Alprostadil Solution for injection

What is this medicine?

ALPROSTADIL (al PROS ta dil) is used to treat erectile dysfunction (ED). This medicine helps to create and maintain an erection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an abnormally formed penis

• have been advised not to engage in sexual activity

• have ever had a painful erection that lasted more than 4 hours

• heart problems

• leukemia

• low blood pressure

• penile implant

• sickle cell disease or trait

• tumor of the bone marrow (multiple myeloma)

• an unusual or allergic reaction to alprostadil or other medicines, foods, dyes, or preservatives

How should I use this medicine?

This medicine is for injection into the penis. You will be taught how to use this medicine. Use exactly as directed. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

This medicine is for use in men only and is not for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

You should not use this medicine more than 3 times a week. Each dose should be given at least 24 hours apart.

What may interact with this medicine?

• medicines for blood pressure

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Contact your doctor or health care professional right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

Do not change the dose of your medication. Call your doctor or health care professional to determine if your dose needs to be changed.

This medicine does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• prolonged or painful erection

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bleeding, bruising, or pain at site of injection

• change in blood pressure

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Caverject: Store unopened product at or below 25 degrees C (77 degrees F). Do not freeze. See product instructions for storage when product is in use. Different products may have different instructions for storage. Throw away any unused medicine after the expiration date.

Edex: Store unopened product at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. See product instructions for storage when product is in use. Throw away any unused medicine after the expiration date.

When traveling, do not store this medicine in checked luggage during air travel or leave in a closed automobile.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Alprostadil Solution for injection [Ductus Arteriosus Patency]

What is this medicine?

ALPROSTADIL (al PROS ta dil) is a natural protein. It is used to treat neonates with a specific heart defect. This medicine is used for a short time until the condition can be corrected.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding problems

• breathing problems

• stomach blockage

• an unusual or allergic reaction to alprostadil or other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborn for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

• medicines for blood pressure

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in blood pressure

• changes in heart rate

• extremely irritable

• fever

• flushing

• seizures

• trouble passing urine or change in the amount of urine

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Alprostadil Urethral suppository

What is this medicine?

ALPROSTADIL (al PROS ta dil) is a natural protein. It is used to treat erectile dysfunction (ED). This medicine helps to create and maintain an erection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have, or have had any of these conditions:

• an abnormally formed penis

• bleeding disorders

• have a condition that might cause a painful, prolonged erection, such as sickle cell disease or trait, leukemia, or multiple myeloma

• have been advised not to engage in sexual activity

• history of blood clots

• history of fainting

• history of low blood pressure

• penile implant

• trouble passing urine

• an unusual or allergic reaction to alprostadil or other medicines, foods, dyes, or preservatives

• if your partner is pregnant or intends to become pregnant

How should I use this medicine?

This medicine is for insertion into the penis. Follow the directions that come with your medicine. If you are unsure how to use this medicine, contact your doctor or health care professional. Do not change the dose of your medicine. Call your doctor or health care professional to determine if your dose needs to be changed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

This medicine is for use in men only and is not for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine should only be used as needed to achieve an erection. Do not use this medicine more often than directed. Do not use more than 2 times in each 24-hour period. Each suppository is for a single use only and should be properly discarded after use.

What may interact with this medicine?

• medicines for blood pressure

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your condition.

If you experience dizziness or feel faint during sexual intercourse, this may be due to the lowering of your blood pressure. Lie down immediately and raise your legs. If symptoms persist, call your doctor promptly.

Contact your doctor or health care professional right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

Men should inform their doctors if they wish to father a child. This medicine may be found in human semen and may have the potential for side effects to an unborn child. A female partner should not become pregnant while you are using this medicine. It is also recommended that you do not use this medicine while your partner is pregnant. Inform your doctor if your female partner wishes to become pregnant or think they might be pregnant. Talk to your health care professional or pharmacist for more information. It is recommended that you use a condom during sexual intercourse with a female partner who is of child-bearing age. If you are not using a condom, your female partner may also experience mild vaginal itching or burning.

This medicine does not protect you or your partner against HIV infection (AIDS) or any other sexually transmitted diseases.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue)

• dizziness or light-headedness

• fainting

• fast, irregular heartbeat

• prolonged or painful erection (lasting longer than 4 hours)

• swelling of the legs

• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aching in the penis, testicles, legs, or in the perineum (area between the penis and rectum)

• minor discomfort on insertion

• redness of the penis due to increased blood flow

• small amount of bleeding or spotting from the urethra due to improper use

• warmth or burning sensation in the urethra

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Store unopened foil pouches in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). You may store this medicine at room temperature for up to 14 days before use. Do not expose to temperatures above 30 degrees C (86 degrees F). Do not expose to direct sunlight. When traveling, store this medicine in a portable ice pack or cooler. Do not store in the trunk of a car or in baggage storage areas. Throw away any unused medicine after the expiration date.

The suppository must be thrown away after it is used. It is for single use only. Discard any used medicine and packaging carefully. This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Follow the directions you receive with each prescription refill.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.