Serious Warnings and Precautions

VASOTEC should not be used during pregnancy. If you discover that you are pregnant while taking VASOTEC, stop the medication and please contact your physician as soon as possible.

This medicine may not be suitable for certain people. Tell your physician or pharmacist if you think any of the following applies to you:

• You have previously taken VASOTEC or other medication of the same type—Angiotensin Converting Enzyme (ACE) inhibitors such as enalapril, lisinopril, captopril, and you were allergic or reacted badly to it, particularly if you experienced swelling of the face, lips, tongue, or throat, or had sudden difficulty breathing or swallowing. These are symptoms of conditions called hereditary angioedema or idiopathic angioedema.
• Are taking a medicine that contains aliskiren, such as RASILEZ, used to lower high blood pressure. The combination with VASOTEC is not recommended.
• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
• Are taking anti-cancer (temsirolimus, everolimus) or anti-rejection (sirolimus) medications. Use of ACE inhibitors, such asVASOTEC, with these drugs may increase the chance of having an allergic reaction (angioedema).
• You should not take this medicine if you have been diagnosed with hereditary angioedema or idiopathic angioedema (angioedema of unknown cause).
• Dizziness or drowsiness may occasionally occur when taking medication to lower blood pressure. Therefore, before you perform tasks which may require special attention (driving a car or operating dangerous machinery), wait until you know how you respond to your medicine.
• You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors.
• You are pregnant, breast-feeding or thinking of becoming pregnant. Taking VASOTEC during pregnancy can cause injury and even death to your developing baby. This medicine should not be used during pregnancy. If you become pregnant while taking VASOTEC, stop the medication and report to your physician as soon as possible. It is possible that VASOTEC passes into breast milk. You should not breast-feed while taking VASOTEC.
• You suffer from low blood pressure (you may notice this as faintness or dizziness, especially when standing).
• You are undergoing dialysis.
• You have any of these conditions:
  • diabetes
  • heart or blood vessel disease
  • liver disease
  • kidney disease
• You are receiving gold (sodium aurothiomalate) injections.
• You are taking “water pills” or potassium supplements.
• You use potassium containing salt substitutes with your food.

You should also inform your physician or pharmacist if you have recently suffered from excessive vomiting or diarrhea.

If you have diabetes and are taking oral medicines to treat diabetes or insulin, you should closely monitor for low blood glucose levels, especially during the first month of treatment with VASOTEC.

If you have to undergo any dental or other surgery, inform the dentist or the physician in charge that you are taking this medicine.

Remember: This medicine is prescribed for the particular condition that you have. Do not give this medicine to other people, nor use it for any other condition.

Do not use outdated medicine.

Along with its intended action, any medication, including VASOTEC, may cause side effects. Most people do not experience any problem when taking these medicines; but if you notice any of the following, have other side effects or if the condition persists or worsens, seek medical attention.

• Dry cough, sore throat.
• The initial dose may cause a greater fall in blood pressure than will occur following continued treatment. You may notice this as faintness or dizziness and it may help to lie down. If concerned, please consult your physician or pharmacist.

Do not take any other medicines unless you have discussed the matter with your physician or pharmacist. Certain medications tend to increase your blood pressure, for example, non-prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems, or may also react badly with VASOTEC.

Your physician or pharmacist also needs to know if you are taking any other medication, whether on prescription or otherwise. It is particularly important to inform your physician or pharmacist if you are taking:

• Diuretics or “water pills”; any other medicines to reduce blood pressure.
• Diabetes medicine and/or insulin.
• Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ), or angiotensin receptor blockers (ARBs).
• Potassium-containing medicines, potassium supplements.
• Salt substitutes that contain potassium, as these may lead to increased levels of potassium in the blood which can be serious. In these cases, your physician may need to adjust the dosage of VASOTEC or monitor your blood level of potassium.
• Lithium (a drug used to treat a certain kind of depression).
• Certain pain and arthritis medicines, including gold therapy and non-steroidal anti-inflammatory drugs.
• mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy. Taking these drugs together could increase the risk for an allergic reaction called angioedema.

Usual dose:

• Take this medicine exactly as your physician ordered.
• The absorption of this medicine is not affected by food; so it can be taken with or without a meal.
• Try to take your medicine every day at the same time. This way it becomes easy to remember your doses.
• The splitting of VASOTEC tablets is not advised.

For patients with high blood pressure:

Adults:

Your physician may adjust the dose according to your blood pressure response. The usual dose range is 10 mg to 40 mg per day given in a single dose or two divided doses. The maximum daily dose for VASOTEC oral administration is 40 mg.

Children (less than 16 years)

The usual starting dose is up to 5 mg once daily. Doses above 40 mg have not been studied.

For patients with congestive heart failure:

The initial dose is 2.5 mg taken once a day. Your physician will closely monitor you to determine the initial effect on your blood pressure. The usual daily dose is 5 mg to 20 mg given in a single dose or two divided doses. The maximum daily dose is 40 mg.

Overdose:

In case of an overdose, contact your physician, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms. The most likely symptom would be a feeling of lightheadedness or dizziness due to a sudden or excessive drop in blood pressure.

Missed dose:

If you miss a dose of this medicine, take it as soon as possible. However, if no more than six hours have elapsed since the missed dose, you may take that day's dose of medication and then go back to your regular dosing schedule. Do not take a double dose.

You should not use this medication if you have a severe form of psoriasis (with pus, skin peeling, severe redness).

Before using VECTICAL topical, tell your doctor if you have low or high levels of calcium in your blood, a calcium disorder or metabolic imbalance, or if you are receiving UV light treatments (phototherapy) for your psoriasis.

Tell your doctor about all other medicines you are using to treat psoriasis. Also tell your doctor if you are taking a diuretic (water pill) or vitamin or mineral supplements that contain calcium or vitamin D.

VECTICAL topical is for use only on areas of psoriasis. Avoid getting it on healthy skin areas. VECTICAL topical should not be applied to the face or the vaginal area.

Stop using this medication and call your doctor if you have a serious side effect such as blistering or severe redness, itching, or other irritation of treated skin.

Using VECTICAL topical can affect your body's ability to metabolize calcium. This can result in high levels of calcium in your blood (hypercalcemia). Symptoms of this condition include nausea, loss of appetite, constipation, increased thirst and urination, muscle weakness, confusion, and feeling tired or restless. Call your doctor if you have any of these symptoms.

You should not use this medication if you have a severe form of psoriasis (with pus, skin peeling, severe redness).

To make sure you can safely use VECTICAL topical, tell your doctor if you have any of these other conditions:

• low or high levels of calcium in your blood;
• a calcium disorder or metabolic imbalance; or
• if you are receiving UV light treatments (phototherapy) for your psoriasis.

FDA pregnancy category C. It is not known whether VECTICAL topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known if VECTICAL topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on anyone under 18 years old without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using VECTICAL topical and call your doctor at once if you have any of these serious side effects:

• blistering, or severe redness, itching, or other irritation of treated areas; or
• worsened symptoms or no improvement in psoriasis.

Using VECTICAL topical can affect your body's ability to metabolize calcium. This can result in high levels of calcium in your blood (hypercalcemia). Symptoms of this condition include nausea, constipation, loss of appetite, increased thirst and urination, muscle weakness, confusion, and feeling tired or restless. Call your doctor if you have any of these symptoms.

Less serious side effects may include mild itching or skin discomfort.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid exposing treated skin areas to sunlight or tanning beds. VECTICAL topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid getting this medication in your eyes or mouth, or on your lips. If this does happen, rinse with water.

Tell your doctor about all other medicines you use, especially:

• other medicines to treat psoriasis;
• vitamin or mineral supplements that contain calcium or vitamin D; or
• a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

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

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

VECTICAL topical is usually applied once in the morning and once in the evening. Follow your doctor's instructions.

Do not share this medication with other people, even if they have the same symptoms you have.

Wash your hands before and after applying this medicine.

Apply a thin layer of the medication and rub it in completely.

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

VECTICAL topical is for use only on areas of psoriasis. Avoid getting it on healthy skin areas.

VECTICAL topical should not be applied to the face or the vaginal area.

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

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include nausea, weakness, or confusion.

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

VEPESID can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

You should not use VEPESID if you are allergic to it.

To make sure you can safely take VEPESID, tell your doctor if you have kidney disease.

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

Do not use VEPESID if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether VEPESID passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using VEPESID.

Call your doctor at once if you have:

• sudden chest pain or discomfort, wheezing, dry cough or hack;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• vision problems;
• seizure (convulsions);
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
• low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting; or
• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

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

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

Other drugs may interact with VEPESID, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with VEPESID, especially:

• cyclosporine (Gengraf, Neoral, Sandimmune);
• a blood thinner--warfarin, Coumadin, Jantoven; or
• seizure medicine--carbamazepine, phenobarbital, phenytoin, valproic acid, and others.

This list is not complete. Other drugs may interact with VEPESID, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Take this medicine with a full glass of water.

Do not break or open the VEPESID capsule. Do not use a pill that has been accidentally broken.

The medicine from a broken capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Wear disposable rubber gloves when you handle a VEPESID capsule. Throw the gloves away after one use.

VEPESID can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Store VEPESID capsules in the refrigerator, do not freeze.

VEPESID is injected into a vein through an IV. A healthcare provider will give you this injection.

VEPESID is usually given as part of a 4-day or 5-day treatment cycle every 3 or 4 weeks. Follow your doctor's dosing instructions very carefully.

VEPESID can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

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

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