Thursday, 9 August 2012

Varivax


Generic Name: Varicella Virus Vaccine Live
Class: Vaccines
ATC Class: J07BK01
VA Class: IM100

Introduction

Live, attenuated virus vaccine.1 27 137 Varicella virus vaccine live contains varicella zoster virus (VZV) of the Oka/Merck strain1 27 and is used to stimulate active immunity to varicella (chickenpox).1 27 Commercially available in the US as a monovalent vaccine (Varivax) and a fixed-combination vaccine containing measles, mumps, rubella, and varicella antigens (MMRV; ProQuad).1 125 Other varicella vaccines may be available in other countries (e.g., Oka/Biken vaccine).8 11 15 27 45


Uses for Varivax


Prevention of Varicella (Chickenpox) Infection


Prevention of varicella (chickenpox) in adults, adolescents, and children ≥12 months of age.1 27 71 82 89 92 100 114 129 137


Varicella is caused by primary infection with varicella zoster virus (VZV).1 6 9 11 14 27 41 64 75 137 138 In otherwise healthy children, varicella usually is an acute, self-limited disease characterized by fever, malaise, and a generalized vesicular rash consisting of 200–500 lesions.1 6 9 11 14 27 41 64 75 137 138 In neonates, adolescents, adults, and immunocompromised individuals, it may be a more serious illness associated with a greater number of lesions and an increased risk of complications (e.g., pneumonia, encephalitis, glomerulonephritis, bacterial superinfection including necrotizing fasciitis).6 9 11 15 27 34 41 64 75 80 89 91 94 137 138 In the past, there were an average of 4 million cases of varicella and 100–150 varicella-associated deaths each year in the US.6 27 64 137 Since 1995, when varicella vaccine became commercially available, there have been substantial decreases in the incidence of varicella and varicella-associated hospitalizations in the US in all age groups, especially in children 1–9 years of age.112 138 The number of hospitalizations and deaths from varicella decreased >90% in the US since 1996.138


USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all susceptible children 12 months through 12 years of age be vaccinated against varicella, unless the vaccine is contraindicated.27 71 100 137 (See Contraindications under Cautions.)


ACIP, AAP, AAFP, American College of Obstetricians and Gynecologists (ACOG), and American College of Physicians (ACP) recommend that all susceptible adults and adolescents ≥13 years of age be vaccinated against varicella, unless contraindicated.27 71 89 100 114 129 (See Contraindications under Cautions.)


For internationally adopted children whose immune status is uncertain, vaccinations can be repeated or serologic tests performed to confirm immunity.26 Because varicella vaccine is not available in the majority of countries, especially developing countries, all internationally adopted children without reliable evidence of varicella immunity should be vaccinated according to the US recommended immunization schedule.26 112 (See Dosage and Administration.) Although serologic testing to verify immunization status in children >12 months of age is available, such testing prior to vaccination is not recommended in children <12 years of age coming from tropical countries, unless there is a history of the disease.112


The fixed-combination vaccine containing measles, mumps, and rubella virus vaccine live (MMR) and varicella virus vaccine live (MMRV; ProQuad) may be used instead of the monovalent varicella vaccine in children 12 months through 12 years of age when a dose of MMR and a dose of varicella vaccine is indicated in this age group.27 125 136 137 145 ACIP, AAP, and AAFP state that use of a combination vaccine generally is preferred over separate injections of the equivalent component vaccines.71 However, although use of MMRV (ProQuad) reduces the number of required injections when both vaccines are indicated during a single health-care visit,27 128 there is some evidence that the relative risk for febrile seizures in infants 12 through 23 months of age may be higher with MMRV (ProQuad) than when a dose of Varivax and a dose of MMR are given concomitantly.125 136 145 (See Use of Fixed Combinations under Cautions.)


ACIP states that evidence of varicella immunity includes documentation of age-appropriate vaccination against varicella, laboratory evidence of immunity or laboratory confirmation of prior varicella, birth in the US before 1980 (except pregnant women, immunocompromised individuals, health-care personnel), diagnosis or verification of history of varicella by health-care provider, or diagnosis or verification of history of herpes zoster (shingles, zoster) by health-care provider.27 Individuals without such evidence should be considered susceptible to varicella.27


Preexposure Vaccination Against Varicella Infection in High-risk Groups


Health-care personnel should ensure that they are immune to varicella, especially those who have close contact with individuals at high risk for serious complications from varicella.27 113 ACIP and the Hospital Infection Control Practices Advisory Committee of the US Public Health Service (HICPAC) recommend vaccination against varicella in all susceptible health-care personnel.27 113 This protects the worker following varicella exposure in the workplace and also may help reduce nosocomial transmission of VZV.11 27


Travelers should be vaccinated against varicella.27 112 Varicella occurs worldwide.112 138 Although vaccination against varicella is not a requirement for entry into any country (including the US), CDC states that individuals traveling or living abroad should ensure that they are immune.112


Certain immunocompromised individuals at risk of severe complications from varicella may benefit from vaccination against the disease.27 52 100 137 143 144 However, varicella vaccine generally is contraindicated in adults, adolescents, and children who are immunocompromised†.1 54 70 100 137 (See Individuals with Altered Immunocompetence under Cautions.)


ACIP, AAP, CDC, National Institutes of Health (NIH), HIV Medicine Association of the Infectious Diseases Society of America (IDSA), Pediatric Infectious Diseases Society, and others recommend that vaccination against varicella be considered for certain HIV-infected individuals†, especially those who are asymptomatic or only mildly symptomatic.27 100 137 143 144 These experts state that, after weighing risks and benefits, use of monovalent varicella vaccine should be considered in HIV-infected children 1–8 years of age with age-specific CD4+ T-cell percentages ≥15%27 137 144 and may be considered in HIV-infected adults, adolescents, and children >8 years of age with CD4+ T-cell counts ≥200/mm3.27 143 144 Other HIV-infected adults, adolescents, or children who are more severely immunocompromised should not receive varicella vaccine.1 27 143 144 (See Individuals with Altered Immunocompetence under Cautions.)


Although monovalent varicella vaccine was previously used under an investigational protocol in certain children and adolescents with acute lymphocytic (lymphoblastic) leukemia (ALL)† in remission,27 52 100 this protocol has been terminated.100 The ACIP and AAP state that varicella vaccine should not be used routinely in susceptible children with leukemia and use of the vaccine in leukemic children in remission who do not have evidence of immunity to varicella should only be undertaken with expert guidance and only if antiviral therapy is available in case complications occur.27 100 137 (See Individuals with Altered Immunocompetence under Cautions.)


Postexposure Vaccination Against Varicella Infection and Outbreak Control


Postexposure vaccination in susceptible adults, adolescents, or children with recent exposure to varicella, unless contraindicated.27 100 138


Prevention and control of varicella outbreaks (e.g., in child-care facilities, schools, institutions).27 138 Varicella outbreaks can persist for up to 4–6 months.27 138


May prevent varicella or modify severity of the disease if given within 3 days, and possibly up to 5 days, after exposure.27 100 112 115 116 138


If the exposure does not cause infection, postexposure vaccination should provide protection against subsequent exposure.27 100 138 If the exposure results in infection, vaccination during the presymptomatic or prodromal stage of varicella does not appear to increase risk for vaccine-associated adverse effects or cause more severe natural disease.27 100 138


During varicella outbreaks, ACIP recommends a second dose of varicella vaccine for those who previously received only a single dose, provided the age-appropriate time interval has elapsed since the first dose (i.e., 3 months for children 12 months through 12 years of age, at least 4 weeks for adults and adolescents ≥13 years of age).27 138


In hospital settings, consider postexposure vaccination for unvaccinated health-care personnel who have no evidence of immunity at the time of varicella exposure.27 113 138 Preexposure vaccination is the preferred method for preventing varicella in health-care settings.27 138


When varicella vaccine cannot be used (e.g., pregnant women, neonates, immunocompromised individuals) and postexposure prophylaxis is considered necessary, passive immunization with varicella zoster immune globulin (VZIG) is recommended to prevent or reduce severity of varicella.15 27 100 138 143 144 The only VZIG preparation currently available for use in the US (VariZIG; Cangene) must be obtained through an investigational new drug (IND) expanded access protocol from the distributor (FFF Enterprises at 800-843-7477).134 135 If VZIG is not available for postexposure prophylaxis, immune globulin IV (IGIV) can be used.100


Varivax Dosage and Administration


Administration


Sub-Q Administration


Administer monovalent varicella vaccine (Varivax) by sub-Q injection.1


Administer fixed-combination vaccine containing MMR and varicella vaccine (MMRV; ProQuad) by sub-Q injection.125


Do not administer monovalent or fixed-combination vaccine IM†.1 125 Inadvertent IM administration does not necessitate revaccination.26 30


Depending on patient age, administer sub-Q into the upper-outer triceps area or anterolateral thigh.1 26 125 For children ≥1 year of age, adolescents, and adults, the upper-outer triceps area usually is preferred.26


To ensure appropriate delivery, sub-Q injections should be made at a 45° angle using a 5/8-inch, 23- to 25-gauge needle.26


Prior to injection, ensure that needle is not in a blood vessel.1


Since syncope may occur following vaccination, observe vaccinees for approximately 15 minutes after the vaccine dose.26 If syncope occurs, observe patient until symptoms resolve.26 Syncope after vaccination occurs most frequently in adolescents and young adults.26


Do not administer concomitantly with VZIG.1 (See Specific Drugs and Laboratory Tests under Interactions.)


May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites).26 71 100 129 137 (See Interactions.)


When multiple vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites.26 Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.26 If multiple vaccines must be given into a single limb, the deltoid may be used in older children and adults, but the anterolateral thigh is preferred in infants and younger children.26


Reconstitution

Varicella vaccine (Varivax): Reconstitute lyophilized vaccine by adding 0.7 mL of diluent provided by the manufacturer and gently agitating vial.1 Use only the diluent supplied by the manufacturer.1


MMRV (ProQuad): Reconstitute lyophilized vaccine according to manufacturer’s directions using diluent provided by the manufacturer.125 Gently agitate vial.125 Use only the diluent supplied by the manufacturer.125


Use sterile syringes and needles free of preservatives, antiseptics, and detergents to avoid inactivating the live virus vaccine.1 125


To minimize loss of potency and ensure an adequate immunizing dose, administer immediately following reconstitution; discard reconstituted vaccine not used within 30 minutes.1 125


Dosage


Pediatric Patients


Prevention of Varicella (Chickenpox)

Children 12 Months Through 12 Years of Age (Varivax)

Sub-Q

Each dose is 0.5 mL.1


Primary immunization consists of 2 doses given at least 3 months apart.1 27 71 100 137


ACIP, AAP, and AAFP recommend that the initial dose be given at 12 through 15 months of age and the second dose at 4 through 6 years of age (i.e., before child begins kindergarten or first grade).27 71 100 137 Second dose may be administered prior to 4 years of age, provided at least 3 months have elapsed since initial dose and both doses are administered at ≥12 months of age.1 27 71 100 137 If second dose was inadvertently administered early (but at least 28 days after initial dose), it does not need to be repeated.27 71 100 137


For catch-up vaccination in those not previously vaccinated, give 2 doses at least 3 months apart.1 27 71 100 137 In those who previously received a single dose of vaccine containing varicella vaccine, give a second dose preferably at least 3 months after initial dose.1 27 71 100 137


Children 12 Months Through 12 Years of Age (MMRV; ProQuad)

Sub-Q

Each dose is 0.5 mL.125


May be used when simultaneous administration of the first or second dose of varicella vaccine and first or second dose of MMR is indicated or whenever any components of the fixed-combination vaccine are indicated and the other components are not contraindicated.27 71 125


When considering use in infants and children 12 through 47 months of age, ACIP states that providers should advise the parent or caregiver about the benefits and risks associated with MMRV (ProQuad) compared with the individual component vaccines.145 (See Use of Fixed Combinations under Cautions.)


At least 1 month should elapse between a dose of a measles-containing vaccine (e.g., MMR) and a dose of MMRV (ProQuad) and preferably at least 3 months should elapse between a dose of Varivax and a dose of MMRV (ProQuad); however, if a second dose of a varicella-containing vaccine was administered at least 28 days following the first dose, the second dose does not need to be repeated.71 125


Adolescents 13–16 Years of Age (Varivax)

Sub-Q

Each dose is 0.5 mL.1


Primary immunization consists of 2 doses given at least 4–8 weeks apart.1 27 71 89 100 137 The minimum interval between the first and second dose is 28 days.71 100 A longer interval between first and second doses does not necessitate a third dose, but may leave individual susceptible during the intervening months.27 100


For catch-up vaccination in those who previously received only a single dose, give second dose at least 4 weeks (28 days) after first dose.1 27 71 137


HIV-infected Children† 12 Months Through 8 Years of Age with Age-specific CD4+ T-cell Percentages ≥15% (Varivax)

Sub-Q

2 doses given at least 3 months apart recommended by ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, and Pediatric Infectious Diseases Society.27 144 Give first dose as soon as possible after the first birthday.144


HIV-infected Adolescents and Children >8 Years of Age† with CD4+ T-cell Counts ≥200/mm3 (Varivax)

Sub-Q

2 doses given at least 3 months apart recommended by ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, and Pediatric Infectious Diseases Society.27 137 143 144


Postexposure Vaccination Against Varicella Infection and Outbreak Control (Varivax)

Sub-Q

Children ≥12 months of age who are unvaccinated or incompletely vaccinated: Give a vaccine dose within 3–5 days after exposure and complete primary immunization.27


For outbreak control, give a second dose to those who previously received only a single dose, provided the appropriate interval has elapsed since first dose (i.e., at least 3 months in children 12 months through 12 years of age and at least 4 weeks in adolescents ≥13 years of age).27 138


Adults


Prevention of Varicella (Chickenpox) Infection

Adults (Varivax)

Sub-Q

Each dose is 0.5 mL.125


Primary immunization consists of 2 doses given 4–8 weeks apart.1 27 82 129 A longer interval between first and second doses does not necessitate a third dose, but may leave individual susceptible for the intervening months.27


For catch-up vaccination in those who previously received only a single dose, give second dose at least 4 weeks after first dose.1 27 129


HIV-infected Adults† with CD4+ T-cell Counts ≥200/mm3 (Varivax)

Sub-Q

2 doses given at least 3 months apart recommended by ACIP, NIH, CDC, and HIV Medicine Association of IDSA.27 129 143 144


Postexposure Vaccination Against Varicella (Chickenpox) Infection and Outbreak Control (Varivax)

Sub-Q

Unvaccinated or incompletely vaccinated: Give a vaccine dose within 3–5 days after exposure and complete primary immunization.27


For outbreak control, give a second dose to those who previously received only a single dose, provided the appropriate interval has elapsed since first dose (i.e., at least 4 weeks in adults).27 138


Special Populations


Hepatic Impairment


No specific dosage recommendations.1


Renal Impairment


No specific dosage recommendations.1


Geriatric Patients


No specific dosage recommendations.1


Cautions for Varivax


Contraindications


  • Monovalent Varicella Vaccine (Varivax) or Fixed Combination of Varicella Vaccine and MMR (MMRV; ProQuad)


  • Hypersensitivity to the vaccine or any component in the formulation, including gelatin.1 27 100 125 (See Gelatin Allergy under Cautions.)




  • History of anaphylactic reaction to neomycin.1 26 100 125 (See Neomycin Allergy under Cautions.)




  • Blood dyscrasias, leukemia, lymphomas of any type, or any other malignant neoplasms affecting the bone marrow or lymphatic system.1 26 70 92 100 125 (See Individuals with Altered Immunocompetence under Cautions.)




  • Primary and acquired immunodeficiencies, including acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of HIV infection, cellular immune deficiency, hypogammaglobulinemia, and dysgammaglobulinemia.1 26 54 70 92 100 125 (See Individuals with Altered Immunocompetence under Cautions.)




  • Immunosuppressive therapy (e.g., corticosteroids, antineoplastic agents, radiation).1 26 54 70 92 100 125 (See Specific Drugs and Laboratory Tests under Interactions.)




  • Family history of congenital or hereditary immunodeficiency, unless immune competence has been demonstrated in the potential vaccine recipient.1 125 (See Individuals with Altered Immunocompetence under Cautions.)




  • Active untreated tuberculosis.1 125 (See Tuberculosis under Cautions.)




  • Febrile respiratory illness or other active febrile infection.1 125 (See Concomitant Illness under Cautions.)




  • Pregnancy.1 125 (See Pregnancy under Cautions.)



Warnings/Precautions


Warnings


Individuals with Altered Immunocompetence

Because monovalent varicella vaccine (Varivax ) and MMRV (ProQuad) contain live, attenuated viruses, they generally are contraindicated in individuals with altered immunocompetence, including those with primary or acquired immunodeficiencies or those receiving immunosuppressive therapy.1 27 70 100 125 137 143 144


These vaccines usually contraindicated in those with primary immunodeficiencies (e.g., cellular immune deficiency, hypogammaglobulinemia, dysgammaglobulinemia) and in individuals with suppressed immune responses resulting from AIDS or other clinical manifestations of HIV infection, blood dyscrasias, leukemia, lymphomas of any type, or any other malignant neoplasms affecting the bone marrow or lymphatic systems.1 27 70 100 125 137 143 144 Also generally contraindicated in individuals with a family history of congenital or hereditary immunodeficiency in a first-degree relative (e.g., parents and siblings), unless the immune competence of the potential vaccine recipient has been clinically substantiated or verified by a laboratory.1 20 27 100 125 137


Safety and efficacy not established in HIV-infected children, adolescents, or adults.1 27 125 However, because HIV-infected adults, adolescents, and children are at increased risk for morbidity from varicella and herpes zoster, ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, Pediatric Infectious Diseases Society, and others state that use of Varivax can be considered in selected HIV-infected individuals† after weighing potential benefits and risks.27 100 137 143 144 (See Preexposure Vaccination Against Varicella Infection in High-risk Groups under Uses.) If Varivax is used in an HIV-infected individual, consider possibility that such individuals may be at increased risk for complications after vaccination with a live virus since they have impaired cellular immunity; encourage patient to consult clinicians if a postvaccination varicella-like rash develops.27 100 Do not use MMRV (ProQuad) in HIV-infected individuals.27 125 137 144


Safety and efficacy not established in children with leukemia†.1 27 125 137 ACIP states that use of live virus vaccines can be considered in patients with leukemia or other malignancies if the disease is in remission and chemotherapy was terminated at least 3 months prior to vaccination.26 However, use of Varivax in susceptible leukemic children in remission should be undertaken only with expert guidance and only when antiviral agents are available to treat complications if they occur.27 100 137


The presence of an immunocompromised or HIV-infected individual in a household does not preclude administration of Varivax or MMRV (ProQuad) to other household members.27 100 137 Vaccination of household contacts decreases the likelihood that wild-type varicella will be introduced into the household.27 143 144 However, if vaccinee develops a varicelliform rash, they should avoid contact with immunocompromised household members.27 100 137 (See Transmission of Vaccine Virus under Cautions.)


Cerebral Injury or Seizures

MMRV (ProQuad): Use caution in individuals with a history of cerebral injury, individual or family history of seizures, or any other condition in which fever-induced stress should be avoided.125 (See Use of Fixed Combinations under Cautions.)


Interim results from an ongoing study indicate that the relative risk for febrile seizures 5–12 days after a dose of MMRV (ProQuad) in children 12–60 months of age (995 were 12–23 months of age) is 2.3 times higher than that reported with concurrent administration of a dose of Varivax and a dose of MMR given during a single health-care visit.136 (See Use of Fixed Combinations under Cautions.)


Thrombocytopenia

Thrombocytopenia has been reported after administration of varicella vaccine or MMR; thrombocytopenia has worsened in those with preexisting thrombocytopenia and may worsen with subsequent doses.27 125


Manufacturer of MMRV (ProQuad) states that potential benefits and risks should be evaluated before considering use of the vaccine in patients who develop thrombocytopenia or had worsening of thrombocytopenia with a previous dose.125 Serologic testing for antibody to MMR should be considered to determine whether additional doses should be given.125


Risk of Transmissible Agents in Preparations Containing Albumin

MMRV (ProQuad) contains albumin human.125


Since albumin is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).125 141


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylaxis,1 27 rash,1 urticaria,1 hypersensitivity vasculitis,105 erythema multiforme,1 27 and Stevens-Johnson syndrome1 reported rarely.


Prior to vaccine administration, question recipient and/or parent or guardian concerning reactions to previous doses of the vaccine or similar preparations.1 125


Epinephrine and other appropriate agents should be readily available in case anaphylaxis or similar reaction occurs.1 125


Gelatin Allergy

Varivax and MMRV (ProQuad) contain hydrolyzed gelatin as a stabilizer.1 125


Immediate reactions (i.e., wheezing and dyspnea with or without urticaria) and other reactions (i.e., erythema and swelling at injection site) have occurred and may be related to gelatin hypersensitivity.106 Consider possibility of such reactions.26 100 106 125


Although skin testing for gelatin sensitivity before administering a gelatin-containing vaccine can be considered, there are no specific protocols for this purpose.26 100 Because gelatin used in vaccines manufactured in the US usually is derived from porcine sources, and food gelatin may be derived solely from bovine sources, a negative food history does not exclude the possibility of a reaction to the gelatin contained in the vaccine.100


Neomycin Allergy

Varivax and MMRV (ProQuad) contain trace amounts of neomycin and are contraindicated in those with a history of anaphylactic reactions to neomycin.1 125


Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis.26 27 100 125 ACIP and AAP state that vaccines containing trace amounts of neomycin should not be used in individuals with a history of anaphylactic reaction to neomycin, but use of such vaccines may be considered in those with a history of delayed-type neomycin hypersensitivity if benefits of vaccination outweigh risks.26 27 100


Manufacturer of MMRV (ProQuad) states that if use of this vaccine is considered medically necessary in an individual with a history of anaphylactic reactions to neomycin, an allergist or immunologist should be consulted and the vaccine should be given only in settings where anaphylactic reactions can be managed appropriately.125


Allergy to Egg-related Antigens

MMRV (ProQuad): MMR component of this fixed-combination vaccine is produced in chick embryo cell culture.125


Individuals with a history of anaphylactic or other immediate hypersensitivity reactions (e.g., hives, swelling of the mouth or throat, difficulty breathing, hypotension, shock) after egg ingestion may be at increased risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of chick embryo antigen.125


Consider potential benefits versus possible risks before administering MMRV (ProQuad) to an individual with a history of anaphylactic or other immediate hypersensitivity reaction to egg ingestion.125 Use extreme caution and have adequate treatment readily available in case a reaction occurs.125


Children with egg allergy, even those with severe hypersensitivity, are at low risk for anaphylactic reactions to MMRV (Proquad) and skin testing with dilute vaccine in such children is not predictive of reactions to the vaccine.100 125


Individuals who have egg allergies that are not anaphylactic in nature generally are not at increased risk of hypersensitivity reactions to vaccines produced in chick embryo cell cultures.26 125 There is no evidence that individuals with allergies to chickens or feathers are at increased risk of allergic reactions to such vaccines.26 125


General Precautions


Breakthrough Varicella Infections

Despite seroconversion following vaccination with varicella vaccine, breakthrough varicella infections may occur in some children or adults exposed to wild-type virus.1 13 16 17 18 20 24 27 42 44 47 48 52 53 55 75 77 122 123 137 These infections (i.e., wild-type VZV infection occurring >42 days after vaccination) generally are milder than those reported in unvaccinated individuals and are associated with a low rate of fever and rapid recovery.1 13 16 17 24 27 42 47 48 52 75 77 137


In vaccinated healthy children and adolescents 12 months to 17 years of age, breakthrough infections occur in about 19% within 10 years and generally involve <100 vesicles.1 13 16 17 27 47 48 75 77


In vaccinated healthy adults, breakthrough infections have occurred following household exposure in 4–27%.1 These infections generally involve <50 vesicles,1 11 27 137 but may be associated with ≥50–300 vesicles.1 11


Latent Infections and Herpes Zoster

Primary immunization with varicella vaccine does not necessarily ensure protection against subsequent latent infection with natural wild-type VZV or reactivation of latent infections.8 9 27 42 49 50 74 137


Herpes zoster has been reported rarely in immunocompromised children and healthy children, adolescents, and adults who received primary immunization with varicella vaccine.1 8 9 42 47 49 50 51 52 55 74 Most cases occurred 3–5 years after vaccination and were mild without sequelae.1 9 50 74


Herpes zoster in vaccinated individuals may be caused by vaccine virus or by wild-type virus.1 8 9 27 49 74 137 No evidence to date that latent vaccine virus infections are any more likely to reactivate than latent infections caused by wild-type virus.8 55


Waning cell-mediated immunity to VZV may predispose to reactivation of the virus.6 9 74 137 The long-term effect of primary immunization with varicella vaccine on the incidence of subsequent herpes zoster, particularly in vaccinees exposed to natural varicella, is unknown.1 9 21 24

Monday, 6 August 2012

Hibiclens Liquid


Pronunciation: klor-HEX-ih-deen
Generic Name: Chlorhexidine
Brand Name: Examples include Betasept and Hibiclens


Hibiclens Liquid is used for:

Cleansing skin and wound areas. It may also be used for other conditions as determined by your doctor.


Hibiclens Liquid is a topical antimicrobial. It works by reacting with the microbial cell surface, destroying the cell membrane, and killing the cell.


Do NOT use Hibiclens Liquid if:


  • you are allergic to any ingredient in Hibiclens Liquid

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



Before using Hibiclens Liquid:


Tell your health care provider 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

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


Ask your health care provider if Hibiclens 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 Hibiclens Liquid:


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


  • To cleanse the skin, thoroughly rinse the area to be cleansed with water. Apply the minimum amount necessary to cover the skin or wound area and wash gently. Rinse thoroughly.

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

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



Important safety information:


  • Hibiclens Liquid is for external use only. Avoid contact with eyes, ears, and mouth. If Hibiclens Liquid contacts any of these areas, rinse out promptly and thoroughly with water.

  • Hibiclens Liquid may stain clothing.

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


Possible side effects of Hibiclens 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:



Skin irritation, itching, or redness.



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).



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: Hibiclens side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Hibiclens Liquid may be harmful if swallowed.


Proper storage of Hibiclens Liquid:

Store Hibiclens Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid excessive heat above 104 degrees F (40 degrees C), and light. Keep Hibiclens Liquid out of the reach of children and away from pets.


General information:


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

  • Hibiclens 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.

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

This information is a summary only. It does not contain all information about Hibiclens 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.

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Sunday, 5 August 2012

Wellbutrin XL



Generic Name: bupropion (Oral route)

bue-PROE-pee-on

Oral route(Tablet;Tablet, Extended Release;Tablet, Extended Release, 12 HR;Tablet, Extended Release, 24 HR)

Wellbutrin(R) formulations and Forfivo XL: Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients. Zyban(R): Serious neuropsychiatric events, including depression, suicidal ideation, suicide attempt, and completed suicide, have been reported in patients with and without preexisting psychiatric disease who were taking bupropion for smoking cessation; some experienced worsening of their psychiatric illnesses. All patients should be observed for changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. The patient should stop taking bupropion and contact a healthcare provider immediately if any neuropsychiatric behavior that is not typical for the patient is observed, or if the patient develops suicidal ideation or suicidal behavior. This risk should be weighed against the benefits of its use .


Oral route(Tablet, Extended Release)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .



Commonly used brand name(s)

In the U.S.


  • Aplenzin

  • Budeprion SR

  • Budeprion XL

  • Buproban

  • Wellbutrin

  • Wellbutrin SR

  • Wellbutrin XL

  • Zyban

Available Dosage Forms:


  • Tablet, Extended Release, 24 HR

  • Tablet, Extended Release, 12 HR

  • Tablet

  • Tablet, Extended Release

Therapeutic Class: Antidepressant


Chemical Class: Aminoketone


Uses For Wellbutrin XL


Bupropion is used to treat mental depression. It is also used as part of a support program to help people stop smoking. This medicine may also be used to prevent depression in patients with seasonal affective disorder, which is sometimes called winter depression.


Bupropion is sold under different brand names for different uses. If you are already taking medicine for mental depression or to help you stop smoking, discuss this with your doctor before taking bupropion. It is very important that you receive only one prescription for bupropion at a time.


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


Before Using Wellbutrin XL


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


Allergies


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


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of bupropion in the pediatric population. Studies with other medicines used for depression have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking these medicines. Because of this toxicity, use in children is not recommended.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bupropion in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving bupropion.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


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


Interactions with Medicines


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


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


  • Clorgyline

  • Iproniazid

  • Isocarboxazid

  • Methylene Blue

  • Metoclopramide

  • Moclobemide

  • Nialamide

  • Pargyline

  • Phenelzine

  • Procarbazine

  • Selegiline

  • Toloxatone

  • Tranylcypromine

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


  • Betamethasone

  • Budesonide

  • Carbimazole

  • Clobetasone

  • Corticotropin

  • Cortisone

  • Cosyntropin

  • Danazol

  • Deflazacort

  • Desonide

  • Dexamethasone

  • Fludrocortisone

  • Flunisolide

  • Fluticasone

  • Hydrocortisone

  • Linezolid

  • Methenolone

  • Methylprednisolone

  • Methyltestosterone

  • Nandrolone

  • Oxandrolone

  • Oxymetholone

  • Paramethasone

  • Prednisolone

  • Prednisone

  • Rimexolone

  • Stanozolol

  • Testosterone

  • Theophylline

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


  • Amantadine

  • Citalopram

  • Desipramine

  • Efavirenz

  • Flecainide

  • Fluoxetine

  • Haloperidol

  • Levodopa

  • Lopinavir

  • Metoprolol

  • Nortriptyline

  • Paroxetine

  • Propafenone

  • Risperidone

  • Ritonavir

  • Sertraline

  • St John's Wort

  • Thioridazine

  • Tipranavir

  • Zolpidem

Interactions with Food/Tobacco/Alcohol


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


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


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


  • Alcohol use, if stopped suddenly, or

  • Eating disorders (e.g., anorexia nervosa, bulimia nervosa), history of or

  • Sedative (sleeping medicine) use, if stopped suddenly (e.g., alprazolam [Xanax®], diazepam [Valium®], triazolam [Restoril®]), or

  • Seizures or epilepsy, history of—Should not be used in patients with these conditions.

  • Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or

  • Depression, history of or

  • Hypertension (high blood pressure) or

  • Psychosis (mental disease that affects emotions and behaviors) or

  • Schizophrenia (mental illness)—Use with caution. May make these conditions worse.

  • Brain or spine tumor or

  • Diabetes or

  • Drug or alcohol abuse (e.g., opiates, cocaine, stimulants) or

  • Head injury, history of or

  • Liver disease (including cirrhosis), severe—The risk of seizures may be increased when bupropion is taken by patients with these conditions.

  • Heart attack, recent or

  • Heart disease, unstable—The effects of bupropion in patients with these conditions are not known.

  • Kidney disease or

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

  • Mania or hypomania, history of—Use of bupropion may activate these conditions.

Proper Use of bupropion

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


Use bupropion only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so, may increase the chance of side effects.


This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.


Swallow the sustained-release tablets whole. Do not break, crush, divide, or chew it.


You may take this medicine with or without food. But, if you have nausea, take this medicine with food.


To lessen stomach upset, this medicine may be taken with food, unless your doctor has told you to take it on an empty stomach.


If you are taking Zyban® tablets to help you stop smoking, you may continue to smoke for about 1 week after you start using this medicine. Then, you should set a target date to quit smoking during your second week of Zyban® treatment. Talk to your doctor if you are having trouble to stop smoking after you have used this medicine for at least 7 weeks.


Do not smoke if you are using a nicotine patch or any other medicine containing nicotine together with Zyban® tablets. To do so, may increase risk for more serious side effects.


This medicine must be taken for several weeks, usually 4 weeks, before you start to feel better. You will probably need to keep taking bupropion for several months to help prevent the return of your depression. Your doctor will check your progress at regular visits, especially during the first few weeks that you take this medicine.


If you have trouble with sleeping (insomnia), do not take this medicine too close to bedtime.


For patients taking the extended-release tablet form of this medicine:


  • Take doses at least 24 hours apart to decrease the chance of seizures.

  • Swallow the tablets whole. Do not crush, break, or chew them.

  • While taking this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

  • If you use this medicine to prevent depression in seasonal affective disorder, take it during the autumn season before your symptoms start. Continue using this medicine through the winter season and until early spring.

To help you remember to use your medicine, take it at the same time each day.


Dosing


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


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


  • For oral dosage form (extended-release tablets):
    • For depression:
      • Adults—
        • Aplenzin™: At first, 174 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 522 mg per day.

        • Forfivo XL®: 450 mg once a day.

        • Wellbutrin XL®: At first, 150 mg once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 450 mg once a day.


      • Children—Use and dose must be determined by your doctor.


    • For seasonal affective disorder:
      • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 300 mg once a day.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (tablets):
    • For depression:
      • Adults—At first, 100 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg three times a day. Take doses at least 4 hours apart to decrease the chance of seizures.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (sustained-release tablets):
    • For depression:
      • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 200 mg two times a day. Take doses at least 8 hours apart to decrease the chance of seizures.

      • Children—Use and dose must be determined by your doctor.


    • To help you stop smoking:
      • Adults—At first, 150 milligrams (mg) once a day for the first 3 days. Then, your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day. Take doses at least 8 hours apart to decrease the chance of seizures.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


If you are taking the extended-release tablets and you miss a dose, skip the missed dose and go back to your regular dosing schedule.


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Wellbutrin XL


Your doctor will check your progress at regular visits, especially during the first few months that you take this medicine. The amount of bupropion you take may have to be adjusted to meet the needs of your condition and to help avoid unwanted effects.


Do not take bupropion with or within 14 days of taking a drug with monoamine oxidase inhibitor (MAOI) activity (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor within 14 days of taking bupropion. If you do, you might have convulsions (seizures).


Your blood pressure might get too high while you are using this medicine. This may cause headaches, blurred vision, and other symptoms. You might need to measure your blood pressure at home. If you think your blood pressure is getting too high, call your doctor right away.


Bupropion may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.


This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you take this medicine.


Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.


Drinking alcoholic beverages should be limited or avoided, if possible, while taking bupropion. This will help prevent seizures.


This medicine may cause some people to have a false sense of well-being, or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded.


Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having side effects such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headache, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness when you stop the medicine.


Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


This medicine may cause changes in your appetite or weight. Your doctor may need to check your weight regularly during treatment with this medicine.


Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.


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


Wellbutrin XL Side Effects


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


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


More common
  • Anxiety

  • dry mouth

  • hyperventilation

  • irregular heartbeats

  • irritability

  • nervousness

  • restlessness

  • shaking

  • shortness of breath

  • trouble with sleeping

Less common
  • Buzzing or ringing in the ears

  • headache (severe)

  • skin rash, hives, or itching

Rare
  • Confusion

  • fainting

  • false beliefs that cannot be changed by facts

  • having extreme distrust of people

  • seeing, hearing, or feeling things that are not there

  • seizures (convulsions)

  • trouble with concentrating

Incidence not known
  • Actions that are out of control

  • anger

  • assaulting others

  • attacking others

  • being aggressive

  • being impulsive

  • chest pain or discomfort

  • fast or pounding heartbeat

  • force

  • inability to sit still

  • need to keep moving

  • sweating

  • talking, feeling, or acting with excitement

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


Symptoms of overdose
  • Blue lips, fingernails, or skin

  • blurred vision

  • change in consciousness

  • dark-colored urine

  • decreased awareness or responsiveness

  • difficult or troubled breathing

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

  • fever

  • irregular, fast or slow, or shallow breathing

  • loss of consciousness

  • muscle cramps, pain, or spasms

  • muscle stiffness or tightness

  • nausea

  • severe sleepiness

  • unusual tiredness or weakness

  • vomiting

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


More common
  • Abdominal or stomach pain

  • constipation

  • decrease in appetite

  • dizziness

  • increased sweating

  • trembling

  • weight loss (unusual)

Less common
  • Blurred vision

  • change in sense of taste

  • drowsiness

  • frequent need to urinate

  • sore throat

  • unusual feeling of well-being

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: Wellbutrin XL side effects (in more detail)



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More Wellbutrin XL resources


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


  • Wellbutrin XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Wellbutrin XL Prescribing Information (FDA)

  • Aplenzin Prescribing Information (FDA)

  • Aplenzin Consumer Overview

  • Aplenzin Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Budeprion XL Prescribing Information (FDA)

  • Bupropion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bupropion Prescribing Information (FDA)

  • Bupropion Professional Patient Advice (Wolters Kluwer)

  • Bupropion Hydrochloride Monograph (AHFS DI)

  • Wellbutrin Consumer Overview

  • Wellbutrin Prescribing Information (FDA)

  • Wellbutrin SR Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Wellbutrin SR Prescribing Information (FDA)

  • Zyban Prescribing Information (FDA)

  • Zyban Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zyban Consumer Overview



Compare Wellbutrin XL with other medications


  • Depression
  • Seasonal Affective Disorder

Saturday, 4 August 2012

Nescon-PD


Generic Name: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)

Brand Names: Aldex G, Aquatab D, Crantex, D-Phen 1000, D-Tab, Deconex, Deconsal II, Deconsal Pediatric, Despec, Donatussin Drops, Duomax, Duraphen 1000, Duraphen II, Duratuss, Dynex LA, ExeTuss, Extendryl G, Fenesin PE IR, Genexa LA, Gentex LA, Gilphex TR, Guaiphen-D 1200, Guaiphen-D 600, Guaiphen-PD, Guiadex PD, Guiatex PE, J-Max, Liquibid D-R, Liquibid-D, Liquibid-PD, Lusonex, Maxiphen, Medent-PE, MontePhen, Mucinex Children's Cold, Mucus Relief Sinus, Mydex, Nariz, Nasex, Nescon-PD, Nexphen PD, Norel EX, PE-Guai, Pendex, Prolex D, Refenesen PE, Reluri, Rescon-GG, Respa-PE, Robitussin Head & Chest Congestion, Simuc, Simuc-GP, Sina-12X, Sinupan, SINUvent PE, Sitrex PD, Sudafed PE Non-Drying Sinus, Sudex, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec, Xedec II, Xpect-PE, Zotex GPX


What is Nescon-PD (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.


Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.


Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Nescon-PD (guaifenesin and phenylephrine)?


There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

What should I discuss with my healthcare provider before taking Nescon-PD (guaifenesin and phenylephrine)?


You should not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use guaifenesin and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use guaifenesin and phenylephrine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:



  • heart disease or high blood pressure;




  • diabetes;




  • circulation problems;




  • glaucoma;




  • overactive thyroid; or




  • enlarged prostate or problems with urination.




It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor's advice if you are pregnant. This medication passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take Nescon-PD (guaifenesin and phenylephrine)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cough or cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, numbness or tingly feeling, dizziness, and feeling restless or nervous.


What should I avoid while taking Nescon-PD (guaifenesin and phenylephrine)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Nescon-PD (guaifenesin and phenylephrine) 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;




  • severe dizziness, anxiety, restless feeling, or nervousness;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • vomiting, upset stomach;




  • warmth, tingling, or redness under your skin;




  • feeling excited or restless (especially in children);




  • sleep problems (insomnia);




  • skin rash or itching;




  • headache; or




  • dizziness.



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


What other drugs will affect Nescon-PD (guaifenesin and phenylephrine)?


Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:



  • medicines to treat high blood pressure;




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or




  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.



This list is not complete and other drugs may interact with guaifenesin and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Nescon-PD resources


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


  • Crantex Prescribing Information (FDA)

  • Despec Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Entex LA Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Gentex LA Sustained-Release Tablets (12 Hour) MedFacts Consumer Leaflet (Wolters Kluwer)

  • Guiatex PE Prescribing Information (FDA)

  • Lusonex Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Rescon-GG Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Sina-12X Suspension MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Nescon-PD with other medications


  • Cough and Nasal Congestion
  • Sinus Symptoms


Where can I get more information?


  • Your pharmacist can provide more information about guaifenesin and phenylephrine.

See also: Nescon-PD side effects (in more detail)


Friday, 3 August 2012

Vivelle Patch


Pronunciation: ESS-truh-DIE-ole
Generic Name: Estradiol
Brand Name: Examples include Estraderm and Vivelle

Estrogens have been reported to increase the chance of uterine (womb) cancer. Estrogen-containing products should not be used to prevent heart disease or dementia. Estrogen given alone or in combination with another hormone (progestin) for replacement therapy may increase your risk for heart disease (eg, heart attacks), stroke, serious blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism), dementia, or breast cancer. These risks appear to depend on the length of time Vivelle Patch is used and the amount of estrogen per dose. Therefore, Vivelle Patch should be used exactly as prescribed by your doctor, for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.





Vivelle Patch is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, or dryness), preventing osteoporosis (brittle bones) in certain women who have already gone through menopause, or replacing estrogen if the ovaries do not produce enough or are removed. It may also be used for other conditions as determined by your doctor.


Vivelle Patch is an estrogen hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.


Do NOT use Vivelle Patch if:


  • you are allergic to any ingredient in Vivelle Patch

  • you are pregnant or suspect you may be pregnant

  • you have undiagnosed, abnormal vaginal bleeding

  • you have known or suspected abnormal estrogen-dependent growths, known or suspected breast cancer, or a history of breast cancer

  • you have or have a history of blood clots in your legs, lungs, or other blood vessels

  • you have had a heart attack or stroke within the past year or you have liver problems

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



Before using Vivelle Patch:


Some medical conditions may interact with Vivelle Patch. 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 breast lumps or disease, an abnormal mammogram, or a family history of breast cancer

  • if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or if you have high blood pressure during pregnancy (toxemia)

  • if you have a vaginal infection or womb problems (eg, uterine fibroids, endometriosis, abnormal vaginal bleeding, other uterine problems)

  • if you have asthma, cancer (eg, breast cancer), certain blood problems (eg, porphyria), cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems (eg, heart attack, congestive heart failure), high blood pressure, kidney or liver disease, underactive thyroid, lupus, migraine headaches, pancreas disease, seizures, yellowing of the skin or eyes (jaundice), or a history of abnormal calcium levels in the blood, or if you are very overweight

  • if you smoke or will be having surgery

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


  • Clarithromycin, erythromycin, azole antifungals (eg, itraconazole, ketoconazole), or ritonavir because they may increase the risk of Vivelle Patch's side effects

  • Anticoagulants (eg, warfarin) because their actions and side effects may be increased by Vivelle Patch

  • Carbamazepine, hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), rifampin, or St. John's wort because they may decrease Vivelle Patch's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vivelle Patch 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 Vivelle Patch:


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


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

  • If you are switching from oral estrogen to Vivelle Patch, stop taking the oral estrogen and wait 1 week before using Vivelle Patch. However, if your symptoms return, you may start using Vivelle Patch sooner.

  • The patch is usually replaced twice a week (about every 3 to 4 days), or as directed by your doctor. Follow the dosing schedule carefully.

  • Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply the patch to a clean, dry, hairless area of the body, such as the lower abdomen or the upper part of the buttock, as described in the patient information leaflet or on the package. If you have any questions about where to apply the patch, contact your doctor or pharmacist for instructions. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts off of your skin, press down to reapply. Wear only 1 system at any one time.

  • Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on an area where sitting may loosen it. Do not apply to a site that is exposed to sunlight. Contact with water while bathing, showering, or swimming will not affect the patch.

  • When it is time to change the patch, remove it slowly. After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.

  • Apply a new patch to a different area to prevent skin irritation. It is best to rotate the areas where the patch is applied, allowing at least 1 week in between applications to the same site. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor promptly.

  • Grapefruit and grapefruit juice may increase the risk of Vivelle Patch's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vivelle Patch.

  • If you miss a dose of Vivelle Patch, use it as soon as possible. If a patch falls off, reapply it or apply a new patch and wear it for the rest of the scheduled period, then resume your usual dosing schedule. Do not use 2 doses at once.

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



Important safety information:


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

  • Vivelle Patch may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.

  • Vivelle Patch may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).

  • Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.

  • Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vivelle Patch.

  • Follow your doctor's instructions for examining your breasts, and report any lumps immediately.

  • If you wear contact lenses and you develop problems with them, contact your doctor.

  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken while you are taking Vivelle Patch.

  • Nondrug therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.

  • Vivelle Patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vivelle Patch.

  • Diabetes patients - Vivelle Patch 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 physical exams and blood pressure, may be performed while you use Vivelle Patch. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.

  • Use Vivelle Patch with caution in the ELDERLY; they may be more sensitive to its effects, especially dementia.

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

  • PREGNANCY and BREAST-FEEDING: Do not use Vivelle Patch if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vivelle Patch may be found in breast milk. If you are or will be breast-feeding while you use Vivelle Patch, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Vivelle Patch:


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:



Bone or limb pain; breakthrough bleeding; breast tenderness; dizziness or lightheadedness; neck or back pain; nausea; skin redness/irritation at the application site; upset stomach; weight change.



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); abnormal vaginal bleeding; breast lumps; breast pain; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, severe depression, memory loss); one-sided weakness; pain or tenderness in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.



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


See also: Vivelle side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.


Proper storage of Vivelle Patch:

Store Vivelle Patch at room temperature, 59 to 86 degrees F (15 to 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vivelle Patch out of the reach of children and away from pets.


General information:


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

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

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

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

This information is a summary only. It does not contain all information about Vivelle Patch. 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 Vivelle resources


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


Compare Vivelle with other medications


  • Atrophic Urethritis
  • Atrophic Vaginitis
  • Hypoestrogenism
  • Oophorectomy
  • Osteoporosis
  • Postmenopausal Symptoms
  • Primary Ovarian Failure

Thursday, 2 August 2012

Isoket




Isoket may be available in the countries listed below.


UK matches:

  • Isoket 0.5 mg/ml Solution for Infusion or Injection (SPC)
  • Isoket 1 mg/ml concentrate for solution for injection or infusion (SPC)
  • Isoket Retard 20 (SPC)
  • Isoket Retard 40 (SPC)

Ingredient matches for Isoket



Isosorbide Dinitrate

Isosorbide Dinitrate is reported as an ingredient of Isoket in the following countries:


  • Argentina

  • Austria

  • Bulgaria

  • China

  • Estonia

  • Georgia

  • Germany

  • Hong Kong

  • Indonesia

  • Ireland

  • Israel

  • Latvia

  • Lithuania

  • Luxembourg

  • Malaysia

  • Oman

  • Peru

  • Philippines

  • Poland

  • Portugal

  • Russian Federation

  • Singapore

  • Slovakia

  • South Africa

  • Sri Lanka

  • Switzerland

  • Taiwan

  • Thailand

  • United Kingdom

  • Venezuela

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.