U.S. BRAND NAMES — Ziagen®
CANADIAN BRAND NAMES — Ziagen®
MEXICAN BRAND NAMES — Ziagenavir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Never restart this medicine if you have had an allergic reaction. Swollen liver and an acid condition in the blood have occurred with the use of this medicine.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you have liver disease.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir works to injure the virus and fight the infection.
How is it best taken? Use prescription as directed, even if feeling better. This medicine is usually taken with at least two other medicines. Take this medicine with or without food. Take with food if it causes an upset stomach. A liquid (solution) is available if you cannot swallow pills. Those who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Do not run out of this medicine. Wear disease medical alert identification. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Avoid alcohol (includes wine, beer, and liquor). To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Weight gain. Diarrhea. Not hungry.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain. Dark urine or yellow skin or eyes. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store tablets at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen. Store liquid (solution) at room temperature or in a refrigerator. Do not freeze.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins. Read the package insert for more details.
Friday, February 1, 2008
Abacavir
U.S. BRAND NAMES — Ziagen®
CANADIAN BRAND NAMES — Ziagen®
MEXICAN BRAND NAMES — Ziagenavir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Never restart this medicine if you have had an allergic reaction. Swollen liver and an acid condition in the blood have occurred with the use of this medicine.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you have liver disease.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir works to injure the virus and fight the infection.
How is it best taken? Use prescription as directed, even if feeling better. This medicine is usually taken with at least two other medicines. Take this medicine with or without food. Take with food if it causes an upset stomach. A liquid (solution) is available if you cannot swallow pills. Those who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Do not run out of this medicine. Wear disease medical alert identification. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Avoid alcohol (includes wine, beer, and liquor). To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Weight gain. Diarrhea. Not hungry.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain. Dark urine or yellow skin or eyes. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store tablets at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen. Store liquid (solution) at room temperature or in a refrigerator. Do not freeze.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins. Read the package insert for more details.
CANADIAN BRAND NAMES — Ziagen®
MEXICAN BRAND NAMES — Ziagenavir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Never restart this medicine if you have had an allergic reaction. Swollen liver and an acid condition in the blood have occurred with the use of this medicine.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you have liver disease.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir works to injure the virus and fight the infection.
How is it best taken? Use prescription as directed, even if feeling better. This medicine is usually taken with at least two other medicines. Take this medicine with or without food. Take with food if it causes an upset stomach. A liquid (solution) is available if you cannot swallow pills. Those who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Do not run out of this medicine. Wear disease medical alert identification. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Avoid alcohol (includes wine, beer, and liquor). To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Weight gain. Diarrhea. Not hungry.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain. Dark urine or yellow skin or eyes. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store tablets at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen. Store liquid (solution) at room temperature or in a refrigerator. Do not freeze.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins. Read the package insert for more details.
Thursday, January 31, 2008
Agalsidase bet
U.S. BRAND NAMES — Fabrazyme®
CANADIAN BRAND NAMES — Fabrazyme®
SYNONYMS — Fabrase; Recombinant Human Alpha-Galactosidase A
THERAPEUTIC CATEGORY Enzyme, alpha-galactosidase AFabry's Disease, Treatment Agent
DOSING — I.V.: Children and Adults: 1 mg/kg/dose every two weeks
(For additional information see "Agalsidase beta: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution: 5 mg [contains mannitol 33 mg; derived from Chinese hamster cells]; 35 mg [contains mannitol 222 mg/vial; derived from Chinese hamster cells]
GENERIC AVAILABLE — No
ADMINISTRATION — I.V.: Reconstitute vial with 7.2 mL SWI to result in 5 mg/mL concentration; swirl to dissolve; do not shake; further dilute dosage in 500 mL NS*. Initial infusion not to exceed 15 mg/hour (0.25 mg/minute); after patient tolerance to initial infusion rate is established, the infusion rate may be increased in increments of 3-5 mg/hour (0.05-0.08 mg/minute) with subsequent infusions. In clinical studies, patients have tolerated infusion rates 33 mg/hour. Pretreatment with acetaminophen and an antihistamine is recommended to reduce infusion related side effects (See Warnings)
*Agalsidase beta stability when diluted in NS at a concentration of 2.55 mg/mL has been demonstrated by the manufacturer. Infusion volumes as low as 100 mL were used in phase I/II clinical trials. (Personal communication, Genzyme Corporation, 2003)
USE — Treatment of Fabry's disease
ADVERSE REACTIONS Cardiovascular: Tachycardia, hypertension, hypotension, chest pain, chest tightness, bradycardia, arrhythmias, cardiac arrest, edema, pallor
Central nervous system: Headache, dizziness, fever, anxiety, depression, chills, rigors, vertigo
Dermatologic: Pruritus, urticaria
Gastrointestinal: Dyspepsia, nausea, abdominal pain, vomiting
Genitourinary: Testicular pain
Neuromuscular & skeletal: Arthrosis, skeletal pain, myalgia
Otic: Hypoacousia
Respiratory: Bronchitis, bronchospasm, laryngitis, pharyngitis, sinusitis, rhinitis, dyspnea
Miscellaneous: Hypersensitivity reactions
CONTRAINDICATIONS — Hypersensitivity to agalsidase beta or any component
PRECAUTIONS — Use with caution in patients with compromised cardiac function (seen in advanced Fabry's disease) due to an increased potential for severe infusion related reactions; monitor these patients closely; patients may develop IgG antibodies to agalsidase beta
WARNINGS — Infusion-related reactions (ranging from mild to severe) including fever, rigors, chest tightness, hypertension, hypotension, pruritus, myalgia, dyspnea, urticaria, abdominal pain, and headache have been reported; these reactions may be minimized by pretreatment with acetaminophen and an antihistamine; if an infusion related reaction occurs, regardless of pretreatment, decreasing the infusion rate, temporarily stopping the infusion, and/or additional administration of analgesics, antihistamines, or corticosteroids may ameliorate the reaction.
DRUG INTERACTIONS — None as yet have been identified
PREGNANCY RISK FACTOR — B (show table)
MONITORING PARAMETERS — Vital signs during infusion; globotriaosylceramide (GL3) plasma levels; improvement in symptomatology
REFERENCE RANGE — Normal endogenous activity of alpha-galactosidase A in plasma is approximately 170 nmol/hour/mL; in patients with Fabry's disease this activity is <1.5 nmol/hour/mL
Normal (goal) globotriaosylceramide (GL3) <1.2 ng/microliter
STABILITY — Store in refrigerator 2ºC to 8ºC (36ºF to 46ºF); reconstituted solution is stable for 24 hours refrigerated
MECHANISM OF ACTION — Agalsidase beta is a recombinant human alpha-galactosidase A enzyme with the same amino acid sequence as the naturally-occurring enzyme. Fabry's disease is an X-linked genetic disorder occurring in 1 in 50,000 male births, which results in a deficiency of alpha-galactosidase A. Lack of this enzyme leads to a progressive accumulation of glycosphingolipids, predominantly GL-3, in the vascular endothelium, leading to ischemia and infarction, especially in the kidney, heart, and brain. Clinical manifestations of Fabry's disease in childhood include intermittent severe pain in the extremities, characteristic vascular skin lesions (angiokeratomas), corneal and lenticular opacities that do not affect vision, decreased ability to sweat, intolerance to heat, cold, and exercise, mild proteinuria, and GI problems. By adulthood, this progresses to renal failure, cardiomyopathy, and cerebrovascular accidents.
PHARMACOKINETICS Distribution: Vd: Adults: 80-330 mL/kg
Half-life: Adults: 45-102 minutes (dose dependent)
ADDITIONAL INFORMATION — Agalsidase beta is an orphan drug; a Fabry Patient Support Group (800-745-4447) is available to assist patients in obtaining reimbursement from private insurers, Medicare, and Medicaid, and a Charitable Access Program sponsored by Genzyme provides the drug gratis to those patients in need. Detailed information regarding organizations and websites is also available in the Expert Panel Recommendations (Desnick, 2003)
CANADIAN BRAND NAMES — Fabrazyme®
SYNONYMS — Fabrase; Recombinant Human Alpha-Galactosidase A
THERAPEUTIC CATEGORY Enzyme, alpha-galactosidase AFabry's Disease, Treatment Agent
DOSING — I.V.: Children and Adults: 1 mg/kg/dose every two weeks
(For additional information see "Agalsidase beta: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution: 5 mg [contains mannitol 33 mg; derived from Chinese hamster cells]; 35 mg [contains mannitol 222 mg/vial; derived from Chinese hamster cells]
GENERIC AVAILABLE — No
ADMINISTRATION — I.V.: Reconstitute vial with 7.2 mL SWI to result in 5 mg/mL concentration; swirl to dissolve; do not shake; further dilute dosage in 500 mL NS*. Initial infusion not to exceed 15 mg/hour (0.25 mg/minute); after patient tolerance to initial infusion rate is established, the infusion rate may be increased in increments of 3-5 mg/hour (0.05-0.08 mg/minute) with subsequent infusions. In clinical studies, patients have tolerated infusion rates 33 mg/hour. Pretreatment with acetaminophen and an antihistamine is recommended to reduce infusion related side effects (See Warnings)
*Agalsidase beta stability when diluted in NS at a concentration of 2.55 mg/mL has been demonstrated by the manufacturer. Infusion volumes as low as 100 mL were used in phase I/II clinical trials. (Personal communication, Genzyme Corporation, 2003)
USE — Treatment of Fabry's disease
ADVERSE REACTIONS Cardiovascular: Tachycardia, hypertension, hypotension, chest pain, chest tightness, bradycardia, arrhythmias, cardiac arrest, edema, pallor
Central nervous system: Headache, dizziness, fever, anxiety, depression, chills, rigors, vertigo
Dermatologic: Pruritus, urticaria
Gastrointestinal: Dyspepsia, nausea, abdominal pain, vomiting
Genitourinary: Testicular pain
Neuromuscular & skeletal: Arthrosis, skeletal pain, myalgia
Otic: Hypoacousia
Respiratory: Bronchitis, bronchospasm, laryngitis, pharyngitis, sinusitis, rhinitis, dyspnea
Miscellaneous: Hypersensitivity reactions
CONTRAINDICATIONS — Hypersensitivity to agalsidase beta or any component
PRECAUTIONS — Use with caution in patients with compromised cardiac function (seen in advanced Fabry's disease) due to an increased potential for severe infusion related reactions; monitor these patients closely; patients may develop IgG antibodies to agalsidase beta
WARNINGS — Infusion-related reactions (ranging from mild to severe) including fever, rigors, chest tightness, hypertension, hypotension, pruritus, myalgia, dyspnea, urticaria, abdominal pain, and headache have been reported; these reactions may be minimized by pretreatment with acetaminophen and an antihistamine; if an infusion related reaction occurs, regardless of pretreatment, decreasing the infusion rate, temporarily stopping the infusion, and/or additional administration of analgesics, antihistamines, or corticosteroids may ameliorate the reaction.
DRUG INTERACTIONS — None as yet have been identified
PREGNANCY RISK FACTOR — B (show table)
MONITORING PARAMETERS — Vital signs during infusion; globotriaosylceramide (GL3) plasma levels; improvement in symptomatology
REFERENCE RANGE — Normal endogenous activity of alpha-galactosidase A in plasma is approximately 170 nmol/hour/mL; in patients with Fabry's disease this activity is <1.5 nmol/hour/mL
Normal (goal) globotriaosylceramide (GL3) <1.2 ng/microliter
STABILITY — Store in refrigerator 2ºC to 8ºC (36ºF to 46ºF); reconstituted solution is stable for 24 hours refrigerated
MECHANISM OF ACTION — Agalsidase beta is a recombinant human alpha-galactosidase A enzyme with the same amino acid sequence as the naturally-occurring enzyme. Fabry's disease is an X-linked genetic disorder occurring in 1 in 50,000 male births, which results in a deficiency of alpha-galactosidase A. Lack of this enzyme leads to a progressive accumulation of glycosphingolipids, predominantly GL-3, in the vascular endothelium, leading to ischemia and infarction, especially in the kidney, heart, and brain. Clinical manifestations of Fabry's disease in childhood include intermittent severe pain in the extremities, characteristic vascular skin lesions (angiokeratomas), corneal and lenticular opacities that do not affect vision, decreased ability to sweat, intolerance to heat, cold, and exercise, mild proteinuria, and GI problems. By adulthood, this progresses to renal failure, cardiomyopathy, and cerebrovascular accidents.
PHARMACOKINETICS Distribution: Vd: Adults: 80-330 mL/kg
Half-life: Adults: 45-102 minutes (dose dependent)
ADDITIONAL INFORMATION — Agalsidase beta is an orphan drug; a Fabry Patient Support Group (800-745-4447) is available to assist patients in obtaining reimbursement from private insurers, Medicare, and Medicaid, and a Charitable Access Program sponsored by Genzyme provides the drug gratis to those patients in need. Detailed information regarding organizations and websites is also available in the Expert Panel Recommendations (Desnick, 2003)
Agalsidase bet
U.S. BRAND NAMES — Fabrazyme®
CANADIAN BRAND NAMES — Fabrazyme®
SYNONYMS — Fabrase; Recombinant Human Alpha-Galactosidase A
THERAPEUTIC CATEGORY Enzyme, alpha-galactosidase AFabry's Disease, Treatment Agent
DOSING — I.V.: Children and Adults: 1 mg/kg/dose every two weeks
(For additional information see "Agalsidase beta: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution: 5 mg [contains mannitol 33 mg; derived from Chinese hamster cells]; 35 mg [contains mannitol 222 mg/vial; derived from Chinese hamster cells]
GENERIC AVAILABLE — No
ADMINISTRATION — I.V.: Reconstitute vial with 7.2 mL SWI to result in 5 mg/mL concentration; swirl to dissolve; do not shake; further dilute dosage in 500 mL NS*. Initial infusion not to exceed 15 mg/hour (0.25 mg/minute); after patient tolerance to initial infusion rate is established, the infusion rate may be increased in increments of 3-5 mg/hour (0.05-0.08 mg/minute) with subsequent infusions. In clinical studies, patients have tolerated infusion rates 33 mg/hour. Pretreatment with acetaminophen and an antihistamine is recommended to reduce infusion related side effects (See Warnings)
*Agalsidase beta stability when diluted in NS at a concentration of 2.55 mg/mL has been demonstrated by the manufacturer. Infusion volumes as low as 100 mL were used in phase I/II clinical trials. (Personal communication, Genzyme Corporation, 2003)
USE — Treatment of Fabry's disease
ADVERSE REACTIONS Cardiovascular: Tachycardia, hypertension, hypotension, chest pain, chest tightness, bradycardia, arrhythmias, cardiac arrest, edema, pallor
Central nervous system: Headache, dizziness, fever, anxiety, depression, chills, rigors, vertigo
Dermatologic: Pruritus, urticaria
Gastrointestinal: Dyspepsia, nausea, abdominal pain, vomiting
Genitourinary: Testicular pain
Neuromuscular & skeletal: Arthrosis, skeletal pain, myalgia
Otic: Hypoacousia
Respiratory: Bronchitis, bronchospasm, laryngitis, pharyngitis, sinusitis, rhinitis, dyspnea
Miscellaneous: Hypersensitivity reactions
CONTRAINDICATIONS — Hypersensitivity to agalsidase beta or any component
PRECAUTIONS — Use with caution in patients with compromised cardiac function (seen in advanced Fabry's disease) due to an increased potential for severe infusion related reactions; monitor these patients closely; patients may develop IgG antibodies to agalsidase beta
WARNINGS — Infusion-related reactions (ranging from mild to severe) including fever, rigors, chest tightness, hypertension, hypotension, pruritus, myalgia, dyspnea, urticaria, abdominal pain, and headache have been reported; these reactions may be minimized by pretreatment with acetaminophen and an antihistamine; if an infusion related reaction occurs, regardless of pretreatment, decreasing the infusion rate, temporarily stopping the infusion, and/or additional administration of analgesics, antihistamines, or corticosteroids may ameliorate the reaction.
DRUG INTERACTIONS — None as yet have been identified
PREGNANCY RISK FACTOR — B (show table)
MONITORING PARAMETERS — Vital signs during infusion; globotriaosylceramide (GL3) plasma levels; improvement in symptomatology
REFERENCE RANGE — Normal endogenous activity of alpha-galactosidase A in plasma is approximately 170 nmol/hour/mL; in patients with Fabry's disease this activity is <1.5 nmol/hour/mL
Normal (goal) globotriaosylceramide (GL3) <1.2 ng/microliter
STABILITY — Store in refrigerator 2ºC to 8ºC (36ºF to 46ºF); reconstituted solution is stable for 24 hours refrigerated
MECHANISM OF ACTION — Agalsidase beta is a recombinant human alpha-galactosidase A enzyme with the same amino acid sequence as the naturally-occurring enzyme. Fabry's disease is an X-linked genetic disorder occurring in 1 in 50,000 male births, which results in a deficiency of alpha-galactosidase A. Lack of this enzyme leads to a progressive accumulation of glycosphingolipids, predominantly GL-3, in the vascular endothelium, leading to ischemia and infarction, especially in the kidney, heart, and brain. Clinical manifestations of Fabry's disease in childhood include intermittent severe pain in the extremities, characteristic vascular skin lesions (angiokeratomas), corneal and lenticular opacities that do not affect vision, decreased ability to sweat, intolerance to heat, cold, and exercise, mild proteinuria, and GI problems. By adulthood, this progresses to renal failure, cardiomyopathy, and cerebrovascular accidents.
PHARMACOKINETICS Distribution: Vd: Adults: 80-330 mL/kg
Half-life: Adults: 45-102 minutes (dose dependent)
ADDITIONAL INFORMATION — Agalsidase beta is an orphan drug; a Fabry Patient Support Group (800-745-4447) is available to assist patients in obtaining reimbursement from private insurers, Medicare, and Medicaid, and a Charitable Access Program sponsored by Genzyme provides the drug gratis to those patients in need. Detailed information regarding organizations and websites is also available in the Expert Panel Recommendations (Desnick, 2003)
CANADIAN BRAND NAMES — Fabrazyme®
SYNONYMS — Fabrase; Recombinant Human Alpha-Galactosidase A
THERAPEUTIC CATEGORY Enzyme, alpha-galactosidase AFabry's Disease, Treatment Agent
DOSING — I.V.: Children and Adults: 1 mg/kg/dose every two weeks
(For additional information see "Agalsidase beta: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution: 5 mg [contains mannitol 33 mg; derived from Chinese hamster cells]; 35 mg [contains mannitol 222 mg/vial; derived from Chinese hamster cells]
GENERIC AVAILABLE — No
ADMINISTRATION — I.V.: Reconstitute vial with 7.2 mL SWI to result in 5 mg/mL concentration; swirl to dissolve; do not shake; further dilute dosage in 500 mL NS*. Initial infusion not to exceed 15 mg/hour (0.25 mg/minute); after patient tolerance to initial infusion rate is established, the infusion rate may be increased in increments of 3-5 mg/hour (0.05-0.08 mg/minute) with subsequent infusions. In clinical studies, patients have tolerated infusion rates 33 mg/hour. Pretreatment with acetaminophen and an antihistamine is recommended to reduce infusion related side effects (See Warnings)
*Agalsidase beta stability when diluted in NS at a concentration of 2.55 mg/mL has been demonstrated by the manufacturer. Infusion volumes as low as 100 mL were used in phase I/II clinical trials. (Personal communication, Genzyme Corporation, 2003)
USE — Treatment of Fabry's disease
ADVERSE REACTIONS Cardiovascular: Tachycardia, hypertension, hypotension, chest pain, chest tightness, bradycardia, arrhythmias, cardiac arrest, edema, pallor
Central nervous system: Headache, dizziness, fever, anxiety, depression, chills, rigors, vertigo
Dermatologic: Pruritus, urticaria
Gastrointestinal: Dyspepsia, nausea, abdominal pain, vomiting
Genitourinary: Testicular pain
Neuromuscular & skeletal: Arthrosis, skeletal pain, myalgia
Otic: Hypoacousia
Respiratory: Bronchitis, bronchospasm, laryngitis, pharyngitis, sinusitis, rhinitis, dyspnea
Miscellaneous: Hypersensitivity reactions
CONTRAINDICATIONS — Hypersensitivity to agalsidase beta or any component
PRECAUTIONS — Use with caution in patients with compromised cardiac function (seen in advanced Fabry's disease) due to an increased potential for severe infusion related reactions; monitor these patients closely; patients may develop IgG antibodies to agalsidase beta
WARNINGS — Infusion-related reactions (ranging from mild to severe) including fever, rigors, chest tightness, hypertension, hypotension, pruritus, myalgia, dyspnea, urticaria, abdominal pain, and headache have been reported; these reactions may be minimized by pretreatment with acetaminophen and an antihistamine; if an infusion related reaction occurs, regardless of pretreatment, decreasing the infusion rate, temporarily stopping the infusion, and/or additional administration of analgesics, antihistamines, or corticosteroids may ameliorate the reaction.
DRUG INTERACTIONS — None as yet have been identified
PREGNANCY RISK FACTOR — B (show table)
MONITORING PARAMETERS — Vital signs during infusion; globotriaosylceramide (GL3) plasma levels; improvement in symptomatology
REFERENCE RANGE — Normal endogenous activity of alpha-galactosidase A in plasma is approximately 170 nmol/hour/mL; in patients with Fabry's disease this activity is <1.5 nmol/hour/mL
Normal (goal) globotriaosylceramide (GL3) <1.2 ng/microliter
STABILITY — Store in refrigerator 2ºC to 8ºC (36ºF to 46ºF); reconstituted solution is stable for 24 hours refrigerated
MECHANISM OF ACTION — Agalsidase beta is a recombinant human alpha-galactosidase A enzyme with the same amino acid sequence as the naturally-occurring enzyme. Fabry's disease is an X-linked genetic disorder occurring in 1 in 50,000 male births, which results in a deficiency of alpha-galactosidase A. Lack of this enzyme leads to a progressive accumulation of glycosphingolipids, predominantly GL-3, in the vascular endothelium, leading to ischemia and infarction, especially in the kidney, heart, and brain. Clinical manifestations of Fabry's disease in childhood include intermittent severe pain in the extremities, characteristic vascular skin lesions (angiokeratomas), corneal and lenticular opacities that do not affect vision, decreased ability to sweat, intolerance to heat, cold, and exercise, mild proteinuria, and GI problems. By adulthood, this progresses to renal failure, cardiomyopathy, and cerebrovascular accidents.
PHARMACOKINETICS Distribution: Vd: Adults: 80-330 mL/kg
Half-life: Adults: 45-102 minutes (dose dependent)
ADDITIONAL INFORMATION — Agalsidase beta is an orphan drug; a Fabry Patient Support Group (800-745-4447) is available to assist patients in obtaining reimbursement from private insurers, Medicare, and Medicaid, and a Charitable Access Program sponsored by Genzyme provides the drug gratis to those patients in need. Detailed information regarding organizations and websites is also available in the Expert Panel Recommendations (Desnick, 2003)
Adenosine
U.S. BRAND NAMES — Adenocard®; Adenoscan®
CANADIAN BRAND NAMES — Adenocard®; Adenoscan®; Adenosine Injection, USP
SYNONYMS — 9-Beta-D-ribofuranosyladenine
THERAPEUTIC CATEGORY Antiarrhythmic Agent, Miscellaneous
DOSING — Note: Adequate controlled studies in pediatric patients have not been conducted.
(For additional information see "Adenosine: Drug information")
Manufacturer's recommendations: Rapid I.V.: Neonates, Infants, Children, and Adolescents weighing <50 kg: Initial dose: 0.05-0.1 mg/kg; if not effective within 1-2 minutes, increase dose by 0.05-0.1 mg/kg increments every 1-2 minutes to a maximum single dose of 0.3 mg/kg or until termination of PSVT Children and Adolescents weighing 50 kg and Adults: 6 mg, if not effective within 1-2 minutes, 12 mg may be given; may repeat 12 mg bolus if needed
Alternative pediatric dosing: Neonates: Rapid I.V.: Initial dose: 0.05 mg/kg; if not effective within 2 minutes, increase dose by 0.05 mg/kg increments every 2 minutes to a maximum dose of 0.25 mg/kg or until termination of PSVT Infants and Children: PALS dose for treatment of SVT: Rapid I.V.; I.O.: Initial: 0.1 mg/kg (maximum: 6 mg); if not effective, give 0.2 mg/kg (maximum: 12 mg)
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free]: 3 mg/mL (2 mL, 4 mL) Adenocard®: 3 mg/mL (2 mL, 4 mL) Adenoscan®: 3 mg/mL (20 mL, 30 mL)
GENERIC AVAILABLE — Yes
ADMINISTRATION — Parenteral: For rapid bolus I.V. use, administer over 1-2 seconds at peripheral I.V. site closest to patient's heart (I.V. administration into lower extremities may result in therapeutic failure or requirement of higher doses); follow each bolus with NS flush (infants and children: 5-10 mL; adults: 20 mL); if given peripherally in adults, elevate the extremity for 10-20 seconds after the NS flush. To administer doses <600 mcg (0.2 mL of commercial product), a dilution with NS (final concentration: 300 mcg/mL) may be made. Note: Preliminary results in adults suggest adenosine may be administered via a central line at lower doses (eg, Adults: Initial dose: 3 mg); FDA approved labeling for pediatric patients weighing <50 kg states that doses listed may be administered either peripherally or centrally (further studies are needed)
USE — Treatment of paroxysmal supraventricular tachycardia (PSVT); used in adult ACLS algorithms for narrow-complex tachycardias, stable narrow-complex supraventricular tachycardias, and wide-complex tachycardias that are supraventricular in origin; used in PALS algorithms for probable supraventricular tachycardia; investigationally used as a continuous infusion for the treatment of primary pulmonary hypertension in adults and persistent pulmonary hypertension of the newborn (PPHN) (see Additional Information)
ADVERSE REACTIONS Cardiovascular: Flushing, arrhythmias, palpitations, chest pain, bradycardia, heart block, minimal hemodynamic disturbances, hypotension (<1%)
Central nervous system: Irritability, headaches, lightheadedness, dizziness
Gastrointestinal: Nausea, metallic taste
Respiratory: Dyspnea, hyperventilation, bronchoconstriction in asthmatics
CONTRAINDICATIONS — Hypersensitivity to adenosine or any component; second and third degree A-V block or sick sinus syndrome unless pacemaker placed
PRECAUTIONS — Bronchoconstriction may occur in asthmatics (avoid use in patients with bronchospasm or bronchoconstriction); use with caution in patients with underlying dysfunction of sinus or A-V node, obstructive lung disease, and those taking digoxin or verapamil; initial adenosine dose should be significantly decreased in patients receiving dipyridamole
WARNINGS — Heart block, including transient or prolonged asystole may occur as well as other arrhythmias; episodes of asystole or other arrhythmias may be fatal; if arrhythmia is not due to re-entry pathway through A-V node or sinus node (ie, atrial fibrillation, flutter, or tachycardia or ventricular tachycardia), adenosine will not terminate the arrhythmia but can produce transient ventriculoatrial or A-V block; possible mutagenic effects
DRUG INTERACTIONS — Dipyridamole potentiates effects of adenosine (dose of adenosine should be significantly reduced); methylxanthines (aminophylline, theophylline, caffeine) antagonize adenosine's effects so that larger doses of adenosine or an alternative agent may be required; carbamazepine may increase heart block; digoxin and verapamil may cause ventricular fibrillation (rare cases reported)
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Continuous EKG, heart rate, blood pressure, respirations
STABILITY — Do not refrigerate, precipitation may occur; contains no preservatives, discard unused portion
MECHANISM OF ACTION — Slows conduction time through the A-V node, interrupting the re-entry pathways through the A-V node, restoring normal sinus rhythm
PHARMACODYNAMICS Onset of action: Rapid
Duration: Very brief
PHARMACOKINETICS Metabolism: Removed from systemic circulation primarily by vascular endothelial cells and erythrocytes (by cellular uptake); rapidly metabolized intracellularly; phosphorylated by adenosine kinase to adenosine monophosphate (AMP) which is then incorporated into high-energy pool; intracellular adenosine is also deaminated by adenosine deaminase to inosine; inosine can be metabolized to hypoxanthine, then xanthine and finally to uric acid.
Half-life: <10 seconds
NURSING IMPLICATIONS — Be alert for dyspnea, shortness of breath, and possible exacerbation of asthma
ADDITIONAL INFORMATION — Not effective in atrial flutter, atrial fibrillation, or ventricular tachycardia; short duration of action is an advantage as adverse effects are usually rapidly self-limiting; effects may be prolonged in patients with denervated transplanted hearts. Individualize treatment of prolonged adverse effects: Give I.V. fluids for hypotension, aminophylline/theophylline may antagonize effects.
Limited information is available regarding the use of adenosine for the treatment of persistent pulmonary hypertension of the newborn (PPHN); efficacy, optimal dose, and duration of therapy is not established; a randomized, masked, placebo-controlled pilot study of 18 term infants with PPHN used initial doses of 25 mcg/kg/minute (n=9); after 30 minutes, doses were increased to 50 mcg/kg/minute if no improvement in PaO2 was observed; all patients received study drug via central line into the right atrium (inserted via the umbilical vein); significant improvement in oxygenation was observed in 4 of 9 newborns receiving 50 mcg/kg/minute; hypotension or tachycardia were not observed; further studies are needed (Kondur, 1996).
Adenosine is also available as Adenoscan®, which is used in adults as an adjunct to thallium-201 myocardial perfusion scintigraphy; see package insert for further information on this use.
CANADIAN BRAND NAMES — Adenocard®; Adenoscan®; Adenosine Injection, USP
SYNONYMS — 9-Beta-D-ribofuranosyladenine
THERAPEUTIC CATEGORY Antiarrhythmic Agent, Miscellaneous
DOSING — Note: Adequate controlled studies in pediatric patients have not been conducted.
(For additional information see "Adenosine: Drug information")
Manufacturer's recommendations: Rapid I.V.: Neonates, Infants, Children, and Adolescents weighing <50 kg: Initial dose: 0.05-0.1 mg/kg; if not effective within 1-2 minutes, increase dose by 0.05-0.1 mg/kg increments every 1-2 minutes to a maximum single dose of 0.3 mg/kg or until termination of PSVT Children and Adolescents weighing 50 kg and Adults: 6 mg, if not effective within 1-2 minutes, 12 mg may be given; may repeat 12 mg bolus if needed
Alternative pediatric dosing: Neonates: Rapid I.V.: Initial dose: 0.05 mg/kg; if not effective within 2 minutes, increase dose by 0.05 mg/kg increments every 2 minutes to a maximum dose of 0.25 mg/kg or until termination of PSVT Infants and Children: PALS dose for treatment of SVT: Rapid I.V.; I.O.: Initial: 0.1 mg/kg (maximum: 6 mg); if not effective, give 0.2 mg/kg (maximum: 12 mg)
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free]: 3 mg/mL (2 mL, 4 mL) Adenocard®: 3 mg/mL (2 mL, 4 mL) Adenoscan®: 3 mg/mL (20 mL, 30 mL)
GENERIC AVAILABLE — Yes
ADMINISTRATION — Parenteral: For rapid bolus I.V. use, administer over 1-2 seconds at peripheral I.V. site closest to patient's heart (I.V. administration into lower extremities may result in therapeutic failure or requirement of higher doses); follow each bolus with NS flush (infants and children: 5-10 mL; adults: 20 mL); if given peripherally in adults, elevate the extremity for 10-20 seconds after the NS flush. To administer doses <600 mcg (0.2 mL of commercial product), a dilution with NS (final concentration: 300 mcg/mL) may be made. Note: Preliminary results in adults suggest adenosine may be administered via a central line at lower doses (eg, Adults: Initial dose: 3 mg); FDA approved labeling for pediatric patients weighing <50 kg states that doses listed may be administered either peripherally or centrally (further studies are needed)
USE — Treatment of paroxysmal supraventricular tachycardia (PSVT); used in adult ACLS algorithms for narrow-complex tachycardias, stable narrow-complex supraventricular tachycardias, and wide-complex tachycardias that are supraventricular in origin; used in PALS algorithms for probable supraventricular tachycardia; investigationally used as a continuous infusion for the treatment of primary pulmonary hypertension in adults and persistent pulmonary hypertension of the newborn (PPHN) (see Additional Information)
ADVERSE REACTIONS Cardiovascular: Flushing, arrhythmias, palpitations, chest pain, bradycardia, heart block, minimal hemodynamic disturbances, hypotension (<1%)
Central nervous system: Irritability, headaches, lightheadedness, dizziness
Gastrointestinal: Nausea, metallic taste
Respiratory: Dyspnea, hyperventilation, bronchoconstriction in asthmatics
CONTRAINDICATIONS — Hypersensitivity to adenosine or any component; second and third degree A-V block or sick sinus syndrome unless pacemaker placed
PRECAUTIONS — Bronchoconstriction may occur in asthmatics (avoid use in patients with bronchospasm or bronchoconstriction); use with caution in patients with underlying dysfunction of sinus or A-V node, obstructive lung disease, and those taking digoxin or verapamil; initial adenosine dose should be significantly decreased in patients receiving dipyridamole
WARNINGS — Heart block, including transient or prolonged asystole may occur as well as other arrhythmias; episodes of asystole or other arrhythmias may be fatal; if arrhythmia is not due to re-entry pathway through A-V node or sinus node (ie, atrial fibrillation, flutter, or tachycardia or ventricular tachycardia), adenosine will not terminate the arrhythmia but can produce transient ventriculoatrial or A-V block; possible mutagenic effects
DRUG INTERACTIONS — Dipyridamole potentiates effects of adenosine (dose of adenosine should be significantly reduced); methylxanthines (aminophylline, theophylline, caffeine) antagonize adenosine's effects so that larger doses of adenosine or an alternative agent may be required; carbamazepine may increase heart block; digoxin and verapamil may cause ventricular fibrillation (rare cases reported)
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Continuous EKG, heart rate, blood pressure, respirations
STABILITY — Do not refrigerate, precipitation may occur; contains no preservatives, discard unused portion
MECHANISM OF ACTION — Slows conduction time through the A-V node, interrupting the re-entry pathways through the A-V node, restoring normal sinus rhythm
PHARMACODYNAMICS Onset of action: Rapid
Duration: Very brief
PHARMACOKINETICS Metabolism: Removed from systemic circulation primarily by vascular endothelial cells and erythrocytes (by cellular uptake); rapidly metabolized intracellularly; phosphorylated by adenosine kinase to adenosine monophosphate (AMP) which is then incorporated into high-energy pool; intracellular adenosine is also deaminated by adenosine deaminase to inosine; inosine can be metabolized to hypoxanthine, then xanthine and finally to uric acid.
Half-life: <10 seconds
NURSING IMPLICATIONS — Be alert for dyspnea, shortness of breath, and possible exacerbation of asthma
ADDITIONAL INFORMATION — Not effective in atrial flutter, atrial fibrillation, or ventricular tachycardia; short duration of action is an advantage as adverse effects are usually rapidly self-limiting; effects may be prolonged in patients with denervated transplanted hearts. Individualize treatment of prolonged adverse effects: Give I.V. fluids for hypotension, aminophylline/theophylline may antagonize effects.
Limited information is available regarding the use of adenosine for the treatment of persistent pulmonary hypertension of the newborn (PPHN); efficacy, optimal dose, and duration of therapy is not established; a randomized, masked, placebo-controlled pilot study of 18 term infants with PPHN used initial doses of 25 mcg/kg/minute (n=9); after 30 minutes, doses were increased to 50 mcg/kg/minute if no improvement in PaO2 was observed; all patients received study drug via central line into the right atrium (inserted via the umbilical vein); significant improvement in oxygenation was observed in 4 of 9 newborns receiving 50 mcg/kg/minute; hypotension or tachycardia were not observed; further studies are needed (Kondur, 1996).
Adenosine is also available as Adenoscan®, which is used in adults as an adjunct to thallium-201 myocardial perfusion scintigraphy; see package insert for further information on this use.
Adenosine
U.S. BRAND NAMES — Adenocard®; Adenoscan®
CANADIAN BRAND NAMES — Adenocard®; Adenoscan®; Adenosine Injection, USP
SYNONYMS — 9-Beta-D-ribofuranosyladenine
THERAPEUTIC CATEGORY Antiarrhythmic Agent, Miscellaneous
DOSING — Note: Adequate controlled studies in pediatric patients have not been conducted.
(For additional information see "Adenosine: Drug information")
Manufacturer's recommendations: Rapid I.V.: Neonates, Infants, Children, and Adolescents weighing <50 kg: Initial dose: 0.05-0.1 mg/kg; if not effective within 1-2 minutes, increase dose by 0.05-0.1 mg/kg increments every 1-2 minutes to a maximum single dose of 0.3 mg/kg or until termination of PSVT Children and Adolescents weighing 50 kg and Adults: 6 mg, if not effective within 1-2 minutes, 12 mg may be given; may repeat 12 mg bolus if needed
Alternative pediatric dosing: Neonates: Rapid I.V.: Initial dose: 0.05 mg/kg; if not effective within 2 minutes, increase dose by 0.05 mg/kg increments every 2 minutes to a maximum dose of 0.25 mg/kg or until termination of PSVT Infants and Children: PALS dose for treatment of SVT: Rapid I.V.; I.O.: Initial: 0.1 mg/kg (maximum: 6 mg); if not effective, give 0.2 mg/kg (maximum: 12 mg)
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free]: 3 mg/mL (2 mL, 4 mL) Adenocard®: 3 mg/mL (2 mL, 4 mL) Adenoscan®: 3 mg/mL (20 mL, 30 mL)
GENERIC AVAILABLE — Yes
ADMINISTRATION — Parenteral: For rapid bolus I.V. use, administer over 1-2 seconds at peripheral I.V. site closest to patient's heart (I.V. administration into lower extremities may result in therapeutic failure or requirement of higher doses); follow each bolus with NS flush (infants and children: 5-10 mL; adults: 20 mL); if given peripherally in adults, elevate the extremity for 10-20 seconds after the NS flush. To administer doses <600 mcg (0.2 mL of commercial product), a dilution with NS (final concentration: 300 mcg/mL) may be made. Note: Preliminary results in adults suggest adenosine may be administered via a central line at lower doses (eg, Adults: Initial dose: 3 mg); FDA approved labeling for pediatric patients weighing <50 kg states that doses listed may be administered either peripherally or centrally (further studies are needed)
USE — Treatment of paroxysmal supraventricular tachycardia (PSVT); used in adult ACLS algorithms for narrow-complex tachycardias, stable narrow-complex supraventricular tachycardias, and wide-complex tachycardias that are supraventricular in origin; used in PALS algorithms for probable supraventricular tachycardia; investigationally used as a continuous infusion for the treatment of primary pulmonary hypertension in adults and persistent pulmonary hypertension of the newborn (PPHN) (see Additional Information)
ADVERSE REACTIONS Cardiovascular: Flushing, arrhythmias, palpitations, chest pain, bradycardia, heart block, minimal hemodynamic disturbances, hypotension (<1%)
Central nervous system: Irritability, headaches, lightheadedness, dizziness
Gastrointestinal: Nausea, metallic taste
Respiratory: Dyspnea, hyperventilation, bronchoconstriction in asthmatics
CONTRAINDICATIONS — Hypersensitivity to adenosine or any component; second and third degree A-V block or sick sinus syndrome unless pacemaker placed
PRECAUTIONS — Bronchoconstriction may occur in asthmatics (avoid use in patients with bronchospasm or bronchoconstriction); use with caution in patients with underlying dysfunction of sinus or A-V node, obstructive lung disease, and those taking digoxin or verapamil; initial adenosine dose should be significantly decreased in patients receiving dipyridamole
WARNINGS — Heart block, including transient or prolonged asystole may occur as well as other arrhythmias; episodes of asystole or other arrhythmias may be fatal; if arrhythmia is not due to re-entry pathway through A-V node or sinus node (ie, atrial fibrillation, flutter, or tachycardia or ventricular tachycardia), adenosine will not terminate the arrhythmia but can produce transient ventriculoatrial or A-V block; possible mutagenic effects
DRUG INTERACTIONS — Dipyridamole potentiates effects of adenosine (dose of adenosine should be significantly reduced); methylxanthines (aminophylline, theophylline, caffeine) antagonize adenosine's effects so that larger doses of adenosine or an alternative agent may be required; carbamazepine may increase heart block; digoxin and verapamil may cause ventricular fibrillation (rare cases reported)
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Continuous EKG, heart rate, blood pressure, respirations
STABILITY — Do not refrigerate, precipitation may occur; contains no preservatives, discard unused portion
MECHANISM OF ACTION — Slows conduction time through the A-V node, interrupting the re-entry pathways through the A-V node, restoring normal sinus rhythm
PHARMACODYNAMICS Onset of action: Rapid
Duration: Very brief
PHARMACOKINETICS Metabolism: Removed from systemic circulation primarily by vascular endothelial cells and erythrocytes (by cellular uptake); rapidly metabolized intracellularly; phosphorylated by adenosine kinase to adenosine monophosphate (AMP) which is then incorporated into high-energy pool; intracellular adenosine is also deaminated by adenosine deaminase to inosine; inosine can be metabolized to hypoxanthine, then xanthine and finally to uric acid.
Half-life: <10 seconds
NURSING IMPLICATIONS — Be alert for dyspnea, shortness of breath, and possible exacerbation of asthma
ADDITIONAL INFORMATION — Not effective in atrial flutter, atrial fibrillation, or ventricular tachycardia; short duration of action is an advantage as adverse effects are usually rapidly self-limiting; effects may be prolonged in patients with denervated transplanted hearts. Individualize treatment of prolonged adverse effects: Give I.V. fluids for hypotension, aminophylline/theophylline may antagonize effects.
Limited information is available regarding the use of adenosine for the treatment of persistent pulmonary hypertension of the newborn (PPHN); efficacy, optimal dose, and duration of therapy is not established; a randomized, masked, placebo-controlled pilot study of 18 term infants with PPHN used initial doses of 25 mcg/kg/minute (n=9); after 30 minutes, doses were increased to 50 mcg/kg/minute if no improvement in PaO2 was observed; all patients received study drug via central line into the right atrium (inserted via the umbilical vein); significant improvement in oxygenation was observed in 4 of 9 newborns receiving 50 mcg/kg/minute; hypotension or tachycardia were not observed; further studies are needed (Kondur, 1996).
Adenosine is also available as Adenoscan®, which is used in adults as an adjunct to thallium-201 myocardial perfusion scintigraphy; see package insert for further information on this use.
CANADIAN BRAND NAMES — Adenocard®; Adenoscan®; Adenosine Injection, USP
SYNONYMS — 9-Beta-D-ribofuranosyladenine
THERAPEUTIC CATEGORY Antiarrhythmic Agent, Miscellaneous
DOSING — Note: Adequate controlled studies in pediatric patients have not been conducted.
(For additional information see "Adenosine: Drug information")
Manufacturer's recommendations: Rapid I.V.: Neonates, Infants, Children, and Adolescents weighing <50 kg: Initial dose: 0.05-0.1 mg/kg; if not effective within 1-2 minutes, increase dose by 0.05-0.1 mg/kg increments every 1-2 minutes to a maximum single dose of 0.3 mg/kg or until termination of PSVT Children and Adolescents weighing 50 kg and Adults: 6 mg, if not effective within 1-2 minutes, 12 mg may be given; may repeat 12 mg bolus if needed
Alternative pediatric dosing: Neonates: Rapid I.V.: Initial dose: 0.05 mg/kg; if not effective within 2 minutes, increase dose by 0.05 mg/kg increments every 2 minutes to a maximum dose of 0.25 mg/kg or until termination of PSVT Infants and Children: PALS dose for treatment of SVT: Rapid I.V.; I.O.: Initial: 0.1 mg/kg (maximum: 6 mg); if not effective, give 0.2 mg/kg (maximum: 12 mg)
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free]: 3 mg/mL (2 mL, 4 mL) Adenocard®: 3 mg/mL (2 mL, 4 mL) Adenoscan®: 3 mg/mL (20 mL, 30 mL)
GENERIC AVAILABLE — Yes
ADMINISTRATION — Parenteral: For rapid bolus I.V. use, administer over 1-2 seconds at peripheral I.V. site closest to patient's heart (I.V. administration into lower extremities may result in therapeutic failure or requirement of higher doses); follow each bolus with NS flush (infants and children: 5-10 mL; adults: 20 mL); if given peripherally in adults, elevate the extremity for 10-20 seconds after the NS flush. To administer doses <600 mcg (0.2 mL of commercial product), a dilution with NS (final concentration: 300 mcg/mL) may be made. Note: Preliminary results in adults suggest adenosine may be administered via a central line at lower doses (eg, Adults: Initial dose: 3 mg); FDA approved labeling for pediatric patients weighing <50 kg states that doses listed may be administered either peripherally or centrally (further studies are needed)
USE — Treatment of paroxysmal supraventricular tachycardia (PSVT); used in adult ACLS algorithms for narrow-complex tachycardias, stable narrow-complex supraventricular tachycardias, and wide-complex tachycardias that are supraventricular in origin; used in PALS algorithms for probable supraventricular tachycardia; investigationally used as a continuous infusion for the treatment of primary pulmonary hypertension in adults and persistent pulmonary hypertension of the newborn (PPHN) (see Additional Information)
ADVERSE REACTIONS Cardiovascular: Flushing, arrhythmias, palpitations, chest pain, bradycardia, heart block, minimal hemodynamic disturbances, hypotension (<1%)
Central nervous system: Irritability, headaches, lightheadedness, dizziness
Gastrointestinal: Nausea, metallic taste
Respiratory: Dyspnea, hyperventilation, bronchoconstriction in asthmatics
CONTRAINDICATIONS — Hypersensitivity to adenosine or any component; second and third degree A-V block or sick sinus syndrome unless pacemaker placed
PRECAUTIONS — Bronchoconstriction may occur in asthmatics (avoid use in patients with bronchospasm or bronchoconstriction); use with caution in patients with underlying dysfunction of sinus or A-V node, obstructive lung disease, and those taking digoxin or verapamil; initial adenosine dose should be significantly decreased in patients receiving dipyridamole
WARNINGS — Heart block, including transient or prolonged asystole may occur as well as other arrhythmias; episodes of asystole or other arrhythmias may be fatal; if arrhythmia is not due to re-entry pathway through A-V node or sinus node (ie, atrial fibrillation, flutter, or tachycardia or ventricular tachycardia), adenosine will not terminate the arrhythmia but can produce transient ventriculoatrial or A-V block; possible mutagenic effects
DRUG INTERACTIONS — Dipyridamole potentiates effects of adenosine (dose of adenosine should be significantly reduced); methylxanthines (aminophylline, theophylline, caffeine) antagonize adenosine's effects so that larger doses of adenosine or an alternative agent may be required; carbamazepine may increase heart block; digoxin and verapamil may cause ventricular fibrillation (rare cases reported)
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Continuous EKG, heart rate, blood pressure, respirations
STABILITY — Do not refrigerate, precipitation may occur; contains no preservatives, discard unused portion
MECHANISM OF ACTION — Slows conduction time through the A-V node, interrupting the re-entry pathways through the A-V node, restoring normal sinus rhythm
PHARMACODYNAMICS Onset of action: Rapid
Duration: Very brief
PHARMACOKINETICS Metabolism: Removed from systemic circulation primarily by vascular endothelial cells and erythrocytes (by cellular uptake); rapidly metabolized intracellularly; phosphorylated by adenosine kinase to adenosine monophosphate (AMP) which is then incorporated into high-energy pool; intracellular adenosine is also deaminated by adenosine deaminase to inosine; inosine can be metabolized to hypoxanthine, then xanthine and finally to uric acid.
Half-life: <10 seconds
NURSING IMPLICATIONS — Be alert for dyspnea, shortness of breath, and possible exacerbation of asthma
ADDITIONAL INFORMATION — Not effective in atrial flutter, atrial fibrillation, or ventricular tachycardia; short duration of action is an advantage as adverse effects are usually rapidly self-limiting; effects may be prolonged in patients with denervated transplanted hearts. Individualize treatment of prolonged adverse effects: Give I.V. fluids for hypotension, aminophylline/theophylline may antagonize effects.
Limited information is available regarding the use of adenosine for the treatment of persistent pulmonary hypertension of the newborn (PPHN); efficacy, optimal dose, and duration of therapy is not established; a randomized, masked, placebo-controlled pilot study of 18 term infants with PPHN used initial doses of 25 mcg/kg/minute (n=9); after 30 minutes, doses were increased to 50 mcg/kg/minute if no improvement in PaO2 was observed; all patients received study drug via central line into the right atrium (inserted via the umbilical vein); significant improvement in oxygenation was observed in 4 of 9 newborns receiving 50 mcg/kg/minute; hypotension or tachycardia were not observed; further studies are needed (Kondur, 1996).
Adenosine is also available as Adenoscan®, which is used in adults as an adjunct to thallium-201 myocardial perfusion scintigraphy; see package insert for further information on this use.
Adapalene
U.S. BRAND NAMES — Differin®
CANADIAN BRAND NAMES — Differin® XP; Differin®
SYNONYMS — CD271
THERAPEUTIC CATEGORY Acne Products
DOSING — Topical: Children >12 years and Adults: Apply topically once daily in the evening
(For additional information see "Adapalene: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
GENERIC AVAILABLE — No
ADMINISTRATION — Topical: After cleansing the affected area with mild or soapless cleanser, using gloves, apply a thin film of medication (cream or gel) before retiring in the evening. Avoid contact with eyes, angles of the nose, lips and mucous membranes.
USE — Topical treatment of acne vulgaris
ADVERSE REACTIONS Dermatologic: Erythema, scaling, dry skin, skin irritation, pruritus, acne flares, photosensitivity, sunburn, skin discoloration
Local: Pruritus or burning immediately after application
Ophthalmic: Eyelid edema, conjunctivitis
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component; sunburn
PRECAUTIONS — Use with caution in patients with eczema
WARNINGS — Avoid excessive exposure to sunlight and sunlamps; avoid contact with abraded skin, mucous membranes, eyes, mouth, or angles of the nose
DRUG INTERACTIONS — Topical sulfur, benzoyl peroxide, salicylic acid, and resorcinol potentiate adverse reactions seen with adapalene; other topical products containing alcohol, astringents, or lime may increase drying effects
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Reduction in lesion size and/or inflammation; reduction in the number of lesions
STABILITY — Store at controlled room temperature
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS — Onset of action: 8-12 weeks
PHARMACOKINETICS Absorption: Absorption through the skin is very low; only trace amounts have been measured in serum after chronic application
Elimination: Primarily in bile
PATIENT INFORMATION — For external use only; apply using gloves; avoid contact with eyes, mouth, mucous membranes, or open wounds. Do not apply occlusive dressing. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. Wax epilation should not be performed on treated skin due to the potential for skin erosions. Transient burning or stinging immediately after applying may occur. Mild to moderate redness, dryness, scaling, burning or itching are likely to occur during the first 2-4 weeks and will usually lessen with continued use; report worsening of condition or skin redness, dryness, peeling, or burning that persists between applications to the healthcare provider. May cause photosensitivity reactions (eg, exposure to sunlight may cause severe sunburn, skin rash, redness, or itching); avoid exposure to sunlight and artificial light sources (sunlamps, tanning booth/bed); wear protective clothing, wide-brimmed hats, sunglasses, and lip sunscreen (SPF 15); use a sunscreen [broad-spectrum sunscreen or physical sunscreen(preferred) or sunblock with SPF 15]; contact physician if reaction occurs.
CANADIAN BRAND NAMES — Differin® XP; Differin®
SYNONYMS — CD271
THERAPEUTIC CATEGORY Acne Products
DOSING — Topical: Children >12 years and Adults: Apply topically once daily in the evening
(For additional information see "Adapalene: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
GENERIC AVAILABLE — No
ADMINISTRATION — Topical: After cleansing the affected area with mild or soapless cleanser, using gloves, apply a thin film of medication (cream or gel) before retiring in the evening. Avoid contact with eyes, angles of the nose, lips and mucous membranes.
USE — Topical treatment of acne vulgaris
ADVERSE REACTIONS Dermatologic: Erythema, scaling, dry skin, skin irritation, pruritus, acne flares, photosensitivity, sunburn, skin discoloration
Local: Pruritus or burning immediately after application
Ophthalmic: Eyelid edema, conjunctivitis
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component; sunburn
PRECAUTIONS — Use with caution in patients with eczema
WARNINGS — Avoid excessive exposure to sunlight and sunlamps; avoid contact with abraded skin, mucous membranes, eyes, mouth, or angles of the nose
DRUG INTERACTIONS — Topical sulfur, benzoyl peroxide, salicylic acid, and resorcinol potentiate adverse reactions seen with adapalene; other topical products containing alcohol, astringents, or lime may increase drying effects
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Reduction in lesion size and/or inflammation; reduction in the number of lesions
STABILITY — Store at controlled room temperature
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS — Onset of action: 8-12 weeks
PHARMACOKINETICS Absorption: Absorption through the skin is very low; only trace amounts have been measured in serum after chronic application
Elimination: Primarily in bile
PATIENT INFORMATION — For external use only; apply using gloves; avoid contact with eyes, mouth, mucous membranes, or open wounds. Do not apply occlusive dressing. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. Wax epilation should not be performed on treated skin due to the potential for skin erosions. Transient burning or stinging immediately after applying may occur. Mild to moderate redness, dryness, scaling, burning or itching are likely to occur during the first 2-4 weeks and will usually lessen with continued use; report worsening of condition or skin redness, dryness, peeling, or burning that persists between applications to the healthcare provider. May cause photosensitivity reactions (eg, exposure to sunlight may cause severe sunburn, skin rash, redness, or itching); avoid exposure to sunlight and artificial light sources (sunlamps, tanning booth/bed); wear protective clothing, wide-brimmed hats, sunglasses, and lip sunscreen (SPF 15); use a sunscreen [broad-spectrum sunscreen or physical sunscreen(preferred) or sunblock with SPF 15]; contact physician if reaction occurs.
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