Generic Name: ethinyl estradiol and levonorgestrel (ETH in ill ess tra DYE ol and LEE vo nor JESS trel)
Brand Names: Alesse, Aviane, Enpresse, Lessina, Levlen, Levlite, Levora, Lutera, Lybrel, Nordette, Portia, Sronyx, Tri-Levlen, Triphasil-21, Triphasil-28, Trivora-28

What is Lutera (ethinyl estradiol and levonorgestrel)?

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

Ethinyl estradiol and levonorgestrel are used as contraception to prevent pregnancy.

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

What is the most important information I should know about Lutera (ethinyl estradiol and levonorgestrel)?

Do not use ethinyl estradiol and levonorgestrel if you are pregnant or if you recently had a baby. Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

What should I discuss with my healthcare provider before taking Lutera (ethinyl estradiol and levonorgestrel)?

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

• a history of a stroke or blood clot;

• circulation problems (especially if caused by diabetes);

• a hormone-related cancer such as breast or uterine cancer;

• abnormal vaginal bleeding;

• liver disease or liver cancer;

• severe high blood pressure;

• severe migraine headaches;

• a heart valve disorder; or

• a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have:

• high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

• high cholesterol or if you are overweight;

• a history of depression;

• gallbladder disease;

• diabetes;

• seizures or epilepsy;

• a history of irregular menstrual cycles;

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;

• uterine fibroid tumors;

• varicose veins; or

• tuberculosis.

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

How should I take Lutera (ethinyl estradiol and levonorgestrel)?

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

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

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

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

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the next day. You may get pregnant if you do not use this medication regularly.

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

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

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

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

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

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

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

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

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

What happens if I overdose?

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

What should I avoid while taking Lutera (ethinyl estradiol and levonorgestrel)?

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

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

Lutera (ethinyl estradiol and levonorgestrel) side effects

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

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

• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• a change in the pattern or severity of migraine headaches;

• nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet; or

• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;

• breast pain, tenderness, or swelling;

• freckles or darkening of facial skin;

• increased hair growth, loss of scalp hair;

• changes in weight or appetite;

• problems with contact lenses;

• vaginal itching or discharge;

• changes in your menstrual periods, decreased sex drive; or

• headache, nervousness, dizziness, tired feeling.

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 Lutera (ethinyl estradiol and levonorgestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

• acetaminophen (Tylenol) or ascorbic acid (vitamin C);

• prednisolone (Orapred);

• theophylline (Respbid, Theo-Dur);

• cyclosporine (Neoral, Sandimmune, Gengraf);

• St. John’s wort;

• an antibiotic;

• seizure medications;

• a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

• HIV or AIDS medications.

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

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and levonorgestrel.

• 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: 8.01. Revision Date: 11/03/2009 1:59:23 PM.

Generic Name: lutropin alfa (lou TRO peen aal fa)
Brand Names: Luveris

What is lutropin alfa?

Lutropin alfa is a hormone used to support Follicle Stimulating Hormone (FSH) therapy.

Lutropin alfa is used with follitropin alfa (Gonal-F) to stimulate a follicle(egg) to develop and mature. The therapy used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature.

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

What is the most important information I should know about lutropin alfa?

Treatment with lutropin alfa increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.

Patients treated with lutropin alfa may develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms.

What should I discuss with my healthcare provider before using lutropin alfa?

Lutropin alfa will not induce ovulation if the ovaries are not capable of producing an egg.

Before using this medication, tell your doctor if you

• might be pregnant;

• have a thyroid problem;

• have adrenal dysfunction;

• have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland;

• have undiagnosed abnormal vaginal bleeding; or

• have ovarian cysts or enlargement not due to polycystic ovary disease (PCOD).

You may not be able to use lutropin alfa, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Treatment with lutropin alfa increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.

Do not use this medication if you are pregnant. Lutropin alfa is in the FDA pregnancy category X. This means that lutropin alfa is known to cause birth defects in an unborn baby (when used beyond the period of ovulation). It is not known whether lutropin alfa passes into breast milk. Do not use lutropin alfa without first talking to your doctor if you are breast-feeding a baby.

How should I use lutropin alfa?

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

Lutropin alfa should only be administered subcutaneously. If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and give the injection. Do not inject this medication if you are not sure how.

Do not shake the vial, but gently swirl until the solution is clear. Do not inject any medication that is discolored or that has particles in it.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Lutropin alfa should be used immediately after mixing. Any unused portion should be thrown away.

What happens if I miss a dose?

Contact your doctor if you miss a dose of lutropin alfa.

What happens if I overdose?

An overdose of lutropin alfa is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice if an overdose is suspected.

Symptoms of a lutropin alfa overdose are not known.

What should I avoid while using lutropin alfa?

There are no restrictions on food, beverages, or activity during treatment with lutropin alfa unless otherwise directed by your doctor.

Lutropin alfa side effects

Stop using lutropin alfa and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);

• confusion, severe dizziness, severe headache; or

• difficulty breathing.

Patients treated with lutropin alfa may develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms.

Other side effects may also occur. Notify your doctor if you experience

• ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;

• nausea, vomiting, diarrhea, or flatulence (gas);

• fever or chills;

• headache;

• dizziness;

• rapid pulse or heart rate;

• muscle or joint weakness or aching;

• breast tenderness;

• spotting or menstrual changes;

• pain, swelling, or irritation at the injection site; or

• dry skin, a rash, or hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Lutropin alfa Dosing Information

Usual Adult Dose for Follicle Stimulation:

75 intl units subcutaneously daily. Treatment duration should not normally exceed 14 days unless signs of imminent follicular development are present.

What other drugs will affect lutropin alfa?

It is not known whether other medications will interact with lutropin alfa. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has additional information about lutropin alfa written for health professionals that you may read.

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:45:24 PM.

loo-TROE-pin AL-fa

Commonly used brand name(s):

In the U.S.

• Luveris

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Human Luteinizing Hormone

Uses For lutropin alfa

Lutropin alfa is a drug whose actions are almost the same as those of luteinizing hormone (LH), which is produced by the pituitary gland. It is a hormone also normally produced by the placenta in pregnancy.

Lutropin alfa is used to help conception occur. It is usually given in combination with follitropin alfa. Many women being treated with these drugs usually have not been able to conceive yet.

lutropin alfa is available only with your doctor’s prescription.

Before Using lutropin alfa

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 lutropin alfa, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lutropin alfa 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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Abnormal bleeding of genitals or uterus (unknown cause)—Use of lutropin alfa may make the diagnosis of this problem more difficult

• Adrenal gland or thyroid disease (not controlled) or
• Tumor, brain or
• Tumor, sex hormone-dependent—Use of lutropin alfa may make these conditions worse

• Ovarian cyst or enlarged ovaries—Use of lutropin alfa may increase the size of a cyst on an ovary or increase the size of enlarged ovaries

• Primary ovarian failure—Lutropin alfa will not work in patients whose ovaries no longer develop eggs
• Thrombophlebitis, active—Lutropin alfa may increase the risk of side effects

Proper Use of lutropin alfa

To make using lutropin alfa as safe and reliable as possible, you should understand how and when to use lutropin alfa and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of lutropin alfa. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes lutropin alfa can be given by injection at home. If you are using lutropin alfa at home:

• Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.
• Wash your hands with soap and water and use a clean work area to prepare your injection.
• Make sure you clearly understand and carefully follow your doctor’s instructions on how to give yourself an injection, including using the proper needle and syringe.
• Do not inject more or less of the medicine than your doctor ordered.
• Remember to move the site of injection to different areas to prevent skin problems from developing.
• Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

Tell your doctor when you use the last dose of lutropin alfa. Follitropin alfa often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of lutropin alfa is given. Your doctor will give you lutropin alfa or arrange for you to get lutropin alfa at the right time.

Dosing

The dose of lutropin alfa 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 lutropin alfa. 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 injection dosage form
  • For treatment of female infertility:
    • Adults—75 international units (IU) injected under the skin once a day for approximately fourteen days. Lutropin alfa is administered together with 75 to 150 IU of follitropin alfa as two separate injections. Using lutropin alfa for longer than fourteen days may be needed, but only if directed by your doctor. Report when you receive your last dose of lutropin alfa because you may be given an injection of hCG twenty-four hours later. If abdominal pain occurs with the use of lutropin alfa, report it to your doctor immediately, discontinue treatment, do not receive the dose of hCG, and avoid sexual intercourse.
    • Children—Not for use in children.

Missed Dose

Call your doctor or pharmacist for instructions.

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 lutropin alfa

It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream. After you no longer receive lutropin alfa and follitropin alfa therapy, your progress still must be checked for at least 2 weeks.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor’s directions carefully.

If abdominal pain occurs with use of lutropin alfa, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

lutropin alfa 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 lutropin alfa and get emergency help immediately if any of the following effects occur:

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

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site
• bloating
• stomach or pelvic discomfort, aching, or heaviness
• diarrhea

Observed after pregnancy, frequency unknown

• Congenital abnormalities
• ectopic pregnancy
• postpartum fever
• premature labor
• spontaneous abortion

Observed during menotropin therapy, frequency unknown

• Adnexal torsion as a complication of ovarian enlargement
• changes in skin color
• cold hands and feet
• blood in the peritoneal cavity
• ovarian enlargement mild to moderate
• pain, redness, or swelling in arm or leg
• shortness of breath or troubled breathing

Symptoms of overdose

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

• Abdominal pain
• bloating
• diarrhea
• multiple gestation
• rapid weight gain
• severe nausea
• vomiting

• Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

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

More common

• Breast pain
• bloated full feeling
• excess air or gas in stomach or intestines
• headache
• pain
• passing gas
• unusual tiredness or weakness

Less common

• Body aches or pain
• chills
• cough
• cramps
• difficulty in breathing
• difficulty having a bowel movement (stool)
• ear congestion
• fever
• heavy bleeding
• loss of voice
• nasal congestion
• ovarian disorder
• pain
• runny nose
• sneezing, or sore throat

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.

Generic Name: Phenylephrine (fen-il-EFF-rin)
Brand Name: Lusonal

Lusonal Liquid is used for:

Relieving congestion due to colds, flu, and allergies. It may also be used for other conditions as determined by your doctor.

Lusonal Liquid is a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Lusonal Liquid if:

• you are allergic to any ingredient in Lusonal Liquid
• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days
• you have high blood pressure or an abnormally fast heartbeat

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

Before using Lusonal Liquid:

Some medical conditions may interact with Lusonal Liquid. 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 heart disease, diabetes, phenylketonuria (PKU), an adrenal gland tumor, or thyroid disease

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

• Rauwolfia derivatives (eg, reserpine) or tricyclic antidepressants (eg, amitriptyline) because the effectiveness of Lusonal Liquid may be decreased
• Cocaine, furazolidone, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Lusonal Liquid may be increased
• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), or droxidopa because the actions and side effects of these medicines may be increased
• Guanethidine because its effectiveness may be decreased by Lusonal Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lusonal Liquid 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 Lusonal Liquid:

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

• Take Lusonal Liquid with food, water, or milk to minimize stomach irritation.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Lusonal Liquid and are taking it regularly, 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 Lusonal Liquid.

Important safety information:

• Lusonal Liquid may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lusonal Liquid. Using Lusonal Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Lusonal Liquid.
• Do not take diet or appetite control medicines while you are taking Lusonal Liquid.
• Phenylketonuria patients – Lusonal Liquid may contain phenylalanine.
• Diabetes patients – Lusonal Liquid may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Use Lusonal Liquid with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Lusonal Liquid with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Lusonal Liquid during pregnancy. It is unknown if Lusonal Liquid is excreted in breast milk. If you are or will be breast-feeding while you are using Lusonal Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Lusonal Liquid. This is known as DEPENDENCE or addiction. If you are addicted and suddenly stop taking Lusonal Liquid, you may experience WITHDRAWAL symptoms, including depression.

Possible side effects of Lusonal Liquid:

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:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Lusonal Liquid:

Store Lusonal Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lusonal Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Lusonal Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Lusonal Liquid 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 Lusonal Liquid. 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: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)
Brand Names: Amitex LA, Crantex, Deconex, Deconsal II, Despec, Duraphen II, Duratuss PE, Genexa LA, Gentex LA, Guaifed Caps, Liquibid-D, Lusonex, Nasex-G, Nescon-PD, Phenavent, Prolex D, Rescon-GG, Robitussin Head & Chest Congestion, Sina-12X, Sinupan, SINUvent PE, Sudafed PE Non-Drying Sinus, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec

What is Lusonex (guaifenesin and phenylephrine)?

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

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

The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.

Guaifenesin and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lusonex (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains a decongestant or expectorant.

What should I discuss with my healthcare provider before taking Lusonex (guaifenesin and phenylephrine)?

Do not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), o tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• circulation problems;

• glaucoma;

• overactive thyroid; or

• enlarged prostate or problems with urination.

It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor’s advice if you are pregnant. This medication passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

How should I take Lusonex (guaifenesin and phenylephrine)?

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

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

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

Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, numbness or tingly feeling, dizziness, and feeling restless or nervous.

What should I avoid while taking Lusonex (guaifenesin and phenylephrine)?

Avoid drinking alcohol while you are taking this medicine. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Guaifenesin and phenylephrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains a decongestant or expectorant.

Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Lusonex (guaifenesin and phenylephrine) 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;

• severe dizziness, anxiety, restless feeling, or nervousness;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

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

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Less serious side effects may include:

• nausea, vomiting, upset stomach, loss of appetite;

• warmth, tingling, or redness under your skin;

• feeling excited or restless;

• sleep problems (insomnia);

• skin rash or itching;

• headache; or

• dizziness.

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 Lusonex (guaifenesin and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:

• medicines to treat high blood pressure;

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and there may be other drugs that can interact with guaifenesin and phenylephrine. 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 guaifenesin and phenylephrine.

• 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: 8.01. Revision Date: 10/05/2009 12:07:30 PM.

Generic Name: Guaifenesin/Phenylephrine (gwye-FEN-e-sin/fen-il-EF-rin)
Brand Name: Examples include Lusonex and Miraphen PE

Lusonex Controlled-Release Tablets are used for:

Relieving symptoms of congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Lusonex Controlled-Release Tablets are a decongestant and expectorant combination. It works by constricting blood vessels and shrinking swollen and congested nasal tissues (mucous membranes) and by thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Lusonex Controlled-Release Tablets if:

• you are allergic to any ingredient in Lusonex Controlled-Release Tablets
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (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 Lusonex Controlled-Release Tablets:

Some medical conditions may interact with Lusonex Controlled-Release Tablets. 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 fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid
• if you have chronic cough

Some MEDICINES MAY INTERACT with Lusonex Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Lusonex Controlled-Release Tablets’s side effects
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine because the risk of its side effects may be increased by Lusonex Controlled-Release Tablets
• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Lusonex Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lusonex Controlled-Release Tablets 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 Lusonex Controlled-Release Tablets:

Use Lusonex Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Lusonex Controlled-Release Tablets by mouth with or without food.
• Take Lusonex Controlled-Release Tablets with a full glass of water (8 oz/240 mL) unless your doctor directs otherwise.
• Swallow Lusonex Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Lusonex Controlled-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
• If you miss a dose of Lusonex Controlled-Release Tablets, 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 Lusonex Controlled-Release Tablets.

Important safety information:

• Lusonex Controlled-Release Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Lusonex Controlled-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not take diet or appetite control medicines while you are taking Lusonex Controlled-Release Tablets without checking with you doctor.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
• Lusonex Controlled-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Lusonex Controlled-Release Tablets.
• Tell your doctor or dentist that you take Lusonex Controlled-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Use Lusonex Controlled-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Lusonex Controlled-Release Tablets in CHILDREN; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lusonex Controlled-Release Tablets while you are pregnant. It is not known if Lusonex Controlled-Release Tablets are found in breast milk. Do not breast-feed while taking Lusonex Controlled-Release Tablets.

Possible side effects of Lusonex Controlled-Release Tablets:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Lusonex Controlled-Release Tablets:

Store Lusonex Controlled-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lusonex Controlled-Release Tablets out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Lusonex Controlled-Release Tablets. 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: hydroquinone topical (HYE droe KWIN one)
Brand Names: Aclaro, Aclaro PD, Alera, Alphaquin HP, Alustra, Claripel, Eldopaque, Eldopaque Forte, Eldoquin, Eldoquin Forte, EpiQuin Micro, Esoterica, Esoterica with Sunscreen, Glyquin, Glyquin-XM, Hydroquinone and Sunscreen, Lustra, Lustra-AF, Lustra-Ultra, Melpaque HP, Melquin HP, Melquin-3, Nuquin HP, Solaquin, Solaquin Forte

What is Lustra (hydroquinone topical)?

Hydroquinone decreases the formation of melanin in the skin. Melanin is the pigment in skin that gives it a brown color.

Hydroquinone topical is used to lighten areas of darkened skin such as freckles, age spots, chloasma, and melasma.

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

What is the most important information I should know about Lustra (hydroquinone topical)?

Before using hydroquinone topical, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What should I discuss with my healthcare provider before using Lustra (hydroquinone topical)?

Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical.

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

• liver disease; or

• kidney disease.

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

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

How should I use Lustra (hydroquinone topical)?

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

Hydroquinone topical is for external use only. Wash your hands before and after applying this medication, unless you are treating a skin area on your hand.

Apply the medication to clean, dry skin. Apply just enough medication to cover the affected area. Avoid applying to the unaffected surrounding skin. Rub in the medication gently and completely.

Avoid getting this medication on your lips or inside your nose or mouth. Hydroquinone may cause numbness of these areas. If the medication does get on any of these areas, rinse with water.

It is important to use hydroquinone topical regularly to get the most benefit.

Store hydroquinone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

An overdose of topically applied hydroquinone is not likely to cause life-threatening symptoms.

What should I avoid while using Lustra (hydroquinone topical)?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use hydroquinone topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Using hydroquinone topical together with benzoyl peroxide, hydrogen peroxide, or other peroxide products may cause a temporary staining of your skin. This staining can usually be removed with soap and water. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Lustra (hydroquinone topical) 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 hydroquinone topical and call your doctor if you have severe burning, stinging, or other irritation of your skin after apply the medication.

Less serious side effects may include mild burning, stinging, itching, redness, or irritation of treated skin.

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 Lustra (hydroquinone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydroquinone. But many drugs can interact with each other. 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 hydroquinone topical.

• 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: 1.05. Revision Date: 4/12/2009 4:39:41 PM.

Generic Name: hydroquinone topical (HYE droe KWIN one)
Brand Names: Aclaro, Aclaro PD, Alera, Alphaquin HP, Alustra, Claripel, Eldopaque, Eldopaque Forte, Eldoquin, Eldoquin Forte, EpiQuin Micro, Esoterica, Esoterica with Sunscreen, Glyquin, Glyquin-XM, Hydroquinone and Sunscreen, Lustra, Lustra-AF, Lustra-Ultra, Melpaque HP, Melquin HP, Melquin-3, Nuquin HP, Solaquin, Solaquin Forte

What is Lustra-AF (hydroquinone topical)?

Hydroquinone decreases the formation of melanin in the skin. Melanin is the pigment in skin that gives it a brown color.

Hydroquinone topical is used to lighten areas of darkened skin such as freckles, age spots, chloasma, and melasma.

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

What is the most important information I should know about Lustra-AF (hydroquinone topical)?

Before using hydroquinone topical, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What should I discuss with my healthcare provider before using Lustra-AF (hydroquinone topical)?

Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical.

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

• liver disease; or

• kidney disease.

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

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

How should I use Lustra-AF (hydroquinone topical)?

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

Hydroquinone topical is for external use only. Wash your hands before and after applying this medication, unless you are treating a skin area on your hand.

Apply the medication to clean, dry skin. Apply just enough medication to cover the affected area. Avoid applying to the unaffected surrounding skin. Rub in the medication gently and completely.

Avoid getting this medication on your lips or inside your nose or mouth. Hydroquinone may cause numbness of these areas. If the medication does get on any of these areas, rinse with water.

It is important to use hydroquinone topical regularly to get the most benefit.

Store hydroquinone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

An overdose of topically applied hydroquinone is not likely to cause life-threatening symptoms.

What should I avoid while using Lustra-AF (hydroquinone topical)?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use hydroquinone topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Using hydroquinone topical together with benzoyl peroxide, hydrogen peroxide, or other peroxide products may cause a temporary staining of your skin. This staining can usually be removed with soap and water. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Lustra-AF (hydroquinone topical) 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 hydroquinone topical and call your doctor if you have severe burning, stinging, or other irritation of your skin after apply the medication.

Less serious side effects may include mild burning, stinging, itching, redness, or irritation of treated skin.

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 Lustra-AF (hydroquinone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydroquinone. But many drugs can interact with each other. 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 hydroquinone topical.

• 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: 1.05. Revision Date: 4/12/2009 4:39:41 PM.

Generic Name: Sodium Fluoride (SO-dee-um FLOR-ide)
Brand Name: Examples include Karidium and Luride

Luride Drops are used for:

Preventing cavities in children older than 6 months of age when the amount of fluoride in the water supply is too low.

Luride Drops are a mineral. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.

Do NOT use Luride Drops if:

• you are allergic to any ingredient in Luride Drops
• your drinking water has a fluoride content greater than 0.6 parts per million (ppm)

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

Before using Luride Drops:

Some medical conditions may interact with Luride Drops. 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 joint pain, severe kidney problems, or stomach or intestinal ulcers

Some MEDICINES MAY INTERACT with Luride Drops. However, no specific interactions with Luride Drops are known at this time.

Ask your health care provider if Luride Drops 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 Luride Drops:

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

• Take Luride Drops by mouth with or without food. Do not eat or drink dairy products within 1 hour before or 2 hours after taking Luride Drops.
• Do not take an antacid that has aluminum, calcium, or magnesium in it for several hours after you take Luride Drops.
• Use the dropper that comes with Luride Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Luride Drops, 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 Luride Drops.

Important safety information:

• Do not exceed the dose recommended by your doctor or dentist.
• Notify your dentist if your teeth become spotted or stained.
• Luride Drops should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
• Caution is advised when using Luride Drops in CHILDREN younger than 6 years of age. The appropriate dose of Luride Drops depends on the child’s age and the amount of fluoride in the drinking water. Talk with your doctor if you have questions about the appropriate dose for your child or the amount of fluoride in your drinking water.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Luride Drops, contact your doctor. You will need to discuss the benefits and risks of using Luride Drops while pregnant. It is not known if Luride Drops are found in breast milk. If you are or will be breast-feeding while you are using Luride Drops, check with your doctor. Discuss the risks to your baby.

Possible side effects of Luride Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Luride Drops. 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).

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 diarrhea; extreme thirst; increased drooling; muscle weakness; nausea; paleness of the skin; seizures; shallow, rapid breathing; shaking; stomach pain; vomiting; weak or fast heartbeat.

Proper storage of Luride Drops:

Store Luride Drops at room temperature, between 68 and 77 degrees F (20 and 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 Luride Drops out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Luride Drops. 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: fospropofol (Intravenous route)

fos-proe-POE-fol

Commonly used brand name(s):

In the U.S.

• Lusedra

Available Dosage Forms:

• Solution

Therapeutic Class: Sedative-Hypnotic

Uses For Lusedra

Fospropofol is used to make a person relax or sleep (be unconscious) before and during surgery or procedures. This medicine is a strong sedative.

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

Before Using Lusedra

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 have not been performed on the relationship of age to the effects of fospropofol 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 fospropofol in the elderly. However, elderly patients are more likely to have age-related heart disease, which may require an adjustment in the dose for patients receiving fospropofol.

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

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

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.

• Alfentanil
• Alprazolam
• Amobarbital
• Barbital
• Butabarbital
• Butorphanol
• Chloral Hydrate
• Chlordiazepoxide
• Clonazepam
• Clorazepate
• Diazepam
• Dichloralphenazone
• Estazolam
• Eszopiclone
• Fentanyl
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Levorphanol
• Lorazepam
• Meperidine
• Mephobarbital
• Meprobamate
• Methadone
• Midazolam
• Nalbuphine
• Oxazepam
• Oxycodone
• Oxymorphone
• Paraldehyde
• Pentazocine
• Prazepam
• Propoxyphene Napsylate
• Ramelteon
• Remifentanil
• Secobarbital
• Sufentanil
• Temazepam
• Triazolam
• Zaleplon
• Zolpidem
• Zopiclone

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:

• Breathing problems or
• Heart disease or
• Hypotension (low blood pressure) or
• Hypoxemia (low oxygen in the blood)—Use with caution. May make these conditions worse.

Proper Use of Lusedra

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

Precautions While Using Lusedra

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel dizzy or lightheaded when getting up suddenly from a lying or sitting position, so get up slowly.

This medicine may cause your skin to itch and a side effect called paresthesias. This may cause burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings on your skin. Check with your doctor if you have these symptoms after receiving the injection.

Lusedra 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

• Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings

Less common

• Bluish lips or skin
• blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• sweating
• unusual tiredness or weakness

Rare

• Difficult or troubled breathing
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• shortness of breath

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

More common

• Itching skin

Less common

• Headache
• nausea
• 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.

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