Bisoprolol Fumarate

Class: beta-Adrenergic Blocking Agents
VA Class: CV100
Chemical Name: 2-Propanol, 1 - (4 - ((2 - (1 - methylethoxy)ethoxy)methyl)phenoxy) - 3 - ((1 - methylethyl)amino),(±),(E) - 2 - butenedioate (2:1) (salt)
Molecular Formula: C₁₈H₃₁NO₄•½C₄H₄O₄
CAS Number: 104344-23-2
Brands: Zebeta, Ziac

Introduction

β₁-selective adrenergic blocking agent

Uses for Bisoprolol Fumarate

Hypertension

Management of hypertension as monotherapy or in combination with other classes of antihypertensive agents.^{1 2 3 4 5 6 7 18 21}

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, ischemic heart disease, and/or diabetes mellitus.⁴⁴

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁴⁴

CHF

Management of mild to moderately severe (NYHA class II or III) heart failure of ischemic or cardiomyopathic origin† in conjunction with cardiac glycosides, diuretics, and ACE inhibitors.^{22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38}

Bisoprolol, carvedilol, and extended-release metoprolol succinate have been shown to be effective in reducing the risk of death in patients with chronic heart failure; however, these positive findings should not be considered indicative of β-adrenergic blocking agent class effect.⁵⁵

Bisoprolol Fumarate Dosage and Administration

General

• 
  

  Individualize dosage according to patient response and tolerance.^{3 18}

  
  


• 
  

  If long-term therapy is discontinued, reduce dosage gradually over a period of about 1–2 weeks.^{1 2 20} (See Abrupt Withdrawal of Therapy under Cautions.)

  
  

Administration

Oral Administration

Administer orally;^{1 2 3 4 5 6 7} absorption does not appear to be affected by food.^{1 2 3 4 6 7}

Dosage

Available as bisoprolol fumarate; dosage expressed in terms of the fumarate.^{1 2 3}

Pediatric Patients

Hypertension†

Combination Therapy

Oral

Some experts state that the initial dosage of the commercially available fixed-combination tablets (containing 2.5 mg of bisoprolol fumarate and 6.25 mg of hydrochlorothiazide) is 1 tablet daily.⁵² If needed, dosage may be increased to the fixed-combination preparation containing 10 mg of bisoprolol fumarate and 6.25 mg of hydrochlorothiazide administered once daily.⁵²

Adults

Hypertension

Monotherapy

Oral

Initially, 2.5–5 mg once daily.^{1 3 5 18 21 44}

Increase dosage gradually up to 20 mg daily.^{1 2 3 18}

Bisoprolol/Hydrochlorothiazide Combination Therapy

Oral

Patients in whom BP is not adequately controlled by monotherapy with bisoprolol fumarate 2.5–20 mg daily or those who respond adequately to a hydrochlorothiazide dosage of 50 mg daily, but potassium loss is problematic, can switch to a fixed-combination preparation containing bisoprolol and hydrochlorothiazide.^{2 3}

Initial use of fixed-combination preparations generally is not recommended, adjust by administering each drug separately, then use the fixed combination if optimum maintenance dosage corresponds to the drug dosages in the combination preparation.^{18 19}

Alternatively, may initiate daily therapy with the fixed-combination preparation containing bisoprolol fumarate 2.5 mg and hydrochlorothiazide 6.25 mg daily.^{2 3 21}

CHF†

Oral

Initially, 1.25 mg daily⁴⁰ for 2–4 weeks or less in adults with mild to moderately severe heart failure.^{22 30}

If tolerated, increase to 2.5 mg daily for 2–4 weeks; subsequent dosages can be doubled every 2–4 weeks.^{22 30}

If deterioration (usually transient) occurs during titration, increase dosage of concurrent diuretic⁴⁰ and decrease dosage of β -blocker or temporarily discontinue β -blocker.⁴⁰ Do not continue dosage titration until symptoms of worsening heart failure have stabilized.⁴⁰ Initial difficulty in dosage titration should not preclude subsequent attempts to successfully titrate the dosage.⁴⁰

Reduce dosage in patients with CHF who experience symptomatic bradycardia (e.g., dizziness) or 2nd or 3rd degree heart block.⁴⁰

Prescribing Limits

Pediatric Patients

Hypertension†

Combination Therapy

Oral

Some experts state that the maximum dosage of bisoprolol fumarate in fixed combination with hydrochlorothiazide is 10 mg of bisoprolol fumarate and 6.25 mg of hydrochlorothiazide (i.e., 1 tablet of the 10/6.25-mg fixed combination) daily.⁵²

Adults

Hypertension

Monotherapy

Oral

Maximum is 20 mg daily.^{1 2 3 18} However, JNC 7 currently recommends a lower maximum dosage of 10 mg daily.⁴⁴

Combination Therapy

Oral

Dosage of bisoprolol/hydrochlorothiazide fixed combination generally should not exceed bisoprolol fumarate 20 mg and hydrochlorothiazide 12.5 mg (i.e., 2 tablets of the 10/6.25-mg fixed combination) daily.^{2 3}

CHF†

Oral

Maximum recommended by ACC and AHA: 10 mg once daily.⁴⁰

Special Populations

Hepatic Impairment

Hepatitis or Cirrhosis

Initially 2.5 mg once daily.¹

Increase dosage with caution.^{1 3}

Renal Impairment

Cl_cr <40 mL/minute

Initially 2.5 mg daily.¹

Increase dosage with caution.^{1 3}

Discontinue bisoprolol/hydrochlorothiazide fixed combination if progressive renal impairment develops.²

Cl_cr <20 mL/minute per 1.73 m²

Generally, maximum 10 mg once daily.^{4 6 8 a}

Hemodialysis

Apparently not removed by dialysis; supplemental dose is not required after dialysis.^{1 3}

Geriatric Patients

Dosage adjustment not required unless appreciable renal or hepatic impairment is present.^{1 2}

Bronchospastic Disease

Initially, 2.5 mg daily;^{1 3} use the possible lowest dosage.¹

Cautions for Bisoprolol Fumarate

Contraindications

• 
  

  Patients with sinus bradycardia, heart block greater than first degree, cardiogenic shock, or overt cardiac failure.^{1 2}

  
  


• 
  

  Hypersensitivity to bisoprolol fumarate, any ingredient in the formulation, or sulfonamides.²

  
  

Warnings/Precautions

Warnings

Cardiac Failure

Possible precipitation of CHF.^{1 2}

Avoid use in overt CHF;^{1 2} may use cautiously in patients with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics).^{1 2}

Adequate treatment (e.g., with a cardiac glycoside and/or diuretic) and close observation recommended if signs or symptoms of impending cardiac failure occur; if cardiac failure continues, discontinue therapy, gradually if possible.^{1 2 22 40}

Abrupt Withdrawal of Therapy

Abrupt discontinuance of therapy is not recommended as it may exacerbate symptoms or precipitate MI or ventricular arrhythmias in patients with CAD.^{1 2} Gradually decrease dosage over 1–2 weeks and monitor patients carefully.^{1 2 3 18 19 20 21} If manifestations of withdrawal (exacerbation of angina or hypotension) occur, increase dosage or reinstitute therapy, at least temporarily.^{1 2 3 18}

Peripheral Vascular Disease

Possible precipitation or aggravation of symptoms of arterial insufficiency; use with caution.^{1 2}

Bronchospastic Disease

Generally should not be used in patients with bronchospastic disease,^{1 2} but may be used with caution in such patients who do not respond to or cannot tolerate alternative treatment.^{1 2}

Administer the lowest effective dosage (initially 2.5 mg once daily);^{1 2} a bronchodilator (e.g. a β₂-adrenergic agonist) should be available.^{1 2}

Major Surgery

Use with caution in patients undergoing major surgery involving general anesthesia.^{1 2} Use particular care if anesthetics that depress the myocardium (e.g., cyclopropane, ether, trichloroethylene) are used.^{1 2} (See Myocardial depressant general anesthetics under Interactions.)

Diabetes and Hypoglycemia

Possible decreased signs and symptoms of hypoglycemia (e.g., tachycardia).^{1 2}

Use with caution in patients with diabetes mellitus receiving hypoglycemic drugs.^{1 2}

Thyrotoxicosis

Signs of hyperthyroidism (e.g., tachycardia) may be masked.^{1 2} Possible exacerbation of hyperthyroidism or precipitation of thyroid storm if therapy is abruptly withdrawn; carefully monitor patients having or suspected of developing thyrotoxicosis.^{1 2}

General Precautions

History of Anaphylactic Reactions

Possible increased reactivity to repeated, accidental, diagnostic, or therapeutic challenges with a variety of allergens while taking β-blockers.^{1 2} Such patients may be unresponsive to usual doses of epinephrine.^{1 2}

Other Precautions

Shares the toxic potentials of β-blockers; observe the usual precautions of these agents.^{1 2} In addition, when used in fixed-combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with thiazide diuretics.^{1 2}

Specific Populations

Pregnancy

Category C.^{1 2}

Lactation

Not known whether bisoprolol fumarate is distributed into human milk.^{1 2} Use with caution.¹

Pediatric Use

Safety and efficacy not established in children;^{1 2} however, some experts recommend the use of bisoprolol fumarate/hydrochlorothiazide fixed combination in hypertensive children (1–17 years of age).⁵²

Geriatric Use

Safety and efficacy profiles in geriatric individuals are similar to those in younger adults.^{1 2}

Hepatic Impairment

In patients with hepatitis or cirrhosis, reduce initial dosage and adjust dosage cautiously.^{1 3} (See Hepatic Impairment under Dosage and Administration).

Renal Impairment

Cl_cr <40 mL/minute: threefold increase in half-life;^{1 2} reduce initial dosage and adjust dosage cautiously.^{1 3} (See Renal Impairment under Dosage and Administration).

Common Adverse Effects

Fatigue, headache, diarrhea, peripheral edema, and upper respiratory tract infection.^{1 2}

Interactions for Bisoprolol Fumarate

Not metabolized by isoenzyme CYP2D6.

Specific Drugs

Drug	Interaction	Comments
β-Adrenergic blocking agents		Do not use with other β- blockers1 2
Catecholamine-depleting drugs (e.g., reserpine, guanethidine)	Possible additive effects with concurrent use1 2	Monitor closely for excessive decreases in sympathetic activity1 2
Calcium-channel blocking agents (e.g., verapamil, diltiazem])	Potential for additive negative effects on AV nodal conduction	Use with caution1 2
Cimetidine	No clinically important pharmacokinetic interaction1 2
Clonidine	β-Adrenergic blockade may exacerbate rebound hypertension which may occur following clonidine discontinuance a	Discontinue β-blockers several days before withdrawal of clonidine 1 2
Digoxin	No clinically important pharmacokinetic interaction
Disopyramide	Potential for additive negative effects on AV nodal conduction1 2	Use with caution1 2
Myocardial depressant general anesthetics (e.g., ether, cyclopropane, trichloroethylene)	Increased risk of hypotension and heart failure1 2	Use with caution1 2 41
Rifampin	Potential for increased clearance and decreased elimination half-life of bisoprolol1 2	Initial dosage adjustments of bisoprolol are not necessary1 2
Thiazide diuretics	No clinically important pharmacokinetic interaction1 2
Warfarin	No effect on prothrombin time with stable warfarin dosage1 2

Bisoprolol Fumarate Pharmacokinetics

Absorption

Bioavailability

About 80%.^{1 2}

Onset

In healthy individuals, decreased tachycardia (exercise- and isoproterenol-induced) occurs within 1–4 hours.^{1 2}

Duration

In normal individuals, decreased tachycardia generally persists for 24 hours.^{1 2}

Food

Food does not appear to affect absorption.¹

Distribution

Extent

Not known whether distributed into human milk.^{1 2}

Plasma Protein Binding

About 30%.^{1 2}

Elimination

Metabolism

Not metabolized by CYP2D6.^{1 2}

20% first-pass metabolism.^{1 2}

Elimination Route

Excreted in urine as unchanged drug (50%) and as inactive metabolites; less than 2% excreted in feces.^{1 2}

Half-life

9–12 hours.^{1 2}

Special Populations

In patients with cirrhosis, half-life is more variable and substantially prolonged (range: 8.3–21.7 hours).^{1 2}

In renal impairment (Cl_cr <40 mL/minute): threefold increase in half-life.¹ (See Renal Impairment under Dosage and Administration.)

In geriatrics, half-life slightly increased due to decreased renal function.^{1 2}

Stability

Storage

Oral

Tablets

Tight containers at 20–25°C.¹

Tablets (Bisoprolol Fumarate and Hydrochlorothiazide)

Tight containers at 20–25°C.²

ActionsActions

• 
  

  Inhibits response to adrenergic stimuli by competitively blocking β₁-adrenergic receptors within the myocardium.¹ Blocks β₂-adrenergic receptors within the bronchial and vascular smooth muscle only at high doses.^{1 2 3 4 7}

  
  


• 
  

  Decreases resting and exercise-stimulated heart rate and cardiac output, decreases isoproterenol-induced tachycardia, prolongs sinus node recovery time, refractory period of the AV node, and AV nodal conduction (with rapid atrial stimulation).^{1 2}

  
  


• 
  

  No intrinsic sympathomimetic activity or membrane-stabilizing effect on the heart.^{1 2}

  
  


• 
  

  Reduces blood pressure by decreasing cardiac output, decreasing sympathetic outflow from the CNS, and or suppressing renin release.^{1 2}

  
  

Advice to Patients

• 
  

  Importance of taking medication exactly as prescribed.¹

  
  


• 
  

  Importance of not interrupting or discontinuing therapy without consulting clinician.^{1 2}

  
  


• 
  

  Importance of informing clinician at the first sign or symptom of congestive cardiac failure, excessive bradycardia, or if any difficulty in breathing occurs.^{1 2}

  
  


• 
  

  Importance of informing anesthesiologist or dentist that they are receiving bisoprolol therapy prior to undergoing major surgery.^{1 2}

  
  


• 
  

  Importance of informing patients with diabetes that the drug may mask signs and symptoms of hypoglycemia, including increased heart rate.^{1 2}

  
  


• 
  

  Importance of avoiding some activities (e.g., operating machinery or driving a motor vehicle or those requiring mental alertness).^{1 2}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.^{1 2}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 2}

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Bisoprolol Fumarate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	5 mg*	Bisoprolol Fumarate Tablets
			Zebeta (scored)	Barr
		10 mg*	Bisoprolol Fumarate Tablets
			Zebeta	Barr

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Bisoprolol Fumarate and Hydrochlorothiazide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	2.5 mg with Hydrochlorothiazide 6.25 mg*	Ziac	Barr
		5 mg with Hydrochlorothiazide 6.25 mg*	Ziac	Barr
		10 mg with Hydrochlorothiazide 6.25 mg*	Ziac	Barr

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Bisoprolol Fumarate 10MG Tablets (SANDOZ): 30/$37.99 or 90/$95.97

Bisoprolol Fumarate 5MG Tablets (MYLAN): 30/$35.99 or 90/$92.98

Bisoprolol-Hydrochlorothiazide 10-6.25MG Tablets (SANDOZ): 30/$22.99 or 90/$59.97

Bisoprolol-Hydrochlorothiazide 2.5-6.25MG Tablets (SANDOZ): 90/$59.99 or 180/$105.97

Bisoprolol-Hydrochlorothiazide 5-6.25MG Tablets (SANDOZ): 90/$19.96 or 180/$39.93

Zebeta 10MG Tablets (TEVA PHARMACEUTICALS USA): 30/$104.99 or 90/$309.98

Zebeta 5MG Tablets (TEVA PHARMACEUTICALS USA): 30/$104.99 or 90/$309.98

Ziac 10-6.25MG Tablets (TEVA PHARMACEUTICALS USA): 30/$105.18 or 90/$288.6

Ziac 2.5-6.25MG Tablets (TEVA PHARMACEUTICALS USA): 30/$105.16 or 90/$293.46

Ziac 5-6.25MG Tablets (TEVA PHARMACEUTICALS USA): 30/$105.13 or 90/$288.58

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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53. Wright JT, Dunn JK, Cutler JA et al. Outcomes in hypertensive black and nonblack patients treated with chlorthalidone, amlodipine, and lisinopril. JAMA. 2005; 293:1595-607. [IDIS 531054] [PubMed 15811979]

54. Neaton JD, Kuller LH. Diuretics are color blind. JAMA. 2005; 293:1663-6. [IDIS 531056] [PubMed 15811986]

55. American College of Cardiology and American Heart Association. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Summary Article. Circulation. 2005; 112:1825-52.

56. Thadani U. Beta blockers in hypertension. Am J Cardiol. 1983; 52:10-5D.

57. Shand DG. State-of-the-art: comparative pharmacology of the β-adrenoceptor blocking drugs. Drugs. 1983; 25(Suppl 2):92-9.

58. Breckenridge A. Which beta blocker? Br Med J. 1983; 286:1085-8.

59. Anon. Choice of a beta-blocker. Med Lett Drugs Ther. 1986; 28:20-2. [PubMed 2869400]

60. Wallin JD, Shah SV. β-Adrenergic blocking agents in the treatment of hypertension: choices based on pharmacological properties and patient characteristics. Arch Intern Med. 1987; 147:654-9. [IDIS 227948] [PubMed 2881524]

61. McDevitt DG. β-Adrenoceptor blocking drugs and partial agonist activity: is it clinically relevant? Drugs. 1983; 25:331-8.

62. McDevitt DG. Clinical significance of cardioselectivity: state-of-the-art. Drugs. 1983; 25(Suppl 2):219-26.

63. Frishman WH. β-Adrenoceptor antagonists: new drugs and new indications. N Engl J Med. 1981; 305:500-6. [IDIS 136600] [PubMed 6114433]

64. Thadani U, Davidson C, Chir B et al. Comparison of the immediate effects of five β-adrenoceptor-blocking drugs with different ancillary properties in angina pectoris. N Engl J Med. 1979; 300:750-5. [PubMed 581782]

65. Lewis RV, McDevitt DG. Adverse reactions and interactions with β-adrenoceptor blocking drugs. Med Toxicol. 1986; 1:343-61. [IDIS 239050] [PubMed 2878346]

66. Frishman WH. Clinical differences between beta-adrenergic blocking agents: implications for therapeutic substitution. Am Heart J. 1987; 113:1190-8. [IDIS 229873] [PubMed 2883867]

a. AHFS Drug Information 2005. McEvoy GK, ed. Bisoprolol. American Society of Health System Pharmacists; 2005:1763--5.

More Bisoprolol Fumarate resources

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• Bisoprolol Fumarate Support Group
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• Bisoprolol Prescribing Information (FDA)


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Blocadren

Pronunciation: TIM-oh-lole
Generic Name: Timolol
Brand Name: Blocadren

Do not suddenly stop taking Blocadren. Sharp chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Blocadren. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Blocadren for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Blocadren again.

Blocadren is used for:

Treating high blood pressure. It is also used to help prevent a second heart attack in patients who have survived a first heart attack and are stable and to prevent migraines. It may also be used for other conditions as determined by your doctor.

Blocadren is a beta-blocker. It works by interfering with body chemicals that shrink blood vessels and interfere with normal heart contractions.

Do NOT use Blocadren if:

• you are allergic to any ingredient in Blocadren or to similar medicines


• you have asthma, a history of asthma, or severe chronic obstructive pulmonary disease (COPD)


• you have severe slow heartbeat or rapid heartbeat; heart blockage, failure, or shock; or low systolic blood pressure


• you are taking mibefradil, theophyllines (eg, aminophylline), cocaine, or sympathomimetics (eg, epinephrine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Blocadren:

Some medical conditions may interact with Blocadren. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart disease, heart failure, blood flow problems, bronchitis or another lung problem, tumors on your adrenal gland, diabetes mellitus, an overactive thyroid, or you are suffering from an allergic reaction, or you will be having surgery

Some MEDICINES MAY INTERACT with Blocadren. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Indomethacin and derivatives, ibuprofen, naproxen, phenylpropanolamine, sulfinpyrazone, or sulindac because they may decrease Blocadren's effectiveness


• Anticholinesterases (eg, pyridostigmine), cimetidine, diltiazem, disopyramide, flecainide, ketanserin, lithium, mefloquine, mibefradil, nifedipine and derivatives, propafenone, quinidine, reserpine, serotonin reuptake inhibitors (eg, fluoxetine), or verapamil and derivatives because side effects, such as low blood pressure and slowed heart rate, may occur


• Bupivacaine, carbonic anhydrase inhibitors (eg, acetazolamide), cocaine, disopyramide, sympathomimetics (eg, epinephrine), ergot alkaloids (eg, ergotamine), flecainide, insulin, ketanserin, mefloquine, meglitinide antidiabetics (eg, repaglinide), methyldopa, nifedipine and derivatives, quinazolines (eg, imatinib), serotonin reuptake inhibitors (eg, fluoxetine), or verapamil and derivatives because the risk of their side effects may be increased by Blocadren


• Glucagon, meglitinide antidiabetics (eg, repaglinide), phenformin, sympathomimetics (eg, pseudoephedrine, albuterol), or theophyllines (eg, aminophylline) because the their effectiveness may be decreased by Blocadren


• Clonidine because when it is discontinued it may cause rebound high blood pressure

This may not be a complete list of all interactions that may occur. Ask your health care provider if Blocadren may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Blocadren:

Use Blocadren as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Blocadren by mouth with or without food.


• If you miss a dose of Blocadren, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Blocadren.

Important safety information:

• Blocadren may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Blocadren with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Additional monitoring of your dose or condition may be needed if you are taking prazosin.


• Tell your doctor or dentist that you take Blocadren before you receive any medical or dental care, emergency care, or surgery.


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Diabetes patients - Blocadren may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• If your doctor has instructed you to check your blood pressure and heart rate regularly, be sure to do so.


• Blocadren should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Blocadren while you are pregnant. Blocadren is found in breast milk. Do not breast-feed while taking Blocadren.

Possible side effects of Blocadren:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; fatigue/tiredness; lightheadedness; mild drowsiness; slow heartbeat; unusual weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; chest pain; irregular heart rhythms.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Blocadren side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficult or slowed breathing; fainting; low blood pressure; severe dizziness; very slow heart rate; weakness.

Proper storage of Blocadren:

Store Blocadren at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Blocadren out of the reach of children and away from pets.

General information:

• If you have any questions about Blocadren, please talk with your doctor, pharmacist, or other health care provider.


• Blocadren is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Blocadren. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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• Blocadren Side Effects (in more detail)
• Blocadren Dosage
• Blocadren Use in Pregnancy & Breastfeeding
• Drug Images
• Blocadren Drug Interactions
• Blocadren Support Group
• 0 Reviews for Blocadren - Add your own review/rating

• Blocadren Prescribing Information (FDA)


• Blocadren Concise Consumer Information (Cerner Multum)


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Compare Blocadren with other medications

• Angina
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• Migraine Prevention

Blood Stop

Dosage Form: FOR ANIMAL USE ONLY
Blood Stop POWDER

INDICATIONS

INDICATIONS: For use as an aid in controlling minor bleeding from superficial cuts and wounds and after dehorning.

Blood Stop Dosage and Administration

DOSAGE AND ADMINISTRATION: Apply powder freely to bleeding surface.  Repeat as needed. Bandage if necessary.

Contraindications

CONTRAINDICATIONS: In case of deep or puncture wounds or serious burns, consult veterinarian. If redness, irritation, or swelling persists or increases, discontinue use and consult veterinarian.

B-1101-07               Rev. 1-96

CONTENTS

CONTENTS: Ferrous Sulfate • 7H2O 84.0%, Ammonium Alum 5%, Chloroxylenol 1%, Tannic Acid 1%, In a free-flowing absorbent base. Not sterilized.

For external use only.

Store at controlled room temperature between 15o-30oC (59o-86oF)

Keep container tightly closed.

TAKE TIME OBSERVE LABEL DIRECTIONS

Lot No.

Exp. Date

Blood Stop  iron  powder

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 58005-730 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS SULFATE (IRON) FERROUS SULFATE 381.4 g  in 454 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58005-730-07 454 g In 1 JAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/11/1995

Labeler - Sparhawk Laboratories, Inc. (958829558)

Revised: 01/2010Sparhawk Laboratories, Inc.

bivalirudin Intravenous

bye-VAL-i-roo-din

Commonly used brand name(s)

In the U.S.

• Angiomax

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Anticoagulant

Pharmacologic Class: Thrombin Inhibitor, Direct

Chemical Class: Hirudin Related

Uses For bivalirudin

Bivalirudin is used together with aspirin to decrease the clotting ability of the blood and to help prevent harmful clots from forming in the blood vessels. It is used in patients who are having certain heart and blood vessel procedures, such as coronary angioplasty.

bivalirudin is available only with your doctor's prescription.

Before Using bivalirudin

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 bivalirudin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bivalirudin 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 bivalirudin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bivalirudin in the elderly. However, elderly patients are more likely to have bleeding problems than younger adults, which may require caution in patients receiving bivalirudin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 receiving bivalirudin, 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 bivalirudin 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.

• Abciximab


• Acenocoumarol


• Alteplase, Recombinant


• Anistreplase


• Argatroban


• Bromfenac


• Celecoxib


• Chamomile


• Citalopram


• Clopidogrel


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desvenlafaxine


• Diclofenac


• Diflunisal


• Dipyridamole


• Drotrecogin Alfa


• Enoxaparin


• Eptifibatide


• Escitalopram


• Etodolac


• Fluoxetine


• Flurbiprofen


• Fluvoxamine


• Fondaparinux


• Garlic


• Ginkgo


• Heparin


• Ibuprofen


• Ibuprofen Lysine


• Indomethacin


• Ketoprofen


• Ketorolac


• Lepirudin


• Magnesium Salicylate


• Mefenamic Acid


• Meloxicam


• Milnacipran


• Nabumetone


• Naproxen


• Nepafenac


• Oxaprozin


• Papaya


• Paroxetine


• Phenindione


• Phenprocoumon


• Piroxicam


• Reteplase, Recombinant


• Rivaroxaban


• Salsalate


• Sertraline


• St John's Wort


• Streptokinase


• Sulindac


• Tan-Shen


• Tenecteplase


• Ticlopidine


• Tinzaparin


• Tirofiban


• Tolmetin


• Urokinase


• Venlafaxine


• Warfarin

Using bivalirudin 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.

• Avocado


• Chondroitin


• Coenzyme Q10


• Curcumin


• Dong Quai


• Ginger


• Green Tea


• Vitamin A

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Bleeding problems, active—Should not be used in patients with this condition.

• Brachytherapy (a radiation treatment)—Use with caution. Your chance of having blot clots may be increased.

• Kidney disease—Use with caution. May require an adjustment of dosage for patients with this condition.

Proper Use of bivalirudin

A nurse or other trained health professional will give you bivalirudin. bivalirudin is given through a needle placed into one of your veins.

Precautions While Using bivalirudin

It is very important that your doctor check you at regular visits after you leave the hospital for any problems or unwanted effects that may be caused by bivalirudin. Be sure to keep all appointments.

Bivalirudin may increase your chance of bleeding. Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

bivalirudin Side Effects

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 or nurse immediately if any of the following side effects occur:

More common

• Abdominal pain or swelling


• arm, back, or jaw pain


• black, tarry stools


• blood in the eyes


• blood in the urine


• blurred vision


• bruising or purple areas on the skin


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• coughing up blood


• decreased alertness


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• headache


• joint pain or swelling


• nausea


• nervousness


• nosebleeds


• pounding in the ears


• shortness of breath


• slow, fast, or irregular heartbeat


• sweating


• unusual tiredness or weakness

Less common

• Decrease in frequency of urination


• decrease in urine volume


• difficulty in passing urine (dribbling)


• lightheadedness or fainting


• painful urination

Rare

• Blue lips and fingernails


• changes in skin color


• cold hands and feet


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• difficult, fast, noisy breathing, sometimes with wheezing


• fever or chills


• increased blood pressure


• increased thirst


• loss of appetite


• lower back or side pain


• pain, redness, or swelling in the arm or leg


• pale skin


• paralysis of the face


• rapid, shallow breathing


• severe numbness, especially on one side of the face or body


• swelling in the legs and ankles


• swelling of the face, fingers, or lower legs


• troubled breathing


• vomiting


• weight gain

Incidence not known

• Bleeding gums


• difficulty in swallowing


• hives


• increased menstrual flow or vaginal bleeding


• irritation


• itching


• joint stiffness


• pains in the chest, groin, or legs, especially calves of legs


• paralysis


• prolonged bleeding from cuts


• rash


• red or dark brown urine


• redness of the skin


• severe headaches of sudden onset


• sudden loss of coordination


• sudden onset of shortness of breath for no apparent reason


• sudden onset of slurred speech


• sudden vision changes


• swelling of the eyelids, lips, hands, or feet


• wheezing

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:

More common

• Fear or nervousness


• pain where the needle is placed


• pelvic pain


• sleeplessness


• trouble sleeping


• unable to sleep

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort, upset, or pain

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.

See also: bivalirudin Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More bivalirudin Intravenous resources

• Bivalirudin Intravenous Side Effects (in more detail)
• Bivalirudin Intravenous Use in Pregnancy & Breastfeeding
• Bivalirudin Intravenous Drug Interactions
• Bivalirudin Intravenous Support Group
• 0 Reviews for Bivalirudin Intravenous - Add your own review/rating

Compare bivalirudin Intravenous with other medications

• Angina
• Percutaneous Coronary Intervention

Bleph 10

Generic Name: Sulfacetamide
Class: Antibacterials
ATC Class: S01AB
VA Class: OP210
CAS Number: 6209-17-2

Introduction

Sulfonamide anti-infective.¹⁰⁷

Uses for Bleph 10

Bacterial Ophthalmic Infections

Treatment of conjunctivitis, corneal ulcers, and other superficial infections of the eye caused by susceptible Staphylococcus aureus, Streptococcus pneumoniae, viridans streptococci, Haemophilus influenzae, Enterobacter, Escherichia coli, and Klebsiella.^{107 108 f}

Used alone or in fixed combination with topical corticosteroids (e.g., fluorometholone, prednisolone) when such combination therapy is indicated.^{b c e g}

Ineffective for treatment of infections caused by Neisseria, Serratia marcescens, or Pseudomonas aeruginosa.^{108 b c e f g} Consider that staphylococci frequently are resistant to sulfonamides.^{108 b c e f g}

Chlamydial Ophthalmic Infections

Has been used as an adjunct to systemic anti-infectives for treatment of trachoma; ^{107 108 f} however, systemic anti-infectives are recommended.¹⁰⁶ No data to support use of topical anti-infectives in conjunction with systemic therapy.¹⁰⁶

Bleph 10 Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment, solution, or suspension.^{107 108 b c e f g}

Not for injection;^{107 108 b c e f} do not inject subconjunctivally or instill directly into the anterior chamber of the eye.^g

Avoid contamination of the tip of the container.^{b c e f g}

Shake suspension well prior to use.^{b g}

Dosage

Available as sulfacetamide sodium; dosage expressed in terms of the salt.^f

Available as fixed combinations containing sulfacetamide sodium and prednisolone acetate, prednisolone sodium phosphate, or fluorometholone; dosage expressed in terms of the salt.^{b c e g}

Pediatric Patients

Bacterial Ophthalmic Infections

Sulfacetamide 10%

Ophthalmic Solution

Children ≥2 months of age: Initially, 1 or 2 drops into the conjunctival sac of the affected eye(s) every 2–3 hours.^f Reduce dosing frequency as infection improves.^f Usual duration of treatment is 7–10 days.^f

Sulfacetamide 10% and Fluorometholone 0.1%

Ophthalmic Suspension

Children ≥2 years of age: 1 drop into the conjunctival sac of the affected eye(s) 4 times daily.^g Reduce dosing frequency as infection improves.^g

If improvement does not occur after 2 days, reevaluate the patient.^g Do not discontinue prematurely.^g

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.^g

Sulfacetamide 10% and Prednisolone Acetate 0.2%

Ophthalmic Ointment

Children ≥6 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.^c Reduce dosing frequency as infection improves.^c

If improvement does not occur after 2 days, reevaluate the patient.^{b c} Do not discontinue prematurely.^{b c}

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.^{b c}

Ophthalmic Suspension

Children ≥6 years of age: 2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.^b Reduce dosing frequency as infection improves.^b

If improvement does not occur after 2 days, reevaluate the patient.^{b c} Do not discontinue prematurely.^{b c}

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.^{b c}

Sulfacetamide 10% and Prednisolone Sodium Phosphate 0.25%

Ophthalmic Solution

Children ≥6 years of age: 2 drops into the affected eye(s) every 4 hours.^e Reduce dosing frequency as infection improves.^e

If improvement does not occur after 2 days, reevaluate the patient.^e Do not discontinue prematurely.^e

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.^e

Chlamydial Ophthalmic Infections

Trachoma

Ophthalmic Solution

Sulfacetamide 10% in children ≥2 months of age: 2 drops into the conjunctival sac of the affected eye(s) every 2 hours in conjunction with systemic anti-infectives.^f

Adults

Bacterial Ophthalmic Infections

Sulfacetamide 10%

Ophthalmic Solution

Initially, 1 or 2 drops of solution into the conjunctival sac of the affected eye(s) every 2–3 hours.^f Reduce dosing frequency as infection improves.^f Usual duration of treatment is 7–10 days.^f

Sulfacetamide 10% and Fluorometholone 0.1%

Ophthalmic Suspension

1 drop into the conjunctival sac of the affected eye(s) 4 times daily.^g Reduce dosing frequency as infection improves.^g

If improvement does not occur after 2 days, reevaluate the patient.^g Do not discontinue prematurely.^g

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.^g

Sulfacetamide 10% and Prednisolone Acetate 0.2%

Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3 or 4 times daily during the day and once or twice during the night.^c Reduce dosing frequency as infection improves.^c

If improvement does not occur after 2 days, reevaluate the patient.^{b c} Do not discontinue prematurely.^{b c}

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.^{b c}

Ophthalmic Suspension

2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.^b Reduce dosing frequency as infection improves.^b

If improvement does not occur after 2 days, reevaluate the patient.^{b c} Do not discontinue prematurely.^{b c}

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.^{b c}

Sulfacetamide 10% and Prednisolone Sodium Phosphate 0.25%

Ophthalmic Solution

2 drops into the affected eye(s) every 4 hours.^e Reduce dosing frequency as infection improves.^e

If improvement does not occur after 2 days, reevaluate the patient.^e Do not discontinue prematurely.^e

When discontinuing therapy in chronic conditions, gradually taper dosing frequency.^e

Chlamydial Ophthalmic Infections

Trachoma

Ophthalmic Solution

Sulfacetamide 10%: 2 drops into the conjunctival sac of the affected eye(s) every 2 hours, in conjunction with systemic anti-infectives.^f

Special Populations

No special population dosage recommendations at this time.^{a b c e f g}

Cautions for Bleph 10

Contraindications

• 
  

  Known or suspected hypersensitivity to sulfonamides or to any ingredient in the formulation.^{107 108 b c e f g}

  
  

Warnings/Precautions

Warnings

Severe Reactions

Severe, fatal reactions to sulfonamides have occurred rarely, including dermatologic reactions, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, or other blood dyscrasias.^{107 108 f g}

Adverse reactions reported with systemic sulfonamides could occur with topical application.¹⁰⁷

Sensitivity Reactions

Hypersensitivity

Topical application of sulfonamides may produce sensitization and preclude later systemic use of these drugs.^{107 a f g} In addition, patients who have been sensitized by systemic sulfonamide administration may exhibit hypersensitivity reactions following topical application of the drugs.^{107 a f g}

Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely following topical application in individuals with a history of hypersensitivity to systemic sulfonamides.^{107 108 f g}

Cross-sensitivity occurs among the various sulfonamides.^{108 f}

Discontinue sulfonamide therapy immediately at the first sign of hypersensitivity, rash, or other serious reaction.^{107 108 f g}

General Precautions

Superinfection

Use of sulfonamides may result in the overgrowth of nonsusceptible organisms, including fungi.^{107 108 f g} Bacterial and fungal corneal ulcers have developed during use of ophthalmic sulfonamide preparations.¹⁰⁸

Discontinue drug and institute appropriate therapy if superinfection occurs.¹⁰⁷

Ophthalmic Ointments

Ophthalmic ointments may delay corneal healing.^c

Use of Fixed Combinations Containing Corticosteroids

Concomitant topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the antibiotic; or suppress hypersensitivity reactions to sulfonamides or other ingredients in the formulation.^{107 c}

When sulfacetamide is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with EENT corticosteroids.^{b c e g}

Specific Populations

Pregnancy

Category C.^{108 f}

Lactation

Systemically absorbed sulfonamides can cause kernicterus in neonates and infants.^{108 f g} Discontinue nursing or the drug.^{108 f g}

Pediatric Use

Safety and efficacy of ophthalmic sulfacetamide sodium not established in infants <2 months of age.^{107 108 f}

Safety and efficacy of fixed-combination ophthalmic sulfacetamide and prednisolone not established in children <6 years of age.^{b c e}

Safety and efficacy of fixed-combination ophthalmic sulfacetamide and fluorometholone not established in children <2 years of age.^g

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.^g

Common Adverse Effects

Local irritation, transient stinging or burning.^{107 a f}

Interactions for Bleph 10

Specific Drugs

Drug	Interaction	Comments
Anesthetics, local (p-aminobenzoic acid related	Possible antagonism of action of sulfonamides107
Gentamicin	In vitro antagonismb c e	Do not use concomitantlyb c e

Bleph 10 Pharmacokinetics

Absorption

Extent

Sulfonamides do not appear to be appreciably absorbed from mucous membranes.¹⁰⁷

Distribution

Extent

Systemic sulfonamides cross the placenta and are distributed into human milk in low concentrations.^h

Stability

Storage

Ophthalmic

Sulfonamide preparations darken on prolonged standing and exposure to heat and light.^{b e f} Discard preparations that have darkened; yellow discoloration does not affect activity.^{b e f}

Ointment

Sulfacetamide sodium and prednisolone acetate: Tightly closed containers at 15–25°C.^c

Solution

Sulfacetamide sodium: 8–25°C; protect from light and freezing.^f

Sulfacetamide sodium and prednisolone sodium phosphate: 15–25°C; protect from light.^e

Suspension

Sulfacetamide sodium and fluorometholone: 15–30°C; protect from light and freezing.^g

Sulfacetamide sodium and prednisolone acetate: Upright position at 8–24°C; protect from light and freezing.^b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Ophthalmic

Ointment or Solution

Sulfacetamide sodium is incompatible with preparations containing silver.^{107 108 f}

Precipitation may occur if zinc sulfate is added to sulfacetamide sodium solutions, depending on the concentration of each drug.¹⁰⁷

Actions and SpectrumActions

• 
  

  Usually bacteriostatic,^f but may be bactericidal at very high concentrations.^{107 108}

  
  


• 
  

  Sulfonamides interfere with utilization of aminobenzoic or aminobenzoic glutamic acids by susceptible organisms, thus inhibiting biosynthesis of folic acid which is essential for growth.^{107 a f} Only organisms that synthesize their own folic acid are inhibited by sulfonamides; animal cells and bacteria that are capable of utilizing folic acid precursors or preformed folic acid are not affected.¹⁰⁷

  
  


• 
  

  Antibacterial activity is decreased in the presence of blood or purulent exudates containing p-aminobenzoic acid.^{107 108 a f}

  
  


• 
  

  Spectrum of activity includes some aerobic gram-positive and -negative bacteria.^{107 a}

  
  


• 
  

  Gram-positive aerobic bacteria: Active against S. aureus, S. pneumoniae, and viridans streptococci.^{107 108 a f g} Many staphylococci are resistant.^{107 108 g}

  
  


• 
  

  Gram-negative aerobic bacteria: Active against H. influenzae, Enterobacter, E. coli, and Klebsiella.^{108 a f g}

  
  


• 
  

  Cross-resistance usually occurs among the various sulfonamides.^{107 a f}

  
  

Advice to Patients

• 
  

  Importance of not touching tip of container to eye, eyelid, or any other surface.^{108 b c e f g} Advise patient to keep container tightly closed when not in use.^g

  
  


• 
  

  Importance of discontinuing use and contacting clinician at first sign of hypersensitivity, increase in discharge, or if pain or swelling worsen.^{108 b c f}

  
  


• 
  

  Advise patient not to share the drug with any other person.^{c g}

  
  


• 
  

  Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloride and of delaying reinsertion of the lenses for ≥5 minutes after administration.^{b i}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^f

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^f

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sulfacetamide Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder
Ophthalmic	Ointment	10%*	Sulfacetamide Sodium Ophthalmic Ointment	Fougera
	Solution	10%*	Bleph 10 (with benzalkonium chloride)	Allergan
			Sulfacetamide Sodium Ophthalmic Solution	Bausch & Lomb, Falcon

Sulfacetamide Sodium and Prednisolone Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Ointment	10% Sulfacetamide Sodium and Prednisolone Acetate 0.2%	Blephamide (with phenylmercuric acetate)	Allergan
	Suspension	10% Sulfacetamide Sodium and Prednisolone Acetate 0.2%	Blephamide (with benzalkonium chloride)	Allergan

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Other Sulfacetamide Sodium Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	10% with 0.25% Prednisolone Sodium Phosphate (0.23% of prednisolone phosphate)*	Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution	Bausch & Lomb, Falcon
Ophthalmic	Suspension	10% with Fluorometholone 0.1%	FML-S (with benzalkonium chloride and povidone)	Allergan

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Bleph-10 10% Solution (ALLERGAN): 5/$27.99 or 15/$61.97

Blephamide 10-0.2% Suspension (ALLERGAN): 10/$95.99 or 30/$275.97

Blephamide 10-0.2% Suspension (ALLERGAN): 5/$67.99 or 15/$189.98

Blephamide S.O.P. 10-0.2% Ointment (ALLERGAN): 3/$68.99 or 10/$185.96

Sulfacetamide Sodium 10% Solution (FALCON PHARMACEUTICALS): 15/$12.99 or 30/$18.98

Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH &amp; LOMB): 10/$30.99 or 20/$53.97

Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH &amp; LOMB): 5/$21.99 or 15/$53.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

101. Allergan, Inc. Bleph-10 (sulfacetamide sodium) ophthalmic ointment prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 34th ed. Montvale, NJ: Thomson PDR; 2006:219-20.

102. Fougera. Sulfacetamide sodium ophthalmic ointment USP, 10% prescribing information. Melville, NY; 1998 Mar.

103. Falcon Pharmaceuticals, Ltd. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution. Fort Worth, TX; 2003 Nov.

104. Allergan. FML-S (fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10% prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 34th ed. Montevale, NJ: Thomson PDR; 2006:226-7.

105. American Academy of Pediatrics. Red book: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006;252-7.

106. American Academy of Ophthalmology. Preferred Practice Pattern: Conjunctivitis. 2003. From the American Academy of Ophthalmology website. Accessed 11 May 2006.

107. AHFS Drug Information 2003. McEvoy, GK, ed. Sulfonamides (ophthalmic). Bethesda, MD: American Society of Health-System Pharmacists; 2003:2613-4.

108. Akorn. AK-Sulf (sulfacetamide sodium) ophthalmic solution prescribing information. Buffalo Grove, IL: 2000 May.

109. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:210.

110. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther. 2001; 43:69-78. [PubMed 11518876]

111. Allergan, Inc. Bleph-10 (sulfacetamide sodium) ophthalmic ointment prescribing information. Irvine, CA; 1993 Sept.

a. AHFS drug information 2008. McEvoy, GK, ed. Sulfacetamide sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2855-6.

b. Allergan, Inc. Blephamide (sulfacetamide sodium and prednisolone acetate, USP ophthalmic suspension) 10%/0.2% prescribing information. Irvine, CA; 2004 Jun.

c. Allergan, Inc. Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% prescribing information. Irvine, CA; 2004 Sept.

e. Falcon Pharmaceuticals, Ltd. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution prescribing information. Fort Worth, TX; 2007 Jul.

f. Allergan, Inc. Bleph-10 (sulfacetamide sodium ophthalmic solution, USP) 10% prescribing information. Irvine, CA; 2005 Feb.

g. Allergan, Inc. FML-S (fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10% prescribing information. Irvine, CA; 2005 Feb.

h. Briggs CC, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation, 7th ed. Philadelphia, PA: Lippincott, Williams, & Wilkins; 2005: 1508-10.

i. Christensen MT, Barry JR, Turner FD. Five-minute removal of soft lenses prevents most absorption of a topical ophthalmic solution. CLAO J. 1998; 24:227-31. [PubMed 9800062]

More Bleph 10 resources

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