FSC Pediatrics, Inc. is dedicated to improving pediatric patient care and to supporting the healthcare professionals who care for them. We provide high-quality prescription medications and devices to support the unique medical needs of children. All of our products are approved by the FDA for pediatric medical use. Every FSC Pediatrics employee is committed to serving pediatric medical practices dedicated to children's healthcare. Read more...

Important Safety Information for Primsol® (trimethoprim hydrochloride):

Why is Primsol Prescribed?

Primsol (trimethoprim hydrochloride) Solution is used to treat middle ear infections, also known as acute otitis media (AOM), which are caused by certain kinds of bacteria.  Not all ear infections can be treated with Primsol. Only your doctor can determine if Primsol is right for you or your child.

The most important facts about Primsol:

If you or your child are sensitive to or have had an allergic reaction to trimethoprim; have  megaloblastic anemia; or have a folate deficiency, you should not take Primsol

Primsol is an antibiotic used to treat bacterial infections.  It does not treat viral infections such as a common cold.  As with all antibiotics, it is important to complete the full dosage schedule for Primsol, even if you or your child are feeling better.  Not completing the full dosage schedule can decrease the drug’s effectiveness and increase the chances the bacteria may become resistant to Primsol.

Special warnings regarding Primsol:

Primsol contains trimethoprim which can interfere with normal blood cell formation, however this is very rare.  Tell your doctor if you or your child develop pale skin, or red or purple skin spots while taking Primsol as this could be a sign of a serious blood condition.  

If you or your child have kidney or liver problems tell your doctor before taking Primsol. 

Side effects which can occur with Primsol:

 As with other medications, side effects can occur while taking Primsol.  The most commonly reported side effects are diarrhea, vomiting, abdominal pain, and rash. If you or your child develop unexplained symptoms or experience a change in intensity of existing symptoms, let your doctor know as soon as possible.  Only your doctor can determine if it is safe to continue taking Primsol.

This is not a complete summary of safety information. For additional safety information, please click here for Full Prescribing Information and discuss with your doctor.  You may also call FSC Pediatrics at 1-866-764-7822.

IMPORTANT PRODUCT INFORMATION FOR ADENOPLUS®:

INTENDED USE

AdenoPlus® is rapid immunoassay test for the visual, qualitative in vitro detection of Adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for professional use as an aid in the rapid differential diagnosis of acute conjunctivitis.

WARNINGS AND PRECAUTIONS:

For in vitro diagnostic use only.

Keep the test cassette and sample collector in the foil pouches until just before use. The Dacron material used in the sampling fleece may cause allergic reactions for some people.

Do not use AdenoPlus past the expiration date.

All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. Proper handling and disposal methods should be established according to local, state and federal regulations. Wear disposable gloves while handling samples and wash hands after the test is complete.

Both AdenoPlus and the buffer vial are single use items. Do not reuse with multiple specimens.

AdenoPlus requires a visual readout. Do not interpret the test result if you have color-impaired vision.

Result interpretation requires a brightly lit environment.

Do not use the same AdenoPlus test kit on more than one patient.

IMPORTANT PRODUCT INFORMATION FOR BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%

INDICATION AND USAGE:

BEPREVE is indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

IMPORTANT RISK INFORMATION:

BEPREVE is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients.

BEPREVE is for topical ophthalmic use only.

To minimize risk of contamination, do not touch the dropper tip to any surface. Keep the bottle closed when not in use. BEPREVE should not be used to treat contact lens–related irritation. Remove contact lenses prior to instillation of BEPREVE.

The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions occurring in 2%‐5% of patients were eye irritation, headache, and nasopharyngitis.

This is not a complete summary of risk information. For additional risk information, please click here for the Full Prescribing Information and discuss with your doctor. You may also call Bausch and Lomb Incorporated at 1-800-323-0000.

IMPORTANT PRODUCT INFORMATION FOR BESIVANCE® (besifloxacin ophthalmic suspension) 0.6%

INDICATIONS AND USAGE:

Besivance® (besifloxacin ophthalmic suspension) 0.6% is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius*

*Efficacy for this organism was studied in fewer than 10 infections. (1)

IMPORTANT RISK INFORMATION:

Besivance® is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

As with other anti-infectives, prolonged use of Besivance® may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy.

Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance®.

The most common adverse event reported in 2% of patients treated with Besivance® was conjunctival redness. Other adverse events reported in patients receiving Besivance® occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

Besivance® is not intended to be administered systemically. Quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose. Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.

Safety and effectiveness in infants below one year of age have not been established.

This is not a complete summary of risk information. For additional risk information, please click here for the Full Prescribing Information and discuss with your doctor. You may also call Bausch and Lomb Incorporated at 1-800-323-0000.

IMPORTANT SAFETY INFORMATION FOR DENAVIR® (PENCICLOVIR CREAM,1%)

Denavir® is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.

Denavir® should only be used on herpes labialis on the lips or face. Application to mucous membranes is not recommended. Denavir® should not be used in patients with known hypersensitivity to the product or any of its ingredients. There are no adequate and well-controlled Denavir® studies in pregnant women; therefore, Denavir® should be used during pregnancy only if clearly needed. There is no information on whether Denavir® is excreted in human milk after topical administration; a decision whether to discontinue Denavir® should take into account the importance of the drug to the mother. The effect of Denavir® has not been established in immunocompromised patients. Denavir® does not cure cold sores.

In clinical studies, the most common adverse reaction with Denavir® was headache, which occurred in 5.3% of patients who received Denavir® and 5.8% of patients who received placebo. Other adverse reactions with Denavir® occurred in less than 2% of patients and included application site reaction, decreased sensitivity to touch/local anesthesia, taste perversion, and rash. Other reported adverse reactions have included swelling of the mouth or throat, pain, alterations in sense of smell, abnormal touch sensation, itching, skin discoloration, and hives.

Denavir® is available by prescription only.

Please see the Full Prescribing Information

Suspected Adverse Reactions

To report suspected adverse reactions, please contact FSC at 1-866-764-7822 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

LEGAL NOTICES:

BESIVANCE & BEPREVE are registered trademarks of Bausch & Lomb Incorporated or its affiliates. All other product/brand names are trademarks of their respective owners.

E-Z Spacer is a registered trademark of FSC Laboratories, Inc.

Primsol is a registered trademark of FSC Laboratories, Inc.

Denavir is a registered trademark of Denco Asset, LLC

AdenoPlus is a registered trademark of Rapid Pathogen Screening, Inc.