Drugs Details

Drugs Info of Neodecadron
Drugs Details
  • Drugs Type  : Multum
  • Date : 24th Feb 2015 02:05 am
  • Brand Name : Neodecadron
  • Generic Name : neomycin and dexamethasone ophthalmic (Pronunciation: nee oh MYE sin DEX a METH a sone off THAL mik)
Descriptions

Ophthalmic Solution NEODECADRON (Neomycin Sulfate-Dexamethasone Sodium Phosphate) is a topical corticosteroid-antibiotic solution for ophthalmic use.

Dexamethasone sodium phosphate is 9-fluoro-11β 17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1, 4-diene-3, 20-dione disodium salt. Its empirical formula is C22H28FNa2O8P and its structural formula is:

 

Dexamethasone sodium phosphate Structural Formula Illustration

Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone).

Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. Its molecular weight is 516.41.

Neomycin sulfate, an antibiotic of the aminoglycoside group, is a mixture of the sulfate salts of neomycin, produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). Neomycin is a complex typically containing 8-13% neomycin C, less than 0.2% neomycin A, and the rest, neomycin B. The empirical formula for both neomycin B and neomycin C is C23H46N6O13, and the molecular weight for each is 614.65. Neomycin A (also referred to as neamine) has an empirical formula of C12H26N4O6 and a molecular weight of 322.36. The structural formulae for neomycin sulfate are:

 

Neomycin sulfate Structural Formula Illustration

Each milliliter of buffered Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) in the OCUMETER* ophthalmic dispenser contains: dexamethasone sodium phosphate equivalent to 1 mg (0.1%) dexamethasone phosphate, and neomycin sulfate equivalent to 3.5 mg neomycin base. Inactive ingredients: creatinine, sodium citrate, sodium borate, polysorbate 80, disodium edetate, hydrochloric acid to adjust pH to 6.6 -7.2, and water for injection. Benzalkonium chloride 0.02% and sodium bisulfite 0.1% added as preservatives.

What are the possible side effects of neomycin and dexamethasone ophthalmic ()?

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Neodecadron »

This monograph has been modified to include the generic and brand name in many instances.

Indications

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 steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid 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.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

Staphylococcus aureus
Escherichia coli

Haemophilus influenzae

Klebsiella/Enterobacter
species
Neisseria
species

The product does not provide adequate coverage against:

Pseudomonas aeruginosa
Serratia marcescens

Streptococci, including Streptococcus pneumoniae

Dosage Administration

The duration of treatment will vary with the type of lesion and may extend from a few days to several weeks, according to therapeutic response.

Instill one or two drops of Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms.

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

How Supplied

Sterile Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) is a clear, colorless to pale yellow solution.

No. 7639 — Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) is supplied as follows:

NDC 0006-7639-03 in 5 mL white opaque, plastic OCUMETER ophthalmic dispenser with a controlled drop tip.

(6505-01-039-4352 0.1% 5 mL).

Storage

Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from light.

Distributed by: MERCK & CO., INC., West Point, PA 19486, USA. Issued December 1995.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, the combination, or any other component of the product. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. 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

The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

Read the Neodecadron (neomycin and dexamethasone) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Not For Injection Into 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 in posterior subcapsular cataract formation.

Prolonged use of corticosteroids 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 this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Corticosteroids should be used with caution in the presence of ocular hypertension and/or glaucoma. Intraocular pressure should be checked frequently.

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 a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; periodic slit lamp microscopy is essential. (See CONTRAINDICATIONS.)

Neomycin sulfate may occasionally cause cutaneous sensitization. If any reaction indicating such sensitivity is observed, discontinue use.

Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Precautions

General

The initial prescription and renewal of the medication order beyond 20 milliliters 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 two 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 WARNINGS).

There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. (See PRECAUTIONS: Information for Patients.)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) . Treatment of human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 μg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Pregnancy

Teratogenic effects

Pregnancy Category C

Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. There are no adequate and well-controlled studies in pregnant women. Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically-administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

NEODECADRON (neomycin and dexamethasone) is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. NEODECADRON (neomycin and dexamethasone) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, including sulfites, and to other corticosteroids (see WARNINGS). (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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, a concomitant antimicrobial drug 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 an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drug are in the same formulation and, particularly, that 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

The anti-infective component in Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) is included to provide action against specific organisms susceptible to it. Neomycin sulfate is active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, and Neisseria species. The product does not provide adequate coverage against: Pseudomonas aeruginosa, Serratia marcescens, and streptococci, including Streptococcus pneumoniae. (See INDICATIONS AND USAGE.)

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection. Keep tightly closed when not in use.

Patients should also be instructed that ocular preparations, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated preparations (see PRECAUTIONS, General).

If redness, irritation, swelling or pain persists or becomes aggravated, the patient should be advised to consult a physician. Patients should also be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice.

One of the preservatives in Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) , benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling Ophthalmic Solution NEODECADRON (neomycin and dexamethasone) before they insert their lenses.

Keep out of the reach of children.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names:

Generic Name: neomycin and dexamethasone ophthalmic (Pronunciation: nee oh MYE sin DEX a METH a sone off THAL mik)

  • What is neomycin and dexamethasone ophthalmic ?
  • What are the possible side effects of neomycin and dexamethasone ophthalmic ?
  • What is the most important information I should know about neomycin and dexamethasone ophthalmic ?
  • Who should not use neomycin and dexamethasone ophthalmic ?
  • How should I use neomycin and dexamethasone ophthalmic ?
  • What happens if I miss a dose ?
  • What happens if I overdose ?
  • What should I avoid while using neomycin and dexamethasone ophthalmic ?
  • What other drugs will affect neomycin and dexamethasone ophthalmic ?
  • Where can I get more information?

What is neomycin and dexamethasone ophthalmic ?

Neomycin is an antibiotic. It is used to treat bacterial infections.

Dexamethasone is a steroid. It is used to treat the inflammation associated with bacterial infections of the eye.

Neomycin and dexamethasone ophthalmic is used to treat bacterial infections of the eyes.

Neomycin and dexamethasone ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of neomycin and dexamethasone ophthalmic ?

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Neodecadron (neomycin and dexamethasone) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about neomycin and dexamethasone ophthalmic ?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Side Effects Centers
  • Neodecadron

Patient Detailed How Take

Who should not use neomycin and dexamethasone ophthalmic ?

Do not use neomycin and dexamethasone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

Neomycin and dexamethasone ophthalmic is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant.

It is also not known whether neomycin and dexamethasone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use neomycin and dexamethasone ophthalmic ?

Use neomycin and dexamethasone ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using your eyedrops or ointment.

To apply the eyedrops:

  • Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. Repeat the process in the other eye if your doctor has prescribed drops in both eyes. If you are using more than one drop in the same eye, repeat the process with about 5 minutes between drops.

To apply the ointment:

  • Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. Repeat the process in the other eye if your doctor has prescribed ointment in both eyes.

If you are applying another eye medication, allow at least 10 minutes before your next application.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Do not use any eyedrop that is discolored or has particles in it.

Store neomycin and dexamethasone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

Side Effects Centers
  • Neodecadron

Patient Detailed Avoid Taking

What happens if I miss a dose ?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose ?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using neomycin and dexamethasone ophthalmic ?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Neomycin and dexamethasone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

What other drugs will affect neomycin and dexamethasone ophthalmic ?

Avoid other eye medications unless they are approved by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with neomycin and dexamethasone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about neomycin and dexamethasone ophthalmic written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 3.03. Revision date: 12/15/2010.

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