Neupogen Singleject Syringes

Neupogen Singleject 30 MU (0.6 mg/ml)

Neupogen Singleject 48 MU (0.96 mg/ml)

solution for injection in a pre-filled syringe

filgrastim

Read all of this leaflet carefully before you start using this medicine.

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


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

In this leaflet:

1. What Neupogen is and what it is used for

2. Before you use Neupogen

3. How to use Neupogen

4. Possible side effects

5. How to store Neupogen

6. Further information

7. Instructions for injecting Neupogen

What Neupogen Is And What It Is Used For

Neupogen is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines. Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. Neupogen works by encouraging the bone marrow to produce more white blood cells.

A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Neupogen stimulates the bone marrow to produce new white cells quickly.

Neupogen can be used:

• to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;


• to increase the number of white blood cells after a bone marrow transplant to help prevent infections;


• before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment. These can be taken from you or from a donor. The stem cells will then go back into the bone marrow and produce blood cells;


• to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;


• in patients with advanced HIV infection which will help reduce the risk of infections.

Before You Use Neupogen

Do not use Neupogen

• if you are allergic (hypersensitive) to filgrastim or any of the other ingredients of Neupogen.


• if you have Kostman’s Syndrome (severe condition acquired at birth), your doctor will discuss with you whether or not you should take Neupogen.

Take special care with Neupogen

Please tell your doctor before starting treatment:

• if you have sickle cell anaemia, as Neupogen may cause sickle cell crisis;


• if you have an allergy to natural rubber (latex). The needle cover on the syringe is made from a type of natural rubber and may cause severe allergic reactions;


• if you have osteoporosis (bone disease).

If you are a stem cell donor, you must be aged between 16 and 60 years.

Take special care with other products that stimulate white blood cells.

Neupogen is one of a group of products that stimulate the production of white blood cells. Your healthcare professional should always record the exact product you are using.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as they may affect the way Neupogen works.

Pregnancy and breast feeding

Neupogen has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine. Neupogen could affect your ability to become pregnant or stay pregnant.

You must not use this medicine if you are breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Neupogen should not affect your ability to drive and use machines. However, it is advisable to wait and see how you feel after taking Neupogen and before driving or operating machinery.

Important information about some of the ingredients of Neupogen

Neupogen contains less than 1 mmol (23 mg) sodium per 0.6 mg/ml or 0.96 mg/ml dose, i.e. essentially sodium free.

Neupogen contains sorbitol (E420), if you have been told by your doctor that you have a reaction to some sugars, contact your doctor before taking this medicinal product.

How To Use Neupogen

Always use Neupogen exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.

How is Neupogen given and how much should I take?

Neupogen is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). It can also be given as a daily slow injection into the vein (known as an intravenous infusion). The usual dose varies depending on your illness and weight. Your doctor will tell you how much Neupogen you should take.

You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home. However, you should not attempt this unless you have been properly trained first.

How long will I have to take Neupogen?

You will need to take Neupogen until your white blood cell count is normal. Regular blood tests will be taken to monitor the number of white blood cells in your body. Your doctor will tell you how long you will need to take Neupogen.

Neupogen and children

Neupogen is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia). The dosing in children is the same as for adults.

If you use more Neupogen than you should

Do not increase the dose your doctor has given you. If you think you have injected more than you should, contact your doctor as soon as possible.

If you forget to use Neupogen

If you have missed an injection, or injected too little, contact your doctor as soon as possible. Do not take a double dose to make up for any missed doses.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

Possible Side Effects

Please tell your doctor immediately during treatment:

• if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea);


• if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Adult Respiratory Distress Syndrome (ARDS);


• if you get left upper belly (abdominal) pain or pain at the tip of your shoulder, as there may be a problem with your spleen.

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

Very common side effects (seen in more than 1 in 10 people who take Neupogen):

in cancer patients

• nausea and vomiting


• pain in your bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics)


• changes in blood chemistry

in normal stem cell donors

• headache


• increase in white blood cells (leukocytosis), decrease of platelets which reduces the bloods ability to clot (thrombocytopenia)


• pain in your bones (musculoskeletal pain), which can be treated with standard pain relief tablets

in severe chronic neutropenia patients

• low red blood cell count (anaemia), enlargement of the spleen (splenomegaly)


• changes in blood chemistry


• pain in your bones (musculoskeletal pain)


• nose bleeds (epistaxis)

in HIV patients

• pain in your bones (musculoskeletal)

Common side effects (seen in more than 1 in 100 people taking Neupogen):

in cancer patients

• tiredness (fatigue), generalised weakness


• headache


• constipation, anorexia, diarrhoea, soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucositis)


• chest pain, pain in your bones (musculoskeletal pain)


• cough, sore throat


• unusual hair loss or thinning (alopecia), skin rash

in normal stem cell donors

• changes in blood chemistry

in severe chronic neutropenia patients

• headache


• diarrhoea


• decrease of platelets which reduces the bloods ability to clot (thrombocytopenia)


• enlargement of the liver (hepatomegaly)


• disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)


• unusual hair loss or thinning (alopecia), injection site pain, rash

in HIV patients

• enlargement of the spleen (splenomegaly)

Uncommon side effects (seen in more than 1 in 1000 people taking Neupogen):

in cancer patients

• unspecified pain

in normal stem cell donors

• changes in blood chemistry


• enlargement of the spleen (splenomegaly)

in severe chronic neutropenia patients

• enlargement of the spleen (splenomegaly)


• blood in the urine (haematuria)


• excess protein in the urine (proteinuria)

Rare side effects (seen in more than 1 in 10,000 people taking Neupogen):

in cancer patients

• problems with your blood vessels (vascular disorders)

Very rare side effects (seen in less than 1 in 10,000 people taking Neupogen):

in cancer patients

• pain when passing urine (dysuria)

Frequency unknown

in cancer patients

• inflammation of the blood vessels in the skin (cutaneous vasculitis)


• plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweet’s syndrome)


• worsening of rheumatoid arthritis


• a cough, fever and difficulty breathing (dyspnoea)


• problems with your lungs (pulmonary) including serious lung infection (interstitial pneumonia), swelling and/or fluid in the lungs (pulmonary oedema)


• pain and swelling of the joints, similar to gout (pseudogout)

in normal stem cell donors

• cough, fever and difficulty breathing or coughing up blood.

Some changes may occur in your blood, but these will be detected by routine blood tests.

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

How To Store Neupogen

Keep out of the reach and sight of children.

Store in a refrigerator (2°C – 8°C).

Accidental freezing will not harm Neupogen.

Do not use Neupogen after the expiry date which is stated on the syringe label and carton after EXP.

The expiry date refers to the last day of that month.

Do not use Neupogen if you notice discolouration, cloudiness or particles, it should be a clear, colourless liquid.

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 Neupogen contains

• The active substance is filgrastim 30 million units (0.6 mg/ml) or 48 million units (0.96 mg/ml).


• The other ingredients are sodium acetate, sorbitol (E420), polysorbate 80, water for injections.

What Neupogen looks like and contents of the pack

Neupogen is a clear colourless solution for injection (injection) /concentrate for solution for infusion (sterile concentrate) in a pre-filled syringe.

Neupogen is available in packs of one or five pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

This medicine is marketed in the European Economic Area under the name Neupogen, except in Cyprus, Greece and Italy where it is called Granulokine.

This leaflet was last approved in July 2010.

Detailed information on this medicine can be found on the following web sites:

• For UK residents, the Medicines and Healthcare products Regulatory Agency (MHRA) www.mhra.gov.uk.

Instructions For Injecting Neupogen

This section contains information on how to give an injection of Neupogen.

Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.

Neupogen is injected into the tissue just under the skin. This is known as a subcutaneous injection.

Equipment that you need

To give yourself a subcutaneous injection you will need:

• a new pre-filled syringe of Neupogen; and


• alcohol wipes or similar.

What do I do before I give myself a subcutaneous injection of Neupogen?

1. Remove the syringe from the refrigerator. Leave the syringe at room temperature for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes. This will make the injection more comfortable. Do not warm Neupogen in any other way (for example, do not warm it in a microwave or in hot water).

2. Do not shake the pre-filled syringe.

3. Do not remove the needle cover until you are ready to inject.

4. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.

5. Check the appearance of Neupogen. It must be a clear and colourless liquid. If there is discolouration, cloudiness or particles in it, you must not use it.

7. Wash your hands thoroughly.

8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

How do I prepare my Neupogen injection?

Before you inject Neupogen you must do the following:

1. To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2.

2. Do not touch the needle or push the plunger.

3. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.

4. You can now use the pre-filled syringe.

Where do I give my injection?

The best places to inject are the top of your thighs and the abdomen. If someone else is injecting you, they can also use the back of your arms.

You may change the injection site if you notice the area is red or sore.

How do I give my injection?

1. Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.

2. Put the needle fully into the skin as shown by your nurse or doctor.

3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, pull the needle out and re-insert it in another place.

4. Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.

5. Remove the needle and let go of your skin.

6. If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If needed, you may cover the injection site with a plaster.

7. Only use each syringe for one injection. Do not use any Neupogen that may be left in the syringe.

Remember: if you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes

• Do not put the cover back on used needles, as you may accidentally prick yourself.


• Keep used syringes out of the reach and sight of children.


• Syringes should not be thrown out in the household rubbish. Your pharmacist will know how to dispose of used syringes or syringes no longer needed.

Local representative of the marketing authorisation holder:

United Kingdom

Amgen Limited

240 Cambridge Science Park

Cambridge

CB4 0WD

United Kingdom

Tel:01223 420305

Neupogen is available on the Royal National Institute of the Blind (RNIB) Medicines Information Line who can provide this leaflet in a number of physical formats including large/clear print, Braille and audio CD.

You can also listen to this leaflet when you call the Medicines Information Line.

The RNIB Medicines Information Line is free to use and available 24 hours a day, 7 days a week. Please call them on
0800 198 5000.

Neutra-Phos-K Powder for Solution

Pronunciation: poe-TASS-ee-um FOS-fate
Generic Name: Potassium Phosphate
Brand Name: Neutra-Phos-K

Neutra-Phos-K Powder for Solution is used for:

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

Neutra-Phos-K Powder for Solution is a urinary acidifier. It works by increasing the amount of acid in the urine, which lowers the pH of the urine. This may reduce the growth of some bacteria in the urine and help dissolve calcium kidney stones.

Do NOT use Neutra-Phos-K Powder for Solution if:

• you are allergic to any ingredient in Neutra-Phos-K Powder for Solution


• you have severe adrenal insufficiency (Addison disease), infected kidney stones, struvite stones, severe kidney damage, or high levels of phosphates or potassium in the blood


• you are taking a potassium-sparing diuretic (eg, triamterene)

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

Before using Neutra-Phos-K Powder for Solution:

Some medical conditions may interact with Neutra-Phos-K Powder for Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are on a sodium- or potassium-restricted diet


• if you have heart disease or heart failure, kidney problems, myotonia congenita, swelling of the hands and feet, difficulty breathing due to swelling of the lungs, liver problems, severe burns, softening of the bones, high sodium levels in the blood, high blood pressure, an underactive adrenal gland, inflammation of the pancreas, or rickets


• if you are dehydrated

Some MEDICINES MAY INTERACT with Neutra-Phos-K Powder for Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aldosterone blockers (eg, eplerenone), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), or potassium-sparing diuretics (eg, triamterene) because high potassium levels, possibly with irregular heartbeat or a heart attack, may occur

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

How to use Neutra-Phos-K Powder for Solution:

Use Neutra-Phos-K Powder for Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Neutra-Phos-K Powder for Solution is usually taken after meals and at bedtime. Ask your doctor when you should take Neutra-Phos-K Powder for Solution.


• Packet - Empty contents of 1 packet into one third of a glass of water (about 75 mL/2.5 ounces). Stir the solution vigorously until all particles are dissolved.


• Bottle - Dissolve entire contents of 1 bottle in 1 gallon of water or other liquid (eg, milk, juice) and take as directed by your doctor. Do not add any additional liquid, but chill the solution if you have trouble drinking it. The solution may be stored for up to 60 days after mixing.


• Do not take antacids containing aluminum, magnesium, or calcium with Neutra-Phos-K Powder for Solution without checking with your doctor or pharmacist.


• If you miss a dose of Neutra-Phos-K Powder for Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Neutra-Phos-K Powder for Solution.

Important safety information:

• Neutra-Phos-K Powder for Solution may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Neutra-Phos-K Powder for Solution. Using Neutra-Phos-K Powder for Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• While taking Neutra-Phos-K Powder for Solution, the possibility of passing old kidney stones is increased.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Neutra-Phos-K Powder for Solution, discuss with your doctor the benefits and risks of using Neutra-Phos-K Powder for Solution during pregnancy. It is unknown if Neutra-Phos-K Powder for Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Neutra-Phos-K Powder for Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Neutra-Phos-K Powder for Solution:

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

Abdominal pain; diarrhea; nausea; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased urination; seizures; shortness of breath; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Neutra-Phos-K side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Neutra-Phos-K Powder for Solution:

Store Neutra-Phos-K Powder for Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. The solution may be chilled after mixing and stored for up to 60 days. Keep Neutra-Phos-K Powder for Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Neutra-Phos-K Powder for Solution, please talk with your doctor, pharmacist, or other health care provider.


• Neutra-Phos-K Powder for Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Neutra-Phos-K resources

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

Compare Neutra-Phos-K with other medications

• Constipation
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• Hypophosphatemia

NuvaRing Ring

Pronunciation: e-toe-noe-JES-trel/ETH-i-nil es-tra-DYE-ol
Generic Name: Etonogestrel/Ethinyl Estradiol
Brand Name: NuvaRing

Cigarette smoking while taking NuvaRing Ring increases the risk of serious heart problems. The risk increases with age (older than 35 years) and with heavy smoking (15 or more cigarettes per day). Patients who use NuvaRing Ring are strongly advised not to smoke.

NuvaRing Ring is used for:

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

NuvaRing Ring is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries and thereby preventing pregnancy.

Do NOT use NuvaRing Ring if:

• you are allergic to any ingredient in NuvaRing Ring


• you are pregnant or think you may be pregnant


• you have blood clots in the legs, lungs, or eyes; or a history of heart attack, chest pain, or stroke


• you have heart valve problems with blood clotting complications


• you have known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina, or have had vaginal bleeding of unknown causes


• you have a liver tumor or active liver disease, or a history of yellowing of the eyes or skin during pregnancy or previous birth control use


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

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

Before using NuvaRing Ring:

Some medical conditions may interact with NuvaRing Ring. Tell your health care provider 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; heart valve problems; or pancreatitis or gallbladder problems; or if 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, prolapsed uterus, or irregular or scanty menstrual periods


• if you have diabetes, headaches, migraine headaches, epilepsy, or a history of mental depression or toxic shock syndrome (TSS)


• if you are having surgery


• if you are a heavy smoker (15 or more cigarettes per day), especially if you are older than 35 years

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

• Aprepitant, azole antifungals (eg, itraconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), phenylbutazone, rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease NuvaRing Ring'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), selegiline, theophyllines (eg, aminophylline), or troleandomycin because their side effects may be increased by NuvaRing Ring


• Lamotrigine because its effectiveness may be decreased by NuvaRing Ring

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

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

• An extra patient leaflet is available with NuvaRing Ring. Talk to your pharmacist if you have questions about this information.


• Wash and dry your hands before removing the ring from the pouch. The ring becomes slippery when wet, so make sure your hands are dry.


• To insert the ring, choose a comfortable position, such as lying down, squatting, or standing with one leg up. Hold the ring between your thumb and index finger and press the opposite sides of the ring together. Gently insert and push the folded ring into the vagina as far as comfortably possible. The exact position of the ring is the vagina is not important for it to work.


• Rarely, some women have inserted the ring into the bladder by mistake. Do not insert the ring into your bladder. Insert the ring into the vagina.


• You may not feel the ring once it is in place. If you feel discomfort, the ring is probably not inserted far enough in your vagina. Use your finger to gently push the ring further into your vagina. There is no danger in the ring being pushed too far up the vagina or getting lost. It can be inserted only as far as the end of the vagina. The cervix will block it from going any further.


• The ring should not interfere with sexual intercourse.


• Some women have experienced moving or gliding of the ring within the vagina due to bowel movements, straining, constipation, or coughing. If this occurs, push it back into place with your finger.


• After insertion, the ring should be left in place for 3 weeks (21 days) and then removed. It should be removed at about the same time and on the same day of the week that it was inserted. To remove the ring, wash and dry your hands thoroughly. Find a comfortable position, either standing, squatting, or lying down. Loop your finger through the ring and gently pull it out. Discard the used ring in the trash container. Do not flush it down the toilet.


• After removing the ring, wait 7 days and then insert a new ring. The new ring should be inserted at about the same time and on the same day of the week as it was inserted in the last cycle.


• If the ring is removed or falls out of the vagina and remains out for less than 3 hours, rinse the ring with lukewarm water and reinsert it. No other contraceptive measures are necessary.


• If the ring is removed or falls out of the vagina and remains out for more than 3 hours, rinse the ring with lukewarm water and reinsert it. In this case, you may not be adequately protected from pregnancy. You must use an additional form of birth control (eg, male condoms, spermicide) until the ring has been in place for 7 days in a row.


• If the ring is removed or falls out and is lost, or if the ring becomes disconnected at the joint, you must insert a new ring and use it on the same schedule as you would have used the lost or disconnected ring.


• If you miss inserting the new ring on the scheduled day, insert it as soon as you remember. You must use a backup form of birth control until the new ring has been in place for 7 days. If you are not sure what to do if you miss inserting the new ring on the scheduled day, use an extra form of birth control (eg, condoms) and talk with your doctor.

Ask your health care provider any questions you may have about how to use NuvaRing Ring.

Important safety information:

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


• If you miss your period, call your doctor immediately. A missed period may indicate that you are pregnant.


• NuvaRing Ring may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.


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


• NuvaRing Ring may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using NuvaRing Ring.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks beforehand. Special precautions may need to be taken in these circumstances while you are taking NuvaRing Ring.


• Bleeding or spotting may occur while taking NuvaRing Ring. Do not stop taking NuvaRing Ring if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.


• NuvaRing Ring may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.


• Taking certain antibiotics or anticonvulsants while you are using NuvaRing Ring, or vomiting or diarrhea may decrease the effectiveness of NuvaRing Ring. To prevent pregnancy, use an additional form of birth control (such as condoms, spermicide, diaphragm) until your next period. If you have any questions, contact your doctor or pharmacist.


• Some women have rarely placed NuvaRing Ring into the bladder by mistake. Contact your doctor right away if you develop persistent bladder problems (eg, difficult or painful urination) and you can not locate the ring in your vagina.


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


• Use of NuvaRing Ring will not prevent the spread of sexually transmitted diseases (STDs).


• Lab tests, including physical exams and blood pressure, may be performed while you use NuvaRing Ring. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.


• NuvaRing Ring should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use NuvaRing Ring if you are pregnant. If you think you may be pregnant, contact your doctor right away. Continue to use another method of birth control (such as condoms). NuvaRing Ring is found in breast milk. Do not breast-feed while taking NuvaRing Ring. Do not take NuvaRing Ring soon after delivery of a baby even if you are not breast-feeding. You should wait 4 weeks after delivery if you are not breast-feeding or 4 weeks after a second trimester abortion.

Possible side effects of NuvaRing Ring:

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; change in appetite; changes in weight; dizziness; headache; mild hair loss; nausea; nervousness; stomach cramps or bloating; vaginal spotting or breakthrough bleeding.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); absent menstrual period; breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in the amount of urine produced; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (eg, depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe pain or tenderness in the stomach; shortness of breath; slurred speech; sudden, severe headache or vomiting; swelling of the fingers, hands, legs, or ankles; symptoms of toxic shock syndrome (eg, diarrhea, dizziness, sudden fever, sunburn-like rash on the face or body, or vomiting); unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation, discharge, or change in secretions; vision changes (eg, double vision, sudden vision loss); yellowing of the skin or eyes (with or without fever).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: NuvaRing side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms of overdose may include nausea or vomiting; vaginal bleeding.

Proper storage of NuvaRing Ring:

Store NuvaRing Ring at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep NuvaRing Ring out of the reach of children and away from pets.

General information:

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


• NuvaRing Ring 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 NuvaRing Ring. 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 NuvaRing resources

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

Compare NuvaRing with other medications

• Birth Control

etoposide phosphate

Generic Name: etoposide phosphate (e TOE poe side FOS fate)

Brand Names: Etopophos

What is etoposide phosphate?

Etoposide phosphate is a cancer medicine that interferes with the growth of cancer cells and slows their growth and spread in the body.

Etoposide phosphate is used to treat cancer of the lung or testicles.

Etoposide phosphate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about etoposide phosphate?

Do not receive etoposide phosphate if you are pregnant. It could harm the unborn baby.

Before receiving etoposide phosphate, tell your doctor if you have kidney disease or a weak immune system.

Etoposide phosphate can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury. Tell your doctor at once if you develop signs of infection.

Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Using etoposide phosphate may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.

What should I discuss with my health care provider before using etoposide phosphate?

You should not use this medication if you are allergic to etoposide.

To make sure you can safely receive etoposide phosphate, tell your doctor if you have any of these other conditions:

• kidney disease; or


• 
  

  a weak immune system (from disease or from taking certain medicines).

  
  

FDA pregnancy category D. Do not use etoposide phosphate if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether etoposide phosphate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are being treated with etoposide phosphate.

Using etoposide phosphate may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.

How is etoposide phosphate given?

Etoposide phosphate is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. The medicine is sometimes given slowly through an IV infusion, and can take up to 3-1/2 hours to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when etoposide phosphate is injected.

Etoposide phosphate is usually given for 4 or 5 days in a row every 3 to 4 weeks. Follow your doctor's instructions.

Etoposide phosphate can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Your blood may need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Etoposide phosphate is used together with other cancer medications. Read the medication guide or patient instructions provided with each of your medications.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your etoposide phosphate injection.

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 receiving etoposide phosphate?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Etoposide phosphate 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  
  


• 
  

  pain, burning, irritation, or skin changes where the injection was given;

  
  


• 
  

  feeling like you might pass out; or

  
  


• 
  

  severe nausea and vomiting.

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, stomach pain, loss of appetite;

  
  


• 
  

  constipation, diarrhea;

  
  


• 
  

  dizziness, feeling tired or weak;

  
  


• 
  

  temporary hair loss; or

  
  


• 
  

  mild skin rash.

  
  

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.

Etoposide phosphate Dosing Information

Usual Adult Dose for Testicular Cancer:

(In combination with other approved chemotherapeutic agents) Initial dose: 50 to 100 mg/m2 IV once a day on days 1 through 5 or 100 mg/m2 IV once a day on days 1,3 and 5.

Usual Adult Dose for Small Cell Lung Cancer:

(In combination with other approved chemotherapeutic agents) Initial dose: 35 to 50 mg/m2 IV once a day for 4 to 5 days.

Usual Geriatric Dose for Testicular Cancer:

The manufacturer has stated that clinical studies of etoposide for the treatment of refractory testicular tumors did not include sufficient numbers of patients aged 65 years or over to determine if they respond differently from younger patients.

What other drugs will affect etoposide phosphate?

Before you receive etoposide phosphate, tell your doctor if you are using cyclosporine (Neoral, Sandimmune, Gengraf).

There may be other drugs that can interact with etoposide phosphate. 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 etoposide phosphate resources

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

• Etopophos Prescribing Information (FDA)


• Etopophos Advanced Consumer (Micromedex) - Includes Dosage Information


• Etopophos MedFacts Consumer Leaflet (Wolters Kluwer)

Compare etoposide phosphate with other medications

• Cancer
• Hodgkin's Lymphoma
• Ovarian Cancer
• Small Cell Lung Cancer
• Testicular Cancer

Where can I get more information?

• Your doctor or pharmacist can provide more information about etoposide phosphate.

See also: etoposide phosphate side effects (in more detail)

Perfect Choice

Generic Name: fluoride topical (FLOR ide TOP i kal)

Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N

What is Perfect Choice (fluoride topical)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

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

What is the most important information I should know about Perfect Choice (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.

Do not eat, drink, or rinse your mouth for 30 minutes after using a fluoride topical. Do not swallow fluoride topical. Spit it out after use. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I discuss with my healthcare provider before using Perfect Choice (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.

If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.

Talk to your doctor and dentist before using fluoride topical if you are pregnant. Talk to your doctor and dentist before using fluoride topical if you are breast-feeding. The use of fluoride is particularly important in children to protect against tooth decay. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age. The American Academy of Pediatrics recommends fluoride supplementation in children until the age of 16 years old. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

How should I use Perfect Choice (fluoride topical)?

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

Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.

Swish this medication in your mouth without swallowing. Then spit it out.

Do not eat, drink, or rinse your mouth for 30 minutes after using fluoride topical. Store fluoride topical at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I avoid while using Perfect Choice (fluoride topical)?

Do not swallow fluoride topical. Spit it out after use.

Perfect Choice (fluoride 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. Call your doctor if you have any of the following side effects:

• 
  

  discolored teeth;

  
  


• 
  

  weakened tooth enamel; or

  
  


• 
  

  any changes in the appearance of your teeth.

  
  

Less serious side effects may include:

• 
  

  stomach upset;

  
  


• 
  

  headache; or

  
  


• 
  

  weakness.

  
  

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 Perfect Choice (fluoride topical)?

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

More Perfect Choice resources

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

• APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information


• EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer)


• Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer)


• Prevident 5000 Booster Prescribing Information (FDA)


• Prevident 5000 Dry Mouth Prescribing Information (FDA)


• Prevident 5000 Enamel Protect Prescribing Information (FDA)


• Prevident 5000 Sensitive Prescribing Information (FDA)

Compare Perfect Choice with other medications

• Prevention of Dental Caries

Where can I get more information?

• Your pharmacist can provide more information about fluoride topical.

See also: Perfect Choice side effects (in more detail)

carmustine Intravenous

kar-MUS-teen

Intravenous route(Powder for Solution)

Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of carmustine. Blood counts should be monitored weekly for at least 6 weeks after a dose. At the recommended dosage, courses of carmustine should not be given more frequently than every 6 weeks. Pulmonary toxicity from carmustine appears to be dose related, as patients receiving greater than 1400 mg/m(2) cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood .

Commonly used brand name(s)

In the U.S.

• Bicnu

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrosourea

Uses For carmustine

Carmustine injection is used alone or together with other medicines to treat certain type of brain tumors (e.g., glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors), cancer of the lymph system (e.g., Hodgkin's disease, non-Hodgkin's lymphoma), and a certain type of cancer in the bone marrow (e.g., multiple myeloma). It may also be used to treat other kinds of cancer, as determined by your doctor.

Carmustine belongs to the group of alkylating agents. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by carmustine, other effects may occur. Some of these may be serious and must be reported to your doctor. Other effects (e.g., hair loss), may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with carmustine, you and your doctor should talk about the benefits carmustine will do as well as the risks.

carmustine is to be administered only by or under the immediate supervision of your doctor.

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

• Cancer of the colon and rectum.


• Cancer of the stomach.


• Malignant melanoma (a type of skin cancer).


• Mycosis fungoides (tumors on the skin).


• Waldenström's macroglobulinemia (a certain type of cancer of the blood).

Before Using carmustine

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 carmustine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to carmustine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of carmustine injection have not been performed in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of carmustine injection in geriatric patients. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving carmustine injection.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving carmustine, 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 carmustine 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.

• Rotavirus Vaccine, Live

Using carmustine 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.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Cimetidine


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

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

• Anemia (low red cells in the blood) or


• Bone marrow problems (e.g., leukemia) or


• Leukopenia or neutropenia (low white cells in the blood) or


• Liver disease or


• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles) or


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

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Lung disease (e.g., pulmonary fibrosis, pulmonary toxicity)—Use with caution. May increase risk of lung problems.

Proper Use of carmustine

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

A nurse or other trained health professional will give you carmustine in a hospital. carmustine is given through a needle placed in one of your veins.

carmustine is usually given every 6 weeks. This maybe given as a single dose or divided into daily injections on two consecutive days.

Carmustine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to take them at the right times.

carmustine often causes nausea and vomiting, which usually last no longer than 4 to 6 hours. It is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

Precautions While Using carmustine

It is very important that your doctor check your progress at regular visits to make sure that carmustine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

carmustine may increase your risk of developing cancer and lung problems (such as pulmonary fibrosis or toxicity). This is more likely if you receive high doses of carmustine or use it for a long time.

While you are being treated with carmustine injection, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Carmustine may lower your body's resistance and the vaccine may not work as well for you or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

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

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


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


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


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


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


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

If carmustine accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the injection site.

carmustine may increase risk of lung problems while smoking.

carmustine Side Effects

Along with its needed effects, medicines like carmustine can sometimes cause some unwanted effects such as blood problems, loss of hair, and other side effects ; these are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

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

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

More common

• Cough


• pain or redness at the injection site


• shortness of breath

Less common

• Black, tarry stools


• blood in the urine or stools


• cough or hoarseness, accompanied by fever or chills


• fever or chills


• flushing of the face


• lower back or side pain, accompanied by fever or chills


• painful or difficult urination, accompanied by fever or chills


• pinpoint red spots on the skin


• sores in the mouth or on the lips


• unusual bleeding or bruising


• unusual tiredness or weakness

Rare

• Decrease in urination


• swelling of the feet or lower legs

Incidence not known

• Abdominal or stomach pain, severe


• bleeding gums


• bone pain


• chest pain


• cloudy urine


• confusion


• dark urine


• decreased frequency or amount of urine


• difficulty with swallowing


• dizziness


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


• dry mouth


• fast, pounding, or irregular heartbeat or pulse


• feeling of warmth


• hives


• increased blood pressure


• increased thirst


• itching


• loss of appetite


• nausea or vomiting


• pain in the lower back or side


• pale skin


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


• redness of the face, neck, arms, and occasionally, upper chest


• skin rash


• sore throat


• sweating


• swelling of the face, fingers, or lower legs


• swollen glands


• thirst


• tightness in the chest


• troubled breathing


• troubled breathing with exertion


• weight gain


• wheezing


• yellow eyes or skin

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

Less common

• Diarrhea


• discoloration of the skin along the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: carmustine Intravenous side effects (in more detail)

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More carmustine Intravenous resources

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

Compare carmustine Intravenous with other medications

• Brain Tumor
• Glioblastoma Multiforme
• Hodgkin's Lymphoma
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Sulfatol C Cream

sulfacetamide sodium and sulfur

Dosage Form: cream
Sulfatol C™ Cream

Rx Only

PRODUCT DESCRIPTION

Sulfatol C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is available by prescription only and contains the following active ingredients: Sulfacetamide Sodium 10% and Sulfur 5%.

Chemically, sulfacetamide sodium is Acetamide, N-[(4-aminophenyl) sulfonyl], monosodium salt, monohydrate. The structural formula is:

INACTIVE INGREDIENTS: Benzyl Alcohol, Cetyl Alcohol, Cocoglycerides, Dimethicone, Disodium EDTA, Fragrance, Glyceryl and PEG-100 Stearate, Isopropyl Myristate, Light Mineral Oil, Polysorbate 60, Propylene Glycol, Sodium Thiosulfate, Sorbitan Monostearate, Stearyl Alcohol, Urea, Purified Water, Xanthan Gum, Zinc Ricinoleate.

Sulfatol C Cream - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS

Sulfatol C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sulfatol C™ Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfatol C™ Cream is not to be used by patients with kidney disease.

FOR EXTERNAL USE ONLY. Keep out of reach of children. Keep away from eyes. Keep tube tightly closed.

Warnings

Although rare, sensitivity to sulfacetamide sodium may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

Precautions

General

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sulfacetamide sodium and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris but patients should be cautioned about the possibility.

Information for Patients

Sulfatol C™ Cream is intended for external use only. Avoid contact with eyes, eyelids, lips, other mucous membranes (e.g., inside the nose), and any damaged areas of the skin, such as wounds or open sores. If accidental contact with one of these areas occurs, rinse thoroughly with water.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Category C

Animal reproduction studies have not been conducted with Sulfatol C™ Cream. It also is not known whether Sulfatol C™ Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfatol C™ Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether sulfacetamide sodium is excreted in human milk following topical use of Sulfatol C™ Cream. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfatol C™ Cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under 12 years of age has not been established.

Possible Side Effects

Like any medication, Sulfatol C™ Cream may occasionally cause side effects in some people. Although uncommon, some possible side effects may include skin irritation such as redness, dryness, itching or swelling. If you experience excessive skin irritation, contact your physician.

Directions For Use

Apply Sulfatol C™ Cream to affected area(s) 1-3 times daily, or as directed by your physician.

1)

Cleanse your skin thoroughly before application.

2)

Apply a thin layer of Sulfatol C™ Cream to the affected area(s) as directed by your physician

3)

Start by using Sulfatol C™ Cream once daily to minimize dryness.

Then, increase application frequency to 2-3 times daily or as directed by your physician.

How is Sulfatol C Cream Supplied

Sulfatol C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is available in 1 oz. tubes. (NDC 51991-559-41)

Storage

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in original container.

Warning

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Groupe Parima Inc., Montréal, QC Canada H4S 1X6

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Iss: 9/08

PRINCIPAL DISPLAY PANEL - 28g tube carton

Breckenridge

Pharmaceutical, Inc.

NDC 51991-559-41

Sulfatol C™ Cream

Sulfacetamide Sodium 10% and Sulfur 5%

Rx Only

Net Wt. 1 oz. (28g)

Skin Cream

For The Topical Control Of

• Acne Vulgaris


• Acne Rosacea


• Seborrheic Dermatitis

SULFATOL C  sulfacetamide sodium and sulfur  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-559 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (Sulfacetamide) Sulfacetamide Sodium 2.8 g  in 28 g Sulfur (Sulfur) Sulfur 1.4 g  in 28 g

Inactive Ingredients Ingredient Name Strength Benzyl Alcohol   Cetyl Alcohol   Coco-glycerides   Dimethicone   Edetate Disodium   Glycerin   Polyoxyl 100 Stearate   Isopropyl Myristate   Light Mineral Oil   Polysorbate 60   Propylene Glycol   Sodium Thiosulfate   Sorbitan Monostearate   Stearyl Alcohol   Urea   Water   Xanthan Gum

Product Characteristics Color YELLOW (light-yellow) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-559-41 1 TUBE In 1 BOX contains a TUBE 1 28 g In 1 TUBE This package is contained within the BOX (51991-559-41)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/01/2009	09/30/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Groupe Parima		252437850	MANUFACTURE

Revised: 05/2010Breckenridge Pharmaceutical, Inc.

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