Product Ordering Information

Product Information

• Packaged 5 topical systems per envelope
• 6 envelopes per carton
• 15 days of therapy per carton
• Package: Carton box
• NDC: 82347-0405-5
• WAC: $306.12 

Customer Service
For more information contact us at info@yaralpharma.com or call 866-218-9009.

Sales Department
Office: 908-905-0537 Ext. 103
To speak directly with our Vice President of Sales, Joe Hodge, call: 908‑632‑6899.

Ordering Information
yaralCS@eversana.com

Prescribing Information,
Including Boxed Warning

INDICATION & IMPORTANT SAFETY INFORMATION for Diclofenac Epolamine Topical System 1.3%

INDICATIONS AND USAGE

DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in the following patients:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• In the setting of coronary artery bypass graft (CABG) surgery
• On non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds

WARNINGS AND PRECAUTIONS

• Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
• Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
• Heart Failure and Edema: Avoid use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
• Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
• Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
• Exacerbation of Asthma Related to Aspirin Sensitivity: DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
• Serious Skin Reactions: Discontinue DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% at first appearance of skin rash or other signs of hypersensitivity.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically.
• Fetal Toxicity: Limit use of NSAIDs, including DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%, 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.
• Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

ADVERSE REACTIONS
The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and placebo-treated adult patients were pruritus (5% and 8%, respectively) and nausea (3% and 2%, respectively). The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% treated pediatric patients were headache (9%) and application site pruritus (7%).

DRUG INTERACTIONS

• Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly using DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% with drugs that interfere with hemostasis. Concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and analgesic doses of aspirin is not generally recommended.
• ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
• ACE Inhibitors and ARBs: Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.
• Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
• Digoxin: Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% may increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels

USE IN SPECIFIC POPULATIONS

• Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in women who have difficulties conceiving.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Yaral Pharma, Inc. at 1-866-218-9009.

Please see additional Important Safety Information throughout and accompanying full Prescribing Information, including BOXED WARNING at www.yaralpharma.com/diclofenac-pi

REF-1347-V2

Product Information

Levothyroxine Sodium Capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous, amber-colored liquid.

They are supplied as follows:

• Box of 30 capsules; consisting of 3 blisters with
  10 capsules each
• 30 days of therapy per box

Levothyroxine Sodium Capsules
Strength (mcg)	Color**	Capsule Imprint Code	NDC	WAC Price
13 mcg	Green	A	82347-0005-4	$123.69
25 mcg	Orange	E	82347-0010-4
50 mcg	White	G	82347-0015-4
75 mcg	Purple	H	82347-0020-4
88 mcg	Olive	J	82347-0025-4
100 mcg	Yellow	K	82347-0030-4
112 mcg	Rose	M	82347-0035-4
125 mcg	Brown	N	82347-0040-4
137 mcg	Turquoise	P	82347-0045-4
150 mcg	Blue	S	82347-0050-4
175 mcg	Lilac	U	82347-0055-4
200 mcg	Pink	Y	82347-0060-4
** Shown on box and blister packaging, not on individual capsules. **

Customer Service
For more information contact us at info@yaralpharma.com or call 866-218-9009.

Sales Department
Office: 908-905-0537 Ext. 103
To speak directly with our Vice President of Sales, Joe Hodge, call: 908‑632‑6899.

Ordering Information
yaralCS@eversana.com

Prescribing Information,
Including Boxed Warning

USE & IMPORTANT SAFETY INFORMATION for Levothyroxine Sodium Capsules

INDICATIONS AND USAGE
Levothyroxine sodium capsules are L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with:

• Hypothyroidism – As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
• Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression – As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

LIMITATIONS OF USE

• LEVOTHYROXINE SODIUM CAPSULES are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in
• iodine-sufficient patients.
• LEVOTHYROXINE SODIUM CAPSULES are not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.

CONTRAINDICATIONS

• LEVOTHYROXINE SODIUM CAPSULES are contraindicated in patients with uncorrected adrenal insufficiency.

WARNINGS AND PRECAUTIONS

• Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate LEVOTHYROXINE SODIUM CAPSULES at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation.
• Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma.
• Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of LEVOTHYROXINE SODIUM CAPSULES treatment.
• Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism.
• Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy.
• Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose.

ADVERSE REACTIONS 
Adverse reactions with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage. They include the following:

• General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating
• Central Nervous System: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia
• Musculoskeletal: tremors, muscle weakness, muscle spasm
• Cardiovascular: palpitations, tachycardia, arrythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest
• Respiratory: dyspnea
• Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests
• Dermatologic: hair loss, flushing, rash
• Endocrine: decreased bone mineral density
• Reproductive: menstrual irregularities, impaired fertility

ADVERSE REACTIONS IN CHILDREN
Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height. Seizures have been reported rarely with the institution of levothyroxine therapy.

HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions to inactive ingredients (in this product or other levothyroxine products) have occurred in patients treated with thyroid hormone products. These include urticaria, pruritis, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.

DRUG INTERACTIONS
Many drugs and some foods can exert effects on thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT. Administer at least 4 hours before or after drugs that are known to interfere with absorption. See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism.

Please see Important Safety Information throughout and for Full Prescribing Information, including Boxed Warning, visit www.yaralpharma.com/levothyroxine-pi.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088, or contact Yaral Pharma, Inc. at 1-866-218-9009.

REF-1076-v3

Lidocaine Patch 5% is available as the following:

• Carton of 30 Patches (each packaged in individual child-resistant envelopes).
• NDC:  82347-0505-5
• WAC: $85.50

Customer Service
For more information contact us at info@yaralpharma.com or call 866-218-9009.

Sales Department
Office: 908-905-0537 Ext. 103
To speak directly with our Vice President of Sales, Joe Hodge, call: 908‑632‑6899.

Ordering Information
yaralCS@eversana.com

Prescribing Information

Indication and Important Safety Information

  INDICATION & IMPORTANT SAFETY INFORMATION for Lidocaine Patch 5%

INDICATION
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Lidocaine patch 5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

WARNINGS

RISK OF METHEMOGLOBINEMIA

• Cases of methemoglobinemia have been reported in association with local anesthetic use. All patients are at risk for met­hemoglobinemia.
• If local anesthetics must be used in patients with glucose-6-phosphate dehydro­genase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites, close monitoring for symptoms and signs of methemoglobinemia is recommended as these patients are more susceptible to developing clinical manifestations of the condition.
• Signs of methemoglobinemia, including cyanotic skin discoloration and/or abnormal coloration of the blood may occur immediately or may be delayed some hours after exposure. Methemoglobin levels may continue to rise which may lead to more serious central nervous system and cardiovascular adverse effects, including sei­zures, coma, arrhythmias, and death. Discontinue lidocaine patch 5% and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care or may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

ACCIDENTAL EXPOSURE IN CHILDREN

• Small children or pets could suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch 5%.  Store and dispose of lidocaine patch 5% properly and keep out of reach of children, pets and others.

EXCESSIVE DOSING AND OVERDOSE

• Excessive dosing could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects, including lidocaine toxicity.  Longer duration  of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increased blood concentration levels of lidocaine.
• Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24-hour period. If lidocaine overdose is suspected, check blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment.

PRECAUTIONS

• HEPATIC DISEASE: Patients with severe hepatic disease are at greater risk of devel­oping toxic blood concentrations of lidocaine.
• ALLERGIC REACTIONS: Lidocaine patch 5% should be used with cau­tion in patients allergic to PABA derivatives or with a history of drug sensitivities, especially if the etiologic agent is uncertain.
• NON-INTACT SKIN: Apply lidocaine patch 5% on intact skin only. Application to broken or inflamed skin may result in higher blood concentrations of lidocaine from increased absorption.
• EXTERNAL HEAT SOURCES: Placement of external heat sources, such as heating pads or elec­tric blankets, over lidocaine patch 5% is not recommended and may increase plasma lidocaine levels.
• EYE EXPOSURE: Avoid contact of lidocaine patch 5% with eyes.  If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

ADVERSE REACTIONS

• APPLICATION SITE REACTION: Side effects of lidocaine patch 5% include application site reactions such as blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pru­ritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours.
• ALLERGIC REACTIONS: Allergic and anaphylactoid reactions associated with lidocaine, such as angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngo­spasm, pruritus, shock, and urticaria, can occur and should be managed by conventional means.
• SYSTEMIC REACTIONS: Systemic adverse reactions following appropriate use of lidocaine patch 5% are unlikely and are similar in nature to those observed with other amide local anesthetic agents.

DRUG INTERACTIONS

• ANTIARRHYTHMIC DRUGS: Lidocaine patch 5% should be used with caution with Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
• LOCAL ANESTHETICS: When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
• DRUGS THAT MAY CAUSE METHEMOGLOBINEMIA WHEN USED WITH LIDOCAINE PATCH 5%: Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarial, anticonvulsants, acetaminophen and other drugs associated with the risk of methemoglobinemia.

USE IN SPECIFIC POPULATIONS

• LACTATION: Use of lidocaine patch 5% during lactation should be used with caution as lidocaine is excreted in breast milk.
• PREGNANCY: Lidocaine patch 5% has not been studied in pregnancy or in labor and delivery and therefore should be used only if clearly needed and total doses contributed by all formulations must be considered.
• PEDIATRICS: Safety and effectiveness in pediatric patients have not been established.

These are not all of the adverse reactions that may occur with use of lidocaine patch 5%.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Yaral Pharma, Inc. at 1-866-218-9009.

Please see Full Prescribing Information for Lidocaine patch 5% at: www.yaralpharma.com/lidocaine-pi.

REF-1490-v1