PAIN RELIEF DATA
SYSTEMIC EXPOSURE DATA
PAIN TARGETING MECHANISM
DOSING INSTRUCTIONS

PAIN RELIEF DATA

TARGETED OA KNEE PAIN RELIEF1-3

  • PENNSAID 2% provided 36.3% reduction in OA knee pain at baseline after 4 weeks (compared with 28.6% with vehicle control)1,3
    • Vehicle control contained dimethyl sulfoxide (DMSO) and all other inactive ingredients in PENNSAID 2%4
  • Relief measured as reduction of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score from baseline at 4 weeks1,3

Significantly greater reductions in pain scores for Pennsaid 2% versus vehicle-control at 4 weeks3*

Solution with DMSO and all other inactive ingredients (n=129) PENNSAID 2% (n=130)

*Pain was evaluated using the WOMAC pain subscale.
OA=osteoarthritis.

SELECT IMPORTANT SAFETY INFORMATION

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events

SYSTEMIC EXPOSURE DATA

REDUCED SYSTEMIC EXPOSURE OF A TOPICAL2

93% REDUCTION IN SYSTEMIC EXPOSURE

When compared with oral diclofenac sodium, PENNSAID 2% reduced systemic exposure by 93%.2

In a pharmacokinetic (PK) study of 22 healthy individuals, PENNSAID 2% demonstrated only 7% systemic absorption compared with oral diclofenac sodium, 75 mg twice daily.2

Oral diclofenac

Representation of systemic exposure with oral diclofenac sodium

PENNSAID 2%

Representation of systemic exposure with PENNSAID 2%

93% reduction

PAIN TARGETING MECHANISM
DMSO helps to facilitate the penetration of PENNSAID 2% directly to the site of pain DMSO helps to facilitate the penetration of PENNSAID 2% directly to the site of pain DMSO helps to facilitate the penetration of PENNSAID 2% directly to the site of pain

ENHANCED PENETRATION RIGHT AT THE SITE OF PAIN

DMSO FACILITATES PENETRATION THROUGH THE SKIN

DMSO facilitates penetration of diclofenac through the skin barrier.5 DMSO enhances the permeability of cell membranes, facilitating localized delivery of diclofenac sodium by driving it through the skin barrier directly to the site of pain.1,5

DOSING INSTRUCTIONS

2X DAILY DOSING THAT’S EASY TO APPLY

CONSISTENT ACCURATE DOSING WITH A METERED-DOSE PUMP

  • PENNSAID 2%: no measuring and little mess1
  • 2 pumps, 2 times daily1

CONVENIENT 2X DAILY DOSING1

Image of dosing instructions for PENNSAID (diclofenac sodium topical solution) 2%
  • Another topical, Voltaren® Gel (diclofenac sodium topical gel), is applied 4x daily and requires patients to use a dosing card for accurate dosing6

For full application and dosing instructions see Instructions for Use.

SELECT IMPORTANT SAFETY INFORMATION

Patients should:

  • Wash and dry hands before and after use. Avoid contact of PENNSAID with the eyes and mucous membranes
  • Protect treated knee(s) from natural or artificial sunlight
  • Wait until the treated knee(s) is completely dry before applying sunscreen, insect repellent, lotion, moisturizer, cosmetics, or other topical medication
  • The most common adverse reactions to PENNSAID 1.5% or PENNSAID 2% in clinical trials were: application site reactions such as dryness, exfoliation, erythema, pruritus, pain, induration, rash, scabbing, contact dermatitis characterized by skin erythema and induration, contact dermatitis with vesicles; urinary tract infection; contusion; sinus congestion; nausea; dyspepsia; abdominal pain; flatulence; diarrhea; constipation; edema

TARGETED OA KNEE PAIN RELIEF + REDUCED SYSTEMIC EXPOSURE OF A TOPICAL

pain icon

Significant OA knee pain relief1,3

arrow icon

93% reduction in systemic exposure compared to oral diclofenac2

target icon

Targeted at the site of pain1,5

bottle icon

2X daily dosing that’s easy to apply1

non narcotic icon

Non-narcotic & non-addictive

Prescription pad and bottle of PENNSAID (diclofenac sodium topical solution) 2%
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PENNSAID 2% samples

Start your OA knee pain patients with samples of PENNSAID 2%.

REQUEST SAMPLES
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We’ll come to you

Get more information by having your PENNSAID 2% representative come to your practice.

REQUEST A REPRESENTATIVE
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Talk to someone now

Our support team is available to address
your questions and provide information
via phone (833) 736-6724.

833-PENNSAID

OTHER HORIZON INFLAMMATION CARE PRODUCT
OPTIONS FOR YOUR PATIENTS

FOR YOUR OA OR RA PATIENTS

Powerful relief + built-in gastroprotection

REVIEW THE DATA

FOR YOUR PATIENTS WITH CERTAIN INFLAMMATORY CONDITIONS

The only delayed-release prednisone for the treatment of RA and other inflammatory conditions

SEE HOW IT WORKS

RA=rheumatoid arthritis.

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INDICATIONS AND IMPORTANT SAFETY INFORMATION
See more

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) SELECT IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • PENNSAID is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) INDICATIONS AND USAGE

PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s).

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • PENNSAID is contraindicated in patients with:
    • known hypersensitivity to diclofenac or any component of the drug product
    • a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs,
    • in the setting of CABG surgery.

WARNINGS AND PRECAUTIONS

  • Use the lowest effective dose of PENNSAID for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious GI events. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. Measure transaminases at baseline and periodically in patients receiving long-term therapy with PENNSAID. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen or if clinical signs and/or symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely.
  • Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of PENNSAID in patients with advanced renal disease unless benefits are expect to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.
  • NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue PENNSAID at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PENNSAID. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue PENNSAID and evaluate the patient immediately.
  • Limit use of NSAIDs, including PENNSAID between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of premature closure of the fetal ductus arteriosus and oligohydramnios/fetal renal dysfunction.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Concurrent use of PENNSAID with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
  • When applying PENNSAID, DO NOT: apply to open wounds, shower for at least 30 minutes after applying, wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry. When applying PENNSAID, DO: wash and dry hands before and after use, avoid contact of PENNSAID with the eyes and mucous membranes, protect treated knee(s) from natural or artificial sunlight, wait until the treated knee(s) is completely dry before applying sunscreen, insect repellent, lotion, moisturizer, cosmetics, or other topical medication.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions in the PENNSAID 1.5% or PENNSAID 2% clinical trials were: application site reactions such as dryness, exfoliation, erythema, pruritus, pain, induration, rash, scabbing, contact dermatitis characterized by skin erythema and induration, contact dermatitis with vesicles; urinary tract infection; contusion; sinus congestion; nausea; dyspepsia; abdominal pain; flatulence; diarrhea; constipation; and edema.

USE IN SPECIFIC POPULATIONS

  • Use of NSAIDs, including PENNSAID, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of PENNSAID in pediatric patients has not been established.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) SELECT IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • DUEXIS is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) INDICATIONS AND USAGE

DUEXIS® (ibuprofen and famotidine), a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • DUEXIS is contraindicated in patients:
    • With a known hypersensitivity to ibuprofen or famotidine or any components of the drug product or known hypersensitivity to other H2-receptor antagonists
    • Who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Fatal anaphylactic reactions to NSAIDs have been reported in such patients
    • In the setting of coronary artery bypass graft (CABG) surgery

WARNINGS AND PRECAUTIONS

  • Use ibuprofen at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as DUEXIS, increases the risk of serious GI events.
  • Avoid use of DUEXIS in patients with a recent MI unless benefits are expected to outweigh the risk of recurrent CV thrombotic events. If DUEXIS is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
  • Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. DUEXIS should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely with DUEXIS treatment.
  • Avoid use of DUEXIS in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to DUEXIS and in patients with aspirin-sensitive asthma.
  • DUEXIS can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue use at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as DUEXIS. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue DUEXIS and evaluate the patient immediately.
  • Limit use of NSAIDs, including DUEXIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions in clinical trials (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain, and headache.

USE IN SPECIFIC POPULATIONS

  • Use of NSAIDs, including DUEXIS, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs, including DUEXIS, in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of DUEXIS in pediatric patients has not been established.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

RAYOS® (PREDNISONE) DELAYED-RELEASE TABLETS INDICATIONS AND USAGE

RAYOS is a corticosteroid indicated:

  • As an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation
  • For the treatment of certain endocrine conditions
  • For palliation of certain neoplastic conditions

RAYOS® (PREDNISONE) DELAYED-RELEASE TABLETS IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Known hypersensitivity to prednisone or any excipients in the formulation

WARNINGS AND PRECAUTIONS

  • Corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia. Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use
  • RAYOS may increase susceptibility to new infection and increase risk of exacerbation, dissemination or reactivation of latent infection. RAYOS may mask signs and symptoms of infection. The rate of infectious complications increases with increasing doses of corticosteroids
  • Corticosteroids can cause elevated blood pressure, salt and water retention and hypokalemia. Monitor blood pressure and sodium, potassium serum levels. RAYOS should be used with caution in patients with a history of recent myocardial infarction, congestive heart failure, hypertension or renal insufficiency
  • There is an increased risk of gastrointestinal (GI) perforation in patients with certain GI disorders. RAYOS may mask signs and symptoms of GI perforation
  • Corticosteroid use may be associated with behavioral and mood disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. Existing conditions may be aggravated
  • Corticosteroid use may lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Give special consideration to patients at increased risk of osteoporosis (eg, postmenopausal women) before initiating corticosteroid therapy, and bone density should be monitored in patients on long-term corticosteroid therapy
  • Prolonged use of corticosteroids may result in cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks
  • Do not administer live or attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids
  • Long‐term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long‐term corticosteroid therapy
  • Corticosteroids can cause fetal harm, including a small but inconsistent risk of orofacial clefts during the first trimester. Advise pregnant women of potential harm to the fetus
  • Prednisolone has been found in human milk following administration to lactating women; use the lowest dose in lactating women to achieve desired clinical effect

ADVERSE REACTIONS

  • Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain

Please see full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATIONS AND IMPORTANT SAFETY INFORMATION
See more

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) SELECT IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • PENNSAID is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) INDICATIONS AND USAGE

PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s).

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • PENNSAID is contraindicated in patients with:
    • known hypersensitivity to diclofenac or any component of the drug product
    • a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs,
    • in the setting of CABG surgery.

WARNINGS AND PRECAUTIONS

  • Use the lowest effective dose of PENNSAID for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious GI events. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. Measure transaminases at baseline and periodically in patients receiving long-term therapy with PENNSAID. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen or if clinical signs and/or symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely.
  • Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of PENNSAID in patients with advanced renal disease unless benefits are expect to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.
  • NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue PENNSAID at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PENNSAID. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue PENNSAID and evaluate the patient immediately.
  • Limit use of NSAIDs, including PENNSAID between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of premature closure of the fetal ductus arteriosus and oligohydramnios/fetal renal dysfunction.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Concurrent use of PENNSAID with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
  • When applying PENNSAID, DO NOT: apply to open wounds, shower for at least 30 minutes after applying, wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry. When applying PENNSAID, DO: wash and dry hands before and after use, avoid contact of PENNSAID with the eyes and mucous membranes, protect treated knee(s) from natural or artificial sunlight, wait until the treated knee(s) is completely dry before applying sunscreen, insect repellent, lotion, moisturizer, cosmetics, or other topical medication.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions in the PENNSAID 1.5% or PENNSAID 2% clinical trials were: application site reactions such as dryness, exfoliation, erythema, pruritus, pain, induration, rash, scabbing, contact dermatitis characterized by skin erythema and induration, contact dermatitis with vesicles; urinary tract infection; contusion; sinus congestion; nausea; dyspepsia; abdominal pain; flatulence; diarrhea; constipation; and edema.

USE IN SPECIFIC POPULATIONS

  • Use of NSAIDs, including PENNSAID, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of PENNSAID in pediatric patients has not been established.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) SELECT IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • DUEXIS is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) INDICATIONS AND USAGE

DUEXIS® (ibuprofen and famotidine), a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • DUEXIS is contraindicated in patients:
    • With a known hypersensitivity to ibuprofen or famotidine or any components of the drug product or known hypersensitivity to other H2-receptor antagonists
    • Who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Fatal anaphylactic reactions to NSAIDs have been reported in such patients
    • In the setting of coronary artery bypass graft (CABG) surgery

WARNINGS AND PRECAUTIONS

  • Use ibuprofen at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as DUEXIS, increases the risk of serious GI events.
  • Avoid use of DUEXIS in patients with a recent MI unless benefits are expected to outweigh the risk of recurrent CV thrombotic events. If DUEXIS is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
  • Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. DUEXIS should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely with DUEXIS treatment.
  • Avoid use of DUEXIS in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to DUEXIS and in patients with aspirin-sensitive asthma.
  • DUEXIS can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue use at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as DUEXIS. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue DUEXIS and evaluate the patient immediately.
  • Limit use of NSAIDs, including DUEXIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions in clinical trials (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain, and headache.

USE IN SPECIFIC POPULATIONS

  • Use of NSAIDs, including DUEXIS, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs, including DUEXIS, in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of DUEXIS in pediatric patients has not been established.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

RAYOS® (PREDNISONE) DELAYED-RELEASE TABLETS INDICATIONS AND USAGE

RAYOS is a corticosteroid indicated:

  • As an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation
  • For the treatment of certain endocrine conditions
  • For palliation of certain neoplastic conditions

RAYOS® (PREDNISONE) DELAYED-RELEASE TABLETS IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Known hypersensitivity to prednisone or any excipients in the formulation

WARNINGS AND PRECAUTIONS

  • Corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia. Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use
  • RAYOS may increase susceptibility to new infection and increase risk of exacerbation, dissemination or reactivation of latent infection. RAYOS may mask signs and symptoms of infection. The rate of infectious complications increases with increasing doses of corticosteroids
  • Corticosteroids can cause elevated blood pressure, salt and water retention and hypokalemia. Monitor blood pressure and sodium, potassium serum levels. RAYOS should be used with caution in patients with a history of recent myocardial infarction, congestive heart failure, hypertension or renal insufficiency
  • There is an increased risk of gastrointestinal (GI) perforation in patients with certain GI disorders. RAYOS may mask signs and symptoms of GI perforation
  • Corticosteroid use may be associated with behavioral and mood disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. Existing conditions may be aggravated
  • Corticosteroid use may lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Give special consideration to patients at increased risk of osteoporosis (eg, postmenopausal women) before initiating corticosteroid therapy, and bone density should be monitored in patients on long-term corticosteroid therapy
  • Prolonged use of corticosteroids may result in cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks
  • Do not administer live or attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids
  • Long‐term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long‐term corticosteroid therapy
  • Corticosteroids can cause fetal harm, including a small but inconsistent risk of orofacial clefts during the first trimester. Advise pregnant women of potential harm to the fetus
  • Prednisolone has been found in human milk following administration to lactating women; use the lowest dose in lactating women to achieve desired clinical effect

ADVERSE REACTIONS

  • Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain

Please see full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

  • PENNSAID (diclofenac sodium topical solution) 2% [prescribing information] Horizon.
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  • Wadsworth LT, Kent JD, Holt RJ. Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. Curr Med Res Opin. 2016;32(2):241-250.
  • Data on file. Horizon.
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  • GSK. What is Voltaren? Voltaren gel website. https://www.voltarengel.com/what-is-voltaren. Accessed June 4, 2020.