Normosol-M and Dextrose

Dosage Form: injection, solution
NORMOSOLTM-M and 5% DEXTROSE Injection

MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP

Flexible Plastic Container

Rx Only

Normosol-M and Dextrose Description

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic, hypertonic solution of balanced maintenance electrolytes and 5% dextrose injection in water for injection.

The solution is administered by intravenous infusion for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories.

Each 100 mL contains dextrose, hydrous 5 g, sodium chloride, 234 mg, potassium acetate, 128 mg and magnesium acetate, anhydrous 21 mg. May contain hydrochloric acid for pH adjustment. The electrolyte content (not including hydrochloric acid) and other characteristics are as follows:

Sodium (Na+)	40 mEq/liter
Potassium (K+)	13 mEq/liter
Magnesium (Mg++)	3 mEq/liter
Chloride (Cl−)	40 mEq/liter
Bicarbonate (HCO3−) as acetate	16 mEq/liter
Caloric value (dextrose)	170 Calories/liter
Tonicity	Hypertonic
Osmolarity	363 mOsmol/liter (calc.)
pH (range)	5.0 (4.0 to 6.5)

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.

Normosol-M and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient replenisher.

Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Potassium Acetate, USP is chemically designated CH3COOK, colorless crystals or white crystalline powder very soluble in water.

Magnesium acetate is chemically designated Mg (C2H3O2)2, colorless or white crystals very soluble in water.

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

——————————————————————

™Normosol −−multiple electrolyte solutions, Hospira.

Normosol-M and Dextrose - Clinical Pharmacology

When administered intravenously, Normosol-M and 5% Dextrose Injection provides water and electrolytes (with dextrose as a readily available source of carbohydrate) for maintenance of daily fluid and electrolyte requirements, plus minimal carbohydrate calories. The electrolyte composition approaches that of the principal ions of normal plasma (extracellular fluid). The electrolyte concentration is hypotonic (112 mOsmol/liter) in relation to the extracellular fluid (280 mOsmol/liter). One liter provides approximately one-third of the average adult daily requirement for water and principal electrolytes in balanced proportions, with acetate as a bicarbonate alternate, plus 170 calories from dextrose.

Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and supply calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide in water.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl−) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl−) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output.

Potassium acetate in water dissociates to provide potassium (K+) and acetate (CH3COO−) ions. Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter) in a healthy adult and child over 10 days old; 3.5 to 6.0 mEq/liter in a child less than 10 days old. Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion.

Magnesium acetate in water dissociates to provide magnesium (Mg++) and acetate (CH3COO−) ions. Magnesium is the second most plentiful cation of the intracellular fluids. It is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. Normal plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq per liter. Magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration.

Acetate anion (CH3COO−), a source of hydrogen ion acceptors, serves as an alternate source of bicarbonate (HCO3−) by metabolic conversion in the liver. This has been shown to proceed readily even in the presence of severe liver disease. Thus, acetate anion exerts a mild systemic antiacidotic action that may be advantageous during fluid and electrolyte replacement therapy.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Average normal pediatric daily requirements are based on the child’s weight as described in the table below:

Weight	Fluid Requirements
Up to 10 kg	100 mL/kg
11 to 20 kg	1,000 mL + 50 mL/kg for each kg above 10 kg
Above 20 kg	1,500 mL + 20 mL/kg for each kg above 20 kg

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications and Usage for Normosol-M and Dextrose

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. Magnesium in the formula may help to prevent iatrogenic magnesium deficiency in patients receiving prolonged parenteral therapy.

Contraindications

None known.

Warnings

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.

Administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Precautions

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

Solutions containing acetate should be used with caution, as excess administration may result in metabolic alkalosis.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Normosol-M and 5% Dextrose Injection. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.

Pediatric Use.

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates and very small infants the volume of fluid may affect fluid and electrolyte balance.

Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdosage

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

Normosol-M and Dextrose Dosage and Administration

Normosol-M and 5% Dextrose Injection is administered by intravenous infusion. The dose is dependent upon the age, weight and clinical condition of the patient. A daily total amount of 1500 mL/M2of body surface will meet the usual adult daily requirements for water and principal electrolytes in patients unable to take anything by mouth. The usual daily maintenance amount for an average adult (70 kg and 1.8 square meters of body surface) is approximately three liters.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

To avoid precipitation of calcium salts that may occur when certain drugs are added, Normosol-M and 5% Dextrose Injection does not contain calcium.

Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

INSTRUCTIONS FOR USE

To Open

Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

If supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication

1. 
   

   Prepare additive port.

   
   


2. 
   

   Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.

   
   


3. 
   

   The additive port may be protected by covering with an additive cap.

   
   


4. 
   

   Mix container contents thoroughly.

   
   

To Administer

1. 
   

   Attach administration set per manufacturer’s instructions.

   
   


2. 
   

   Regulate rate of administration per institutional policy.

   
   

WARNING: Do not use flexible container in series connections.

How is Normosol-M and Dextrose Supplied

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in single-dose flexible plastic containers.

NDC No.	Product	Container Size (mL)
0409-7965-03	Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP)	500
0409-7965-09	Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP)	1000

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Revised: August, 2009

EN-2220

Printed in USA

Hospira, Inc., Lake Forest, IL 60045 USA

 

[PACKAGE LABEL.PRINCIPAL DISPLAY PANEL]

IM-0918

Normosol-M and Dextrose  dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7965 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (DEXTROSE) DEXTROSE MONOHYDRATE 5 g  in 100 mL SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 234 mg  in 100 mL POTASSIUM ACETATE (POTASSIUM CATION) POTASSIUM ACETATE 128 mg  in 100 mL MAGNESIUM ACETATE (MAGNESIUM CATION) MAGNESIUM ACETATE 21 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-7965-03 24 POUCH In 1 CASE contains a POUCH 1 1 BAG In 1 POUCH This package is contained within the CASE (0409-7965-03) and contains a BAG 1 500 mL In 1 BAG This package is contained within a POUCH and a CASE (0409-7965-03) 2 0409-7965-09 12 POUCH In 1 CASE contains a POUCH 2 1 BAG In 1 POUCH This package is contained within the CASE (0409-7965-09) and contains a BAG 2 1000 mL In 1 BAG This package is contained within a POUCH and a CASE (0409-7965-09)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA017610	09/06/2011

Labeler - Hospira, Inc. (141588017)

Revised: 09/2011Hospira, Inc.

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Cortisporin

Dosage Form: ophthalmic ointment

Description

Cortisporin® Ophthalmic Ointment (neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ophthalmic ointment) is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units, hydrocortisone 10 mg (1%), and white petrolatum, q.s.

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

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

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula is:

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

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 appropriate 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: The anti-infective components in Cortisporin Ophthalmic Ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens (see INDICATIONS AND USAGE).

Indications and Usage

Cortisporin Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial 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 CLINICAL PHARMACOLOGY: Microbiology).

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus , streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacterspecies, Neisseria species, and Pseudomonas aeruginosa.

The product does not provide adequate coverage against Serratia marcescens.

Contraindications

Cortisporin Ophthalmic Ointment 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.

Cortisporin Ophthalmic Ointment 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.

Warnings

NOT FOR INJECTION INTO THE EYE. Cortisporin Ophthalmic Ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.

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 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 the 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. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

Precautions

General

The initial prescription and renewal of the medication order beyond 8 grams 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 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 PRECAUTIONS: Information for Patients).

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.

Information for Patients

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.

Patients should also be instructed that ocular products, 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 products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentrations (80 µg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size, or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet. Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Corticosteroids have been found to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women. Cortisporin Ophthalmic Ointment 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 Cortisporin Ophthalmic Ointment, 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 children have not been established.

Adverse Reactions

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 WARNINGS). 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: The development of the 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.

Local irritation on installation has been reported.

Dosage and Administration

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

How Supplied

Tube of 1/8 oz. (3.5 g) with ophthalmic tip (NDC 61570-035-35).

Rx only.

Store at 15° to 25°C (59° to 77°F).

Rev. 9/98

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: Draxis Pharma, Inc., Kirkland, Quebec H9H 4J4

Cortisporin  neomycin sulfate, polymyxin b sulfate, bacitracin zinc and hydrocortisone  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61570-035 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength neomycin sulfate (neomycin) Active 3.5 MILLIGRAM  In 1 GRAM polymyxin B sulfate (polymyxin B) Active 10000 UNITS  In 1 GRAM bacitracin zinc (bacitracin) Active 400 UNITS  In 1 GRAM hydrocortisone (hydrocortisone) Active 10 MILLIGRAM  In 1 GRAM petrolatum Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61570-035-35 3.5 g (GRAM) In 1 TUBE None

Revised: 10/2006Monarch Pharmaceuticals, Inc.

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• Conjunctivitis, Bacterial
• Uveitis

Serzone

Generic Name: nefazodone (Oral route)

ne-FAZ-oh-done

Oral route(Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients. Cases of life-threatening hepatic failure have been reported. Treatment should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. Patients should be advised to be alert for signs and symptoms of liver dysfunction and to report them to their doctor immediately if they occur. Patients who develop evidence of hepatocellular injury should be withdrawn from the drug .

Commonly used brand name(s)

In the U.S.

• Serzone

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin/Norepinephrine Reuptake Inhibitor

Chemical Class: Phenylpiperazine

Uses For Serzone

Nefazodone is used to treat mental depression.

This medicine is available only with your doctor's prescription.

Before Using Serzone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on nefazodone have been done only in adult patients, and there is no specific information comparing use of this medicine in children up to 18 years of age with use in other age groups.

Nefazodone must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure nefazodone is safe and effective in children.

Geriatric

The relationship of age to the effects of nefazodone has not been systematically studied in older people. However, blood levels of nefazodone have been found to be higher in older patients. An older adult may require a lower dose of nefazodone than a younger adult.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole


• Carbamazepine


• Cisapride


• Colchicine


• Dihydroergotamine


• Dronedarone


• Eplerenone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Furazolidone


• Isocarboxazid


• Linezolid


• Methylergonovine


• Metoclopramide


• Phenelzine


• Pimozide


• Ranolazine


• Silodosin


• Simvastatin


• Terfenadine


• Tolvaptan


• Triazolam

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Abiraterone


• Aceclofenac


• Acemetacin


• Alclofenac


• Almotriptan


• Amitriptyline


• Apazone


• Aprepitant


• Aspirin


• Atorvastatin


• Benoxaprofen


• Brentuximab Vedotin


• Bromfenac


• Bufexamac


• Cabazitaxel


• Carprofen


• Cilostazol


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• Flurbiprofen


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• Venlafaxine


• Vilazodone


• Zolmitriptan


• Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam


• Buspirone


• Clozapine


• Cyclosporine


• Digoxin


• Foxglove


• Ginkgo


• Haloperidol


• Methylprednisolone


• Pravastatin


• Ritonavir


• St John's Wort


• Trazodone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Convulsions (seizures) (history of)—The risk of seizures may be increased

• Dehydration or


• Hypovolemia (low blood volume)—May increase the chance that low blood pressure (hypotension) will occur

• Heart disease or


• Stroke (or history of)—Nefazodone may make these conditions worse by causing low blood pressure (hypotension)

• Liver function problems—If your liver does not function well, due to liver problems or liver disease and you take nefazodone, the amount of nefazodone in your blood may be too high. This may cause serious disease or damage in your liver.

• Liver function problems when taking this medicine before and you had to stop taking it—You may have a greater chance of having liver problems if you take nefazodone again. Tell your doctor immediately if you have taken this medicine before.

• Mania (a type of mental illness) (history of)—Nefazodone may cause this problem to recur

Proper Use of Serzone

Take this medicine only as directed by your doctor. Do not take more or less of it and do not take it more or less often than your doctor ordered.

Sometimes this medicine must be taken for several weeks before you begin to feel better.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For mental depression:
    
    • Adults (18 years of age and older)—To start, 200 milligrams (mg) a day, divided into two doses. Your doctor may increase the dose if needed.
    
    
    • Older adults—To start, 100 mg a day, divided into two doses. Your doctor may increase the dose if needed.
    
    
    • Children up to 18 years of age—Use and dose must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Serzone

It is important that your doctor check your progress at regular visits to allow dosage adjustments and to help reduce side effects.

Do not take astemizole, cisapride, pimozide, or terfenadine while you are taking nefazodone. If you do, you may develop a very serious change in the rhythm of your heartbeat.

Do not take carbamazepine while you are taking nefazodone. It may cause the medicine to not work or to not work as well.

This medicine may cause serious problems with your liver. Call your doctor right away for any of the following problems. Abdominal pain, nausea, vomiting, yellow eyes or skin, dark colored urine, light-colored stools, feeling very tired or weak

Do not take a monoamine oxidase (MAO) inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine) while you are taking or less than 7 days after taking nefazodone. Do not take nefazodone less than 14 days after taking an MAO inhibitor. If you do, you may develop convulsions (seizures), extremely high fever, or other serious unwanted effects.

Nefazodone may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become dizzy or drowsy, or to have blurred vision or other vision changes. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert and able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth feels dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Serzone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Blurred vision or other changes in vision


• clumsiness or unsteadiness


• lightheadedness or fainting


• ringing in the ears


• skin rash or itching

Less common

• Bladder pain


• bloody or cloudy


• cough or hoarseness


• diarrhea


• excessive muscle tone


• eye pain


• feeling dizzy


• frequent urge to urinate


• itching of the vagina or genital area


• muscle stiffness


• muscle tension or tightness


• nausea


• pain during sexual intercourse


• painful, burning, or difficult urination


• shortness of breath, tightness in chest, or wheezing


• stomach pain


• thick, white vaginal discharge with no odor or with a mild odor


• troubled breathing

Rare

• Asthma


• bleeding from the rectum


• bloody or black, tarry stools


• change in sexual desire or performance


• chest pain


• double vision


• dryness of eye


• ear pain


• fainting


• fast heartbeat


• fever, chills, or sore throat


• hallucinations (seeing, hearing, or feeling things that are not there)


• hives


• increased sense of hearing


• increased sensitivity to sun


• irritation or soreness of mouth


• joint or muscle pain or stiffness


• kidney stones


• large pupils of eyes


• lower back, side, or stomach pain


• menstrual changes


• mood or mental changes


• nerve pain or twitching


• pelvic pain


• problems in speaking


• problems with urination


• prolonged, painful, inappropriate penile erection


• red or irritated eyes


• sensitivity of eyes to light


• swelling of face


• swollen glands


• talking, feeling, and acting with excitement and activity you cannot control


• unusual bleeding or bruising


• unusual feeling of well-being


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds

Incidence not known

• Blistering, peeling, or loosening of skin


• light-colored stools


• confusion


• dark urine


• decreased urine output


• fever


• increased thirst


• itching


• lack of appetite


• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• muscle pain or cramps


• muscle spasm or jerking of all extremities


• muscle stiffness


• pain, warmth, or burning in fingers, toes, and legs


• red skin lesions, often with a purple center


• sore throat


• sudden loss of consciousness


• sweating


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal dreams


• agitation


• confusion


• constipation


• diarrhea


• dizziness


• drowsiness


• dryness of mouth


• flushing or feeling of warmth


• headache


• heartburn


• increased appetite


• increased cough


• memory problems


• nausea


• swelling of arms or legs


• tingling, burning, or prickly sensations


• tremor


• trouble in sleeping


• vomiting

Less common or rare

• Breast pain


• generalized slowing of mental and physical activity


• increased thirst


• loss of strength or energy


• muscle weakness

Incidence not known

• Unexpected or excess milk flow from breasts


• swelling of the breasts or breast soreness in males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Serzone side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Serzone resources

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

• Serzone Consumer Overview


• Serzone Prescribing Information (FDA)


• Nefazodone Prescribing Information (FDA)


• Nefazodone MedFacts Consumer Leaflet (Wolters Kluwer)


• Nefazodone Hydrochloride Monograph (AHFS DI)

Compare Serzone with other medications

• Anxiety
• Depression
• Panic Disorder

Natrecor

Generic Name: nesiritide (Intravenous route)

ne-SIR-i-tide

Commonly used brand name(s)

In the U.S.

• Natrecor

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Natriuretic Peptide

Uses For Natrecor

Nesiritide is used for patients who have severe congestive heart failure that has recently become worse. Nesiritide is for patients who are short of breath while at rest or with minimal activity.

Before Using Natrecor

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of nesiritide in children with use in other age groups.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Benazepril


• Captopril


• Cilazapril


• Enalapril Maleate


• Fosinopril


• Lisinopril


• Quinapril


• Ramipril


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease (other than congestive heart failure)—Nesiritide may make heart problems worse.

• Low blood pressure—Nesiritide may make this condition worse.

Proper Use of Natrecor

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For congestive heart failure:
    
    • Adults—Dose is based on your weight and must be determined by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Natrecor Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Low blood pressure

Less common

• Bluish lips or skin


• chest pain, tightness, or discomfort


• cool, clammy skin


• difficulty in breathing or shortness of breath


• dizziness


• fainting


• lightheadedness


• fast, slow, or irregular heartbeat


• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Less common

• Abdominal or stomach pain


• anxiety


• back pain


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings on the skin


• change in vision


• confusion


• coughing or spitting up blood


• fever


• increased cough


• itching skin


• leg cramps


• nausea


• pain or irritation at the injection site


• pale skin, unusual bleeding or bruising


• rash


• sleepiness or unusual drowsiness


• sleeplessness


• sweating


• trembling or shakiness


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Natrecor side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Natrecor resources

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

• Natrecor Prescribing Information (FDA)


• Natrecor Consumer Overview


• Natrecor Monograph (AHFS DI)


• Natrecor MedFacts Consumer Leaflet (Wolters Kluwer)


• Nesiritide Professional Patient Advice (Wolters Kluwer)

Compare Natrecor with other medications

• Heart Failure

Vibra-Tabs

Pronunciation: DOX-i-SYE-kleen HYE-klate
Generic Name: Doxycycline Hyclate
Brand Name: Examples include Vibra-Tabs and Vibramycin

Vibra-Tabs is used for:

Treating certain bacterial infections. It may be used in combination with other medicines to treat acne or certain amoeba infections. It may be used to prevent certain types of malaria in travelers who will be visiting malaria-infected areas for less than 4 months. It may also be used to prevent or slow the progression of anthrax after exposure.

Vibra-Tabs is a tetracycline antibiotic. It works by slowing the growth of bacteria. Slowing the bacteria's growth allows the body's immune system to destroy the bacteria.

Do NOT use Vibra-Tabs if:

• you are allergic to any ingredient in Vibra-Tabs or to another tetracycline (eg, minocycline)


• you are taking acitretin, isotretinoin, or a penicillin (eg, amoxicillin)


• you have recently received or will be receiving a live oral typhoid vaccine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vibra-Tabs:

Some medical conditions may interact with Vibra-Tabs. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diarrhea, a history of lupus, or the blood disease porphyria

Some MEDICINES MAY INTERACT with Vibra-Tabs. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), iron, or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Vibra-Tabs's effectiveness


• Acitretin, anticoagulants (eg, warfarin), digoxin, isotretinoin, methotrexate, or methoxyflurane because the side effects and toxic effects may be increased by Vibra-Tabs


• Live oral typhoid vaccine, hormonal birth control (eg, birth control pills), or penicillins (eg, amoxicillin) because their effectiveness may be decreased by Vibra-Tabs

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vibra-Tabs may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vibra-Tabs:

Use Vibra-Tabs as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Vibra-Tabs by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Do not take an antacid that has aluminum, calcium, or magnesium in it; bismuth-containing products; iron; urinary alkalinizers (eg, sodium bicarbonate); or multivitamins with minerals within 2 hours before or 2 hours after you take Vibra-Tabs.


• To clear up your infection completely, take Vibra-Tabs for the full course of treatment. Keep taking it even if you feel better in a few days.


• Drink plenty of fluids with Vibra-Tabs to wash it down and avoid the risk of throat irritation.


• Do not use Vibra-Tabs if it is outdated or has been stored incorrectly.


• If you are taking Vibra-Tabs to prevent malaria, you should begin to take it 1 to 2 days before you travel to the malaria-infected area. You will need to keep taking it for 4 weeks after you leave the area. Discuss any questions with your doctor.


• If you miss a dose of Vibra-Tabs, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Vibra-Tabs.

Important safety information:

• Be sure to use Vibra-Tabs for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Vibra-Tabs only works against bacteria; it does not treat viral infections (eg, the common cold).


• Long-term or repeated use of Vibra-Tabs may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• If you are taking Vibra-Tabs to prevent malaria, please note that no malaria medicine, including Vibra-Tabs, guarantees protection against malaria. Stay in well-screened areas, use mosquito nets, cover the body with clothing, and use insect repellent to avoid being bitten by mosquitoes.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Vibra-Tabs. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Vibra-Tabs may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Vibra-Tabs. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or blood stools occur. Do not treat diarrhea without first checking with your doctor.


• Do not take more than the recommended dose or take Vibra-Tabs for longer than prescribed without checking with your doctor.


• Tell your doctor or dentist that you take Vibra-Tabs before you receive any medical or dental care, emergency care, or surgery.


• Vibra-Tabs may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Vibra-Tabs.


• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Vibra-Tabs. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Vibra-Tabs with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• Vibra-Tabs should not be used in CHILDREN younger than 8 years old; permanent yellow-gray-brown tooth discoloration may occur.


• PREGNANCY and BREAST-FEEDING: Vibra-Tabs has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vibra-Tabs while you are pregnant. Vibra-Tabs is found in breast milk. Do not breast-feed while taking Vibra-Tabs.

Possible side effects of Vibra-Tabs:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Loss of appetite; nausea; sensitivity to sunlight; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; chest pain; dark urine; decreased urination; fever, chills, or sore throat; moderate to severe sunburn; red, swollen, blistered, or peeling skin; severe diarrhea; severe or persistent headache; stomach pain or cramps; throat irritation; trouble swallowing; unusual bruising or bleeding; unusual joint pain; unusual tiredness; vaginal irritation or discharge; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Vibra-Tabs side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Vibra-Tabs:

Store Vibra-Tabs at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vibra-Tabs out of the reach of children and away from pets.

General information:

• If you have any questions about Vibra-Tabs, please talk with your doctor, pharmacist, or other health care provider.


• Vibra-Tabs is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vibra-Tabs. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Vibra-Tabs resources

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

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Proscar

Pronunciation: fin-AS-ter-ide
Generic Name: Finasteride
Brand Name: Proscar

Proscar is used for:

Treating urinary problems caused by an enlarged prostate gland (benign prostatic hyperplasia [BPH]). It is also used to lower the risk of needing surgery to treat BPH. It may be used with another medicine (doxazosin) to lower the risk of worsening BPH. It may also be used for other conditions as determined by your doctor.

Proscar is a type of steroid reductase inhibitor. It works by reducing the amount of the hormone dihydrotestosterone (DHT) in the body. This makes the prostate gland smaller, which helps to relieve urinary problems.

Do NOT use Proscar if:

• you are allergic to any ingredient in Proscar


• you are or may be pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Proscar:

Some medical conditions may interact with Proscar. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have narrowing or a blockage in the urinary tract, prostate cancer, nerve or muscle problems of the bladder, a bladder infection, severe trouble urinating, or if you are unable to urinate


• if you have a history of increased serum prostate-specific antigen (PSA) levels, abnormal liver function tests, or liver problems

Some MEDICINES MAY INTERACT with Proscar. However, no specific interactions with Proscar are known at this time.

Ask your health care provider if Proscar may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Proscar:

Use Proscar as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Proscar. Talk to your pharmacist if you have questions about this information.


• Take Proscar by mouth with or without food.


• Continue to take Proscar even if you feel well. Do not miss any doses.


• Taking Proscar at the same time each day will help you remember to take it.


• If you miss a dose of Proscar, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Proscar.

Important safety information:

• Proscar may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Proscar with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Proscar may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Proscar may increase the risk of certain birth defects, including abnormal formation of genitalia in male fetuses. Proscar is coated to prevent contact with finasteride while handling undamaged tablets. The coating is not effective if the tablets are damaged, broken, or crushed. Women who are pregnant or may be pregnant should avoid contact with damaged, broken, or crushed tablets. If contact occurs, tell your doctor at once.


• Proscar may increase the risk of a certain type of prostate cancer. Discuss any questions or concerns with your doctor.


• Rarely, there have been cases of male breast cancer reported in patients taking Proscar. Discuss any questions or concerns with your doctor. Tell your doctor right away if you develop breast changes, such as lumps, pain, or nipple discharge.


• Do not donate blood while you take Proscar and for at least 1 month after your last dose of Proscar to prevent exposure through a blood transfusion to a pregnant woman.


• Proscar may interfere with certain lab tests, including PSA tests. Be sure your doctor and lab personnel know you are taking Proscar.


• Proscar should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY AND BREAST-FEEDING: Proscar may cause harm to the fetus. It is not known if Proscar is found in breast milk. Proscar is not approved for use in women.

Possible side effects of Proscar:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased sexual desire or ability.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement, lumps, pain, or tenderness; depression; nipple discharge; testicular pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Proscar side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Proscar:

Store Proscar at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Proscar out of the reach of children and away from pets.

General information:

• If you have any questions about Proscar, please talk with your doctor, pharmacist, or other health care provider.


• Proscar is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Proscar. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Proscar resources

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

• Proscar Prescribing Information (FDA)


• Proscar Advanced Consumer (Micromedex) - Includes Dosage Information


• Proscar Consumer Overview


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• Finasteride Monograph (AHFS DI)


• Finasteride Professional Patient Advice (Wolters Kluwer)


• Propecia Consumer Overview


• Propecia Prescribing Information (FDA)

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• Benign Prostatic Hyperplasia