Immune Globulin

Class: Serums
VA Class: IM500
CAS Number: 9007-83-4
Brands: Carimune, Flebogamma, Flebogamma DIF, Gammagard, GamaSTAN, Gammaplex, Gamunex, Hizentra, Octagam, Privigen, Vivaglobin

• Acute Renal Dysfunction and Failure


• 
  

  IGIV has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death.^{125 151 249 263 264 265 266 282 292 308} (See Renal Effects under Cautions.)

  
  


• 
  

  Renal dysfunction and acute renal failure reported more commonly in patients receiving IGIV preparations that contain sucrose.^{125 151 263 264 265 266 282 292 308}

  
  


• 
  

  Patients predisposed or at increased risk of acute renal failure include those with any degree of preexisting renal insufficiency, diabetes mellitus, volume depletion, sepsis, or paraproteinemia; those receiving concomitant nephrotoxic drugs; and/or those >65 years of age.^{125 151 249 263 264 265 266 282 308}

  
  


• 
  

  Administer IGIV at the minimum concentration available and at the minimum practicable infusion rate, especially in patients at risk for renal dysfunction or acute renal failure.^{125 151 249 263 264 265 266 282 292 308}

  
  

Introduction

Immune globulin IM (IGIM), immune globulin IV (IGIV), and immune globulin subcutaneous; sterile, nonpyrogenic solutions of globulins containing many antibodies normally present in adult human blood.^{154 263 264 266 273 282 292 294 308}

Uses for Immune Globulin

Hepatitis A Virus (HAV) Infection (Preexposure Prophylaxis)

IGIM is used to provide passive immunity to HAV infection for preexposure prophylaxis in certain susceptible individuals who are at risk of exposure to the virus.^{154 186 187 286}

Preexposure passive immunization with IGIM is recommended if hepatitis A vaccine cannot be used because it is contraindicated or unavailable and short-term protection against HAV is needed.^{186 187 191 192 193 206 286} In addition, for optimal protection, use of IGIM for passive immunization may be considered in conjunction with active immunization with hepatitis A vaccine in certain individuals.^{206 286}

Travelers to areas with intermediate or high levels of endemic HAV are at risk of exposure to the disease.^{186 206 286} Risk of acquiring HAV while traveling varies with living conditions, length of stay, and incidence of HAV infection in the area visited.²⁰⁶ Consider that many cases of HAV occur in travelers to developing countries with standard tourist itineraries, accommodations, and food consumption behaviors.²⁰⁶ CDC website () has information regarding which countries have high or intermediate levels of HAV endemicity.²⁰⁶

USPHS Advisory Committee on Immunization Practices (ACIP), CDC, WHO, and others recommend preexposure vaccination against HAV for all susceptible individuals traveling to areas with intermediate or high levels of endemic HAV.^{186 189 193 206 286 291} Although active immunization with hepatitis A vaccine is preferred since it provides long-term protection, if the vaccine is contraindicated or cannot be used (e.g., in children <1 year of age, individuals hypersensitive to vaccine components) or the traveler chooses not to receive the vaccine, passive immunization with IGIM is recommended.^{186 231 206 286 291}

For optimal protection in travelers at greatest risk for HAV (older adults or individuals with altered immunocompetence, chronic liver disease, or other chronic medical condition) who plan to depart in <2 weeks, the ACIP and CDC recommend that a single dose of IGIM be given concomitantly with the initial dose of hepatitis A vaccine (at a different site).^{206 286}

A single 0.02-mL/kg dose of IGIM confers short-term protection (up to 3 months) against HAV and a single 0.06-mL/kg dose confers longer-term protection (3–5 months).^{186 206 286 291}

Hepatitis A Virus (HAV) Infection (Postexposure Prophylaxis)

IGIM is used for postexposure prophylaxis of HAV in susceptible individuals with recent (within 2 weeks) exposure to the virus.^{154 186 187 286}

The choice of active immunization with hepatitis A vaccine and/or passive immunization with IGIM should take into account the magnitude of risk associated with the exposure and characteristics of the patient that may be associated with more severe manifestations of HAV (e.g., older age, chronic liver disease).^{107 186 187 286}

Although IGIM is 80–90% effective if administered within 2 weeks of exposure^{186 286} and was traditionally the recommended regimen for HAV postexposure prophylaxis,^{186 187 286} there is some evidence that monovalent hepatitis A vaccine administered within 2 weeks of exposure may be as effective as IGIM in preventing symptomatic HAV infection in susceptible contacts 2–40 years of age.^{187 286 287} The vaccine also offers certain advantages over IGIM (e.g., induces active immunity and longer protection, more readily available, easier to administer, greater patient acceptance).^{286 287}

For HAV postexposure prophylaxis in healthy individuals 12 months to 40 years of age, ACIP and AAP prefer use of monovalent hepatitis A vaccine.^{187 286} In adults >40 years of age, IGIM is preferred since data are not available to date regarding efficacy of the vaccine for postexposure prophylaxis in this age group and these individuals are at risk for more severe manifestations of HAV; the vaccine can be used if IGIM cannot be obtained.^{187 286} Use IGIM for HAV postexposure prophylaxis in children <12 months of age, immunocompromised individuals, individuals with chronic liver disease, and whenever the vaccine is contraindicated.^{187 286}

In individuals in whom IGIM is preferred for HAV postexposure prophylaxis, administer a dose of hepatitis A vaccine simultaneously (using different syringes and different injection sites) if the vaccine is indicated for other reasons (e.g., catch-up vaccination, preexposure vaccination in high-risk groups) and is not contraindicated.^{187 286} If a dose of hepatitis A vaccine is used (with or without IGIM) for HAV postexposure prophylaxis, administer an additional (booster) dose of the vaccine according to the usually recommended schedule to ensure long-term protection.^{186 187 286}

If HAV postexposure prophylaxis is indicated, administer as soon as possible (within 2 weeks of exposure).^{186 187 286} Data not available regarding efficacy of HAV postexposure prophylaxis administered >2 weeks after exposure.²⁸⁶ Routine serologic screening of contacts for markers of HAV infection prior to administration of HAV postexposure prophylaxis is not recommended since this would delay prophylaxis.^{186 187}

HAV postexposure prophylaxis is indicated in all previously unvaccinated individuals who have had household or sexual (heterosexual or homosexual) contact (within the past 2 weeks) with an individual with serologically confirmed HAV.²⁸⁶ Also consider HAV postexposure prophylaxis for individuals exposed (within the past 2 weeks) through other types of ongoing, close personal contact (e.g., regular babysitting).²⁸⁶

Contacts who have shared illicit drugs (within the past 2 weeks) with an individual with serologically confirmed HAV should receive HAV postexposure prophylaxis.²⁸⁶

Administer HAV postexposure prophylaxis to all previously unvaccinated staff and attendees of child-care centers or homes if ≥1 case of HAV is recognized in children or employees or if HAV is recognized in ≥2 households of center attendees (within the past 2 weeks).²⁸⁶ In centers that do not provide care to children who wear diapers, HAV postexposure prophylaxis is indicated only in classroom contacts of the index patient.²⁸⁶ If an outbreak occurs (i.e., HAV in ≥3 families), also consider HAV postexposure prophylaxis for members of households that have diapered children attending the center.²⁸⁶

If HAV is diagnosed in a food handler, ACIP recommends HAV postexposure prophylaxis (within 2 weeks) for other food handlers at the same establishment.²⁸⁶ Because common-source transmission to patrons is unlikely, HAV postexposure prophylaxis is not usually indicated for patrons, but may be considered if the food handler directly handled uncooked or cooked food and had diarrhea or poor hygienic practices and if patrons can be identified and given prophylaxis within 2 weeks after exposure.^{186 286} Settings where repeated HAV exposure might have occurred (e.g., institutional cafeterias) warrant stronger consideration of postexposure prophylaxis for patrons.^{186 286}

HAV postexposure prophylaxis is not usually indicated after a common-source HAV outbreak if cases have begun to occur because the 2-week period when such prophylaxis is known to be effective will have been exceeded.²⁸⁶

When an individual with HAV is admitted to a hospital, health-care personnel do not need to receive routine HAV postexposure prophylaxis; careful hygienic practices should be emphasized in such situations.^{107 182 186 187 286}

If an epidemiologic investigation indicates that HAV transmission has occurred among students in a school or among hospital patients and/or hospital staff, ACIP recommends HAV postexposure prophylaxis in individuals who have close contact with index patients.²⁸⁶

Routine HAV postexposure prophylaxis is not indicated when a single HAV case occurs in an elementary or secondary school or an office or other work setting and the source case is outside the school or work setting.²⁸⁶

Hepatitis B Virus (HBV) Infection

IGIM is not effective for postexposure prophylaxis of HBV infection since concentrations of anti-HBs in IGIM are too low.¹⁸⁷

Hepatitis B immune globulin (HBIG) is the only immune globulin recommended by ACIP and AAP for passive immunization for postexposure prophylaxis of HBV.^{100 126 182 187}

Hepatitis C Virus (HCV) Infection

IGIM has been used in attempt to prevent HCV† infection or other parenterally transmitted non-A, non-B hepatitis†.^{107 182}

ACIP and AAP state that available data indicate that immune globulin is not effective for, and not recommended for, postexposure prophylaxis of HCV, including following occupational exposures to HCV.^{107 187 246} Manage occupational exposures through early identification of the disease in exposed individuals and appropriate antiviral therapy if indicated.¹⁰⁰

ACIP states that immune globulin is not recommended for postexposure prophylaxis in infants born to HCV-positive women.²⁴⁶

Hepatitis E Virus (HEV) Infection

No evidence that IGIM is effective for postexposure prophylaxis of HEV infection.^{182 230} Travelers who received IGIM for protection against HAV should not assume that they are protected against HEV.^{182 230} Consult CDC website () for information regarding where HEV is endemic.²⁰⁶

Measles

IGIM is used to prevent or modify symptoms of measles (rubeola) in susceptible individuals exposed to the disease <6 days previously.^{154 187 206}

Postexposure vaccination (i.e., within 72 hours of exposure) generally is preferred to postexposure prophylaxis with IGIM for most susceptible individuals ≥12 months of age who are exposed to measles in most settings (e.g., day-care facilities, schools, colleges, health-care facilities), and is acceptable for susceptible individuals ≥6 months of age who are household contacts of measles patients.¹³³ ACIP and AAP recommend that susceptible individuals receive vaccination against measles within 72 hours after exposure, unless the vaccine is contraindicated.^{101 133 187} If measles is not recognized within this time frame, postexposure prophylaxis with IGIM is recommended (if administered within 6 days of exposure), especially for susceptible household contacts for whom the risk of measles complications is high (e.g., contacts ≤12 months of age, pregnant women, immunocompromised individuals).^{133 187}

If measles is diagnosed in a mother, unvaccinated children of all ages in the household who lack evidence of measles immunity should receive IGIM.¹³³

Postexposure prophylaxis with IGIM is not indicated for household contacts who have received a dose of vaccine containing measles virus vaccine live on or after 12 months of age, unless they are immunocompromised.^{133 187}

When postexposure prophylaxis is indicated in a pregnant woman with documented measles exposure, administer IGIM within 6 days of exposure.^{187 206}

Passive immunity to measles following IGIM administration is temporary (unless modified or typical measles occurs); 5–6 months after IGIM administration, initiate immunization with vaccine containing measles virus vaccine live in individuals ≥12 months of age who have no contraindications to the vaccine.^{133 206} Do not administer the vaccine and IGIM concurrently.^{133 206} (See Specific Drugs and Laboratory Tests under Interactions.)

Do not use IGIM to control measles outbreaks.^{101 133}

IGIM is used following measles exposure in children and young adults with symptomatic HIV infection and immunosuppression associated with AIDS or other clinical manifestations of HIV infection, regardless of vaccination status;^{132 133 187} however, IGIM may not be necessary if the patient has been receiving IGIV (100–400 mg/kg) at regular intervals and received the last dose within 2–3 weeks of exposure to measles.^{133 150 187}

IGIM (given within 6 days of exposure) can be used to prevent or modify measles infection in asymptomatic HIV-infected children.¹⁵⁰ In addition, administer IGIM to measles-susceptible household contacts of asymptomatic HIV-infected children, particularly contacts <1 year of age and pregnant women.^{150 187}

Consider preexposure prophylaxis with immune globulin in susceptible individuals with severe immunosuppression (e.g., HIV-infected individuals) who are planning travel to measles-endemic areas; vaccines containing measles virus vaccine live are not recommended for severely immunocompromised individuals.²⁹³

Mumps

IGIM is not effective for and should not be used for postexposure prophylaxis of mumps infection.^{133 154 187}

Poliomyelitis

IGIM should not be used for postexposure prophylaxis of poliomyelitis.¹⁵⁴

Rubella

Although some studies suggest that use of IGIM in susceptible women exposed to rubella during the first trimester of pregnancy† may lessen the likelihood of infection and adverse fetal effects, ACIP states that use of IGIM after exposure to rubella will not prevent infection or viremia but may modify or suppress symptoms and can create an unwarranted sense of security.^{131 133}

ACIP and AAP state that IGIM should not be used routinely for postexposure prophylaxis of rubella in early pregnancy or any other circumstance.^{131 133 187} The only instance in which IGIM might be considered for postexposure prophylaxis of rubella is in a susceptible pregnant woman who is exposed to a confirmed case of rubella early in the pregnancy and who will not consider terminating the pregnancy under any circumstances.^{131 133 187} Administration within 72 hours of exposure might reduce, but will not eliminate, risk for rubella.^{131 133}

Varicella

ACIP, AAP, and others state that varicella-zoster immune globulin (VZIG) is the preferred immune globulin for postexposure prophylaxis of varicella in individuals who do not have evidence of immunity (i.e., without a history of varicella or varicella vaccination) and are at high risk for severe disease and complications (e.g., HIV-infected individuals).^{187 215 269 272 293}

IGIV is recommended as an alternative to VZIG for postexposure prophylaxis of varicella† in susceptible individuals when VZIG is unavailable (e.g., cannot be obtained within 96 hours of exposure).^{187 215 268 269 272} ACIP and others state that IGIV may be used (if VZIG is unavailable) in immunocompromised patients (including HIV-infected patients),^{215 269} neonates whose mothers develop signs and symptoms of varicella around the time of delivery (within 5 days before to 2 days after delivery),²⁶⁹ premature infants exposed during the neonatal period whose mothers do not have evidence of varicella immunity,²⁶⁹ or premature infants exposed during the neonatal period who were born at <28 weeks’ gestation or with a birthweight of ≤1 kg (regardless of maternal history of varicella).²⁶⁹

ACIP, AAP, CDC, National Institutes of Health (NIH), and other experts state that HIV-infected children, adolescents, or adults who are receiving IGIV replacement therapy (≥400 mg/kg given at regular intervals) and received a dose of IGIV within 3 weeks prior to exposure should be protected and should not require postexposure prophylaxis with VZIG.^{134 187 215 269 293}

IGIV may prolong the incubation period; therefore, closely observe the patient for signs or symptoms of varicella for 28 days following exposure.²⁶⁹

IGIM has been used as an alternative to VZIG for postexposure prophylaxis of varicella in susceptible individuals,¹⁵⁴ but IGIV (not IGIM) is recommended when VZIG is unavailable.^{187 215 268 269 272}

If the exposed patient does not develop varicella, administer varicella virus vaccine live at a later date, unless contraindicated.²⁶⁹ (See Specific Drugs and Laboratory Tests under Interactions.)

Primary Immunodeficiency Diseases

Immune globulins (IGIM, IGIV, immune globulin subcutaneous) are used as replacement therapy to promote passive immunity in patients with primary humoral immunodeficiency diseases.^{125 263 264 265 266 273 274 275 276 280 292 294 308}

IGIV and immune globulin subcutaneous are used in patients with IgG and other antibody-deficiency diseases, including congenital agammaglobulinemia (e.g., X-linked agammaglobulinemia), common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency syndromes.^{125 151 263 264 265 266 282 292 294 308}

Prophylactic IGIM therapy, especially against infections caused by encapsulated bacteria, is often effective in Bruton-type, sex-linked congenital agammaglobulinemia, agammaglobulinemia associated with thymoma, and acquired agammaglobulinemia.¹⁵⁴ IGIM may not prevent chronic infections of the external secretory tissues (e.g., respiratory and GI tracts).¹⁵⁴

IGIV (not IGIM) may be preferred in patients who require an immediate or large increase in intravascular immunoglobulin concentrations, in patients with small muscle mass, and in patients with bleeding tendencies in whom IM injections are contraindicated.^{125 264 280 282}

Self-administration of immune globulin subcutaneous (at home) may result in improved quality of life and treatment satisfaction compared with use of IGIV (administered in the hospital or clinician’s office).^{275 276}

IGIM, IGIV, and immune globulin subcutaneous should not be used in individuals with selective IgA deficiency^{151 154 266 280 282} and should not be used in IgA-deficient individuals^{125 151 154 263 264 265 266 273 280 282 292 294 308} with antibodies against IgA.^{125 263 264 265 273 292 294 308} (See Contraindications under Cautions and see IgA Deficiency under Cautions.)

Idiopathic Thrombocytopenic Purpura (ITP)

IGIV (i.e., Carimune NF, Gammagard S/D, Gamunex 10%, Privigen 10%) is used for the treatment of acute or chronic (e.g., >6 months duration) ITP (also known as immune thrombocytopenic purpura).^{125 138 139 151 265 292}

In patients in whom an IGIV response is obtained, the rise in platelet count is generally rapid (within 1–5 days) and transient (usually lasting from several days to 2–4 weeks)^{125 130 139 151} but rarely may last 4–12 months or longer.^{125 130 138}

Chronic Inflammatory Demyelinating Polyneuropathy

IGIV (i.e., Gamunex 10%) is used for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.²⁶⁵

Some clinicians consider IGIV the preferred treatment for CIDP, especially in children, patients with poor venous access that precludes use of plasma exchange, and in those susceptible to complications of long-term corticosteroid therapy.^{305 306}

Kawasaki Disease

IGIV (i.e., Gammagard S/D) is used in conjunction with aspirin therapy for initial treatment of the acute phase of Kawasaki disease.^{103 104 105 128 151 155 156 157 163 187 237 238 240 241 299 300}

Concomitant use of IGIV and high-dose aspirin therapy initiated within 10 days of the onset of fever is more effective than aspirin alone in preventing or reducing the occurrence of coronary artery abnormalities associated with Kawasaki disease and may result in more rapid resolution of fever and other manifestations of acute inflammation.^{104 128 151 187 280 299}

AAP, AHA, and American College of Chest Physicians (ACCP) state that combined therapy with IGIV and aspirin should be administered as soon as possible after Kawasaki disease is diagnosed or strongly suspected (optimally within 7–10 days of disease onset).^{187 299 300} In those with a delayed diagnosis (i.e., >10 days after disease onset), AAP and AHA suggest that combined therapy with IGIV and aspirin should be initiated if the patient has unexplained persistent fever or aneurysms and manifestations of ongoing systemic inflammation (elevated erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) or evolving CAD.^{187 237 238 299}

Approximately ≥10% of patients with Kawasaki disease fail to respond to initial treatment with IGIV and aspirin therapy and have persistent fever or recurrent fever after an initial afebrile period.^{187 299} Retreatment with IGIV (within 24–48 hours of persistent or recrudescent fever) and continued aspirin therapy usually is recommended for these patients.^{187 237 299}

Coronary artery abnormalities develop in 15–25% of children with Kawasaki disease if they are not treated within 10 days of fever onset;^{187 299 300} 2–4% of patients develop coronary artery abnormalities despite prompt treatment with IGIV and aspirin.¹⁸⁷ Long-term management of those who develop coronary abnormalities depends on the severity of coronary involvement and may include low-dose aspirin (with or without clopidogrel or dipyridamole), anticoagulant therapy with warfarin or low molecular weight heparin, or a combination of antiplatelet and anticoagulant therapy (usually low-dose aspirin and warfarin).^{187 299 300} Consult specialized references for additional information on long-term management of Kawasaki disease in individuals with coronary abnormalities.^{299 300}

B-cell Chronic Lymphocytic Leukemia (CLL)

IGIV (i.e., Gammagard S/D) is used for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL.^{151 153 155 156 157}

Prevention of Serious Bacterial Infections in HIV-infected Individuals

IGIV has been used in children with symptomatic HIV infection† who are immunosuppressed in association with AIDS or AIDS-related complex (ARC) in an attempt to control or prevent infections and improve immunologic parameters.^{130 139 155 156 157 173 174 175 176 177 178 179 180 181 184 215 216}

IGIV also has been used in HIV-infected adults†.^{130 155 156 157}

IGIV reduces the incidence of recurrent bacterial infections and sepsis, including upper respiratory tract infections, in adults and children with symptomatic HIV infection.^{155 156 157 175 176 177 178 216}

The ACIP, AAP, CDC, NIH, HIV Medicine Association of the IDSA, Pediatric Infectious Diseases Society, and other experts state that HIV-infected infants and children with hypogammaglobulinemia (IgG <400 mg/dL) should receive IGIV (400 mg/kg once every 2–4 weeks) to prevent serious bacterial infections.²¹⁵ These experts state that use of IGIV is no longer recommended for routine primary prevention of serious bacterial infections in HIV-infected infants and children; IGIV should only be used for prevention of serious bacterial infections if hypogammaglobulinemia is present or functional antibody deficiency is demonstrated by either poor specific antibody titers or recurrent bacterial infections.²¹⁵

Bone Marrow Transplantation (BMT)

IGIV has been used in adults and children undergoing BMT† to decrease the risk of infections (e.g., septicemia), interstitial pneumonia of infectious or idiopathic etiologies, and acute graft-versus-host disease (GVHD).^{221 223 224 225 306}

Effect of IGIV on the incidence of cytomegalovirus (CMV) infection, other infections, or GVHD in patients undergoing allogeneic BMT is unclear.^{221 222 223 224 225 304 306} IGIV prophylaxis in BMT patients does not appear to affect survival or risk of cancer relapse, and the long-term effects of such therapy remain to be determined.²²¹

Although efficacy and safety in BMT patients have not been established, some clinicians suggest that IGIV be used for prophylaxis in all allogeneic BMT patients, especially CMV-positive patients or those who have received a transplant from a CMV-positive donor.²²²

Some clinicians suggest that, although there is a perceived benefit of IGIV prophylaxis in infants with severe combined immunodeficiency or other primary immunodeficiency diseases undergoing BMT, the effect of IGIV in these children is difficult to study since they generally are receiving IGIV for replacement therapy.³⁰⁶ These clinicians also state that use of IGIV appears to offer little benefit in patients with malignancies undergoing HLA-identical sibling BMT and that additional study is needed to determine whether the drug is beneficial in those undergoing HLA-matched unrelated BMT or cord blood transplants.³⁰⁶

Hematopoietic Stem Cell Transplant (HSCT) Recipients

CDC, IDSA, and ASBMT state that, although routine use of IGIV for prophylaxis is not recommended for autologous HSCT recipients, some clinicians recommend use of IGIV to prevent bacterial infections (e.g., Streptococcus pneumoniae sinopulmonary infections) in adult, adolescent, or pediatric allogeneic HSCT recipients† who experience severe hypogammaglobulinemia (IgG <400 mg/dL) within the first 100 days after transplant.²⁶²

Routine administration of IGIV in HSCT recipients >90 days after HSCT is not recommended in the absence of severe hypogammaglobulinemia.²⁶²

Infections in Low-birthweight Neonates

IGIV has been used for prophylaxis and treatment of infections in certain high-risk, preterm, low-birthweight neonates†.^{130 137 155 156 157 166 167 168 169 170 171 172 214} However, until further data are available, do not use IGIV routinely for prophylaxis or treatment of nosocomial infections in preterm, low-birthweight infants.^{155 167 170 171 172 187 214}

Toxic Shock Syndrome

Some clinicians suggest that IGIV may be considered as an adjunct in the treatment of staphylococcal or streptococcal toxic shock syndrome† or necrotizing fasciitis† in severely ill patients.^{187 201 306}

Although efficacy and safety have not been established, AAP suggests that IGIV may be considered in the management of severe staphylococcal or streptococcal toxic shock syndrome† when the infection is refractory to several hours of aggressive therapy, an undrainable focus is present, or the patient has persistent oliguria with pulmonary edema.¹⁸⁷

Tetanus

IGIV has been recommended as an alternative for the treatment of tetanus† when tetanus immune globulin (TIG) is unavailable; TIG is the immune globulin of choice.¹⁸⁷

IGIV has been recommended as an alternative for postexposure prophylaxis of tetanus† in individuals with tetanus-prone wounds when TIG is unavailable; TIG is the immune globulin of choice.¹⁸⁷

Other Bacterial or Viral Infections

IGIV has been used alone or in conjunction with appropriate anti-infective therapy to prevent or modify acute bacterial or viral infections (e.g., CMV infections) in patients with iatrogenically induced or disease-associated immunosuppression† (e.g., patients undergoing major surgery [e.g., cardiac transplants]; patients with hematologic malignancies, extensive burns, or collagen-vascular diseases).^{130 136 141 155 156 157}

Autoimmune Neutropenia and Autoimmune Hemolytic Anemia

IGIV has been used with some success in a limited number of adults and children for the treatment of autoimmune neutropenia†.^{130 138 140 156 157 164} May be beneficial in some patients,^{304 306} but unclear whether IGIV offers any advantage over corticosteroid therapy.³⁰⁶

IGIV has been used with variable results in patients with autoimmune hemolytic anemia†.^{130 140 142 143 157} Some clinicians state IGIV should be used in the management of autoimmune hemolytic anemia only in those who fail to respond to other treatment options.³⁰⁶

Systemic Lupus Erythematosus

IGIV has been used with some success in the treatment of systemic lupus erythematosus† (SLE);^{218 301 304 305 306} efficacy and safety not definitely established and additional study is needed.^{305 306} Some clinicians suggest use of IGIV can be considered in patients with severe active SLE when other drugs have been ineffective or not tolerated;²¹⁸ other clinicians recommend caution.³⁰⁶

Neurologic and Neuromuscular Disorders

IGIV has been used in the treatment of Guillain-Barré syndrome† (GBS).^{165 219 301 304 305 306 310 312 317 318} Although safety and efficacy have not been established, IGIV initiated within 2 weeks of symptom onset appears to be as effective as plasma exchange^{218 301 305 306 310 312 317} and is recommended by some clinicians as a treatment of choice for GBS in adults or children,^{218 301 305 306 310 312 318} especially if disease is severe.^{301 312} Additional study needed to determine whether IGIV is beneficial in patients with mild GBS or Miller Fischer syndrome.^{310 312 317}

IGIV has been used in the management of multifocal motor neuropathy† (MMN) and may provide benefits (e.g., improved muscle strength) in some patients.^{301 304 305 306 310 311 312 313 314 315 316} Although efficacy and safety have not been established, some clinicians recommend IGIV as a treatment of choice for MMN^{301 305 306 310 311} when severe disability warrants treatment.³¹¹

IGIV has been used in the management of multiple sclerosis† (MS) and has provided benefits (e.g., reduced exacerbations, reduced disability scores) in some patients with relapsing-remitting MS.^{301 305 306 310 318} Although some clinicians suggest that IGIV can be considered as a potentially effective second- or third-line treatment in patients with relapsing-remitting MS,^{306 310} others state that additional study is needed to further evaluate potential benefits and role of the drug in this disease.

Humulin R (Concentrated) U-500

Generic Name: insulin regular, concentrated (U-500) (IN soo lin)

Brand Names: HumuLIN R (Concentrated)

What is concentrated insulin?

Concentrated insulin is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Concentrated insulin (U-500) is a long-acting form of insulin that is different from other forms that are made from animal insulin.

Concentrated insulin is used to treat type 1 (insulin-dependent) diabetes in people with significant daily insulin needs (more than 200 units per day).

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

What is the most important information I should know about concentrated insulin?

Concentrated insulin works differently from other types of insulin, and its effects may last for up to 24 hours after a single dose. Always check your medicine when it is refilled to make sure you have received the correct brand and type prescribed by your doctor.

While you are using concentrated insulin, do not use any other type of insulin or diabetes medications you take by mouth unless your doctor tells you to.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of hypoglycemia may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating.

If your blood sugar gets too high (hyperglycemia), you may have symptoms such as increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting. Call your doctor right away if you have any of these symptoms.

What should I discuss with my healthcare provider before using concentrated insulin?

Measure each dose of this medication carefully. Concentrated insulin contains 500 units of insulin in each milliliter. This is five times the concentration of other Humulin or Novolin insulins. Using too much concentrated insulin can cause severely low blood sugar (hypoglycemia), which could lead to insulin shock or death.

You should not use concentrated insulin if you are in a state of hypoglycemia.

Tell your doctor if you are pregnant or plan to become pregnant while you are using concentrated insulin. It is not known whether concentrated insulin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use concentrated insulin?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. It is important to use insulin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Concentrated insulin works differently than other types of insulin, and its effects may last for up to 24 hours after a single dose. The length of insulin effect will depend on your dose, your level of physical activity, and many other factors.

Concentrated insulin is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will show you how to inject your medicine at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

Use only an insulin or tuberculin syringe to inject this medication. Do not mix or dilute concentrated insulin with any other insulin.

Use a different place on your body each time you give yourself an injection. Your care provider will show you the places on your body where you can safely inject the medication.

Use a disposable needle and syringe only one time. Throw away used needles and syringes in a puncture-proof container. If your medicine does not come with such a container, ask your pharmacist where you can get one. Keep this container out of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the container.

Some needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Check your blood sugar levels often, especially during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your doctor may adjust your insulin dose if your levels are too high or too low.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose tablets or gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection. Be sure your family and close friends know how to help you in an emergency.

If your blood sugar gets too high (hyperglycemia), you may have symptoms such as increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting. Call your doctor right away if you have any of these symptoms.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type prescribed by your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are a diabetic.

Insulin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, overall proper health care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely.

Store concentrated insulin in the refrigerator, but do not allow it to freeze.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. Concentrated insulin should look as clear as water.

What happens if I miss a dose?

Follow your doctor's directions if you miss a dose of insulin. To prevent missed doses, be sure to keep insulin on hand at all times, especially when you are traveling away from home.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using concentrated insulin?

Avoid drinking alcohol while using concentrated insulin. Alcohol can lower your blood sugar.

Concentrated insulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your doctor if you have any pain, redness, swelling, or skin changes where the insulin was injected.

Low blood sugar is the most common side effect of concentrated insulin. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, seizure (convulsions), or death. Watch for signs of low blood sugar.

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

What other drugs will affect concentrated insulin?

Do not use any other insulins or diabetes medications you take by mouth, unless your doctor tells you to.

Hyperglycemia (high blood sugar) may be more likely to occur if you also use certain other medications such as:

• 
  

  diuretics (water pills);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  phenothiazines (Compazine and others);

  
  


• 
  

  thyroid medicine (Synthroid and others);

  
  


• 
  

  birth control pills and other hormones;

  
  


• 
  

  seizure medicines (Dilantin and others);

  
  


• 
  

  diet pills, or medicines to treat asthma, colds or allergies.

  
  

Hypoglycemia (low blood sugar) may be more likely to occur if you also use certain other medications such as:

• 
  

  some nonsteroidal anti-inflammatory drugs (NSAIDs);

  
  


• 
  

  aspirin or other salicylates (including Pepto-Bismol);

  
  


• 
  

  sulfa drugs (Bactrim and others);

  
  


• 
  

  a monoamine oxidase inhibitor (MAOI); or

  
  


• 
  

  beta-blockers (Tenormin and others).

  
  

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

More Humulin R (Concentrated) resources

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

Compare Humulin R (Concentrated) with other medications

• Diabetes, Type 1
• Diabetes, Type 2
• Diabetic Ketoacidosis
• Gestational Diabetes
• Growth Hormone Reserve Test
• Hyperkalemia
• Insulin Resistance Syndrome
• Nonketotic Hyperosmolar Syndrome

Where can I get more information?

• Your pharmacist can provide more information about concentrated insulin (U-500).

See also: Humulin R (Concentrated) side effects (in more detail)

Gastrografin

Dosage Form: solution

Gastrografin Description

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. Inactive ingredients: edetate disodium, flavor, polysorbate 80, purified water, saccharin sodium, simethicone, and sodium citrate.

Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas:

Gastrografin - Clinical Pharmacology

The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast with surrounding tissues.

Diagnostic enteral radiopaque agents have few known pharmacological effects. Diatrizoate meglumine and diatrizoate sodium exert a mild laxative effect attributable to their high osmolarity.

Diatrizoate meglumine and diatrizoate sodium are sparingly absorbed from the intact gastrointestinal tract, and therefore permit gastrointestinal opacification and delineation after oral or rectal administration. Oral administration is used for radiographic evaluation of the esophagus, stomach and proximal small intestine. Rectal administration is used for examination of the colon; however, visualization of the distal small bowel is generally unsatisfactory, since the hypertonicity of the medium causes intraluminal diffusion of water with subsequent dilution of the medium. Enough absorption from the gastrointestinal tract to permit incidental visualization of the urinary tract has been reported; this should also be considered when thyroid testing is being contemplated, since iodine-mediated thyrotropic effects may occur (see PRECAUTIONS).

Indications and Usage for Gastrografin

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.

Gastrografin may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.

Contraindications

Do not administer to patients with a known hypersensitivity to Gastrografin or any of its components.

Warnings

Dehydration: Administration of hypertonic Gastrografin solutions may lead to hypovolemia and hypotension due to fluid loss from the intestine. A 1 in 4.6 (1:4.6) dilution of Gastrografin yields an approximately isotonic 16.5 percent diatrizoate salts solution; less dilute solutions are hypertonic and may lead to intraluminal movement of fluid with resulting hypovolemia. In young or debilitated children and in elderly cachectic persons, the loss of plasma fluid may be sufficient to cause a shock-like state. If Gastrografin is used in infants and children (under 10 kg) or in dehydrated or debilitated patients, the solution must be prepared using the specific dilutions described in DOSAGE AND ADMINISTRATION. In debilitated patients and in patients with electrolyte imbalances, postprocedural monitoring of hydration, serum osmolarity, electrolytes and clinical status is essential. In pediatric or severely debilitated patients, the maintenance of an open intravenous fluid line for rehydration may be advisable should hypotension or shock supervene. Electrolyte disturbances must be corrected prior to the administration of any hypertonic Gastrografin solutions.

Aspiration: Aspiration of Gastrografin into the trachea and airways may result in serious pulmonary complications including, pulmonary edema, pneumonitis or death Bronchial entry of any orally administered contrast medium causes a copious osmotic effusion. Therefore, avoid use of Gastrografin in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients. If Gastrografin is given by nasogastric tube, the position of the tube in the stomach must be verified before administration.

Anaphylactic reactions: Anaphylactic reactions, including fatalities, have been reported with the use of Gastrografin. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies). Medical personnel trained in the treatment of anaphylactic reactions and the necessary drugs and medical equipment should always be readily available when Gastrografin is used.

Precautions

General

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of administration, as well as for treatment of reaction to the contrast medium (see ADVERSE REACTIONS, and PRECAUTIONS, Information for the Patient).

Rectal administration of undiluted Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) in any patient, particularly with large doses and/or in those with overdistention, has been reported to be associated with mucosal irritation.

Cases of hyperthyroidism have been reported with the use of oral contrast media. Some of these patients reportedly had multinodular goiters which may have been responsible for the increased hormone synthesis in response to excess iodine. Administration of an intravascular iodinated radiopaque diagnostic agent to a hyperthyroid patient precipitated thyroid storm; a similar situation could follow administration of oral preparations of iodides. Therefore, caution should be exercised when administering enteral gastrointestinal radiopaque agents to hyperthyroid and euthyroid goiterous patients.

Consideration should be given to the potential for precipitation of water-soluble contrast agents under conditions that may promote hyperacidity (i.e., fasting, emotional upset, or stress). Harmful effects directly attributable to precipitate formation have not been reported. However, the possibility of interpreting the precipitate radiologically as an anatomical abnormality (i.e., ulceration of the stomach or small intestine) or injury, should be kept in mind.

Information for the Patient

Patients should receive the following information and instructions:

1. This drug has been prescribed to perform an x-ray of the gastrointestinal tract.


2. Inform the physician if pregnant or if allergic to iodine, any foods, or x-ray materials.


3. The iodine in diatrizoate salts may interfere with some thyroid tests if these are needed in the future. Inform the attending physician at that time about this gastrointestinal study.


4. This drug may cause abdominal cramping, nausea, vomiting, diarrhea, skin rashes, itching, heartburn, dizziness, or headache in some patients, but most reactions are mild and pass quickly.

Drug/Laboratory Test Interactions

Thyroid Function Tests

The results of protein bound iodine (PBI) and radioactive iodine uptake studies, which depend on iodine estimations, will not accurately reflect thyroid function for six months, and possibly as long as one year, following the administration of diagnostic enteral radiopaque media.

Thyroid function tests, if indicated, generally should be performed prior to the administration of any iodinated agent. However, thyroid function can be evaluated after use of these agents by using T3 resin uptake and total or free thyroxine (T4) assays which are not dependent on iodine estimations.

Pancreatic Tests

Small quantities of contrast medium in the intestinal tract may cause false low trypsin values when determined spectrophotometrically. Therefore, duodenal instillation should not precede pancreatic function tests involving spectrophotometric trypsin assays.

Any test which might be affected by contrast media should be performed prior to administration of the contrast medium.

Carcinogenesis, Mutagenesis,

Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

Pregnancy Category B

When administered intravenously, diatrizoate salts cross the placenta and are evenly distributed in fetal tissues.

No teratogenic effects attributable to diatrizoate meglumine or diatrizoate sodium have been observed in teratology studies performed in animals. There are, however, no adequate and well-controlled studies in pregnant women. Because small amounts of these agents may be absorbed, and animal teratology studies are not always predictive of human response, these agents should be used during pregnancy only when clearly needed.

Procedures including radiation involve a certain risk related to the exposure of the fetus.

Nursing Mothers

Diatrizoate meglumine is excreted in breast milk following intravascular administration.

Because small amounts of enteral gastrointestinal radiopaque agents may be absorbed following oral or rectal administration, caution should be exercised when they are administered to a nursing woman.

Pediatric Use

See WARNINGS, and PRECAUTIONS, General.

Local injury to the colonic mucosa, particularly in the presence of underlying disease which interferes with intestinal viability, has been reported in cases where recommended doses and dilutions (see DOSAGE AND ADMINISTRATION) were not used; when extemporaneous dosage is elected, the polysorbate 80 level in the dose may be a contributing factor to injury.

Adverse Reactions

Most adverse reactions to enteral diagnostic radiopaque agents are mild and transitory. Nausea, vomiting and/or diarrhea, urticaria with erythema, hypoxia, acute dyspnea, tachyarrhythmia, and anaphylaxis have occurred following ingestion of the contrast medium, particularly when high concentrations of large volumes of solution are administered. Severe changes in serum osmolarity and electrolyte concentrations may produce shock-like states (see WARNINGS). It should be kept in mind that serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes.

Overdosage

See WARNINGS regarding potential hypovolemia, hypotension, or shock. The maintenance of an open intravenous fluid line for rehydration may be advisable. See DOSAGE AND ADMINISTRATION for appropriate doses and dilutions. Treatment of an overdose should be directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

Gastrografin Dosage and Administration

General

This medium is not to be used for the preparation of solutions for parenteral administration. Oral or rectal administration only.

The routine preparatory measures employed for barium studies are also appropriate for this agent.

For pediatric and severely cachectic patients the maintenance of an intravenous fluid line may be advisable.

Radiographic Examination of Segments of the Gastrointestinal Tract

Oral Administration: Adult oral dosage may range from 30 to 90 mL (11 to 33 g iodine), depending on the nature of the examination and the size of the patient. For infants and children less than 5 years of age, 30 mL (11 g iodine) are usually adequate; for children 5 to 10 years of age, the suggested dose is 60 mL (22 g iodine). These pediatric doses may be diluted 1:1, if desired, with water, carbonated beverage, milk, or mineral oil. When used in infants, the solution may be given in a nursing bottle. Pediatric doses may also be used in dehydrated and/or debilitated adult patients. A 1:1 dilution is also recommended when the contrast medium is used in elderly cachectic individuals.

For very young (under 10 kg) and debilitated children the dose should be diluted: 1 part Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) in 3 parts water is recommended.

For Enemas or Enterostomy Instillations: Gastrografin should be diluted when it is used for enemas and enterostomy instillations. When used as an enema, the suggested dilution for adults is 240 mL (88 g iodine) in 1,000 mL of tap water. For children under 5 years of age, a 1:5 dilution in tap water is suggested; for children over 5 years of age, 90 mL (33 g iodine) in 500 mL of tap water is a suitable dilution.

Tomography (Body Imaging)

A usual adult dose is 240 mL of a dilute Gastrografin solution prepared by diluting 25 mL (9.17 g iodine) to one liter with tap water. Less dilute solutions [up to 77 mL (28.26 g iodine) diluted to one liter with tap water] may be used when indicated. The dose is administered orally about 15 to 30 minutes prior to imaging in order to permit the contrast medium to reach the pelvic loops.

How is Gastrografin Supplied

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP) is available in packages of:

Twenty-four 30 mL single dose bottles (NDC 0270-0445-35).

Twelve 120 mL bottles (NDC 0270-0445-40).

Storage

Protect from light. Store at 20-25°C (68-77°F) [See USP]; avoid excessive heat.

Manufactured for

Bracco Diagnostics Inc.

Princeton, NJ 08543

by Therapex, Division of E-Z-EM Canada, Inc.

Anjou, Quebec H1J 2Z4, Canada

Rev. September 2007

CW1336-3

Gastrografin   diatrizoate meglumine and diatrizoate sodium  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0270-0445 Route of Administration ORAL, RECTAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength diatrizoate meglumine (diatrizoic acid) Active 660 MILLIGRAM  In 1 MILLILITER diatrizoate sodium (diatrizoic acid) Active 100 MILLIGRAM  In 1 MILLILITER sodium citrate Inactive 3.22 MILLIGRAM  In 1 MILLILITER sodium saccharin Inactive 2.77 MILLIGRAM  In 1 MILLILITER edetate disodium Inactive 0.403 MILLIGRAM  In 1 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0270-0445-35 24 BOTTLE In 1 PACKAGE contains a BOTTLE 1 30 mL (MILLILITER) In 1 BOTTLE This package is contained within the PACKAGE (0270-0445-35) 2 0270-0445-40 12 BOTTLE In 1 PACKAGE contains a BOTTLE 2 120 mL (MILLILITER) In 1 BOTTLE This package is contained within the PACKAGE (0270-0445-40)

Revised: 04/2008Bracco Diagnostics Inc.

More Gastrografin resources

• Gastrografin Side Effects (in more detail)
• Gastrografin Drug Interactions
• Gastrografin Support Group
• 0 Reviews · Be the first to review/rate this drug

• Diatrizoate Meglumine Professional Patient Advice (Wolters Kluwer)

Liquimat Topical

Generic Name: sulfur (Topical route)

SUL-fur

Commonly used brand name(s)

In the U.S.

• Liquimat


• Sastid Soap


• Sulfoam


• Sulfo-Lo


• Sulmasque


• Sulpho-Lac


• Sul-Ray Aloe Vera Acne


• Thylox Acne Treatment


• Zapzyt Cleansing

Available Dosage Forms:

• Soap


• Ointment


• Shampoo


• Liquid


• Lotion


• Cream


• Gel/Jelly


• Solution

Therapeutic Class: Antiacne

Uses For Liquimat

Sulfur is used to treat many kinds of skin disorders. Sulfur cream, lotion, ointment, and bar soap are used to treat acne. Sulfur ointment is used to treat seborrheic dermatitis and scabies. Sulfur may also be used for other conditions as determined by your doctor.

Some of these preparations are available only with your doctor's prescription.

Before Using Liquimat

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

Although there is no specific information comparing use of this medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of sulfur in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of sulfur

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

Use this medicine only as directed. Do not use it more often and do not use it for a longer period of time than recommended on the label, unless otherwise directed by your doctor.

Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.

To use the cream or lotion form of this medicine:

• Before applying the medicine, wash the affected areas with soap and water and dry thoroughly. Then apply enough medicine to cover the affected areas and rub in gently.

To use the ointment form of this medicine for seborrheic dermatitis:

• Before applying the medicine, wash the affected areas with soap and water and dry thoroughly. Then apply enough medicine to cover the affected areas and rub in gently.

To use the ointment form of this medicine for scabies:

• Before applying the medicine, wash your entire body with soap and water and dry thoroughly.


• At bedtime, apply enough medicine to cover your entire body from the neck down and rub in gently. Leave the medicine on your body for 24 hours.


• Before applying the medicine again, you may wash your entire body.


• 24 hours after the last treatment with this medicine, it is important that you thoroughly wash your entire body again.

To use the soap form of this medicine:

• Work up a rich lather with the soap, using warm water. Wash the affected areas and rinse thoroughly. Apply again, and rub in gently for a few minutes. Remove excess lather with a towel or tissue without rinsing.

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 acne:
  
  • For cream and bar soap dosage forms:
    
    • Adults and children—Use on the skin as needed.
    
    
  
  
  • For lotion dosage form:
    
    • Adults and children—Use two or three times a day.
    
    
  
  
  • For ointment dosage form:
    
    • Adults and children—Use the 0.5% ointment on the skin as needed.
    
    
  
  


• For seborrheic dermatitis:
  
  • For ointment dosage form:
    
    • Adults and children—Use the 5 to 10% ointment one or two times a day.
    
    
  
  


• For scabies:
  
  • For ointment dosage form:
    
    • Adults and children—Use the 6% ointment each night for three nights.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Liquimat

When using sulfur, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers


• Alcohol-containing preparations


• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, salicylic acid, or tretinoin [vitamin A acid])


• Cosmetics or soaps that dry the skin


• Medicated cosmetics


• Other topical medicine for the skin

To use any of the above preparations on the same affected area as sulfur may cause severe irritation of the skin.

Do not use any topical mercury-containing preparation, such as ammoniated mercury ointment, on the same area as this medicine. To do so may cause a foul odor, may be irritating to the skin, and may stain the skin black. If you have any questions about this, check with your health care professional.

Liquimat Side Effects

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

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

• Skin irritation not present before use of this medicine

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:

• Redness and peeling of skin (may occur after a few days)

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: Liquimat Topical 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 Liquimat Topical resources

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

Compare Liquimat Topical with other medications

• Acne

Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets

Pronunciation: dex-troe-meth-OR-fan/gwye-FEN-e-sin/soo-doe-e-FED-rin
Generic Name: Dextromethorphan/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Ambi 60/580/30 and Maxifed DM

Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets are used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets are a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets if:

• you are allergic to any ingredient in Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets


• you have severe high blood pressure, a fast heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you are taking droxidopa or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days


• you are breast-feeding

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

Before using Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets:

Some medical conditions may interact with Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have a history of glaucoma or increased pressure in the eye, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, stroke, trouble sleeping, or seizures


• if you have chronic cough, a cough that produces large amounts of mucus, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema)


• if you have had an unusual reaction to a sympathomimetic (eg, ephedrine)

Some MEDICINES MAY INTERACT with Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets 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 Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets:

Use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets by mouth with or without food.


• Drink plenty of water while taking Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets.


• Swallow Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets may be broken in half before they are taken. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand may be broken in half.


• If you miss a dose of Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets.

Important safety information:

• Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take appetite suppressants while you are taking Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets without checking with your doctor first.


• Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets contains pseudoephedrine and dextromethorphan. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine or dextromethorphan. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 days, if they become worse, or if you have a fever, check with your doctor.


• Tell your doctor or dentist that you take Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets may interfere with certain lab tests. Be sure that your doctor and lab personnel know you are taking Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets.


• Use Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations and seizures.


• Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets are should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these 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 Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets while you are pregnant. It is not known if Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets.

Possible side effects of Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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); difficulty urinating; fast or irregular heartbeat; fever; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; unusually pale skin.

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: Ambi 60/580/30 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; change in amount or frequency of urination; confusion; hallucinations; increased thirst; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; unusually pale skin; vomiting.

Proper storage of Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets:

Store Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets are 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 Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets. 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 Ambi 60/580/30 resources

• Ambi 60/580/30 Side Effects (in more detail)
• Ambi 60/580/30 Use in Pregnancy & Breastfeeding
• Ambi 60/580/30 Drug Interactions
• 0 Reviews for Ambi 60/580/30 - Add your own review/rating

Compare Ambi 60/580/30 with other medications

• Cough and Nasal Congestion

Prednisolone Sodium Phosphate Liquid

Generic Name: Prednisolone Sodium Phosphate (pred-NIS-oh-lone SO-dee-uhm FOSS-fate)
Brand Name: PediaPred

Prednisolone Sodium Phosphate Liquid is used for:

Treating severe allergies, arthritis, asthma, certain blood disorders, and skin conditions. It may also be used for other conditions as determined by your doctor.

Prednisolone Sodium Phosphate Liquid is a corticosteroid. It works by modifying the body's immune response to various conditions and decreasing inflammation.

Do NOT use Prednisolone Sodium Phosphate Liquid if:

• you are allergic to any ingredient in Prednisolone Sodium Phosphate Liquid


• you have a systemic fungal infection, a certain type of malaria, inflammation of the optic nerve, or herpes infection of the eye


• you are scheduled to have a live or attenuated live vaccination (eg, smallpox)


• you are taking mifepristone

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

Before using Prednisolone Sodium Phosphate Liquid:

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

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


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


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


• if you have a history of heart problems (eg, congestive heart failure), heart attack, high blood pressure, kidney problems, liver problems, diabetes, seizures, an underactive thyroid, adrenal gland problems, or any mental or mood problems


• if you have or have recently had a fungal, bacterial, viral, or other type of infection; herpes infection of the eye; chickenpox; measles; or shingles


• if you have HIV infection or tuberculosis (TB) infection, or you have had ever had a positive TB skin test


• if you have any stomach problems (eg, ulcers), intestinal problems (eg, blockage, perforation, or infection; unexplained diarrhea; diverticulitis; ulcerative colitis), recent intestinal surgery, or inflammation of the esophagus


• if you have weak bones (eg, osteoporosis) or muscle problems (eg, myasthenia gravis)


• if you have had a recent vaccination (eg, smallpox)

Some MEDICINES MAY INTERACT with Prednisolone Sodium Phosphate Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), carbamazepine, ephedrine, hydantoins (eg, phenytoin), or rifampin because they may decrease Prednisolone Sodium Phosphate Liquid's effectiveness


• Clarithromycin, cyclosporine, estrogens (eg, estradiol), ketoconazole, or oral contraceptives (eg, birth control pills) because they may increase the risk of Prednisolone Sodium Phosphate Liquid's side effects


• Anticholinesterases (eg, pyridostigmine), aspirin, diuretics, furosemide, hydrochlorothiazide, live or attenuated live vaccines, methotrexate, mifepristone, or ritodrine because the risk of their side effects may be increased by Prednisolone Sodium Phosphate Liquid


• Anticoagulants (eg, warfarin) or killed or inactivated vaccines because their effectiveness may be decreased by Prednisolone Sodium Phosphate Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prednisolone Sodium Phosphate Liquid 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 Prednisolone Sodium Phosphate Liquid:

Use Prednisolone Sodium Phosphate Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Prednisolone Sodium Phosphate Liquid by mouth with food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Prednisolone Sodium Phosphate Liquid and you are taking 1 dose daily, take it as soon as possible. If you do not remember until the next day, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prednisolone Sodium Phosphate Liquid.

Important safety information:

• Prednisolone Sodium Phosphate Liquid may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.


• Report to your doctor any injuries or signs of infection (fever, sore throat, pain during urination, or muscle aches) for up to 12 months after stopping Prednisolone Sodium Phosphate Liquid.


• Carry an ID card at all times that says you take Prednisolone Sodium Phosphate Liquid.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Prednisolone Sodium Phosphate Liquid. Talk with your doctor before you receive any vaccine.


• Tell your doctor or dentist that you take Prednisolone Sodium Phosphate Liquid before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Prednisolone Sodium Phosphate Liquid may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including adrenal function tests, may be performed while you use Prednisolone Sodium Phosphate Liquid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Caution is advised when using Prednisolone Sodium Phosphate Liquid in CHILDREN; they may be more sensitive to its effects.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Prednisolone Sodium Phosphate Liquid.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prednisolone Sodium Phosphate Liquid while you are pregnant. Prednisolone Sodium Phosphate Liquid is found in breast milk. If you are or will be breast-feeding while you use Prednisolone Sodium Phosphate Liquid, check with your doctor. Discuss any possible risks to your baby.

If you are on long-term or high dosage therapy and you suddenly stop taking Prednisolone Sodium Phosphate Liquid, you may have WITHDRAWAL symptoms, including fever, vomiting, appetite loss, diarrhea, nausea, dizziness, weight loss, weakness, general body discomfort, or joint or muscle pain.

Possible side effects of Prednisolone Sodium Phosphate Liquid:

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:

Acne; clumsiness; dizziness; facial flushing; feeling of a whirling motion; general body discomfort; headache; increased appetite; increased sweating; nausea; nervousness; sleeplessness; upset stomach.

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); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; infection (eg, fever, chills, sore throat); mental or mood changes (eg, depression); muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; sudden severe dizziness or headache; swelling of feet or legs; tendon or bone pain; thinning of skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

Esta no es una lista completa de todos los efectos secundarios que se pueden presentar. Si tiene dudas acerca de los efectos secundarios, consulte a su profesional del cuidado de la salud. Llame a su médico para obtener asesoramiento sobre los efectos secundarios. Puede informar los efectos secundarios a la FDA al 1-800-FDA-1088. También puede informarlos al http://www.fda.gov/medwatch.

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 Prednisolone Sodium Phosphate Liquid:

Store Prednisolone Sodium Phosphate Liquid at room temperature, between 59 and 77 degrees F (15 to 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prednisolone Sodium Phosphate Liquid out of the reach of children and away from pets.

General information:

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


• Prednisolone Sodium Phosphate Liquid 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.

This information is a summary only. It does not contain all information about Prednisolone Sodium Phosphate Liquid. 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 Prednisolone Sodium Phosphate resources

• Prednisolone Sodium Phosphate Use in Pregnancy & Breastfeeding
• Drug Images
• Prednisolone Sodium Phosphate Drug Interactions
• Prednisolone Sodium Phosphate Support Group
• 13 Reviews for Prednisolone Sodium Phosphate - Add your own review/rating

Compare Prednisolone Sodium Phosphate with other medications

• Asthma, acute
• Bronchopulmonary Dysplasia
• Bullous Pemphigoid
• Dermatitis
• Immunosuppression
• Inflammatory Conditions
• Multiple Sclerosis
• Nephrotic Syndrome
• Pemphigoid
• Pemphigus