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travelers diarrhea and cholera vaccine inactivated (Dukoral, Mutacol Berna)

 

Classes: Vaccines, Travel

Dosing and uses of Dukoral, Mutacol Berna (travelers diarrhea and cholera vaccine inactivated)

 

Adult dosage forms and strengths

Not available in the Us

vial vaccine + sachet effervescent granules

 

Enterotoxigenic E. Coli

Indicated for prevention of travelers' diarrhea caused by enterotoxigenic E coli (ETEC)

Primary immunization: 2 doses PO

Booster: 1 dose PO after 3 months, then q3Months PRn

 

Cholera

Indicated for prevention of cholera caused by V cholerae in endemic areas (age >2 yr)

Primary immunization: 2 doses PO

Booster: 1 dose PO after 2 years

 

Dosing Considerations

Not available in the United States

 

Pediatric dosage forms and strengths

Not available in the Us

vial vaccine + sachet effervescent granules

 

Enterotoxigenic E. Coli

Indicated for prevention of travelers' diarrhea caused by enterotoxigenic E coli (ETEC)

Primary immunization: 2 doses PO

Booster: 1 dose PO after 3 months, then q3Months PRn

 

Cholera

Indicated for prevention of cholera caused by V cholerae in endemic areas (age >2 yr)

<2 years: Safety and efficacy not established

Aged 2-6 years

  • Primary immunization: 3 doses PO
  • Booster: 1 dose PO after 6 months

Aged >6 years

  • Primary immunization: 2 doses PO
  • Booster: 1 dose PO after 2 years

 

Dosing Considerations

Not available in the United States

 

Dukoral, Mutacol Berna (travelers diarrhea and cholera vaccine inactivated) adverse (side) effects

>10%

Abd pain (16%)

 

Warnings

Contraindications

Hypersensitivity to any component

Acute illness, especially febrile illness

Parenteral administration

 

Cautions

Immunocompromised persons may not obtain expected immune response

Travellers should use care in food/water choice, & use good hygiene measures

Efficacy not studied in pts. >65 yo, but use is recommended

Not generally recommended for use in pregnancy, but may be considered after risk/benefit analysis (theoretically no risk to fetus)

Not demonstrated effective against V cholerae O139 Bengal strain in South Asia

 

Pregnancy and lactation

Pregnancy category: N/A

Lactation: safe for nursing mothers

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Dukoral, Mutacol Berna (travelers diarrhea and cholera vaccine inactivated)

Mechanism of action

Killed V cholerae and the nontoxic recombinant cholera toxin B subunit

Antibodies against cholera toxin also confer protection against enterotoxigenic E coli (ETEC)

 

Administration

Oral Administration

Mix effervescent granules with 150 mL water, then add vaccine viaL

Administer doses at intervals of 1-6 weeks

Avoid food 1 hr before and after dosing; separate from oral typhoid vaccine by 8 hr