Use of Target-Specific Oral Anticoagulants (TSOACs) in the Elderly

By: Richard P. Barna, Pharm. D., R.Ph.

Is Warfarin a thing of the past? With four new target-specific oral anticoagulants (TSOACs) now available, numerous therapeutic options exist for treatment and prophylaxis against venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), in addition to atrial fibrillation. The availability of dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa) offer the clinician the option of utilizing a therapeutic agent that requires no routine monitoring, no dietary restrictions, and few drug-drug interactions compared with Warfarin without compromising efficacy. How do these agents really stack up and what do you need to know about using these drugs in the elderly? Dabigatran’s approval by the FDA in 2010 represented the first new anticoagulant to reach the market in 50 years. This drug exerts its anticoagulant effect by blocking the activity of factor IIa. This drug is approved for anticoagulation in individuals with atrial fibrillation who do not have a mechanical heart valve as well as for the treatment and reduction in risk of recurrence of VTE. For all indications, for individuals with a CrCl above 30 mL/min, the drug should be dosed at 150 mg orally twice daily.

For non-valvular atrial fibrillation (NVAF), for patients with CrCl between 15-30 mL/min, the dose should be 75 mg orally twice daily. Capsules should not be crushed, opened, broken or chewed when administering this medication. Monitor patients for heartburn and dyspepsia as these gastrointestinal adverse effects are common with therapy. Rivaroxaban, apixaban, and edoxaban are all direct-acting inhibitors of factor Xa. Regarding rivaroxaban, this medication is indicated as an anticoagulant in NVAF and for treatment and prophylaxis of VTE. For atrial fibrillation, this medication is administered at a dose of 20 mg (if CrCl>50 mL/min) or 15 mg (if the CrCl is between 15-50 mL/min) orally once daily with the evening meal, as food increases the absorption of this medication; use should be avoided in patients with CrCl less than 15 mL/min. For treating VTE and reducing the risk of recurrence, the drug is dosed at 15 mg orally twice daily with food for the first 21 days of therapy followed by 20 mg orally once daily for the remainder of the treatment period. A dose of 10 mg once daily is used for prophylaxis of DVT following hip or knee replacement surgery.

For VTE treatment and prophylaxis, use should be avoided in individuals with a CrCl less than 30 mL/min. Apixaban shares the same mechanism of action and indications as rivaroxaban. This medication is dosed 5 mg BID; 2.5 mg BID for patients with two or more of the following: age 80 years and older, weight 60 kg or less, serum creatinine 1.5 mg/dL or greater for patients with NVAF. For VTE prevention post-hip or knee replacement, dosing should be 2.5 mg PO twice daily for 35 days [hip] or 12 days [knee] starting 12 to 24 hrs. post-operatively. Finally for DVT/PE treatment, 10 mg BID for seven days, then 5 mg BID, or DVT/PE prevention of recurrence 2.5 mg BID after at least six months of treatment. Edoxaban is the newest drug in this class that received approved in January 2015. This agent is similar to rivaroxaban and apixaban in indications and mechanism. This medication is dosed 60 mg orally once daily for treatment of NVAF, DVT and PE. The medication shouldn’t be used in patients with CrCl above 95 mL/min and a reduced dose of 30 mg orally once daily is indicated for patients with CrCl 15-50 mL/min for atrial fibrillation and treatment of DVT and PE, respectively. Comparing all of the new TSOACs, the clinician should be mindful of the differences in cost, need for dosage adjustment in patients with renal dysfunction, and bleeding risks, all of which are pivotal characteristics of concern for the elderly population.

No head-to-head clinical trials are currently available to provide comparative efficacy. In evaluating a patient for candidacy for one of these newer agents, the clinician must consider whether the individual is a candidate for a TSOAC, whether they have comorbid illnesses that would preclude use of the agent under consideration, and finally the patient’s ability to comply with and afford the medication. Importantly, specific antidotes for the management of bleeding with these medications are in development but are not currently available. Warfarin, with all its limitations, including drug-drug interactions, dietary issues, and need for therapeutic monitoring, may still be a reasonable choice for some individuals.

Protecting Yourself Against Sun Exposure

By: Neel Patel, Pharm. D.

With the upcoming summer months approaching, understanding different products of sunscreen can help protect against excessive sun exposure. Proper knowledge of the vast sunscreen products and common terms are a prerequisite to selecting the best product. Sunscreen products found over the counter may be labeled as “broad spectrum” and/or “sun protection factor (SPF)”. The term broad spectrum implies that it protects against both ultraviolet B (UVB) radiation and ultraviolet A (UVA) radiation. Both UVA and UVB can cause sunburn (primarily UVB), skin cancer, and premature skin aging. The term sun protection factor or SPF is used to measure the extent of sunscreen protection against UVB rays, and does not measure protection against UVA rays. Under new regulations all products that protect against all types of sun-induced skin damage will be labeled “Broad Spectrum” and “SPF” 15 or higher on the front. In contrast, products that are labeled as broad spectrum and SPF values between 2 and 14 have only proven to show protection against sunburn. In fact, these particular sunscreens will be labeled with a warning “Skin Cancer/Skin Aging Alert”. Some products available have water resistant capabilities as well, not to be confused with waterproof. It is important to note the label on how long you can expect to use the product with the extent of the SPF, usually a value between 40 – 80 minutes.

Some key factors to remember are:

  • Use sunscreens with broad spectrum SPF values of 15 or greater
  • Limit the amount of sun exposure as much as possible with peak sun exposure times between 10 a.m. and 2 p.m.
  • Wear appropriate clothing when applicable i.e. long sleeved shirts, pants, sunglasses, and hats.
  • Reapply sunscreen at least every 2 hours and more frequently if sweating or in and out of water

http://www.fda.gov/forconsumers/consumerupdates/ucm258416.htm

NAMENDA XR®

NAMENDA XR® (extended-release capsules) is now available in all strengths, 7mg, 14mg, 21mg, and 28mg. NAMENDA XR capsules offer convenient once-daily dosing for your patients, and can be administered day or night, with or without food. Dosing and Administration

  • The recommended starting dose of NAMENDA XR is 7 mg once daily. The recommended and maximum target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week and only if the previous dose has been well tolerated.
  • It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 28 mg once-daily capsules the day following the last dose of a 10 mg NAMENDA tablet. There is no study addressing the comparative efficacy of these 2 regimens.
  • It is recommended that a patient with severe renal impairment who is on a regimen of 5 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 14 mg once-daily capsules the day following the last dose of a 5 mg NAMENDA tablet.
  • If a patient is not currently taking NAMENDA twice a day, it’s recommended to start NAMENDA XR according to the pictured schedule. The patient should stay on the same dose for at least 7 days. The dose should be increased only if the previous dose was well tolerated.
  • NAMENDA XR capsules may be opened and the contents sprinkled on applesauce. Make sure the entire contents of the capsule are taken all at once.

http://www.namendaxr.com

Immunizations Primarily Recommended for the Elderly

By: Jenny Punnoose Pharm. D.

Immunizations are a major means of preventing diseases and one of the best ways to put an end to the serious effects of certain diseases. Currently, the Advisory Committee on Immunization Practices (ACIP) and the centers for disease control and prevention (CDC) recommend that all individuals 65 years and older receive four vaccines. These vaccines include an influenza vaccine, annually, 23-Valent pneumococcal polysaccharide vaccine (PPSV23), tetanus, diphtheria, and pertussis (Tdap) or tetanus diphtheria (Td) booster every 10 years and a onetime dose of the varicella-zoster vaccine. There are several types of influenza vaccines available; however, only two are approved in the elderly.

The first is the inactivated trivalent or quadravalent influenza vaccine, approved for all individual 6 months or older. In December of 2009, a high-dose influenza vaccine was developed for older adults. It contains four times more antigen than the standard vaccine which increases the productions of antibodies providing higher efficacy. Currently this vaccine is only approved for those 65 years of age and older. Flubok is an influenza vaccine that is not produced in eggs and can be given to individuals with a significant egg allergy. Fluzone intradermal is an alternate parenteral vaccine available. Risk factors that increase the incidence of pneumonia are particularly higher in the older individuals due to the following chronic conditions such as pulmonary diseases, cardiopathy, diabetes mellitus, smoking, alcoholism, liver disease, and nephropathy. The current PPSV23 vaccine covers the 23 most prevalent bacterial strains from streptococcus pneumoniae species, which are responsible for majority of pneumonia cases.

CDC recommends that all adults older than 65 should receive one time dose of PPSV23 unless the person was previously vaccinated. If a person was vaccinated prior to age 65, a second vaccination should be administered 5 years from the first vaccination. CDC also recommends that all adults 65 years of age and older unvaccinated previously, receive the PCV13 followed by PPSV23 six to twelve months later. The incidence of tetanus diphtheria and pertussis has become more prevalent in recent years. After the initial DTap vaccine received during childhood, it was recommended that the adults receive Td booster every ten years, which contained only tetanus and diphtheria antigens. Since 2005, CDC recommends one time substitution of Tdap, which contains pertussis antigens in addition to tetanus and diphtheria because of the increased incidence of pertussis in the last decade. The varicella Zoster virus, which causes shingles, is the same virus that causes chicken pox in children. When this virus is reactivated years later, it causes shingles, manifested by significant pain and itching along nerve branches. Shingles typically affects people as they age and therefore, older adults are at an increased risk of developing shingles. CDC recommends all adults older than age 60 to receive a one-time dose of varicella-zoster vaccine. However, the Food and Drug Administration recommends and has approved the vaccine for adults 50 years and older.

http://www.cdc.gov/vaccines/schedules/downloads/adult/adult-schedule-easy-read.pdf

Importance of Vitamin D in Reducing Fracture Risk in Elderly

By: Nirali Patel, Pharm. D. Rph.

Research suggests that vitamin D plays a role in the prevention of more than just fractures. Adequate intake appears to decrease the risk of colon cancer and perhaps other cancers. The risk of diabetes, hypertension, cardiovascular disease, and multiple sclerosis may also be linked to low levels of vitamin D. A 2009 meta-analysis determined that for people over the age of 65 years, taking vitamin D 482 IU to 770 IU/day can decrease non-vertebral fracture risk by 20%, and hip fracture risk by 18%. Non-vertebral fracture risk was reduced by 29% in community-living seniors, and by 15% in institutionalized patients taking these doses. Based on this analysis, 800 IU of vitamin D daily for 1 to 7 years will prevent one hip fracture and 1 non-vertebral fracture. It is interesting to note that vitamin D 800 IU daily has not been effective for fracture prevention in all studies, and some studies using 400 IU daily have shown benefit. The key is to take enough vitamin D to achieve adequate serum levels. Recommend aiming for at least 30 ng/mL…but under 100 ng/ml.   

Recommended starting with 800 to 2000 IU/day for most adults to prevent deficiency and maintain adequate levels. Patients at risk for deficiency, such as those with bone pain or muscle weakness, taking meds that increase fracture risk (corticosteroids, etc.), or in older patients with a previous fall, it is recommend to increase the vitamin D dose if it doesn’t achieve adequate levels. Suggest 1000 IU/day for every 10 ng/mL shortfall. It is also important to note that that vitamin D3 (cholecalciferol) is a little more potent than D2 (ergocalciferol). Furthermore, meta-analysis of fracture studies suggests cholecalciferol is more effective for reducing fracture risk. It is recommend waiting at least 6 weeks to check 25-hydroxyvitamin D levels after starting treatment or a dose increase.

7 Tips to Ease Allergy Season

Like the rest of the population, Seniors are not exempt from seasonal allergies. However, they frequently have additional complicating factors, such as chronic disease, that can compound the problem.

“Allergies have a larger impact on the lives and health of the elderly” says Christopher Randolph, M.D., member of the American Academy of Allergy, Asthma and Immunology’s Asthma and Allergic Diseases in the Elderly Committee. And points to several ways caregivers can make allergy season bearable for the Seniors:

  1. Look for the signs: People falsely assume that the elderly do not get seasonal allergies when, in fact, they are just as likely as anyone to be affected when spring booms begin to appear – even if a loved one has not suffered from seasonal allergies in the past. It is important for caregivers to be on the lookout for the usual signs: sneezing, a runny nose, coughing and itchy eyes.
  2. Recognize their discomfort: Post nasal drip can be uncomfortable and make it difficult to breathe for anyone. However, allergies pose serious health risks for an older person with conditions such as COPD, heart disease or lung cancer.
  3. Alert their Physician: According to Randolph, rapid and aggressive treatment is the best practice when it comes to Seniors. Allergy concerns should be brought to the physician’s attention at the first sign, especially because, when focused on a Senior’s larger health issues, it can be difficult to diagnose allergies.
  4. Avoid traditional antihistamines: Antihistamines, the drug most commonly prescribed to treat allergies, can be dangerous to Seniors. According to Randolph, antihistamines can cause dangerous interactions with medications commonly prescribed to Seniors and can result in changes in mood, behavior and sleep patterns.
  5. Be mindful of diet and nutrition. There are certain fruits and vegetables that may aggravate allergies – a phenomenon known as oral allergy syndrome. Culprits include bananas, cantaloupe, cucumbers, honeydew, watermelon and raw zucchini.
  6. Minimize exposure: Keep windows shut and use air conditioning when possible. Cleaning air conditioning filters frequently, shutting car windows when traveling, and making sure our Seniors wear glasses when outside, are measures that can go a long way in helping them through allergy season.
  7. Be on the lookout for upcoming treatment options: Randolph points that there is a new type of treatment for allergies being developed specifically for the elderly. By combining an antihistamine with a steroid inhaler, this new treatment delivers the antihistamine directly into the nose, avoiding the unpleasant effects traditionally associated with the drug. Randolph expects the treatment to be available to the public in the near future.

Parenteral Nutrition (PN) Errors

By: Ramy Bartash

Over the past four decades, parenteral nutrition (PN) has become an important primary (e.g., intestinal failure) and adjunctive therapy in a variety of disease states. Parenteral nutrition refers to all PN formulations; total nutrient admixtures (TNA) are PN formulations that include intravenous fat emulsions (IVFE); and 2 in 1 formulations are PN formulations that do not include IVFE.

PN benefits patients having significant disruption in gastrointestinal (GI) function becoming a lifeline for those who have a permanent loss of the GI tract such as patients with GI fistulas or short bowel syndrome.

New knowledge and technology have improved patient selection for PN therapy. Refinement of PN will continue to make it a useful therapy in the management of patients with dysfunctional GI tracts. However, PN formulations are extremely complex admixtures containing 40 or more components including amino acids, dextrose, fat emulsions, water, electrolytes, trace elements, and vitamins.

Each of these components is a regulated prescription drug product. Serious harm and death have occurred from improperly prepared and administered PN formulations.

With a potential for significant benefit to many patients, its complexity warrants an effective process of ordering, preparation, administration and monitoring to assure a quality outcome from therapy. Early PN programs focused on minimizing the frequency, severity, and type of complications that could result from this therapy. The interdisciplinary approach was found to improve efficacy, reduce complications, and facilitate efficient, cost-effective PN therapy.

Despite the highly successful use of PN for many years, the following adverse events demonstrate the types of PN errors that can result in serious harm and even death:
Two deaths related to errors in PN compounding led to a Safety Alert being issued by the U.S. Food and Drug Administration (FDA).(1) Autopsies of the patients involved found diffuse microvascular pulmonary emboli. There were also at least two other cases of respiratory distress occurring in patients at the same institution. These patients had received total nutrient admixtures (TNA) thought to contain a precipitate of calcium phosphate that resulted from improper admixture practices in the pharmacy.

Hospital personnel misinterpreted the dextrose content on the label of a PN formulation used in home care, which resulted in a pediatric patient’s death.(2) The home care label read: “300 mL of 50% dextrose.” The hospital pharmacy interpreted this as a final concentration of dextrose 50% (up to twice the concentration typically used in PN therapy). The patient died after 2 days of receiving infusion of the incorrect formula.

Two other fatal incidents have been reported involving pharmacy-compounding operations for pediatric dextrose solutions.(3) One infant was overdosed with dextrose when the PN was prepared with amino acids and two bags of 50% dextrose in place of one bag of 50% dextrose and one bag of sterile water. The other infant was under dosed with dextrose while receiving a 1.75% final concentration of dextrose solution rather than a 17.5% concentration.

Another PN formulation was compounded with no dextrose, resulting in irreversible brain damage when administered to a neonate.(4)

An incident involving the misinterpretation of a label resulted in iron overload and liver toxicity in a child receiving PN with iron dextran.5 In this case, the PN label read, “iron dextran 1 mL,” the intention being to use a 1-mg/mL concentration pre-diluted by the pharmacy. However, the solution containing the undiluted, 50-mg/mL concentration was used in compounding and resulted in a 50-fold error in the dose administered.

Four children were infected, two of whom died as a result of receiving contaminated PN admixtures.(6) Enterobacter cloacae was cultured from disposable tubing that was used in the automated compounding of these PN admixtures.

A 2-year old child receiving home PN died after an excessively high level of potassium was identified in the PN formulation. The most likely explanation provided for the death was human error in the manual preparation of the PN formulation.(7)
Two premature infants developed extreme magnesium toxicity while receiving PN that was the result of an automated PN compounder malfunction.(8)

PN has the potential for serious adverse events involving many PN components as well as system breakdowns. Analysis of data reported to the United States Pharmacopeia Medication Error Reporting Program (MERP), presented in cooperation with the ISMP, and the MEDMARX medication error database suggests that PN events are low in frequency but have the capacity to cause patient harm. Errors were related to wrong drug preparation, improper dose, labeling and problems with automated compounding devices. The PN components most commonly associated with errors were electrolytes, concurrent drug therapy, insulin and dextrose.(9) It is unclear what proportion of actual PN associated errors are actually reported to the USP.

The information provided in the ‘Safe Practices for Parenteral Nutrition’ document provides guidelines along with supporting evidence to foster quality PN therapy. The intent is for the principles provided in the document to become incorporated into healthcare organization practice for the purpose of minimizing the risk of PN. The complexity of this therapy cannot be understated. There is good evidence in support of practices that favor positive patient outcomes.

REFERENCES
1. Food and Drug Administration. Safety Alert: Hazards of precipitation associated with parenteral nutrition. Am J Hosp Pharm.
1994;51:1427–1428.
2. Carey LC, Haffey M. Incident: Home TPN formula order misinterpreted after hospital admission. Home Care Highlights. 1995;
(spring):7.
3. Cobel MR. Compounding pediatric dextrose solutions. Medication error alert. ASHP Newsletter. 1995;(Aug):3.
4. Gebbart F. Test hyperal solutions? Florida mom says yes. HospPharm Report. 1992;(Feb):35.
5. Iron overdose due to miscommunication of TPN order. Error alert. Pharmacy Today. 1995;(Sep).
6. Two children die after receiving infected TPN solutions. Pharm J. 1994;(Aug):3. 2.
7. www.hopkinsmedicine.org/Press_releases/2003/12_19_03.html.
8. Ali A, Walentik C, Mantych GJ, Sadiq HF, Keenan WJ, Noguchi A. Iatrogenic acute hypermagnesemia after total parenteral
nutrition infusion mimicking septic shock syndrome: two case reports. Pediatrics. 2003;112(1 Pt 1):e70–e72.
9. The U.S. Pharmacopeia Center for the Advancement of Patient
Safety medication error reporting programs

Nutritional Supplements

By: Sanket Patel

Enteral nutrition products are medical foods used to supplement an individual’s nutritional needs.  Many patients require enteral nutrition products to provide nutrition to individuals unable to ingest food or liquid as a consequence of a medical condition, or those who have impaired digestion.  Usually, enteral nutrition products are formulated as semisynthetic liquids that are administered through a feeding tube.  However, not all patients use enteral nutrition products as a sole source of nutrition.  Some enteral nutrition products are used to supplement a patient’s nutritional needs, especially among the aging population.  Many individuals affected by chronic diseases use enteral nutrition to supplement their diet.

Some clinical studies suggest that having appropriate nutrition may improve a patient’s quality of life and clinical outcome.  This may also lead to a decrease in overall healthcare costs.

Enteral nutrition is not only for patients who need the extra supplementation but also for healthy individuals who have active lifestyles, are attempting to lose weight, or seeking a high protein supplement.  Healthcare providers sometimes recommend these products for patients who require supplementation, experience decreased appetite, have difficulty chewing or swallowing solid foods, or require increased nutrition for recovery after an injury or surgery.

There are three categories of enteral products used depending on the patients’ requirements:

Category Comments
Polymeric formulas
  • Most frequently used enteral products
  • Can generally be safely used for meal replacement or self-care when taken orally
  • Designed for patients with normal digestive processes
  • Contain macronutrients in the form of intact proteins, fatty acids, or oils plus carbohydrates
  • Majority of individuals who need nutritional support tolerate and thrive with standard polymeric formulas
Oligomeric formulas
  • Rarely consumed orally because of poor palatability
  • Require medical supervision
  • Sometimes known as predigested (requiring minimal digestion) or elemental supplements; contain hydrolyzed or partially hydrolyzed proteins in the form of free amino acids or peptides
  • Carbohydrates are less complex
  • Fat content is usually altered to enhance absorption in patients with impaired absorption
Modular formulas
  • Formulated to supplement a single macronutrient, such as protein powder, medium-chain triglyceride oil, and powdered flavored glucose polymers
  • Can be taken with other foods to increase the caloric and protein content consumed

 

 

Role of Decongestants in Allergic Rhinitis

By: Nirali Patel PharmD. Rph.

Allergic rhinitis is a common chronic respiratory illness that affects quality of life, productivity, and other comorbid conditions, including asthma. It is an immunoglobulin E–mediated disease, thought to occur after exposure to indoor and outdoor allergens such as dust mites, insects, animal dander, mold, and pollen. Symptoms include rhinorrhea, nasal congestion, obstruction, and pruritus.

Treatment options for allergic rhinitis include oral and topical decongestants which improve the nasal congestion associated with allergic rhinitis by acting on adrenergic receptors, which causes vasoconstriction in the nasal mucosa, resulting in decreased inflammation. The most commonly available decongestants are phenylephrine, oxymetazoline (Afrin), and pseudoephedrine.

Nasal spray decongestants work within about 10 minutes and may provide relief for up to 12 hours. Common adverse effects that occur with the use of intranasal decongestants are sneezing and nasal dryness and nasal bleeding. Therefore, duration of use of nasal decongestants for more than three to five days is usually not recommended, because patients may develop rhinitis medicamentosa or have rebound or recurring congestion. However, a study of 35 patients found no rebound when oxymetazoline was used for 10 days.

Oral decongestants work within 30 minutes and may provide relief for up to 24 hours. Oral decongestants may cause potentially serious adverse effects, such as: headache, elevated blood pressure, tremor, urinary retention, dizziness, tachycardia, anxiety and insomnia. Therefore, patients with underlying cardiovascular conditions, glaucoma, or hyperthyroidism should only use these medications with close monitoring. A study of 25 patients with controlled hypertension provides some reassurance about the use of oral decongestants; compared with placebo, this randomized crossover study found minimal effect on blood pressure with pseudoephedrine use.

In geriatric patients, decongestants should only be considered when congestion is not controlled by other agents.

Caution is advised in patients with diabetes mellitus, ischemic heart disease, unstable hypertension, prostatic hypertrophy, hyperthyroidism, and narrow-angle glaucoma.

Oral decongestants are contraindicated with co-administration with monoamine oxidase inhibitors (MAOIs), and in patients with uncontrolled hypertension, severe coronary artery disease and benign prostatic hyperplasia (BPH).

FDA Approves Pazeo™ Solution for Ocular Allergy

By: Ankur Dave Pharm D.

The FDA recently approved Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7% for ocular itching associated with allergic conjunctivitis. Pazeo was created by Alcon, the global leader in eye care and a division of Novartis Pharmaceuticals. The solution can be taken once a day with proven efficacy data at 24 hours post dose.

Results from two Conjunctival Allergen Challenge clinical studies, showed that Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, demonstrated statistically significantly improved relief of ocular itching associated with allergic conjunctivitis at 24 hours post-treatment compared to olopatadine 0.2% (known as Pataday® solution). The safety profile of Pazeo solution is comparable to that of olopatadine 0.2%. In the two clinical studies, the most common adverse reactions occurred in 2 to 5% of patients treated with either Pazeo solution or a vehicle. These events were blurred vision, dry eye, superficial punctate keratitis, dysgeusia, and abnormal sensation in the eye.

As much as 30% of the US population is affected by seasonal allergy symptoms, with as many as 70-80% of these people showing ocular symptoms such as itching. Allergic conjunctivitis, more commonly referred to as eye allergies, affects the conjunctiva, which is the clear layer of skin overlying the eyes. Although eye allergies are not typically harmful to person’s eye and vision they can be a 24-hour-a-day burden. “Patients now have an available option that can provide ocular itch relief with efficacy demonstrated at 24 hours. This approval represents an exciting new option in ocular allergy itch relief therapy,” says Eric Donnenfeld, MD founding partner of Ophthalmic Consultants of Long Island and Clinical Professor of Ophthalmology at NYU.

As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution, keeping the bottle tightly closed when not in use. The preservative in Pazeo solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients should be instructed to wait at least five minutes after instilling Pazeo solution before they insert their contact lenses. Pazeo solution is anticipated to be available by prescription in the United States in March 2015, followed by Latin American and Asian markets through 2017.

http://www.novartis.com/newsroom/media-releases/en/2015/1890563.shtml