Norelgestromin/Ethinyl Estradiol Patch

Pronunciation: nor-el-JES-troe-min/ETH-i-nil ES-tra-DYE-ol
Generic Name: Norelgestromin/Ethinyl Estradiol
Brand Name: Ortho Evra

Smoking cigarettes while using Norelgestromin/Ethinyl Estradiol Patch increases the risk of serious heart problems. The risk increases with age (older than 35 years) and with frequent smoking. Patients who use Norelgestromin/Ethinyl Estradiol Patch are strongly advised not to smoke. Do not use Norelgestromin/Ethinyl Estradiol Patch if you are older than 35 years and you smoke.

Women who use Norelgestromin/Ethinyl Estradiol Patch may have a higher risk of developing serious blood clots than women who use birth control pills. Discuss any questions or concerns with your doctor.

Norelgestromin/Ethinyl Estradiol Patch is used for:

Preventing pregnancy. It may also be used for other conditions as determined by your doctor.

Norelgestromin/Ethinyl Estradiol Patch is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries and thereby preventing pregnancy.

Do NOT use Norelgestromin/Ethinyl Estradiol Patch if:

• you are allergic to any ingredient in Norelgestromin/Ethinyl Estradiol Patch


• you are pregnant or suspect you may be pregnant, have recently given birth, or are breast-feeding


• you have blood clots in the legs, lungs, or eyes, or a history of other blood clotting problems


• you have a history of blood vessel problems of the heart or brain, a heart attack, chest pain, or a stroke


• you have a history of yellowing of the eyes or skin during pregnancy or previous hormonal birth control use


• you have a history of breast cancer; or known or suspected breast cancer or cancer of the uterus, cervix, or vagina; cancer that is estrogen-dependent; or you have unusual vaginal bleeding from an unknown cause


• you have a liver tumor, liver cancer, or active liver disease; severe high blood pressure; blood vessel problems caused by diabetes; certain heart valve problems; or the blood disease porphyria


• you have headaches with neurological symptoms or will be on bed rest for a long period following surgery


• you are taking birth control pills

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

Before using Norelgestromin/Ethinyl Estradiol Patch:

Some medical conditions may interact with Norelgestromin/Ethinyl Estradiol Patch. 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 high blood pressure; high cholesterol, triglycerides, or calcium levels; or pancreatitis or gallbladder problems; or you are obese


• if you have breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, endometriosis or endometrial carcinomas, uterine fibroids, or irregular or scanty menstrual periods


• if a member of your family has had breast cancer


• if you have liver or kidney problems, heart problems, diabetes, headaches, migraine headaches, epilepsy, or a history of mental depression


• if you smoke, weigh 198 lbs or more, or will be having surgery


• if you have recently given birth or had a miscarriage or abortion


• if you are taking an antibiotic

Some MEDICINES MAY INTERACT with Norelgestromin/Ethinyl Estradiol Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, ketoconazole) or HMG-CoA reductase inhibitors (eg, atorvastatin) because they may increase the risk of Norelgestromin/Ethinyl Estradiol Patch's side effects


• Aprepitant, azole antifungals (eg, itraconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, nevirapine), oxcarbazepine, penicillins (eg, amoxicillin), rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Norelgestromin/Ethinyl Estradiol Patch's effectiveness. Alternative forms of birth control are strongly recommended when taking any of these medicines along with this birth control medicine


• Beta-blockers (eg, atenolol), corticosteroids (eg, prednisolone), selegiline, theophyllines (eg, aminophylline), or troleandomycin because the risk of their side effects may be increased by Norelgestromin/Ethinyl Estradiol Patch


• Lamotrigine, morphine, or temazepam because their effectiveness may be decreased by Norelgestromin/Ethinyl Estradiol Patch

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norelgestromin/Ethinyl Estradiol Patch 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 Norelgestromin/Ethinyl Estradiol Patch:

Use Norelgestromin/Ethinyl Estradiol Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Norelgestromin/Ethinyl Estradiol Patch. Talk to your pharmacist if you have questions about this information.


• One patch is usually applied to the skin, worn for 1 week, and then replaced. Follow the dosing schedule carefully.


• Do not open the sealed pouch containing the patch until you are ready to use it. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the patch lifts, press down to reapply. Wear only 1 patch at any one time.


• Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight or where the skin is red, irritated, or cut. Do not use creams, oils, powder, or makeup on your skin where you will put a patch or near a patch you are using because it may cause the patch to become loose. Contact with water while bathing, showering, or swimming will not affect the patch.


• When it is time to change the patch, remove it slowly. After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.


• Apply a new patch to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, remove that patch. Apply a new patch at a different site until your next scheduled patch change. If the irritation continues or becomes worse, notify your doctor promptly.


• If the patch has become loose or has fallen off for less than 1 day, try to reapply it or apply a new patch immediately. No other contraceptive measures are necessary.


• If the patch has become loose or has fallen off for more than 1 day or if you are not sure how long it has been off, apply a new patch to begin a new cycle. In this case, you may not be adequately protected from pregnancy. You must use an additional form of birth control (eg, diaphragm, male condoms, spermicide) until the patch has been in place for 7 days in a row.


• Do not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it, or if it has previously come loose or fallen off. Do not use any tapes or wraps to keep the patch in place. If you cannot reapply a patch, apply a new patch immediately.


• Check with your doctor before you eat grapefruit or drink grapefruit juice while you use Norelgestromin/Ethinyl Estradiol Patch. Eating grapefruit or drinking grapefruit juice may increase the risk of Norelgestromin/Ethinyl Estradiol Patch's side effects.


• If you forget to change your patch on the scheduled day, follow the directions in the additional patient leaflet that comes with Norelgestromin/Ethinyl Estradiol Patch. You may need to use a backup form of birth control (eg, condoms). If you forget to change your patch on the scheduled day and you are not sure what to do, use an extra form of birth control (eg, condoms) and check with your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Norelgestromin/Ethinyl Estradiol Patch.

Important safety information:

• Norelgestromin/Ethinyl Estradiol Patch may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Norelgestromin/Ethinyl Estradiol Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Limit alcoholic beverages.


• Norelgestromin/Ethinyl Estradiol Patch may cause dark skin patches on your face (melasma). Avoid the sun, sunlamps, or tanning booths until you know how you react to Norelgestromin/Ethinyl Estradiol Patch. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Norelgestromin/Ethinyl Estradiol Patch may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years).


• The risk of developing a blood clot may be greater with Norelgestromin/Ethinyl Estradiol Patch than with other forms of hormonal birth control (eg, birth control pill). Talk with your doctor about the benefits and risks of Norelgestromin/Ethinyl Estradiol Patch or other forms of hormonal birth control.


• Some antibiotics may decrease Norelgestromin/Ethinyl Estradiol Patch's effectiveness. If you take an antibiotic while you are using Norelgestromin/Ethinyl Estradiol Patch, talk with your doctor or pharmacist. You may need to use an additional form of birth control (eg, condoms) while you take the antibiotic. Discuss any questions or concerns with your doctor.


• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.


• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while using Norelgestromin/Ethinyl Estradiol Patch.


• Follow your doctor's instructions for examining your breasts and report any lumps immediately.


• If you wear contact lenses and you develop problems with them, contact your doctor.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using Norelgestromin/Ethinyl Estradiol Patch.


• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.


• Norelgestromin/Ethinyl Estradiol Patch may increase the risk of breast and endometrial cancer.


• Norelgestromin/Ethinyl Estradiol Patch does not stop the spread of HIV and other sexually transmitted diseases (STDs). Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Diabetes patients - Norelgestromin/Ethinyl Estradiol Patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Norelgestromin/Ethinyl Estradiol Patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Norelgestromin/Ethinyl Estradiol Patch.


• Lab tests will be required to monitor therapy. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a Pap test, at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Norelgestromin/Ethinyl Estradiol Patch is not approved for use in CHILDREN who have not yet had their first menstrual period; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Norelgestromin/Ethinyl Estradiol Patch if you are pregnant. Avoid becoming pregnant while you are using it. If you miss a menstrual period or think you may be pregnant, contact your doctor right away. Norelgestromin/Ethinyl Estradiol Patch may be found in breast milk. If you are or will be breast-feeding while you use Norelgestromin/Ethinyl Estradiol Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Norelgestromin/Ethinyl Estradiol Patch:

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:

Breast tenderness or enlargement; headache; menstrual cramps; mild skin irritation at the application site; nausea; stomach pain, cramps, or bloating; vaginal spotting or breakthrough bleeding; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; breast pain; calf pain, swelling, or tenderness; changes in vision (eg, double vision, loss of vision); chest pain; confusion; coughing up blood; fainting; mental or mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent dizziness; severe or persistent trouble sleeping; severe or persistent vaginal bleeding; slurred speech; sudden shortness of breath; swelling of the hands or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite); unusual tiredness or weakness; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg.

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.

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 excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Norelgestromin/Ethinyl Estradiol Patch:

Store Norelgestromin/Ethinyl Estradiol Patch at 77 degrees F (25 degrees C) in the original sealed pouch. 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 Norelgestromin/Ethinyl Estradiol Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Norelgestromin/Ethinyl Estradiol Patch, please talk with your doctor, pharmacist, or other health care provider.


• Norelgestromin/Ethinyl Estradiol Patch 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 Norelgestromin/Ethinyl Estradiol Patch. 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 Norelgestromin/Ethinyl Estradiol resources

• Norelgestromin/Ethinyl Estradiol Use in Pregnancy & Breastfeeding
• Norelgestromin/Ethinyl Estradiol Drug Interactions
• Norelgestromin/Ethinyl Estradiol Support Group
• 63 Reviews for Norelgestromin/Ethinyl Estradiol - Add your own review/rating

Compare Norelgestromin/Ethinyl Estradiol with other medications

• Birth Control

Next Choice Oral, Implantation, Parenteral

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

Commonly used brand name(s)

In the U.S.

• Aygestin


• Camila


• Errin


• Jolivette


• Next Choice


• Nora-BE


• Nor-QD


• Ortho Micronor


• Ovrette


• Plan B


• Plan B One-Step


• Provera

Available Dosage Forms:

• Tablet

Uses For Next Choice

Progestins are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman's egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner's sperm to reach the egg. The fertilization of the woman's egg with her partner's sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.

Progestin contraceptives are available only with your doctor's prescription.

Importance of Diet

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using Next Choice

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

Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.

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

Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast Feeding

Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

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 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.

• 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—May cause fluid buildup and make these conditions worse.

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

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

• Central nervous system (CNS) disorders (e.g., depression), or history of or


• High blood cholesterol or


• Osteoporosis (brittle bones), or a family history of—May cause these conditions to occur or make these conditions worse.

• Diabetes mellitus—May cause a mild increase in blood sugar and a need to monitor blood sugar more often.

• Liver disease—The effects of some progestins may be increased. May make this condition worse.

Proper Use of progestin contraceptives

This section provides information on the proper use of a number of products that contain progestin contraceptives. It may not be specific to Next Choice. 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 for contraception usually come with patient directions. Read them carefully before taking or using this medicine.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

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.

When using levonorgestrel tablet dosage form for emergency contraception:

• The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

• Your injection is given by a health care professional every 3 months.


• To stop using medroxyprogesterone injection for contraception, simply do not have another injection.


• Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

• Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.


• Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.


• When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.


• Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.

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 levonorgestrel


• For oral dosage form (tablets):
  
  • For emergency contraception for preventing pregnancy:
    
    • Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.
    
    
  
  

• For medroxyprogesterone


• For muscular injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
    
    
  
  


• For subcutaneous injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).
    
    
  
  

• For norethindrone


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

• For norgestrel


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

• When you miss 1 day's dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

• If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.


• If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

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 Next Choice

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

• If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.

Progestins may cause dizziness in some people. 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.

It is possible that certain doses of progestins may cause a 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 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 steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:

• If 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 call your doctor immediately.

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

The following medicines might reduce the effectiveness of progestins for contraception:

• Aminoglutethimide (e.g., Cytadren®)


• Carbamazepine (e.g., Tegretol®)


• Phenobarbital


• Phenytoin (e.g., Dilantin®)


• Rifabutin (e.g., Mycobutin®)


• Rifampin (e.g., Rifadin®)

Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.

If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

Next Choice Side Effects

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

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

More common

• Changes in uterine bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods


• heavier uterine bleeding between regular monthly periods


• lighter uterine bleeding between menstrual periods


• or stopping of menstrual periods

Less common

• Mental depression


• skin rash


• unexpected or increased flow of breast milk

Incidence not known - for patients taking Depo-Provera Contraceptive Injection

• Cough


• decrease in height


• difficulty swallowing


• fast heartbeat


• hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue


• pain in back, ribs, arms, or legs


• pain or swelling in arms or legs without any injury


• shortness of breath


• skin rash


• tightness in chest


• wheezing

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


• diarrhea


• dizziness


• fatigue


• mild headache


• mood changes


• nausea


• nervousness


• pain or irritation at the injection site


• swelling of face, ankles, or feet


• unusual tiredness or weakness


• vomiting


• 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 any of the following side effects:

• 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.

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.

Pentoxyvérine

Pentoxyvérine may be available in the countries listed below.

Ingredient matches for Pentoxyvérine

Pentoxyverine

Pentoxyvérine (DCF) is also known as Pentoxyverine (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Neomycin Sulfate

Class: Aminoglycosides
VA Class: AM300
CAS Number: 1405-10-3
Brands: Neo-Fradin, Neo-Rx

• Neurotoxicity and Ototoxicity


• 
  

  Neurotoxicity (manifested as both auditory and vestibular ototoxicity) can occur, even at recommended doses.^{1 2}

  
  


• 
  

  Risk of eighth-cranial nerve impairment is increased in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended.^{1 2}

  
  


• 
  

  Aminoglycoside-induced ototoxicity is irreversible, usually bilateral, and may be partial or total.^{1 2}

  
  


• 
  

  Patients developing cochlear damage may not have symptoms during aminoglycoside treatment to warn them of eighth-cranial nerve toxicity and total or partial, irreversible, bilateral deafness may occur after drug discontinued.^{1 2}

  
  

• Nephrotoxicity


• 
  

  Potentially nephrotoxic, even at recommended doses.^{1 2}

  
  


• 
  

  Nephrotoxicity develops principally in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended.^{1 2}

  
  

• Patient Monitoring


• 
  

  Patients should be under close clinical observation because of potential toxicities.^{1 2}

  
  


• 
  

  Oral neomycin is absorbed systemically; toxic reactions may occur.^{1 2}

  
  


• 
  

  Closely monitor renal and eighth-cranial nerve function.^{1 2} Perform serial, vestibular, and audiometric tests and tests of renal function, particularly in high-risk patients.^{1 2}

  
  


• 
  

  Advanced age and dehydration may increase risk of toxicity.^{1 2}

  
  

• Neuromuscular Blockade


• 
  

  Neuromuscular blockage and respiratory paralysis reported with oral neomycin.^{1 2}

  
  


• 
  

  Concomitant use of an aminoglycoside with anesthesia and muscle-relaxing drugs may cause neuromuscular blockade with respiratory paralysis.^{1 2}

  
  


• 
  

  Consider possibility of neuromuscular blockade and respiratory paralysis when administering aminoglycosides, especially if used concurrently with anesthetics or neuromuscular-blocking agents (e.g., tubocurarine, succinylcholine, decamethonium) or in patients receiving massive transfusions of citrate-anticoagulated blood.^{1 2} (See Specific Drugs under Interactions.)

  
  


• 
  

  Calcium salts may reduce manifestations if blockade occurs; may require mechanical respiratory assistance.^{1 2}

  
  

• Interactions


• 
  

  Avoid concurrent and/or sequential use of other systemic, topical, or oral neurotoxic or nephrotoxic drugs, particularly other aminoglycosides (including paromomycin), amphotericin B, bacitracin, cisplatin, colistin, polymyxin B, vancomycin, and viomycin (not commercially available in the US).^{1 2} (See Interactions.)

  
  


• 
  

  Avoid concurrent use of potent diuretics (e.g., ethacrynic acid, furosemide) since diuretics themselves may cause ototoxicity and IV diuretics enhance toxicity by altering serum and tissue aminoglycoside concentrations.^{1 2} (See Interactions.)

  
  

Introduction

Antibacterial; aminoglycoside antibiotic obtained from cultures of Streptomyces fradiae.^{1 2 14 23}

Uses for Neomycin Sulfate

Hepatic Encephalopathy

Management of hepatic encephalopathy.^{1 2 11 13 26 27 28} Used to inhibit ammonia-forming bacteria in the GI tract in patients with hepatic (portal-systemic) encephalopathy as an adjunct to protein restriction and supportive therapy.^{1 2 11 13 26 27 28} Subsequent reduction in blood ammonia may result in neurologic improvement.^{1 2 11 27}

Although efficacy of such adjunctive treatment is not clearly established,¹² it has been suggested that nonabsorbable disaccharides (lactulose) are first-line treatment to reduce blood ammonia in adults with acute hepatic encephalopathy and anti-infectives (e.g., oral neomycin or metronidazole) are alternatives.^{11 28}

Perioperative Prophylaxis

Adjunct to mechanical cleansing of the large intestines for preoperative prophylaxis in patients undergoing colorectal surgery.^{2 3 6 13} Used in conjunction with oral erythromycin or oral metronidazole and with an appropriate diet and catharsis.^{2 3 6}

Preferred regimens for patients undergoing colorectal surgery are IV cefoxitin or IV cefotetan alone; IV cefazolin and IV metronidazole; oral erythromycin and oral neomycin; or oral metronidazole and oral neomycin.^{3 6}

Hypercholesterolemia

Treatment of hypercholesterolemia†.^{13 16 17 20 25} Therapeutic value may be due in part to reduction in GI absorption of cholesterol, resulting in enhanced elimination of cholesterol as neutral sterols in the feces.^{13 16 20}

Not a first- or second-line agent; use only after all conventional treatments have been tried.^{18 25}

GI Infections

Not recommended for treatment of any GI infections†.¹³

Neomycin Sulfate Dosage and Administration

Administration

Oral Administration

Administer orally.^{1 2}

Dosage

Available as neomycin sulfate; dosage expressed in terms of the sulfate.^a

To minimize risk of toxicity, use lowest possible dosage and shortest duration of therapy.^{1 2} Closely monitor patients for aminoglycoside toxicity, especially when used for adjunctive treatment of chronic hepatic insufficiency.^{1 2 11}

Treatment duration >2 weeks is not recommended.^{1 2} Weigh risks of nephrotoxicity, permanent ototoxicity, and neuromuscular blockade against benefits of prolonged treatment.¹ If treatment is prolonged, closely monitor serum neomycin concentrations and renal, auditory, and vestibular functions.¹

Individualize dosage taking into consideration the patient's pretreatment body weight, renal status, and serum concentrations of the drug.^b Because of potential toxicity, fixed-dosage recommendations that are not based on patient weight or serum drug concentrations are not advised.^b

Pediatric Patients

General Pediatric Dosage

Oral

Neonates ≤1 month of age†: AAP recommends 25 mg/kg every 6 hours.⁵

Infants and children >1 month of age†: AAP recommends 100 mg/kg daily given in 4 equally divided doses.⁵

Manufacturers state that if neomycin is considered necessary in children <18 years of age†, duration of therapy should not exceed 2 weeks^{1 2} . (See Pediatric Use under Cautions.)

Hepatic Encephalopathy

Oral

Children†: 100 mg/kg daily given in 4 divided doses for ≤7 days.²⁷

Prior to initiation of neomycin, withdraw protein from the diet and avoid diuretics; incrementally return protein back to the diet during treatment.^{1 2} Monitor closely;^{1 2 11} give supportive therapy (including blood products) as indicated.^{1 2}

Adults

Hepatic Encephalopathy

Oral

Hepatic coma: 4–12 g daily given in divided doses (e.g., 4 doses daily) for 5–6 days recommended by the manufacturers and others.^{1 2 26 28}

Chronic hepatic insufficiency when less toxic drugs cannot be used: Up to 4 g daily recommended by the manufacturers.^{1 2}

Some clinicians recommend 3–6 g daily for 1–2 weeks for acute encephalopathy¹¹ and 1–2 g daily for chronic encephalopathy.¹¹

Prior to initiation of neomycin, withdraw protein from the diet and avoid diuretics; incrementally return protein back to the diet during treatment.^{1 2} Monitor closely;^{1 2 11} give supportive therapy (including blood products) as indicated.^{1 2}

Perioperative Prophylaxis

Adjunct to Mechanical Cleansing in Patients Undergoing Colorectal Surgery

Oral

For 8 a.m. surgery: Give 1 g neomycin sulfate and 1 g erythromycin base at 1 p.m., 2 p.m., and 11 p.m. on the day preceding surgery.^{2 3 6} Alternatively, give 2 g neomycin sulfate and 2 g metronidazole at 7 p.m. and 11 p.m. on the day preceding surgery.³

Begin a minimum residue or clear liquid diet 1–3 days before colorectal surgery with appropriate catharsis.^{2 3 6}

Hypercholesterolemia†

Oral

0.5–2 g daily.^{16 25} Do not use for long-term treatment.¹³

Prescribing Limits

Adults

Hepatic Encephalopathy

Chronic Hepatic Encephalopathy

Oral

Maximum: 4 g daily.^{1 2}

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time other than those for patients with hepatic encephalopathy.^{1 2 a}

Renal Impairment

Reduce dosage or discontinue drug in patients with renal impairment.¹

Some clinicians recommend that doses be given every 6 hours in those with GFR >50 mL/minute, every 12–18 hours in those with GFR 10–50 mL/minute, or every 18–24 hours in those with GFR <10 mL/minute.²⁴

Geriatric Patients

Select dosage with caution and closely monitor renal function because of age-related decreases in renal function.^{1 2}

Cautions for Neomycin Sulfate

Contraindications

• 
  

  History of hypersensitivity or serious toxic reactions to neomycin or other aminoglycosides.^{1 2}

  
  


• 
  

  Intestinal obstruction.^{1 2}

  
  


• 
  

  Inflammatory or ulcerative GI disease; may enhance GI absorption of neomycin.^{1 2}

  
  

Warnings/Precautions

Warnings

Neurotoxicity and Ototoxicity

Patients receiving aminoglycosides should be under close clinical observation because of possible ototoxicity.^{1 2}

Vestibular and permanent bilateral auditory ototoxicity occurs most frequently in those with past or present history of renal impairment, those receiving other ototoxic drugs, and those who receive high dosages or prolonged treatment.^{1 2}

Perform serial, vestibular, and audiometric tests, if feasible, in patients old enough to be tested, particularly in high-risk patients.^{1 2}

Perform tests of the vestibulocochlearis nerve (eighth cranial nerve) function prior to and periodically during neomycin therapy.^{1 2}

Numbness, skin tingling, muscle twitching, and convulsions also may be signs of neurotoxicity.^{1 2}

Risk of hearing loss continues after drug withdrawal.^{1 2}

Some aminoglycosides have caused fetal ototoxicity when administered to pregnant women.^{1 2} (See Pregnancy under Cautions.)

Nephrotoxicity

Patients receiving aminoglycosides should be under close clinical observation because of possible nephrotoxicity.^{1 2} Renal function should be assessed prior to therapy and daily, or more frequently, during therapy.^{1 2}

Nephrotoxicity occurs most frequently in those with past or present history of renal impairment, those receiving other nephrotoxic drugs, and those who receive high dosage or prolonged treatment.^{1 2}

Monitor urine for increased protein excretion, decreased specific gravity, and the presence of cells and casts.^{1 2} Obtain Cl_cr, S_cr, and/or BUN at the onset of therapy and periodically during therapy.^{1 2}

Decrease dosage or discontinue drug if renal insufficiency develops.^{1 2}

Neuromuscular Blockade

Neuromuscular blockade and respiratory paralysis reported following oral neomycin.^{1 2}

Possibility of neuromuscular blockade should be considered, especially in patients receiving anesthetics or neuromuscular blocking agents (e.g., tubocurarine, succinylcholine, decamethonium) or in those receiving massive transfusions of citrate-anticoagulated blood.^{1 2}

Calcium salts may reverse neuromuscular blockade, but mechanical respiratory assistance may be necessary.^{1 2}

Sensitivity Reactions

Hypersensitivity

Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with aminoglycosides.

Cross-sensitivity

Cross-sensitivity occurs among the aminoglycosides.^{1 2}

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of neomycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.²

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.² In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.²

Topical Instillation

Quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation or intraoperative topical application in association with medical procedures; neurotoxicity, nephrotoxicity, neuromuscular blockade, or respiratory paralysis may occur, even with minute quantities of neomycin, regardless of renal function.^{1 2}

Neuromuscular Disorders

Use with caution in patients with neuromuscular disorders such as myasthenia gravis or parkinsonism; may aggravate muscle weakness because of potential curare-like effect on the neuromuscular junction.^{1 2}

Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.^{1 2} Institute appropriate therapy if superinfection occurs.^{1 2}

Malabsorption Syndrome

May produce a malabsorption syndrome for a variety of substances including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin, and iron.^{1 2} Usually reversible and dose-related; occurs most frequently in prolonged therapy or at high dosage (i.e., 12 g daily).^{1 2 13 23}

Specific Populations

Pregnancy

Category D.^{1 2}

Possibility of fetal harm if administered to a pregnant woman.^{1 2} Complete, irreversible, bilateral congenital deafness reported when another aminoglycoside (i.e., streptomycin) was used during pregnancy.^{1 2}

Lactation

IM neomycin is distributed into milk in cows; not known whether distributed into human milk.^{1 2} Discontinue nursing or the drug.^{1 2}

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 2}

If neomycin is considered necessary in children <18 years of age†, use with caution ^{1 2} and do not treat for >2 weeks^{1 2} since GI absorption may occur.^{1 2}

Risk of toxicity is increased in premature infants and neonates†.^{1 2}

Geriatric Use

Increased risk of toxicity; use with caution and closely monitor renal function.^{1 2}

When assessing renal function in geriatric patients, Cl_cr may be more useful than BUN or S_cr.^{1 2}

Renal Impairment

Patients with renal impairment are at higher risk of nephrotoxicity and ototoxicity.^{1 2}

Patients with renal insufficiency may develop toxic blood concentrations unless doses are properly regulated.^{1 2}

Common Adverse Effects

Nausea,^{1 2} vomiting,^{1 2} diarrhea,^{1 2} abdominal cramps.^{13 23}

Interactions for Neomycin Sulfate

Neurotoxic, Ototoxic, or Nephrotoxic Drugs

Concomitant or sequential use with other drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, if possible.^{1 2}

Because of the possibility of an increased risk of ototoxicity due to additive effects or altered serum and tissue aminoglycoside concentrations, do not use concurrently with potent diuretics.^{1 2}

Specific Drugs

Drug	Interaction	Comments
Aminoglycosides	Concurrent or serial use may enhance nephrotoxicity, ototoxicity, and/or potentiate neuromuscular blockade1 2	Avoid concurrent or sequential use, if possible1 2
Amphotericin B	Possible increased incidence of nephrotoxicity and/or neurotoxicity1 2	Avoid concurrent or sequential use, if possible1 2
Anticoagulants, oral	Neomycin may enhance warfarin effects by decreasing vitamin K availability1 2	Monitor prothrombin time; adjust warfarin dosage as requiredb
Anti-emetics (e.g., dimenhydrinate, meclizine)	Anti-emetics that suppress nausea and vomiting of vestibular origin and vertigo may mask symptoms of vestibular ototoxicity23
Bacitracin	Possible increased incidence of nephrotoxicity and/or neurotoxicity1 2	Avoid concurrent or sequential use, if possible1 2
β-Lactam antibiotics (cephalosporins, penicillins)	Possible increased incidence of nephrotoxicity reported with some cephalosporins; cephalosporins may spuriously elevate creatinine concentrationsb Potential in vitro and in vivo inactivation of aminoglycosidesb	Monitor serum aminoglycoside concentrations, especially when high penicillin doses are used or patient has renal impairmentb
Cisplatin	Possible increased incidence of nephrotoxicity and/or neurotoxicity1 2	Avoid concurrent or sequential use, if possible1 2
Colistimethate/Colistin	Possible increased incidence of nephrotoxicity and/or neurotoxicity1 2	Avoid concurrent or sequential use, if possible1 2
Cyanocobalamin (vitamin B12)	Neomycin inhibits GI absorption of oral vitamin B121 2	Clinical importance unclearb
Digoxin	Neomycin inhibits GI absorption of digoxin1 2	Monitor digoxin serum concentrations1 2
Diuretics (ethacrynic acid, furosemide)	Possible increased risk of ototoxicity (diuretics themselves may cause ototoxicity) or increased risk of other aminoglycoside-related adverse effects (diuretics may alter aminoglycoside serum or tissue concentrations)1 2
5-Fluorouracil	Neomycin inhibits GI absorption of 5-fluorouracil1 2	Clinical importance unclearb
Methotrexate	Neomycin inhibits GI absorption of methotrexate1 2	Clinical importance unclearb
Neuromuscular blocking agents and general anesthetics (succinylcholine, tubocurarine, decamethonium)	Possible potentiation of neuromuscular blockade and respiratory paralysis1 2	Use concomitantly with caution; observe closely for signs of respiratory depression1 2
NSAIAs	Possible increased serum aminoglycoside concentrations reported with indomethacin in premature neonates; may be related to indomethacin-induced decreases in urine output	Closely monitor aminoglycoside concentrations and adjust dosage accordingly
Penicillin V	Neomycin inhibits GI absorption of penicillin V1 2	Clinical importance unclearb
Polymyxins	Possible increased incidence of nephrotoxicity and/or neurotoxicity; possible potentiation of neuromuscular blockade1 2	Avoid concurrent or sequential use, if possible1 2
Vancomycin	Possible increased incidence of nephrotoxicity and/or neurotoxicity1 2	Avoid concurrent or sequential use, if possible1 2

Neomycin Sulfate Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the GI tract;^{26 29} about 3% of an oral dose is absorbed.^{1 2 21 22} Damaged or inflamed mucosa may increase GI absorption.²⁹

Rapidly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation or intraoperative topical application in association with medical procedures.^{1 2}

Plasma Concentrations

In adults, a single 4-g oral dose produced peak plasma concentrations of 2.5–6.1 mcg/mL at 1–4 hours after the dose.²¹

Distribution

Extent

Distributed in low concentrations in intestinal wall and muscles.¹⁹

Distributed into milk in animals; not known whether distributed into human milk.^{1 2}

Plasma Protein Binding

0–30%.^{1 2}

Elimination

Elimination Route

Excreted principally in feces (97%) as unchanged drug^{1 2 13 26} and in urine (1%).^{13 21 22}

Removed by hemodialysis.^{1 2}

Half-life

Adults with normal renal function: 2–3 hours.^{23 24 29}

Severe renal impairment: 12–24 hours.²⁴

Stability

Storage

Oral

Tablets

20–25°C in tight container.²

Oral Solution

15–30°C.¹

Actions and SpectrumActions

• 
  

  Usually bactericidal.^{1 2 b}

  
  


• 
  

  Inhibits protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.^b

  
  


• 
  

  Following oral administration, rapidly suppresses growth of most intestinal bacteria; these are replaced by nonpathogenic yeasts and, occasionally, resistant strains of Enterobacter aerogenes.^{1 2} Suppression persists for 48–72 hours after the dose.^{1 2}

  
  


• 
  

  In vitro spectrum of activity includes many gram-negative aerobic bacteria and some aerobic gram-positive bacteria.^{1 2} Inactive against fungi,^b viruses,^b and most anaerobic bacteria.^{1 2 b}

  
  


• 
  

  Gram-negative aerobes: Active in vitro against Enterobacter, Escherichia coli, and Klebsiella.^{1 2}

  
  


• 
  

  Partial cross-resistance occurs between neomycin and other aminoglycosides.^b

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including neomycin) should only be used to treat bacterial infections and not be used to treat viral infections (e.g., the common cold).²

  
  


• 
  

  Importance of completing full course of therapy, even if feeling better after a few days.²

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with neomycin or other antibacterials in the future.²

  
  


• 
  

  Advise patients of the risk of toxic effects on the eighth nerve, including partial or total deafness.^{1 2} Inform patients that the possibility of acute toxicity is increased in premature infants and neonates.^{1 2}

  
  


• 
  

  Importance of informing clinician if there is evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss), other neurotoxicity (numbness, skin tingling, muscle twitching, seizures), or nephrotoxicity (e.g., decreased urine output).^{1 2}

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{1 2}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 2}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^{1 2} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin Sulfate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder*		Neo-Rx Powder	X-Gen
Oral	Solution	125 mg (87.5 mg of neomycin) per 5 mL	Neo-Fradin	X-Gen
	Tablets	500 mg (350 mg of neomycin)*	Neomycin Sulfate Tablets (with povidone)	Teva

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Pharma-Tek Inc. Neo-Fradin (neomycin sulfate) oral solution prescribing information. Huntington, NY. 2002 Jul.

2. Teva. Neomycin sulfate tablets USP prescribing information. Sellersville, PA. 2003 Mar.

3. Anon. Antimicrobial prophylaxis for surgery. Med Lett Treat Guid. 2004; 2:27-32.

4. Nichols RL, Smith JW, Garcia RY et al. Current practices of preoperative bowel preparation among North American colorectal surgeons. Clin Infect Dis. 1997; 24:609-19. [IDIS 384359] [PubMed 9145734]

5. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:751, 753.

6. Bratzler DW, Houck PM, for the Surgical Infection Prevention Guidelines Writers Workgroup. antimicrobial prophylaxis for surgery: an advisory statement from the national surgical infection prevention project. Clin Infect Dis. 2004; 38:1706-15. [PubMed 15227616]

7. Schoetz DJ, Roberts PL, Murray JJ et al. Addition of parenteral cefoxitin to regimen of oral antibiotics for elective colorectal operations. Ann Surg. 1990; 212:209-12. [IDIS 269407] [PubMed 2100983]

8. Espin-Basany E, Sanchez-Garcia JL, Lopez-Cano M et al. Prospective, randomized study on antibiotic prophylaxis in colorectal surgery. Is it really necessary to use oral antibiotics? Int J Colorectal Dis. 2005; 20:542-6.

9. Wren SM, Ahmed N, Jamal A et al. Preoperative oral antibiotics in colorectal surgery increase the rate of Clostridium difficile colitis. Arch Surg. 2005; 140:752-6. [PubMed 16103284]

10. Lewis RT. Oral versus systemic antibiotic prophylaxis in elective colon surgery: a randomized study and meta-analysis send a message from the 1990s. Can J Surg. 2002; 45:173-80. [PubMed 12067168]

11. Blei AT, Cordoba J, the Practice Parameters Committee of the American College of Gastroenterology. Hepatic encephalopathy. Am J Gastroenterol. 2001; 96:1968-76. [PubMed 11467622]

12. Als-Nielsen B, Gluud LL, Gluud C. Nonabsorbable disaccharides for hepatic encephalopathy (review). Cochrane Database Syst Rev. 2004; 2:CD003044.

13. Kucers A, Crowe S, Grayson ML et al, eds. The use of antibiotics. A clinical review of antibacterial, antifungal, and antiviral drugs. 5th ed. Jordan Hill, Oxford: Butterworth-Heinemann; 1997: 533-41.

14. The United States pharmacopoeia, 29th rev, and The national formulary, 24th ed. Rockville, MD: The United States Pharmacopeial Convention; 2005:1491-3,3217.

15. Nelson JD. Duration of neomycin for enteropathogenic Escherichia coli diarrheal disease: a comparative study of 113 cases. Pediatrics. 1971; 48:248-58. [PubMed 5560618]

16. Samuel P. Treatment of hypercholesterolemia with neomycin–a time for reappraisal. N Engl J Med. 1979; 301:595-7. [PubMed 381924]

17. Gylling H, Miettinen TA. The effect of cholesterol absorption inhibition on low density lipoprotein cholesterol level. Atherosclerosis. 1995; 117:305-8. [PubMed 8801876]

18. Meisel S, Rate R. Neomycin for hypercholesterolemia. N Engl J Med. 1980; 302:233. [PubMed 7350468]

19. DiPiro JT, Patrias JM, Townsend RJ et al. Oral neomycin sulfate and erythromycin base before colon surgery: a comparison of serum and tissue concentrations. Pharmacotherapy. 1985; 5:91-4. [PubMed 4000983]

20. Sedaghat A, Samuel P, Crouse JR et al. Effects of neomycin on absorption, synthesis, and/or flux of cholesterol in man. J Clin Invest. 1975; 55:12-21. [PubMed 1109175]

21. Kunin CM, Chalmers TC, Leevy CM et al. Absorption of orally administered neomycin and kanamycin with special reference to patients with severe hepatic and renal disease. N Engl J Med. 1960; 262:380-5. [PubMed 14412744]

22. Breen KJ, Bryant RE, Levinson JD et al. Neomycin absorption in man. Studies of oral and enema administration and effect of intestinal ulceration. Ann Intern Med. 1972; 76:211-8. [PubMed 5009591]

23. Barza M, Scheife RT. Drug therapy reviews: antimicrobial spectrum, pharmacology and therapeutic use of antibiotics, part 4: aminoglycosides. Am J Hosp Pharm. 1977; 34:723-37. [PubMed 407790]

24. Bennett WM, Muther RS, Parker RA et al. Drug therapy in renal failure: dosing guidelines for adults. Ann Intern Med. 1980; 93:62-89. [IDIS 122057] [PubMed 6994534]

25. Hritcko P, Kapadia VK, Folstad J. Treatment of hypercholesterolemia with oral neomycin. AJHP. 1999; 56:2227-9. [PubMed 10565703]

26. Chambers HF. Aminoglycosides. In: Brunton LL, Lazo JS, Parker KL et al, eds. Goodman and Gillman’s the pharmacological basis of therapeutics. 11th ed. New York, NY: McGraw-Hill; 2006:1155-71.

27. Debray D, Yousef N, Durand P. New management options for end-stage chronic liver disease and acute liver failure. Pediatr Drugs. 2006; 8:1-13.

28. Harrison’s principles of internal medicine. 16th ed. Kasper DL, Braunwald E, Fauci AS et al, eds. New York: McGraw-Hill; 2006.

29. Sweetman S, ed. Martindale: the complete drug reference. London: Pharmaceutical Press. Electronic version. 2006.

a. AHFS drug information 2007. McEvoy GK, ed. Neomycin. Bethesda, MD: American Society of Health-System Pharmacists; 2007:80-81.

b. AHFS drug information 2007. McEvoy GK, ed. Aminoglycosides general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:60-69.

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Neo-Synephrine Ophthalmic

Generic Name: phenylephrine (Ophthalmic route)

fen-il-EF-rin

Commonly used brand name(s)

In the U.S.

• AK-Dilate


• Altafrin


• Eye Cool


• Mydfrin


• Neofrin


• Neo-Synephrine


• Ocu-Phrin


• Prefrin Liquifilm

Available Dosage Forms:

• Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Sympathomimetic

Chemical Class: Alkylarylamine

Uses For Neo-Synephrine

Ophthalmic phenylephrine in strengths of 2.5 and 10% is used to dilate (enlarge) the pupil. It is used before eye examinations, before and after eye surgery, and to treat certain eye conditions. In the U.S., these preparations are available only with your doctor's prescription.

Before Using Neo-Synephrine

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

Children may be especially sensitive to the effects of phenylephrine. This may increase the chance of side effects during treatment. In addition, the 10% strength is not recommended for use in infants. Also, the 2.5 and 10% strengths are not recommended for use in low birth weight infants.

Geriatric

Repeated use of 2.5 or 10% phenylephrine may increase the chance of problems during treatment with this medicine. In addition, heart and blood vessel problems have occurred more often in elderly patients than in younger adults.

Pregnancy

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

Breast Feeding

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

• Clorgyline


• Iproniazid


• Isocarboxazid


• Nialamide


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Tranylcypromine

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.

• Amitriptyline


• Amoxapine


• Clomipramine


• Desipramine


• Dothiepin


• Doxepin


• Furazolidone


• Imipramine


• Lofepramine


• Midodrine


• Nortriptyline


• Opipramol


• Pargyline


• Protriptyline


• Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Guanethidine


• Propranolol

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:

• Type 2 diabetes mellitus or


• Heart or blood vessel disease or


• High blood pressure—The 2.5 and 10% strengths of phenylephrine may make the condition worse

• Idiopathic orthostatic hypotension (a certain kind of low blood pressure)—Use of this medicine may cause a large increase in blood pressure to occur

Proper Use of phenylephrine

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

Do not use if the solution turns brown or becomes cloudy.

To use:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.


• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the 2.5 or 10% eye drops:

• It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in children or in patients with heart disease or high blood pressure, since high doses of this medicine may cause an irregular heartbeat and an increase in blood pressure.

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 solution (eye drops) dosage form:
  
  • For eye redness:
    
    • Adults and children—Use one drop of 0.12% solution every three or four hours as needed.
    
    
  
  
  • For eye exams:
    
    • Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test.
    
    
  
  
  • For use before eye surgery:
    
    • Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery.
    
    
    • Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery.
    
    
  
  
  • For certain eye conditions:
    
    • Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day.
    
    
    • Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.
    
    
  
  

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 non-prescription strength eye drops, follow the package directions.

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 Neo-Synephrine

If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.

For patients using the 2.5 or 10% eye drops:

• After you apply this medicine to your eyes, your pupils will become unusually large. This will cause your eyes to become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor. Also, if this effect continues for longer than 12 hours after you have stopped using this medicine, check with your doctor.

Neo-Synephrine Side Effects

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

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

Symptoms of too much medicine being absorbed into the body - Less common with 10% solution; rare with 2.5% or weaker solution

• Dizziness


• fast, irregular, or pounding heartbeat


• increased sweating


• increase in blood pressure


• paleness


• trembling

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 with 2.5 or 10% solution

• Burning or stinging of eyes


• headache or browache


• sensitivity of eyes to light


• watering of eyes

Less common

• Eye irritation not present before use of this medicine

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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The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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