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Volume 17, Number 4 December 2016 Web Version
Now Available
Introducing FDA-approved, AB-rated generics to
Benicar® (olmesartan medoxomil) Tablets and Benicar HCT®
(olmesartan medoxomil and hydrochlorothiazide) Tablets1-4
Mylan now offers Olmesartan Medoxomil Tablets in 5 mg, 20 mg, and 40 mg
dosage strengths1, and Olmesartan Medoxomil and Hydrochlorothiazide Tablets
in 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg dosage strengths.2
SUMMARY INDICATION and USAGE:
Olmesartan medoxomil tablets and Olmesartan medoxomil and hydrochlorothiazide
(HCTZ) tablets are indicated for the treatment of hypertension. They may be used alone
or in combination with other antihypertensive medications.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial infarctions however, there are no controlled trials
demonstrating risk reduction with Olmesartan medoxomil tablets or Olmesartan
The Mylan Blue Bottle®
medoxomil and HCTZ tablets.
stands for Mylan quality
Control of high blood pressure should be part of comprehensive cardiovascular risk
management, including, as appropriate, lipid control, diabetes management, antithrombotic
therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require
more than one drug to achieve blood pressure goals.
Olmesartan medoxomil and HCTZ tablets are not indicated for the initial therapy of hypertension.
IMPORTANT SAFETY INFORMATION
WARNING: FETAL TOXICITY
• When pregnancy is detected, discontinue Olmesartan medoxomil tablets and Olmesartan medoxomil and HCTZ tablets as
soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
See PI WARNINGS AND PRECAUTIONS: Fetal Toxicity.
CONTRAINDICATIONS: In patients with diabetes, do not co-administer aliskiren with Olmesartan medoxomil tablets or
Olmesartan medoxomil and HCTZ tablets.
Olmesartan medoxomil and HCTZ tablets are contraindicated in patients with anuria.
Click here for full Prescribing Information for Olmesartan Medoxomil Tablets, including Boxed WARNING regarding
FETAL TOXICITY.
Click here for full Prescribing Information for Olmesartan Medoxomil Tablets and Hydrochlorothiazide Tablets,
including Boxed WARNING regarding FETAL TOXICITY.
SEE NEW
PRODUCTS
ONLINE
Since the last
edition of Pharmacy
Exchange in August,
Mylan has introduced a
number of products.
For a complete listing
of products introduced
since the last edition of
Pharmacy Exchange,
click here.
IMPORTANT SAFETY INFORMATION FOR OLMESARTAN MEDOXOMIL TABLETS AND OLMESARTAN MEDOXOMIL
AND HYDROCHLOROTHIAZIDE TABLETS (CONT’D)
WARNINGS AND PRECAUTIONS
Fetal Toxicity: Pregnancy Category D
INFANTS: Do not administer to children <1 year of age to treat hypertension. Drugs that
act directly on the renin-angiotensin aldosterone system (RAAS) can have effects on the
development of immature kidneys.
Use in Pediatric Patients: Olmesartan medoxomil tablets have not been shown to be
effective for hypertension in children < 6 years of age.
The safety and effectiveness of Olmesartan medoxomil and HCTZ tablets have not been
established in pediatric patients.
Hypotension in Volume- or Salt-Depleted Patients: In patients with an activated
renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being
treated with high doses of diuretics), symptomatic hypotension may occur after initiation of
treatment with Olmesartan medoxomil or Olmesartan medoxomil HCTZ.
Impaired Renal Function: Patients whose renal function may depend in part upon
the activity of the renin-angiotensin-aldosterone system (e.g. patients with renal artery
stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion),
may be at particular risk of developing acute renal failure on treatment. Monitor renal
function periodically in these patients. Consider withholding or discontinuing therapy in
patients who develop a clinically significant decrease in renal function on Olmesartan
medoxomil or Olmesartan medoxomil and HCTZ.
Safety and effectiveness of Olmesartan medoxomil and HCTZ in patients with severe renal
impairment (CrCl ≤ 30 mL/min) have not been established.
Sprue-like Enteropathy: Severe, chronic diarrhea with substantial weight loss has
been reported in patients taking olmesartan months to years after drug initiation. Intestinal
biopsies of patients often demonstrated villous atrophy. If a patient develops these
symptoms during treatment, exclude other etiologies and consider discontinuation of
olmesartan in cases where no other etiology is identified.
Electrolyte and Metabolic Imbalances: Olmesartan is a drug that inhibits the reninangiotensin system (RAS) and such drugs can cause hyperkalemia. Monitor serum
electrolytes periodically.
Olmesartan medoxomil and hydrochlorothiazide tablets contain hydrochlorothiazide (HCTZ).
Thiazides such as HCTZ can cause hypokalemia and hyponatremia. Hypomagnesemia can
result in hypokalemia which may be difficult to treat despite potassium repletion.
HCTZ may alter glucose tolerance, raise serum levels of cholesterol and triglycerides, and
cause elevations of serum calcium. Therapy with thiazides may precipitate hyperuricemia
or frank gout in patients.
Hepatic impairment : HCTZ, may cause minor alterations of fluid and electrolyte balance
that may precipitate hepatic coma in patients with impaired hepatic function or progressive
liver disease.
Hypersensitivity Reaction: Hypersensitivity reactions to the component HCTZ may occur
in patients with or without a history of allergy or bronchial asthma, but are more likely in
patients with such a history.
Systemic Lupus Erythematosus: Thiazides have been reported to cause exacerbation
or activation of systemic lupus erythematosus.
Benicar and Benicar HCT are registered trademarks of Daiichi Sankyo.
The color blue of the blue bottle is a trademark of Mylan Pharmaceuticals Inc.
The Mylan logo is a registered trademark of Mylan Inc.
Acute Myopia and Secondary Angle-Closure Glaucoma: Thiazides can cause
an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure
glaucoma. Discontinue Olmesartan medoxomil and HCTZ tablets as rapidly as possible in
these patients.
ADVERSE REACTIONS:
Olmesartan medoxomil tablets: In placebo-controlled trials, the only adverse reaction
that occurred in more than 1% of patients treated with olmesartan medoxomil and more
frequently than placebo was dizziness (3% vs.1%).
Olmesartan medoxomil and HCTZ tablets: In a clinical trial, the following adverse reactions
occurred in >2% of patients, and more often on the Olmesartan medoxomil and HCTZ
combination than on placebo: nausea (3% vs 0%), hyperuricemia (4% vs 2%), dizziness
(9% vs 2%), and upper respiratory tract infection (7% vs 0%).
Clinical Laboratory Test Findings: Minor elevations in creatinine and BUN occurred in 1.7%
and 2.5% respectively, of patients taking Olmesartan medoxomil and HCTZ tablets and 0%
and 0% respectively, given placebo in controlled clinical trials.
DRUG INTERACTIONS:
Non-Steroidal Anti-Inflammatory Agents: Concurrent administration of nonsteroidal anti-inflammatory drugs (NSAIDs) may lead to increased risk of renal impairment
(including possible acute renal failure) and loss of antihypertensive effect of Olmesartan
medoxomil tablets and Olmesartan medoxomil and HCTZ tablets.
Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS
with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased
risks of hypotension, hyperkalemia, and changes in renal function (including acute renal
failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors and
closely monitor blood pressure, renal function, and electrolytes.
Avoid use of aliskiren with Olmesartan medoxomil or Olmesartan medoxomil and HCTZ in
patients with renal impairment (GFR <60 mL/min).
Concurrent Use with Colesevelam Hydrochloride: Concurrent administration with
colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration
of olmesartan. Consider administering Olmesartan medoxomil or Olmesartan medoxomil
and HCTZ at least 4 hours before the colesevelam hydrochloride dose.
Lithium: Monitor serum lithium levels during concomitant use with Olmesartan
medoxomil or Olmesartan medoxomil and HCTZ due to potential increases in lithium
concentration and lithium toxicity during concomitant use.
Use of HCTZ with other drugs: When administered concurrently, the following drugs
may interact with thiazides:
Antidiabetic drugs: Dosage adjustment of the antidiabetic drug may be required due to
HCTZ in Olmesartan medoxomil and HCTZ tablets.
Ion Exchange Resins: (e.g., cholestyramine and colestipol): may reduce absorption
of thiazides. Dosing Olmesartan medoxomil and HCTZ tablets at least 4 hours before or
4-6 hours after the administration of the resin may potentially minimize the interaction.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia in
conjunction with HCTZ.
USE IN SPECIFIC POPULATIONS:
Nursing Mothers: If treating a nursing mother, a decision should be made to discontinue
either nursing or the drug.
Mylan Olmesartan Medoxomil Tablets
Dosage Strength
5 mg
20 mg
Mylan NDC
Dosage Form
30 tablets
0378-7012-93
90 tablets
0378-7012-77
500 tablets
0378-7012-05
White to off-white,
film-coated, round,
unscored tablet
30 tablets
0378-7112-93
90 tablets
0378-7112-77
White to off-white,
film-coated, round,
unscored tablet
Not actual size
Not actual size
500 tablets
0378-7112-05
40 mg
30 tablets
0378-7124-93
90 tablets
0378-7124-77
500 tablets
0378-7124-05
White to off-white,
film-coated, round,
unscored tablet
Not actual size
Mylan Olmesartan Medoxomil and
Hydrochlorothiazide Tablets
Dosage Strength
20 mg/
12.5 mg
40 mg/
12.5 mg
40 mg/
25 mg
Mylan NDC
Dosage Form
30 tablets
0378-1413-93
90 tablets
0378-1413-77
500 tablets
0378-1413-05
Pink, film-coated,
round, unscored
tablet
30 tablets
0378-1422-93
90 tablets
0378-1422-77
500 tablets
0378-1422-05
Pink, film-coated,
modified capsule
shaped, unscored
tablet
30 tablets
0378-1425-93
90 tablets
0378-1425-77
500 tablets
0378-1425-05
Not actual size
Not actual size
Pink, film-coated,
round, unscored
tablet
Not actual size
For more information, call Mylan Customer Relations at 1.800.796.9526.
Click here for full Prescribing Information for Olmesartan Medoxomil Tablets including Boxed WARNING regarding
FETAL TOXICITY and Patient Counseling Information.
Click here for full Prescribing Information for Olmesartan Medoxomil Tablets and Hydrochlorothiazide Tablets,
including Boxed WARNING regarding FETAL TOXICITY and Patient Counseling Information.
References
1. Olmesartan Medoxomil Tablets Prescribing Information.
Morgantown, WV: Mylan Pharmaceuticals Inc.
2. Olmesartan Medoxomil and Hydrochlorothiazide Tablets Prescribing
Information. Morgantown, WV: Mylan Pharmaceuticals Inc.
3. Food and Drug Administration. Approval Letter for
Olmesartan Medoxomil Tablets, October 2016.
4. Food and Drug Administration. Approval Letter for Olmesartan
Medoxomil and Hydrochlorothiazide Tablets, October 2016.
IMPORTANT SAFETY INFORMATION FOR OLMESARTAN MEDOXOMIL TABLETS AND OLMESARTAN MEDOXOMIL
AND HYDROCHLOROTHIAZIDE TABLETS (CONT’D)
WARNINGS AND PRECAUTIONS
Fetal Toxicity: Pregnancy Category D
INFANTS: Do not administer to children <1 year of age to treat hypertension. Drugs that
act directly on the renin-angiotensin aldosterone system (RAAS) can have effects on the
development of immature kidneys.
Use in Pediatric Patients: Olmesartan medoxomil tablets have not been shown to be
effective for hypertension in children < 6 years of age.
The safety and effectiveness of Olmesartan medoxomil and HCTZ tablets have not been
established in pediatric patients.
Hypotension in Volume- or Salt-Depleted Patients: In patients with an activated
renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being
treated with high doses of diuretics), symptomatic hypotension may occur after initiation of
treatment with Olmesartan medoxomil or Olmesartan medoxomil HCTZ.
Impaired Renal Function: Patients whose renal function may depend in part upon
the activity of the renin-angiotensin-aldosterone system (e.g. patients with renal artery
stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion),
may be at particular risk of developing acute renal failure on treatment. Monitor renal
function periodically in these patients. Consider withholding or discontinuing therapy in
patients who develop a clinically significant decrease in renal function on Olmesartan
medoxomil or Olmesartan medoxomil and HCTZ.
Safety and effectiveness of Olmesartan medoxomil and HCTZ in patients with severe renal
impairment (CrCl ≤ 30 mL/min) have not been established.
Sprue-like Enteropathy: Severe, chronic diarrhea with substantial weight loss has
been reported in patients taking olmesartan months to years after drug initiation. Intestinal
biopsies of patients often demonstrated villous atrophy. If a patient develops these
symptoms during treatment, exclude other etiologies and consider discontinuation of
olmesartan in cases where no other etiology is identified.
Electrolyte and Metabolic Imbalances: Olmesartan is a drug that inhibits the reninangiotensin system (RAS) and such drugs can cause hyperkalemia. Monitor serum
electrolytes periodically.
Olmesartan medoxomil and hydrochlorothiazide tablets contain hydrochlorothiazide (HCTZ).
Thiazides such as HCTZ can cause hypokalemia and hyponatremia. Hypomagnesemia can
result in hypokalemia which may be difficult to treat despite potassium repletion.
HCTZ may alter glucose tolerance, raise serum levels of cholesterol and triglycerides, and
cause elevations of serum calcium. Therapy with thiazides may precipitate hyperuricemia
or frank gout in patients.
Hepatic impairment : HCTZ, may cause minor alterations of fluid and electrolyte balance
that may precipitate hepatic coma in patients with impaired hepatic function or progressive
liver disease.
Hypersensitivity Reaction: Hypersensitivity reactions to the component HCTZ may occur
in patients with or without a history of allergy or bronchial asthma, but are more likely in
patients with such a history.
Systemic Lupus Erythematosus: Thiazides have been reported to cause exacerbation
or activation of systemic lupus erythematosus.
Benicar and Benicar HCT are registered trademarks of Daiichi Sankyo.
The color blue of the blue bottle is a trademark of Mylan Pharmaceuticals Inc.
The Mylan logo is a registered trademark of Mylan Inc.
Acute Myopia and Secondary Angle-Closure Glaucoma: Thiazides can cause
an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure
glaucoma. Discontinue Olmesartan medoxomil and HCTZ tablets as rapidly as possible in
these patients.
ADVERSE REACTIONS:
Olmesartan medoxomil tablets: In placebo-controlled trials, the only adverse reaction
that occurred in more than 1% of patients treated with olmesartan medoxomil and more
frequently than placebo was dizziness (3% vs.1%).
Olmesartan medoxomil and HCTZ tablets: In a clinical trial, the following adverse reactions
occurred in >2% of patients, and more often on the Olmesartan medoxomil and HCTZ
combination than on placebo: nausea (3% vs 0%), hyperuricemia (4% vs 2%), dizziness
(9% vs 2%), and upper respiratory tract infection (7% vs 0%).
Clinical Laboratory Test Findings: Minor elevations in creatinine and BUN occurred in 1.7%
and 2.5% respectively, of patients taking Olmesartan medoxomil and HCTZ tablets and 0%
and 0% respectively, given placebo in controlled clinical trials.
DRUG INTERACTIONS:
Non-Steroidal Anti-Inflammatory Agents: Concurrent administration of nonsteroidal anti-inflammatory drugs (NSAIDs) may lead to increased risk of renal impairment
(including possible acute renal failure) and loss of antihypertensive effect of Olmesartan
medoxomil tablets and Olmesartan medoxomil and HCTZ tablets.
Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS
with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased
risks of hypotension, hyperkalemia, and changes in renal function (including acute renal
failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors and
closely monitor blood pressure, renal function, and electrolytes.
Avoid use of aliskiren with Olmesartan medoxomil or Olmesartan medoxomil and HCTZ in
patients with renal impairment (GFR <60 mL/min).
Concurrent Use with Colesevelam Hydrochloride: Concurrent administration with
colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration
of olmesartan. Consider administering Olmesartan medoxomil or Olmesartan medoxomil
and HCTZ at least 4 hours before the colesevelam hydrochloride dose.
Lithium: Monitor serum lithium levels during concomitant use with Olmesartan
medoxomil or Olmesartan medoxomil and HCTZ due to potential increases in lithium
concentration and lithium toxicity during concomitant use.
Use of HCTZ with other drugs: When administered concurrently, the following drugs
may interact with thiazides:
Antidiabetic drugs: Dosage adjustment of the antidiabetic drug may be required due to
HCTZ in Olmesartan medoxomil and HCTZ tablets.
Ion Exchange Resins: (e.g., cholestyramine and colestipol): may reduce absorption
of thiazides. Dosing Olmesartan medoxomil and HCTZ tablets at least 4 hours before or
4-6 hours after the administration of the resin may potentially minimize the interaction.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia in
conjunction with HCTZ.
Mylan Olmesartan Medoxomil Tablets
Dosage Strength
5 mg
20 mg
Mylan NDC
Dosage Form
30 tablets
0378-7012-93
90 tablets
0378-7012-77
500 tablets
0378-7012-05
White to off-white,
film-coated, round,
unscored tablet
30 tablets
0378-7112-93
90 tablets
0378-7112-77
White to off-white,
film-coated, round,
unscored tablet
Not actual size
Not actual size
500 tablets
0378-7112-05
40 mg
30 tablets
0378-7124-93
90 tablets
0378-7124-77
500 tablets
0378-7124-05
White to off-white,
film-coated, round,
unscored tablet
Not actual size
Mylan Olmesartan Medoxomil and
Hydrochlorothiazide Tablets
Dosage Strength
20 mg/
12.5 mg
40 mg/
12.5 mg
40 mg/
25 mg
Mylan NDC
30 tablets
0378-1413-93
90 tablets
0378-1413-77
500 tablets
0378-1413-05
Pink, film-coated,
round, unscored
tablet
30 tablets
0378-1422-93
90 tablets
0378-1422-77
500 tablets
0378-1422-05
Pink, film-coated,
modified capsule
shaped, unscored
tablet
30 tablets
0378-1425-93
90 tablets
0378-1425-77
500 tablets
0378-1425-05
For more information, call Mylan Customer Relations at 1.800.796.9526.
USE IN SPECIFIC POPULATIONS:
Nursing Mothers: If treating a nursing mother, a decision should be made to discontinue
either nursing or the drug.
References
1. Olmesartan Medoxomil Tablets Prescribing Information.
Morgantown, WV: Mylan Pharmaceuticals Inc.
2. Olmesartan Medoxomil and Hydrochlorothiazide Tablets Prescribing
Information. Morgantown, WV: Mylan Pharmaceuticals Inc.
Dosage Form
3. Food and Drug Administration. Approval Letter for
Olmesartan Medoxomil Tablets, October 2016.
4. Food and Drug Administration. Approval Letter for Olmesartan
Medoxomil and Hydrochlorothiazide Tablets, October 2016.
Not actual size
Not actual size
Pink, film-coated,
round, unscored
tablet
Not actual size
A COMMITMENT TO PHARMACY PROFESSIONALS
Since our founding in 1961, Mylan has supported pharmacies across America with quality generic
products for their customers and services that have recognized the educational and informational
needs of the pharmacy profession. These have included:
• The Excellence in Pharmacy Award,
which acknowledges pharmacy school graduates who demonstrate academic achievement,
personal motivation and a unique ability to communicate drug information. Last year, nearly
every pharmacy school in the United States participated.
• The GBR®–Generic Brand Reference–Guide, which contains a
comprehensive cross-referenced listing of generic and brand
pharmaceuticals. Currently available in print and as an app for
Android™* and Apple®† devices, the GBR Guide has become
recognized as a useful reference by Pharmacists and Pharmacy
Technicians. Since 2003, Mylan is proud to have produced
1.3 million copies of the GBR Guide print edition.
*Trademark of Google Inc.
†
Registered trademark of Apple, Inc.
• Support of Continuing Education (CE) lessons by independent providers accredited through
the Accreditation Council for Pharmacy Education (ACPE). In fact, over the past 5 years, Mylansupported CE lessons distributed through Pharm/alert have resulted in the grading of more than
640,000 examinations.1
As we look to the future, we remain committed to Pharmacists and Pharmacy
Technicians, who provide a vital link in the healthcare delivery system.
Reference: 1. Postgraduate Healthcare Education, LLC. (Examinations graded from October 2011 through October 2016.)
Products Introduced Since July 2016 (Products not actual size)
• DEXTROAMPHETAMINE SULFATE Extended-release Capsules
Generic for: Dexedrine®* Spansule®
—5 mg, 10 mg, and 15 mg
5 mg
10 mg
15 mg
Click here for full Prescribing Information, including Boxed WARNING regarding A HIGH POTENTIAL FOR ABUSE, DRUG DEPENDENCE and MISUSE THAT MAY CAUSE SUDDEN DEATH and
SERIOUS CARDIOVASCULAR ADVERSE EVENTS and Medication Guide.
• FINASTERIDE TABLETS, USP—1 mg
Generic for: Propecia®* Tablets
1 mg
Click here for full Prescribing Information and Patient Information Leaflet.
• METFORMIN HYDROCHLORIDE Extended-release Tablets, USP—500 mg and 1000 mg
Generic for: Fortamet®* Tablets
1000 mg
500 mg
Click here for full Prescribing Information, including Boxed WARNING regarding LACTIC ACIDOSIS and Patient Information.
• ROSUVASTATIN CALCIUM Tablets—5 mg, 10 mg, 20 mg, and 40 mg
Generic for: Crestor®* Tablets
5 mg
10 mg
20 mg
Click here for full Prescribing Information and Patient Information.
*Brand names are the trademarks of the products’ manufacturers and/or owners.
GBR ® is a registered trademark of Mylan Pharmaceuticals Inc.
The Mylan logo is a registered trademark of Mylan Inc.
© 2016 Mylan Pharmaceuticals Inc. All rights reserved. OLM-2016-0016 MYNMKT600 (12/16)
40 mg