Ocular infections Archives - MPR

AZASITE

Haymarket Media — Thu, 22 Jul 2021 10:30:13 +0000

Azithromycin 1%; oph. soln; contains benzalkonium chloride.

Bacitracin Ophthalmic Ointment

Haymarket Media — Thu, 22 Jul 2021 11:11:55 +0000

Bacitracin 500Units/g.

Bacterial Conjunctivitis Treatments

Haymarket Media — Tue, 10 Mar 2015 17:00:00 +0000

Bacterial Conjunctivitis Treatments

BACTERIAL CONJUNCTIVITIS TREATMENTS
Generic	Brand		Strength	Size	Form	Dose
azithromycin	Azasite	Rx	1%	2.5mL	soln¹	<1yr: Not established. ≥1yr: 1 drop twice daily (8−12hrs apart) for 2 days, then once daily for 5 days.
bacitracin	Bacitracin Ophthalmic Ointment	Rx	500U/g	3.5g	oint	Adults and Children: Apply 1−3 times daily. Blepharitis: remove scales and crusts before applying to lid margins.
besifloxacin	Besivance	Rx	0.6%	5mL	susp¹	<1yr: Not established. ≥1yr: 1 drop in affected eye(s) 3 times daily (4−12hrs apart) for 7 days. Shake bottle once before use.
ciprofloxacin	Ciloxan	Rx	0.3%	3.5g	oint	<2yrs: Not established. ≥2yrs: Apply ½ inch into conjunctival sac 3 times daily for 2 days, then twice daily for next 5 days.
ciprofloxacin	Ciloxan	Rx	0.3%	5mL	soln¹	Adults and Children: 1–2 drops in conjunctival sac(s) every 2hrs while awake for 2 days, then 1–2 drops every 4hrs while awake for next 5 days.
erythro– mycin	Erythro– mycin Ophthalmic Ointment	Rx	5mg/g	3.5g	oint	Adults and Children: Apply 1cm ribbon of ointment to infected area up to 6 times daily. Prophylaxis of neonatal gonoccocal or chlamydial conjunctivitis: instill 1cm ribbon of ointment into each lower conjunctival sac.
gatifloxacin	Zymaxid	Rx	0.5%	2.5mL	soln¹	<1yr: Not established. ≥1yr: 1 drop every 2hrs (max 8 doses) on Day 1 then 1 drop 2−4 times daily while awake on Days 2−7.
gentamicin sulfate	—	Rx	0.3%	contact supplier	soln¹	Adults and Children: 1 or 2 drops in affected eye(s) every 4hrs. Severe infections: Up to 2 drops once every hour.
gentamicin sulfate	Gentak	Rx	0.3%	3.5g	oint	Adults and Children: Apply a ½ inch of ointment 2−3 times daily.
levofloxacin	—	Rx	0.5%	contact supplier	soln¹	<6yrs: Not established. ≥6yrs: 1−2 drops every 2hrs while awake (max 8 times/day) on Days 1 and 2, then 1−2 drops every 4hrs while awake (max 4 times/day) on Days 3−7.
moxifloxacin	Moxeza	Rx	0.5%	3mL	soln	<4mos: Not established. ≥4mos: 1 drop twice daily for 7 days.
moxifloxacin	Vigamox	Rx	0.5%	3mL	soln	Adults and Children: 1 drop 3 times daily for 7 days.
ofloxacin	Ocuflox	Rx	0.3%	5mL	soln¹	<1yr: Not established. ≥1yr: 1−2 drops every 2−4hrs for 2 days, then 4 times daily for 5 more days.
polymyxin B sulfate	—	Rx	10000U/g	contact supplier	oint	Adults and Children: Apply every 3−4hrs for 7−10 days.
bacitracin zinc	—	Rx	500U/g	contact supplier	oint	Adults and Children: Apply every 3−4hrs for 7−10 days.
polymyxin B sulfate	—	Rx	10000U/g	contact supplier	oint	Adults and Children: Apply every 4hrs for 7−10 days.
bacitracin zinc			400U/g
neomycin (as sulfate)			3.5mg/g
polymyxin B sulfate	Neosporin	Rx	10000U/ mL	10mL	soln³	Children: Not recommended. Adults: 1−2 drops every 4hrs for 7−10 days. Max up to 2 drops every hour.
neomycin sulfate			1.75mg/ mL
gramicidin			0.025mg/ mL
polymyxin B sulfate	Polytrim	Rx	10000U/ mL	10mL	soln¹	<2mos: Not recommended. ≥2mos: 1 drop every 3hrs for 7−10 days; max 6 doses/day.
trimetho– prim sulfate	Polytrim	Rx	1mg/mL	10mL	soln¹
sulfacet– amide sodium	Bleph‑10	Rx	10%	5mL	soln¹	<2mos: Not recommended. ≥2mos: Initially 1−2 drops every 2−3hrs during the day (less often at night). Treat for 7−10 days.
tobramycin	Tobrex	Rx	0.3%	3.5g	oint²	<2mos: Not established. ≥2mos: Mild to moderate infections: 1–2 drops every 4hrs or ½ inch of ointment 2–3 times daily. Severe infections: 2 drops every hr or ½ inch of ointment every 3–4hrs until improvement; then reduce before discontinuing.
tobramycin	Tobrex	Rx	0.3%	5mL	soln¹
NOTES
Do not wear contact lenses with signs and symptoms of bacterial conjunctivitis. To prevent contamination, the dropper tip should not touch the eyelids or surrounding areas. Keep the bottle tightly closed when not in use. ¹contains benzalkonium chloride. May be absorbed by soft contact lenses. ²contains chlorobutanol. ³contains alcohol, thimerosal. Not an inclusive list of medications, official indications, and/or dosing. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. (Rev. 9/2022)

BESIVANCE

Haymarket Media — Mon, 06 Feb 2023 19:51:12 +0000

Besifloxacin 0.6%; oph susp; contains benzalkonium chloride.

BLEPH-10

Haymarket Media — Mon, 06 Feb 2023 15:50:01 +0000

Sulfacetamide sodium 10%; oph. soln; contains benzalkonium chloride.

CILOXAN

Haymarket Media — Thu, 22 Jul 2021 10:30:26 +0000

Ciprofloxacin (as HCl) 0.3%; oph. soln; contains benzalkonium chloride.

CILOXAN OPH OINT

Haymarket Media — Thu, 22 Jul 2021 10:30:28 +0000

Ciprofloxacin (as HCl) 0.3%.

Erythromycin Ophthalmic Ointment

Haymarket Media — Mon, 06 Feb 2023 19:39:05 +0000

Erythromycin 5mg/g.

GENTAK

Haymarket Media — Thu, 22 Jul 2021 11:55:07 +0000

Gentamicin sulfate 0.3%; oph oint; contains parabens.

Gentamicin sulfate Ophthalmic Solution

Haymarket Media — Thu, 22 Jul 2021 11:25:47 +0000

Gentamicin sulfate 0.3%; contains benzalkonium chloride.

Levofloxacin Ophthalmic Solution

Haymarket Media — Thu, 22 Jul 2021 10:31:02 +0000

Levofloxacin (as hemihydrate) 0.5%; oph. soln; contains benzalkonium chloride.

March 2023 Recap: Drug Pipeline Updates

Steve Duffy — Fri, 07 Apr 2023 18:08:36 +0000

The table below is a review of notable updates that occurred in March 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

Drug	Pharmacologic Class	Proposed Indication	Status
Cardiovascular Disease
Omecamtiv mecarbil (Cytokinetics)	Selective small molecule cardiac myosin activator	Treatment of heart failure with reduced ejection failure.	Complete Response Letter issued
Dermatological Disorders
Berdazimer gel (SB206; Novan)	Nitric oxide-releasing topical antiviral gel	Treatment of molluscum contagiosum.	NDA accepted for filing
Dupilumab (Dupixent; Regeneron Pharmaceuticals, Inc)	Interleukin-4 receptor alpha antagonist	Treatment of patients 12 years of age and older with chronic spontaneous urticaria that is inadequately controlled with standard-of-care H1 antihistamines.	sBLA accepted for review
Endocrine Disorders
Empagliflozin (Jardiance; Eli Lilly)	SGLT2 inhibitor	As an adjunct to diet and exercise to improve glycemic control in patients 10 years of age and older with type 2 diabetes.	sNDA accepted for review
Hematological Disorders
Valoctocogene roxaparvovec (BioMarin)	Adeno-associated virus gene therapy	Treatment of hemophilia A in adults.	FDA review period extended for BLA
Immunization
RSVPreF3 (GlaxoSmithKline)	RSV vaccine candidate	For active immunization to prevent RSV-associated lower respiratory tract disease in adults 60 years of age and older.	FDA panel voted
Metabolic Disorders
Eplontersen (Ionis Pharmaceutics)	Ligand-conjugated antisense medicine	Treatment of hereditary transthyretin-mediated amyloid polyneuropathy.	NDA accepted for review
Zagociguat (Cyclerion Therapeutics)	Small molecule activator of soluble guanylate cyclase	Treatment of mitochondrial disease.	Orphan Drug designation
Musculoskeletal Disorders
Voxzogo (vosoritide; BioMarin)	Analogue of C-type natriuretic peptide	Treatment of children less than 5 years of age with achondroplasia.	sNDA accepted for review
Neurologic Disorders
ABBV-951 (foscarbidopa/ foslevodopa; AbbVie)	Dopa-decarboxylase inhibitor + dopamine precursor	Treatment of motor fluctuations in adults with advanced Parkinson disease.	Complete Response Letter issued
Lecanemab-irmb (Leqembi; Eisai)	Humanized immunoglobulin gamma 1 monoclonal antibody	Conversion of accelerated approval status to a traditional approval for the treatment of Alzheimer disease.	sBLA accepted for Priority Review
Solanezumab (Eli Lilly)	Humanized monoclonal antibody	Treatment of patients with Alzheimer disease.	Clinical development discontinued
Tofersen (Biogen)	Antisense medicine to reduce synthesis of SOD1 protein production	Treatment of patients with superoxide dismutase 1 amyotrophic lateral sclerosis.	FDA panel voted
Ganaxolone (Ztalmy; Marinus Pharmaceuticals)	Neuroactive steroid GABA A receptor positive modulator	Treatment of Lennox-Gastaut syndrome.	Orphan Drug designation
Ob/Gyn
Opill (norgestrel; Perrigo Company plc)	Progestin-only daily birth control pill	For the prevention of pregnancy.	FDA panel to review the application for Rx to OTC switch
Oncology
ADX-2191 (methotrexate injection; Aldeyra Therapeutics, Inc.)	Intravitreal formulation of methotrexate	Treatment of primary vitreoretinal lymphoma.	NDA accepted for Priority Review
FORE8394 (FORE Biotherapeutics)	Small molecule, next-generation, orally available selective inhibitor of mutated BRAF	Treatment of primary brain and CNS malignancies.	Orphan Drug designation
Osemitamab (TST001; Transcenta Holding Limited)	High affinity, humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody	Treatment of patients with pancreatic cancer.	Orphan Drug designation
PBP1510 (ulenistamab; Prestige Biopharma)	Targets pancreatic adenocarcinoma upregulated factor	Treatment of unresectable or metastatic pancreatic adenocarcinoma that has relapsed following and/or is refractory to at least 1 line of prior therapy.	Fast Track designation
RRx-001 (EpicentRx)	Small molecule inflammasome NLRP3 inhibitor and Nrf2 upregulator	For the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients.	Fast Track designation
Ruxolitinib extended-release tablets (Incyte)	Janus kinase (JAK)1/2 inhibitor	For once-daily use in the treatment of certain types of myelofibrosis, polycythemia vera, and graft-vs-host disease.	Complete Response Letter issued
Niraparib (Zejula; GlaxoSmithKline) plus abiraterone acetate	Poly (ADP-ribose) polymerase inhibitor + CYP17 inhibitor	Treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer.	NDA submitted
Pain Management
Bupivacaine liposome injectable suspension (Exparel; Pacira BioSciences, Inc.)	Local anesthetic (amide-type)	As a single-dose sciatic nerve block in the popliteal fossa and as a single-dose femoral nerve block in the adductor canal.	sNDA accepted for review
Respiratory Disorders
ARINA-1 (ascorbic acid and glutathione; Renovion, Inc.)	At-home nebulized therapy	For the prevention of bronchiolitis obliterans syndrome progression in adults with a bilateral lung transplant.	Fast Track designation

MOXEZA

Haymarket Media — Thu, 02 Sep 2021 19:44:05 +0000

Moxifloxacin (as HCl) 0.5%; oph soln.

MPR Weekly Dose Podcast 167

Steve Duffy — Fri, 28 Jul 2023 12:38:00 +0000

Drug-device combo approved to treat molluscum contagiosum; Xdermvy has gotten the green light to treat Demodex blepharitis; warfarin reversal treatment for use in urgent surgery; weight loss drug in short supply through 2023; cervical pessary assessed for reducing preterm birth.

NATACYN

Haymarket Media — Thu, 22 Jul 2021 11:18:54 +0000

Natamycin 5%; oph susp; contains benzalkonium chloride 0.02%.

NEO-POLYCIN

Haymarket Media — Thu, 22 Jul 2021 11:23:28 +0000

Neomycin (as sulfate) 3.5mg, polymyxin B sulfate 10000 Units, bacitracin zinc 400 Units; per g; oph oint.

NEOSPORIN OPH SOLN

Haymarket Media — Thu, 22 Jul 2021 10:31:16 +0000

Polymyxin B sulfate 10000Units, neomycin (as sulfate) 1.75mg, gramicidin 0.025mg; per mL; contains alcohol 0.5%, thimerosal.

OCUFLOX

Haymarket Media — Wed, 08 Feb 2023 19:19:36 +0000

Ofloxacin 0.3%; oph. soln; contains benzalkonium chloride.

Oral Azithromycin Equivalent to 6 Weeks Doxycycline for Meibomian Gland Dysfunction

Haymarket Media — Mon, 03 Apr 2023 13:00:00 +0000

HealthDay News — Three weeks of oral azithromycin seems to be equivalent to 6 weeks of doxycycline for treatment of severe meibomian gland dysfunction (MGD), according to a study published online March 23 in JAMA Ophthalmology.

Phit Upaphong, MD, from Chiang Mai University in Thailand, and colleagues conducted a randomized trial involving patients with moderate-to-severe MGD who were randomly assigned to receive oral azithromycin (1g once per week for 3 weeks) or oral doxycycline (200mg daily for 6 weeks). Overall, 137 eyes from 137 patients were randomly assigned to the azithromycin and doxycycline groups (68 and 69 eyes, respectively).

The researchers found that the adjusted mean between-group difference of total MGD scores was −0.33 and 0.13 at weeks 6 and 8, respectively. At 6 and 8 weeks, the adjusted mean between-group difference in Ocular Surface Disease Index score was −1.20 and −1.59, respectively. Patients treated with azithromycin had fewer gastrointestinal adverse effects (4.4 vs 15.9%).

“The reduced dosing of azithromycin supports its use as an alternative to doxycycline for at least six weeks,” the authors write. “However, longer-term follow-up in each group would be needed to determine if these outcomes persist for this chronic condition.”

Abstract/Full Text (subscription or payment may be required)

POLYCIN

Haymarket Media — Thu, 22 Jul 2021 11:23:44 +0000

Polymyxin B sulfate 10000 Units, bacitracin zinc 500 Units; per g; oph oint.

Polymyxin B/Bacitracin Oph Oint

Haymarket Media — Thu, 22 Jul 2021 10:31:29 +0000

Polymyxin B sulfate 10000 Units, bacitracin zinc 500 Units; per g.

Polymyxin B/Bacitracin/Neomycin Oph Oint

Haymarket Media — Thu, 22 Jul 2021 10:31:31 +0000

Polymyxin B sulfate 10000Units, bacitracin zinc 400Units, neomycin (as sulfate) 3.5mg; per g; oph oint.

POLYTRIM

Haymarket Media — Thu, 02 Mar 2023 16:32:25 +0000

Trimethoprim (as sulfate) 1 mg, polymyxin B sulfate 10000 Units/mL; oph. soln; contains benzalkonium chloride.

Sterility Issues Prompt Recall of Another Ophthalmic Product

Steve Duffy — Wed, 08 Mar 2023 18:15:00 +0000

Pharmedica USA has voluntarily recalled 2 lots of Purely Soothing, 15% MSM Drops to the consumer level due to nonsterility.

The product is used as an anti-inflammatory intended to relieve ocular irritation and/or swelling. The recalled lots for Purely Soothing, 15% MSM Drops include Lot# 2203PS01; Package Size 1 oz; UPC 7 31034 91379 9, and Lot# 1808051; Package Size 0.5 oz; UPC 7 31034 91382 9. The recalled products were distributed worldwide via online e-commerce and trade shows (eg, Amazon Marketplace, etc.).

The administration of contaminated eye drops carries a risk for eye infection and possibly blindness. Consumers should discontinue use of the affected products immediately. To date, the Company has not received any reports of adverse events or illness related to the recalled product.

Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.

There have been a number of recent recalls related to eye care products. These have included an artificial tears eye dop, an eye ointment, and a glaucoma medication.

TOBREX

Haymarket Media — Thu, 22 Jul 2021 10:32:07 +0000

Tobramycin 0.3%; oph. soln; contains benzalkonium chloride.