Jolivette Oral, Parenteral, Vaginal

Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

• Aygestin


• Camila


• Crinone


• Errin


• First-Progesterone VGS


• Jolivette


• Megace


• Megace ES


• Next Choice


• Ovrette


• Plan B


• Prochieve


• Prometrium

In Canada

• Alti-Mpa


• Megace Os

Available Dosage Forms:

• Tablet


• Suspension


• Capsule, Liquid Filled


• Gel/Jelly


• Cream


• Kit


• Suppository

Uses For Jolivette

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

• To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. .


• To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body.


• To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT).


• To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs.


• To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle.


• To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor.


• To test the body's production of certain hormones such as estrogen.


• To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

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

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

• Carcinoma of the prostate


• Corpus luteum insufficiency


• Hot flashes


• Polycystic ovary syndrome


• Precocious puberty

Before Using Jolivette

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

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. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Boceprevir


• Dofetilide

Using medicines in this class 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.

• Felbamate


• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Epilepsy (or history of) or


• Heart or circulation problems or


• Kidney disease (severe) or


• Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse.

• Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult.

• Blood clots, or history of or


• Breast cancer, or history of or


• Deep vein thrombosis (blood clot in the leg), active or history of or


• Heart attack, active or history of or


• Liver disease, including jaundice, or history of or


• Pulmonary embolism (clot in the lung), active or history of or


• Stroke , active or history of or


• Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions.

• Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins.

• Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem.

• Memory loss (dementia)—May make this condition worse.

• Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse.

Proper Use of progestin

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

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class 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 these medicines. 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 medroxyprogesterone


• For oral dosage form (tablets):
  
  • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor.
    
    
  
  
  • For preparing the uterus for the menstrual period:
    
    • Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor.
    
    
  
  
  • For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women:
    
    • Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them.
    
    
  
  


• For intramuscular injection dosage form:
  
  • For treating cancer of the kidneys or uterus:
    
    • Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month.
    
    
  
  


• For subcutaneous injection dosage form:
  
  • For treating pain related to endometriosis:
    
    • Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years.
    
    
  
  

• For megestrol


• For oral dosage form (suspension):
  
  • For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS):
    
    • Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months.
    
    
  
  


• For oral dosage form (tablets):
  
  • For treating cancer of the breast:
    
    • Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months.
    
    
  
  
  • For treating cancer of the uterus:
    
    • Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months.
    
    
  
  
  • For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer:
    
    • Adults and teenagers—400 to 800 milligrams (mg) a day.
    
    
  
  

• For norethindrone


• For oral dosage form (tablets):
  
  • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed.
    
    
  
  
  • For treating endometriosis:
    
    • Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time.
    
    
  
  

• For progesterone


• For oral dosage form (capsules):
  
  • For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women:
    
    • Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month.
    
    
  
  
  • For treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults—400 milligrams (mg) per day at bedtime for ten days.
    
    
  
  


• For vaginal dosage form (gel):
  
  • For treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed.
    
    
  
  
  • For use with infertility procedures:
    
    • Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks.
    
    
  
  


• For injection dosage form:
  
  • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine.
    
    
  
  


• For vaginal dosage form (suppositories):
  
  • For maintaining a pregnancy (at ovulation and at the beginning of pregnancy):
    
    • Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks.
    
    
  
  

Missed Dose

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

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

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Jolivette

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

• If unusual or unexpected vaginal bleeding continues for an unusually long time.


• If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Jolivette Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare

• Symptoms of blood clotting problems, usually severe or sudden, such as:


• headache or migraine


• loss of or change in speech, coordination, or vision


• numbness of or pain in chest, arm, or leg


• unexplained shortness of breath

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

More common

• Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods)


• symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst)

Less common

• Mental depression


• skin rash


• unexpected or increased flow of breast milk

RareFor megestrol—During chronic treatment

• Backache


• dizziness


• filling or rounding out of the face


• irritability


• mental depression


• nausea or vomiting


• unusual decrease in sexual desire or ability in men


• unusual tiredness or weakness

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

• Abdominal pain or cramping


• bloating or swelling of ankles or feet


• blood pressure increase (mild)


• dizziness


• drowsiness (progesterone only)


• headache (mild)


• mood changes


• nervousness


• pain or irritation at place of injection site


• swelling of face, ankles, or feet


• unusual or rapid weight gain

Less common

• Acne


• breast pain or tenderness


• brown spots on exposed skin, possibly long-lasting


• hot flashes


• loss or gain of body, facial, or scalp hair


• loss of sexual desire


• trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol

• Dizziness


• nausea or vomiting


• unusual tiredness or weakness

• Delayed return to fertility


• stopping of menstrual periods


• unusual menstrual bleeding (continuing)

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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Mylotarg

Generic Name: gemtuzumab (Intravenous route)

jem-TOOZ-oo-mab oh-zoe-ga-MYE-sin

Intravenous route(Powder for Solution)

Should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials. Severe myelosuppression occurs when gemtuzumab is used at recommended doses. Severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events have occurred with therapy. Some of these hypersensitivity reactions have been fatal. Patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome; physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/ microliters prior to administration of gemtuzumab. Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported with therapy. Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD .

Commonly used brand name(s):

In the U.S.

• Mylotarg

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Mylotarg

Gemtuzumab injection is a monoclonal antibody that is used to treat a type of cancer called acute myeloid leukemia (AML) in patients 60 years of age or older. It is used when other cancer treatments have not worked very well for these patients. Gemtuzumab interferes with the growth of leukemia cells, which are then destroyed by the body.

This medicine was to be administered only by or under the immediate supervision of your doctor.

Products containing gemtuzumab were withdrawn from the U.S. market by Pfizer Inc. on October 15, 2010.

Before Using Mylotarg

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 gemtuzumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemtuzumab injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or


• Hypotension (low blood pressure) or


• Kidney disease or


• Liver disease or


• Lung disease or


• Neutropenia (low white blood cell count) or


• Thrombocytopenia (low platelet count)—Use with caution. May make these conditions worse.

• Chickenpox, or recent exposure, or


• Herpes zoster (shingles)—Risk of severe infection affecting other parts of the body.

• High white blood cell counts or


• Stem-cell transplant, history of—Use with caution. May increase risk for more serious side effects.

• Infection—May decrease your body's ability to fight an infection.

Proper Use of Mylotarg

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor while you are receiving this medicine.

A doctor or nurse will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for about 2 hours.

This medicine consists of two doses, usually given 14 days apart. You may also receive a medicine to prevent allergic reactions (such as diphenhydramine, methylprednisolone, or Benadryl®) before you receive this medicine.

Your doctor may want you to drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems. Talk to your doctor if you have questions about this.

Precautions While Using Mylotarg

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

While you are being treated with gemtuzumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Gemtuzumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Gemtuzumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor or nurse right away if you have blue lips, fingernails, or skin; difficult or fast breathing; dizziness, fainting, or lightheadedness; fever or chills; rash; trouble breathing or swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.

Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Mylotarg 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

• Black, tarry stools


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the stools or urine


• bluish color of the fingernails, lips, skin, palms, or nailbeds


• blurred vision


• burning or stinging of the skin


• chest pain


• chills


• confusion


• convulsions (seizures)


• cough or hoarseness


• cracked lips


• decrease or increase in urine


• diarrhea


• difficulty with swallowing


• dizziness


• dry mouth


• excessive sweating


• fainting


• fast or slow heartbeat


• fever


• flushed, dry skin


• fruit-like breath odor


• headache, sudden and severe


• heavy, nonmenstrual vaginal bleeding


• inability to speak


• increased thirst or hunger


• irregular heartbeat


• large, flat, blue, or purplish patches in the skin


• lightheadedness


• lower back, joint, or side pain


• loss of appetite


• mood changes


• muscle pain or cramps


• muscle trembling or twitching


• nausea or vomiting


• numbness or tingling in the hands, feet, or lips


• pain, difficulty, or burning while urinating


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• pale skin


• palpitations


• persistent bleeding or oozing from puncture sites, mouth, or nose


• pinpoint red spots on the skin


• pounding in the ears


• rapid, shallow breathing


• rapid weight gain


• red or purplish patches or spots on the skin


• severe or continuing dull nervousness


• shortness of breath


• slurred speech


• small red or purple spots on the skin


• sneezing


• sore throat


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• stomachache


• sweating


• swelling or inflammation of the mouth, face, fingers, feet, or lower legs


• swollen glands


• temporary blindness


• tightness in the chest


• tingling of the hands or feet


• troubled breathing, exertional


• unexplained nosebleeds


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• weakness in the arm or leg on one side of the body, sudden and severe


• wheezing


• yellow eyes or skin

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

• Acid or sour stomach


• belching


• difficulty with moving


• dry, red, hot, or irritated skin


• full or bloated feeling or pressure in the stomach


• heartburn


• indigestion


• lack or loss of strength


• muscle pain or stiffness


• pain, swelling, or redness in the joints


• runny, stuffy nose


• stomach discomfort upset


• swelling of the abdominal or stomach area


• trouble with sleeping

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.

See also: Mylotarg side effects (in more detail)

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.

More Mylotarg resources

• Mylotarg Side Effects (in more detail)
• Mylotarg Use in Pregnancy & Breastfeeding
• Mylotarg Drug Interactions
• Mylotarg Support Group
• 0 Reviews for Mylotarg - Add your own review/rating

• Mylotarg Prescribing Information (FDA)


• Mylotarg Concise Consumer Information (Cerner Multum)


• Mylotarg Monograph (AHFS DI)


• Mylotarg MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Mylotarg with other medications

• Acute Myeloid Leukemia

Alphagan P

Generic Name: brimonidine (Ophthalmic route)

bri-MOE-ni-deen

Commonly used brand name(s)

In the U.S.

• Alphagan P

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Alpha-2 Adrenergic Agonist

Uses For Alphagan P

Brimonidine ophthalmic (eye) drops is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called hypertension of the eye (ocular hypertension). This medicine is an alpha-adrenergic agonist.

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

Before Using Alphagan P

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 brimonidine eye drops in children 2 years of age and older. Because of brimonidine's toxicity, use in children younger than 2 years of age is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brimonidine eye drops in the elderly.

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

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:

• Depression or


• Heart attack, history of or


• Heart disease or


• Orthostatic hypotension (low blood pressure when standing up) or


• Raynaud disease (blood vessel disease) or


• Stroke, history of or


• Thromboangiitis obliterans (blood vessel disease)—Use with caution. May make these conditions worse.

Proper Use of Alphagan P

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.

If your doctor ordered two different eye drops to be used together, wait at least 5 minutes after you put the first medicine in your eye to use the second medicine. This will prevent the second medicine from “washing out” the first one.

To use the eye drops:

• Wash your hands with soap and water before and after using this medicine.


• Shake the eye drops well just before each use.


• Tilt your head back and press your finger gently on the skin just beneath the lower eyelid. Pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.


• If you think you did not get the drop of medicine into your eye properly, repeat the directions with a second drop.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed when you are not using the drops.


• If germs get in the bottle, your eye could become infected. Serious eye infections can cause blindness.


• The eye drops will normally be a clear liquid with a greenish-yellow color. If the color changes or the liquid becomes cloudy, do not use the medicine. Get a new bottle from the pharmacy.

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 ophthalmic dosage form (eye drops):
  
  • For glaucoma or ocular hypertension:
    
    • Adults, teenagers, and children 2 years of age and older—One drop in the affected eye 3 times a day, about 8 hours apart.
    
    
    • Children younger than 2 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Alphagan P

The eye doctor will want to examine your or your child's eyes at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, stop using this medicine and check with your doctor. These symptoms may mean that you or your child are allergic to this medicine.

If you or your child have an eye injury or infection, or need to have eye surgery, talk with your doctor right away. You may need to change the medicine or stop using it.

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

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

Brimonidine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

Alphagan P Side Effects

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

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

More common

• Blurred or loss of vision


• burning, dry, or itching eyes


• discharge or excessive tearing


• disturbed color perception


• double vision


• halos around lights


• headache


• itching of the eye


• night blindness


• overbright appearance of lights


• redness of the eye or inner lining of the eyelid


• swelling of the eyelid


• tearing of the eye


• tunnel vision

Less common

• Ache or pain in the eye


• blindness


• bloody eye


• blurred vision or other change in vision


• change in color vision


• confusion


• decreased vision


• difficult or labored breathing


• difficulty seeing at night


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• drainage from the eye


• fainting


• fast heartbeat


• feeling of something in the eye


• gradual blurring or loss of vision


• increased blood pressure


• increased sensitivity of the eye to light


• mental depression


• muscle pain


• nausea or vomiting


• oozing in the eye


• redness, swelling, or itching of the eye or eyelid


• runny or stuffy nose


• seeing flashes or sparks of light


• seeing floating dark spots or material before eyes


• seeing floating spots before the eyes or a veil or curtain appearing across part of vision


• shortness of breath


• skin rash


• sneezing


• sweating


• swelling of the eye


• tightness in the chest


• unusual tiredness or weakness


• watery eyes


• wheezing

Incidence not known

• Bluish lips or skin


• chest pain or discomfort


• confusion


• fast, pounding, or irregular heartbeat or pulse


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• irregular, fast, slow, or shallow breathing


• low body temperature


• muscle aches or weakness


• shivering


• slow or irregular heartbeat


• weak or feeble pulse


• weight gain

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

• Burning, stinging, or tearing of the eye


• drowsiness or tiredness


• dryness of the mouth

Less common

• Acid or sour stomach


• anxiety


• bad, unusual, or unpleasant (after) taste


• belching


• body aches or pain


• change in taste


• chills


• congestion


• cough


• cough producing mucus


• crusting on eyelid or corner of eye


• diarrhea


• difficulty breathing


• discoloration of white part of the eye


• dryness of the eye


• dryness or soreness of the throat


• fever


• general feeling of discomfort or illness


• hoarseness


• indigestion


• joint pain


• lack or loss of strength


• large amounts of cholesterol in the blood


• lid disorder


• loss of appetite


• muscle aches and pains


• pain or tenderness around the eyes and cheekbones


• paleness of the eye or inner lining of the eyelid


• passing of gas


• pounding heartbeat


• rash


• shivering


• sleepiness or unusual drowsiness


• sleeplessness


• sneezing


• sore throat


• stomach discomfort, fullness, upset, or pain


• tender, swollen glands in the neck


• trouble with sleeping


• trouble with swallowing


• troubled breathing


• unable to sleep


• voice changes

Incidence not known

• Constricted, pinpoint, or small pupils (black part of the eye)


• redness of the skin


• sensitivity to light


• throbbing pain


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• unusual weak feeling


• unusually warm 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.

See also: Alphagan P side effects (in more detail)

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.

More Alphagan P resources

• Alphagan P Side Effects (in more detail)
• Alphagan P Use in Pregnancy & Breastfeeding
• Alphagan P Drug Interactions
• Alphagan P Support Group
• 2 Reviews for Alphagan P - Add your own review/rating

• Alphagan P Prescribing Information (FDA)


• Alphagan P Monograph (AHFS DI)


• Alphagan P MedFacts Consumer Leaflet (Wolters Kluwer)


• Alphagan Consumer Overview

Compare Alphagan P with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension

Embeline Solution

Pronunciation: kloe-BAY-ta-sol
Generic Name: Clobetasol
Brand Name: Examples include Embeline and Temovate

Embeline Solution is used for:

Treating inflammation and itching of the scalp due to certain skin conditions. It is also used to treat moderate to severe psoriasis. It may also be used for other conditions as determined by your doctor.

Embeline Solution is a topical adrenocortical steroid. It works by reducing skin inflammation (eg, redness, swelling, itching, irritation) in a way that is not clearly understood.

Do NOT use Embeline Solution if:

• you are allergic to any ingredient in Embeline Solution or to other corticosteroids (eg, prednisone)

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

Before using Embeline Solution:

Some medical conditions may interact with Embeline Solution. 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 any kind of skin infection of the scalp, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Embeline Solution. Because little, if any, of Embeline Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Embeline Solution 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 Embeline Solution:

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

• Wash and completely dry the affected area before applying Embeline Solution.


• Apply a small amount of Embeline Solution to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Embeline Solution.


• If applying to an area with hair, part the hair when applying so that Embeline Solution reaches the skin.


• Do not bandage or cover the treated skin area unless directed by your doctor. Do not wear tight-fitting clothes over the treated area.


• If you miss a dose of Embeline Solution, apply 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 apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Embeline Solution.

Important safety information:

• Embeline Solution is for external use only. Do not get Embeline Solution in your eyes, nose, mouth, or on your lips. If contact is made with the eyes, flush them immediately with tap water.


• Use Embeline Solution with extreme caution if treating the face, groin, diaper area, or underarms.


• Do not use Embeline Solution to treat rosacea or conditions around the mouth.


• Do NOT take more than the recommended dose or use for longer than 2 weeks without checking with your doctor.


• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Do not use Embeline Solution to treat large areas of your body without first checking with your doctor.


• Tell your doctor or dentist that you take Embeline Solution before you receive any medical or dental care, emergency care, or surgery.


• Check with your doctor before having vaccinations while using Embeline Solution.


• Do not use Embeline Solution for other skin conditions at a later time.


• Embeline Solution has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Embeline Solution is flammable. Do not store or use near an open flame or while smoking.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Embeline Solution.


• Embeline Solution should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these 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 Embeline Solution while you are pregnant. It is not known if Embeline Solution is found in breast milk after topical use. If you are or will be breast-feeding while you use Embeline Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Embeline Solution:

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:

Dryness; itching; mild burning or stinging.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Embeline Solution; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Embeline side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Embeline Solution:

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

General information:

• If you have any questions about Embeline Solution, please talk with your doctor, pharmacist, or other health care provider.


• Embeline Solution 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.


• Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Embeline resources

• Embeline Side Effects (in more detail)
• Embeline Use in Pregnancy & Breastfeeding
• Embeline Drug Interactions
• Embeline Support Group
• 1 Review for Embeline - Add your own review/rating

Compare Embeline with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Planus
• Lichen Sclerosus
• Psoriasis

Nicotine

Class: Autonomic Drugs, Miscellaneous
VA Class: AD900
Chemical Name: S-3-(1-Methyl-2-pyrrolidinyl)pyridine
Molecular Formula: C₁₀H₁₄N₂• x(C₁₀H₁₀•C₄H₆O₂)x
CAS Number: 54-11-5
Brands: Nicotrol NS, Nicotrol Inhaler, Nicoderm CQ, Commit, Nicorette

Introduction

Ganglionic (nicotinic) cholinergic-receptor agonist.^a

Uses for Nicotine

Smoking Cessation

Used for nicotine replacement therapy as a temporary adjunct in the cessation of cigarette smoking either unsupervised (self-medication)^{188 189 190 246 257} or in conjunction with a behavior modification program under clinician supervision.^{1 2 5 6 7 8 9 10 11 29 30 31 96 97 191 192 193 194 195 196 244 245 257 258 263}

Nicotine replacement therapy considered first-line therapy by USPHS for treatment for dependence on tobacco.²⁵⁷

Provides alternative sources of nicotine that help reduce the withdrawal symptoms associated with nicotine dependence.^{1 2 50 78 79 80 97 101 102 103 104} Chewing the resin complex-containing gum may act as a substitute oral activity in behavior modification.⁵

Ulcerative Colitis

Transdermal nicotine has been used in the management of ulcerative colitis†.^{125 204 205 206 207 208 209 210}

Nicotine Dosage and Administration

General

• 
  

  To increase smoking cessation rate,^{101 144 194 195 196} use as part of a comprehensive program of multiple treatment strategies, including behavioral modification.^{43 44 101 102 103 104 115 116 119 126 131 144 148 149 167 193 194 195 196 257 258 a}

  
  


• 
  

  Individualize duration of therapy based on patient response and degree of nicotine dependence.^{1 190 257 263 264 a}

  
  


• 
  

  Stop smoking prior to initiating nicotine replacement therapy;^{1 190 257 263 264} self-medication not recommended in patients who continue to smoke, chew tobacco, or use snuff or other nicotine-containing preparations.^{188 189 190}

  
  


• 
  

  Discontinue therapy in patients who continue to smoke 4 weeks after initiating treatment;^{101 102 103 104} may use nicotine replacement therapy again in subsequent attempts to quit smoking.^{101 102 103 104 121}

  
  

Administration

Administer nicotine percutaneously by topical application of a transdermal system.^{b i}

Administer nicotine transmucosally by oral inhalation using a special nicotine oral inhaler or intranasally using a metered-dose spray pump. ^{d 265 g}

Administer nicotine polacrilex intrabuccally (transmucosally) as a lozenge or chewing gum.^{c h}

May be administered as a single nicotine preparation (i.e., intrabuccally, intranasally, percutaneously, or by oral inhalation); however, if single therapy does not enable patients to quit smoking, use of transdermal nicotine may be combined with another form of nicotine replacement (i.e., either buccal nicotine polacrilex or nicotine nasal spray).²⁵⁷

Buccal Administration

Chewing Gum

Self-administer one piece of gum in response to the urge to smoke.¹

Chew gum very slowly until a distinctive peppery taste of nicotine, minty, cinnamon, or orange taste of the gum, or a slight tingling in the mouth is perceived (typically about 15 chews);¹ stop chewing gum and park between cheek and gum; once tingling is almost gone (about 1 minute), repeat chewing procedure.^{1 257} Continue for about 30 minutes or until taste dissipates.^{1 257} Do not swallow gum.¹

Do not eat or drink anything other than water for 15 minutes before and during chewing of gum.^{1 190 257}

Do not chew multiple pieces of gum simultaneously; do not chew too rapidly or chew pieces in succession.¹ May cause excessive release of nicotine and result in adverse effects (e.g., lightheadedness, nausea, vomiting, irritation of the throat and mouth, hiccups, indigestion).¹

Chew at least 9 pieces of gum daily to improve chances of quitting.^c

Do not attempt to discontinue nicotine polacrilex gum therapy until craving is satisfied by 1 or 2 pieces of the gum daily; but do not continue therapy for >6 months,¹ unless otherwise instructed by clinician.^{9 43 65}

4-mg strength gum recommended in highly dependent smokers because of evidence of increased efficacy.^a

Lozenges

Suck on lozenge until dissolved; do not swallow, bite, or chew.^{260 263 264} Allow to dissolve slowly in the mouth over 20–30 minutes, periodically moving the lozenge (e.g., with the tongue) from one side of the mouth to the other; minimize swallowing.^{263 264} A warm or tingling sensation may be perceived.^h

Do not eat or drink anything other than water for 15 minutes before and during sucking on the lozenge.^{257 263 264}

Use at least 9 lozenges daily for the first 6 weeks to improve chances of quitting.^h

Using >1 lozenge simultaneously or using one lozenge after another in uninterrupted sequence may result in adverse effects (e.g., hiccups, heartburn, nausea).^h

Self-administer lozenge in response to nicotine craving; decrease frequency of administration over time.^{263 264}

Topical Administration

Administer percutaneously by topical application of a transdermal system once daily.^{b i}

Apply at the same time each day, usually after awakening.^{101 102 103 104 129 167 188 189 257}

Expose the adhesive surface of the system by peeling and discarding the protective liner just prior to application and apply system immediately to avoid loss of nicotine through volatilization.^{101 102 103 104 129}

Apply transdermal system to a clean, dry, hairless area of intact skin^{43 101 129} on the trunk or upper outer arm^{101 102 103 104 129 167 188 189 257} by firmly pressing the system with the adhesive side touching the skin.^{101 129 167} Press system firmly in place with heel of hand for about 10 seconds, ensuring good contact, particularly around the edges.^{101 129 167 a} Do not apply to sites that are oily, damaged, or irritated;^{43 101 129} if necessary, hair may be clipped, but do not shave area.¹⁶⁷

System may be worn for 16 or 24 hours.^{b i} If cravings begin upon awakening, wear patch for 24 hours.^{189 b} If vivid dreams or sleep disruptions occur, wear patch for 16 hours; remove at bedtime and apply new patch upon awakening.^{189 257 b i}

If system inadvertently comes off during the period of use, apply a new system; ^{101 102 103 104 167 a} continue current application schedule or change so that the next system is applied 24 hours later.¹²⁹

Rotate application sites to minimize potential skin irritation; allow ≥1 week before reusing a given site.^{101 102 103 129} (See Dermatologic Effects under Cautions.)

Avoid unnecessary contact with transdermal systems.^{101 102 103 104} Avoid touching eyes after handling; wash hands with water alone as soap may enhance percutaneous absorption.^{101 102 103 104 167}

Intranasal Administration

Administer intranasally using a metered-dose spray pump.¹⁹¹

Prime spray pump prior to initial use by spraying into a tissue until a fine spray is seen (6–8 times); discard tissue.^d

If spray pump is not used for 24 hours, reprime pump by spraying into a tissue 1–2 times.^d

Clear nasal passages prior to administration.^d

Tilt the head back slightly;^{191 257 d} insert tip of bottle into one nostril as far as is comfortable.^d Breathe through the mouth and spray once into nostril; do not sniff, swallow or inhale through the nose while administering.^{191 257} Repeat this procedure for the other nostril.^d

If nose runs, sniff gently to keep nasal spray in nose; wait 2–3 minutes before blowing nose.^d

Avoid contact with skin, eyes, and mouth; if contact occurs, rinse with plain water immediately.^d If intranasal bottle breaks, wear protective gloves, wipe with paper towels, and wash surfaces thoroughly.^d

Oral Inhalation

Administer transmucosally as an inhaled vapor by oral inhalation using a special nicotine oral inhaler that mimics smoking cigarettes.^{244 245 246 247 248}

Hold the oral inhaler with two hands; separate the top and bottom pieces by pushing and turning the pieces until markings line up.^g Insert one nicotine cartridge and push the cartridge until it pops into place.^g Line up markings on the top and bottom pieces of the inhaler and push pieces together tightly; lock inhaler by turning pieces until markings do not line up.^g

Place the mouthpiece of the inhaler between lips and puff on the inhaler using rapid shallow sucking (“buccal mode”);^{244 248 257} alternatively, inhale slowly and deeply into back of throat (“pulmonary mode”).^{248 g} Nicotine is vaporized and absorbed in mouth and throat.^g (See Absorption under Pharmacokinetics.) Shallow puffing method generally is preferred.^{244 248 250 257} Deep inhalation technique requires considerable effort and does not result in substantially increased drug delivery or other benefits.²⁴⁸

Individualize orally inhaled dosage to the level of nicotine replacement required; optimum results generally achieved by frequent continuous puffing of the inhaler over 20 minutes.²⁴⁴

Nicotine is used up from cartridge after about four 5-minute sessions or one 20-minute session of active puffing.²⁵⁰

When cartridge is empty, remove top of mouthpiece; discard empty cartridge away from children and pets.^g Store with mouthpiece in locked position and cartridges in plastic case.^g Clean reusable mouthpiece regularly with soap and water.²⁴⁴

Use inhaler at temperatures >60°F; cold temperatures decrease the amount of nicotine inhaled.^g

Dosage

Chewing gum and lozenge available as nicotine polacrilex; dosage expressed in terms of nicotine.^{1 264}

Nicotine oral inhaler cartridges labeled as containing 10 mg of nicotine deliver ≤4 mg total with repeated inhalation.^{244 247 250 257} The amount of nicotine released depends on the volume and temperature of the air passing through the inhaler.^{244 245 246 247 248} An intensive inhalation regimen (80 deep inhalations over 20 minutes) releases approximately 4 mg of nicotine.²⁶⁵

Metered nasal spray delivers 0.5 mg of nicotine per metered spray and about 200 sprays (i.e., 100 doses) per 100-mg container.^{191 257}

Adults

Smoking Cessation

Buccal (Chewing Gum)

Patients who smoke <25 cigarettes daily: Chew a 2-mg piece of gum every 2 hours during weeks 1–6; chew a 2-mg piece every 2–4 hours during weeks 7–9; and chew a 2-mg piece every 4–8 hours during weeks 10–12 of therapy.^c Alternatively, chew a 2-mg piece of gum whenever the urge to smoke occurs; do not exceed 2 pieces (4 mg) per hour.¹

Patients who smoke ≥25 cigarettes daily: Chew a 4-mg piece of gum every 2 hours during weeks 1–6; chew a 4-mg piece every 2–4 hours during weeks 7–9; and chew a 4-mg piece every 4–8 hours during weeks 10–12 of therapy.^c Alternatively, chew a 4-mg piece whenever the urge to smoke occurs; do not exceed 2 pieces (8 mg) per hour.¹

Taper dosage by chewing each piece for only 10–15 minutes and gradually reducing the number of pieces chewed, or chew each piece for longer than 30 minutes but reduce the total pieces per day, or substitute regular chewing gum for some pieces.^c

Buccal (Lozenges)

Patients who smoke first cigarette >30 minutes after waking: One 2-mg lozenge every 1–2 hours during weeks 1–6; then one 2-mg lozenge every 2–4 hours during weeks 7–9; and once 2-mg lozenge every 4–8 hours during weeks 10–12.^{263 264 h}

Patients who smoke first cigarette ≤30 minutes after waking: One 4-mg lozenge every 1–2 hours during weeks 1–6; then one 4-mg lozenge every 2–4 hours during weeks 7–9; and one 4-mg lozenge every 4–8 hours during weeks 10–12.^{263 264 h}

Do not exceed 5 lozenges in 6 hours or 20 lozenges daily.^{263 264}

Discontinue therapy if mouth problems, persistent indigestion, severe sore throat, irregular heartbeat, palpitations or symptoms suggestive of overdosage (nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat) develop.²⁶⁴

Transdermal

Patients who smoke ≤10 cigarettes daily: Initially, 14 mg daily for 6 weeks, then 7 mg daily for 2 weeks, then discontinue.^{189 b i}

Patients who smoke >10 cigarettes daily: Initially, 21 mg daily for 4–6 weeks; then 14 mg daily for 2 weeks; then 7 mg daily for 2 weeks; then discontinue therapy.^{189 257 b i}

Intranasal

Initially, 1–2 sprays (0.5–1 mg) in each nostril per hour (1–2 mg per hour total); may increase up to a maximum of 5 sprays (5 mg) in each nostril per hour (10 mg total) or a maximum total of 80 sprays (40 mg) daily.^{191 257 e}

Initially, use at least 16 sprays (8 mg total) daily to increase chance of efficacy.^{191 257} Then, individualize dosage based on nicotine dependence and occurrence of symptoms of nicotine excess.¹⁹¹

Continue treatment in successfully abstinent patients for up to 8 weeks then discontinue over 4–6 weeks.¹⁹¹

Taper dosage by using only 1 spray at a time, using the spray less frequently, keeping a tally of daily usage, trying to meet a steadily reducing usage target, skipping a dose by not medicating every hour, or setting a planned “quit date” for stopping use of the spray.¹⁹¹ Some patients may not require tapering.¹⁹¹

Oral Inhalation

Initially, 6–16 cartridges daily for up to 12 weeks, then gradually decrease daily dosage over 6–12 weeks.^{244 245 246 257}

Use ≥6 cartridges daily for the first 3–6 weeks to increase chance of efficacy.²⁴⁴ Individualize dosage based on nicotine dependence and occurrence of symptoms of nicotine excess.²⁴⁴

Taper dosage by using less frequently, keeping a tally of daily usage, trying to meet a steadily reducing usage target, or setting a planned “quit date” for stopping use of the inhaler.²⁶⁵ Some patients may not require tapering.²⁶⁵

Prescribing Limits

Adults

Smoking Cessation

Buccal (Chewing Gum)

Maximum 2 pieces of 2-mg gum per hour (i.e., maximum 24 pieces [48 mg nicotine] daily).^c Maximum 12 weeks of therapy.^c

Maximum 2 pieces of 4-mg gum per hour (i.e., maximum 24 pieces [96 mg nicotine] daily).^c Maximum 12 weeks of therapy.^c

Clinician supervised: Maximum 30 pieces of 2-mg gum daily (i.e., 60 mg nicotine) or 24 pieces of 4-mg gum daily (i.e., 96 mg nicotine).^{1 190 195}

Buccal (Lozenges)

Maximum 5 lozenges in 6 hours or 20 lozenges daily.^h Maximum 12 weeks of therapy.^h

Transdermal

Patients who smoke ≤10 cigarettes daily: Maximum 8 weeks of therapy.^b

Patients who smoke >10 cigarettes daily: Maximum 10 weeks of therapy.^b

Continued therapy for periods longer than usually recommended may be appropriate for certain patients to promote extended abstinence.²⁵⁷ Continuation of therapy >12 weeks not recommended by manufacturer.^{101 102 103 104}

Intranasal

Maximum 5 sprays (5 mg) in each nostril per hour (maximum 10 mg total) or a maximum total of 80 sprays (40 mg) daily.^{191 257 e}

Manufacturer states that continuing therapy >12 weeks does not improve outcome.^e Safety of continuing therapy >6 months not established.^e

Oral Inhalation

Maximum 16 cartridges daily for up to 12 weeks.²⁶⁵

Manufacturer states that safety of continuing therapy >6 months not established.²⁶⁵

Special Populations

No special population dosage recommendations at this time.^{a b}

Cautions for Nicotine

Contraindications

• 
  

  Known hypersensitivity to nicotine, menthol (oral inhaler), or any ingredient in the formulation.^{101 102 103 104 191 244}

  
  


• 
  

  Nicotine polacrilex gum in patients with temporomandibular joint disease.^{101 102 103 104 191 244} (See Oral and Dental Effects under Cautions.)

  
  

Warnings/Precautions

Warnings

Nicotine Toxicity

Risk of nicotine toxicity (e.g., nausea, hypersalivation, abdominal pain, vomiting, diarrhea, perspiration, headache, dizziness, hearing and visual disturbances, mental confusion, weakness)^{1 4 36 97 191 244} and addiction.^{101 102 103 104 244} Sustained use of nicotine preparations is not recommended.^{1 81 101 102 103 104 244} Weigh risk of nicotine replacement against hazard of continued smoking concurrent with nicotine-replacement therapy and likelihood of smoking cessation without nicotine replacement.^{101 102 103 104 244}

Discontinue nicotine polacrilex lozenges if symptoms suggestive of overdosage (nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat) occur.²⁶⁴

Fetal/Neonatal Morbidity

Animal studies indicate fetal harm; pregnant women should attempt smoking cessation with educational and behavioral interventions before considering nicotine therapy.^{1 101 102 103 104 128 191 194 195 196 244 257 264 e}

Use during pregnancy only if the increased likelihood of smoking cessation justifies potential risk to the fetus and patient of nicotine replacement and possible continued smoking.^{1 101 102 103 104 128 191 194 195 196 244 257 264} If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.^{e 265}

General Precautions

Respiratory Effects

Possible exacerbation of bronchospasm.²⁴⁴ Use oral inhaler with caution in patients with bronchospastic disease;²⁴⁴ other dosage forms may be preferable.²⁴⁴

Intranasal nicotine is not recommended in patients with severe reactive airway disease.^{191 257}

Nasopharyngeal Effects

Nicotine nasal spray may irritate nasal mucosa;^e use of nasal spray not recommended in patients with a history of chronic nasal disorders (e.g., allergy, rhinitis, polyps, sinusitis).^{191 257}

Discontinue nicotine polacrilex lozenges if severe sore throat occurs.²⁶⁴

Cardiovascular Effects

Possible increased risk of adverse cardiovascular effects;^{144 149 164 165 211 212 213 214 215} however, causal relationship between nicotine replacement therapy and cardiac complications not established.^{101 102 103 104 144 148 149 191 244 257}

Discontinue therapy if irregular heartbeat or palpitations occur.^{264 b c h i}

Use with caution and only after careful evaluation in patients with coronary heart disease (i.e., history of MI, angina pectoris), serious cardiac arrhythmias, or vasospastic diseases (e.g., Buerger's disease, Prinzmetal's variant angina, Raynaud's phenomena).^{101 102 103 104 144 148 149 191 244 257} Benefit of nicotine replacement therapy must outweigh risks of continued cigarette smoking.^{43 257}

Self-medication not recommended in patients in the immediate post-MI period, with serious arhythmias, or with severe or worsening angina.^{188 189 190}

Endocrine Effects

Possible hyperinsulinemia and insulin resistance with prolonged nicotine replacement therapy.²⁵⁴ Use with caution in hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes.^{101 102 103 104 191 244}

GI Effects

Possible delayed healing of peptic ulcer; use with caution.^{101 102 103 104 191 244}

Discontinue nicotine polacrilex lozenges if persistent indigestion develops.²⁶⁴

Use nicotine polacrilex gum with caution in patients with a history of esophagitis.^{1 97}

Hypertension

Possible increased risk of malignant hypertension in patients with accelerated hypertension; use with caution in such patients.^{1 101 102 103 104 191 244}

Possible perpetuation of hypertension; use with caution in patients with systemic hypertension.^a

Nicotine Dependence

Transference of dependence on nicotine may occur;^{1 81 87 88 90 96 97 98 191 195 244 257} potential for abuse and dependence on nicotine nasal spray appears to be greater than that for other formulations of nicotine (i.e., nicotine polacrilex gum, transdermal nicotine systems) but less than that of cigarettes.^{191 196 201 202 257}

To minimize withdrawal symptoms⁸⁷ and the risk of dependence on nicotine, withdraw gradually or discontinue use of nicotine polacrilex gum or transdermal or intranasal nicotine after 2–3 months of therapy.^{1 2 3 36 191 195 244}

Phenylketonuria

Commit nicotine polacrilex lozenges contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 3.4 mg of phenylalanine per lozenge.²⁶⁴

Oral and Dental Effects

Risk of occlusal stress when nicotine polacrilex gum chewed for long periods of time; may result in displaced dental restorations or loosening of dental inlays or fillings.^{1 72} Gum may stick to dentures, dental caps, or partial bridges; if excessive sticking or damage to dental work occurs, discontinue gum and consult clinician.¹

Use nicotine polacrilex gum with caution in patients with a history of oral or pharyngeal inflammation, or dental conditions exacerbated by chewing gum.^{1 97}

Discontinue nicotine polacrilex lozenges if mouth problems develop.²⁶⁴

Dermatologic Effects

Possible skin reactions (e.g., urticaria, hives, rash) with transdermal systems.^{101 102 103 104 129} Increased risk of such reactions in patients with some dermatologic conditions (e.g., psoriasis, atopic or eczematous dermatitis).^{101 102 103 104}

If skin reaction occurs, discontinue transdermal system and contact clinician;^{101 102 103 104 129} topical corticosteroids and/or oral antihistamines recommended.^{43 112 144 149 195}

Risk of contact sensitization with transdermal systems; serious reaction may occur with re-exposure to smoking or other nicotine products.^{101 102 103 104}

Nervous System Effects

Potential adverse nervous system effects (e.g., insomnia,^{1 102 136 137} headache,^{1 68 101 102 103 104 109 111 118 137 244 246 263} dizziness, lightheadedness).^{1 27 104 109}

Specific Populations

Pregnancy

Category D.^{e 265} (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Distributed into milk.^{1 34 70 73 101 102 103 104 191 244 257} Use caution.^{1 34 70 73 101 102 103 104 191 244 257}

Weigh risk of exposure to nicotine in drug versus risk of nicotine and other components of tobacco smoke from cigarettes.^{1 101 102 103 104 191 244}

Pediatric Use

Safety and efficacy not established.^{1 101 102 103 104 191 196 244} However, the USPHS states that nicotine replacement therapy may be considered in adolescents when there is evidence of nicotine dependence and a desire to quit the use of tobacco.^{196 257}

Use or ingestion of used or unused nicotine replacement systems by children may cause poisoning or be fatal; keep used and unused containers out of reach of children.^{101 102 103 104 191 244}

Risk of choking if nicotine oral inhalers are swallowed; keep out of reach of children.²⁴⁴

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults;^{101 102 103 104 244} select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease.^{e 265}

Hepatic Impairment

Not studied in patients with hepatic impairment; use with caution.^{101 102 103 104 244}

Renal Impairment

Not studied in patients with renal impairment; clearance may be decreased in patients with severe renal impairment.^{44 101 102 103 104 244}

Common Adverse Effects

Buccal therapy (gum): Indigestion;^{1 7 27 85 96 257} nausea;^{1 6 9 27 68 85 95} hiccups;^{1 7 68 89 94 96 257} traumatic injury to oral mucosa and/or teeth;^{1 68 257} irritation and/or tingling of the tongue, mouth, and throat;^{1 5 9 27 29 68 85 89 95 96} oral mucosal ulceration;^{1 5 6 7 29 68 89 96} jaw-muscle ache;^{1 5 6 7 29 68} eructation;^{1 68 95} gum sticking to teeth;⁸⁹ unpleasant taste;^{5 85 95} dizziness;^{1 27} lightheadedness;^{1 27} headache;^{1 68} insomnia.¹

Buccal therapy (lozenge): Nausea,²⁶³ dyspepsia,²⁶³ flatulence,²⁶³ headache,²⁶³ upper respiratory tract infections.²⁶³

Transdermal therapy: Application site reactions (i.e., pruritus, burning, or erythema),^{101 102 103 104 113 114 115 118 126 136 137 195 257} diarrhea,^{101 102} dyspepsia,^{103 137} abdominal pain,¹⁰³ dry mouth.^{101 102 109 137}

Intranasal therapy: Runny nose,^{191 196 202 203} throat irritation,^{191 196 201 202 203} watery eyes,^{191 196 201}