Coreg is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Coreg is used to treat heart failure and hypertension (high blood pressure).

Coreg is also used after a heart attack that has caused your heart not to pump as well.

Warnings

You should not take Coreg if you have asthma, bronchitis, emphysema, severe liver disease, or a serious heart condition such as heart block, “sick sinus syndrome,” or slow heart rate (unless you have a pacemaker).

Avoid drinking alcohol within 2 hours before or after taking extended-release Coreg CR capsules. Also avoid taking medicines or other products that might contain alcohol. Alcohol may cause the carvedilol in the controlled release (CR) capsule to be released too quickly into the body.

If you are being treated for high blood pressure, keep using Coreg even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your l

Before taking this medicine

You should not take Coreg if you are allergic to carvedilol, or if you have:

• asthma, bronchitis, emphysema;
• severe liver disease; or
• a serious heart condition such as severe heart failure, heart block, “sick sinus syndrome,” or slow heart rate (unless you have a pacemaker).

To make sure Coreg is safe for you, tell your doctor if you have:

• coronary artery disease (clogged arteries);
• slow heartbeats that have caused you to faint;
• fluid retention;
• asthma or other lung problems;
• angina (chest pain);
• diabetes (taking carvedilol can make it harder for you to tell when you have low blood sugar);
• a thyroid disorder;
• kidney disease;
• circulation problems (such as Raynaud’s syndrome); or
• pheochromocytoma (tumor of the adrenal gland).

Tell your doctor if you are pregnant or breastfeeding.

Coreg is not approved for use by anyone younger than 18 years old.

How should I take Coreg?

Take Coreg exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Coreg works best if you take it with food, at the same time every day.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of cold applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

If you are switched from the tablets to Coreg CR extended-release capsules, your daily total dose of this medicine may be higher or lower than before. Older adults may be more likely to become dizzy or feel faint when switching from tablets to extended-release capsules. Follow your doctor’s instructions.

Your blood pressure will need to be checked often.

If you need surgery (including cataract surgery), tell your surgeon you currently use this medicine. You may need to stop for a short time.

You should not stop using Coreg suddenly. Stopping suddenly may cause chest pain or a heart attack. Follow your doctor’s instructions about tapering your dose.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Coreg is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include uneven heartbeats, shortness of breath, bluish-colored fingernails, dizziness, weakness, fainting, and seizure (convulsions).

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Coreg side effects

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• slow or uneven heartbeats;
• cold feeling or numbness in your fingers or toes;
• chest pain, dry cough, wheezing, chest tightness;
• heart problems – swelling, rapid weight gain, feeling short of breath; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

Common Coreg side effects may include:

• dizziness;
• slow heartbeats;
• diarrhea;
• weight gain;
• dry eyes; or
• problems wearing contact lenses.

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

What other drugs will affect Coreg?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with carvedilol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Chlorthalidone is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Chlorthalidone treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or kidney disorders, or edema caused by taking steroids or estrogen.

Chlorthalidone is also used to treat high blood pressure (hypertension).

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

Chlorthalidone side effects

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

Chlorthalidone may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• low sodium–headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• low magnesium–dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or
• kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects of chlorthalidone may include:

• low blood pressure (feeling light-headed);
• kidney problems;
• dizziness; or
• an electrolyte imbalance (such as low levels of potassium, sodium, or magnesium in your blood).

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

Warnings

You should not use chlorthalidone if you are unable to urinate, or if you are allergic to sulfa drugs.

Before taking this medicine

You should not use chlorthalidone if you are allergic to it, or if:

• you are unable to urinate; or
• you are allergic to sulfa drugs.

Tell your doctor if you have ever had:

• kidney disease;
• heart failure;
• gout;
• high cholesterol or triglycerides;
• diabetes; or
• if you are on a low-salt diet.

Tell your doctor if you are pregnant or plan to become pregnant. Taking chlorthalidone during pregnancy may cause side effects in the newborn baby, such as jaundice (yellowing of the skin or eyes), bruising or bleeding, low blood sugar, or an electrolyte imbalance.

Do not start or stop taking chlorthalidone during pregnancy without your doctor’s advice. Although chlorthalidone may cause side effects in a newborn, having high blood pressure during pregnancy can cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating hypertension may outweigh any risks to the baby.

You should not breastfeed while using chlorthalidone.

How should I take chlorthalidone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking chlorthalidone. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

Your blood pressure will need to be checked often. Your blood and urine may both be tested if you have been vomiting or are dehydrated.

chlorthalidone can affect the results of certain medical tests. Tell any doctor who treats you that you are using chlorthalidone.

If you need surgery, tell your surgeon you currently use this medicine.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store this medicine at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Chlorthalidone dosing information

Usual Adult Dose for Hypertension:

-Initial dose: 25 mg orally once a day
-Titration: Increase to 50 mg orally once a day if response is inadequate; if response is still inadequate, increase to 100 mg orally once a day, or a second antihypertensive drug (step 2 therapy) may be added
-Maintenance dose: 25 to 100 mg orally once a day
-Maximum dose: 100 mg orally once a day

Comments:
-Doses should be taken in the morning with food.
-Maintenance doses may be lower than initial doses and should be adjusted according to individual patient response.
-Effectiveness is well sustained during continued use.

Use: Hypertension (alone or with another antihypertensive drug)

Usual Adult Dose for Edema:

-Initial dose: 50 to 100 mg orally once a day, or 100 mg orally every other day; some patients may require 150 to 200 mg orally at these intervals
-Maximum dose: 200 mg orally once a day

Comments:
-Doses should be taken in the morning with food.
-Maintenance doses may be lower than initial doses and should be adjusted according to individual patient response.
-Effectiveness is well sustained during continued use.

Use: For edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include nausea, weakness, dizziness, drowsiness, extreme thirst, muscle pain, or rapid heartbeats.

What should I avoid while taking chlorthalidone?

Drinking alcohol with chlorthalidone can cause side effects.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

What other drugs will affect chlorthalidone?

Using chlorthalidone with other drugs that make you light-headed can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• other blood pressure medications;
• lithium;
• digoxin, digitalis;
• insulin or oral diabetes medicine; or
• steroid medicine.

Carvedilol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Carvedilol is used to treat heart failure and hypertension (high blood pressure). It is also used after a heart attack that has caused your heart not to pump as well.

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

Warnings

You should not take carvedilol if you have asthma, bronchitis, emphysema, severe liver disease, or a serious heart condition such as heart block, “sick sinus syndrome,” or slow heart rate (unless you have a pacemaker).

Avoid drinking alcohol within 2 hours before or after taking extended-release carvedilol (Coreg CR). Also avoid taking medicines or other products that might contain alcohol. Alcohol may cause the carvedilol in Coreg CR to be released too quickly into the body.

If you are being treated for high blood pressure, keep using carvedilol even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

You should not take carvedilol if you are allergic to it, or if you have:

• asthma, bronchitis, emphysema;
• severe liver disease; or
• a serious heart condition such as heart block, “sick sinus syndrome,” or slow heart rate (unless you have a pacemaker).

To make sure carvedilol is safe for you, tell your doctor if you have:

• diabetes (taking carvedilol can make it harder for you to tell when you have low blood sugar);
• angina (chest pain);
• liver or kidney disease;
• a thyroid disorder;
• pheochromocytoma (tumor of the adrenal gland);
• circulation problems (such as Raynaud’s syndrome); or
• a history of allergies.

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

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

How should I take carvedilol?

Take carvedilol exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Carvedilol works best if you take it with food.

You may open the carvedilol capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Take carvedilol at the same time every day. Do not skip doses or stop taking carvedilol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you are switched from carvedilol tablets to carvedilol extended-release capsules (Coreg CR), your daily total dose of this medicine may be higher or lower than before. Older adults may be more likely to become dizzy or feel faint when switching from tablets to extended-release capsules. Follow your doctor’s instructions.

Your blood pressure will need to be checked often.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

If you need surgery, tell the surgeon ahead of time that you are using carvedilol. You may need to stop using the medicine for a short time.

You should not stop using carvedilol suddenly. Stopping suddenly may make your condition worse.

Carvedilol can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using carvedilol before surgery unless your surgeon tells you to.

Carvedilol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include uneven heartbeats, shortness of breath, bluish-colored fingernails, dizziness, weakness, fainting, and seizure (convulsions).

What to avoid

Carvedilol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of carvedilol. You should especially avoid drinking alcohol within 2 hours before or after taking extended-release carvedilol (Coreg CR).

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Carvedilol side effects

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

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

• a light-headed feeling, like you might pass out;
• slow or uneven heartbeats;
• swelling, rapid weight gain, feeling short of breath (even with mild exertion);
• cold feeling or numbness in your fingers or toes;
• chest pain, dry cough, wheezing, chest tightness, trouble breathing; or
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Common carvedilol side effects may include:

• weakness, dizziness;
• diarrhea;
• dry eyes;
• tired feeling; or
• weight gain.

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

What other drugs will affect carvedilol?

Other drugs may interact with carvedilol, 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.

Candesartan is an angiotensin II receptor blocker (sometimes called an ARB).

Candesartan is used to treat high blood pressure (hypertension) in adults and children who are at least 1 year old. Lowering blood pressure may lower your risk of a stroke or heart attack.

Candesartan is also used in adults to treat certain types of heart failure and lower your risk of death or needing to be hospitalized for heart damage.

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

Candesartan side effects

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

Candesartan may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• little or no urination; or
• high potassium level–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects of candesartan may include:

• high potassium;
• headache, back pain;
• cold symptoms such as stuffy or runny nose, sneezing, sore throat;
• dizziness; or
• abnormal kidney test.

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

Warnings

Do not use if you are pregnant. Stop using candesartan and tell your doctor right away if you become pregnant.

If you have diabetes, do not take candesartan with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine

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

If you have diabetes, do not take candesartan with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking candesartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• a heart condition other than one being treated with candesartan;
• kidney disease (or if you are on dialysis);
• liver disease; or
• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Candesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you plan to get pregnant, ask your doctor for a safer medicine to use before and during pregnancy. Having high blood pressure during pregnancy may cause complications in the mother and the baby.

You should not breastfeed while using candesartan.

How should I take candesartan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take candesartan with or without food.

For a child who cannot swallow a tablet whole, a pharmacist can mix the medicine into a liquid.

Shake the liquid before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Candesartan doses are based on weight in children and/or teenagers. Your child’s dose needs may change if the child gains or loses weight.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking candesartan.

It may take 2 to 4 weeks before your blood pressure is under control. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms.

You may need to use blood pressure medicine for the rest of your life. Treatment may also include diet, exercise, lowering cholesterol, not smoking, and controlling diabetes.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Store at room temperature away from moisture and heat.

Candesartan dosing information

Usual Adult Dose for Hypertension:

Initial dose: 16 mg orally once a day
Maintenance dose: 8 to 32 mg/day orally in 1 to 2 divided doses
Maximum dose: 32 mg/day

Comments:
-Consider administration of a lower initial dose in volume depleted patients.
-Most of the antihypertensive effect is present within 2 weeks; maximum blood pressure reduction at a given dose is generally observed within 4 to 6 weeks of starting that dose.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 4 mg orally once a day; double dose every 2 weeks, as tolerated, to target dose of 32 mg orally once a day

Use: Treatment of New York Heart Association (NYHA) class II through IV heart failure

Usual Pediatric Dose for Hypertension:

1 TO LESS THAN 6 YEARS:
Initial dose: 0.2 mg/kg/day orally in 1 to 2 divided doses
Maintenance dose: 0.05 to 0.4 mg/kg/day orally in 1 to 2 divided doses

6 TO LESS THAN 17 YEARS:
Less than 50 kg:
-Initial dose: 4 to 8 mg/day orally in 1 to 2 divided doses
-Maintenance dose: 2 to 16 mg/day orally in 1 to 2 divided doses
Greater than 50 kg:
-Initial dose: 8 to 16 mg/day orally in 1 to 2 divided doses
-Maintenance dose: 4 to 32 mg/day orally in 1 to 2 divided doses

Comments:
-For patients with possible intravascular volume depletion (e.g., patients treated with diuretics, especially those with renal impairment), initiate this drug under close supervision and consider administration of a lower dose.
-Antihypertensive effect is present within 2 weeks; maximum blood pressure reduction at a given dose is generally observed within 4 weeks of starting that dose.
-For children unable to swallow tablets, an extemporaneous suspension may be used instead.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include dizziness, fast heartbeats, or fainting.

What should I avoid while taking candesartan?

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What other drugs will affect candesartan?

Tell your doctor about all your other medicines, especially:

• any other heart or blood pressure medications;
• a diuretic or “water pill”;
• lithium; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

What is Cabometyx?

Cabometyx is used to treat certain types of kidney cancer (renal cell carcinoma), liver cancer (hepatocellular carcinoma), differentiated thyroid cancer, and pancreatic and extra-pancreatic neuroendocrine tumors. It is an oral tablet taken once daily.

Cabometyx (cabozantinib) gained FDA approval on November 29, 2012. There is no generic.

FDA Approvals and Uses

Cabometyx (cabozantinib) is an oral kinase inhibitor approved to treat:

• Advanced renal cell carcinoma (RCC that has spread), as monotherapy
• Advanced RCC as first-line treatment in combination with nivolumab
• Hepatocellular carcinoma in patients previously treated with sorafenib
• Locally advanced or metastatic differentiated thyroid cancer (DTC) in adults and children 12 years and older that has progressed following VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.
• Previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) or extra-pancreatic neuroendocrine tumors (epNET) in adults and children 12 years and older

It is not known if Cabometyx is safe and effective in children younger than 12 years of age.

Side Effects

Common Side Effects

The most common side effects of Cabometyx are:

• Tiredness
• Nausea and vomiting
• Constipation
• Decreased appetite
• Weight decreased.

The most common side effects of Cabometyx when used in combination with nivolumab are:

• Tiredness
• Mouth sores
• Rash
• Low thyroid hormone levels (hypothyroidism)
• Pain in muscles, bones, and joints
• Decreased appetite
• Nausea
• Changes in the way things taste
• Stomach-area (abdominal) pain
• Cough
• Upper respiratory tract infection.

Cabometyx may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

Serious side effects and warnings

Cabometyx may cause the following serious side effects.

Bleeding (hemorrhage)

Cabometyx can cause severe bleeding that may lead to death. Tell your healthcare provider right away if you get any signs of bleeding during treatment with Cabometyx, including:

• Coughing up blood or blood clots
• Vomiting blood, or if your vomit looks like coffee grounds
• Red or black (looks like tar) stools
• Menstrual bleeding that is heavier than normal
• Any unusual or heavy bleeding

Perforations and fistulas

Cabometyx can cause a tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you get tenderness or pain in your stomacharea (abdomen) that is severe, or that does not go away.

Blood clots, stroke, heart attack, and chest pain

Cabometyx may affect the way your blood clots and increase the risk of blood clots, a stroke, heart attack, or chest pain. Get emergency help right away if you get:

• Swelling or pain in your arms or legs
• Shortness of breath
• Feel lightheaded or faint
• Sweating more than usual
• Numbness or weakness of your face, arm or leg, especially on one side of your body
• Sudden confusion, trouble speaking, or understanding
• Sudden trouble seeing in one or both eyes
• Sudden trouble walking
• Dizziness, loss of balance, or coordination
• A sudden severe headache.

High blood pressure (hypertension)

Hypertension is common with Cabometyx and sometimes can be severe. Your healthcare provider will check your blood pressure before starting Cabometyx and regularly during treatment. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure. Tell your healthcare provider if you develop severe headaches, nose bleeds, tiredness or confusion, vision changes, chest pain, trouble breathing, irregular heartbeat, or blood in your urine.

Heart problems

Cabometyx can cause heart failure that may lead to death. Your healthcare provider may check your heart function before and during treatment with Cabometyx. Tell your healthcare provider right away if you get any of the following signs and symptoms:

• Feeling like your heart is pounding, racing, or beating irregularly
• Swelling of your ankles or feet
• Feeling lightheaded
• Shortness of breath
• Tiredness

Diarrhea

Diarrhea is common with Cabometyx and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away if you have frequent loose, watery bowel movements.

Hand-foot skin reaction

Hand-foot skin reactions are common with Cabometyx and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.

Liver problems

Liver problems may happen during treatment with Cabometyx. When Cabometyx is taken in combination with nivolumab, severe changes in liver function tests may happen more often than if you take Cabometyx alone. Your healthcare provider will do blood tests to check your liver function before and during treatment with Cabometyx. Tell your healthcare provider right away if you develop symptoms of liver problems, including yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine, bleeding, or bruising more easily than normal.

Adrenal gland problems

Your healthcare provider will monitor you for this problem. Your healthcare provider may prescribe hormone replacement therapy or corticosteroid medicines if needed. Tell your healthcare provider right away if you develop any of the following signs or symptoms: extreme tiredness, dizziness or fainting, weakness, nausea, or vomiting.

Protein in your urine and possible kidney problems

Symptoms may include swelling in your hands, arms, legs, or feet. Your healthcare provider will check you for this problem during treatment with Cabometyx.  

Severe jawbone problems (osteonecrosis)

Your healthcare provider should examine your mouth before you start and during treatment with Cabometyx. Tell your dentist that you are taking Cabometyx. It is important for you to practice good mouth care during treatment with Cabometyx. Tell your healthcare provider right away if you develop any symptoms of jaw problems, including: jaw pain, toothache, or sores on your gums.

Wound healing problems

Wound healing problems have happened in people who take Cabometyx. Tell your healthcare provider if you plan to have any surgery before or during treatment with Cabometyx.

• You should stop taking Cabometyx at least 3 weeks before planned surgery.
• Your healthcare provider should tell you when you may start taking Cabometyx again after surgery.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

A condition called reversible posterior leukoencephalopathy syndrome can happen during treatment with Cabometyx. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.

Change in thyroid function

Cabometyx can cause changes in your thyroid function, including changes to thyroid hormone levels in your blood. Your healthcare provider will do blood tests to check your thyroid function before and during treatment with Cabometyx.

Decreased calcium level in your blood (hypocalcemia)

Cabometyx can cause you to have a decreased amount of calcium in your blood. Your healthcare provider will do blood tests to check you for this problem and give you calcium if needed. Tell your healthcare provider right away if you get any of the following signs or symptoms:

• Muscle stiffness or muscle spasms
• Sudden weight gain
• Numbness or tingling in your fingers, toes, or around your mouth
• Swelling of your arms, hands, legs, and ankles
• Seizures.

Notes:

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Cabometyx if you have certain side effects.

These are not all of the possible side effects of Cabometyx. Call your doctor for medical advice about side effects.

How does Cabometyx work?

Cabometyx (cabozantinib) works by blocking multiple tyrosine kinase enzymes, including MET, VEGFR, AXL, RET, and others. These enzymes regulate normal cell functions but also drive cancer-related processes like tumor growth, spread, blood vessel formation, drug resistance, and tumor microenvironment maintenance.

Cabometyx (cabozantinib) belongs to the drug class called multikinase inhibitors. It may also be called a VEGF/VEGFR inhibitor.

Before taking this medicine

Before you take Cabometyx, tell your healthcare provider about all of your medical conditions, including if you:

• Have had a liver problem other than liver cancer
• Have a recent history of bleeding, including coughing up or vomiting blood, or black tarry stools.
• Have an open or healing wound
• Have high blood pressure
• Have heart problems
• Have a low calcium level in your blood (hypocalcemia)
• Plan to have any surgery, dental procedure, or have had a recent surgery. You should stop taking Cabometyx at least 3 weeks before planned surgery
• Are pregnant, or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

Cabometyx can harm your unborn baby.

• If you can become pregnant, your healthcare provider will check your pregnancy status before you start treatment with Cabometyx.
• Females who can become pregnant should use effective birth control (contraception) during treatment and for 4 months after their last dose of Cabometyx.
• Talk to your healthcare provider about birth control methods that may be right for you.
• If you become pregnant or think you are pregnant, tell your healthcare provider right away.

Breastfeeding

It is not known if Cabometyx passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of Cabometyx.

How should I take Cabometyx?

• Take Cabometyx exactly as your healthcare provider tells you to take it.
• Do not take Cabometyx with food. Take Cabometyx on an empty stomach at least 1 hour before or at least 2 hours after eating.
• Swallow Cabometyx tablets whole.
• Do not crush, chew, or split Cabometyx tablets.

What happens if I miss a dose?

If you miss a dose and your next scheduled dose is in less than 12 hours, take your next dose at the normal time. Do not make up the missed dose.

What should I avoid while taking Cabometyx?

Avoid drinking grapefruit juice, eating grapefruit, or taking supplements that contain grapefruit or St. John’s wort during treatment with Cabometyx.

What other drugs will affect Cabometyx?

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Cabometyx and certain other medicines may affect each other, causing side effects.

Do NOT substitute Cabometyx tablets with cabozantinib capsules. 

Dosing information

• Administer on an empty stomach at least 1 hour before or at least 2 hours after eating.
• Stop treatment with Cabometyx at least 3 weeks before scheduled surgery, including dental surgery.

Adult Dose of Cabometyx for RCC

• Monotherapy: 60 mg orally once daily
• Combination therapy: 40 mg orally once daily with:
  • nivolumab 240 mg by intravenous infusion every 2 weeks

OR

• • nivolumab 480 mg by intravenous infusion every 4 weeks

OR

• • nivolumab 600 mg and hyaluronidase 10,000 units subcutaneously every 2 weeks

OR

• • nivolumab 1,200 mg and hyaluronidase 20,000 units subcutaneously every 4 weeks

Adult Dose of Cabometyx for HCC

• 60 mg orally once daily

Adult and Pediatric 12+ Dose of Cabometyx for DTC, pNET, epNET

• ≥40 kg: 60 mg orally once daily
• <40 kg: 40 mg orally once daily.

Storage

Store Cabometyx at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children.

What are the ingredients in Cabometyx?

Active ingredient: cabozantinib

Inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow.

Available as 20 mg, 40 mg, 60 mg, oral tablets.

Company

Cabometyx is manufactured for Exelixis, Inc. Alameda, CA 94502.

Bystolic belongs to a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Bystolic is used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack.

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

Warnings

Do not skip doses or stop taking Bystolic without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems such as severe chest pain or heart attack. You may need to use less and less before you stop the medication completely. If you need surgery, tell the surgeon ahead of time that you are using Bystolic.

Bystolic may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Bystolic is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Keep using Bystolic as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

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

• severe liver disease; or
• a heart problem such as heart block, sick sinus syndrome, slow heart rate, or heart failure.

If you have any of these other conditions, you may need a Bystolic dose adjustment or special tests:

• asthma, bronchitis, emphysema;
• liver or kidney disease;
• diabetes;
• a thyroid disorder;
• a history of allergies;
• problems with circulation (such as Raynaud’s syndrome);
• pheochromocytoma (tumor of the adrenal gland); or
• if you have recently had a heart attack.

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

How should I take Bystolic?

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

Take Bystolic at the same time every day. You may take the medication with or without food.

Do not skip doses or stop taking Bystolic without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems such as severe chest pain or heart attack. You may need to use less and less before you stop the medication completely.

Your blood pressure will need to be checked often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using Bystolic.

Bystolic is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Keep using Bystolic as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store Bystolic at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include slow heart rate, dizziness, vomiting, trouble breathing, or feeling like you might pass out.

What should I avoid?

Bystolic may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Bystolic side effects

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

• feeling short of breath, even with mild exertion;
• swelling of your ankles or feet;
• slow or uneven heartbeats; or
• numbness or cold feeling in your hands and feet.

Less serious Bystolic side effects may include:

• headache;
• tired feeling;
• nausea, stomach pain;
• diarrhea; or
• sleep problems (insomnia).

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

What other drugs will affect Bystolic?

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

• cimetidine (Tagamet);
• clonidine (Catapres);
• digitalis (digoxin, Lanoxin);
• isoniazid (for treating tuberculosis);
• methimazole (Tapazole);
• reserpine;
• ropinirole (Requip);
• ticlopidine (Ticlid);
• another beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
• an antibiotic such as terbinafine (Lamisil);
• an antidepressant such as clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra, Symbyax), imipramine (Tofranil), paroxetine (Paxil, Pexeva), sertraline (Zoloft), or tranylcypromine (Parnate);
• anti-malaria medication such as chloroquine (Aralen) or pyrimethamine (Daraprim), or quinine (Qualaquin);
• heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), clonidine (Catapres, Clorpres, Kapvay, Nexiclon), diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan, Tarka), and others;
• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), quinidine (Quin-G), procainamide (Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others;
• HIV or AIDS medicine such as delavirdine (Rescriptor) or ritonavir (Norvir, Kaletra); or
• medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

Benicar is an angiotensin II receptor blocker (sometimes called an ARB). Olmesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Benicar is used to treat high blood pressure (hypertension) in adults and children at least 6 years old.

Benicar is sometimes given together with other blood pressure medications.

Warnings

Do not use if you are pregnant. Stop using Benicar and tell your doctor right away if you become pregnant. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you have diabetes, do not take Benicar with any medication that contains aliskiren (a blood pressure medicine – brand names include Amturnide, Tekturna, and Tekamlo).

Before taking this medicine

You should not take Benicar if you are allergic to olmesartan.

If you have diabetes, do not use Benicar together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking Benicar with aliskiren if you have kidney disease.

To make sure Benicar is safe for you, tell your doctor if you have:

• a heart condition other than one being treated with Benicar;
• kidney disease; or
• if you are on a low salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you plan to get pregnant, ask your doctor for a safer medicine to use before and during pregnancy. Having high blood pressure during pregnancy may cause complications in the mother and the baby.

You should not breastfeed while using this medicine.

How should I take Benicar?

Take Benicar exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Benicar with or without food.

For a child who cannot swallow a tablet whole, a pharmacist can mix the medicine into a liquid.

Shake the liquid before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Olmesartan doses are based on weight in children and/or teenagers. Your child’s dose needs may change if the child gains or loses weight.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Benicar.

It may take up to 2 weeks before your blood pressure is under control. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms.

You may need to use blood pressure medicine for the rest of your life. Treatment may also include diet, exercise, lowering cholesterol, not smoking, and controlling diabetes.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

Store tablets at room temperature away from moisture and heat.

Store the liquid in a refrigerator. Throw away any liquid leftover after 4 weeks.

Dosing information

Usual Adult Dose for Hypertension:

20 mg orally once a day; may increase dose to 40 mg in two weeks if further blood pressure reduction is needed.

Maximum dose: 40 mg orally once a day

Comments:
-For patients with possible intravascular volume depletion (e.g., patients treated with diuretics, especially those with impaired renal function), initiate this drug under close supervision and give consideration to a lower starting dose.
-Twice daily dosing offers no additional benefit over the same total dose give once daily.

Usual Pediatric Dose for Hypertension:

6 to 16 years:
-20 to less than 35 kg: 10 mg orally once a day; may increase dose to 20 mg in two weeks if further blood pressure reduction is needed
-35 kg or more: 20 mg orally once a day; may increase dose to 40 mg in two weeks if further blood pressure reduction is needed

Comments:
-For children who cannot swallow tablets, the same dose can be given using an extemporaneously compounded oral suspension.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include fast heartbeats or fainting.

What should I avoid while taking Benicar?

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Benicar side effects

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• little or no urination;
• severe diarrhea and weight loss; or
• high potassium level – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Benazepril is used alone or in combination with other medications to treat high blood pressure in adults and children at least 6 years old.

Lowering blood pressure may lower your risk of a stroke or heart attack.

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

Benazepril side effects

Get emergency medical help if you have signs of an allergic reaction: hives, severe stomach pain, difficulty breathing, swelling of your face, lips, tongue, or throat.

Benazepril may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• kidney problems–swelling, urinating less, feeling tired or short of breath;
• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• liver problems–loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of benazepril may include:

• headache; or
• cough.

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

Warnings

Do not use if you are pregnant. Stop using benazepril and tell your doctor right away if you become pregnant.

Tell your doctor about all your other medicines. Some drugs should not be used with benazepril.

Before taking this medicine

You should not use benazepril if you are allergic to it or to any other ACE (angiotensin converting enzyme) inhibitor such as captopril, fosinopril, enalapril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

Do not take benazepril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use benazepril together with any medication that contains aliskiren (a blood pressure medicine).

Do not take benazepril if you have a history of angioedema (severe allergic reaction).

Tell your doctor if you have ever had:

• heart disease, heart problems such as a recent heart attack;
• stomach pain;
• low blood pressure;
• if you are on a low-salt diet;
• diabetes;
• liver disease; or
• kidney disease (or if you are on dialysis).

You may also need to avoid taking benazepril with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Benazepril can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

How should I take benazepril?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take benazepril with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking benazepril. This can lead to very low blood pressure, an electrolyte imbalance, or kidney failure.

Your blood pressure will need to be checked often and you may need frequent blood tests. Your treatment may also include diet, exercise, lifestyle changes, and other medications. Follow your doctor’s instructions very carefully.

Tell your doctor if you have a planned surgery.

Keep using benazepril even if you feel well. High blood pressure often has no symptoms.

Store tightly closed at room temperature, away from moisture and heat.

Benazepril dosing information

Usual Adult Dose for Hypertension:

Initial dose: With a diuretic: 5 mg orally once a day; without a diuretic: 10 mg orally once a day
Maintenance dose: 20 to 40 mg/day orally as a single dose or in two equally divided doses
Maximum dose: 80 mg/day

Comments:
-The divided dose regimen was more effective in controlling pre-dosing blood pressure.
-If discontinuing a diuretic prior to initiating this drug to reduce the likelihood of hypotension, conclude diuretic therapy 2 to 3 days prior to starting this drug.

Usual Pediatric Dose for Hypertension:

6 YEARS OR OLDER:
Initial dose: 0.2 mg/kg orally once a day as monotherapy
Maximum dose: 0.6 mg/kg; 40 mg/day

Comments:
-Doses between 0.1 and 0.6 mg/kg once a day have been studied; doses greater than 0.1 mg/kg were shown to reduce blood pressure; doses above 0.6 mg/kg or 40 mg/day have not been studied in pediatric patients.
-Prepare a suspension for pediatric patients who cannot swallow tablets or for whom the calculated dosage does not correspond to available tablet strengths.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking benazepril?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Do not take potassium supplements or use salt substitutes, unless your doctor has told you to.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

What other drugs will affect benazepril?

Benazepril can harm your kidneys, especially if you also use certain medicines for infections, cancer, or osteoporosis.

Tell your doctor about all your other medicines, especially:

• a diuretic or “water pill” that may increase blood potassium such as spironolactone, triamterene, or amiloride;
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;
• insulin or diabetes medications;
• medicine to prevent organ transplant rejection such as temsirolimus, sirolimus, or everolimus; or
• heart or blood pressure medication.