HyperRHO S/D Full Dose

Dosage Form: injection
Talecris - HyperRHO S/D Full Dose

Solvent/Detergent Treated

HyperRHO S/D Full Dose Description

Rho(D) Immune Globulin (Human) — HyperRHOTM S/D Full Dose treated with solvent/ detergent is a sterile solution of immune globulin containing antibodies to Rho(D) for intramuscular administration; it is preservative-free, in a latex-free delivery system. HyperRHO S/D Full Dose is prepared by cold ethanol fractionation from human plasma. The immune globulin is isolated from solubilized Cohn fraction II. The fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperRHO S/D Full Dose is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. HyperRHO S/D Full Dose is then incubated in the final container for 21–28 days at 20–27°C.

The potency is equal to or greater than 1500 IU. Each single dose syringe contains sufficient anti-Rho(D) to effectively suppress the immunizing potential of 15 mL of Rho(D) positive red blood cells.2-4

The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperRHO S/D Full Dose has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.18-21

Studies of the HyperRHO S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

HyperRHO S/D Full Dose - Clinical Pharmacology

HyperRHO S/D Full Dose is used to prevent isoimmunization in the Rho(D) negative individual exposed to Rho(D) positive blood as a result of a fetomaternal hemorrhage occurring during a delivery of an Rho(D) positive infant, abortion (either spontaneous or induced), or following amniocentesis or abdominal trauma. Similarly, immunization resulting in the production of anti-Rho(D) following transfusion of Rh positive red cells to an Rho(D) negative recipient may be prevented by admin istering Rho(D) Immune Globulin (Human).5,6

Rh hemolytic disease of the newborn is the result of the active immunization of an Rho(D) negative mother by Rho(D) positive red cells entering the maternal circulation during a previous delivery, abortion, amniocentesis, abdominal trauma, or as a result of red cell transfusion.7,8 HyperRHO S/D Full Dose acts by suppressing the immune response of Rho(D) negative individuals to Rho(D) positive red blood cells. The mechanism of action of HyperRHO S/D Full Dose is not fully understood.

The administration of Rho(D) Immune Globulin (Human) within 72 hours of a full-term delivery of an Rho(D) positive infant by an Rho(D) negative mother reduces the incidence of Rh isoimmunization from 12%–13% to 1%–2%.9

The 1%–2% treatment failures are probably due to isoimmunization occurring during the latter part of pregnancy or following delivery.10 Bowman and Pollock11 have reported that the incidence of isoimmunization can be further reduced from approximately 1.6% to less than 0.1% by administering Rho(D) Immune Globulin (Human) in two doses, one ante natal at 28 weeks’ gestation and another following delivery.

In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRABTM S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.

Indications and Usage for HyperRHO S/D Full Dose

Pregnancy and Other Obstetric Conditions

HyperRHO S/D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 hours after birth of an Rho(D) positive infant,12 providing the following criteria are met:

1. 
   

   The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) factor.

   
   


2. 
   

   Her child must be Rho(D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS).

   
   

If HyperRHO S/D Full Dose is administered antepartum, it is essential that the mother receive another dose of HyperRHO S/D Full Dose after delivery of an Rho(D) positive infant.

If the father can be determined to be Rho(D) negative, HyperRHO S/D Full Dose need not be given.

HyperRHO S/D Full Dose should be administered within 72 hours to all nonimmunized Rho(D) negative women who have undergone spontaneous or induced abortion, following ruptured tubal pregnancy, amniocentesis or abdominal trauma unless the blood group of the fetus or the father is known to be Rho(D) negative.7,8 If the fetal blood group cannot be determined, one must assume that it is Rho(D) positive,2 and HyperRHO S/D Full Dose should be administered to the mother.

Transfusion

HyperRHO S/D Full Dose may be used to prevent isoimmunization in Rho(D) negative individuals who have been transfused with Rho(D) positive red blood cells or blood components containing red blood cells.5,13

Contraindications

None known.

Warnings

HyperRHO S/D Full Dose is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1-800-520-2807].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

NEVER ADMINISTER HyperRHO S/D Full Dose INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.

Rho(D) Immune Globulin (Human) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

The attending physician who wishes to administer Rho(D) Immune Globulin (Human) to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

Precautions

General

A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive Du test result. If there is any doubt about the mother’s Rh type, she should be given Rho(D) Immune Globulin (Human). A screening test to detect fetal red blood cells may be helpful in such cases.

If more than 15 mL of D-positive fetal red blood cells are present in the mother’s circulation, more than a single dose of HyperRHO S/D Full Dose is required. Failure to recognize this may result in the administration of an inadequate dose.

Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic reactions.

Drug Interactions

Other antibodies in the Rho(D) Immune Globulin (Human) preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after Rho(D) Immune Globulin (Human) administration.

Drug/Laboratory Interactions

Babies born of women given Rho(D) Immune Globulin (Human) antepartum may have a weakly positive direct antiglobulin test at birth.

Passively acquired anti-Rho(D) may be detected in maternal serum if antibody screening tests are performed subsequent to antepartum or postpartum administration of Rho(D) Immune Globulin (Human).

Pregnancy Category C

Animal reproduction studies have not been conducted with HyperRHO S/D Full Dose. It is also not known whether Rho(D) Immune Globulin (Human) — HyperRHOTM S/D Full Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperRHO S/D Full Dose should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

ADVERSE REACTIONS SECTION

Reactions to Rho(D) Immune Globulin (Human) are infrequent in Rho(D) negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human immune globulin is extremely rare, it has occurred. Elevated bilirubin levels have been reported in some individuals receiving multiple doses of Rho(D) Immune Globulin (Human) following mismatched transfusions. This is believed to be due to a relatively rapid rate of foreign red cell destruction.

HyperRHO S/D Full Dose Dosage and Administration

NEVER ADMINISTER HyperRHO S/D Full Dose INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.

Pregnancy and Other Obstetric Conditions

1. 
   

   For postpartum prophylaxis, administer one syringe of HyperRHO S/D Full Dose, preferably within 72 hours of delivery. Although a lesser degree of protection is afforded if Rh antibody is administered beyond the 72-hour period, HyperRHO S/D Full Dose may still be given.7,14 Full-term deliveries can vary in their dosage requirements depending on the magnitude of the fetomaternal hemorrhage. One full dose syringe of HyperRHO S/D Full Dose provides sufficient antibody to prevent Rh sensitization if  the volume of red blood cells that has entered the circulation is 15 mL or less.2-4 In instances where a large (greater than 30 mL of whole blood or 15 mL red blood cells) fetomaternal hemorrhage is suspected, a fetal red cell count by an approved laboratory technique (e.g., modified Kleihauer-Betke acid elution stain technique) should be performed to determine the dosage of immune globulin required.8,15 The red blood cell volume of the calculated fetomaternal hemorrhage is divided by 15 mL to obtain the number of syringes of HyperRHO S/D Full Dose for administration.3,8,13 If more than 15 mL of red cells is suspected or if the dose calculation results in a fraction, administer the next higher whole number of syringes (e.g., if 1.4, give 2 syringes).

   
   


2. 
   

   For antenatal prophylaxis, one full dose syringe of HyperRHO S/D Full Dose is administered at approximately 28 weeks’ gestation. This must be followed by another full dose, preferably within 72 hours following delivery, if the infant is Rh positive.

   
   


3. 
   

   Following threatened abortion at any stage of gestation with continuation of pregnancy, it is recommended that a full dose of HyperRHO S/D Full Dose be given. If more than 15 mL of red cells is suspected due to fetomaternal hemorrhage, the same dose modification in No. 1 above applies.

   
   


4. 
   

   Following miscarriage, abortion, or termination of ectopic pregnancy at or beyond 13 weeks’ gestation, it is recommended that a HyperRHO S/D Full Dose be given. If more than 15 mL of red cells is suspected due to fetomaternal hemorrhage, the same dose modification in No. 1 above applies. If pregnancy is terminated prior to 13 weeks’ gestation, where licensed, a single dose of HyperRHOTM S/D Mini-Dose may be used instead of HyperRHO S/D Full Dose.

   
   


5. 
   

   Following amniocentesis at either 15 to 18 weeks’ gestation or during the third trimester, or following abdominal trauma in the second or third trimester, it is recommended that a HyperRHO S/D Full Dose be administered. If there is a fetomaternal hemorrhage in excess of 15 mL of red cells, the same dose modification in No. 1 applies.

   
   

If abdominal trauma, amniocentesis, or other adverse event requires the administration of HyperRHO S/D Full Dose at 13 to 18 weeks’ gestation, another full dose should be given at 26 to 28 weeks. To maintain protection throughout pregnancy, the level of passively acquired anti-Rho(D) should not be allowed to fall below the level required to prevent an immune response to Rh positive red cells. The half-life of IgG is 23 to 26 days. In any case, a HyperRHO S/D Full Dose should be given within 72 hours after delivery if the baby is Rh positive. If delivery occurs within 3 weeks after the last dose, the postpartum dose may be withheld unless there is a fetomaternal hemorrhage in excess of 15 mL of red blood cells.16

Transfusion

In the case of a transfusion of Rho(D) positive red cells to an Rho(D) negative recipient, the volume of Rh positive whole blood administered is multiplied by the hematocrit of the donor unit giving the volume of red blood cells transfused. The volume of red blood cells is divided by 15 mL which provides the number of syringes of HyperRHO S/D Full Dose to be administered.

If the dose calculated results in a fraction, the next higher whole number of syringes should be administered (e.g., if 1.4, give 2 syringes). HyperRHO S/D Full Dose should be administered within 72 hours after an incompatible transfusion, but preferably as soon as possible.

Injection Procedure

DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT NEONATE. HyperRHO S/D Full Dose is administered intramuscularly, preferably in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve.17

A.

Single Syringe Dose 

 

INJECT ENTIRE CONTENTS OF THE SYRINGE INTO THE INDIVIDUAL INTRAMUSCULARLY.

B.

Multiple Syringe Dose

 

1. Calculate the number of syringes of HyperRHO S/D Full Dose to be given (see Dosage section).


2. The total volume of HyperRHO S/D Full Dose can be given in divided doses at different sites at one time or the total dose may be divided and injected at intervals, provided the total dosage is given within 72 hours of the fetomaternal hemorrhage or transfusion. USING STERILE TECHNIQUE, INJECT THE ENTIRE CONTENTS OF THE CALCULATED NUMBER OF SYRINGES INTRAMUSCULARLY INTO THE PATIENT.

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

HyperRHO S/D Full Dose is supplied with a syringe and an attached UltraSafe® Needle Guard for your protection and convenience. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage

1. Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger.


2. Twist the plunger rod clockwise until the threads are seated.


3. With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.


4. Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]


5. Proceed with hypodermic needle puncture.


6. Aspirate prior to injection to confirm that the needle is not in a vein or artery.


7. Inject the medication.


8. Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)


9. Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

How is HyperRHO S/D Full Dose Supplied

HyperRHO S/D Full Dose is available in single dose syringes with attached needles. HyperRHO S/D Full Dose is preservative-free, in a latex-free delivery system.

NDC Number	Size
13533-631-02	Syringe

STORAGE

Store at 2–8°C (36–46°F). Do not freeze.

CAUTION

Rx only

U.S. federal law prohibits dispensing without prescription.

REFERENCES

1. 
   

   Gunson HH, Bowell PJ, Kirkwood TBL: Collaborative study to recalibrate the International Reference Preparation of Anti-D Immunoglobulin. J Clin Pathol 33:249-53, 1980.

   
   


2. 
   

   Rho(D) immune globulin (human). Med Lett Drugs Ther 16(1):3-4, 1974.

   
   


3. 
   

   Pollack W, Ascari WQ, Kochesky RJ, et al: Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size of antigenic stimulus. Transfusion 11(6):333-9, 1971.

   
   


4. 
   

   Unpublished data on file.

   
   


5. 
   

   Pollack W, Ascari WQ, Crispen JF, et al: Studies on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh positive blood. Transfusion 11(6):340-4, 1971.

   
   


6. 
   

   Keith LG, Houser GH: Anti-Rh immune globulin after a massive transfusion accident. Transfusion 11(3):176, 1971.

   
   


7. 
   

   The selective use of Rho(D) immune globulin (RhIG). ACOG Tech Bull 61, 1981.

   
   


8. 
   

   Current uses of Rho immune globulin and detection of antibodies. ACOG Tech Bull 35, 1976.

   
   


9. 
   

   Pollack W: Rh hemolytic disease of the newborn: its cause and prevention. Prog Clin Biol Res 70:185-203, 1981.

   
   


10. 
    

    Bowman JM, Chown B, Lewis M, et al: Rh isoimmunization during pregnancy: antenatal prophylaxis. Can Med Assoc J 118(6):623-7, 1978.

    
    


11. 
    

    Bowman JM, Pollock JM: Antenatal prophylaxis of Rh isoimmunization: 28-weeks'- gestation service program. Can Med Assoc J 118(6):627-30, 1978.

    
    


12. 
    

    Ascari WQ, Allen AE, Baker WJ, et al: Rho(D) immune globulin (human): evaluation in women at risk of Rh immunization. JAMA 205(1):1-4, 1968.

    
    


13. 
    

    Prevention of Rh sensitization. WHO Tech Rep Ser 468:25, 1971.

    
    


14. 
    

    Samson D, Mollison PL: Effect on primary Rh immunization of delayed administration of anti-Rh. Immunology 28:349-57, 1975.

    
    


15. 
    

    Finn R, Harper DT, Stallings SA, et al: Transplacental hemorrhage. Transfusion 3(2):114-24, 1963.

    
    


16. 
    

    Garraty G (ed.): Hemolytic disease of the newborn. Arlington, VA, American Association of Blood Banks, 1984, p 78.

    
    


17. 
    

    Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP): General recommendations on immunization. MMWR 2002: 51(RR02), 1-36.

    
    


18. 
    

    Stenland CJ, Lee DC, Brown P, et al: Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion 2002. 42(11):1497-500.

    
    


19. 
    

    Lee DC, Stenland CJ, Miller JL, et al: A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 2001. 41(4):449-55.

    
    


20. 
    

    Lee DC, Stenland CJ, Hartwell RC, et al: Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 2000. 84(1):77-89.

    
    


21. 
    

    Cai K, Miller JL, Stenland CJ, et al: Solvent-dependent precipitation of prion protein. Biochim Biophys Acta 2002. 1597(1):28-35.

    
    

INFORMATION FOR PATIENTS

The Rh Factor and Your Pregnancy

Information About Pregnancy Protection

The Rh Factor and When It Is Important

The Rh factor is one of many blood group antigens found on the surface of red blood cells. If you have this antigen you are considered Rh positive. If you don’t, then you are considered Rh negative. Everyone is either Rh positive or Rh negative. One type is neither better nor worse than the other, only different.

Your Rh factor is important if you are an Rh negative woman and you become pregnant, or if you receive a blood transfusion.

How the Rh Factor Can Affect Your Future

If you have Rh negative blood, there are two situations that can affect you:

1.

If the father of your baby is Rh positive, the baby will probably be Rh positive too. An Rh negative woman carrying an Rh positive baby may have an immune reaction if some of the baby’s Rh positive blood cells enter her bloodstream.

 

This immune reaction, called isoimmunization, means your body’s defense system recognizes Rh positive blood as foreign from your own and produces “antibodies” to destroy the invading Rh positive blood cells.

 

The passage of blood from the baby to the mother’s bloodstream happens most often at delivery, but can also occur during miscarriage, the termination of pregnancy, amnio centesis (test performed to determine fetal health), or due to an injury or trauma. It is important to note that a small number of women develop antibodies to Rh positive blood cells during pregnancy for no apparent reason.

 

Antibodies to Rh positive blood may not be a problem in first pregnancies; however, the antibodies stay in your bloodstream, ready to attack invading Rh positive blood cells, for many years to come. This can lead to problems in future pregnancies by causing miscarriage or a disease known as hemolytic disease of the newborn.

 

Babies born to Rh positive mothers, regardless of the father’s blood type, will usually be free of the dangers of hemolytic disease.

2.

Someday it may become necessary for you to receive a blood transfusion. If Rh positive antibodies already reside in your bloodstream due to isoimmunization and the blood you receive is Rh positive due to error or lifesaving reasons, your Rh positive antibodies will become mobilized and de stroy the donor Rh positive cells. As a result, the transfusion could be unsuccessful and possibly harmful to you.

Hemolytic Disease of the Newborn: A Threat to Your Baby

When an Rh negative woman has Rh positive antibodies in her blood and the baby she is carrying is Rh positive, the antibodies could possibly enter the baby’s bloodstream, attack the baby’s red blood cells and cause hemolytic disease of the new born. At birth, the infant suffering from hemolytic disease may be jaundiced and anemic or suffer permanent damage of the brain and central nervous system which may result in mental retardation, hearing loss, or cerebral palsy. Extensive medical care can be required, including an exchange transfusion, in which all of the baby’s blood is replaced. This usually stops the destruction of the baby’s red blood cells and gives the infant a chance to survive.

The risk of hemolytic disease of the newborn is slight with the first baby, but increases with each successive pregnancy.

Preventing Hemolytic Disease

HyperRHOTM S/D, Rho(D) Immune Globulin (Human) can prevent hemolytic disease of the newborn, provided Rh positive antibodies do not already reside in your bloodstream.

HyperRHO S/D is a specially prepared gamma globulin with a high level of preformed antibodies against Rh positive blood cells. The injection of HyperRHO S/D destroys any Rh positive blood cells that may have entered the mother’s bloodstream and prevents the mother's immune system from producing Rh positive antibodies; thus protecting the baby from developing hemolytic disease.

HyperRHO S/D Full Dose — When Prescribed

Pregnancy and Other Obstetric Conditions Pertaining to Rh Negative Women

HyperRHO S/D Full Dose is administered during pregnancy if you fall into a high-risk category. For example, you are at risk of producing Rh positive antibodies if you have an amniocentesis procedure performed, or if you have a miscarriage or other termination of pregnancy at or beyond 13 weeks' gestation.

Laboratory findings have shown that some Rh negative women develop Rh positive antibodies during the last weeks of pregnancy even without an antibody-stimulating event. As a preventive measure, your physician will probably recommend the first injection of HyperRHO S/D Full Dose at the 28th week of pregnancy.

In both of the above situations, if the blood type of the father or baby can be determined to be Rh negative, an injection of HyperRHO S/D is not required.

Another injection of HyperRHO S/D Full Dose is administered within 72 hours of delivery of an Rh positive baby.

Blood Transfusion

HyperRHO S/D Full Dose may be used to prevent isoimmunization in Rh negative individuals who have been transfused with Rh positive red blood cells or blood components containing red blood cells.

HyperRHO S/D Mini-Dose — When Prescribed

A single dose of HyperRHO S/D Mini-Dose may be prescribed for an Rh negative woman instead of HyperRHO S/D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation. HyperRHO S/D Mini-Dose is not required if the blood type of the father or fetus can be determined to be Rh negative.

Will You Need HyperRHO S/D Again?

HyperRHO S/D provides protection only if you have not already produced Rh positive antibodies. Women who have developed antibodies through previous pregnancy, miscarriage, other termination of pregnancy, or blood transfusion cannot be protected by HyperRHO S/D. This is why with each pregnancy it is important to have HyperRHO S/D injections within the prescribed time period.

Reactions to HyperRHO S/D

You may feel a temporary soreness at the site of the injection. You may also have a slight and temporary change in body temperature. In very rare instances, an allergic type of reaction can occur, for which your physician will take appropriate measures.

Delivering a Sound, Healthy Baby

Your physician can answer any questions you may have about receiving a HyperRHO S/D injection to prevent hemolytic disease of the newborn. If you know that you are Rh negative and you are pregnant, you should discuss your situation with your physician. Today, with HyperRHO S/D, hemolytic disease of the newborn can be reduced to its lowest possible rate of incidence.

08938830 (Rev. May 2008)

Talecris Biotherapeutics, Inc.

Research Triangle Park, NC 27709 USA

U.S. License No. 1716

Development of Hemolytic Disease

1 Rh positive (+) father. Rh negative (–) mother.	2 Pregnancy: Rh– mother is carrying Rh+ baby.
3. The passage of Rh+ blood from the baby to the mother's bloodstream happens most often at delivery, but can also occur during miscarriage, other termination of pregnancy, amniocentesis, or due to injury or trauma.	4. Rh+ antibodies stay in your blood stream, ready to attack invading Rh+ blood cells, for many years to come.
5. Next pregnancy, mother’s Rh+ anti bodies enter baby’s Rh+ bloodstream, attacking baby’s blood cells and causing hemolytic disease of the newborn.

How HyperRHO S/D Immune Globulin Can Prevent Hemolytic Disease

1 You will probably be given two injections of HyperRHO S/D Full Dose, one at the 28th week of your pregnancy and another within 72 hours of delivery, miscarriage or other termination of pregnancy. A single injection of HyperRHO S/D Mini-Dose may be prescribed instead of HyperRHO S/D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation.	2 HyperRHO S/D immunization prevents formation of mother's own Rh+ antibodies. Mother’s blood stream remains free of Rh+ antibodies.
3 Next pregnancy, baby develops normally. HyperRHO S/D should be administered following delivery, miscarriage, or other termination of pregnancy to continue protection if baby is Rh+.

PACKAGE LABEL

Rho(D) Immune Globulin (Human)

HyperRHOTM S/D Full Dose

Preservative-free, latex-free delivery system

Contents: One single dose disposable syringe with attached needle

Rho(D) immune Globulin (Human) -- HyperRHOTM S/D is a sterile solution of Immunoglobulin containing 15%-18% protein stabilized with 0.21-0.32 M glycine. The pH is adjusted with sodium carbonate.

The potency of each single dose of HyperRHOTM S/D is equal to or greater then 1500 IU.

Caution: RhoD Immune Globulin (Human) should be administered to unsensitized Rh negative women preferably within 3 days after any miscarriage or after delivery of an Rh positive infant.

FOR INTRAMUSCULAR INJECTION ONLY. DO NOT GIVE INTRAVENOUSLY. NEVER ADMINISTER TO NEONATES.

Store at 2-8°C (36-46°F). Do not freeze.

Talecris Biotherapeutics NDC 13533-631-02

The patient and physician should discuss the risks and benefits of this product.

For complete dosage and administratin information, read enclosed package insert.

For directions for syringe usage, see enclosed package insert.

Do not use if the syringe is prematurely engaged.

Not returnable for credit or exchange.

Rx only

CAUTION:  U.S. federal law prohibits dispensing without prescription.

08938442

Talecris Biotherapeutics, Inc.

Research Triangle Park, NC 27709 USA

U.S. License No. 1716

Rho(D) Immune

Globulin (Human)

HyperRHOTM S/D Full Dose

Solvent/Detergent Treated

Talecris

Biotherapeutics, Inc.

RTP, NC 27709 USAU.S. License No. 1716

The patient and physician

should discuss the risks and

benefits of this product.

HyperRHO S/D Full Dose   rho(d) immune globulin (human)  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13533-631 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Human Rho(d) Immune Globulin (Human Rho(d) Immune Globulin) Human Rho(d) Immune Globulin 1500 [iU]  in 1 [iU]

Inactive Ingredients Ingredient Name Strength Glycine

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 13533-631-02 1 SYRINGE In 1 CARTON contains a SYRINGE 1 1500 [iU] In 1 SYRINGE This package is contained within the CARTON (13533-631-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA101141	08/14/1996

Labeler - TALECRIS BIOTHERAPEUTICS, INC. (839731507)

Establishment
Name	Address	ID/FEI	Operations
TALECRIS BIOTHERAPEUTICS HOLDINGS CORP		611019113	MANUFACTURE

Revised: 05/2008TALECRIS BIOTHERAPEUTICS, INC.

More HyperRHO S/D Full Dose resources

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

• BayRho-D Advanced Consumer (Micromedex) - Includes Dosage Information


• Bayrho-D full dose


• MICRhoGAM MedFacts Consumer Leaflet (Wolters Kluwer)


• Rhophylac MedFacts Consumer Leaflet (Wolters Kluwer)


• Rhophylac Consumer Overview


• WinRho SDF MedFacts Consumer Leaflet (Wolters Kluwer)

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• Idiopathic Thrombocytopenic Purpura
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urokinase Intravenous

ure-oh-KYE-nase

Commonly used brand name(s)

In the U.S.

• Abbokinase


• Kinlytic

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Thrombolytic

Pharmacologic Class: Tissue Plasminogen Activator

Uses For urokinase

Urokinase injection is used to dissolve blood clots that have formed in the lungs (pulmonary embolism).

urokinase was available only with your doctor's prescription.

urokinase is not available in the United States as of October 2010.

Before Using urokinase

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 urokinase, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to urokinase 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 have not been performed on the relationship of age to the effects of urokinase injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of urokinase injection in geriatric patients.

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 urokinase, 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 urokinase 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.

• Acenocoumarol


• Alteplase, Recombinant


• Anistreplase


• Ardeparin


• Argatroban


• Bivalirudin


• Certoparin


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Drotrecogin Alfa


• Enoxaparin


• Fondaparinux


• Heparin


• Lepirudin


• Nadroparin


• Parnaparin


• Phenindione


• Phenprocoumon


• Protein C, Human


• Reteplase, Recombinant


• Reviparin


• Rivaroxaban


• Streptokinase


• Tenecteplase


• Tinzaparin


• Urokinase


• Warfarin

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

• Bleeding problems or a history of bleeding in any part of the body or


• Blood vessel problems (e.g., aneurysm) or


• Brain disease or tumor or


• Hypertension (high blood pressure), uncontrolled or


• Stroke, recent (within two months) or


• Surgery or injury to the brain or spine, recent (within two months) or


• Trauma including CPR (cardiopulmonary resuscitation), recent—Should not be used in patients with these conditions.

• Blood clotting disorders or


• Diabetic eye problems (e.g., hemorrhagic retinopathy) or


• Heart disease or infections (e.g., endocarditis, mitral stenosis) or


• Injections into a blood vessel or


• Kidney disease, severe or


• Liver disease, severe or


• Placement of any tube into the body or


• Surgery or injury of any kind, major and recent—The chance of serious bleeding may be increased.

• High cholesterol, history of—The chance of having a serious side effect may be increased.

Proper Use of urokinase

A doctor or other trained health professional will give you urokinase. urokinase is given through a needle placed into one of your veins.

Precautions While Using urokinase

Urokinase can cause bleeding that usually is not serious. However, serious bleeding may occur in some people. To help prevent serious bleeding, carefully follow any instructions given by your doctor. Move around as little as possible, and do not get out of bed on your own, unless your doctor tells you it is all right to do so.

Watch for any bleeding or oozing on your skin, such as around the place of injection or where blood was drawn from your arm. Also, check for blood in your urine or bowel movements. If you have any bleeding or injuries, tell your doctor or nurse right away.

urokinase 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:

More common

• Bleeding gums


• coughing up blood


• difficulty with breathing or swallowing


• dizziness


• headache


• increased menstrual flow or vaginal bleeding


• nosebleeds


• paralysis


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• shortness of breath

Rare

• Cough


• fast heartbeat


• hives or welts


• itching skin


• noisy breathing


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness of the skin


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Incidence not known

• Blue lips and fingernails


• blurred vision


• chest pain or discomfort


• confusion


• convulsions


• coughing that sometimes produces a pink frothy sputum


• difficult, fast, or noisy breathing, sometimes with wheezing


• fainting


• fast, irregular, pounding, or racing heartbeat or pulse


• inability to speak


• increased sweating


• low blood pressure or pulse


• numbness or tingling in the face, arms, or legs


• pale skin


• severe or sudden headache


• severe or sudden weakness in the arm or leg on one side of the body


• slurred speech


• swelling in the legs and ankles


• trouble with walking or speaking


• unconsciousness

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: urokinase 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 urokinase Intravenous resources

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

Compare urokinase Intravenous with other medications

• Deep Vein Thrombosis
• Heart Attack
• Pulmonary Embolism
• Thrombotic/Thromboembolic Disorder

Fabrazyme

Pronunciation: ay-GAL-si-dase
Generic Name: Agalsidase Beta
Brand Name: Fabrazyme

Fabrazyme is used for:

Treating Fabry disease.

Fabrazyme is a glycoprotein. It works by providing the enzyme alpha-galactosidase A to the body.

Do NOT use Fabrazyme if:

• you are allergic to any ingredient in Fabrazyme

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

Before using Fabrazyme:

Some medical conditions may interact with Fabrazyme. 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 are or have recently been ill


• if you have heart or lung problems

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

Ask your health care provider if Fabrazyme 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 Fabrazyme:

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

• Fabrazyme is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Fabrazyme if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• Continue to use Fabrazyme even if you feel well. Do not miss any doses.


• If you miss a dose of Fabrazyme, contact your doctor right away.

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

Important safety information:

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


• Many patients may experience a reaction while they are receiving their dose of Fabrazyme. Some reactions may be severe. Tell your doctor right away if you develop fever, chills, headache, rash, hives, itching, swelling, stomach pain, nausea, vomiting, muscle pain, dizziness, chest pain or tightness, fast heartbeat, throat tightness, or shortness of breath while you are receiving your dose. Discuss any questions or concerns with your doctor.


• Lab tests, including allergy tests, may be performed while you use Fabrazyme. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Fabrazyme should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fabrazyme while you are pregnant. It is not known if Fabrazyme is found in breast milk. If you are or will be breast-feeding while you are using Fabrazyme, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fabrazyme:

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:

Dizziness; headache; nausea; runny or stuffy nose; sore throat; stomach upset.

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); bone pain; chest pain or tightness; chills; confusion; decreased hearing or hearing loss; decreased or painful urination; fainting; fast, slow, or irregular heartbeat; fever; joint pain; loss of coordination; mental or mood changes (eg, anxiety, depression); muscle pain or weakness; numbness or pain of an arm or leg; one-sided weakness; severe headache, dizziness, or nausea; shortness of breath; slurred speech; stomach pain; sudden vision changes; swelling (eg, hands, legs, feet, lips, ears); throat tightness; unusual tiredness or weakness; unusually pale skin; vomiting.

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: Fabrazyme 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 Fabrazyme:

Fabrazyme is usually handled and stored by a health care provider. If you are using Fabrazyme at home, store Fabrazyme as directed by your pharmacist or health care provider. Keep Fabrazyme out of the reach of children and away from pets.

General information:

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


• Fabrazyme 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 Fabrazyme. 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 Fabrazyme resources

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

• Fabrazyme Prescribing Information (FDA)


• Fabrazyme Consumer Overview


• Fabrazyme Monograph (AHFS DI)


• Fabrazyme Advanced Consumer (Micromedex) - Includes Dosage Information


• Agalsidase Beta Professional Patient Advice (Wolters Kluwer)

Compare Fabrazyme with other medications

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Astepro

Generic Name: azelastine (Nasal route)

a-ZEL-as-teen

Commonly used brand name(s)

In the U.S.

• Astelin


• Astelin Ready-Spray


• Astepro

Available Dosage Forms:

• Spray

Therapeutic Class: Nasal Agent

Pharmacologic Class: Antihistamine

Uses For Astepro

Azelastine nasal spray is used to help relieve symptoms (e.g., stuffy or runny nose, itching, sneezing) of seasonal (short-term) or perennial (year-round) allergic rhinitis (hay fever), and vasomotor rhinitis.

This medicine works by preventing certain cells to release substances that cause the allergic reaction.

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

Before Using Astepro

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

Appropriate studies have not been performed on the relationship of age to the effects of azelastine in children below 12 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of azelastine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving azelastine.

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.

• Cimetidine

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:

• Kidney disease—Blood levels of azelastine may be increased, leading to increased effects.

Proper Use of azelastine

This section provides information on the proper use of a number of products that contain azelastine. It may not be specific to Astepro. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your mouth. If it does get on these areas, rinse it off right away.

Before using this medicine, gently blow your nose to clear the nostrils.

To prepare this medicine:

• Before you use a new bottle of azelastine spray, the spray pump will need to be primed (started). If your pharmacist assembled the unit for you, check to see if it has already been primed by pumping the unit once. If a full spray comes out, the unit has already been primed; if not you must prime the pump.


• To prime a new bottle, hold the bottle upright and away from you, then pump it six times or until you see a fine spray.


• If you have not used the spray for 3 or more days, pump it two times or until you see a fine spray.

To keep the applicator clean, wipe the nosepiece with a clean tissue and replace the dust cap after each use.

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 nasal dosage form (spray):
  
  • For symptoms of seasonal allergic rhinitis:
    
    • Adults, teenagers, and children 12 years of age and older—1 or 2 sprays in each nostril two times a day, or 2 sprays in each nostril once a day.
    
    
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For symptoms of perennial allergic rhinitis:
    
    • Adults, teenagers, and children 12 years of age and older—2 sprays in each nostril two times a day.
    
    
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of vasomotor rhinitis:
    
    • Adults and teenagers—Use 2 sprays in each nostril two times a day.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the bottle upright with the pump tightly closed.

Precautions While Using Astepro

Your doctor should check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that makes 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; 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, drowsy, or less alert than they are normally. Even if used at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Keep the spray away from the eyes because this medicine may cause irritation or blurred vision. Closing your eyes while you are using this medicine may help keep it out of your eyes.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Astepro 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:

Rare

• Blood in the urine


• cough


• eye pain, eye redness, blurred vision or other change in vision


• rapid heartbeat


• shortness of breath, tightness in the chest, troubled breathing, or wheezing


• skin rash, hives, or itching


• sores in the mouth or on the lips

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

• Bitter taste in the mouth


• drowsiness or sleepiness

Less common

• Bloody mucus or unexplained nosebleeds


• burning inside the nose


• dizziness


• dryness of the mouth


• headache


• muscle aches or pain


• nausea


• sore throat


• sudden outbursts of sneezing


• unusual tiredness or weakness


• weight gain

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: Astepro 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 Astepro resources

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

• Astepro Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Astepro Prescribing Information (FDA)


• Astepro Consumer Overview


• Astelin Prescribing Information (FDA)


• Astelin Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Astelin Consumer Overview

Compare Astepro with other medications

• Hay Fever

Liquifilm Tears

LIQUIFILM TEARS

1.4% w/v, eye drops, solution

Polyvinyl alcohol

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use LIQUIFILM TEARS carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.


• Ask your pharmacist if you need more information or advice.


• You must contact a doctor if your symptoms worsen or do not improve after 3 days.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What LIQUIFILM TEARS is and what it is used for


• 2. Before you use LIQUIFILM TEARS


• 3. How to use LIQUIFILM TEARS


• 4. Possible side effects


• 5. How to store LIQUIFILM TEARS


• 6. Further information

What Liquifilm Tears Is And What It Is Used For

LIQUIFILM TEARS is a substitute for tears and contains a lubricant called polyvinyl alcohol. It is an eye drops solution used for the relief of the symptoms of dry eye (such as soreness, burning, irritation or dryness) caused by your eyes not producing enough tears.

Before You Use Liquifilm Tears

Do NOT use LIQUIFILM TEARS:

• 
  if you are allergic (hypersensitive) to polyvinyl alcohol or any of the other ingredients of LIQUIFILM TEARS listed in Section 6, “What LIQUIFILM TEARS contains”.


• 
  while you are wearing soft contact lenses: you must remove them before using LIQUIFILM TEARS eye drops. After using LIQUIFILM TEARS, wait at least 15 minutes before putting your lenses back in. See also in Section 2, “Important information about some of the ingredients of LIQUIFILM TEARS”.

Take special care with LIQUIFILM TEARS:

Stop using LIQUIFILM TEARS and contact your doctor if:

• you experience long-lasting redness or irritation of the eye, eye pain, changes in vision


• your condition worsens or has not improved 3 days after having started treatment with LIQUIFILM TEARS.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you have to use any other eye medicine during treatment with LIQUIFILM TEARS: first use the other eye medicine, wait 15 minutes, then use LIQUIFILM TEARS.

Pregnancy and breast-feeding

You can use LIQUIFILM TEARS if you are pregnant and when you are breast-feeding.

Driving and using machines

Your sight may become blurred for a short time just after using LIQUIFILM TEARS. You should not drive or use machines until your sight is clear again.

Important information about some of the ingredients of LIQUIFILM TEARS

If you wear soft contact lenses you must remove them before using LIQUIFILM TEARS eye drops. After using LIQUIFILM TEARS, you have to wait at least 15 minutes before putting your lenses back in.

This is important because one of the ingredients of LIQUIFILM TEARS, called benzalkonium chloride, may cause eye irritation and can change the colour of soft contact lenses.

How To Use Liquifilm Tears

If LIQUIFILM TEARS has been recommended for you then use it exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of LIQUIFILM TEARS is 1 or 2 drops in each eye that needs treatment as often as you feel the need.

Instructions for use

Do not use the bottle if the seal around the cap is broken before you first open it.

Wash your hands before opening the bottle. Tilt your head back and look at the ceiling.

• 1. Gently pull down the lower eyelid of the eye that needs treatment until there is a small “pocket”.


• 2. Turn the bottle upside down. Squeeze it to release 1 drop into the “pocket”.


• 3. Let go of the lower lid, and blink your eyes a few times. For a second drop repeat the steps 2 and 3.


• 4. Repeat the steps 1 to 3 for the other eye, if it also needs treatment.

If a drop misses your eye, try again.

To help prevent infection, do not let the tip of the bottle touch your eye, the surrounding tissue or anything else. Put the screw-cap back on to close the bottle, straight after you have used it. Once you have opened the bottle, you must not use it longer than 28 days; please see also Section 5, “How to store LIQUIFILM TEARS”.

If you use more LIQUIFILM TEARS than you should

Using more drops of LIQUIFILM TEARS than you should will not cause you any harm.

If you forget to use LIQUIFILM TEARS

If you have missed a dose of LIQUIFILM TEARS continue with your next dose as normal.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Liquifilm Tears Side Effects

Like all medicines, LIQUIFILM TEARS can cause side effects, although not everybody gets them.

Stop using LIQUIFILM TEARS and contact your doctor if:

• you experience long-lasting redness or irritation of the eye, eye pain, changes in vision


• your condition worsens or has not improved 3 days after having started treatment with LIQUIFILM TEARS.

If you experience any of the following side effects just after putting in the drops, talk to your doctor if they worry you:

• eye pain, eye irritation or feeling of burning in the eye, redness of the eyes, an excess of tears, feeling of something in the eye, an allergic reaction in the eye.

The above mentioned side effects are known to occur, but the number of people likely to be affected can vary.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Liquifilm Tears

Keep out of the reach and sight of children.

Do not use LIQUIFILM TEARS after the expiry date which is stated on the bottle label and the carton after ‘EXP.’. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not refrigerate or freeze.

You must throw away the bottle 28 days after you first opened it, even if there are still some drops left.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What LIQUIFILM TEARS contains

• The active ingredient is polyvinyl alcohol 1.4% w/v.


• The other ingredients are benzalkonium chloride, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, edetate disodium, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

What LIQUIFILM TEARS looks like and contents of the pack

LIQUIFILM TEARS is a solution in a plastic bottle with a screw-cap. Each bottle contains 15 ml of solution.

Each pack contains 1 bottle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Allergan Ltd

Marlow International

The Parkway

Marlow

Bucks

SL7 1YL

UK

Tel:01628 494026

Fax:01628 494057

Email:uk_medinfo@allergan.com

Manufacturer:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

This leaflet was last approved in July 2009.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Polyvinyl alcohol 1.4% w/v reference number PL 00426/0009R.

This is a service provided by the Royal National Institute of the Blind.

Triamcinolone Acetonide eent

Class: Corticosteroids
ATC Class: S02CA04
VA Class: NT200
Chemical Name: (11β,16α) - 9 - Fluoro - 11,21 - dihydroxy - 16,17 - [(1 - methylethylidene)bis(oxy)] - pregna - 1,4 - diene - 3,20 - dione
Molecular Formula: C₂₄H₃₁FO₆
CAS Number: 76-25-5
Brands: Nasacort

Introduction

Synthetic corticosteroid.^{1 2 3}

Uses for Triamcinolone Acetonide

Allergic Rhinitis

Symptomatic treatment of seasonal or perennial allergic rhinitis.^{1 2 3 4 5 6 7 8 9 10 11 17}

Triamcinolone Acetonide Dosage and Administration

General

• 
  

  For therapeutic effectiveness, use at regular intervals.^b

  
  

Administration

Intranasal Administration

Administer by nasal inhalation using a metered-dose nasal spray pump.^{2 3 4 5 8 b}

Shake inhaler gently immediately prior to use.^b

Prior to initial use, the metered-dose pump spray must be primed with 5 actuations or until a fine mist appears.^c Prime pump after a period of nonuse (i.e., > 2 weeks) by actuating once.²

Clear nasal passages prior to administration.^c

Tilt the head slightly forward, insert the spray tip into one nostril, and point the tip toward the back of the nose.^c Pump the drug into one nostril while holding the other nostril closed and concurrently inspire through the nose.^c Repeat this procedure for the other nostril.^c

Dosage

After priming, nasal spray pump delivers about 55 mcg of triamcinolone acetonide per metered spray and about 30 or 120 metered doses per 6.5-g or 16.5-g container, respectively.^{2 b}

Once optimal symptomatic relief is achieved, reduce dosage gradually to the lowest effective level.^{1 2 3}

Intranasal triamcinolone acetonide should not be continued beyond 3 weeks in the absence of adequate symptomatic improvement.^{1 2 16 b}

Pediatric Patients

Seasonal Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).² May be increased to 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Children ≥12 years of age: 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).^{2 b} Maximum, 110 mcg (2 sprays) in each nostril once daily (220 mcg total).^{2 b}

Children ≥12 years of age: Initially 110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Adults

Seasonal Allergic Rhinitis

Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Perennial Allergic Rhinitis

Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total).²

Prescribing Limits

Pediatric Patients

Seasonal or Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 220 mcg (2 sprays in each nostril) daily.^{2 b}

Adults

Seasonal or Perennial Allergic Rhinitis

Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.^b

Perennial Allergic Rhinitis

Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.^b

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.^{1 2 17}

Renal Impairment

No specific dosage recommendations at this time.^{1 2 17}

Geriatric Patients

No specific dosage recommendations at this time.^{1 2 17}

Cautions for Triamcinolone Acetonide

Contraindications

• 
  

  Known hypersensitivity to triamcinolone acetonide or any ingredient in the formulation.^{1 2 17}

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, or severe symptomatic exacerbation of asthma or other clinical conditions if prolonged systemic corticosteroid therapy is replaced with topical corticosteroid therapy; careful monitoring recommended.^{1 2 3 17}

Use particular caution in patients with associated asthma or other conditions that may be exacerbated by too rapid a reduction in systemic corticosteroid dosage.^b

Taper the dosage of the systemic corticosteroid, and carefully monitor patients during dosage reduction.^{1 2 17} In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by intranasal corticosteroids.¹⁶

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs.^{1 2 17} Certain infections (e.g., varicella [chickenpox], measles) can be serious or fatal in such patients, particularly in children.^{1 2 17}

Exposure to varicella and measles should be avoided in previously unexposed patients.^{1 2 17} If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled IM immune globulin (IG) respectively.^{1 2 17} Consider treatment with antiviral agents if varicella (chickenpox) develops.^{1 2}

General Precautions

Systemic Corticosteroid Effects

Possible growth suppression in pediatric patients.^{1 2 17} (See Pediatric Use under Cautions.)

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may increase risk of systemic corticosteroid effects (e.g., hypercortism or adrenal suppression).^b Avoid exceeding the recommended dosages.^{1 2 17}

Nasopharyngeal Effects

Rarely, localized candidial infections of the nose and/or pharynx has been reported.^{1 2 17} Local treatment of such infections and/or discontinuance of intranasal therapy may be required.^{1 2 17}

Nasal septal perforations have been reported rarely.^{1 2 17}

Use with caution until healing occurs in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma.^{1 2 3 17}

Concomitant Infections

Use with extreme caution, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated fungal or bacterial infections; or ocular herpes simplex; or untreated, systemic viral infections.^{1 2 3 16 17}

Specific Populations

Pregnancy

Category C.^b Use during pregnancy may result in hypoadrenalism in infants;^b monitor these infants carefully.^b

Lactation

Not known whether triamcinolone acetonide is distributed in milk.^{1 2 17} Caution if used in nursing women.^{1 2 17}

Pediatric Use

Safety and efficacy not established in children <6 years of age.^{1 2}

Corticosteroids, particularly with high doses for extended periods may cause growth suppression in pediatric patients.^{1 2 17} Titrate dosage to the lowest possible effective level.^b

Geriatric Use

Response similar to that in younger adults.^b

Common Adverse Effects

Pharyngitis, epistaxis, increased cough.^{2 3}

Triamcinolone Acetonide Pharmacokinetics

Absorption

Bioavailability

Systemic absorption is minimal.^{1 2 3} Mean peak plasma concentrations achieved at 1.5 hours following nasal inhalation.^{2 3}

Onset

Symptomatic relief may be evident 10–16 hours following initiation of therapy.^{4 5 8 12 16} Maximum benefit is usually achieved within 1 week.^b

Distribution

Extent

The volume of distribution is 99.5 L.^b

Special Populations

In pediatric patients, similar extent of absorption, peak concentrations, and time to peak concentrations compared to adult patients.^b

Elimination

Metabolism

Metabolized to metabolites that are substantially less active than the parent drug.^b

Half-life

3.1 hours.^b

Stability

Storage

Intranasal Suspension

20–25°C.^b

ActionsActions

• 
  

  Potent glucocorticoid^{1 2 17 b} and weak mineralocorticoid effects.^{3 16}

  
  


• 
  

  May reduce the number of mediator cells (basophils, eosinophils, T-helper cells, mast cells, and neutrophils) in the nasal mucosa.

  
  


• 
  

  Decreases nasal reactivity to allergens and decreases release of inflammatory mediators and proteolytic enzymes.

  
  

Advice to Patients

• 
  

  Provide copy of manufacturer’s patient information.^b

  
  


• 
  

  Importance of understanding proper storage, preparation, and administration techniques.^{1 2 17}

  
  


• 
  

  Importance of shaking container gently prior to each use.^{1 2}

  
  


• 
  

  Importance of avoiding spraying drug directly onto nasal septum.^{1 17}

  
  


• 
  

  Advise patients that containers of triamcinolone acetonide nasal spray should be discarded after 120 actuations.^{1 2}

  
  


• 
  

  Importance of taking as directed and not exceeding prescribed dosage.^{1 2 17}

  
  


• 
  

  Importance of regular use to obtain therapeutic effectiveness.^b

  
  


• 
  

  Importance of contacting a clinician if symptoms worsen or fail to improve after 3 weeks.^{1 2 17 b}

  
  


• 
  

  Necessity of reporting recurrent epistaxis, nasal septum discomfort, irritation, burning, and/or stinging to clinicians.^{1 2 17}

  
  


• 
  

  Importance of avoiding exposure to chickenpox or measles in patients receiving immunosuppressant doses of corticosteroids and, if exposure occurs, consulting a clinician.^{1 2 17 b}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{1 2 17}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.^{1 2 17}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^b (See Cautions.)

  
  

Preparations

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

Triamcinolone Acetonide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Suspension	55 mcg/metered spray	Nasacort AQ Nasal Spray (with benzalkonium chloride)	Aventis

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 November 2004. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Aventis. Nasacort (triamcinolone acetonide) nasal inhaler prescribing information. In: Physicians’ desk reference. 55th ed. Montvale, NJ; Medical Economics Company Inc; 2001:717-9.

2. Aventis. Nasacort AQ (triamcinolone acetonide) prescribing information (dated 1997 Oct). In: Physician’s desk reference. 55th ed. Montvale, NJ: Medical Economics Company, Inc; 2001:719-20.

3. Jeal W, Faulds D. Triamcinolone acetonide: a review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis. Drugs. 1997; 53:257-80.

4. Settipane G, Korenblat PE, Winder J et al. Triamcinolone acetonide aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study. Clin Ther. 1995; 17:252-63.

5. Munk ZM, LaForce C, Furst JA et al. Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1996; 77:277-81.

6. Findlay S, Huber F, Garcia J et al. Efficacy of once-a-day intranasal administration of triamcinolone acetonide in patients with seasonal allergic rhinitis. Ann Allergy. 1992; 68:228-32.

7. Banov CH, Silvers WS, Green AW et al. Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. Clin Ther. 1996; 18:265-72.

8. Kobayashi RH, Beaucher WN, Koepke JW et al. Triamcinolone acetonide aqueous nasal spray for the treatment of patients with perennial allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 1995; 17:503-13.

9. Spector S, Bronsky E, Chervinsky P et al. Multicenter, double-blind, placebo-controlled trial of triamcinolone acetonide nasal aerosol in the treatment of perennial allergic rhinitis. Ann Allergy. 1990; 64:300-5.

10. Storms W, Bronsky E, Findlay S et al. Once daily triamcinolone acetonide nasal spray is effective for the treatment of perennial allergic rhinitis [published erratum appears in Ann Allergy 1991; 66:457]. Ann Allergy. 1991; 66:329-34.

11. Welch MJ, Bronsky EA, Grossman J et al. Clinical evaluation of triamcinolone acetonide nasal aerosol in children with perennial allergic rhinitis.Ann Allergy. 1991; 67:493-8.

12. Day JH, Buckeridge DL, Clark RH et al. A randomized, double-blind, placebo-controlled, controlled antigen delivery study of the onset of action of aerosolized triamcinolone acetonide nasal spray in subjects with ragweed-induced allergic rhinitis. J Allergy Clin Immunol. 1996; 97:1050-7.

13. Howland WC III, Dockhorn R, Gillman S et al. A comparison of effects of triamcinolone acetonide aqueous nasal spray, oral prednisone, and placebo on adrenocortical function in male patients with allergic rhinitis. J Allergy Clin Immunol. 1996; 98:32-8.

14. Feiss G, Morris R, Rom D et al. A comparative study of the effects of intranasal triamcinolone acetonide aerosol (ITAA) and prednisone on adrenocortical function. J Allergy Clin Immunol. 1992; 89:1151-6.

15. Nayak AS, Ellis MH, Gross GN et al. The effects of triamcinolone acetonide aqueous nasal spray on adrenocortical function in children with allergic rhinitis. J Allergy Clin Immunol. 1998; 101(2 Pt 1):157-62.

16. Aventis, Bridgewater, NJ: Personal communication.

17. Muro. Tri-Nasal (triamcinolone acetonide) nasal spray prescribing information. Tewksbury, MA; 2000 Feb.

b. Aventis. Nasacort AQ (triamcinolone acetonide) prescribing information. Bridgewater, NJ; 2004 Mar.

c. Aventis. Nasacort AQ (triamcinolone acetonide) patient information. Bridgewater, NJ; 2004 Mar.

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