Drug Interaction:
Interacting drugs - summary
+ Hepatitis B vaccine
Immunosuppressants- administration of HBV to persons receiving immunosuppressant drugs, including high-dose corticosteroids orradiation therapy, result in an insufficient response to immuninization. They may remain susceptible despite immunization.
Interleukin- 2 - natural interleukin -2 may boost systemic immune response to HBsAg
in immunodeficient nonresponders to hepatitis B vaccination, but a
recombinant interleukin- 2 did not augement response to hepatitis B
vaccine in healthy adults in one study.
Yellow fever vaccine- concurrent vaccination against hepatitis B and yellow fever viruses in
one study reduced the antibody titer expected from yellow fever vaccine. Separate these vaccinations by 1 month if possible.
Anticoagulants- as with drugs admministered by IM injection give hepatitis B vaccine
with caution to persons receiving anticoagulant therapy
Indication:
Prophylaxis against Hepatitis B infection
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Recombinant Vaccine GlaxoSmithKline 01-12-2004
Hepatitis B
Vaccine
Adverse Reaction:
Local- injection sites soreness, erythma, swelling, warmth, induration, pain, tenderness, pruritus, ecchymosis, nodule formation
GI- nausea, vomiting, abdominal pain/ cramps, dyspepsia, diminished appettite, anorexia, diarrhea, abnormal liver function tests.
CNS- headache, lightheadedness, vertigo, dizziness, paresthesia, insomnia, disturbed sleep, somnolence, irritability, agitation, migraine, syncope, paresis, neuropasthy including hypoesthesia, Gullian Barre syndrome, Bells palsy, traverse myelitis.
Respiratory- pharyngitis, upper respiratory infection, rhinitis, influenzaloke syndrome, cough, bronchospasm.
Musculoskeletal- arthalgia, myalgia, back, neck and shoulder pain, neck stiffness
Dermatologic- pruritus, rash (non specified ) angioedema, urticaria, petechiae, erythema, ezema, purpura, herpes zoster
Body as a whole- fatigue/weakness, fever, > 100F, malaise, sweating, achiness, sensation of warmth, chills, flushing , iritability , tingling.
Miscellaneous- lymphodenopathy, earache, hypotension, dysuria, tachycardia, palpitations, thrombocytopenia, conjuntivitis, keratitis, visual disturbances
Contra-Indications:
Hypersenstivity to yeast
Special Precautions-
Infection- serious active infection is raeson to dealy use of Hepatitis B vaccine, except when withholding the vaccine entails greater risk.
Special risk patients- cautiously administer to individuals with severely compromised cardiopulmonary status or when a febrile or systemic reaction could be a significant risk.
Warnings-
Hypersensitivity- have epinephrine 1:1000 immeiately avilable.
Immunosuppressed patients- may require large vaccine doses and may not respond as well as healthy individuals.
Limitations- no hepatitis B vacine will protect against hepatitis A,C, and E viruses or other viruses known to infect the liver.
Elderly- immunogenicity of hepatitis B vaccine is some what reduced in persons > 40 years of age.
Pregnancy-
Safety for use during pregnacy has not been established. Use only when clearly needed.
Lactation- safety for use in the nursing mother has not been established.
Children- Hepatitis B is well tolerated and highly immunogenic ininfants and children of all ages. Newborns also respond well.
Dosages/ Overdosage Etc:
Prophylaxis against Hepatitis B infection
Dosage-
For IM use.never inject IV. The deltoid muscle is the preferred site in adults. Injections given in the
buttocks frequently are given into fatty tissue instead of into muscle and have resulted in lower
seroconversion rate than expected.
Missed dose-
1. If you miss a dose of this medicine, and remember it on the day it should be taken, take it as directed.
2. However, if you do not remember the mised dose until the next day,take the missed dose at that time and reschedule your every-other-day doses from then.
3. It is important that this vaccine be taken exactly as directed so that it can give you protection against Hepatitis.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
Hepatitis B Vaccine- Recombinant
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies
Tell your doctor if you are have ever had any unusual or allergic reaction to
Hepatitis B Vaccine made from human plasma. Also tell your healthcare care
professional if you are allergic to any other substances such as foods,
preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans or animals. However, since the vaccine
does not contain contagious particles, it is not expected to cause problems
during pregnancy.
3. Breast-feeding-
It is known whether hepatitis b vaccine passes into breast milk. However, since
the vaccine does not contain contagious particles, it is not expected to cause
problems in nursing babies
4.Children-
Hepatitis B vaccine has been tested in new borns ,infants and children and in
effective doses, has not shown to cause different side effects or problems
in children than in adults.
5.Older adults-
Persons over 50 years of age may not become as immune to the virus
as do younger adults.
6. Other medicines-
Tell your doctor if you are using any of the prescription or non-prescription
(Over-the counter) OTC medicine.
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Heart disease or
Lung disease- some of the side effects of the vaccine may make the
condition worse
Immune deficiency condition- the condition may decrease the useful
effects of hepatitis B vaccine. The dose of the vaccine may need to
be increased
Moderate or severe illness with or without fever- the symptoms may
be confused with the possible side effects of the vaccine.
Pharmacology/ Pharmacokinetics:
Pharmacology-
The recombinant heaptitis vaccines are derived from HBsAg prodicts in yeast cells. Hepatitis B vaccine induces protective anti-HBs in most individuals receiving the recommended three-dose regimen. .
Pregnancy and lactation:
Pregnancy-
Safety for use during pregnacy has not been established. Use only when clearly needed.
Lactation-
Safety for use in the nursing mother has not been established. Children- Hepatitis B is well tolerated and highly immunogenic ininfants and children of all ages. Newborns also respond well.
Manufacturer Details