Noromectin Pour-On

Dosage Form: FOR ANIMAL USE ONLY
Noromectin®

(ivermectin)

POUR-ON for Cattle

Contains 5 mg ivermectin/mL

ANADA 200-272, Approved by FDA

Parasiticide

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

Introduction

Noromectin (ivermectin) Pour-On delivers internal and external parasite control in one convenient low-volume application.

Indications

Noromectin Pour-On applied at the recommended dose level of 500 mcg/kg is indicated for the effective control of these parasites.

Gastrointestinal Roundworms

Ostertagia ostertagi                                      (adults and L4)

(including inhibited stage)

Haemonchus placei                                     (adults and L4)

Trichostrongylus axei                                   (adults and L4)

T. colubriformis                                              (adults and L4)

Cooperia oncophora                                    (adults and L4)

Cooperia punctata                                        (adults and L4)

Cooperia surnabada                                    (adults and L4)

Strongyloides papillosus                              (adults)

Oesophagostomum radiatum                     (adults and L4)

Trichuris spp.                                                 (adults)

Lungworms

Dictyocaulus viviparous                               (adults and L4)

Cattle Grubs                                               (parasitic stages)

Hypoderma bovis

H. lineatum

Mites

Sarcoptes scabiei  var. bovis

Lice

Linognathus vituli

Haematopinus eurysternus

Damalinia bovis

Solenopotes capillatus

Horn Flies

Haematobia irritans

Persistent Activity

Noromectin Pour-On has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparus for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.

Treatment of Cattle for Horn Flies

Noromectin Pour-On controls horn flies (Haematobia irritans) for up to 28 days after dosing. For best results Noromectin Pour-On should be part of a parasite control program for both internal and external parasites based on the epidemiology of these parasites. Consult your veterinarian or an entomologist for the most effective timing of applications.

Dosage

The dose rate is 1 mL for each 22 lb of body weight. The formulation should be applied along the topline in a narrow strip extending from the withers to the tailhead.

Administration

Collapsible Pack (33.8 fl oz/1 liter pack with dispensing cap)

The dispensing cap is graduated in 5 mL increments. Each 5 mL will treat 110 lbs body weight. When body weight is between markings, use the next higher increment. Attach the dispensing cap to the bottle. Select the correct dose rate by rotating the adjuster top in either direction to position the dose indicator to the appropriate level. Hold the bottle upright and gently squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines. By releasing the pressure, the dose automatically adjusts to the correct level. Tilt the bottle to deliver the dose. The “closed-off-shut” position will close the system between dosing. If the animal being treated weighs more that 550 lbs (250 kg), refill the dispensing cap to the additional amount required to provide the total dose for that animal and apply as directed.

Collapsible Pack (84.5 fl oz/2.5 liter pack; 169 fl oz/5 liter pack with dosing gun/applicator)

Because of the solvents used in Noromectin Pour-On, the applicator gun from Simcro Tech, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage. Remove the shipping cap from the backpack container and replace with the vent cap provided. Attach the hose from the automatic dosing equipment to the outlet from the vent cap. Follow the applicator gun manufacturer's directions for priming the gun, adjusting the dose, and care of the applicator gun following use.

Container (676 fl oz/20 liter container with draw-off device and dosing gun/applicator)

Because of the solvents used in Noromectin Pour-On, the draw-off device and applicator gun from Simcro Tech, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage. Screw Feedlot pack cap and dip tube onto the 20 liter drum ensuring a tight fit. Connect the long 3m feed tube at one end to the spigot on the Feedlot pack cap and the other end to the applicator gun. Then follow the applicator gun manufacturer's directions for priming the gun, adjusting the dose, and care of the applicator gun following use.

When the interval between use of the applicator gun is expected to exceed 12 hours, disconnect the gun, draw off tubing and dip tub and cap from the product container, empty the product from the gun and tubing back into the container and replace the shipping cap.

Weight	Dose
220 lb (100 kg)	10 mL
330 lb (150 kg)	15 mL
440 lb (200 kg)	20 mL
550 lb (250 kg)	25 mL
660 lb (300 kg)	30 mL
770 lb (350 kg)	35 mL
880 lb (400 kg)	40 mL
990 lb (450 kg)	45 mL
1100 lb (500 kg)	50 mL

Mode of Action

Ivermectin is a member of the macrocylic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells.

This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand -gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocylic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

Animal Safety

Studies conducted in the U.S.A. have demonstrated the safety margin for ivermectin. Based on plasma levels, the topically applied formulation is expected to be at least as well tolerated by breeding animals as is the subcutaneous formulation which had no effect on breeding performance.

RESIDUE INFORMATION: Cattle must not be treated within 48 days of slaughter for human consumption. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

WARNING! NOT FOR USE IN HUMANS

This product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water and seek medical attention.

Keep this and all drugs out of the reach of children.

WARNING! FLAMMABLE! KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS, or for assistance call Norbrook at 1-913-599-5777.

PRECAUTIONS

Store away from excessive heat (104°F/40°C) and protect from light.

Use only in well-ventilated areas or outdoors.

Close container tightly when not in use.

Cattle should not be treated when hair or hide is wet since reduced efficacy may be experienced.

Do not use when rain is expected to wet cattle within six hours after treatment.

This product is for application to skin surface only. Do not give orally or parenterally.

Cloudiness in the formulation may occur when Noromectin (ivermectin) Pour-On is stored at temperatures below 32ཐ F. Allowing it to warm at room temperature will restore the normal appearance without affecting efficacy.

Antiparasitic activity of ivermectin will be impaired if the formulation is applied to areas of the skin with mange scabs or lesions, or with dermatoses or adherent materials, e.g. caked mud or manure.

Ivermectin has been associated with adverse reactions in sensitive dogs; therefore, Noromectin Pour-On is not recommended for use in species other than cattle.

When to Treat Cattle with Grubs

Noromectin Pour-On effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to ivermectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat: killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.

Cattle treated with Noromectin Pour-On at the end of the fly season may be re-treated with Noromectin during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

Environmental Safety

Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish or certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least six hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

Package Information

Noromectin Pour-On is available in a 33.8 fl oz/1 L collapsible pack for use with the dispensing cap provided, or in an 84.5 fl oz/2.5 L collapsible pack, in a 169 fl oz/5 L collapsible pack and a 676 fl oz/20 L container intended for use with appropriate automatic dosing equipment.

Restricted Drug - California. Use Only as Directed.

Norbrook Laboratories Limited,

Newry

Co. Down

Northern Ireland.

001670I03

Principal Display Panel – Carton Label

Noromectin®

(ivermectin)

NDC 055529 007 08

ANADA 200-272, Approved by FDA

POUR-ON for Cattle

Contains 5 mg ivermectin / mL

PARASITICIDE

Kills: Roundworms, (including Brown Stomach Worm), Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites, Horn Flies

Contains: 200 x 550 lb doses.

169 fl oz (5L)

Principal Display Panel – Container Label

Noromectin®

(ivermectin)

NDC 055529 007 08

ANADA 200-272, Approved by FDA

POUR-ON for Cattle

Contains 5 mg ivermectin / mL

WARNING! FLAMMABLE!

KEEP AWAY FROM HEAT,

SPARKS, OPEN FLAME, AND

OTHER SOURCE OF IGNITION.

WARNING!

Not for use in humans.

Parasiticide

Kills:

Roundworms, (including Brown Stomach Worm), Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites, Horn Flies

Manufactured by: Lot No. & Exp Date

Norbrook Laboratories Ltd.

Newry, Co. Down, BT35 6PU,

Northern Ireland

169 fl oz (5L)

Principal Display Panel – Container Label

Noromectin®

(ivermectin)

NDC 055529 009 09

ANADA 200-272, Approved by FDA

POUR-ON for Cattle

Contains 5 mg ivermectin / mL

WARNING! FLAMMABLE!

KEEP AWAY FROM HEAT,

SPARKS, OPEN FLAME, AND

OTHER SOURCE OF IGNITION.

WARNING!

Not for use in humans.

Parasiticide

Kills:

Roundworms, (including Brown Stomach Worm), Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites, Horn Flies

Manufactured by Lot No. & Exp Date

Norbrook Laboratories Ltd.

Newry, Co. Down, BT35 6PU,

Northern Ireland

676 fl oz (20 L)

NOROMECTIN   POUR-ON FOR CATTLE ivermectin  solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 55529-007 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength isopropyl myristate   trolamine   FD&C Blue No. 1   isopropyl alcohol

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 55529-007-06 1 CONTAINER In 1 CARTON contains a CONTAINER 1 1000 mL In 1 CONTAINER This package is contained within the CARTON (55529-007-06) 2 55529-007-07 1 CONTAINER In 1 CARTON contains a CONTAINER 2 2500 mL In 1 CONTAINER This package is contained within the CARTON (55529-007-07) 3 55529-007-08 1 CONTAINER In 1 CARTON contains a CONTAINER 3 5000 mL In 1 CONTAINER This package is contained within the CARTON (55529-007-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200272	12/01/2004

NOROMECTIN   POUR-ON FOR CATTLE ivermectin  solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 55529-009 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength isopropyl myristate   trolamine   FD&C Blue No. 1   isopropyl alcohol

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 55529-009-09 20000 mL In 1 CONTAINER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200272	12/01/2004

Labeler - Norbrook Laboratories Limited (214580029)

Establishment
Name	Address	ID/FEI	Operations
Armagh Road		232880554	MANUFACTURE, ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Carnbane Industrial Estate		211218325	MANUFACTURE

Revised: 04/2010Norbrook Laboratories Limited

Sulfamylon

Generic Name: Mafenide Acetate
Class: Local Anti-infectives, Miscellaneous
ATC Class: D06BA03
VA Class: DE101
CAS Number: 13009-99-9

Introduction

Synthetic anti-infective agent.^a

Uses for Sulfamylon

Treatment and Prevention of Burn Infections

Mafenide acetate cream is used topically as adjunctive therapy in second- and third-degree burns to prevent septicemia caused by susceptible organisms, especially Pseudomonas aeruginosa.^{a b}

Control of bacterial growth may prevent conversion of second-degree (partial-thickness) wounds to third-degree (full-thickness) wounds; however, delayed eschar separation reported.^{a b}

Although controlled, comparative studies are lacking, mafenide and silver sulfadiazine are considered by many clinicians to be among the topical anti-infective agents of choice in burn patients.^{d e g h i}

Mafenide appears to penetrate burn eschar better than silver sulfadiazine and may be more effective in minimizing the growth of bacteria and early treatment of wound sepsis.^{d i} Unlike mafenide, silver sulfadiazine does not alter acid-base balance and does not have a limited duration of therapy and area of topical application; softening action of silver sulfadiazine cream may aid in eschar removal and preparation of wound for grafting.^{d f}

Alternative therapies include wet dressings of 0.5% silver nitrate; appears to be of equal efficacy as mafenide cream; mafenide cream may cause more pain on application.^a

Mafenide acetate solution is used topically as adjunctive therapy to control bacterial infections under moist dressings over meshed autografts on excised burn wounds.^c

Sulfamylon Dosage and Administration

Administration

Topical Administration

Administer topically as a cream or solution; not for injection.^{a b c}

Cream

Apply cream only after instituting appropriate measures to control shock and pain.^{a b}

Apply to cleansed, debrided burn wounds using a sterile, gloved hand.^{a b}

Bathe patient daily, preferably in a whirlpool bath, to aid in debridement.^{a b}

Dressings generally not required; if necessary, use only a thin layer.^{a b} Some clinicians apply dressings when the eschar begins to separate (16–20 days) to expedite the separation of the eschar.^a

Solution

Apply topically as a 5% reconstituted solution.^c

Consult manufacturer's information for complete directions for use.^c

Reconstitution

Reconstitute 50-g packet of sterile mafenide acetate powder with 1 L of sterile water for irrigation or 0.9% sodium chloride irrigation by adding powder to solution in suitable container and mixing until completely dissolved.^c (See Storage under Stability.)

Dosage

Available as mafenide acetate; dosage expressed in terms of mafenide.^{a b c}

Each gram of mafenide acetate cream provides the equivalent of 85 mg of mafenide.^a

Pediatric Patients

Treatment and Prevention of Burn Infections

Topical (Cream)

Children: Apply sufficient amount to cover affected area to a thickness of 1/16th inch, once or twice daily.^{a b} Thicker application is not recommended.^{a b}

Burned areas should be covered with cream at all times.^{a b} Reapply whenever necessary if cream removed from any area.^{a b}

Continue therapy until healing is progressing well or until site is ready for grafting.^{a b} Generally, do not discontinue mafenide topical therapy while there is the possibility of infection.^{a b} (See Dosage Modification for Toxicity under Dosage and Administration.)

Topical (Solution)

Infants and children ≥3 months to 16 years of age: Inject solution into the irrigation tubing every 4 hours or irrigate dressing with a syringe every 6–8 hours; may repeat as necessary to keep dressing wet.^c

May leave wound dressings undisturbed for up to 5 days, except for irrigations.^c May initiate additional soaks until engraftment is complete.^c Maceration of skin may result from wet dressings applied for intervals as short as 24 hours.^c Continue treatment until autograft vascularization occurs and healing is progressing, usually about 5 days.^c

Adults

Treatment and Prevention of Burn Infections

Topical (Cream)

Apply sufficient amount to cover affected area to a thickness of 1/16th inch, once or twice daily.^{a b} Thicker application is not recommended.^{a b}

Burned areas should be covered with cream at all times.^{a b} Reapply whenever necessary if cream removed from any area.^{a b}

Continue therapy until healing is progressing well or until site is ready for grafting.^{a b} Generally, do not discontinue mafenide topical therapy while there is the possibility of infection.^{a b} (See Dosage Modification for Toxicity under Dosage and Administration.)

Topical (Solution)

Inject solution into the irrigation tubing every 4 hours or irrigate dressing with a syringe every 6–8 hours; may repeat as necessary to keep dressing wet.^c

May leave wound dressings undisturbed for up to 5 days, except for irrigations.^c May initiate additional soaks until engraftment is complete.^c Maceration of skin may result from wet dressings applied for intervals as short as 24 hours.^c Continue treatment until autograft vascularization occurs and healing is progressing, usually about 5 days.^c

Dosage Modification for Toxicity

Topical (Cream, Solution

Allergic manifestations: Consider mafenide discontinuance if hypersensitivity reactions occur.^{a b c} (See Sensitivity Reactions under Cautions.)

Systemic acidosis: If systemic acidosis occurs and is difficult to control, especially in pulmonary dysfunction, discontinuing mafenide therapy for 24–48 hours may aid in restoring acid-base balance.^{a b c} (See Systemic Acidosis under Cautions.)

During the interruption in mafenide therapy, adjust dressing changes and monitoring of site for bacterial growth accordingly.^c

Prescribing Limits

Pediatric Patients

Topical (Solution)

Safety and efficacy not established for use >5 days for an individual grafting procedure.^c

Adults

Topical (Solution)

Safety and efficacy not established for use >5 days for an individual grafting procedure.^c

Special Populations

No special population dosage recommendations at this time.^{a b c} (See Pulmonary Dysfunction and also Renal Impairment under Cautions.)

Cautions for Sulfamylon

Contraindications

• 
  

  Known hypersensitivity to mafenide or any ingredient in the formulation.^{a b} Unknown if cross-sensitivity to other sulfonamides occurs.^{b c} (See Sensitivity Reactions under Cautions.)

  
  

Warnings/Precautions

Warnings

Hemolytic Anemia

Fatal hemolytic anemia with disseminated intravascular coagulation reported, presumably related to glucose-6-phosphate dehydrogenase deficiency.^{a b c}

Sensitivity Reactions

Hypersensitivity

Hypersensitivity reactions (e.g., rash, pruritus, facial edema, swelling, urticaria, blisters, erythema, eosinophilia) reported 10–14 days after initiation of therapy.^a

If hypersensitivity reaction occurs, consider discontinuing mafenide therapy temporarily or initiating concomitant antihistamine therapy.^a

Potential for cross-sensitivity with other sulfonamides is unknown.^{b c}

Sulfite Sensitivity

Cream contains a sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.^{b j k l m n o p q}

Major Toxicities

Systemic Acidosis

May cause systemic acidosis (tachypnea or hyperventilation, increased serum chloride concentration, and decreased arterial pCO₂).^{a b c} Closely monitor acid-base balance in patients with extensive second-degree (partial-thickness) burns, pulmonary dysfunction, or renal impairment.^{b c} (See Dosage Modification for Toxicity under Dosage and Administration and see Pulmonary Dysfunction and also Renal Impairment under Cautions.)

Syndrome of marked hyperventilation with resulting respiratory alkalosis (slightly alkaline blood pH, low arterial pCO₂, decreased total CO₂) has been reported; change in arterial pO₂ is variable.^{a b c} Etiology and significance unknown.^{a b c}

General Precautions

Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi, both in and below burn eschar.^a

Fungal colonization in wound and in and below burn eschar may occur concomitantly with reduction of bacterial growth; however, systemic fungal infection via dissemination through the burn wound is rare.^{a b c}

Pulmonary Dysfunction

Closely monitor acid-base balance in pulmonary dysfunction.^{a b c} (See Systemic Acidosis under Cautions.)

Specific Populations

Pregnancy

Category C.^{b c}

Not recommended for women of childbearing potential unless the burned area covers >20% of total body surface area or the therapeutic benefits justify the possible risks to the fetus.^{a b c}

Lactation

Not known whether mafenide is distributed into milk.^{a b c} Discontinue nursing or the drug.^{a b c}

Pediatric Use

Safety and efficacy of topical solution not established in infants <3 months of age.^c

Renal Impairment

Increased risk for metabolic acidosis in renal impairment due to substantial carbonic anhydrase inhibition.^{a b c} Closely monitor acid-base balance.^{a b c} (See Systemic Acidosis under Cautions.)

Use with caution in acute renal failure.^{a b c}

Common Adverse Effects

Pain on application, burning sensation. ^{a b c}

Sulfamylon Pharmacokinetics

Absorption

Bioavailability

Topically applied cream and solution diffuse through devascularized areas, including burn eschar.^{a b c} Peak concentrations in burned skin tissue occur at 2 and 4 hours, respectively.^c Peak tissue concentrations are similar for cream and solution.^c

Peak plasma concentrations of topical cream and its metabolite occur at 2 and 3 hours, respectively.^c

Distribution

Extent

Not known whether distributed into human milk.^{a b c}

Elimination

Metabolism

Rapidly metabolized in the liver to p-carboxybenzenesulfonamide, a weak carbonic anhydrase inhibitor.^{a b c}

Elimination Route

Rapidly excreted in urine as metabolite.^{a b c}

Stability

Storage

Topical

Cream

Avoid exposure to excessive heat (>40°C).^b

Solution

Packets: 15–30°C in a dry place.^c

Reconstituted solution: 20–25°C (may be exposed to 15–30°C); up to 28 days in unopened containers.^c Once opened, discard within 48 hours.^c

Actions and SpectrumActions

• 
  

  Exact mechanism of action unknown, but appears to interfere with bacterial cellular metabolism.^a

  
  


• 
  

  Related chemically, but not pharmacologically, to the sulfonamides.^{a c}

  
  


• 
  

  Not antagonized by p-aminobenzoic acid (PABA), pus, serum, or tissue exudates; activity not altered by environmental acidity changes.^{a b c}

  
  


• 
  

  Bacteriostatic against many gram-negative and gram-positive organisms and several strains of anaerobes.^{a b c}

  
  


• 
  

  Active in vitro against Clostridium species, Pseudomonas aeruginosa, coagulase-positive and-negative staphylococci, and hemolytic streptococci.^{a b c}

  
  


• 
  

  Less active against Escherichia coli and Proteus species.^a

  
  


• 
  

  Resistance not reported.^a

  
  

Advice to Patients

• 
  

  Importance of understanding that mafenide preparations are for external topical use only.^{a b c}

  
  


• 
  

  Importance of informing clinician if any signs or symptoms of an allergic reaction occur (e.g., rash, itching, facial or other swelling, blisters, redness).^{b c}

  
  


• 
  

  Importance of informing clinicians of existing concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., kidney or lung disease).^{b c}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{b c}

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Mafenide Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Cream	8.5% (of mafenide)	Sulfamylon	UDL
Topical	Solution	5% w/v (of mafenide)	Sulfamylon	UDL

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2008. McEvoy GK, ed. Mafenide acetate. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3568-9.

b. UDL Laboratories, Inc. Sulfamylon (mafenide acetate, USP) cream prescribing information. Rockford, IL; 2006 Apr.

c. UDL Laboratories, Inc. Sulfamylon (mafenide acetate, USP) for 5% topical solution prescribing information. Rockford, IL; 2008 Apr.

d. AHFS drug information 2008. McEvoy GK, ed. Silver sulfadiazine. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3570-71.

e. Palmieri TL, Greenlaugh DG. Topical treatment of pediatric patients with burns: a practical guide. Am J Clin Dermatol. 2002; 3:529-34. [PubMed 12358554]

f. Liebman PR, Kennelly MM, Hirsch EF. Hypercarbia and acidosis associated with carbonic anhydrase inhibition: a hazard of topical mafenide acetate use in renal failure. Burns Incl Therm Inj. 1982; 8:95-8.

g. Castellano JJ, Shafii SM, Ko F et al. Comparative evaluation of silver-containing antimicrobial dressings and drugs. Int Wound J. 2007; 4:114-22. [PubMed 17651227]

h. Atiyeh BS, Costagliola M, Hayek SN et al. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007; 33:139-48. [PubMed 17137719]

i. Monafo WW, West MA. Current treatment recommendations for topical burn therapy. Drugs. 1990; 40:364-73. [PubMed 2226220]

j. Food and Drug Administration. Sulfites in foods and drugs. FDA Drug Bull. 1983; 13:12. [PubMed 6604672]

k. Sogn D. The ubiquitous sulfites. JAMA. 1984; 251:2986 7. Editorial. [IDIS 185969] [PubMed 6716628]

l. Koepke JW, Christopher KL, Chai H et al. Dose dependent bronchospasm from sulfites in isoetharine. JAMA. 1984; 251:2982 3. [IDIS 185966] [PubMed 6716626]

m. Twarog FJ, Leung DYM. Anaphylaxis to a component of isoetharine (sodium bisulfite). JAMA. 1982; 248:2030 1. [IDIS 158261] [PubMed 7120631]

n. Baker GJ, Collett P, Allen DH. Bronchospasm induced by metabisulphite containing foods and drugs. Med J Aust. 1981; 2:614 7. [IDIS 146240] [PubMed 7334982]

o. Koepke JW, Selner JC, Dunhill AL. Presence of sulfur dioxide in commonly used bronchodilator solutions. J Allergy Clin Immunol. 1983; 72:504 8. [IDIS 178793] [PubMed 6630799]

p. Food and Drug Administration. Sulfiting agents; labeling in drugs for human use: warning statement. [Docket No. 84N 0113] Fed Regist. 1985; 50:47558 63.

q. Food and Drug Administration Center for Food Safety and Applied Nutrition. The reexamination of the GRAS status of sulfiting agents, January 1985. (Doc. No. 223-83-2020.) Bethesda, MD: FASEB Life Sciences Research Office.

More Sulfamylon resources

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

• Sulfamylon Prescribing Information (FDA)


• Sulfamylon Concise Consumer Information (Cerner Multum)


• Sulfamylon Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Sulfamylon Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sulfamylon with other medications

• Burns, External

Sentry AV Ornacycline-Plus

Dosage Form: FOR ANIMAL USE ONLY
Broad-spectrum antibiotic (erythromycin) with essential vitamins & amino acids for use in drinking water as an aid in the treatment for respiratory diseases of pet birds. Also corrects diarrhea and vitamin deficiencies.

INDICATIONS & USAGE

Treatment for respiratory diseases of pet birds.  Also corrects diarrhea and vitamin deficiencies.

• Treats most common bird respiratory ailments


• Safe to use with all species of birds


• Special formula helps correct vitamin deficiencies and diarrhea during treatment


• Readily soluble and easily administered in bird's drinking water

Obvious changes in a bird's appearance or posture indicate the bird is sick.  Ruffled feathers, eyes closing, sitting low on perch, unusual breathing, sneezing or rasping indicate respiratory illness.

INSTRUCTIONS

Ailing birds - For small birds (i.e. canary) use one powder packet per eight ounces of water.  For larger birds (i.e. mynah), use two powder packets per eight ounces of water.  Use as bird's only water supply for five days.  Put in fresh solution each day.  If bird does not respond after two five-day treatments, see your veterinarian.

Precautions

Read instructions before using.  For pet bird use only.  Not for human consumption.  Keep stock solution covered in a refrigerated dark location, and discard after five days.

KEEP OUT OF REACH OF CHILDREN

How is Sentry AV Ornacycline-Plus Supplied

8 Powder Packets

Each Packet Contains:  0.021 oz. (0.6 g)


Contents:  Each powder packet contains 29 mg erythromycin activity, dextrose, cetric acid, vitamin B1, 1 mg; vitamin B2, 1 mg; vitamin B6, 1 mg; vitamin B12, 0.010 mg; niacin, 0.05 mg; lysine methionine.

PACKAGING LABEL PRINCIPAL DISPLAY PANEL

Distributed by:


Sergeant's Pet Care Products, Inc., Omaha NE 68130


Made in USA


www.sentrypetcare.com

SENTRY AV ORNACYN-PLUS  erythromycin  powder

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-321 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERYTHROMYCIN PHOSPHATE (ERYTHROMYCIN) ERYTHROMYCIN PHOSPHATE 29 mg  in 0.6 g

Inactive Ingredients Ingredient Name Strength DEXTROSE   CITRIC ACID MONOHYDRATE   PYRIDOXINE   CYANOCOBALAMIN   NIACIN   METHIONINE   LYSINE   THIAMINE   RIBOFLAVIN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 21091-321-08 8 PACKET In 1 CARTON contains a PACKET 1 0.6 g In 1 PACKET This package is contained within the CARTON (21091-321-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/08/2008

Labeler - Sergeant's Pet Care Products, Inc. (876995171)

Revised: 03/2010Sergeant's Pet Care Products, Inc.

Twilite

Generic Name: diphenhydramine (DYE fen HYE dra meen)

Brand Names: Aler-Tab, Allergy, Allermax, Altaryl, Benadryl Allergy, Benadryl DF, Benadryl Dye Free Allergy, Benadryl Ultratab, Children's Allergy, Diphen Cough, Diphenhist, Dytuss, PediaCare Children's Allergy, Q-Dryl, Q-Dryl A/F, Siladryl, Siladryl Allergy, Silphen Cough, Simply Sleep, Sleep-ettes, Sleep-ettes D, Sominex Maximum Strength Caplet, Theraflu Thin Strips Multi Symptom, Triaminic Thin Strips Cough & Runny Nose, Unisom Sleepgels Maximum Strength, Valu-Dryl

What is Twilite (diphenhydramine)?

Diphenhydramine is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body.

Diphenhydramine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Diphenhydramine is also used to suppress coughs, to treat motion sickness, to induce sleep, and to treat mild forms of Parkinson's disease.

Diphenhydramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Twilite (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

What should I discuss with my healthcare provider before taking Twilite (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  hypertension or any type of heart problems; or

  
  


• 
  

  asthma.

  
  

You may not be able to take diphenhydramine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Diphenhydramine is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take diphenhydramine without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of antihistamines, and side effects could occur in a breast-feeding baby. Do not take diphenhydramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine. You may require a lower dose of this medication.

How should I take Twilite (diphenhydramine)?

Take diphenhydramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Diphenhydramine can be taken with or without food.

For motion sickness, a dose is usually taken 30 minutes before motion, then with meals and at bedtime for the duration of exposure.

As a sleep aid, diphenhydramine should be taken approximately 30 minutes before bedtime.

To ensure that you get a correct dose, measure the liquid forms of diphenhydramine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of diphenhydramine that you should take in any 24-hour period is 300 mg.

Store diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking Twilite (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

Twilite (diphenhydramine) side effects

Stop taking diphenhydramine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine and talk to your doctor if you experience

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

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

What other drugs will affect Twilite (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These products may contain medicines similar to diphenhydramine, which could lead to an antihistamine overdose.

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

• 
  

  anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

  
  


• 
  

  medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

  
  


• 
  

  any other medications that make you feel drowsy, sleepy, or relaxed.

  
  

Drugs other than those listed here may also interact with diphenhydramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Twilite resources

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

• Banophen MedFacts Consumer Leaflet (Wolters Kluwer)


• Ben-Tann Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Benadryl Consumer Overview


• Benadryl Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Benadryl Allergy Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Children's Allergy Prescribing Information (FDA)


• Diphen Advanced Consumer (Micromedex) - Includes Dosage Information


• Diphenhydramine MedFacts Consumer Leaflet (Wolters Kluwer)


• Diphenhydramine Prescribing Information (FDA)


• Diphenhydramine Hydrochloride Monograph (AHFS DI)


• Diphenoxylate Hydrochloride Monograph (AHFS DI)


• Dytuss Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Simply Sleep MedFacts Consumer Leaflet (Wolters Kluwer)


• Sominex MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Twilite with other medications

• Allergic Reactions
• Cold Symptoms
• Cough
• Extrapyramidal Reaction
• Hay Fever
• Insomnia
• Motion Sickness
• Nausea/Vomiting
• Pruritus
• Urticaria

Where can I get more information?

• Your pharmacist can provide more information about diphenhydramine.

See also: Twilite side effects (in more detail)

Tranexamic acid Intravenous

tran-ex-AM-ik AS-id

Commonly used brand name(s)

In the U.S.

• Cyklokapron

Available Dosage Forms:

• Solution

Therapeutic Class: Hemostatic

Uses For tranexamic acid

Tranexamic acid injection is used to control or prevent excessive or heavy bleeding during dental procedures in patients with hemophilia. tranexamic acid is for short-term use only, usually 2 to 8 days.

Tranexamic acid injection is an antifibrinolytic agent. It works by blocking the breakdown of blood clots. It may also be used for other conditions as determined by your doctor.

tranexamic acid is available only with your doctor's prescription.

Before Using tranexamic acid

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 tranexamic acid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tranexamic acid 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tranexamic acid injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tranexamic acid injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving tranexamic acid injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 receiving tranexamic acid, 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 tranexamic acid 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.

• Anti-Inhibitor Coagulant Complex


• Chlorpromazine


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Tretinoin

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 tranexamic acid. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems (bleeding in the brain) or


• Blood clots, active or history of or


• Head injury or


• Vision problems (problems seeing certain colors)—Should not be used in patients with these conditions.

• Blood vessel problems, history of or


• Hematuria (blood in the urine) caused by or


• Retinal artery or vein occlusion (blood clot in the eye) or


• Seizures, history of or


• Urinary tract problems (e.g., bleeding)—Use with caution. May make these conditions worse.

• Disseminated intravascular coagulation or DIC (blood clotting problem)—Should be treated under strict supervision of an experienced doctor in treating this disorder.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of tranexamic acid

A nurse or other trained health professional will give you tranexamic acid in a hospital. tranexamic acid is given through a needle placed in one of your veins.

Precautions While Using tranexamic acid

Your doctor will check the progress of you or your child closely while you are receiving tranexamic acid. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests will be needed to check for unwanted effects.

If you or your child will be receiving tranexamic acid injection for longer than several days, your doctor may want you to have your eyes checked regularly by an ophthalmologist (eye doctor). This will allow your doctor to check for unwanted effects that may be caused by tranexamic acid.

Tranexamic acid injection should not be used together with factor IX complex (e.g., BeneFIX®, Proplex® T) or anti-inhibitor coagulant concentrates (e.g., Feiba VH®). Doing so, may increase the chance of having serious side effects.

tranexamic acid may cause some people to become dizzy or less alert than they are normally. Make sure you know how you react to tranexamic acid before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

tranexamic acid 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 or nurse immediately if any of the following side effects occur:

Rare

• Anxiety


• blurred vision


• changes in vision


• chest pain


• confusion


• cough


• dizziness or lightheadedness


• fainting


• fast heartbeat


• greatly increased or decreased frequency of urination or amount of urine


• increased thirst


• loss of appetite


• nausea or vomiting


• numbness of the hands


• pain, redness, or swelling in the arm or leg


• sudden shortness of breath or troubled breathing

Incidence not known

• Convulsions or seizures


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• sweating


• trouble seeing


• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Diarrhea


• mental depression


• muscle twitching or jerking


• nightmares or unusually vivid dreams


• rash


• rhythmic movement of the muscles

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:

Incidence not known

• Giddiness


• hives, itching, or redness of the skin

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: tranexamic acid Intravenous 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 tranexamic acid Intravenous resources

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

Compare tranexamic acid Intravenous with other medications

• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Menorrhagia
• Menstrual Disorders

Tropicamide

Class: Mydriatics
ATC Class: S01FA06
VA Class: OP600
Chemical Name: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-
Molecular Formula: C₁₇H₂₀N₂O₂
CAS Number: 1508-75-4
Brands: Mydral, Mydriacyl, Paremyd, Tropicacyl

Introduction

Mydriatic and cycloplegic; synthetic tertiary amine antimuscarinic.^{101 102 a}

Uses for Tropicamide

Ophthalmologic Examination

Used to produce mydriasis and cycloplegia prior to diagnostic procedures (e.g., examination of the fundus).^{101 a}

Efficacy may differ slightly in patients with light and dark irides (see Dosage under Dosage and Administration and see Actions).^{101 102}

Used in fixed-combination with hydroxyamphetamine hydrobromide when a short period of mydriasis or only partial cycloplegia is preferred.^{102 a}

Tropicamide Dosage and Administration

General

• 
  

  Prior to use of tropicamide in fixed combination with hydroxyamphetamine hydrobromide, estimate the depth of the angle of the anterior chamber to avoid induction of angle-closure glaucoma in susceptible patients.^{102 a}

  
  

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.^{101 102 a}

For ophthalmic use only; not for injection.^{101 102}

Avoid contamination of the solution container.^{101 102 a}

To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 2–3 minutes after topical instillation of tropicamide.^{101 a}

Dosage

In patients with heavily pigmented irides, higher tropicamide concentrations may be required.^{101 102}

Solution concentrations of 0.5 and 1% produce mydriasis; the 1% concentration also produces cycloplegia.^{101 a} The 0.5% concentration may be useful for producing mydriasis with only slight cycloplegia.¹⁰¹

Pediatric Patients

Ophthalmologic Examination

Mydriasis with Minimal Cycloplegia (e.g., for Fundus Examination)

Ophthalmic

1 or 2 drops of a 0.5% solution into the eye(s) 15–20 minutes before examination.^{101 a}

Tropicamide 0.25% in fixed combination with hydroxyamphetamine hydrobromide 1%: 1 or 2 drops into the conjunctival sac of the eye(s).^{102 a}

Cycloplegia for Refraction

Ophthalmic

1 or 2 drops of a 1% solution into the eye(s); repeat in 5 minutes.^{101 a} Perform the examination within 30 minutes after the second instillation.^{101 a} If patient is not examined within 20–30 minutes, instill an additional drop of the 1% solution.^{101 a}

Adults

Ophthalmologic Examination

Mydriasis with Minimal Cycloplegia (e.g., for Fundus Examination)

Ophthalmic

1 or 2 drops of a 0.5% solution into the eye(s) 15–20 minutes before examination.^{101 a}

Tropicamide 0.25% in fixed combination with hydroxyamphetamine hydrobromide 1%: 1 or 2 drops into the conjunctival sac of the eye(s).^{102 a}

Cycloplegia for Refraction

Ophthalmic

1 or 2 drops of a 1% solution into the eye(s); repeat in 5 minutes.^{101 a} Perform the examination within 30 minutes after the second instillation.^{101 a} If patient is not examined within 20–30 minutes, instill an additional drop of the 1% solution.^{101 a}

Special Populations

Tropicamide alone or in fixed combination with hydroxyamphetamine hydrobromide: No special population dosage recommendations at this time.^{101 102}

Cautions for Tropicamide

Contraindications

• 
  

  Known hypersensitivity to tropicamide or any ingredient in the formulation.^{101 102 a}

  
  


• 
  

  Tropicamide/hydroxyamphetamine fixed combination: Angle-closure glaucoma or narrow angles where mydriasis may precipitate attack of angle-closure glaucoma.^{102 a}

  
  

Warnings/Precautions

Warnings

CNS Effects

Risk of CNS disturbances, including psychotic reactions and behavioral disturbances; may be dangerous in pediatric patients (see Pediatric Use under Cautions).^{101 102 a}

Intraocular Pressure

Mydriatics may cause a transient increase in IOP.^{101 102 a} Consider the possibility of undiagnosed glaucoma in some patients.^a (See Contraindications.)

Sensitivity Reactions

Anticholinergic Sensitivity

Consider risk of psychotic reactions and behavioral disturbances in patients who are hypersensitive to anticholinergic drugs.^{101 102 a} (See CNS Effects and also Pediatric Use under Cautions.)

General Precautions

Use of Fixed Combinations

When tropicamide is used in fixed combination with hydroxyamphetamine hydrobromide, consider the cautions, precautions, and contraindications associated with hydroxyamphetamine hydrobromide.¹⁰²

Concomitant Diseases

When tropicamide is used in fixed combination with hydroxyamphetamine hydrobromide, closely monitor patients with hypertension, hyperthyroidism, diabetes mellitus, cardiac disorders (i.e., arrhythmias, chronic ischemic heart disease), glaucoma, or increased IOP following topical application.^{102 a}

Specific Populations

Pregnancy

Category C.^{101 102}

Lactation

Not known if tropicamide is distributed into milk.^{101 102} Exercise caution if used in nursing women.^{101 102}

Pediatric Use

May rarely cause potentially dangerous CNS disturbances in pediatric patients.^{101 102} (See CNS Effects under Cautions.)

Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported in pediatric patients with use of anticholinergic agents.^{101 102 a}

Tropicamide/hydroxyamphetamine fixed combination: Safety and efficacy not established.¹⁰²

Geriatric Use

Tropicamide: No overall differences in safety and efficacy relative to younger adults.¹⁰¹

Tropicamide/hydroxyamphetamine fixed combination: No overall differences in safety and efficacy relative to younger adults.¹⁰² Consider possibility of undiagnosed glaucoma in geriatric patients.^a Monitor geriatric patients closely following topical application since glaucoma or increased IOP may be precipitated in these patients.^{102 a} (See Contraindications.)

Common Adverse Effects

Ocular: Increased IOP,^{101 a} transient stinging,^{101 a} blurred vision,^{101 a} superficial punctate keratitis,¹⁰¹ photophobia.^{101 a}

Systemic: Mouth dryness,^{101 a} tachycardia,^{101 a} headache,^{101 a} allergic reactions,¹⁰¹ nausea,¹⁰¹ vomiting,¹⁰¹ pallor,¹⁰¹ CNS disturbances, muscle rigidity.¹⁰¹

Interactions for Tropicamide

Specific Drugs

Drug	Interaction
Carbachol	Tropicamide may interfere with ocular antihypertensive action of carbachol101
Cholinesterase inhibitors (ophthalmic)	Tropicamide may interfere with ocular antihypertensive action of ophthalmic cholinesterase inhibitors101
Pilocarpine	Tropicamide may interfere with ocular antihypertensive action of pilocarpine101

Tropicamide Pharmacokinetics

Absorption

Onset

Tropicamide: Maximum mydriatic effect appears in about 20–40 minutes.^a

Tropicamide: Maximum cycloplegia occurs within 20–35 minutes.^a

Tropicamide/hydroxyamphetamine fixed combination: Mydriasis occurs within 15 minutes and peaks in about 60 minutes.^{102 a}

Duration

Tropicamide: Mydriatic effects last about 6–7 hours;^a however, complete recovery from mydriasis may require up to 24 hours in some individuals.¹⁰¹

Tropicamide: Cycloplegia persists for 50 minutes to 6 hours.^a

Tropicamide/hydroxyamphetamine: Mydriasis, inhibition of pupillary light response, and partial cycloplegia generally last for about 3 hours; recovery begins in about 90 minutes, and total recovery usually occurs in 6–8 hours.^{102 a} However, recovery may require up to 24 hours in some individuals.^{102 a} Patients with light irides may experience slightly greater mydriasis than patients with dark irides.¹⁰²

Distribution

Extent

Not known if tropicamide is distributed into milk.^{101 102}

Stability

Storage

Ophthalmic

Solution

Tightly closed containers at 8–27°C.¹⁰¹ Avoid excessive heat.¹⁰¹ Do not refrigerate.¹⁰¹

Tropicamide/hydroxyamphetamine: 20–25°C.¹⁰² Protect from light.¹⁰²

ActionsActions

• 
  

  Blocks responses of the sphincter muscle of the iris and the accommodative ciliary muscle of the lens to cholinergic stimulation, thereby producing mydriasis and cycloplegia.^{101 102 a}

  
  


• 
  

  Paralyzes accommodation (cycloplegia) in higher concentrations (e.g., 1%).¹⁰¹

  
  


• 
  

  Both the 0.5 and 1% concentrations of tropicamide induce mydriasis; the 0.5% concentration may be useful for producing mydriasis with only slight cycloplegia.¹⁰¹

  
  

Advice to Patients

• 
  

  Advise patients not to drive or engage in other hazardous activities while pupils are dilated.^{101 102}

  
  


• 
  

  Importance of protecting eyes in bright illumination during dilation since sensitivity to light may occur.^{101 102}

  
  


• 
  

  If contact lenses are worn, importance of removing lenses prior to tropicamide administration.¹⁰¹

  
  


• 
  

  Importance of learning and adhering to proper administration techniques to avoid contamination of the dropper tip.^{101 102}

  
  


• 
  

  Advise parents to prevent the child from getting the solution into his or her mouth and to wash their own hands and the child’s hands following administration.^{101 102}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{101 102}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{101 102}

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Tropicamide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.5%*	Mydral	OCuSOFT
			Mydriacyl (with benzalkonium chloride)	Alcon
			Tropicacyl (with benzalkonium chloride)	Akorn
			Tropicamide Ophthalmic Solution (with benzalkonium chloride)	Bausch & Lomb, Falcon
		1%*	Mydral	OCuSOFT
			Mydriacyl (with benzalkonium chloride)	Alcon
			Tropicacyl (with benzalkonium chloride)	Akorn
			Tropicamide Ophthalmic Solution (with benzalkonium chloride)	Bausch & Lomb, Falcon

Tropicamide Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.25% with Hydroxyamphetamine Hydrobromide 1%	Paremyd (with benzalkonium chloride)	Akorn

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

101. Alcon Pharmaceuticals. Mydriacyl(tropicamide) ophthalmic solution prescribing information. Fort Worth, TX; 2004 Feb.

102. Akorn. Paremyd (tropicamide and hydroxyamphetamine hydrobromide) ophthalmic solution prescribing information. Buffalo Grove, IL; 2006 Oct.

a. AHFS Drug Information 2008. McEvoy GK, ed. Tropicamide. Bethesda, MD; American Society of Health-System Pharmacists; 2008:2913-4.

More Tropicamide resources

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

• Mydral MedFacts Consumer Leaflet (Wolters Kluwer)


• Mydral Ophthalmic Advanced Consumer (Micromedex) - Includes Dosage Information


• Mydriacyl Concise Consumer Information (Cerner Multum)


• Mydriacyl Prescribing Information (FDA)


• Ocu-Tropic Advanced Consumer (Micromedex) - Includes Dosage Information


• Tropicacyl Prescribing Information (FDA)

Compare Tropicamide with other medications

• Organophosphate Poisoning
• Pupillary Dilation
• Refraction, Assessment