What is clonidine?

Clonidine lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels to relax and your heart to beat more slowly and easily.

Clonidine (Catapres tablet/patch, Javadin) is used to treat hypertension (high blood pressure).

The Kapvay brand is an extended-release tablet used to treat attention deficit hyperactivity disorder (ADHD).

Onyda XR is an extended-release oral suspension used to treat ADHD in children 6 years and older.

Clonidine is sometimes given with other medications. Clonidine is also available as a transdermal patch worn on the skin. Do not use two forms of this medicine at the same time.

Warnings

Before you take clonidine, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, slow heartbeats, low blood pressure, a history of heart attack or stroke, kidney disease, or if you have ever had an allergic reaction to a Catapres TTS transdermal skin patch.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not take this medicine if you are allergic to clonidine.

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

• heart disease or severe coronary artery disease;
• a heart rhythm disorder, slow heartbeats;
• high or low blood pressure, or a history of fainting spells;
• a heart attack or stroke;
• pheochromocytoma (tumor of the adrenal gland);
• kidney disease; or
• if you have ever had an allergic reaction to a Catapres TTS transdermal skin patch.

It is not known if clonidine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clonidine on the baby.

Clonidine may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

If you are breastfeeding, tell your doctor if you notice somnolence, tiredness, rapid breathing, and poor feeding in the nursing baby.

Catapres is not approved for use by anyone younger than 18 years old. Do not give Kapvay to a child younger than 6 years old.

How should I take clonidine?

Take clonidine 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.

Clonidine is usually taken in the morning and at bedtime. If you take different doses of this medicine at each dosing time, it may be best to take the larger dose at bedtime.

Clonidine may be taken with or without food.

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

Javadin oral solution is for adults with hypertension and can be taken with or without food.

Tell your doctor if you have a planned surgery.

You may have withdrawal symptoms if you stop using this medicine suddenly. Ask your doctor before stopping the medicine.

Call your doctor if you are sick with vomiting. This is especially important for a child taking clonidine.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Clonidine Adult Dose for Hypertension

Oral Tablets:

• Initial dose: 0.1 mg orally 2 times a day (morning and bedtime)
• Titration: Increments of 0.1 mg orally per day may be made at weekly intervals to desired response
• Maintenance dose: 0.2 to 0.6 mg orally per day in divided doses
• Maximum dose: 2.4 mg orally per day in divided doses

Comments:
Taking the larger portion of the oral daily dose at bedtime may minimize the transient adjustment effects of dry mouth and drowsiness

Transdermal patches:

• Initial dose: 0.1 mg/24 hr patch applied every 7 days
• Maintenance dose: If, after 1 to 2 weeks, the desired reduction in blood pressure is not achieved, increase the dosage by adding another 0.1 mg/24 hr patch or changing to a larger system
• Maximum dose: Doses above two 0.3 mg/24 hr patches applied every 7 days is usually not associated with additional efficacy

Comments:
-The transdermal patch should be applied to a hairless area of intact skin on the upper outer arm or chest.
-Each new patch should be applied on a different skin site from the previous location.
-If the patch loosens during 7-day wearing, the adhesive cover should be applied directly over the system to ensure good adhesion.
-There have been rare reports of the need for patch changes prior to 7 days to maintain blood pressure control.
-When substituting patches for the oral formulation or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect of the patches may not commence until 2 to 3 days after initial application; therefore, gradual reduction of prior drug dosage is advised. Some or all previous antihypertensive treatment may have to be continued, particularly in patients with more severe forms of hypertension.
Use: For hypertension, alone or in combination with other antihypertensive agents

Javadin Oral Solution:

• Initial dose: 0.1 mg orally twice daily with or without food (morning and bedtime).
• Titrate in increments of 0.1 mg per day at weekly intervals if necessary until the desired response is achieved.
• Usual maintenance dose: 0.2 mg-0.6 mg per day, given in divided doses.

Comments: Store at 20°C to 25°C (68°F to 77°F). Discard unused portion 60 days after first opening. 

Usual Pediatric Dose for Attention Deficit Disorder

Kapvay Extended-release tablets:
6 years and older:
-Initial dose: 0.1 mg orally at bedtime
-Titration: Increase in 0.1 mg/day increments every 7 days until desired response; doses should be administered twice daily (either split equally or with the higher split dosage given at bedtime)
-Maximum dose: 0.4 mg/day in 2 divided doses

Comments:
-May be taken with or without food.
-If a dose is missed, that dose should be skipped and take the next dose as scheduled.
-Tablets should be swallowed whole, and not crushed, chewed, or broken to avoid increasing the rate of drug release.
-When discontinuing therapy, taper daily dose by no more than 0.1 mg every 3 to 7 days.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

Onyda XR Extended-release oral suspension
–Children 6 years and older.
-Initial Onyda XR dose: 0.1 mg orally once daily at bedtime with or without food. Dosage may be increased in increments of 0.1 mg per day at weekly intervals.
-Maximum recommended dosage: 0.4 mg once daily at bedtime.
-Comments: Do not substitute Onyda XR for other clonidine products on a mg-per-mg basis because of differing pharmacokinetic profiles.
-When discontinuing: Taper the dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include feeling cold, irritable, weak, drowsy, or light-headed, or having weak reflexes, pinpoint pupils, slow heartbeats, shallow breathing, or a seizure.

What should I avoid while taking clonidine?

Avoid drinking alcohol. It may increase certain side effects of clonidine.

Avoid driving or hazardous activity until you know how clonidine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Clonidine side effects

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

Call your doctor at once if you have:

• severe chest pain, shortness of breath, irregular heartbeats;
• a very slow heart rate; or
• a light-headed feeling, like you might pass out.

Common clonidine side effects may include:

• drowsiness, dizziness;
• feeling tired or irritable;
• dry mouth;
• constipation, loss of appetite; or
• sleep problems (insomnia), nightmares.

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 clonidine?

Using clonidine with other drugs that make you drowsy 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 heart or blood pressure medications;
• an antidepressant; or
• any other medicine that contains clonidine.

This list is not complete. Other drugs may interact with clonidine, including prescription and over-the-counter medicines, vitamins, and herbal products. 

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.

Captopril is used in adults alone or in combination with other medications to treat high blood pressure (hypertension) and congestive heart failure.

Captopril is also used to improve survival and reduce the risk of heart failure after a heart attack in patients with a heart condition called left ventricular hypertrophy (enlargement of the walls of the left side of the heart). Captopril is also used to treat kidney disease (nephropathy) caused by diabetes in patients with type 1 diabetes and retinopathy (eye disease).

Captopril belongs to a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It decreases certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently.

Warnings

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

If you have diabetes, do not use captopril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo).

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

Before taking this medicine

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

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

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

To make sure captopril is safe for you, tell your doctor if you have ever had:

• heart failure, heart problems;
• severe allergic reaction such as angioedema;
• stomach pain;
• low blood pressure;
• low white blood cell counts;
• a connective tissue disease such as Marfan syndrome, Sjogren’s syndrome, lupus, scleroderma, or rheumatoid arthritis;
• if you are on a low-salt diet;
• to take medicines that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection;
• diabetes;
• liver disease; or
• kidney disease (or if you are on dialysis).

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

Stop using this medicine and tell your doctor right away if you become pregnant. Captopril 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 captopril?

Take captopril 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.

Take on an empty stomach, at least 1 hour before a meal.

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 captopril. 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.

captopril may cause false results on a urine test. Tell the laboratory staff that you use captopril.

Tell your doctor if you have a planned surgery.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

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

Dosing information

Usual Adult Dose for Hypertension:

Initial dose: 25 mg orally 2 to 3 times a day one hour before meals

Maintenance dose: May increase every 1 to 2 weeks up to 50 mg orally three times a day. If blood pressure remains uncontrolled after 1 to 2 weeks at this dose, add a thiazide diuretic (loop diuretic if severe renal impairment exists) and titrate to its highest usual antihypertensive dose before further increases of captopril.

Maximum dose: 450 mg/day

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 25 mg orally three times a day (6.25 to 12.5 mg orally three times a day if hypotensive, hyponatremic, or hypovolemic)

Target maintenance dose: 50 mg orally three times a day for at least two weeks to ensure a satisfactory response

Maximum dose: 450 mg/day

Comments:
-Most patients experience satisfactory clinical improvement at 50 or 100 mg orally three times a day.
-Should generally be used in conjunction with other medicines, according to Guideline-directed medical therapy.

Usual Adult Dose for Left Ventricular Dysfunction:

Initial dose: 6.25 mg orally once as early as three days post-myocardial infarction, followed by 12.5 mg orally three times a day; increase to 25 mg orally three times a day over the next several days, and then increase to target dose over the next several weeks as tolerated.

Target maintenance dose: 50 mg orally three times a day

Use: To improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction of 40% or less and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.

Usual Adult Dose for Diabetic Nephropathy:

25 mg orally three times a day

Comments: Other antihypertensives may be used in conjunction with this drug if additional blood pressure reduction is required.

Use: Treatment of diabetic nephropathy (proteinuria greater than 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy.

Usual Adult Dose for Hypertensive Emergency:

25 mg orally 2 to 3 times a day; continue diuretic therapy and stop other antihypertensives upon initiation of this drug; may increase dose every 24 hours or less until satisfactory blood pressure or maximum dose is reached.

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 captopril?

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.

Avoid strenuous exercise if you are being treated for heart failure. Ask your doctor about your risk.

Captopril side effects

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

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

• chest pain, fast, slow, or uneven heart rate;
• a light-headed feeling, like you might pass out;
• heart problems – swelling, rapid weight gain, feeling short of breath;
• kidney problems – swelling, urinating less, feeling tired or short of breath;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• high blood potassium – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low blood sodium – headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough.

Common captopril side effects may include:

• cough;
• low blood pressure;
• flushing (sudden warmth, redness, or tingly feeling);
• low blood cell counts;
• decreased sense of taste; or
• mild skin itching or rash.

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 captopril?

Captopril 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, amiloride;
• NSAIDs (nonsteroidal anti-inflammatory drugs) – aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;
• medicine to prevent organ transplant rejection such as temsirolimus, sirolimus, or everolimus; or
• heart or blood pressure medication.

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).