have severe, persistent nausea, vomiting, stomach pain, or unusual tiredness or weakness.
• Serious eye problems (eg, peripheral and optic neuropathy) have occurred with the use of Zyvox Suspension. Contact your doctor if you experience vision changes (eg, decreased or blurred vision, changes in color vision, loss of vision).
• Phenylketonuria patients – Zyvox Suspension contains phenylalanine. If you must have a diet that is low in phenylalanine, talk with your doctor or pharmacist.
• Lab tests, including complete blood cell counts and eye exams, may be performed while you use Zyvox Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Zyvox Suspension should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zyvox Suspension while you are pregnant. It is not known if Zyvox Suspension is found in breast milk. If you are or will be breast-feeding while you use Zyvox Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zyvox Suspension:

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

Bad taste in mouth; constipation; diarrhea; dizziness; headache; nausea; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; bloody stools; bloody vomit; chills, fever, or sore throat; confusion; exaggerated reflexes; excitation; fast heartbeat; loss of coordination; mental or mood changes; muscle spasms; prolonged or repeated nausea or vomiting; red, swollen, peeling, or blistered skin; seizures; severe or continuing diarrhea; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of the hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes; white patches in the mouth.

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

If OVERDOSE is suspected:

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

Proper storage of Zyvox Suspension:

Store Zyvox Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep the bottle tightly closed. Discard any unused medicine 21 days after mixing. Keep Zyvox Suspension out of the reach of children and away from pets.

General information:

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

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

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing’s syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

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.

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Generic name: Linezolid
Brand names: Zyvox

Why is Zyvox prescribed?

Zyvox is a member of a new class of antibiotics called oxazolidinones. It is used to treat certain types of pneumonia, some forms of skin infection, and infections involving certain strains of a germ called Enterococcus faecium.

Most important fact about Zyvox

Antibiotic treatment can cause a type of diarrhea that, in rare cases, becomes extremely severe. If you develop diarrhea after starting Zyvox, be sure to notify your doctor immediately.

If you need to take Zyvox for more than two weeks, your doctor will perform blood tests to check for blood abnormalities. Blood tests are also needed if you tend to bleed easily or are taking medications that increase your chance of bleeding.

Zyvox could cause a very rare—but potentially fatal—side effect known as lactic acidosis, especially if the treatment lasts longer than the recommended 28 days. It is caused by a buildup of lactic acid in the blood. Lactic acidosis is a medical emergency that must be treated in a hospital. Notify your doctor immediately if you experience repeated nausea and vomiting or any of the following:

• Symptoms of lactic acidosis may include:
  Dizziness, extreme weakness or tiredness, light-headedness, low body temperature, rapid breathing or trouble breathing, sleepiness, slow or irregular heartbeat, unexpected or unusual stomach discomfort, unusual muscle pain

How should you take Zyvox?

Zyvox should be taken twice a day, every 12 hours, until the prescription is finished. Do not stop taking the medicine when you start to feel better. If you discontinue it too soon, surviving germs may cause a relapse. Zyvox may be taken with or without food.

If you are taking the liquid formulation of Zyvox, gently mix it before each use by turning the bottle upside down and upright 3 to 5 times. Do not shake the bottle.

Your doctor will only prescribe Zyvox to treat a bacterial infection; it will not cure a viral infection, such as the common cold. It’s important to take the full dosage schedule of Zyvox, even if you’re feeling better in a few days. Not completing the full dosage schedule may decrease the drug’s effectiveness and increase the chances that the bacteria may become resistant to Zyvox and similar antibiotics.

• If you miss a dose…
  Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

• Storage instructions…
  Both Zyvox tablets and Zyvox liquid can be stored at room temperature. Keep the bottles tightly closed and protect from light and moisture. The liquid formulation should be used within 21 days.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Zyvox.

• Side effects reported in adults may include:
  Diarrhea, headache, nausea, vomiting

• Side effects reported in children may include:
  Anemia, blood infection, diarrhea, fever, rash, upper respiratory infection, vomiting

Why should Zyvox not be prescribed?

If Zyvox gives you an allergic reaction, you won’t be able to use it.

Special warnings about Zyvox

Let the doctor know if you have high blood pressure. Zyvox has not been tested under these conditions.

If you’re taking Zyvox with a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), there is a chance of developing serotonin syndrome. Symptoms include euphoria, drowsiness, rapid muscle contraction and relaxation, restlessness, dizziness, sweating, coordination problems, and fever. If you experience these symptoms, seek medical attention immediately.

Vision problems─including blurred vision, change in color perception, and problems with depth perception─may be caused by Zyvox treatment that lasts for more than 28 days. If this occurs, contact your doctor right away.

If you have a condition called phenylketonuria and must avoid the amino acid phenylalanine, it’s important to know that the liquid formulation of Zyvox contains this substance.

Possible food and drug interactions when taking Zyvox

If Zyvox is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Zyvox with the following:

Serotonin-boosting antidepressants
Decongestants
Over-the-counter cold medicines and cough syrups that contain pseudoephedrine

While taking Zyvox, it’s important to avoid eating large amounts of foods that contain a chemical called tyramine. Food products high in tyramine include aged cheese, fermented or air-dried meats such as dry sausage, sauerkraut, soy sauce, red wine, tap beers, and any protein-rich food that has been improperly refrigerated.

Special information if you are pregnant or breastfeeding

Zyvox has not been studied in pregnant women or nursing mothers. Because the possibility of harm to the developing baby has not been ruled out, Zyvox should be used during pregnancy only if the potential benefit outweighs the possible risk. If you wish to breastfeed your infant, discuss your treatment options with your doctor.

Recommended dosage for Zyvox

ADULTS AND ADOLESCENTS 12 AND OLDER

Pneumonia and Complicated Skin Infections

The usual dosage is 600 milligrams every 12 hours for 10 to 14 days.

Uncomplicated Skin Infections

Adults: The usual dosage is 400 milligrams every 12 hours for 10 to 14 days.

Adolescents 12 years and older: The usual dosage is 600 milligrams every 12 hours for 10 to 14 days.

Enterococcus faecium Infections

The usual dosage is 600 milligrams every 12 hours for 14 to 28 days.

CHILDREN (BIRTH TO 11 YEARS OLD)

Pneumonia and Complicated Skin Infections

The usual dosage is 10 milligrams for every 2.2 pounds of body weight taken every 8 hours for 10 to 14 days.

Uncomplicated Skin Infections

Children under 5 years old: The usual dosage is 10 milligrams for every 2.2 pounds of body weight taken every 8 hours for 10 to 14 days.

Children 5 to 11 years old: The usual dosage is 10 milligrams for every 2.2 pounds of body weight taken every 12 hours for 10 to 14 days.

Enterococcus faecium Infections

The usual dosage is 10 milligrams for every 2.2 pounds of body weight taken every 8 hours for 14 to 28 days.

Overdosage

Little is known about the effects of a Zyvox overdose. However, any medication taken in excess can have serious consequences, so if you suspect an overdose, seek medical attention immediately.

Generic Name: Cetirizine/Pseudoephedrine (seh-TIH-rih-zeen/SUE-doe-eh-FED-rin)
Brand Name: Zyrtec-D 12 Hour

Zyrtec-D 12 Hour is used for:

Relieving nasal and non-nasal symptoms associated with seasonal and perennial allergies such as watery or itchy eyes, runny nose, sneezing, and stuffy nose.

Zyrtec-D 12 Hour is a decongestant (pseudoephedrine) and antihistamine (cetirizine) combination. It works by blocking a chemical in the body, histamine, which causes allergy symptoms. It also shrinks swollen nasal passages, which relieves nasal congestion.

Do NOT use Zyrtec-D 12 Hour if:

• you are allergic to any ingredient in Zyrtec-D 12 Hour
• you have narrow-angle glaucoma, severe difficulty urinating, very high blood pressure, or severe heart or blood vessel disease
• you are currently taking or have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Zyrtec-D 12 Hour:

Some medical conditions may interact with Zyrtec-D 12 Hour. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have diabetes, difficulty urinating due to an enlarged prostate, heart or kidney problems, an overactive thyroid, glaucoma, or high blood pressure

Some MEDICINES MAY INTERACT with Zyrtec-D 12 Hour. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Furazolidone or MAO inhibitors (eg, phenelzine) because they can cause serious, sometimes fatal, reactions. Do not take MAO inhibitors within 2 weeks of taking Zyrtec-D 12 Hour.
• Certain stimulants (albuterol, amphetamine), digitalis (eg, digoxin), or droxidopa because toxic effects on the heart may occur
• Urinary alkalinizers (eg, sodium bicarbonate) because it may increase the actions and side effects of Zyrtec-D 12 Hour
• Bromocriptine or certain antihypertensives (guanethidine, methyldopa, mecamylamine, reserpine) because their effectiveness may be decreased by Zyrtec-D 12 Hour

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zyrtec-D 12 Hour may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zyrtec-D 12 Hour:

Use Zyrtec-D 12 Hour as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zyrtec-D 12 Hour may be taken with or without food.
• Swallow whole. Do not crush, break, or chew before swallowing.
• If you miss a dose of Zyrtec-D 12 Hour, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zyrtec-D 12 Hour.

Important safety information:

• Zyrtec-D 12 Hour may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Zyrtec-D 12 Hour. Using Zyrtec-D 12 Hour alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Zyrtec-D 12 Hour. Zyrtec-D 12 Hour will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• If you have trouble sleeping, ask your doctor or pharmacist about the best time to take Zyrtec-D 12 Hour.
• Zyrtec-D 12 Hour may interfere with allergy test results. Check with your doctor for more information.
• Diabetes patients – Zyrtec-D 12 Hour may affect your blood sugar level. Your doctor may need to change the amount of diabetes medicine you are taking.
• Use Zyrtec-D 12 Hour with caution in the ELDERLY because they may be more sensitive to its effects, especially drowsiness.
• Zyrtec-D 12 Hour is not recommended for use in children younger than 12 years of age. Safety and effectiveness in the age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Zyrtec-D 12 Hour during pregnancy. Zyrtec-D 12 Hour is excreted in breast milk. Do not breast-feed while taking Zyrtec-D 12 Hour.

Possible side effects of Zyrtec-D 12 Hour:

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

Dizziness; drowsiness; dry mouth; fatigue; headache; nausea; nervousness; sore throat; trouble sleeping.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating; mental or mood changes; persistent tiredness; seizures; sleeplessness; uncontrolled shaking or tremor; unusually fast/irregular heart rhythm; weakness; yellowing of the eyes or skin.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; difficulty breathing; hallucinations; irregular or fast heartbeat; loss of consciousness; seizures; severe drowsiness; sleeplessness; tremors.

Proper storage of Zyrtec-D 12 Hour:

Store Zyrtec-D 12 Hour at room temperature, 68 to 77 degrees F (20 to 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zyrtec-D 12 Hour out of the reach of children and away from pets.

General information:

• If you have any questions about Zyrtec-D 12 Hour, please talk with your doctor, pharmacist, or other health care provider.
• Zyrtec-D 12 Hour is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Zyrtec-D 12 Hour. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: cetirizine and pseudoephedrine (se TIR i zeen and SOO doe e FED rin)
Brand Names: All Day Allergy-D, Zyrtec-D

What is Zyrtec-D (cetirizine and pseudoephedrine)?

Cetirizine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of cetirizine and pseudoephedrine is used to treat cold or allergy symptoms such as nasal and sinus congestion, sneezing, itching, watery eyes, or runny nose.

Cetirizine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Zyrtec-D (cetirizine and pseudoephedrine)?

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

You should not use cetirizine and pseudoephedrine if you are allergic to either drug, or if you have narrow-angle glaucoma, severe high blood pressure (hypertension), severe coronary artery disease, if you are unable to urinate, or if you are allergic to hydralazine (Atarax, Vistaril).

Do not use any other over-the-counter cold medication without first asking your doctor or pharmacist. Pseudoephedrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of this drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine.

Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of cetirizine. Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

What should I discuss with my healthcare provider before taking Zyrtec-D (cetirizine and pseudoephedrine)?

Do not use cetirizine and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious side effects can occur if you take pseudoephedrine before the MAO inhibitor has cleared from your body. You should not use cetirizine and pseudoephedrine if you are allergic to either drug, or if you have:

• narrow-angle glaucoma;

• severe high blood pressure (hypertension);

• severe coronary artery disease;

• if you are unable to urinate; or

• if you are allergic to hydralazine (Atarax, Vistaril).

Ask a doctor or pharmacist about using cetirizine and pseudoephedrine if you have:

• heart disease, coronary artery disease, high blood pressure, or heart rhythm disorder;

• diabetes;

• a thyroid disorder;

• glaucoma;

• kidney or liver disease;

• an enlarged prostate; or

• problems with urination.

FDA pregnancy category C. It is not known whether cetirizine and pseudoephedrine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Cetirizine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from cetirizine and pseudoephedrine.

How should I take Zyrtec-D (cetirizine and pseudoephedrine)?

Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take one tablet every 12 hours, unless your doctor tells you otherwise. You may take this medication with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking or opening the pill may cause too much of the medicine to be released at one time. Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever. Store cetirizine and pseudoephedrine at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous, headache, nausea, vomiting, sweating, anxiety, drowsiness, increased thirst, fast or pounding heartbeats, trouble sleeping, or problems with urination.

What should I avoid while taking Zyrtec-D (cetirizine and pseudoephedrine)?

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

Do not use any other over-the-counter cold medication without first asking your doctor or pharmacist. Pseudoephedrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of this drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine. Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of cetirizine.

Zyrtec-D (cetirizine and pseudoephedrine) side effects

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

• fast, pounding, or uneven heartbeat;

• weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);

• severe restless feeling, hyperactivity;

• extreme feeling of fear or confusion;

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

• problems with vision; or

• urinating less than usual or not at all.

Less serious side effects may include:

• dizziness, drowsiness;

• tired feeling;

• dry mouth;

• nausea, stomach pain, constipation;

• problems with concentration; or

• ringing in your ears.

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

What other drugs will affect Zyrtec-D (cetirizine and pseudoephedrine)?

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by cetirizine.

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

• digoxin (digitalis, Lanoxin);

• blood pressure medication, especially methyldopa (Aldomet), mecamylamine (Inversine), or reserpine; or

• diet pills, stimulants, or ADHD medications.

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

Where can I get more information?

• Your pharmacist can provide more information about cetirizine and pseudoephedrine.

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 04/06/2009 12:03:54 PM.