Corzide

CORZIDE (Nadolol and Bendroflumethiazide Tablets)

• 40 mg nadolol combined with 5 mg bendroflumethiazide in bottles of 100 tablets (NDC 60793- 283-01).
• 80 mg nadolol combined with 5 mg bendroflumethiazide in bottles of 100 tablets (NDC 60793- 284-01).

Round, biconvex tablets are white to bluish white with dark blue specks. Each tablet has a full bisect bar. Tablet identification numbers: 40 mg/5 mg combination embossed with KPI/283 on the scored side and Corzide 40/5 on the other; 80 mg/5 mg combination embossed with KPI/284 on the scored side and Corzide 80/5 on the other.

Storage

Keep bottle tightly closed. Store at room temperature; avoid excessive heat.

Distributed by: Pfizer Ine, New York, NY 10017. Revised: July 2016

Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of therapy without the physician's advice. Although cardiac failure rarely occurs in properly selected patients, patients being treated with beta-adrenergic blocking agents should be advised to consult the physician at the first sign or symptom of impending failure.

The patient should also be advised of a proper course in the event of an inadvertently missed dose.

The patient should be informed of symptoms that would suggest potential adverse effects and told to report them promptly.

Your pharmacist can provide more information about bendroflumethiazide and nadolol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.03. Revision date: 12/15/2010.

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• High Blood Pressure Treatment

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nadolol and bendroflumethiazide combination in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of nadolol and bendroflumethiazide combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving nadolol and bendroflumethiazide combination .

Pregnancy

Breast Feeding

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

Interactions with Medicines

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Bepridil
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonidine
• Clonixin
• Crizotinib
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Diltiazem
• Dipyrone
• Dofetilide
• Dronedarone
• Droperidol
• Droxicam
• Epinephrine
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoldopam
• Fenoprofen
• Fepradinol
• Feprazone
• Fingolimod
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indacaterol
• Indomethacin
• Ketanserin
• Ketoprofen
• Ketorolac
• Lacosamide
• Levomethadyl
• Lidocaine
• Lithium
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metildigoxin
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxymetazoline
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rivastigmine
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sotalol
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib
• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Alfuzosin
• Alogliptin
• Aminolevulinic Acid
• Amiodarone
• Amtolmetin Guacil
• Arbutamine
• Aspirin
• Bromfenac
• Bufexamac
• Bunazosin
• Canagliflozin
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Clonixin
• Dapagliflozin
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Digoxin
• Dipyrone
• Doxazosin
• Droxicam
• Dulaglutide
• Empagliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ginkgo
• Glimepiride
• Glipizide
• Glyburide
• Gossypol
• Ibuprofen
• Indomethacin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Human Inhaled
• Insulin Human Isophane (NPH)
• Insulin Human Regular
• Insulin Lispro, Recombinant
• Ketoprofen
• Ketorolac
• Licorice
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Metildigoxin
• Mibefradil
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenelzine
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propyphenazone
• Proquazone
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Green Tea

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain)—May provoke chest pain if stopped too quickly .

• Anuria (not able to form urine) or
• Asthma or
• Bradycardia (slow heartbeat) or
• Heart block or
• Heart failure—Should not use in patients with these conditions .

• Blood vessel disease (circulation problems) or
• Gout or
• Hyperuricemia (high uric acid in the blood) or
• Hypochloremia (low chloride in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hyponatremia (low sodium in the blood) or
• Parathyroid disease or
• Systemic lupus erythematosus—Use with caution. This medicine may make these conditions worse .

• Diabetes or
• Hyperthyroidism (overactive thyroid) or
• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

• Kidney disease, severe or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Lung disease (e.g., bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .

• Sympathectomy—Use with caution. The effects of this medicine may be increased .

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

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

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• confusion
• cough
• difficulty breathing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• extreme fatigue
• irregular breathing
• lightheadedness, dizziness, or fainting
• noisy breathing
• paleness or cold feeling in fingertips and toes
• shortness of breath
• slow or irregular heartbeat
• slurred speech
• sweating
• swelling of face, fingers, feet, or lower legs
• tightness in chest
• tingling or pain in fingers or toes when exposed to cold
• unusual tiredness or weakness
• weight gain
• wheezing

• Back or leg pains
• black, tarry stools
• bleeding gums
• bloating
• blood in urine or stools
• chills
• clay-colored stools
• cloudy urine
• cold sweats
• constipation
• coughing up blood
• dark urine
• difficulty swallowing
• drowsiness
• dry mouth
• fast heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• general body swelling
• general feeling of discomfort or illness
• general tiredness and weakness
• headache
• hives
• hoarseness
• increased hunger
• increased thirst
• increased urination
• indigestion
• joint pain, stiffness, or swelling
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle tremors
• nausea and vomiting
• nosebleeds
• pain in muscles
• painful or difficult urination
• pains in stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, deep breathing
• rash
• redness, soreness, or itching skin
• restlessness
• skin rash
• sore throat
• sores, ulcers, or white spots on lips or in mouth
• sores, welting or blisters
• stomach cramps
• sugar in the urine
• swollen or painful glands
• tenderness of salivary glands
• thickening of bronchial secretions
• troubled breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual weight loss
• upper right abdominal pain
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Change in consciousness
• decreased urination
• diarrhea
• fast, slow, or shallow breathing
• gas
• heartburn
• increase in heart rate
• increased sweating
• indigestion
• loss of consciousness
• low blood pressure
• muscle cramps
• numbness, tingling, pain, or weakness in hands or feet
• pale or blue lips, fingernails, or skin
• seizures
• sunken eyes
• trembling
• unusual drowsiness, dullness, or feeling of sluggishness
• unusual paleness
• weakness and heaviness of legs
• wrinkled skin

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

• Change in behavior
• continuing ringing or buzzing or other unexplained noise in ears
• decreased interest in sexual intercourse
• dry eyes or skin
• excess air or gas in stomach or intestines
• hair loss, thinning of hair
• hearing loss
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• relaxed and calm
• sleepiness
• stomach soreness or discomfort
• stuffy nose
• weight loss

• Cracks in the skin
• discoloration of skin
• feeling of constant movement of self or surroundings
• increased sensitivity of skin to sunlight
• large, flat, blue or purplish patches in the skin
• loss of heat from the body
• muscle spasm, weakness, or restlessness
• scaly skin
• sensation of spinning
• severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking Corzide as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• This medicine may cause you to pass urine more often. To keep from having sleep problems, try to take before 6 pm.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Very bad dizziness or passing out.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure.
• Slow heartbeat.
• Feeling cold.
• A burning, numbness, or tingling feeling that is not normal.
• Change in the way you act.
• Change in eyesight.
• Fever or chills.
• Sore throat.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Any unexplained bruising or bleeding.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Corzide (nadolol and bendroflumethiazide) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Corzide. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Corzide (Nadolol and Bendroflumethiazide Tablets) for oral administration combines two antihypertensive agents: CORGARD® (nadolol), a nonselective beta-adrenergic blocking agent, and NATURETIN® (bendroflumethiazide), a thiazide diuretic-antihypertensive. Formulations: 40 mg and 80 mg nadolol per tablet combined with 5 mg bendroflumethiazide. Inactive ingredients: cellulose, colorant (FD&C Blue No. 2), lactose, magnesium stearate, povidone, sodium starch glycolate, and starch.

Nadolol

Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol is designated chemically as 1-(tert-butylamino)-3-{(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy}-2-propanol. Structural formula:

C17H27NO4 MW 309.40 CAS-42200-33-9

Bendroflumethiazide

Bendroflumethiazide is a white crystalline powder. It is soluble in alcohol and in sodium hydroxide, and insoluble in hydrochloric acid, water, and chloroform. Bendroflumethiazide is designated chemically as 3-benzyl-3,4-dihydro-6-(trifluoromethyl)-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Structural formula:

C15H14F3N3O4S2 MW 421.41 CAS-73-48-3

Nadolol

Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see WARNINGS).

Bendroflumethiazide

Bendroflumethiazide is contraindicated in anuria. It is also contraindicated in patients who have previously demonstrated hypersensitivity to bendroflumethiazide or other sulfonamide-derived drugs.