NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

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Overview

What is NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is a sterile antimicrobial and anti-inflammatory suspension for ophthalmic use.

Each mL contains: Actives:

Preservative:

Inactives:

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Waksman (Fam. Streptomycetacae). It has a potency equivalent to not less than 600 μg of neomycin standard per mg, calculated on an anhydrous basis. Its structural formula are:

Polymyxin B sulfate is the sulfate salt of Polymyxin, B1 and B2, which are produced by the growth of (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg calculated on an anhydrous basis. Its structural formula are:

Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an anti-inflammatory hormone. Its structural formula is:

neomycin-03 IMAGE

What does NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE look like?

What are the available doses of NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

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What should I talk to my health care provider before I take NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

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How should I use NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (See ).

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: , , , species, species, and .

The product does not provide adequate coverage against and streptococci, including .

One or two drops in the affected eye every 3 or 4 hours, depending on the severity of the condition. The suspension may be used more frequently if necessary.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

What interacts with NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

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What are the warnings of NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

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What are the precautions of NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

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What are the side effects of NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

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What should I look out for while using NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

What might happen if I take too much NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

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How should I store and handle NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

Store below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyNeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USANeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 61314-641-75SHAKE WELL BEFORE USING.Store at 20°-25°C (68°-77°F).Rx Only*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.9002784-0707Mfd. For:FALCON Pharmaceuticals, Ltd.For t Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAPrinted in USA

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Corticosteroids suppress the inflammatory response to a variety of agents, and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, concomitant antimicrobial drugs may be used when this inhibition is considered to be clinically significant in a particular case.

When a decision to administer both a corticosteroid and antimicrobials is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the intended dosage of all drugs is administered. When each type of drug is in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

Microbiology:

in vitro

Staphylococcus aureus

Escherichia coli

Haemophilus influenzae

Klebsiella/Enterbacter

Neisseria

Pseudomonas aeruginosa

Serratia marcescens

Streptococcus pneumoniae

Non-Clinical Toxicology

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

Caution should be exercised when propranolol hydrochloride tablets are administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see

Cardiovascular Drugs

Antiarrhythmics

Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.

Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.

Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.

The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following coadministration with propranolol.

Caution should be exercised when administering propranolol hydrochloride tablets with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers.

Digitalis Glycosides

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Calcium Channel Blockers

Caution should be exercised when patients receiving a beta-blocker are administered a calcium-channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction.

There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.

Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure.

ACE Inhibitors

When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction.

The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol hydrochloride tablets should be administered cautiously to patients withdrawing from clonidine.

Alpha Blockers

Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers.

Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.

Reserpine

Patients receiving catecholamine-depleting drugs, such as reserpine, should be closely observed for excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.

Inotropic Agents

Patients on long term therapy with propranolol may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore not indicated in the treatment of propranolol overdose (see

Isoproterenol and Dobutamine

Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. Also, propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.

NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension should never be directly introduced into the anterior chamber of the eye.

Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma.

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.

Topical antibiotics, particularly, neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter (see ).

The initial prescription and renewal of the medication order beyond 20 mL should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see ).

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see ).

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection:

Local irritation on instillation has been reported.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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