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Monday, 12 March 2012

Caverject

Generic Name: alprostadil (Intraurethral route, Intravenous route, Intracavernosal route)

al-PROS-ta-dil

Intravenous route(Solution)

Apnea is experienced by about 10% to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used only where ventilatory assistance is immediately available .

Commonly used brand name(s)

In the U.S.

Caverject

Edex

Muse

Prostin VR Pediatric

In Canada

Muse Micro

Available Dosage Forms:

Powder for Solution

Suppository

Solution

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Prostaglandin

Uses For Caverject

Alprostadil belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. Alprostadil is used to produce erections in some men who need treatment for erectile dysfunction (sexual impotence). This medicine causes an erection because it increases the blood flow to the penis.

Alprostadil injection should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Alprostadil is used alone or with medical tests to help diagnose erectile dysfunction that may be caused by nerve or blood vessel problems in the penis.

Alprostadil is available only with your doctor's prescription.

Before Using Caverject

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is 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.

Heparin

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.

Proper Use of alprostadil

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

Special patient directions come with the suppositories and some of the injection medicines. Read the directions carefully before using the medicine.

For the injections—There are several alprostadil products that can be injected. Although the injection method is the same, the mixing procedures are different. Be sure you know which of these products you will be using and the proper way to mix the injection.

One product called Alprostadil for Injection (brand names Caverject and Edex) is available as a powder in an injection bottle (vial). Caverject must be mixed with a solution called Bacteriostatic Water for Injection USP. Edex must be mixed with a solution called Sodium Chloride Injection USP. The solution for mixing comes with your product and may be already loaded into a syringe or contained in another injection bottle (vial).

Another product is called Alprostadil Injection (brand names Prostin VR Pediatric and Prostin VR). Although the medicine is already in solution, it is much too strong to be injected into the penis. The solution must be mixed (diluted) with another liquid that is sold as a separate prescription, called 0.9% Sodium Chloride Injection USP. In most cases, a pharmacist will make this solution for you, giving you the proper strength that you need. Check with your doctor or pharmacist to make sure the solution has been diluted before using it.

It is important to follow several steps to prepare your alprostadil injection correctly. Before drawing up the medicine into the syringe:

Wash your hands with soap and water.

Set the bottles on a clean surface. Wipe the top of the injection bottles with an alcohol swab. Do not wipe the needle. Throw away the alcohol swab.

You may need to attach the needle to the syringe. Do not take the cap off yet.

How to mix Caverject:

If the syringe already contains the Bacteriostatic Water for Injection USP, then you need only add the plunger to the syringe. To do this:
- Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force.
- Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
- You are now ready to mix the water and the powder. Skip to the directions under the title, “To mix the water and powder."

If the syringe does not already contain the Bacteriostatic Water for Injection USP, you must withdraw 1 milliliter (mL) of it from the bottle provided. To do this:
- Pick up the syringe and take the cap off the needle. Pull the plunger back to the 1-mL mark on the syringe. This pulls air into the syringe. Insert the needle into rubber top of the bottle while it is upright and inject the 1 mL of air into the bottle.
- Turn the bottle upside down using one hand. Be sure the tip of the needle is covered by solution.
- With your other hand, pull the plunger back slowly to withdraw 1 mL of solution into the syringe. Remove the needle and skip to the directions under the title, "To mix the water and powder."

To mix the water and powder:
- Insert the needle into the bottle of alprostadil and inject 1 milliliter of Bacteriostatic Water for Injection USP from your syringe into the bottle of alprostadil.
- Remove the needle from the bottle, holding the barrel of the syringe.
- Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle.
- Follow the directions below, “How to draw your dose into the syringe."

How to mix Edex:

The syringe already contains the Sodium Chloride Injection USP. You need only attach the needle to the syringe and add the plunger. To do this:
- Remove the needle from its package. Do not remove the needle cap. Gently screw the needle into place on the syringe tip.
- Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force.
- Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
- You are now ready to mix the Sodium Chloride Injection USP and the powder.
- Insert the needle into the bottle of alprostadil and inject 1.2 milliliters of the Sodium Chloride Injection USP from your syringe into the bottle of alprostadil.
- Remove the needle from the bottle, holding the barrel of the syringe.
- Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle.
- Follow the directions below, “How to draw your dose into the syringe."

How to mix Prostin VR or Prostin VR Pediatric:

You will need to get exact mixing instructions from your doctor or pharmacist if you are given two solutions to be mixed. Follow them carefully, asking the pharmacist or doctor any questions that you might have before injecting the medicine.

After you or the pharmacist has mixed these solutions, follow the directions below, “How to draw your dose into the syringe."

How to draw your dose into the syringe (for all injection products):

Check the solution to make sure it is clear. Do not use the mixture if you can see anything solid in the solution or if the solution is cloudy or colored.

After the alprostadil solution is mixed and the needle is inserted into the alprostadil bottle, turn the bottle with the syringe as a unit upside down in one hand. Be sure the tip of the needle is covered by the solution. With your other hand, pull the plunger back slowly to draw the correct dose of the medicine into the syringe.

Hold the syringe with the measuring scale at eye level to see that the proper dose is withdrawn and to check for air bubbles. To remove air bubbles, tap gently on the measuring scale of the syringe to move any bubbles to the top of the syringe near the needle.

If your dose measures too low in the syringe, withdraw more solution from the bottle. If there is too much medicine in the syringe, put some back into the bottle. Then check your dose again.

Remove the needle from the bottle, holding the barrel of the syringe, not the plunger.

Place the cover back on the needle. You are now ready to inject your dose. Follow the directions below, “How to give the alprostadil injection."

How to give the alprostadil injection:

Choose a spot on your penis as directed by your doctor where you will give the injection.

Clean the injection site with alcohol. Sitting upright or slightly reclined, hold your penis against the side of your thigh so that it cannot move.

Remove the cover from the needle and hold the needle at a 90-degree angle to the place of injection.

Insert the needle until almost all of the metal part of the needle is inserted into the penis.

Do not inject the medicine just under the surface of the skin, at the top or head of the penis, or at the base of the penis near the scrotum or testes. Avoid injecting the medicine into blood vessels that you can see.

Press the plunger down slowly, taking 5 to 10 seconds to release the dose into the penis.

The injection is usually not painful. If the injection is very painful or if you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection.

Remove the needle and recap it.

After you have completed the injection, put pressure on the place of injection for about 5 minutes or until any bleeding stops. This will prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that the medicine will work better.

Choose a different place of injection each time you use the medicine to prevent skin problems. This includes switching the place of injection from the right side of the penis for one injection to the left side for the next injection.

After a single-use injection is mixed, the medicine must be used immediately. Throw away any unused mixture in the syringe. It cannot be stored for a later injection.

Do not reuse your needles.

How to throw away the syringes and bottles safely:

Dispose of your materials properly. Caverject comes in a plastic case that can be permanently locked with the red locking device that is included with the packaging. When the case label is removed, you can see a hole in the center of the case. The red locking device can be inserted and, by firmly pressing it down with your thumb, you will permanently lock the case. The locked case is safe to be thrown away.

If you do not have the plastic case or are using Prostin VR or Prostin VR Pediatric injection, unscrew the needle from the barrel of the syringe. Then bend, break, or cut the needle into two pieces with wire cutters. The pieces can be placed in a heavy plastic container, such as a bleach container, and thrown away. Or you may give them to a health care professional to throw away. If you have any questions about disposing of the syringe and needles, ask your health care professional.

For suppositories—Before inserting the suppository, you should urinate. The small amount of urine normally left in your urethra will help dissolve the suppository after it is inserted.

How to insert suppositories:

Remove the delivery device containing the suppository from the foil. Remove the cap from the applicator stem.

Stretch your penis upward to extend its length, pressing your penis top and bottom. Gently insert the delivery stem up to its collar into your urethra (located at the top of the penis). If you have pain or a pulling feeling in the penis, withdraw the device and start again.

Press the button down slowly as far as it will go. This releases the suppository into the urethra. After holding the delivery device within your penis still for 5 seconds, carefully rock the penis and delivery device as a unit from side to side. This helps remove the suppository from the device.

Remove the delivery device while your penis is upright. Look at the device to make sure that the suppository was completely released.

Repeat the process if a part of the suppository remains in the device.

After the suppository is completely released, roll your penis between your hands for 10 seconds. This helps to dissolve the suppository. If you feel any stinging, continue this motion to help stop it.

Sitting, standing, or walking for 10 minutes while an erection is developing helps increase the blood flow to your penis to gain a proper erection.

How to throw away the suppository delivery device safely:

Replace the cap on the delivery device. After storing it in the foil, fold and throw away.

For injections or suppositories—This medicine usually begins to work in about 5 to 10 minutes. You should attempt intercourse within 10 to 30 minutes after using the medicine. An erection may continue after ejaculation.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For the treatment of erectile dysfunction:
- For injection dosage form:
  - Adults—1.25 to 60 micrograms (mcg) as a single dose once a day. Your exact dose will be determined by your doctor. Inject this medicine very slowly into your penis as shown to you by your doctor ten to thirty minutes before intercourse. Allow five to ten seconds to completely inject the dose. Do not inject more than one dose within twenty-four hours. Also, do not use this medicine for more than two days in a row or more than three times a week.
- For suppository dosage form:
  - Adults—125, 250, 500, or 1000 mcg as a single dose once a day. Your exact dose will be determined by your doctor. Insert this medicine into the urethra of your penis as shown to you by your doctor ten to thirty minutes before intercourse. Do not insert more than two doses within twenty-four hours.

Storage

Store in the refrigerator. Do not freeze.

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Alprostadil for Injection while in the powder form can be stored at room temperature (between 15 and 25 °C or 59 and 77 °F) for 3 months. After it is mixed, the solution must be used immediately. Suppositories may be stored at room temperature

Precautions While Using Caverject

Do not use alprostadil if you have a penile implant unless advised by doctor.

If using the alprostadil suppository, use a condom when having sexual intercourse with a pregnant female. Although harm to the fetus is unlikely, using a condom will protect the fetus from exposure to this medicine. If a woman can become pregnant, use of contraceptive methods is recommended because the effects of this medicine on early pregnancy are not known.

Use alprostadil exactly as directed by your doctor . Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the erection lasts too long and does not reverse when it should. This condition is called priapism. If the erection is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

If you notice bleeding at the place where you injected the medicine, put pressure on the spot until the bleeding stops. If it doesn't stop within 10 minutes, check with your doctor.

Caverject Side Effects

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

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

Rare

Curving of penis with pain during erection

erection continuing for 4 to 6 hours

erection continuing longer than 6 hours with severe and continuing pain of the penis

swelling in or pain of the testes

Symptoms of too much medicine being absorbed into the body

Dizziness

faintness

pelvic pain

flu-like symptoms

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

More common

Bleeding at place of injection, short-term

mild bleeding or spotting from urethra (suppository only)

pain at place of injection

painful erection

stinging of urethra (suppository only)

Rare

Female partners may experience itching or stinging of vagina when you first begin using the alprostadil suppository. These side effects may not be caused from the medicine but may result if female partner has not had frequent or recent sexual intercourse.

Bruising or clotted blood in penis at place of injection, usually caused by an incorrect injection

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: Caverject side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Caverject resources

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

Caverject Prescribing Information (FDA)

Caverject MedFacts Consumer Leaflet (Wolters Kluwer)

Caverject injectable and transurethral Concise Consumer Information (Cerner Multum)

Alprostadil Monograph (AHFS DI)

Alprostadil Prescribing Information (FDA)

Edex MedFacts Consumer Leaflet (Wolters Kluwer)

Muse Suppository MedFacts Consumer Leaflet (Wolters Kluwer)

Muse Prescribing Information (FDA)

Prostin VR Pediatric Prescribing Information (FDA)

Compare Caverject with other medications

Erectile Dysfunction

Zovia 1/50

Generic Name: ethinyl estradiol and ethynodiol diacetate (ETH in ill ESS tra DYE ol and ETH in o DYE ol dye AS e tate)

Brand Names: Kelnor, Zovia 1/35, Zovia 1/50

What is Zovia 1/50 (ethinyl estradiol and ethynodiol diacetate)?

Ethinyl estradiol and ethynodiol diacetate 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 ethynodiol diacetate are used as contraception to prevent pregnancy.

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

What is the most important information I should know about Zovia 1/50 (ethinyl estradiol and ethynodiol diacetate)?

Do not use this medication if you are pregnant or if you have recently had a baby or 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 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 Zovia 1/50 (ethinyl estradiol and ethynodiol diacetate)?

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, blood clot, or 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.

Before using this medication, tell your doctor if you have any of the following conditions.

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

high cholesterol or if you are overweight;

kidney disease;

a history of depression;

gallbladder disease;

diabetes;

seizures or epilepsy;

a history of irregular menstrual cycles;

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

uterine fibroid tumors;

varicose veins; or

tuberculosis.

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

How should I take Zovia 1/50 (ethinyl estradiol and ethynodiol diacetate)?

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.

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

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

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

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

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

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

What happens if I overdose?

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

What should I avoid while taking Zovia 1/50 (ethinyl estradiol and ethynodiol diacetate)?

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.

Zovia 1/50 (ethinyl estradiol and ethynodiol diacetate) side effects

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

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

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

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

a change in the pattern or severity of migraine headaches;

nausea, stomach pain, 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 Zovia 1/50 (ethinyl estradiol and ethynodiol diacetate)?

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

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

phenylbutazone (Azolid, Butazolidin);

St. John's wort;

an antibiotic;

seizure medications;

a barbiturate sedative; or

HIV or AIDS medications.

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 Zovia 1/50 resources

Zovia 1/50 Side Effects (in more detail)
Zovia 1/50 Use in Pregnancy & Breastfeeding
Drug Images
Zovia 1/50 Drug Interactions
Zovia 1/50 Support Group
0 Reviews for Zovia/50 - Add your own review/rating

Kelnor Prescribing Information (FDA)

Compare Zovia 1/50 with other medications

Abnormal Uterine Bleeding
Birth Control
Endometriosis
Gonadotropin Inhibition

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and ethynodiol diacetate.

See also: Zovia/50 side effects (in more detail)

Aspirin Effervescent Tablets

Pronunciation: AS-pir-in
Generic Name: Aspirin
Brand Name: Examples include Alka-Seltzer and Medi-Seltzer

Aspirin Effervescent Tablets are used for:

Treating headaches, body aches, pain, heartburn, acid indigestion, and sour stomach. It may also be used for other conditions as determined by your doctor.

Aspirin Effervescent Tablets are an antacid and analgesic combination. Aspirin, the analgesic, works by inhibiting several different chemical processes within the body causing pain and inflammation. The antacid works by neutralizing stomach acid and relieving symptoms.

Do NOT use Aspirin Effervescent Tablets if:

you are allergic to any ingredient in Aspirin Effervescent Tablets

you are a child or teenager with influenza (flu) or chickenpox

you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets

you are taking oral anticoagulants (eg, warfarin), arginine derivatives (eg, argatroban), or methotrexate

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

Before using Aspirin Effervescent Tablets:

Some medical conditions may interact with Aspirin Effervescent Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

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

if you have allergies to medicine, foods, or other substances

if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or an nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day

if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, influenza (flu) or chickenpox, or vitamin K deficiency

if you have a history of stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, or Kawasaki syndrome (a rare inflammation causing heart problems in children)

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

Carbonic anhydrase inhibitors (eg, acetazolamide) or griseofulvin because they may decrease Aspirin Effervescent Tablets's effectiveness

NSAIDs (eg, ibuprofen, celecoxib) because they may decrease Aspirin Effervescent Tablets's effectiveness and the risk of the side effects of both medicines, including stomach irritation and risk of bleeding, may be increased

Activated protein C, oral anticoagulants (eg, warfarin), arginine derivatives (eg, argatroban), ginkgo biloba extract, or heparin because the risk of their side effects, including risk of bleeding, may be increased by Aspirin Effervescent Tablets

Insulin or oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by Aspirin Effervescent Tablets

Methotrexate and valproic acid because the risk of their actions and side effects may be increased by Aspirin Effervescent Tablets.

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, metoprolol, propranolol), bisphosphonates (eg, etidronate), nitrates (nitroglycerin), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Aspirin Effervescent Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aspirin Effervescent Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aspirin Effervescent Tablets:

Use Aspirin Effervescent Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Do not remove the medicine from the package until you are ready to take it. Make sure that your hands are dry when you open Aspirin Effervescent Tablets.

Do not chew or swallow the tablets. Place the tablet in a glass and add about 4 ounces (120 mL) of cold water. Allow the tablet to dissolve completely, then drink all the liquid. Rinse the container with an additional small amount of water and drink the contents to ensure the entire dose is taken.

If you miss a dose of Aspirin Effervescent Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aspirin Effervescent Tablets.

Important safety information:

Aspirin Effervescent Tablets has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Talk to your doctor before you take Aspirin Effervescent Tablets or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Aspirin Effervescent Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Aspirin Effervescent Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Aspirin Effervescent Tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

Aspirin has been linked to a serious illness called Reye syndrome. Do not give Aspirin Effervescent Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

Aspirin Effervescent Tablets contains sodium. Include Aspirin Effervescent Tablets when counting your daily intake of sodium.

If Aspirin Effervescent Tablets has a strong vinegar-like smell upon opening, or if Aspirin Effervescent Tablets does not fizz when placed in water, it means the medicine is breaking down. Throw the medicine away safely and out of the reach of children; contact your pharmacist and replace.

Do not take Aspirin Effervescent Tablets for at least 7 days after any surgery unless directed by your health care provider.

Tell your doctor or dentist that you take Aspirin Effervescent Tablets before you receive any medical or dental care, emergency care, or surgery.

Aspirin Effervescent Tablets should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aspirin Effervescent Tablets while you are pregnant. Aspirin Effervescent Tablets are not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Aspirin Effervescent Tablets are found in breast milk. If you are or will be breast-feeding while you use Aspirin Effervescent Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Aspirin Effervescent Tablets:

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

Heartburn; nausea; upset stomach.

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); bloody or black stools; confusion; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; unusual bruising; vomiting.

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: Aspirin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; fever; hearing loss; lethargy; lightheadedness, especially upon standing; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; vomiting.

Proper storage of Aspirin Effervescent Tablets:

Store Aspirin Effervescent Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aspirin Effervescent Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Aspirin Effervescent Tablets, please talk with your doctor, pharmacist, or other health care provider.

Aspirin Effervescent Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Aspirin resources

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

Compare Aspirin with other medications

Angina
Angina Pectoris Prophylaxis
Ankylosing Spondylitis
Antiphospholipid Syndrome
Aseptic Necrosis
Back Pain
Fever
Heart Attack
Ischemic Stroke
Ischemic Stroke, Prophylaxis
Juvenile Rheumatoid Arthritis
Kawasaki Disease
Myocardial Infarction, Prophylaxis
Niacin Flush
Osteoarthritis
Pain
Prevention of Thromboembolism in Atrial Fibrillation
Prosthetic Heart Valves
Prosthetic Heart Valves, Mechanical Valves
Revascularization Procedures, Prophylaxis
Rheumatic Fever
Rheumatoid Arthritis
Sciatica
Systemic Lupus Erythematosus
Thromboembolic Stroke Prophylaxis
Transient Ischemic Attack

Sunday, 11 March 2012

Vusion

Pronunciation: MYE-KON-a-zole/zinc/pet-roe-LAY-tum
Generic Name: Miconazole/Zinc/White Petrolatum
Brand Name: Vusion

Vusion is used for:

Treating a certain type of diaper rash in certain pediatric patients. It is used along with gentle cleansing of the diaper area and frequent diaper changes.

Vusion is an antifungal and skin protectant ointment. It works by killing sensitive fungi. It also helps to protect the skin from irritation.

Do NOT use Vusion if:

you are allergic to any ingredient in Vusion

Contact your doctor or health care provider right away if this applies to you.

Before using Vusion:

Some medical conditions may interact with Vusion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

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

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

if you have liver problems, bladder problems, a weakened immune system, or the blood disease porphyria

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

Ask your health care provider if Vusion 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 Vusion:

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

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

Gently cleanse the diaper area with very mild soap and lukewarm water before you apply Vusion. Pat the area dry with a soft towel.

Use the fingertips to apply a thin layer of medicine to the diaper area after each diaper change. Do NOT rub the medicine in. Rubbing may cause more irritation.

Wash your hands immediately after using Vusion.

To clear up your infection completely, use Vusion for the full course of treatment. Keep using it even if the condition improves within a few days.

If you miss a dose of Vusion, use 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 use 2 doses at once.

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

Important safety information:

Vusion is for external use only. Avoid contact with the eyes or mouth. If you get Vusion in your eyes, rinse them immediately with a generous amount of cool water.

Do not get Vusion inside the vagina.

Do NOT use more than the recommended dose or for longer than 7 days without checking with your doctor. Vusion is not for long-term use. If symptoms do not get better within 7 days or if they get worse, check with your doctor.

Vusion should not be used to prevent diaper rash. Vusion is not a substitute for frequent diaper changes. You must keep the diaper area clean and dry.

Do not use scented soaps, shampoos, or lotions on the diaper area.

Be sure to use Vusion for the full course of treatment. If you do not, the medicine may not clear up the infection completely. The fungus could also become less sensitive to this or other medicine. This could make the infection harder to treat in the future.

Vusion should not be used in CHILDREN younger than 4 weeks old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Vusion, contact your doctor. You will need to discuss the benefits and risks of using Vusion while you are pregnant. It is not known if Vusion is found in breast milk. If you are or will be breast-feeding while you are using Vusion, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Vusion:

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

See also: Vusion 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 Vusion:

Store Vusion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vusion out of the reach of children and away from pets.

General information:

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

Vusion 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 Vusion. 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

More Vusion resources

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

Vusion Prescribing Information (FDA)

Vusion Consumer Overview

Compare Vusion with other medications

Diaper Rash

Friday, 9 March 2012

Leflunomide 10 mg Film-coated Tablets

1. Name Of The Medicinal Product

Leflunomide 10 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 10 mg of leflunomide.

Excipients:

Each film-coated tablet contains 76 mg of lactose and 0.06 mg of soya lecithin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White to almost white, round film-coated tablet with a diameter of about 6 mm.

4. Clinical Particulars

4.1 Therapeutic Indications

Leflunomide is indicated for the treatment of adult patients with:

• active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD),

Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects.

Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.

4.2 Posology And Method Of Administration

The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis.

Alanine aminotransferase (ALT) (or serum glutamopyruvate transferase SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency:

• before initiation of leflunomide,

• every two weeks during the first six months of treatment, and

• every 8 weeks thereafter (see section 4.4).

Posology

Leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.

• The recommended maintenance dose for rheumatoid arthritis is leflunomide 10 mg to 20 mg once daily. Patients may be started on leflunomide 10 mg or 20 mg depending on the severity activity) of the disease.

The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.

There is no dose adjustment recommended in patients with mild renal insufficiency.

No dosage adjustment is required in patients above 65 years of age.

Paediatric population

Leflunomide is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).

Administration

Leflunomide film-coated tablets should be swallowed whole with sufficient amounts of liquid. The extent of leflunomide absorption is not affected if it is taken with food.

4.3 Contraindications

• Hypersensitivity to the active substance (especially previous Stevens- Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) peanut or soya or to any of the excipients,

• Patients with impairment of liver function,

• Patients with severe immunodeficiency states, e.g. AIDS,

• Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid arthritis,

• Patients with serious infections (see section 4.4),

• Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group,

• Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome,

• Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/l (see section 4.6). Pregnancy must be excluded before start of treatment with leflunomide,

• Breast-feeding women (see section 4.6).

4.4 Special Warnings And Precautions For Use

Leflunomide should be administered to patients only under careful medical supervision.

Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.

The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks. Serious undesirable effects might occur (e.g. hepatotoxicity, haematotoxicity or allergic reactions, see below), even if the treatment with leflunomide has been stopped. Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed. The procedure may be repeated as clinically necessary.

For washout procedures and other recommended actions in case of desired or unintended pregnancy, see section 4.6.

Liver reactions

Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide. Most of the cases occurred within the first 6 months of treatment. Co-treatment with other hepatotoxic medicinal products was frequently present. It is considered essential that monitoring recommendations are strictly adhered to.

ALT (SGPT) must be checked before initiation of leflunomide and at the same frequency as the complete blood cell count (every two weeks) during the first six months of treatment and every 8 weeks thereafter.

For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly. If ALT (SGPT) elevations of more than 2-fold the upper limit of normal persist or if ALT elevations of more than 3-fold the upper limit of normal are present, leflunomide must be discontinued and wash-out procedures initiated. It is recommended that monitoring of liver enzymes be maintained after discontinuation of leflunomide treatment, until liver enzyme levels have normalised.

Due to a potential for additive hepatotoxic effects, it is recommended that alcohol consumption be avoided during treatment with leflunomide.

Since the active metabolite of leflunomide, A771726, is highly protein bound and cleared via hepatic metabolism and biliary secretion, plasma levels of A771726 are expected to be increased in patients with hypoproteinaemia. Leflunomide is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).

Haematological reactions

Together with ALT, a complete blood cell count, including differential white blood cell count and platelets, must be performed before start of leflunomide treatment as well as every 2 weeks for the first 6 months of treatment and every 8 weeks thereafter.

In patients with pre-existing anaemia, leucopenia, and/or thrombocytopenia as well as in patients with impaired bone marrow function or those at risk of bone marrow suppression, the risk of haematological disorders is increased. If such effects occur, a washout (see below) to reduce plasma levels of A771726 should be considered.

In case of severe haematological reactions, including pancytopenia, Leflunomide and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.

Combinations with other treatments

The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents (with the exception of methotrexate, see section 4.5) has not been studied up to now. The risk associated with combination therapy, in particular in long-term treatment, is unknown. Since such therapy can lead to additive or even synergistic toxicity (e.g. hepato- or haematotoxicity), combination with another DMARD (e.g. methotrexate) is not advisable.

Caution is advised when leflunomide is given together with drugs, other than NSAIDs, metabolised by CYP2C9 such as phenytoin, warfarin, phenprocoumon and tolbutamide.

Switching to other treatments

As leflunomide has a long persistence in the body, a switching to another DMARD (e.g. methotrexate) without performing the washout procedure (see below) may raise the possibility of additive risks even for a long time after the switching (i.e. kinetic interaction, organ toxicity).

Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e.g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/risk aspects and closer monitoring is recommended in the initial phase after switching.

Skin reactions

In case of ulcerative stomatitis, leflunomide administration should be discontinued.

Very rare cases of Stevens Johnson syndrome or toxic epidermal necrolysis have been reported in patients treated with leflunomide. As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately. A complete washout is essential in such cases. In such cases re-exposure to leflunomide is contra-indicated (see section 4.3).

Infections

It is known that medicinal products with immunosuppressive properties - like leflunomide - may cause patients to be more susceptible to infections, including opportunistic infections. Infections may be more severe in nature and may, therefore, require early and vigorous treatment. In the event that severe, uncontrolled infections occur, it may be necessary to interrupt leflunomide treatment and administer a washout procedure as described below.

Rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving leflunomide among other immunosuppressants.

Patients with tuberculin reactivity must be carefully monitored because of the risk of tuberculosis reactivation.

Respiratory reactions

Interstitial lung disease has been reported during treatment with leflunomide (see section 4.8). Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy. Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.

Blood pressure

Blood pressure must be checked before the start of leflunomide treatment and periodically thereafter.

Procreation (recommendations for men)

Male patients should be aware of the possible male-mediated foetal toxicity. Reliable contraception during treatment with leflunomide should also be guaranteed.

There are no specific data on the risk of male-mediated foetal toxicity. However, animal studies to evaluate this specific risk have not been conducted. To minimise any possible risk, men wishing to father a child should consider discontinuing use of leflunomide and taking colestyramine 8 g 3 times daily for 11 days or 50 g of activated powdered charcoal 4 times daily for 11 days.

In either case the A771726 plasma concentration is then measured for the first time. Thereafter, the A771726 plasma concentration must be determined again after an interval of at least 14 days. If both plasma concentrations are below 0.02 mg/l, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.

Washout procedure

Colestyramine 8 g is administered 3 times daily. Alternatively, 50 g of activated powdered charcoal is administered 4 times daily. Duration of a complete washout is usually 11 days. The duration may be modified depending on clinical or laboratory variables.

Lactose

Leflunomide contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interactions studies have only been performed in adults.

Increased side effects may occur in case of recent or concomitant use of hepatotoxic or haematotoxic drugs or when leflunomide treatment is followed by such drugs without a washout period (see also guidance concerning combination with other treatments, section 4.4). Therefore, closer monitoring of liver enzymes and haematological parameters is recommended in the initial phase after switching.

In a small (n=30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of 30 patients. All elevations resolved, 2 with continuation of both drugs and 3 after discontinuation of leflunomide. A more than 3-fold increase was seen in another 5 patients. All of these also resolved,2 with continuation of both drugs and 3 after discontinuation of leflunomide.

In patients with rheumatoid arthritis, no pharmacokinetic interaction between the leflunomide (10 to 20 mg per day) and methotrexate (10 to 25 mg per week) was demonstrated.

It is recommended that patients receiving leflunomide are not treated with colestyramine or activated powdered charcoal because this leads to a rapid and significant decrease in plasma A771726 (the active metabolite of leflunomide; see also section 5) concentration. The mechanism is thought to be by interruption of enterohepatic recycling and/or gastrointestinal dialysis of A771726.

If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide.

The enzymes involved in the metabolism of leflunomide and its metabolites are not exactly known. An in vivo interaction study with cimetidine (non-specific cytochrome P450 inhibitor) has demonstrated a lack of a significant interaction. Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40%, whereas the AUC was not significantly changed. The mechanism of this effect is unclear.

In vitro studies indicate that A771726 inhibits cytochrome P4502C9 (CYP2C9) activity. In clinical trials no safety problems were observed when leflunomide and NSAIDs metabolised by CYP2C9 were co-administered. Caution is advised when leflunomide is given together with drugs, other than NSAIDs, metabolised by CYP2C9 such as phenytoin, warfarin, phenprocoumon and tolbutamide.

In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 μg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.

Vaccinations

No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment.

Vaccination with live attenuated vaccines is, however, not recommended. The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide.

4.6 Pregnancy And Lactation

Pregnancy

The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy. Leflunomide is contraindicated in pregnancy (see section 4.3).

Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “waiting period” below) or up to 11 days after treatment (see abbreviated “washout period” below).

The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy. It is possible that rapidly lowering the blood level of the active metabolite, by instituting the drug elimination procedure described below, at the first delay of menses may decrease the risk to the foetus from leflunomide.

In a small prospective study in women (n=64) who became inadvertently pregnant while taking leflunomide for no more than three weeks after conception and followed by a drug elimination procedure, no significant differences (p=0.13) were observed in the overall rate of major structural defects (5.4%) compared to either of the comparison groups (4.2 % in the disease matched group [n=108] and 4.2% in healthy pregnant women [n=78]).

For women receiving leflunomide treatment and who wish to become pregnant, one of the following procedures is recommended in order to ascertain that the foetus is not exposed to toxic concentrations of A771726 (target concentration below 0.02 mg/l):

Waiting period

A771726 plasma levels can be expected to be above 0.02 mg/l for a prolonged period. The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment with leflunomide.

After a 2-year waiting period, the A771726 plasma concentration is measured for the first time. Thereafter, the A771726 plasma concentration must be determined again after an interval of at least 14 days. If both plasma concentrations are below 0.02 mg/l no teratogenic risk is to be expected.

For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).

Washout procedure

After stopping treatment with leflunomide:

• colestyramine 8 g is administered 3 times daily for a period of 11 days,

• alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days.

However, also following either of the washout procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required.

Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant. If a waiting period of up to approximately 2 years under reliable contraception is considered unpractical, prophylactic institution of a washout procedure may be advisable.

Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal. Use of alternative contraceptive methods is recommended.

Lactation

Animal studies indicate that leflunomide or its metabolites pass into breast milk. Breast-feeding women must, therefore, not receive leflunomide.

4.7 Effects On Ability To Drive And Use Machines

In the case of side effects such as dizziness the patient's ability to concentrate and to react properly may be impaired. In such cases patients should refrain from driving cars and using machines.

4.8 Undesirable Effects

The most frequently adverse reactions reported commonly (

Classification of expected frequencies:

Very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Infections and infestations

Rare:

severe infections, including sepsis which may be fatal

Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4). Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia).

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.

Blood and lymphatic system disorders

Common:	leucopenia (leucocytes >2 G/l)
Uncommon:	anaemia, mild thrombocytopenia (platelets <100 G/l)
Rare:	pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes <2 G/l), eosinophilia
Very rare:	agranulocytosis

Recent, concomitant or consecutive use of potentially myelotoxic agents may be associated with a higher risk of haematological effects.

Immune system disorders

Common:	mild allergic reactions
Very rare:	severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis

Metabolism and nutrition disorders

Common:	CPK increased
Uncommon:	hypokalaemia, hyperlipidemia, hypophosphataemia
Rare:	LDH increased
Not known:	hypouricaemia

Psychiatric disorders

Uncommon:

anxiety

Nervous system disorders

Common:	paraesthesia, headache, dizziness
Very rare:	peripheral neuropathy

Cardiac disorders

Common:	mild increase in blood pressure
Rare:	severe increase in blood pressure

Respiratory, thoracic and mediastinal disorders

Rare:

interstitial lung disease (including interstitial pneumonitis), which may be fatal

Gastrointestinal disorders

Common:	diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ceration), abdominal pain
Uncommon:	taste disturbances
Very rare:	pancreatitis

Hepatobiliary disorders

Common:	elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Rare:	hepatitis, jaundice/cholestasis
Very rare:	severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal

Skin and subcutaneous tissue disorders

Common:	increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin
Uncommon:	urticaria
Very rare:	toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme

Musculoskeletal and connective tissue disorders

Common:	tenosynovitis
Uncommon:	tendon rupture

Renal and urinary disorders

Not known:

renal failure

Reproductive system and breast disorders

Not known:

marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility

General disorders and administration site conditions

Common:

anorexia, weight loss (usually insignificant), asthenia

4.9 Overdose

Symptoms

There have been reports of chronic overdose in patients taking Leflunomide at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children. There were no adverse events reported in the majority of case reports of overdose. Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash.

Management

In the event of an overdose or toxicity, colestyramine or charcoal is recommended to accelerate elimination. Colestyramine given orally at a dose of 8 g three times a day for 24 hours to three healthy volunteers decreased plasma levels of A771726 by approximately 40% in 24 hours and by 49% to 65% in 48 hours.

Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite A771726 by 37% in 24 hours and by 48% in 48 hours. These washout procedures may be repeated if clinically necessary.

Studies with both haemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: antineoplastic and immunomodulating agents; immunosuppressants; selective immunosuppressants, ATC code: L04AA13.

Human pharmacology

Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.

Animal pharmacology

Leflunomide is effective in animal models of arthritis and of other autoimmune diseases and transplantation, mainly if administered during the sensitisation phase. It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties. Leflunomide exhibits the best protective effects on animal models of autoimmune diseases when administered in the early phase of the disease progression.

In vivo, it is rapidly and almost completely metabolised to A771726 which is active in vitro, and is presumed to be responsible for the therapeutic effect.

Mode of action

A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.

Rheumatoid arthritis

The efficacy of Leflunomide in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III). The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n=102), leflunomide 5 mg (n=95), 10 mg (n=101) or 25 mg/day (n=104). The treatment duration was 6 months.

All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.

Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=133), sulphasalazine 2 g/day (n=133), or placebo (n=92). Treatment duration was 6 months.

Study MN303 was an optional 6-month blinded continuation of MN301 without the placebo arm, resulting in a 12-month comparison of leflunomide and sulphasalazine.

Study MN302 randomised 999 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=501) or methotrexate at 7.5 mg/week increasing to 15 mg/week (n=498). Folate supplementation was optional and only used in 10% of patients. Treatment duration was 12-months.

Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118). All patients received folate 1 mg bid. Treatment duration was 12 months.

Leflunomide at a daily dose of at least 10 mg (10 to 25 mg in study YU203, 20 mg in studies MN301 and US301) was statistically significantly superior to placebo in reducing the signs and symptoms of rheumatoid arthritis in all 3 placebo-controlled trials. The ACR (American College of Rheumatology) response rates in study YU203 were 27.7% for placebo, 31.9% for 5 mg, 50.5% for 10 mg and 54.5% for 25 mg/day. In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6% vs. 28.6% (study MN301), and 49.4% vs. 26.3% (study US301). After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3% (studies MN301/303), 50.5% (study MN302) and 49.4% (study US301), compared to 53.8% (studies MN301/303) in sulphasalazine patients, 64.8% (study MN302), and 43.9% (study US301) in methotrexate patients. In study MN302 leflunomide was significantly less effective than methotrexate. However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters. No difference was observed between leflunomide and sulphasalazine (study MN301). The leflunomide treatment effect was evident by 1 month, stabilised by 3 to 6 months and continued throughout the course of treatment.

A randomised, double-blind, parallel-group non-inferiority study compared the relative efficacy of two different daily maintenance doses of leflunomide, 10 mg and 20 mg. From the results it can be concluded that efficacy results of the 20 mg maintenance dose were more favourable, on the other hand, the safety results favoured the 10 mg daily maintenance dose.

Paediatrics

Leflunomide was studied in a single multicenter, randomized, double-blind, active-controlled trial in 94 patients (47 per arm) with polyarticular course juvenile rheumatoid arthritis. Patients were 3–17 years of age with active polyarticular course JRA regardless of onset type and naive to methotrexate or leflunomide. In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: <20kg, 20-40 kg, and >40kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI)

The pattern of adverse events of leflunomide and methotrexate seems to be similar, but the dose used in lighter subjects resulted in a relatively low exposure (see section 5.2). These data do not allow an effective and safe dose recommendation.

5.2 Pharmacokinetic Properties

Leflunomide is rapidly converted to the active metabolite, A771726, by first-pass metabolism (ring opening) in gut wall and liver. In a study with radiolabelled 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces. In other studies, unchanged leflunomide levels in plasma have rarely been detected, however, at ng/ml plasma levels.

The only plasma-radiolabelled metabolite detected was A771726. This metabolite is responsible for essentially all the in-vivo activity of Leflunomide.

Absorption

Excretion data from the ¹⁴C study indicated that at least about 82 to 95% of the dose is absorbed. The time to peak plasma concentrations of A771726 is very variable; peak plasma levels can occur between 1 hour and 24 hours after single administration. Leflunomide can be administered with food, since the extent of absorption is comparable in the fed and fasting state. Due to the very long half-life of A771726 (approximately 2 weeks), a loading dose of 100 mg for 3 days was used in clinical studies to facilitate the rapid attainment of steady-state levels of A771726. Without a loading dose, it is estimated that attainment of steady-state plasma concentrations would require nearly two months of dosing. In multiple dose studies in patients with rheumatoid arthritis, the pharmacokinetic parameters of A771726 were linear over the dose range of 5 to 25 mg. In these studies, the clinical effect was closely related to the plasma concentration of A771726 and to the daily dose of leflunomide. At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately 35 μg/ml. At steady state plasma levels accumulate about 33- to 35-fold compared with single dose.

Distribution

In human plasma, A771726 is extensively bound to protein (albumin). The unbound fraction of A771726 is about 0.62%. Binding of A771726 is linear in the therapeutic concentration range. Binding of A771726 appeared slightly reduced and more variable in plasma from patients with rheumatoid arthritis or chronic renal insufficiency. The extensive protein binding of A771726 could lead to displacement of other highly-bound drugs. In vitro plasma protein binding interaction studies with warfarin at clinically relevant concentrations, however, showed no interaction. Similar studies showed that ibuprofen and diclofenac did not displace A771726, whereas the unbound fraction of A771726 is increased 2- to 3-fold in the presence of tolbutamide. A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs is only increased by 10% to 50%. There is no indication that these effects are of clinical relevance. Consistent with extensive protein binding A771726 has a low apparent volume of distribution (approximately 11 litres). There is no preferential uptake in erythrocytes.

Metabolism

Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline). The metabolic biotransformation of leflunomide to A771726 and subsequent metabolism of A771726 is not controlled by a single enzyme and has been shown to occur in microsomal and cytosolic cellular fractions. Interaction studies with cimetidine (non-specific cytochrome P450 inhibitor) and rifampicin (non-specific cytochrome P450 inducer), indicate that in vivo CYP enzymes are involved in the metabolism of leflunomide only to a small extent.

Elimination

Elimination of A771726 is slow and characterised by an apparent clearance of about 31 ml/hr. The elimination half-life in patients is approximately 2 weeks. After administration of a radiolabelled dose of leflunomide, radioactivity was equally excreted in faeces, probably by biliary elimination, and in urine. A771726 was still detectable in urine and faeces 36 days after a single administration. The principal urinary metabolites were glucuronide products derived from leflunomide (mainly in 0 to 24 hour samples) and an oxanilic acid derivative of A771726. The principal faecal component was A771726.

It has been shown in man that administration of an oral suspension of activated powdered charcoal or colestyramine leads to a rapid and significant increase in A771726 elimination rate and decline in plasma concentrations (see section 4.9). This is thought to be achieved by a gastrointestinal dialysis mechanism and/or by interrupting enterohepatic recycling.

Pharmacokinetics in renal failure

Leflunomide was administered as a single oral 100 mg dose to 3 haemodialysis patients and 3 patients on continuous peritoneal dialysis (CAPD). The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers. A more rapid elimination of A771726 was observed in haemodialysis subjects which was not due to extraction of drug in the dialysate.

Pharmacokinetics in liver failure

No data are available regarding treatment of patients with hepatic impairment. The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion. These processes may be affected by hepatic dysfunction.

Pharmacokinetics in paediatrics

The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 paediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years. The results of a population pharmacokinetic analysis of these trials have demonstrated that paediatric patients with body weights

Pharmacokinetics in elderly

Pharmacokinetic data in elderly (>65 years) are limited but consistent with pharmacokinetics in younger adults.

5.3 Preclinical Safety Data

Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats. Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.

The main effects were anaemia, leucopenia, decreased platelet counts and panmyelopathy and reflect the basic mode of action of the compound (inhibition of DNA synthesis). In rats and dogs, Heinz bodies and/or Howell-Jolly bodies were found. Other effects found on heart, liver, cornea and respiratory tract could be explained as infections due to immunosuppression. Toxicity in animals was found at doses equivalent to human therapeutic doses.

Leflunomide was not mutagenic. However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.

In a carcinogenicity study in rats, leflunomide did not show carcinogenic potential. In a carcinogenicity study in mice an increased incidence of malignant lymphoma occurred in males of the highest dose group, considered to be due to the immunosuppressive activity of leflunomide. In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted. The relevance of the findings in mice relative to the clinical use of leflunomide is uncertain.

Leflunomide was not antigenic in animal models.

Leflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range and exerted adverse effects on male reproductive organs in repeated dose toxicity studies. Fertility was not reduced.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

lactose monohydrate

low-substituted hydroxypropyl cellulose

tartaric acid

sodium laurilsulfate

magnesium stearate

Film-coating:

lecithin (soybeans)

poly(vinyl alcohol)

talc

titanium dioxide (E171)

xanthan gum

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Keep the bottle tightly closed in order to protect from moisture.

6.5 Nature And Contents Of Container

40ml HDPE-wide-necked bottle with PP screw cap with desiccant (white silica gel), containing either 10, 15, 20, 28, 30, 42, 50, 56, 60, 90, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sandoz Limited

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

8. Marketing Authorisation Number(S)

PL 04416/1172

9. Date Of First Authorisation/Renewal Of The Authorisation

01/12/2010

10. Date Of Revision Of The Text

01/12/2010

Monday, 12 March 2012

Caverject

Commonly used brand name(s)

Uses For Caverject

Before Using Caverject

Allergies

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of alprostadil

Dosing

Storage

Precautions While Using Caverject

Caverject Side Effects

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Zovia 1/50

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Aspirin Effervescent Tablets

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Sunday, 11 March 2012

Vusion

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Friday, 9 March 2012

Leflunomide 10 mg Film-coated Tablets

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container