Levofloxacin rescue for Helicobacter pylori gastritis

Levofloxacin rescue for Helicobacter pylori gastritis



What is Helicobacter pylori?

This is an ancient bacteria (germ) able to live in the acidic stomach lining. About 40% of Australians over 60 have it in their stomach lining. Most are infected in childhood. It is a harmless coloniser in most and a friendly preventer of disease is some. It causes gastritis in many, gastric or duodenal ulcers in some, and gastric cancer rarely. Levofloxacin-based rescue therapy is only used if standard "triple therapy" fails.

A video about Helicobacter pylori:

Will levofloxacin rescue cure my H pylori?

After 30 years of research, there is no ideal H pylori cure without side effects. Even after two "triple therapy" failures (PPI plus amoxycillin plus clarithromycin or metronidazole), H. pylori can still be cured with "quadruple" or levofloxacin-based “rescue” therapy. In "rescue" studies this levofloxacin-regimen (esomeprazole 40mg, amoxicillin 1g and levofloxacin 500mg twice a day for 10 days) worked in over 80%. Our practice experience has been 95% successful cure. Traditional "quadruple" therapy has about 66% success. Unfortunately, resistance to quinolones is easily acquired, and in countries with a high consumption of these drugs, the resistance rate is already relatively high. Levofloxacin resistance will reduce the successful eradication rate.

What are the possible risks or side effects?

Any decision to treat Helicobacter pylori involves a balance of the risk of not treating against the risk of treating. If you decide to treat with levofloxacin, one study described no side effects in 72% and only 3% had side effects severe enough to require stopping. The most frequent side effects include nausea, headache, diarrhoea, and rashes. There are reported cases of inflamed tendons and tendon rupture and Clostridium difficile diarrhoea. As with all medications, there is the possibility of unknown risks and late side-effects. However, after more than 15 million prescriptions in the US, the rate seems very low - less than 4 in a million.

Why is levofloxacin difficult to find in most pharmacies?

Levofloxacin is not registered in Australia. This means the "Therapeutic Goods Administration (TGA) has not evaluated it either for quality, safety and or efficacy”. In spite of this, levofloxacin does seem simpler to take than quadruple therapy with fewer side effects. Your doctor will need to seek special access approval from the government TGA (tel: 6232 8111) to use for your condition. With your approval, your doctor will fax a Category B form to Canberra with a request to fax approval to Ramsay pharmacy, North Shore Private Hospital, Cincotta pharmacy, Marylands or other pharmacy of your choice. Post or deliver script by hand. Levofloxacin cost is about $60-100 depending on health card status. If there is a delay in getting approval you may contact the TGA directly (if you doctor requests permission on the form).

Suggested steps:

  1. Your doctor faxes Category B form to TGA with a request to send approval to your pharmacy*.
  2. Contact your pharmacist at Ramsay pharmacy (T:8425 3911, F: 8425 3910) or Cincotta (T:98971011, F:88414532) after 2 weeks to confirm levofloxacin approveal. If there is a delay, call TGA direct (6232 8111) and request they fax to pharmacy
  3. On approval, provided you have delivered the script, you may collect the levofloxacin in person or, pay over the phone and the pharmacist will post it to you.
  4. Take 3 medications morning and night for 10 days as directed. Levofloxacin (½ hr before, or if you forget 2 hours after food), Nexium (½ hour before food), Amoxycillin (no special directions)
  5. Stop only if significant side effects and let your doctor know.
  6. Not less than 4 weeks after your last antibiotic taken and off any PPI mediation(omeprazole, Nexium, Somac, Pariet, Zoton, Losex etc) for 2 weeks , repeat the urea breath test. Then make an appointment to review the result with your doctor to confirm H pylori cure.
  7. To assist with our research and future patient care, we would appreciate if you would fill out the brief survey below (or send an email to Dr Samuel's rooms) indicating whether the levofloxacin therapy successfully cured your H pylori infection and whether you had any side effects.

*Dr Samuel has no financial interest in Ramsay or Cincotta pharmacy. They are two pharmacies with expertise in dispensing this currently difficult to attain medicine.