Fenofibrate 267mg Capsules

FENOFIBRATE 267MG CAPSULES

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


• Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

In this leaflet:

• 1. What fenofibrate is and what it is used for


• 2. Before you take fenofibrate


• 3. How to take fenofibrate


• 4. Possible side effects


• 5. How to store fenofibrate


• 6. Further information

What Fenofibrate Is And What It Is Used For

The name of your medicine is Fenofibrate 267mg Capsules (called fenofibrate throughout this leaflet).

This belongs to a group of medicines called ‘fibrates’. It works by lowering the amount of fat in your blood.

Fenofibrate is used to treat something called ‘hyperlipidaemia’.

• This is where you have high levels of fat in your blood


• It is usually given after a low fat diet has failed to reduce these high levels


• People with high levels of fat in their blood have a higher chance of getting the early signs of heart disease

Before You Take Fenofibrate

Do not take fenofibrate and tell your doctor if:

• You are allergic (hypersensitive) to fenofibrate or any of the other ingredients of this medicine (see Section 6: Further information)
  
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  


• You have ever had a skin reaction due to sunlight or artificial UV light (such as on a ‘sun bed’) while taking another fibrate or ketoprofen (an anti-inflammatory medicine)


• You are pregnant, might become pregnant or think you may be pregnant (see “Pregnancy and breast-feeding” section below)


• You are breast-feeding (see “Pregnancy and breast-feeding” section below)


• You have severe kidney problems


• You have severe liver problems including cirrhosis


• You have gallbladder problems

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking fenofibrate.

Take special care and check with your doctor before taking fenofibrate if:

• You or any members of your family suffer from hereditary muscle problems


• You have ever had problems with your muscles as a result of the use of statins or fibrates (medicines used to reduce cholesterol levels)


• You have kidney problems


• You have an under-active thyroid gland (hypothyroidism)


• You have problems with your pancreas (pancreatitis)


• You regularly drink large amounts of alcohol


• You have low albumin blood levels (hypoalbuminaemia).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking fenofibrate.

Taking fenofibrate with other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines.

This includes medicines you buy without a prescription, including herbal medicines. This is because fenofibrate can affect the way some other medicines work. Also some medicines can affect the way fenofibrate works.

Tell your doctor if you are taking any of the following:

• Any other medicines for high blood fat levels called ‘fibrates’, such as clofibrate, bezafibrate, or gemfibrozil


• Medicines for thinning the blood (such as warfarin)


• Medicines containing oestrogen such as the contraceptive pill or hormone replacement therapy (HRT)


• Ciclosporin - used following transplant surgery and to treat rheumatoid arthritis.

Taking fenofibrate with food and drink

• Fenofibrate should always be taken with food.


• Remember to keep to your low fat diet while you are taking fenofibrate


• Do not drink large amounts of alcohol while taking fenofibrate. This is because it can increase the risk of muscle problems

Pregnancy and breast-feeding

Do not use this medicine if:

• You are pregnant, might become pregnant, or think you may be pregnant.


• You are breast-feeding or planning to breast-feed. This is because small amounts of fenofibrate may pass into the mother’s milk

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel dizzy, drowsy or tired while taking fenofibrate. If this happens do not drive or use any tools or machines.

How To Take Fenofibrate

Always take fenofibrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Swallow this capsule whole


• Always take this medicine with food

How much to take

Adults and children over 12 years old

• The usual dose is one capsule each day

Children under 12 years old

• Do not give this medicine to children under 12 years old

People with kidney problems

• If you have kidney problems your doctor may prescribe you a lower dose or tell you to wait longer in between doses.

If you take more fenofibrate than you should

If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital casualty department straight away. Take the pack and any remaining capsules with you. This is so the doctors know what you have taken.

If you forget to take fenofibrate

If you forget to take a dose at the right time, take it as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten capsule.

Blood Tests

• During treatment with fenofibrate your doctor may do blood tests to check how your liver is working or check whether you might be particularly at risk of getting muscle problems.


• If you are going to have any other blood tests, it is important to tell the person doing the test that you are taking fenofibrate. This is because fenofibrate can affect the result of some blood tests.

Possible Side Effects

Like all medicines, fenofibrate can cause side effects, although not everybody gets them.

Stop taking fenofibrate and see a doctor or go to a hospital straight away if:

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria) This may mean you are having an allergic reaction to fenofibrate


• You get unexplained pain, tenderness or weakness in the muscles or pain in your joints. You may also have a high temperature or tiredness. This could be a rare, but possibly life-threatening illness called rhabdomolysis


• You suddenly get pain in your head, chest or legs, or begin to have breathing difficulties. These could be signs of a blood clot.


• You get symptoms such as yellowing of the skin or eyes, tiredness or fever. This may be due to changes in the way your liver is working. This only happens in a very small number of patients taking fenofibrate


• You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis

Other side effects include:

• Pain below your ribs on the right side or in your right shoulder, feeling sick or being sick (particularly after eating a fatty meal). This may mean you have gallstones


• Feeling sick (nausea) or being sick (vomiting), diarrhoea, wind, indigestion or stomach pains


• Headache, tiredness


• Balance problems, feeling dizzy, possibly with a feeling of spinning (vertigo)


• Skin rash (which may be itchy or lumpy)


• Being more sensitive to the sun than usual. In some cases this may cause lumps or boils to appear on your skin. This side effect can also happen after using a sun lamp (UV)


• Problems with your sex drive (sexual asthenia),


• Hair loss (alopecia)


• A blood test may show changes in the way your kidneys are working


• Feeling tired, faint or dizzy, shortness of breath, pale skin. This could be signs of anaemia


• You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)


• Feeling short of breath, especially during or after exercise, and a dry cough (interstitial pneumopathies)

Tell your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet

How To Store Fenofibrate

• Keep this medicine in a safe place where children cannot see or reach it.


• Do not use fenofibrate after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Fenofibrate 267mg Capsules contain

Each capsule contains 267mg of fenofibrate as the active substance.

The other ingredients are, lauroyl macrogoglycerides, macrogol, hydroxypropylcellulose, and sodium starch glycolate, gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171) and indigo carmine (E132).

What fenofibrate looks like and contents of the pack

Fenofibrate capsules are green and caramel hard gelatin capsules. They are supplied in blister packs of 28 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder is:

Winthrop Pharmaceuticals

PO Box 611

Guildford

Surrey

GU1 4YS

UK

Manufacturer is:

Winthrop Pharmaceuticals UK Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

This leaflet was last revised in: August 2009

‘Winthrop’ is a registered trademark © 2009 Winthrop Pharmaceuticals.

Solia

Generic Name: ethinyl estradiol and desogestrel (EH thih nill ess tra DYE ole and des oh JESS trel)

Brand Names: Apri, Cesia, Cyclessa, Desogen, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet

What is Solia (ethinyl estradiol and desogestrel)?

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

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

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

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

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

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

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

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

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

• 
  

  a history of a stroke or blood clot;

  
  


• 
  

  circulation problems (especially if caused by diabetes);

  
  


• 
  

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

  
  


• 
  

  abnormal vaginal bleeding;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe high blood pressure;

  
  


• 
  

  severe migraine headaches;

  
  


• 
  

  a heart valve disorder; or

  
  


• 
  

  a history of jaundice caused by birth control pills.

  
  

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dosage adjustment or special tests to safely take birth control pills.

• 
  

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

  
  


• 
  

  high cholesterol or if you are overweight;

  
  


• 
  

  a history of depression;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  a history of irregular menstrual cycles; or

  
  


• 
  

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

  
  

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

How should I take Solia (ethinyl estradiol and desogestrel)?

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

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

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

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

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

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

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

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

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.

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

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

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

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

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

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

What happens if I overdose?

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

What should I avoid while taking Solia (ethinyl estradiol and desogestrel)?

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

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Solia (ethinyl estradiol and desogestrel) side effects

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

• 
  

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

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

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

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

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

  
  


• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  a breast lump; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, tenderness, or swelling;

  
  


• 
  

  freckles or darkening of facial skin;

  
  


• 
  

  increased hair growth, loss of scalp hair;

  
  


• 
  

  changes in weight or appetite;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  headache, nervousness, dizziness, tired feeling.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Solia (ethinyl estradiol and desogestrel)?

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

• 
  

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

  
  


• 
  

  an antibiotic;

  
  


• 
  

  phenylbutazone (Azolid, Butazolidin);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.

  
  

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

More Solia resources

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

• Solia Prescribing Information (FDA)


• Apri Prescribing Information (FDA)


• Caziant Prescribing Information (FDA)


• Cesia Prescribing Information (FDA)


• Cyclessa Prescribing Information (FDA)


• Cyclessa Advanced Consumer (Micromedex) - Includes Dosage Information


• Desogen Prescribing Information (FDA)


• Desogen Consumer Overview


• Desogen MedFacts Consumer Leaflet (Wolters Kluwer)


• Emoquette Prescribing Information (FDA)


• Kariva Prescribing Information (FDA)


• Mircette Consumer Overview


• Mircette Prescribing Information (FDA)


• Ortho-Cept Prescribing Information (FDA)


• Reclipsen Prescribing Information (FDA)


• Velivet Prescribing Information (FDA)

Compare Solia with other medications

• Abnormal Uterine Bleeding
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Polycystic Ovary Syndrome

Where can I get more information?

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

See also: Solia side effects (in more detail)

Junel Fe 1.5/30

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Junel Fe 1.5/30 (ethinyl estradiol and norethindrone)?

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

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

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

What is the most important information I should know about Junel Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

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

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Junel Fe 1.5/30 (ethinyl estradiol and norethindrone)?

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

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

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

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

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

How should I take Junel Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

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

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

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

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

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

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

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

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

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

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Junel Fe 1.5/30 (ethinyl estradiol and norethindrone)?

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

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

Junel Fe 1.5/30 (ethinyl estradiol and norethindrone) side effects

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

• 
  

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

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

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

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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

What other drugs will affect Junel Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

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

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Junel Fe 1.5/30 resources

• Junel Fe 1.5/30 Side Effects (in more detail)
• Junel Fe 1.5/30 Use in Pregnancy & Breastfeeding
• Drug Images
• Junel Fe 1.5/30 Drug Interactions
• Junel Fe 1.5/30 Support Group
• 2 Reviews for Junel Fe.5/30 - Add your own review/rating

• Aranelle Prescribing Information (FDA)


• Balziva Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Junel Fe 1.5/30 with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms
• Prevention of Osteoporosis

Where can I get more information?

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

See also: Junel Fe.5/30 side effects (in more detail)

SE 10-5 SS

Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)

Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is SE 10-5 SS (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about SE 10-5 SS (sulfacetamide sodium and sulfur topical)?

You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

What should I discuss with my healthcare provider before using SE 10-5 SS (sulfacetamide sodium and sulfur topical)?

You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use SE 10-5 SS (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using SE 10-5 SS (sulfacetamide sodium and sulfur topical)?

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

SE 10-5 SS (sulfacetamide sodium and sulfur topical) side effects

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

• 
  

  new or worsening skin rash;

  
  


• 
  

  joint pain;

  
  


• 
  

  fever; or

  
  


• 
  

  mouth sores.

  
  

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

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

What other drugs will affect SE 10-5 SS (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More SE 10-5 SS resources

• SE 10-5 SS Use in Pregnancy & Breastfeeding
• SE 10-5 SS Drug Interactions
• 0 Reviews for SE0-5 SS - Add your own review/rating

• Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer)


• Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Clarifoam EF Prescribing Information (FDA)


• Plexion Prescribing Information (FDA)


• Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer)


• Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• Prascion Cleanser Prescribing Information (FDA)


• Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Rosaderm Cleanser Prescribing Information (FDA)


• Rosanil Cleanser Prescribing Information (FDA)


• Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Rosula Prescribing Information (FDA)


• Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• Sumadan MedFacts Consumer Leaflet (Wolters Kluwer)


• Sumadan Wash Prescribing Information (FDA)


• Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer)


• Sumaxin Wash Prescribing Information (FDA)


• Zencia Wash Prescribing Information (FDA)

Compare SE 10-5 SS with other medications

• Acne
• Rosacea
• Seborrheic Dermatitis

Where can I get more information?

• Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.

Spectrobid

Generic Name: bacampicillin (ba kam pi SILL in)

Brand Names: Spectrobid

What is Spectrobid (bacampicillin)?

Bacampicillin is an antibiotic in the class of drugs called penicillins. It fights bacteria in the body.

Bacampicillin is used to treat many different types of infections, such as tonsillitis, pneumonia, bronchitis, urinary tract infections, gonorrhea, and infections of the skin.

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

What is the most important information I should know about Spectrobid (bacampicillin)?

Take all of the bacampicillin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. Bacampicillin may decrease the effectiveness of birth control pills. Use a second method of birth control while taking bacampicillin to ensure protection from unintended pregnancy.

What should I discuss with my healthcare provider before taking Spectrobid (bacampicillin)?

If you have ever had an allergic reaction to another penicillin or to a cephalosporin, do not take bacampicillin without first talking to your doctor.

Before taking this medication, tell your doctor if you have kidney disease, stomach or intestinal disease, or infectious mononucleosis. You may not be able to take bacampicillin because of an increased risk of side effects.

If you are a diabetic, some glucose urine tests may give false positive results while you are taking bacampicillin.

Bacampicillin is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not, however, take bacampicillin without first talking to your doctor if you are pregnant or could become pregnant during treatment. Bacampicillin passes into breast milk and may affect a nursing baby, although it is not expected to be harmful. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Spectrobid (bacampicillin)?

Take bacampicillin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Bacampicillin can be taken with or without food.

Bacampicillin should be taken at evenly spaced intervals throughout the day and night to keep the medicine level in your blood high enough to treat the infection.

Take all of the bacampicillin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.

It is important to take bacampicillin regularly to get the most benefit.

Store the tablets at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

If you have only missed one dose, take the rest of the scheduled doses for the day at evenly spaced intervals.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an bacampicillin overdose include muscle spasms or weakness, pain or twitching, pain in the fingers or toes, loss of feeling in the fingers or toes, seizures, confusion, coma, and agitation.

What should I avoid while taking Spectrobid (bacampicillin)?

Alcohol may irritate the stomach if taken with bacampicillin, so use it with moderation.

Spectrobid (bacampicillin) side effects

If you experience any of the following serious side effects, stop taking bacampicillin and seek emergency medical attention or contact your doctor immediatley:

• 
  

  an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);

  
  


• 
  

  seizures;

  
  


• 
  

  severe watery diarrhea and abdominal cramps; or

  
  


• 
  

  unusual bleeding or bruising.

  
  

Other, less serious side effects may be more likely to occur. Continue to take bacampicillin and talk to your doctor if you experience

• 
  

  mild nausea, vomiting, diarrhea, or abdominal pain;

  
  


• 
  

  white patches on the tongue (thrush/yeast infection);

  
  


• 
  

  itching or discharge of the vagina (vaginal yeast infection); or

  
  


• 
  

  black, "hairy" tongue or sore mouth or tongue.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Spectrobid (bacampicillin)?

Before taking bacampicillin, tell your doctor if you are taking any of the following drugs:

• 
  

  cholestyramine (Questran) or colestipol (Colestid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  allopurinol (Zyloprim);

  
  


• 
  

  probenecid (Benemid)

  
  


• 
  

  another antibiotic (for the same or for a different infection) such as erythromycin (Ery-Tab, E-Mycin, E.E.S., others), tetracycline (Sumycin, others), minocycline (Minocin), doxycycline (Doryx, Vibramycin, others), or any other antibiotic.

  
  

Bacampicillin may decrease the effectiveness of birth control pills. Use a second method of birth control while taking bacampicillin to ensure protection from unintended pregnancy.

Drugs other than those listed here may also interact with bacampicillin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Spectrobid resources

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

Compare Spectrobid with other medications

• Bladder Infection
• Gonococcal Infection, Uncomplicated
• Otitis Media
• Pneumonia
• Skin and Structure Infection
• Skin Infection
• Upper Respiratory Tract Infection

Where can I get more information?

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

What does my medication look like?

Bacampicillin is available with a prescription under the brand name Spectrobid. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 
  

  Spectrobid 400 mg--oblong, white, film-coated tablets

  
  

See also: Spectrobid side effects (in more detail)

Solarcaine Plus Aloe

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Anesthetic Lubricant, Americaine Hemorrhoidal, Anacaine, Anbesol Baby, Anbesol Cold Sore, Anbesol Gel, Anbesol Liquid, Anbesol Liquid Cool Mint, Anbesol Maximum Strength, Babee Teething Lotion, Benz-O-Sthetic, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Dual Relief Sore Throat Cherry, Cepacol Dual Relief Sore Throat Mint, Cepacol Extra Strength, Cepacol Extra Strength Cherry, Cepacol Extra Strength Cherry Sugar Free, Cepacol Extra Strength Citrus, Cepacol Extra Strength Honey Lemon, Cepacol Extra Strength Menthol, Cepacol Extra Strength Menthol Sugar Free, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Foille Plus, Hurricaine, Hurricaine Kit, Hurricaine Snap-n-Go, Lanacane, Lanacane Maximum Strength, Lanacane with Aloe, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase Baby Teething Gel, Orabase Gel-B, Orabase Lip Healer, Orabase with Benzocaine, Orajel, Orajel Baby, Orajel Baby Nighttime, Orajel D, Orajel Denture, Orajel Denture Plus, Orajel Maximum Strength, Orajel Maximum Strength PM, Orajel Mouth Sore Medicine, Orajel Mouth-Aid, Orajel Severe Pain Formula, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Solarcaine Plus Aloe (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

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

What is the most important information I should know about Solarcaine Plus Aloe (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Do not use benzocaine topical if you have a blood cell disorder called methemoglobinemia.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, a breathing disorder such as asthma or emphysema, or if you smoke.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Solarcaine Plus Aloe (benzocaine topical)?

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Do not use benzocaine topical if you have a blood cell disorder called methemoglobinemia.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use benzocaine topical:

• 
  

  asthma, bronchitis, emphysema, or other breathing disorder;

  
  


• 
  

  heart disease;

  
  


• 
  

  a personal or family history of methemoglobinemia, or any genetic enzyme deficiency; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 1 year old.

How should I use Solarcaine Plus Aloe (benzocaine topical)?

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

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Solarcaine Plus Aloe (benzocaine topical)?

Benzocaine topical is for use only on the surface of your body, or just inside the vagina or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Solarcaine Plus Aloe (benzocaine topical) side effects

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

• 
  

  severe burning, stinging, or sensitivity where the medicine is applied;

  
  


• 
  

  swelling, warmth, or redness;

  
  


• 
  

  oozing, blistering, or any signs of infection; or

  
  


• 
  

  headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine).

  
  

Less serious side effects may include:

• 
  

  mild stinging, burning, or itching where the medicine is applied;

  
  


• 
  

  skin tenderness or redness; or

  
  


• 
  

  dry white flakes where the medicine was applied.

  
  

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

What other drugs will affect Solarcaine Plus Aloe (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Solarcaine Plus Aloe resources

• Solarcaine Plus Aloe Use in Pregnancy & Breastfeeding
• Solarcaine Plus Aloe Support Group
• 6 Reviews for Solarcaine Plus Aloe - Add your own review/rating

Compare Solarcaine Plus Aloe with other medications

• Anal Itching
• Anesthesia
• Aphthous Ulcer
• Burns, External
• Cold Sores
• Hemorrhoids
• Oral and Dental Conditions
• Pain
• Pruritus
• Sunburn
• Tonsillitis/Pharyngitis

Where can I get more information?

• Your pharmacist can provide more information about benzocaine topical.

Antithymocyte Globulin (Rabbit)

Class: Immunosuppressive Agents
ATC Class: L04AA04
VA Class: IM600
Brands: Thymoglobulin

• 
  

  Should be used only by clinicians experienced in immunosuppressive therapy for the management of renal transplant patients.^b

  
  

Introduction

Antithymocyte globulin (rabbit) (ATG [rabbit]); rabbit-derived polyclonal antibody preparation; immunosuppressive agent.^{2 8 a b g}

Uses for Antithymocyte Globulin (Rabbit)

Renal Allotransplantation

Treatment of acute rejection of renal allografts in conjunction with other immunosuppressive agents.^{2 8 a b e g}

ATG (rabbit) found to be more effective than ATG (equine) in reversing acute rejection episodes (88% compared with 76%) and preventing recurrent rejection episodes in renal transplant recipients.^{2 b}

Has also been used successfully as induction therapy in conjunction with maintenance immunosuppressive therapy for the prevention of renal allograft rejection†.^{4 5 a d g m n o p q r s u w x}

Hepatic Allotransplantation

Induction therapy to prevent hepatic allograft rejection and minimize maintenance immunosuppression† in pediatric patients (designated an orphan drug by FDA for this use)^{j t} and in adults.^v

Myelodysplastic Syndrome and Aplastic Anemia

Has been used for the treatment of myelodysplastic syndrome† (designated an orphan drug by FDA for this use).^{j k}

Has been used for the treatment of aplastic anemia†, usually in conjunction with cyclosporine.^{7 9 a l}

Antithymocyte Globulin (Rabbit) Dosage and Administration

General

• 
  

  To reduce the incidence and intensity of infusion-related adverse effects, the manufacturer and some clinicians recommend premedication with corticosteroids, acetaminophen, and/or an antihistamine (e.g., diphenhydramine) 1 hour prior to each infusion.^{2 9 a b q u} (See Infusion-related Effects under Cautions.)

  
  


• 
  

  The manufacturer recommends prophylactic antiviral therapy (e.g., acyclovir, ganciclovir, valganciclovir) during ATG (rabbit) therapy.^{9 a b m} (See Infectious Complications under Cautions.)

  
  

Administration

IV Administration

For drug compatibility information, see Compatibility under Stability.

ATG (rabbit) is administered by IV infusion.^{1 a b g} The manufacturer states that ATG (rabbit) should be infused through an inline 0.22-μm filter into a high-flow vein.^{a b g} Has also been administered via a peripheral vein† in some patients, but safety not fully established and may increase risk of thrombophlebitis and DVT.^{g h i}

Administer in conjunction with other immunosuppressive agents.^b

Reconstitution

Allow vial to reach room temperature before reconstituting.^{a b} Reconstitute vial containing 25 mg of the drug with 5 mL of sterile water for injection to provide a solution containing 5 mg/mL.^{a b} Gently rotate vial until powder is completely dissolved.^{a b} Use reconstituted solution immediately.^b (See Storage under Stability.)

Dilution

Dilute appropriate dosage of reconstituted ATG (rabbit) in 0.9% sodium chloride or 5% dextrose injection.^{a b} Each reconstituted vial should be diluted in 50 mL of infusion solution; total volume of infusion solution required generally is 50–500 mL.^{a b} Recommended final concentration approximately 0.5 mg/mL.^{9 a} Mix diluted solution by gently inverting infusion bag only once or twice.^{a b}

Rate of Administration

Administer initial dose over ≥6 hours and subsequent doses over ≥4 hours.^{b g} Slowing infusion rate may help prevent or ameliorate acute infusion reactions.^{9 a b} (See Infusion-related Effects under Cautions.)

Dosage

Appropriate dosage for Thymoglobulin differs from dosages for other antithymocyte globulin (ATG) preparations since protein composition and concentrations vary depending on source of ATG used.^b Exercise care to ensure prescribed dose is appropriate for the ATG preparation being administered.^b

Reduce ATG (rabbit) dosage by 50% if WBC is ≥2000 but ≤3000/mm³ or platelet count is ≥50,000 but ≤75,000/m³.^b Consider drug discontinuance if WBC <2000/mm³ or platelet count <50,000/mm³.^b (See Hematologic Effects and Clinical/Laboratory Monitoring under Cautions.)

Pediatric Patients

Renal Allotransplantation

Prevention of Renal Allograft Rejection (Induction Therapy)†

IV Infusion

Optimum dosage not established; 1.5–2.5 mg/kg once daily for 5–10 days has been given.^{4 9 10 m n p q}

Adults

Renal Allotransplantation

Treatment of Allograft Rejection

IV Infusion

1.5 mg/kg once daily for 7–14 days.^{2 a b r} Usually continue other immunosuppressive agents used for treatment of acute renal transplant rejection (e.g., azathioprine, corticosteroids, cyclosporine) during therapy.^{2 a b r} (See Interactions.)

Prevention of Renal Allograft Rejection (Induction Therapy)†

IV Infusion

Optimum dosage not established; 1.5 mg/kg once daily for 5–14 days or 3 mg/kg once daily on day 1 then 1.5 mg/kg once daily on days 2 and 3 has been given.^{5 9 g r u} Intermittent dosage regimens based on CD3⁺ lymphocyte counts^w and regimens in which the first dose is administered intraoperatively also have been given.^{5 r s u}

Myelodysplastic Syndrome† and Aplastic Anemia†

Myelodysplastic Syndrome†

IV Infusion

Optimum dosage not established; 3.75 mg/kg once daily for 5 days has been given.^k

Aplastic Anemia†

IV Infusion

Optimum dosage not established; 3.5 mg/kg once daily for 5 days has been given.^{7 a l}

Special Populations

No special population dosage recommendations at this time.^b

Cautions for Antithymocyte Globulin (Rabbit)

Contraindications

• 
  

  Known hypersensitivity to rabbit proteins^{a b} or any ingredient in the formulation;^{a 9} history of anaphylaxis following ATG (rabbit) administration.^{a b}

  
  


• 
  

  Active or acute infections that contraindicate any additional immunosuppression.^b

  
  

Warnings/Precautions

Warnings

See Boxed Warning.

Close medical supervision required during and after IV infusion of ATG (rabbit).^{a b}

Cytokine Release Syndrome

Severe cytokine release syndrome (CRS), an immune-mediated reaction, reported.^b Severe, acute CRS may cause serious cardiorespiratory effects and/or death.^b

Infectious Complications

Possible increased risk of infections (bacterial, fungal, viral, and protozoal), reactivation of infections (particularly cytomegalovirus [CMV]), and sepsis when ATG (rabbit) is used in combination with multiple immunosuppressive agents.^{2 5 b m n r u} Severe, acute infections may be fatal.^b The manufacturer recommends careful patient monitoring and appropriate anti-infective prophylaxis.^b

Sensitivity Reactions

Anaphylaxis

Serious and fatal anaphylactic reactions reported.^{a b}

If anaphylaxis or other severe hypersensitivity reaction occurs, discontinue ATG (rabbit) infusion immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen, IV fluids, antihistamines, maintenance of BP).^{a b}

Patients with a history of anaphylaxis to ATG (rabbit) should not receive the drug again.^b

General Precautions

Malignancies

Possible increased risk of malignancies with immunosuppressive therapy, including rabbit ATG (e.g., lymphoma, posttransplant lymphoproliferative disease [PTLD]).^{9 a b m n r u}

Hematologic Effects and Clinical/Laboratory Monitoring

T cells decrease during ATG (rabbit) therapy.^b Monitor lymphocyte counts (i.e., total lymphocytes and/or T-cell subsets) to assess level of T-cell depletion in patients receiving the drug.^b

Thrombocytopenia and/or leukopenia (including lymphopenia and neutropenia) commonly reported.^{2 5 a b g r u} Monitor WBC and platelet count; reduce dosage and/or consider drug discontinuance in patients who develop leukopenia and/or thrombocytopenia.^b (See Dosage under Dosage and Administration.)

Antibody Formation

Anti-rabbit antibodies developed in 68% of renal transplant patients who received ATG (rabbit) for 7–14 days for treatment of acute rejection; these antibodies were still present in 24% of patients at 90 days.^{6 a b} Presence of anti-rabbit antibodies not correlated with treatment success or failure in these patients;^{6 a} possible effects of these antibodies on drug's efficacy during subsequent use not evaluated.^b

Infusion-related Effects

Risk of infusion-related effects (e.g., fever, chills and/or rigors, dyspnea, nausea and/or vomiting, diarrhea, hypotension or hypertension, malaise, rash, and/or headache); may occur as soon as first or second infusion during a single course of treatment.^{a b}

May minimize or prevent infusion-related effects by administering initial ATG (rabbit) infusions over ≥6 hours, administering a pretreatment regimen (corticosteroid, acetaminophen, and/or an antihistamine) 1 hour prior to each ATG (rabbit) infusion, and/or slowing the infusion rate.^{2 9 a b q u} (See General and see Administration under Dosage and Administration.)

Immunization

Safety of attenuated live vaccine administration following ATG (rabbit) therapy not established.^b Manufacturer states that immunization with attenuated live vaccines not recommended in patients who recently received the drug.^b

Laboratory Test Interference

Potential interference with rabbit antibody-based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays.^{a b}

Specific Populations

Pregnancy

Category C.^b

Lactation

¹ Not known whether ATG (rabbit) is distributed into milk; however, other immunoglobulins are distributed into human milk.^b Discontinue nursing or the drug.^b

Pediatric Use

The manufacturer states that safety and efficacy not established in children <18 years of age in controlled trials.^{a 9 b} However, ATG (rabbit) has been used as induction therapy in conjunction with maintenance immunosuppressive therapy to prevent renal or hepatic allograft rejection† in pediatric patients 5 months–18 years of age.^{4 9 10 a m n o p q t} (See Hepatic Allotransplantation under Uses.)

Dosage, efficacy, and adverse effect profile in pediatric patients generally appear to be the same as in adults.^{b n p q t}

Common Adverse Effects

Infectious complications (including sepsis, urinary tract infections, and CMV infections),^{5 a b n r u} fever,^b chills,^b leukopenia,^{5 b u} lymphopenia,^{5 d g r} thrombocytopenia,^{b g u} cytokine release syndrome,^g abdominal pain,^b nausea,^b diarrhea,^b asthenia,^b dyspnea,^b headache,^b pain,^b hyperkalemia,^b hypertension,^b peripheral edema,^b tachycardia,^b dizziness,^b infusion site pain/swelling/erythema.^b

Interactions for Antithymocyte Globulin (Rabbit)

No formal drug interaction studies to date.^b

Specific Drugs

Drug	Interaction	Comments
Basiliximab		No increase in adverse effectsf
Daclizumab		Limited experiencec
Immunosuppressive agents	Risk of oversuppression of the immune system and associated susceptibility to infection and malignancies, including lymphomaa b	Consider decreasing maintenance immunosuppressive therapy during concurrent usea b
Vaccines	Safety data not available on the effects of immunization with live vaccines during ATG (rabbit) therapyb	Avoid use of live vaccines in patients who have recently received ATG (rabbit)b

Antithymocyte Globulin (Rabbit) Pharmacokinetics

Absorption

Onset

T-cell depletion usually observed within 1 day after initiating therapy.^{b g}

Plasma Concentrations

Average 21.5 and 87 mcg/mL 4–8 hours post-infusion after first and last IV doses, respectively, when given for 7–11 days.^b

Duration

Lymphopenia may persist ≥1–2 years after ATG (rabbit) administration.^{5 g r}

Distribution

Extent

Not known whether ATG (rabbit) distributes into human milk; however, other immunoglobulins are distributed into human milk.^{a b}

Elimination

Half-life

2–3 days after first dose;^b may increase after multiple-dose administration.^{2 y}

Stability

Storage

Parenteral

Powder for Injection

2–8°C; do not freeze.^b Protect from light.^b

Although reconstituted solutions are stable at room temperature for up to 24 hours, room temperature storage is not recommended by the manufacturer since the preparation contains no preservatives; use immediately.^b

Use diluted solutions immediately.^b

Discard any unused drug after infusion.^b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Drug Compatibility^HID

Admixture Compatibility

Variable
Heparin sodium with hydrocortisone sodium succinate

Y-Site Compatibility

Compatible
Hydrocortisone sodium succinate
Variable
Heparin sodium

Incompatibility not observed with polyvinyl chloride bags or infusion sets.^{9 a z}

ActionsActions

• 
  

  Rabbit-derived polyclonal antibody; immunosuppressive agent.^{2 8 a b g}

  
  


• 
  

  Exact mechanism of immunosuppressive action not fully elucidated; appears to involve clearance of peripheral antigen-reactive T lymphocytes (T cells) and modulation of T-cell activation, homing, and cytotoxicity.^{8 a b g}

  
  


• 
  

  ATG (rabbit) contains antibodies that bind T-cell surface receptors, including CD2, CD3, CD4, CD8, CD11a, CD18, CD25, CD44, CD45, HLA-DR, HLA class I heavy chains, and β₂-microglobulin.^{8 a b g}

  
  


• 
  

  Induces profound depletion of CD2, CD3, CD4, CD8, CD16, CD25, and CD45 lymphocytes within 24 hours of first dose administration.^{b g}

  
  


• 
  

  Not effective for treating antibody-mediated (humoral) transplant rejections.^b

  
  

Advice to Patients

• 
  

  Importance of informing patients about the potential benefits of ATG (rabbit) and attendant risks of immunosuppressive therapy.^b

  
  


• 
  

  Risk of decreased number of platelets and/or WBCs, including lymphocytes.^b Necessity of administration under supervision of a clinician with regular monitoring of platelet and WBC counts.^b

  
  


• 
  

  Potential for reduction of lymphocyte counts, which could increase risk of infection or malignancy.^b Importance of informing clinicians promptly if any signs or symptoms of infection or malignancy occur.^b

  
  


• 
  

  Advise patient of risk of possible fever, chills, itching, and/or rash during ATG (rabbit) infusion and that medication will be given to help control these reactions.^b

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal or nutritional supplements, as well as any concomitant illnesses.^b

  
  


• 
  

  Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.^b

  
  


• 
  

  Importance of informing patients of other important precautionary information.^b (See Cautions.)

  
  

Preparations

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

Antithymocyte Globulin (Rabbit)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	25 mg	Thymoglobulin	Genzyme

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 July 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

1. Sangstat Medical Corporation. Thymoglobulin (anti-thymocyte globulin [rabbit]) prescribing information. Menlo Park, CA; 1998 Dec.

2. Gaber AO, First MR, Tesi RJ et al. Results of the double-blind, randomized, multicenter, phase III clinical trial of Thymoglobulin versus Atgam in the treatment of acute graft rejection episodes after renal transplantation. Transplantation. 1998; 66:29-37. [IDIS 410978] [PubMed 9679818]

3. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97?414). Rockville, MD; 2001 May. From FDA web site ()

4. Broyer M, Gagnadoux MF, Guest G et al. Triple therapy including cyclosporine A versus conventional regimen-a randomized prospective study in pediatric kidney transplantation. Transplant Proc. 1987; 19: 3582-5. [PubMed 3313862]

5. Brennan DC, Flavin K, Lowell JA et al. A randomized, double-blinded comparison of Thymoglobulin versus Atgam for induction immunosuppressive therapy in adult renal transplant recipients. Transplantation. 1999; 67:1011-8. [IDIS 427773] [PubMed 10221486]

6. Regan JF, Campbell K, Van Smith L et al. Sensitization following Thymoglobulin and Atgam rejection therapy as determined with a rapid enzyme-linked immunosorbent assay: US Thymoglobulin Multi-Center Study Group. Transpl Immunol. 1999; 7:115-21. [PubMed 10544442]

7. Di Bona E, Rodeghiero F, Bruno B et al for the Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Rabbit antithymocyte globulin (r-ATG) plus cyclosporine and granulocyte colony stimulating factor is an effective treatment for aplastic anaemia patients unresponsive to a first course of intensive immunosuppressive therapy. Br J Haematol. 1999; 107:330-4. [PubMed 10583220]

8. Ormrod D, Jarvis B. Antithymocyte globulin (rabbit): a review of the use of Thymoglobulin in the prevention and treatment of acute renal allograft rejection. Biodrugs. 2000; 14:255-73.

9. Sangstat. Fremont, CA: Personal communication.

10. Brophy PD, Thomas SE, McBryde KD et al. Comparison of polyclonal induction agents in pediatric renal transplantation. Pediatr Transplant. 2001; 5:174-8. [PubMed 11422819]

a. www.ahfsdruginformation.com. Antithymocyte globulin (rabbit). Accessed February 2008.

b. Genzyme Corporation. Thymoglobulin (anti-thymocyte globulin [rabbit]) prescribing information. Cambridge, MA; 2007 Sep.

c. Hoffmann-La Roche Inc. Zenapax (daclizumab) sterile concentrate for injection prescribing information. Nutley, NJ; 2005 Sep.

d. Hardinger KL, Schnitzler MA, Miller B et. al. Five-year follow up of Thymoglobulin versus ATGAM induction in adult renal transplantation. Transplantation. 2004; 78:136-41. [PubMed 15257052]

e. Schnitzler MA, Woodward RS, Lowell JA et. al. Economics of the antithymocyte globulins Thymoglobulin and Atgam in the treatment of acute renal transplant rejection. Pharmacoeconomics. 2000; 17:287-93. [PubMed 10947303]

f. Novartis Pharmaceuticals Corporation. Simulect (basiliximab) for injection prescribing information. East Hanover, NJ; 2005 Sep.

g. Hardinger KL. Rabbit antithymocyte globulin induction therapy in adult renal transplantation. Pharmacotherapy. 2006; 26:1771-83. [PubMed 17125438]

h. Marvin MR, Droogan C, Sawinski D et al. Administration of rabbit antithymocyte globulin (thymoglobulin) in ambulatory renal-transplant patients. Transplantation. 2003; 76:488-9.

i. Mathis AS, Rao V. Deep vein thrombosis during rabbit antithymocyte globulin administration. Transplant Proc. 2004; 36:3250-1. [PubMed 15686740]

j. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97?414). Rockville, MD; 2007 Oct. From FDA web site ()

k. Stadler M, Germing U, Kliche KO et al. A prospective, randomised, phase II study of horse antithymocyte globulin vs. rabbit antithymocyte globulin as immune-modulating therapy in patients with low-risk myelodysplastic syndromes. Leukemia. 2004; 18:460-5. [PubMed 14712285]

l. Scheinberg P, Nunez O, Young NS. Retreatment with rabbit antithymocyte globulin and ciclosporin for patients with relapsed or refractory severe aplastic anaemia. Br J Haematol. 2006; 133:622-7. [PubMed 16704436]

m. Khositseth S, Matas A, Cook ME et al. Thymoglobulin versus ATGAM induction therapy in pediatric kidney transplant recipients: a single-center report. Transplantation. 2005; 79:958-63. [PubMed 15849550]

n. Schwartz JJ, Ishitani MB, Weckwerth J et al. Decreased incidence of acute rejection in adolescent kidney transplant recipients using antithymocyte induction and triple immunosuppression. Transplantation. 2007; 84:715-21. [PubMed 17893604]

o. Buchler M, Hurault de Ligny B, Madec C et al. Induction therapy by antithymocyte globulin (rabbit) in renal transplantation: a 1-yr follow-up of safety and efficacy. Clin Transplantation. 2003; 17:539-45.

p. Kamel MH, Mohan P, Little DM et al. Rabbit antithymocyte globulin as induction immunotherapy for pediatric deceased donor kidney transplantation. J Urol. 2005; 174:703-7. [PubMed 16006954]

q. Ault BH, Honaker MR, Gaber AO et al. Short term outcomes of thymoglobulin induction in pedatric renal transplant recipients. Pediatr Nephrol. 2002; 17:815-8. [PubMed 12376809]

r. Hardinger KL, Schnitzler MA, Miller B et. al. Five-year follow up of Thymoglobulin versus ATGAM induction in adult renal transplantation. Transplantation. 2004; 78:136-41. [PubMed 15257052]

s. Agha IA, Rueda J, Alvarez A et. al. Short course induction immunosuppression with Thymoglobulin for renal transplant recipients. Transplant. 2002; 73:473-5.

t. Shah A, Agarwal A, Mangus R et al. Induction immunosuppression with rabbit antithymocyte globulin in pediatric liver transplantation. Liver Transpl. 2006; 12:1210-4. [PubMed 16868953]

u. Brennan DC, Daller JA, Lake KD et al. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006; 355:1967-7. [PubMed 17093248]

v. Bajjoka I, Hsaiky L, Brown K et al. Preserving renal function in liver transplant recipients with rabbit anti-thymocyte globulin and delayed initiation of calcineurin inhibitors. Liver Transpl. 2008; 14:66-72. [PubMed 18161842]

w. Peddi VR, Bryant M, Roy-Chaudhury P et al. Safety, efficacy, and cost analysis of thymoglobulin induction therapy with internittent dosing based on CD3+ lymphocyte counts in kidney and kidney-pancreas transplant recipients. Transplantation. 2002; 73:1514-8. [PubMed 12023634]

x. Guttmann RD, Flemming C. Sequential biological immunosuppression: induction therapy with rabbit antithymocyte globulin. Clin Transplant. 1997; 11:185-92. [PubMed 9193840]

y. Bieber CP, Griepp RB, Oyer PE et al. Use of rabbit antithymocyte globulin in cardiac transplantation: relationship of clearance rates to clinical outcome. Transplantation. 1976; 22:478-88. [PubMed 793103]

z. Genzyme Corporation. Cambridge, MA: Personal communication.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:167-8.

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