Sildec-PE DM Drops

Generic Name: chlorpheniramine, dextromethorphan, and phenylephrine (klor feh NEER a meen, dex troe meh THOR fan, and feh nill EH frin)

Brand Names: Alka-Seltzer Plus Cold and Cough, C-Phen DM, C-Phen DM Drops, Cardec DM, Cardec DM Drops, Ceron-DM, Ceron-DM Drops, Cerose DM, Corfen-DM, CP Dec DM, CP Dec-DM Drops, De-Chlor DM, De-Chlor DR, Dec-Chlorphen DM, Dex PC, DM-PE-Chlor, Donatussin DM Drops, Ed A-Hist DM, HistadecDM, Maxiphen ADT, Mintuss DR, Nasohist-DM, Neo DM Drops, Nohist-DMX, Norel DM, P Chlor DM, PD-Cof, PD-Cof Drops, Poly-Tussin DM, Quartuss DM, Reme Tussin DM, Rondec-DM, Rondec-DM Drops, Rondex-DM, Rondex-DM Drops, Sildec-PE DM, Sildec-PE DM Drops, Tri-Vent DPC, Trital DM, Tussplex DM, Zotex-12D

What is Sildec-PE DM Drops (chlorpheniramine, dextromethorphan, and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Chlorpheniramine, dextromethorphan, and phenylephrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlorpheniramine, dextromethorphan, and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sildec-PE DM Drops (chlorpheniramine, dextromethorphan, and phenylephrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. Chlorpheniramine, dextromethorphan, and phenylephrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking Sildec-PE DM Drops (chlorpheniramine, dextromethorphan, and phenylephrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to chlorpheniramine, dextromethorphan, or phenylephrine, or if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  a stomach ulcer or a stomach obstruction,

  
  


• 
  

  emphysema or chronic bronchitis; or

  
  


• 
  

  an enlarged prostate or urination problems.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chlorpheniramine, dextromethorphan, and phenylephrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cough-and-cold medications may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Sildec-PE DM Drops (chlorpheniramine, dextromethorphan, and phenylephrine)?

Use this medication exactly as directed on the label or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. If you use the effervescent tablet, drop the tablet in 8 ounces of water and allow it to dissolve completely. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Take this medicine with food or milk if it upsets your stomach.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Sildec-PE DM Drops (chlorpheniramine, dextromethorphan, and phenylephrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication. Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Sildec-PE DM Drops (chlorpheniramine, dextromethorphan, and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  
  


• 
  

  confusion, hallucinations;

  
  


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  slow, shallow breathing;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


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  mild loss of appetite, stomach upset;

  
  


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  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling excited or restless;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  restless or excitability (especially in children);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration; or

  
  


• 
  

  ringing in your ears.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sildec-PE DM Drops (chlorpheniramine, dextromethorphan, and phenylephrine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  an antidepressant;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  quinidine (Quinaglute, Quinidex);

  
  


• 
  

  ranolazine (Ranexa)

  
  


• 
  

  ritonavir (Norvir);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol); or

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.

  
  

This list is not complete and there may be other drugs that can interact with chlorpheniramine, dextromethorphan, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Sildec-PE DM Drops resources

• Sildec-PE DM Drops Side Effects (in more detail)
• Sildec-PE DM Drops Use in Pregnancy & Breastfeeding
• Sildec-PE DM Drops Drug Interactions
• Sildec-PE DM Drops Support Group
• 0 Reviews for Sildec-PE DM - Add your own review/rating

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• Maxiphen ADT MedFacts Consumer Leaflet (Wolters Kluwer)


• Quartuss DM Prescribing Information (FDA)


• Trital DM Prescribing Information (FDA)

Compare Sildec-PE DM Drops with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine, dextromethorphan, and phenylephrine.

See also: Sildec-PE DM side effects (in more detail)

Adrenal cortical steroids

Adrenal cortical steroids or corticosteroids are hormones synthesized by the adrenal cortex. There are two types of corticosteroids, glucocorticoids and mineralocorticoids.

Glucocorticoids e.g. cortisol and cortisone, are essential for the utilization of carbohydrate, fat and protein by the body and for normal response to stress. Naturally occurring and synthetic glucocorticoids have very powerful anti-inflammatory effects and are used to treat conditions that involve inflammation. They also decrease the body

See also

• corticotropin
• glucocorticoids
• mineralocorticoids

Drug List:

Cherry flavour Ultra Chloraseptic Anaesthetic Throat Spray 0.71% w / v

1. Name Of The Medicinal Product

Throatzone Sore Throat Spray

Cherry Flavour Ultra Chloraseptic Anaesthetic Throat Spray

2. Qualitative And Quantitative Composition

Benzocaine          0.71 % w/v

For full list of excipients, see 6.1

3. Pharmaceutical Form

Oromucosal Spray

Direct application to throat by spraying.

Clear, colourless to straw coloured liquid

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of sore throat pain.

4.2 Posology And Method Of Administration

Posology

Adults and children 13 years and over: Administer 3 sprays (3mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day.

Children 6-12 years: Use only under adult supervision. Administer 1 spray (1mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day

This product is contraindicated in children under 6 years.

Method of administration: oromucosal

Hold breath and spray to the back of the throat.

Do not use in a child who is unable to hold their breath whilst spraying.

Before first use, or after prolonged storage, activate the pump by spraying 3 times away from the face into the sink.

4.3 Contraindications

Children under 6 years.

Epiglottitis

Known hypersensitivity to benzocaine or any of the other ingredients.

Methaemoglobinaemia

4.4 Special Warnings And Precautions For Use

Do not administer to children under 6 years.

Do not use for more than 3 consecutive days.

Do not spray into eyes.

If sore throat is severe or persistent, or accompanied by fever, headache or nausea consult your doctor.

You should experience temporary numbness in your throat after using the spray. This indicates that the product is working. Avoid eating or drinking as long as the numbness lasts.

Labelling will include the following information:

Do not use if you have any difficulty in breathing, noisy breathing or severe difficulty in swallowing.

Do not use if you have been told that you have a rare blood condition called methaemoglobinaemia.

Contains propylene glycol which may cause skin irritation.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

Animal studies are insufficient with respect to effects on pregnancy and lactation. The potential risk for humans is unknown. Therefore Ultra Chloraseptic spray is not recommended during pregnancy or breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None expected

4.8 Undesirable Effects

Allergic reactions have been reported very occasionally with benzocaine. There have been occasional reports of temporary breathing difficulty, face or mouth swelling.

Methaemoglobinaemia has been reported with benzocaine use.

4.9 Overdose

Pronounced reversible anaesthesia would be observed. No systemic adverse effects are expected due to the poor systemic absorption and low administered dose of benzocaine.

Treatment of overdose

N/A

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: R02AD01

Benzocaine is a local anaesthetic of the ester type. The mode of action is a reversible inhibition of the flux of sodium and potassium ions through the axonal membranes of peripheral pain receptors. As a consequence, the depolarisation and propagation of nerve impulses are inhibited.

The onset of action of benzocaine on mucous membranes is rapid due to the spray delivery of the anaesthetic direct to the site of action, rapid absorption, and the surface analgesic effect. The local anaesthesia induced by benzocaine is temporary but Ultra Chloraseptic spray has not been tested for duration of action.

5.2 Pharmacokinetic Properties

Benzocaine is absorbed into the mucosal membranes. After systemic absorption, which is negligible, the drug is thought to be metabolised to ethanol and aminobenzoic acid by plasma esterases. Aminobenzoic acid is excreted unchanged or conjugated with glycerine to amoniohippuric acid in the liver, the metabolites and unchanged benzocaine are excreted in the urine.

5.3 Preclinical Safety Data

No animal data are available on Ultra Chloraseptic spray. Non-clinical studies on benzocaine showed local irritation and sensation, and methaemoglobinaemia at high doses in some species.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol

Macrogol 300

Propylene glycol

Glycerol

Cetylpyridinium chloride

Levomenthol

Saccharin sodium

Cherry Flavouring

Creamfeel flavouring

Sodium dihydrogen phosphate dihydrate

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

No data held

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions

6.5 Nature And Contents Of Container

Uncoloured, clear or textured Type III glass bottle, containing 15ml of product with a polypropylene/low density polyethylene pump and polypropylene cap.

Or

Amber, clear Type III glass bottle, containing 15ml of product with a polypropylene/polyethylene pump.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Prestige Brands (UK) Limited

Beechwood, 3 Scotlands Drive, Farnham Common

Slough, Berkshire, SL2 3ES

United Kingdom

8. Marketing Authorisation Number(S)

PL 18259/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

11/12/2008

10. Date Of Revision Of The Text

24^th October 2010

11 DOSIMETRY (IF APPLICABLE)

Not applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not applicable

Recent History:

24^th October 2010 – 16 – User Test. Sections 4.4, 6.2.

5^th May 2010 – 0028 - Type IB Az Group – Sections 2, 3, 4.2, 5.1, 6.4

30^th Dec 2009 – 0024 - Type IB 29a textured bottle – Section 6.5

Econopred

prednisolone acetate

Dosage Form: ophthalmic suspension

DESCRIPTION

Econopred® and Econopred® Plus (Prednisolone Acetate) are adrenocortical steroid products prepared as sterile ophthalmic suspensions. The active ingredient is represented by the chemical structure:

Each mL contains: Active: Prednisolone Acetate 1.0% or 0.125%. Preservative: Benzalkonium Chloride 0.01%. Vehicle: Hydroxypropyl Methylcellulose. Inactive: Dibasic Sodium Phosphate, Polysorbate 80, Edetate Disodium, Glycerin, Citric Acid and/or Sodium Hydroxide (to adjust pH), Purified Water. DM-02, DM-03

CLINICAL PHARMACOLOGY

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Corticosteroids are capable of producing a rise in intraocular pressure.

INDICATIONS AND USAGE

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

CONTRAINDICATIONS

Econopred and Econopred Plus are 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. Econopred and Econopred Plus are also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

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. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids 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; frequent slit lamp microscopy is recommended.

Corticosteroids are not effective in mustard gas keratitis and Sjögren’s keratoconjunctivitis.

PRECAUTIONS

General

The initial prescription and renewal of the medication order 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.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

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

Information for Patients

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the potential of these effects.

Pregnancy

Teratogenic effects.

Pregnancy Category C. Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate and well controlled studies in pregnant women. Econopred® and Econopred® Plus should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 prednisolone acetate, 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.

ADVERSE REACTIONS

Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.

Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (SEE WARNINGS).

DOSAGE AND ADMINISTRATION

SHAKE WELL BEFORE USING. Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (SEE PRECAUTIONS).

The dosing of Econopred and Econopred Plus may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

HOW SUPPLIED

5mL and 10mL in plastic DROP-TAINER® dispensers.

       1/8% Econopred:                1% Econopred Plus:

5 mL       NDC 0998-0635-05    5 mL      NDC 0998-0637-05

10 mL     NDC 0998-0635-10   10 mL     NDC 0998-0637-10

STORAGE:STORE at 8° - 24°C (46° - 75°F) in an UPRIGHT position.

Rx Only

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

Printed in USA

236055-0598

Econopred  prednisolone acetate  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0998-0635 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength prednisolone acetate (prednisolone) Active 1.25 MILLIGRAM  In 1 MILLILITER benzalkonium chloride Inactive 0.1 MILLIGRAM  In 1 MILLILITER hydroxypropyl methylcellulose Inactive   dibasic sodium phosphate Inactive   polysorbate 80 Inactive   edetate disodium Inactive   glycerin Inactive   citric acid and/or sodium hydroxide Inactive   water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0998-0635-05 5 mL (MILLILITER) In 1 BOTTLE, PLASTIC None 2 0998-0635-10 10 mL (MILLILITER) In 1 BOTTLE, PLASTIC None

Econopred  prednisolone acetate  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0998-0637 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength prednisolone acetate (prednisolone) Active 10 MILLIGRAM  In 10 MILLILITER benzalkonium chloride Inactive 0.1 MILLIGRAM  In 10 MILLILITER hydroxypropyl methylcellulose Inactive   dibasic sodium phosphate Inactive   polysorbate 80 Inactive   edetate disodium Inactive   glycerin Inactive   citric acid and/or sodium hydroxide Inactive   water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0998-0637-05 5 mL (MILLILITER) In 1 BOTTLE, PLASTIC None 2 0998-0637-10 10 mL (MILLILITER) In 1 BOTTLE, PLASTIC None

Revised: 09/2006Alcon Laboratories, Inc.

More Econopred resources

• Econopred Side Effects (in more detail)
• Econopred Dosage
• Econopred Use in Pregnancy & Breastfeeding
• Econopred Drug Interactions
• Econopred Support Group
• 0 Reviews for Econopred - Add your own review/rating

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• Econopred Plus Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Prednisolone Monograph (AHFS DI)


• Prednisolone Acetate eent Monograph (AHFS DI)

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• Postoperative Ocular Inflammation