Anistreplase

In the US, Anistreplase is a member of the drug class thrombolytics and is used to treat Heart Attack.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

B01AD03

CAS registry number (Chemical Abstracts Service)

0081669-57-0

Therapeutic Category

Anticoagulant agent: Fibrinolytic

Chemical Name

Plasminogen-Streptokinase-4-Amidinophenyl p-anisat hydrochlorid (1:1:1)

Foreign Names

• Anistreplasum (Latin)
• Anistreplase (German)
• Anistreplase (French)
• Anistreplasa (Spanish)

Generic Names

• Anistreplase (OS: BAN, DCF, USAN)
• APSAC (IS)
• BRL 26921 (IS)

Brand Name

• Eminase
  Pharmateam, Israel

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Sinecod Tosse Fluidificante

Sinecod Tosse Fluidificante may be available in the countries listed below.

Ingredient matches for Sinecod Tosse Fluidificante

Carbocisteine

Carbocisteine is reported as an ingredient of Sinecod Tosse Fluidificante in the following countries:

• Italy

International Drug Name Search

Lisinopril Qualigen

Lisinopril Qualigen may be available in the countries listed below.

Ingredient matches for Lisinopril Qualigen

Lisinopril

Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Lisinopril Qualigen in the following countries:

• Spain

International Drug Name Search

Benazepril Hydrochloride

Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV400
Chemical Name: [S* - (R*,R*)] - 3 - [[1[(ethoxycarbonyl) - 3 - phenylpropyl]amino] - 2,3,4,5 - tetrahydro - 2 - oxo - 1 - H - 1benzazepine - 1 - acetic acid monohydrochloride
CAS Number: 86541-74-4
Brands: Lotensin, Lotensin HCT, Lotrel

• 
  

  Benazepril may cause fetal and neonatal morbidity and mortality if used during pregnancy.^{1 11 12 48 49 51} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  If pregnancy is detected, discontinue benazepril as soon as possible.^{1 11 12 51}

  
  

Introduction

Benazepril is a nonsulfhydryl ACE inhibitor.^{1 2 3 4}

Uses for Benazepril Hydrochloride

Hypertension

Benazepril is used for management of hypertension (alone or in combination with other classes of antihypertensive agents);^{1 4 10 13 28} may be used in fixed combination with amlodipine or hydrochlorothiazide when such combined therapy is indicated.^{11 12}

ACE inhibitors are one of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.²⁸

Benazepril can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.²⁸

Addition of benazepril to amlodipine usually does not provide additional antihypertensive effects in blacks but appears to reduce development of amlodipine-associated edema regardless of race.¹²

CHF

ACE inhibitors are used for management of symptomatic CHF†, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.^{27 31 32 33 34 35}

Diabetic Nephropathy

ACE inhibitors or angiotensin II receptor antagonists are first-line agents in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.^{37 38 39 50}

Benazepril Hydrochloride Dosage and Administration

General

Hypertension

• 
  

  Benazepril/amlodipine and benazepril/hydrochlorothiazide fixed combinations should not be used for initial treatment of hypertension.^{11 12}

  
  

Administration

Oral Administration

Administer benazepril orally once or twice daily without regard to meals.¹

Administer benazepril as extemporaneously prepared oral suspension in pediatric patients unable to swallow tablets or in those for whom the calculated daily dosage does not correspond to the available tablet strengths.¹

Reconstitution

Preparation of extemporaneous suspension containing benazepril hydrochloride 2 mg/mL: Add 75 mL of suspending vehicle (Ora-Plus) to a polyethylene terephthalate (PET) bottle containing fifteen 20-mg tablets of benazepril hydrochloride; shake the contents for ≥2 minutes.¹ Allow concentrated suspension to stand for a minimum of 60 minutes following reconstitution, then shake for a minimum of 1 additional minute.¹ Dilute the concentrated suspension with 75 mL of syrup (Ora-Sweet); shake the container to disperse the ingredients.¹ Shake suspension before dispensing each dose.¹

Dosage

Benazepril is available as benazepril hydrochloride; dosage expressed in terms of the salt.^{1 11 12}

Pediatric Patients

Hypertension

Benazepril Therapy for Hypertension

Oral

Children ≥6 years of age: Initially, benazepril hydrochloride 0.2 mg/kg (up to 10 mg) once daily.^{1 45} Adjust dosage until the desired BP goal is achieved (up to maximum dosage of 0.6 mg/kg or 40 mg daily).^{1 45}

Adults

Hypertension

Benazepril Therapy for Hypertension

Oral

Initially, benazepril hydrochloride 10 mg once daily as monotherapy.^{1 4 10 13} Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.¹³

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating benazepril.¹ May cautiously resume diuretic therapy if BP not controlled adequately with benazepril alone.¹ If diuretic cannot be discontinued, increase sodium intake and give lower initial benazepril hydrochloride dose (5 mg) under close medical supervision.^{1 13}

Usual benazepril hydrochloride dosage: 20–40 mg daily, given in 1 dose or 2 divided doses.^{1 10 13}

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering benazepril in 2 divided doses.^{1 13}

Benazepril/Hydrochlorothiazide Fixed-combination Therapy for Hypertension

Oral

In studies using benazepril/hydrochlorothiazide fixed combination in dosages of benazepril hydrochloride 5–20 mg daily and hydrochlorothiazide 6.25–25 mg daily, BP response increased with increasing dosages of the drugs.¹¹

If BP is not adequately controlled by monotherapy with benazepril, can switch to the fixed-combination preparation containing benazepril hydrochloride 10 mg and hydrochlorothiazide 12.5 mg or, alternatively, benazepril hydrochloride 20 mg and hydrochlorothiazide 12.5 mg.¹¹ Adjust dosage of either or both drugs according to patient’s response.¹¹

If BP is controlled by monotherapy with hydrochlorothiazide 25 mg daily but potassium loss is problematic, can switch to fixed-combination preparation containing benazepril hydrochloride 5 mg and hydrochlorothiazide 6.25 mg.¹¹

If BP is controlled with benazepril and hydrochlorothiazide (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.¹¹

Benazepril/Amlodipine Fixed-combination Therapy for Hypertension

Oral

In studies using benazepril/amlodipine fixed combination in dosages of benazepril hydrochloride 10–40 mg daily and amlodipine 2.5–10 mg daily, BP response increased with increasing amlodipine dosage in all patient groups and increased with increasing benazepril dosage in nonblack patient groups.¹²

If BP is not adequately controlled by monotherapy with benazepril (or another ACE inhibitor) or amlodipine (or another dihydropyridine-derivative calcium-channel blocker), can switch to benazepril/amlodipine fixed combination.¹²

If BP is adequately controlled by monotherapy with amlodipine, but edema has developed, can switch to benazepril/amlodipine fixed combination to achieve similar or better BP control without edema.¹² May be prudent to reduce amlodipine dosage, especially in nonblack patients, when benazepril is initiated to avoid excessive antihypertensive response.¹²

If BP is controlled with benazepril and amlodipine (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.¹²

Adjust dosage of benazepril/amlodipine fixed combination according to patient’s response; consider that steady-state plasma concentrations of benazepril and amlodipine are reached after 2 and 7 days, respectively.¹²

In small or frail individuals, preparations containing benazepril in fixed combination with 5 or 10 mg of amlodipine exceed the initial recommended dosage (2.5 mg daily) of amlodipine.¹²

Prescribing Limits

Pediatric Patients

Hypertension

Oral

Maximum 0.6 mg/kg or 40 mg of benazepril hydrochloride daily.^{1 45}

Adults

Hypertension

Oral

Maximum 80 mg of benazepril hydrochloride daily.¹

Special Populations

The following information addresses dosage of benazepril in special populations. Dosages of drugs administered in fixed combination with benazepril also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.^{11 12}

Hepatic Impairment

Preparations containing benazepril in fixed combination with 5 or 10 mg of amlodipine exceed the initial recommended dosage of amlodipine (2.5 mg daily) in patients with hepatic impairment.¹²

Renal Impairment

Initially, benazepril hydrochloride 5 mg once daily in adults with Cl_cr <30 mL/minute or S_cr >3 mg/dL; titrate until BP is controlled or to maximum of 40 mg daily.¹ Use of benazepril not recommended in pediatric patients with Cl_cr <30 mL/minute per 1.73 m².^{1 45}

Preparations containing benazepril in fixed combination with hydrochlorothiazide are not recommended in patients with Cl_cr ≤30 mL/minute or S_cr >3 mg/dL.¹¹ Loop diuretics are preferred to thiazides in these patients.¹¹

Preparations containing benazepril in fixed combination with amlodipine are not recommended in patients with Cl_cr ≤30 mL/minute or S_cr >3 mg/dL.¹²

Geriatric Patients

Select dosage of benazepril carefully.^{1 11 12} (See Geriatric Use under Cautions.)

Preparations containing benazepril in fixed combination with 5 or 10 mg of amlodipine exceed the initial recommended dosage (2.5 mg daily) of amlodipine in geriatric patients.¹²

Volume- and/or Salt-depleted Patients

Correct volume and/or salt depletion prior to initiation of benazepril therapy or initiate therapy under close medical supervision using lower initial dosage.¹

Cautions for Benazepril Hydrochloride

Contraindications

• 
  

  Known hypersensitivity (e.g., history of angioedema) to benazepril or another ACE inhibitor.^{1 11 12}

  
  


• 
  

  When benazepril is used in fixed combination with hydrochlorothiazide or amlodipine, consider contraindications associated with the concomitant agent.^{11 12}

  
  

Warnings/Precautions

Warnings

Hypotension

Possible symptomatic hypotension with ACE inhibitors, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics) or patients with CHF with or without associated renal insufficiency.^{1 11 12}

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.^{1 11 12}

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.^{1 7} May minimize potential for hypotension by withholding diuretic therapy and/or increasing sodium intake for 2–3 days prior to initiation of benazepril.^{1 13} (See Dosage and also Special Populations under Dosage and Administration.)

Transient hypotension is not a contraindication to additional doses; may reinstate benazepril therapy cautiously after BP is stabilized (e.g., with volume expansion).^{1 11 12}

Initiate benazepril therapy in patients with CHF (with or without associated renal insufficiency) under close medical supervision; monitor closely for first 2 weeks following initiation of benazepril or diuretic therapy or any increase in benazepril or diuretic dosage.^{1 11 12}

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when benazepril is used during pregnancy.^{1 11 12 13 14 15 16 17 18 19 20 49 51} (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.⁴⁹ Benazepril also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.^{1 11 12 48 49}

Discontinue benazepril as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.^{1 11 12 49} Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.^{8 19}

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.^{1 11 12}

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.^{1 11 12}

Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk of neutropenia appears to depend principally on degree of renal impairment and presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma); risk with benazepril is unknown.^{1 11 12}

Consider monitoring leukocytes in patients with collagen vascular disease, especially if renal impairment exists.^{1 11 12}

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible with ACE inhibitors; if associated with laryngeal edema, may be fatal.^{1 11 12} Institute immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.^{1 11 12}

Intestinal angioedema possible with ACE inhibitors; consider in differential diagnosis of patients who develop abdominal pain.^{1 11 12}

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption or following initiation of hemodialysis that utilized high-flux membrane.^{1 11 12}

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.^{1 11 12}

Benazepril is contraindicated in patients with a history of angioedema associated with ACE inhibitors.^{1 11 12}

General Precautions

Use of Fixed Combinations

When benazepril is used in fixed combination with hydrochlorothiazide or amlodipine, consider cautions, precautions, contraindications, and interactions associated with the concomitant agent.^{11 12} Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.^{11 12}

Renal Effects

Transient increases in BUN and S_cr possible with benazepril, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.^{1 11 12} Possible increases in BUN and S_cr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitor and/or diuretic.^{1 11 12}

Oliguria, progressive azotemia, and, rarely, acute renal failure and/or death reported in patients with severe CHF receiving benazepril.^{1 11 12}

Closely monitor renal function following initiation of benazepril therapy in such patients.¹ Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic and/or adequate sodium repletion.¹

Hyperkalemia

Hyperkalemia reported with benazepril, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).^{1 11 12} (See Specific Drugs under Interactions.)

Monitor serum potassium concentration carefully in these patients.¹

Cough

ACE inhibitors associated with persistent and nonproductive cough; resolves after drug discontinuance.^{1 11 12}

Specific Populations

Pregnancy

Benazepril: Category D.^{1 11 12} (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Benazepril and benazeprilat are distributed into milk in minimal amounts.^{1 11 12} Discontinue nursing or the drug.^{1 11 12}

Pediatric Use

Safety and efficacy of benazepril not established in children <6 years of age¹ or in those with Cl_cr <30 mL/minute per 1.73 m².^{1 45}

Safety and efficacy of benazepril in fixed combination with amlodipine or hydrochlorothiazide not established in children.^{11 12}

Geriatric Use

Safety and efficacy profiles of benazepril alone or in fixed combination with hydrochlorothiazide or amlodipine are similar to those in younger adults.^{1 11 12} However, possible decreased elimination of benazepril due to age-related changes in renal function; cautious dosing recommended.^{1 11 12}

Renal Impairment

Systemic exposure to benazeprilat may be increased.¹ (See Absorption: Special Populations, under Pharmacokinetics.) Initial benazepril dosage adjustment recommended in patients with severe renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Deterioration of renal function may occur.^{1 11 12} Possible increased risk of hyperkalemia.¹ Theoretical risk of neutropenia/agranulocytosis.^{1 11 12} (See Warnings and also General Precautions under Cautions.)

Use of preparations containing benazepril in fixed combination with amlodipine¹² or hydrochlorothiazide¹¹ is not recommended in patients with severe renal impairment. (See Renal Impairment under Dosage and Administration.)

Blacks

BP reduction with ACE inhibitors may be smaller in black patients compared with nonblack patients;^{10 13} however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.^{10 13} Use in combination with a diuretic.^{10 13}

Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.^{1 26 28}

Common Adverse Effects

Benazepril: Headache, dizziness, fatigue, somnolence, postural dizziness, nausea, cough.¹

Interactions for Benazepril Hydrochloride

The following information addresses potential interactions with benazepril. When benazepril is used in fixed combination with hydrochlorothiazide or amlodipine, consider interactions associated with the concomitant agent.^{11 12}

Specific Drugs

Drug	Interaction	Comments
Anticoagulants, oral	Interaction unlikely1
Antidiabetic agents (insulin, oral agents)	Possible hypoglycemia1 11	Advise diabetic patients about the possibility of hypoglycemia; monitor appropriately1 11
Diuretics	Increased hypotensive effect1	If possible, discontinue diuretic before initiating benazepril1 (see General and also Dosage under Dosage and Administration)
Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)	Enhanced hyperkalemic effect1	Use with caution; monitor serum potassium concentrations frequently1
Lithium	Increased serum lithium concentrations; possible toxicity1	Use with caution; monitor serum lithium concentrations frequently1
Potassium supplements or potassium-containing salt substitutes	Enhanced hyperkalemic effect1	Use with caution; monitor serum potassium concentrations frequently1

Benazepril Hydrochloride Pharmacokinetics

Absorption

Bioavailability

About 37% of oral benazepril dose is absorbed.¹ Peak plasma concentrations of benazepril and benazeprilat are achieved within 0.5–1 and 1–2 hours, respectively.¹

Onset

Following a single oral benazepril dose, antihypertensive effects are observed within 1 hour, with peak BP reduction at 2–4 hours.¹

During chronic benazepril therapy, maximum antihypertensive effect with any dose is achieved after 1–2 weeks.¹

Duration

Antihypertensive effect of a single benazepril dose persists for about 24 hours.¹

Food

Food does not affect absorption of benazepril.¹

Peak plasma concentrations of benazeprilat are attained within 2–4 hours following oral administration of benazepril with food.¹

Special Populations

In patients with cirrhosis, benazeprilat concentrations essentially unchanged.¹

In patients with severe renal impairment, increased peak serum benazeprilat concentrations and increased time to steady-state benazeprilat concentrations.¹

Distribution

Extent

In animal studies, benazepril and its metabolites crossed the blood-brain barrier only slightly.^{1 11}

Benazepril crosses the placenta and is distributed into breast milk.¹

Plasma Protein Binding

Benazepril: 96.7%.¹

Benazeprilat: 95.3%.¹

Elimination

Metabolism

Benazepril is metabolized in the liver, principally to an active metabolite, benazeprilat.¹

Elimination Route

Benazepril is eliminated principally in urine (as metabolites) and to lesser extent via biliary excretion.¹

Half-life

Benazeprilat: 10–11 hours.¹

Special Populations

In patients with renal failure, biliary clearance of benazeprilat may compensate to some extent for reduced renal clearance.¹

Stability

Storage

Oral

Extemporaneous Suspension

Benazepril hydrochloride 2 mg/mL in Ora-Sweet and Ora-Plus (see Reconstitution under Dosage and Administration): Up to 30 days at 2–8°C.¹

Tablets

Benazepril: Tight container at ≤30°C.¹

Benazepril/hydrochlorothiazide fixed combination: Tight, light-resistant container at ≤30ºC.¹¹

Capsules

Benazepril/amlodipine fixed combination: Tight container at 25ºC (may be exposed to 15–30ºC).¹²

ActionsActions

• 
  

  Benazepril is a prodrug; not pharmacologically active until hydrolyzed in the liver to benazeprilat.^{1 2 3 4}

  
  


• 
  

  Benazepril suppresses the renin-angiotensin-aldosterone system.¹

  
  

Advice to Patients

• 
  

  When benazepril is used in fixed combination with hydrochlorothiazide or amlodipine, importance of advising patients of important precautionary information about the concomitant agent.^{11 12}

  
  


• 
  

  Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.¹ Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.¹

  
  


• 
  

  Importance of reporting signs of infection (e.g., sore throat, fever).¹

  
  


• 
  

  Risk of hypotension.¹ Importance of informing clinicians promptly if lightheadedness or fainting occurs.¹

  
  


• 
  

  Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.¹

  
  


• 
  

  Risks of use during pregnancy.^{1 11 12 48 49} (See Boxed Warning.)

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium), as well as any concomitant illnesses.¹

  
  


• 
  

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

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (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

Benazepril Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	5 mg*	Benazepril Hydrochloride Tablets
			Lotensin	Novartis
		10 mg*	Benazepril Hydrochloride Tablets
			Lotensin	Novartis
		20 mg*	Benazepril Hydrochloride Tablets
			Lotensin	Novartis
		40 mg*	Benazepril Hydrochloride Tablets
			Lotensin	Novartis

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

Benazepril Hydrochloride Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	10 mg with Amlodipine Besylate 2.5 mg (of amlodipine)*	Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)
			Lotrel	Novartis
		10 mg with Amlodipine Besylate 5 mg (of amlodipine)*	Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)
			Lotrel	Novartis
		20 mg with Amlodipine Besylate 5 mg (of amlodipine)*	Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)
			Lotrel	Novartis
		20 mg with Amlodipine Besylate 10 mg (of amlodipine)*	Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)
			Lotrel	Novartis
		40 mg with Amlodipine Besylate 5 mg (of amlodipine)	Lotrel	Novartis
		40 mg with Amlodipine Besylate 10 mg (of amlodipine)	Lotrel	Novartis
	Tablets, film-coated	5 mg with Hydrochlorothiazide 6.25 mg*	Benazepril with Hydrochlorothiazide Tablets
			Lotensin HCT (scored)	Novartis
		10 mg with Hydrochlorothiazide 12.5 mg*	Benazepril with Hydrochlorothiazide Tablets
			Lotensin HCT (scored)	Novartis
		20 mg with Hydrochlorothiazide 12.5 mg*	Benazepril with Hydrochlorothiazide Tablets
			Lotensin HCT (scored)	Novartis
		20 mg with Hydrochlorothiazide 25 mg*	Benazepril with Hydrochlorothiazide Tablets
			Lotensin HCT (scored)	Novartis

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.

Amlodipine Besy-Benazepril HCl 2.5-10MG Capsules (TEVA PHARMACEUTICALS USA): 30/$69.99 or 90/$199.96

Amlodipine Besy-Benazepril HCl 5-20MG Capsules (SANDOZ): 30/$69.99 or 90/$195.97

Benazepril HCl 10MG Tablets (SANDOZ): 30/$25.99 or 90/$69.97

Benazepril HCl 20MG Tablets (SANDOZ): 30/$25.99 or 90/$69.97

Benazepril HCl 40MG Tablets (SANDOZ): 30/$23.99 or 90/$64.97

Benazepril HCl 5MG Tablets (TEVA PHARMACEUTICALS USA): 90/$64.97 or 180/$129.94

Benazepril-Hydrochlorothiazide 10-12.5MG Tablets (SANDOZ): 30/$22.99 or 90/$56.96

Benazepril-Hydrochlorothiazide 20-12.5MG Tablets (SANDOZ): 30/$26.99 or 90/$69.96

Benazepril-Hydrochlorothiazide 20-25MG Tablets (SANDOZ): 30/$26.99 or 90/$69.96

Benazepril-Hydrochlorothiazide 5-6.25MG Tablets (SANDOZ): 30/$25.91 or 90/$67.18

Lotensin 10MG Tablets (NOVARTIS): 30/$67.99 or 90/$172.97

Lotensin 20MG Tablets (NOVARTIS): 30/$72.99 or 90/$188.97

Lotensin 40MG Tablets (NOVARTIS): 30/$67.99 or 90/$177.98

Lotensin 5MG Tablets (NOVARTIS): 30/$62.8 or 90/$163.34

Lotensin HCT 10-12.5MG Tablets (NOVARTIS): 30/$62.99 or 90/$175.98

Lotensin HCT 20-12.5MG Tablets (NOVARTIS): 30/$63.99 or 90/$168.97

Lotensin HCT 20-25MG Tablets (NOVARTIS): 30/$62.99 or 90/$170.97

Lotrel 10-20MG Capsules (NOVARTIS): 30/$158.99 or 90/$461.99

Lotrel 10-40MG Capsules (NOVARTIS): 30/$164.85 or 90/$469.19

Lotrel 2.5-10MG Capsules (NOVARTIS): 30/$123.99 or 90/$345.98

Lotrel 5-10MG Capsules (NOVARTIS): 30/$123.99 or 90/$340.97

Lotrel 5-20MG Capsules (NOVARTIS): 30/$128.99 or 90/$360.95

Lotrel 5-40MG Capsules (NOVARTIS): 30/$123 or 90/$348.73

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 December 2009. 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.

References

1. Novartis. Lotensin (benazepril hydrochloride) tablets prescribing information. East Hanover, NJ; 2007 Nov.

2. Kaiser G, Ackermann R, Sioufi A. Pharmacokinetics of a new angiotensin-converting enzyme inhibitor, benazepril hydrochloride, in special populations. Am Heart J. 1989; 117:746-51. [IDIS 252976] [PubMed 2919553]

3. Kaiser G. Benazepril—pharmacokinetic profile in specific subpopulations. In: Brunner HR, Salvetti A, Sever PS, eds. Benazepril: profile of a new ACE inhibitor. Royal Society of Medicine Services International Congress and Symposium Series No. 166. London: Royal Society of Medicine Services Limited; 1990:29-39.

4. Balfour JA, Goa KL. Benazepril. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in hypertension and congestive heart failure. Drugs. 1991; 42:511-39. [PubMed 1720384]

5. Squibb. Capoten (captopril) tablets prescribing information. In: Physician’s Desk Reference. 47th ed. Montvale, NJ: Medical Economics Company Inc; 1993: 2356-62.

6. Reviewers’s comments in Enalaprilat/Enalapril 24:32.04 (personal observations).

7. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

8. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

9. Ciba Pharmaceutical Company, Summit, NJ: Personal communication.

10. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

11. Novartis. Lotensin HCT (benazepril hydrochloride/hydrochlorothiazide) tablets prescribing information. East Hanover, NJ; 2007 Nov.

12. Novartis. Lotrel (amlodipine besylate and benazepril hydrochloride) capsules prescribing information. East Hanover, NJ; 2007 Jun.

13. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

14. Rey E, LeLorier J, Burgess E et al. Report of the Canadian Hypertension Society consensus conference: 3. pharmacologic treatment of hypertensive disorders in pregnancy. CMAJ. 1997; 157:1245-54. [IDIS 396283] [PubMed 9361646]

15. American College of Obstetricians and Gynecologists. ACOG technical bulletin No. 219: hypertension in pregnancy. 1996 Jan.

16. Hanssens M, Keirse MJ, Van Assche FA. Fetal and neonatal effects of treatment with angiotensin-converting enzyme inhibitors in pregnancy. Obstet Gynecol. 1991; 78:128-35. [IDIS 284531] [PubMed 2047053]

17. Brent Rl, Beckman D. Angiotensin-coverting enzyme inhibitors, an embryopathic class of drugs with unique properties: information for clinical teratology counselors. Teratology. 1991; 43:543-6. [PubMed 1882342]

18. Piper JM, Ray WA, Rosa FW. Pregnancy outcome following exposure to antiotensin-converting enzyme inhibitors. Obstet Gynecol. 1992; 80:429-32. [IDIS 300973] [PubMed 1495700]

19. Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med. 1996; 335:257-65. [IDIS 369138] [PubMed 8657243]

20. Barr M, Cohen MM. ACE inhibitor fetopathy and hypocalvaria: the kidney-skull connection. Teratology. 1991; 44:485-95. [PubMed 1771591]

21. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

22. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

23. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

24. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

25. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

26. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

27. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9A-38A.

28. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289.

29. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

30. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

31. Merck & Co. Vasotec tablets (enalapril maleate) prescribing information. Whitehouse Station, NJ; 2002 Jan.

32. Bristol-Myers Squibb. Monopril (fosinopril sodium) tablets prescribing information. Princeton, NJ; 2002 Feb.

33. Merck

Tikosyn

In the US, Tikosyn (dofetilide systemic) is a member of the drug class group III antiarrhythmics and is used to treat Arrhythmia.

US matches:

• Tikosyn

Ingredient matches for Tikosyn

Dofetilide

Dofetilide is reported as an ingredient of Tikosyn in the following countries:

• United States

International Drug Name Search

bacillus of calmette and guerin vaccine, live Intravesical

ba-SILL-us of KAL-met and GARE-in VAX-een, lyve

Intravesical route(Powder for Suspension)

Bacillus of calmette and guerin infections have been reported in health care workers and patients due to exposure to the vaccine during preparation and administration. Bacillus of calmette and guerin is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical bacillus of calmette and guerin. THERACYS(R) and TICE(R) BCG contains live, attenuated mycobacteria and because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material .

Commonly used brand name(s)

In the U.S.

• Theracys


• Tice BCG

Available Dosage Forms:

• Powder for Solution


• Powder for Suspension

Therapeutic Class: Vaccine

Uses For bacillus of calmette and guerin vaccine, live

Bacillus Calmette-Guérin (BCG) is used as a solution that is run through a tube (instilled through a catheter) into the bladder to treat bladder cancer. The exact way it works against cancer is not known, but it may work by stimulating the body's immune system.

BCG is to be administered only by or under the immediate supervision of your doctor.

Before Using bacillus of calmette and guerin vaccine, live

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 bacillus of calmette and guerin vaccine, live, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bacillus of calmette and guerin vaccine, live 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

There is no specific information comparing use of BCG for treatment of cancer in children with use in other age groups.

Geriatric

bacillus of calmette and guerin vaccine, live has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 bacillus of calmette and guerin vaccine, live, 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 bacillus of calmette and guerin vaccine, live 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.

• Aclarubicin


• Adalimumab


• Aldesleukin


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Azathioprine


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Everolimus


• Fingolimod


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Mercaptopurine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Sirolimus


• Streptozocin


• Tacrolimus


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Ustekinumab


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Using bacillus of calmette and guerin vaccine, live 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.

• Abatacept


• Leflunomide

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 bacillus of calmette and guerin vaccine, live. Make sure you tell your doctor if you have any other medical problems, especially:

• Fever—Infection may be present and could cause problems

• Immunity problems—BCG treatment is less effective and there is a risk of infection

• Urinary tract infection—Infection and irritation of the bladder may occur

Proper Use of bacillus of calmette and guerin vaccine, live

Your doctor will ask you to empty your bladder completely before the solution is instilled into it.

Follow your doctor's instructions carefully about how long to hold the solution in your bladder:

• The solution should be held in your bladder for 2 hours. If you think you cannot hold it, tell your health care professional.


• During the first hour, your doctor may have you lie for 15 minutes each on your stomach, back, and each side.


• When you do empty your bladder, you should be sitting down.

It is important that you drink extra fluids for several hours after each treatment with BCG so that you will pass more urine. Also, empty your bladder frequently. This will help prevent bladder problems.

BCG is a live product. In other words, it contains active bacteria that can cause infection. Some bacteria will be present for several hours in urine that you pass after each treatment with BCG. Any urine that you pass during the first 6 hours after each treatment should be disinfected with an equal amount (usually about 1 cup) of undiluted household bleach. After the bleach is added to the urine, it should be allowed to sit for 15 minutes before it is flushed. If you have any questions about this, check with your doctor.

Dosing

The dose of bacillus of calmette and guerin vaccine, live will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of bacillus of calmette and guerin vaccine, live. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using bacillus of calmette and guerin vaccine, live

While you are being treated with BCG, and for 6 to 12 weeks after you stop treatment with it, avoid contact with people who have tuberculosis. If you think you have been exposed to someone with tuberculosis, tell your doctor.

While you are being treated with BCG and for a few weeks after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval.

bacillus of calmette and guerin vaccine, live 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 as soon as possible if any of the following side effects occur:

More common

• Blood in urine


• fever and chills


• frequent urge to urinate


• increased frequency of urination


• joint pain


• nausea and vomiting


• painful urination (severe or continuing)

Rare

• Cough


• skin rash

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

• Burning during first urination after treatment

After you stop using bacillus of calmette and guerin vaccine, live, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Cough


• fever

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: bacillus of calmette and guerin vaccine, live Intravesical 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 bacillus of calmette and guerin vaccine, live Intravesical resources

• Bacillus of calmette and guerin vaccine, live Intravesical Side Effects (in more detail)
• Bacillus of calmette and guerin vaccine, live Intravesical Use in Pregnancy & Breastfeeding
• Bacillus of calmette and guerin vaccine, live Intravesical Drug Interactions
• Bacillus of calmette and guerin vaccine, live Intravesical Support Group
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Compare bacillus of calmette and guerin vaccine, live Intravesical with other medications

• Tuberculosis, Prophylaxis
• Urinary Tract Tumors

Rhinocort Turbuhaler

Generic Name: budesonide (Inhalation route)

bue-DES-oh-nide

Commonly used brand name(s)

In the U.S.

• Pulmicort


• Pulmicort Flexhaler


• Pulmicort Respules


• Pulmicort Turbuhaler

In Canada

• Pulmicort Nebuamp


• Rhinocort Turbuhaler

Available Dosage Forms:

• Suspension


• Powder


• Solution


• Aerosol Powder


• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Rhinocort Turbuhaler

Budesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled budesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Budesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

This medicine is available only with your doctor's prescription.

Before Using Rhinocort Turbuhaler

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving inhaled budesonide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

• Boceprevir


• Bupropion


• Telaprevir

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.

• Erythromycin


• Itraconazole


• Ketoconazole

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute—Should not be used in patients with this condition.

• Bone problems (e.g., osteoporosis) or


• Cataracts or


• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox, including recent exposure or


• Measles or


• Herpes simplex virus infection of the eye or


• Infections (virus, bacteria, or fungus) or


• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Milk protein allergy, severe—Use with caution. The Pulmicort Flexhaler™ contains lactose (milk sugar with milk protein), which may cause side effects for patients with this condition.

Proper Use of budesonide

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Rhinocort Turbuhaler. Please read with care.

Inhaled budesonide is used to prevent asthma attacks. It is not used to stop an attack that has already started. For relief of an asthma attack that has already started, you or your child should use another medicine. If you do not have another medicine to use for an acute asthma attack or if you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. This medicine usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

Do not change your dose or stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

When using the Pulmicort Flexhaler™:

• This medicine comes as a powder that you breathe into the lungs with a special inhaler that is placed in the mouth. It is used by adults, teenagers, and children who are 6 years of age and older.


• The medicine comes with patient instructions. Read the instructions carefully before using this medicine. If you or your child do not understand the instructions or are not sure how to use the inhaler, check with your doctor.


• When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Before using this medicine, test or prime it.


• Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip, then twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time.


• You do not have to prime it again after this, even if you have not used it for a long time.


• After the inhaler is primed, twist the cover and lift it off.


• To load a dose, hold the inhaler in the upright position, then twist the grip fully in one direction as far as it will go, and then fully back again in the other direction. You will hear a click.


• Turn your head away from the inhaler and breathe out. Do not shake the inhaler.


• Place the mouthpiece between your lips and breathe in deeply and forcefully. You may not taste or feel the medicine.


• Do not chew or bite on the mouthpiece.


• Remove the inhaler from your mouth and breathe out. Do not blow or breathe into the inhaler.


• Repeat these steps if more than one dose is needed.


• When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water and spit out the water. Do not swallow the water. This helps prevent hoarseness, throat irritation, and infections in the mouth.


• Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.


• Do not use a spacer with the Pulmicort Flexhaler™.


• Keep the inhaler clean and dry at all times. Follow the patient directions for cleaning and storing the inhaler.


• The inhaler has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.


• Discard the whole device when all doses have been used. The inhaler is empty when the number zero appears in the middle of the dose indicator window. You will be given a new inhaler each time you refill your prescription.

When using the Pulmicort Respules® liquid:

• This medicine comes as a liquid that you breathe into the lungs with a special breathing machine called a jet nebulizer. The nebulizer has a face mask or mouthpiece. It is used by children who are 12 months to 8 years of age.


• Your doctor will tell you which type of nebulizer to use with this medicine and will show you how to use the nebulizer. The medicine and nebulizer come with patient instructions. Read the instructions carefully before using the medicine or the machine. If you or your child do not understand the instructions or are not sure how to use the nebulizer, check with your doctor.


• Use this medicine at the same time each day, unless your child's doctor tells you otherwise.


• Do not mix this liquid with other medicines.


• Open the sealed aluminum foil envelope containing the medicine. Remove one container from the strip of five plastic containers with sealed caps. Write the current date on the back of the envelope when you open the foil pouch.


• Each container has one dose of medicine.


• Place the unused containers back in the foil pouch. This will protect the medicine from light.


• Shake the container in a circular motion before using it.


• Hold the container upright and open it by twisting off the cap.


• Slowly squeeze out all of the contents of the container into the nebulizer cup. Throw the empty container away.


• If your child is using a face mask, make sure that the mask fits tightly on the face to avoid getting the medicine in the eyes.


• Turn on the compressor to begin nebulizing the medication. The nebulizer turns the medicine into a fine mist that the child breathes into the lungs using the mouthpiece or mask.


• After the dose is completed, wash your child's face to prevent skin irritation.


• Rinsing your child's mouth with water after each dose may help prevent hoarseness, throat irritation, and infections in the mouth. Do not allow your child to swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For preventing an asthma attack:
  
  • For inhalation dosage form (powder inhaler):
    
    • Adults and children 6 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose as needed.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For inhalation dosage form (suspension in a nebulizer):
    
    • Children 12 months to 8 years of age—0.5 to 1 milligram (mg) in a nebulizer once a day, or divided and given twice a day. Each container of liquid has one dose and a new container is used for each dose.
    
    
    • Infants younger than 12 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Pulmicort Flexhaler™ in a dry place at room temperature with the cover tightly in place.

Store the unused Pulmicort Respules® in an upright position at room temperature. Keep the medicine containers in the foil pouch until you are ready to use them. Do not freeze the containers. Once you have opened a foil pouch, the containers will only be good for 2 weeks. Throw away any unused containers if it has been longer than 2 weeks since you opened the pouch.

Precautions While Using Rhinocort Turbuhaler

It is very important that your doctor check you or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by this medicine.

You or your child should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor if you have any questions about this.

If your or your child's symptoms do not improve within one to two weeks, or if they become worse, check with your doctor.

This medicine may weaken your immune system. Avoid being around people who are sick or who have infections such as chickenpox or measles. Tell your doctor right away if you think you or your child have been exposed to chickenpox or measles.

If you or your child develop a skin rash, hives, or any type of allergic reaction (including anaphylaxis) to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child have any signs of a throat infection.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child to not gain weight or get taller. Talk with your child's doctor if you think this is a problem or if you have any concerns.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist knows that you or your child are using this medicine. You might need to stop using this medicine several days before having surgery.

Your doctor may want you or your child to carry a medical identification card that says this medicine is being used. You or your child may need additional medicine during an emergency, a severe asthma attack, an illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Rhinocort Turbuhaler 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 immediately if any of the following side effects occur:

More common

• Body aches or pain


• chills


• congestion


• cough


• diarrhea


• dryness or soreness of the throat


• fever


• general feeling of discomfort or illness


• headache


• hoarseness


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• pain or tenderness around the eyes and cheekbones


• shivering


• shortness of breath or troubled breathing


• sneezing


• sore throat


• stuffy or runny nose


• sweating


• tender, swollen glands in the neck


• tightness of the chest or wheezing


• trouble with sleeping


• trouble with swallowing


• unusual tiredness or weakness


• voice changes


• vomiting

Less common

• Bruising


• darkening of the skin


• depression


• dizziness


• earache


• excessive muscle tone


• fainting


• fractures


• large, flat, blue, or purplish patches in the skin


• lower back or side pain


• muscle stiffness


• muscle tension or tightness


• painful or difficult urination


• redness or swelling in the ear


• skin rash


• sore mouth or tongue


• white patches in the mouth or on the tongue

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

• Back pain

Less common

• Acid or sour stomach


• belching


• change in taste or bad, unusual, or unpleasant (after) taste


• difficulty with breathing


• difficulty with moving


• dry mouth


• ear congestion


• headache, severe and throbbing


• heartburn


• indigestion


• muscle cramping


• neck pain


• sleeplessness


• stomach discomfort, upset, or pain


• swollen joints


• unable to sleep


• unexplained runny nose or sneezing


• weakness

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.

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 Rhinocort Turbuhaler resources

• Rhinocort Turbuhaler Use in Pregnancy & Breastfeeding
• Rhinocort Turbuhaler Drug Interactions
• Rhinocort Turbuhaler Support Group
• 22 Reviews for Rhinocort Turbuhaler - Add your own review/rating

Compare Rhinocort Turbuhaler with other medications

• Asthma, Maintenance
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Betsolan

Betsolan may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Betsolan

Betamethasone

Betamethasone is reported as an ingredient of Betsolan in the following countries:

• Ireland


• Netherlands


• United Kingdom

Betamethasone 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Betsolan in the following countries:

• United Kingdom

International Drug Name Search

Rifaximin

Class: Rifamycins
VA Class: AM900
Chemical Name: [2S - (2R*,16Z,18E,20R*,21R*,22S*,23S*,24S*,25R*,26S*,27R*,22E)] - 25 - acetyloxy) - 5,6,21,23 - tetrahydroxy - 27 - methoxy - 2,4,11,16,20,22,24,26 - octamethyl - 2,7 - (epoxypentadeca[1,11,13]trienimino)benzofuro[4,5 - e]pyrido[1,2 - a]benzimidazole - 1,15(2H) - dione
Molecular Formula: C₄₃H₅₁N₃O₁₁
CAS Number: 80621-81-4
Brands: Xifaxan

Introduction

Rifamycin antibiotic;^{11 12} structural analog of rifampin.^{1 11 12}

Uses for Rifaximin

Travelers’ Diarrhea

Treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults and adolescents ≥12 years of age.^{1 3 4 12 13 14 15 16}

May be ineffective in and should not be used for treatment of diarrhea complicated by fever or bloody stools.¹

May be ineffective in and should not be used for treatment of diarrhea known or suspected to be caused by pathogens other than E. coli (e.g., Campylobacter jejuni, Shigella, Salmonella).¹

Has been used for prevention of travelers’ diarrhea†, but safety and efficacy for such prophylaxis not established.²

Hepatic Encephalopathy

Has been used for adjunctive treatment of hepatic encephalopathy† to reduce blood ammonia concentrations and decrease severity of neurologic manifestations.^{6 7 8 9 10 11 17} Designated an orphan drug by the FDA for use in this condition.⁵

Rifaximin Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.¹

Dosage

Pediatric Patients

Travelers’ Diarrhea Caused by Noninvasive Strains of E. coli

Treatment

Oral

Adolescents ≥12 years of age: 200 mg 3 times daily for 3 days.¹

Adults

Travelers’ Diarrhea Caused by Noninvasive Strains of E. coli

Treatment

Oral

200 mg 3 times daily for 3 days.¹

Hepatic Encephalopathy†

Treatment

Oral

600–1200 mg daily (usually in 3 divided doses) for 7–21 days has been used.^{2 6 7 8 9 10 17}

Special Populations

Hepatic Impairment

No specific dosage adjustments recommended.¹

Renal Impairment

Not specifically studied in renal impairment, but clinically important differences in elimination not expected.^{1 2 11 12}

Geriatric Patients

Not specifically studied in patients ≥65 years of age.¹

Cautions for Rifaximin

Contraindications

• 
  

  Known hypersensitivity to rifaximin, other rifamycin anti-infectives, or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Treatment of Travelers’ Diarrhea

Do not use for treatment of diarrhea complicated by fever or bloody stools.¹

Do not use for treatment of travelers’ diarrhea known or suspected to be caused by C. jejuni, Shigella, or Salmonella.¹

If diarrhea worsens or persists >24–48 hours after initiating rifaximin, discontinue and consider use of another anti-infective.¹

Superinfection/Clostridium difficile-associated Colitis

Overgrowth of nonsusceptible organisms may occur.¹ If superinfection occurs, appropriate therapy should be instituted.¹

Treatment with anti-infectives may permit overgrowth of clostridia.¹ Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.¹

Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.¹ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.¹

Systemic Infections

Do not use for treatment of systemic bacterial infections since <0.4% of an oral dose is absorbed systemically.^{1 11 12}

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether distributed into milk; discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <12 years of age.^{1 2}

Geriatric Use

Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.¹

Renal Impairment

Not specifically studied in renal impairment, but clinically important changes in elimination not expected since the drug is poorly absorbed from GI tract and almost entirely excreted in feces.^{1 2 11 12}

Common Adverse Effects

GI effects (flatulence, abdominal pain, rectal tenesmus, defecation urgency, nausea, constipation, vomiting), headache, fever.¹

Interactions for Rifaximin

Does not inhibit or induce CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, and 2E1.¹ Has induced CYP3A4 in vitro, but clinically important effects on intestinal or hepatic CYP3A4 unlikely; does not inhibit CYP3A4.^{1 2}

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions with drugs metabolized by CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, and 3A4 unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Hormonal contraceptives (ethinyl estradiol and norgestimate)	No substantial changes in pharmacokinetics of ethinyl estradiol and norgestimate1	Dosage adjustment not necessary2
Midazolam	No substantial changes in pharmacokinetics of midolazam or its major metabolite (1′-hydroxymidazolam) 1 2	Dosage adjustment not necessary2

Rifaximin Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from GI tract;^{1 11 12} <0.4% of an oral dose absorbed systemically.^{1 11 12}

No evidence of accumulation following multiple doses.¹

Food

Oral absorption not appreciably affected by food; systemic absorption remains low in the fasting state and when given within 30 minutes of a high-fat breakfast.¹

Distribution

Extent

Animal studies indicate 80–90% of oral dose concentrated in the gut, <0.2% distributed into liver and kidney, and <0.01% into other tissues.¹

Minimal or no hepatic distribution in patients receiving oral rifaximin (400 mg 4 times daily) for 2 days prior to cholescystectomy.¹¹

Elimination

Metabolism

Does not appear to be metabolized.¹

Elimination Route

Approximately 97% of an oral dose excreted in feces as unchanged drug;^{1 11 12} <0.4% eliminated in urine.^{1 11 12}

Half-life

Approximately 6 hours.¹

Special Populations

Pharmacokinetics not studied in pediatric patients or adults ≥65 years of age.¹

Pharmacokinetics not studied in renal impairment.¹

Stability

Storage

Oral

Tablets

20–25°C (may be exposed to 15–30°C).¹

Actions and SpectrumActions

• 
  

  Like other rifamycins, rifaximin inhibits RNA synthesis in susceptible bacteria by binding to the β subunit of bacterial DNA-dependent RNA polymerase.^{1 11}

  
  


• 
  

  Escherichia coli: Active in vitro and in clinical infections (i.e., infectious diarrhea) against enterotoxigenic and enteroaggregative strains of E. coli.^{1 11} Also active in vitro against other E. coli strains, including enterohemorrhagic, enteroinvasive, enteropathogenic, and Hep-2 adherent strains.^{2 11}

  
  


• 
  

  Other bacteria: Has in vitro activity against Acinetobacter, Aeromonas, Bacillus, Bacteroides, Bifidobacterium, Campylobacter jejuni, Clostridium difficile, Enterobacter cloacae, Fusobacterium, Helicobacter, Klebsiella pneumoniae, Plesiomonas shigelloides, Peptostreptococcus, Prevotella, Proteus, Pseudomonas aeruginosa, Salmonella (groups C1 and C2), Shigella (including S. dysenteriae, S. flexneri, S. sonnei), Serratia, Staphylococcus, Streptococcus, Vibrio, and Yersinia enterocolitica.^{2 11} Also active in vitro against Cryptosporidium and Giardia.²

  
  


• 
  

  Although clinical importance unclear, resistance to rifaximin has developed in E. coli in vitro.¹ Further study needed to determine the resistance profile of rifaximin.²

  
  


• 
  

  Organisms with high rifaximin MICs also have elevated rifampin MICs;¹ however, since rifaximin is not appreciably absorbed following oral administration and is present in high concentrations in the bowel lumen, a comparison of rifaximin MICs and MICs for well-absorbed drugs (e.g., rifampin) should be interpreted with caution.^{11 12 14 15}

  
  


• 
  

  Cross-resistance between rifaximin and other classes of anti-infectives not evaluated.¹

  
  

Advice to Patients

• 
  

  Advise patients and/or their caregivers that rifaximin may be taken with or without food.¹

  
  


• 
  

  Importance of taking rifaximin exactly as prescribed and continuing therapy for entire treatment course.¹

  
  


• 
  

  Importance of discontinuing rifaximin and seeking medical care if diarrhea persists for >24–48 hours or worsens or if fever and/or bloody diarrhea develop.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.¹

  
  


• 
  

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

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Rifaximin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	200 mg	Xifaxan	Salix

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.

Xifaxan 200MG Tablets (SALIX PHARMACEUTICALS INC.): 30/$353.98 or 90/$1019.9

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 July 2005. 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.

References

1. Salix Pharmaceuticals, Inc. Xifaxan tablets prescribing information. Raleigh, NC; 2004 Jun.

2. Salix Pharmaceuticals, Inc., Raleigh, NC: Personal communication.

3. Steffen R, Sack DA, Riopel L, et al. Therapy of traveler’s diarrhea with rifaximin on various continents. Am J Gastroenterol. 2003; 98:1073-8. [IDIS 502876] [PubMed 12809830]

4. Infante RM, Ericsson CD, Jiang Z, et al. Enteroaggregative Escherichia coli diarrhea in travelers: response to rifaximin therapy. Clin Gastroenterol Hepatol. 2003; 2:136-8.

5. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD; From FDA website (http: / / www.fda.gov / ForIndustry / DevelopingProductsforRareDiseasesConditions / HowtoapplyforOrphanProductDesignation / default.htm). Accessed 2004 Aug 19.

6. Riordan SM, Williams R. Treatment of hepatic encephalopathy. N Engl J Med. 1997;337:473-9.

7. Williams R, James OF, Warnes TW et al. Evaluation of the efficacy and safety of rifaximin in the treatment of hepatic encephalopathy: a double-blind, randomized, dose-finding multi-centre study. Eur J Gastroenterol Hepatol. 2000;12:203-8.

8. Puxeddu A, Quartini M, Massimetti A et al. Rifaximin in the treatment of chronic hepatic encephalopathy. Curr Med Res Opin. 1995;13:274-81.

9. Pedretti G, Calzetti C, Missale G et al. Rifaximin versus neomycin on hyperammoniemia in chronic portal systemic encephalopathy of cirrhotics. A double-blind, randomized trial. Ital J Gastroenterol. 1991;23:175-8.

10. Bucci L, Palmieri GC. Double-blind, double-dummy comparison between treatment with rifaximin and lactulose in patients with medium to severe degree hepatic encephalopathy. Curr Med Res Opin. 1993;13:109-18.

11. Gillis JC, Brogden RN.. Rifaximin. A review of its antibacterial activity, pharmacokinetic properties and therapeutic potential in conditions mediated by gastrointestinal bacteria. Drugs 1995;49:467-84.

12. Steffen R. Rifaximin: a nonabsorbed antimicrobial as a new tool for treatment of travelers’ diarrhea. J Travel Med. 2001;8:34-9.

13. DuPont HL, Ericsson CD, Mathewson JJ, et al. Rifaximin: a nonabsorbed antimicrobial in the therapy of travelers’ diarrhea. Digestion. 1998;59:708-14.

14. DuPont HL. Treatment of travelers’ diarrhea. J Travel Med. 2001;8:31-3.

15. Lawler JV, Wallace MR. Diagnosis and treatment of bacterial diarrhea. Curr Gastroenterol Rep. 2003;5:287-94.

16. Ericsson CD. Travelers’ diarrhoea. Int J Antimicrob Agents. 2003;21:116-24.

17. Miglio F, Valpiani D, Rossellini SR, et al. Rifaximin, a non-absorbable rifamycin, for the treatment of hepatic encephalopathy. A double-blind, randomised trial. Curr Med Res Opin. 1997;13:593-601.

18. Anon. Advice for travelers. Treat Guidelines Med Lett. 2004; 2:33-49.

19. Centers for Disease Control and Prevention. Health information for international travel, 2003–2004. Atlanta, GA: Department of Health and Human Services; 2003:184-91. From CDC website ()

More Rifaximin resources

• Rifaximin Side Effects (in more detail)
• Rifaximin Dosage
• Rifaximin Use in Pregnancy & Breastfeeding
• Rifaximin Support Group
• 14 Reviews for Rifaximin - Add your own review/rating

• Rifaximin MedFacts Consumer Leaflet (Wolters Kluwer)


• Rifaximin Professional Patient Advice (Wolters Kluwer)


• rifaximin Advanced Consumer (Micromedex) - Includes Dosage Information


• Xifaxan Prescribing Information (FDA)


• Xifaxan Consumer Overview

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