Gatifloxacin
Encyclopedia
Gatifloxacin sold under the brand names Gatiflo, Tequin and Zymar, is an antibiotic
of the fourth-generation fluoroquinolone family, that like other members of that family, inhibits the bacteria
l enzyme
s DNA gyrase
and topoisomerase IV
. Bristol-Myers Squibb
introduced Gatifloxacin in 1999 under the proprietary name Tequin for the treatment of respiratory tract infections, having licensed the medication from Kyorin Pharmaceutical Company of Japan. Allergan produces an eye-drop formulation called Zymar. In many countries, gatifloxacin is also available as tablet
s and in various aqueous solution
s for intravenous therapy
.
in March 2006 claims Tequin can have "life threatening" side effects
including serious diabetes. An editorial
by
Dr. Jerry Gurwitz in the same issue called for the Food and Drug Administration
(FDA) to consider giving Tequin a black box warning
. This editorial followed distribution of a letter dated February 15 by Bristol-Myers Squibb to health care providers indicating action taken with the FDA to strengthen warnings for the medication. Subsequently it was reported on May 1, 2006 that Bristol-Myers Squibb would stop manufacture of Tequin, end sales of the drug after existing stockpiles were exhausted, and return all rights to Kyorin.
Other serious side effects reported with gatifloxacin include hallucinations, liver damage and purpura
.
Union Health and Family Welfare Ministry of India on 18 march 2011 banned the manufacture, sale and distribution of Gatifloxacin as it caused certain adverse side effects
In China it is sold in tablet as well as in eye drop formulations.
Gatifloxacin was banned in India on the 18th of March along with Tegaserod. A statement from the health ministry said: 'The use of the following drugs is likely to involve certain risks to human beings, whereas safer alternatives to the said drugs are available.' The move comes after international studies revealed that Gatifloxacin posed 17 times higher risk of developing serious hyperglycemia (high blood sugar) than other antibiotics in elderly patients.
gatifloxacin
The Ministry of Health and Family Welfare, Govt of India in the Gazette notification dated on 16th March 2011, has prohibited the manufacture, sale and distribution of two drugs; Gatifloxacin for systemic use and Tegaserod. The prohibitory order on Gatifloxacin is applicable only for its systemic use as mentioned in the Gazette notification and does not apply to any topical formulations of Gatifloxacin.
Ophthalmic anti-infectives are generally well tolerated. The concentration of the drug observed following oral administration of 400 mg Gatifloxacin systemically is approximately 800 times higher than that of the 0.5% Gatifloxacin eye drop. Given as an eye drop, Gatifloxacin Ophthalmic Solution 0.3% & 0.5% cause very low systemic exposures. Therefore, the systemic exposures resulting from the gatifloxacin ophthalmic solution are not likely to pose any risk for systemic toxicities.
Antibiotic
An antibacterial is a compound or substance that kills or slows down the growth of bacteria.The term is often used synonymously with the term antibiotic; today, however, with increased knowledge of the causative agents of various infectious diseases, antibiotic has come to denote a broader range of...
of the fourth-generation fluoroquinolone family, that like other members of that family, inhibits the bacteria
Bacteria
Bacteria are a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria have a wide range of shapes, ranging from spheres to rods and spirals...
l enzyme
Enzyme
Enzymes are proteins that catalyze chemical reactions. In enzymatic reactions, the molecules at the beginning of the process, called substrates, are converted into different molecules, called products. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates...
s DNA gyrase
DNA gyrase
DNA gyrase, often referred to simply as gyrase, is an enzyme that relieves strain while double-stranded DNA is being unwound by helicase. This causes negative supercoiling of the DNA...
and topoisomerase IV
Topoisomerase IV
Topoisomerase IV is one of two type-II topoisomerases in bacteria, the other being DNA gyrase. Like gyrase, topoisomerase IV is able to pass one double-strand of DNA through another double-strand of DNA, thereby changing the linking number of DNA by two in each enzymatic...
. Bristol-Myers Squibb
Bristol-Myers Squibb
Bristol-Myers Squibb , often referred to as BMS, is a pharmaceutical company, headquartered in New York City. The company was formed in 1989, following the merger of its predecessors Bristol-Myers and the Squibb Corporation...
introduced Gatifloxacin in 1999 under the proprietary name Tequin for the treatment of respiratory tract infections, having licensed the medication from Kyorin Pharmaceutical Company of Japan. Allergan produces an eye-drop formulation called Zymar. In many countries, gatifloxacin is also available as tablet
Tablet
A tablet is a pharmaceutical dosage form. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose...
s and in various aqueous solution
Aqueous solution
An aqueous solution is a solution in which the solvent is water. It is usually shown in chemical equations by appending aq to the relevant formula, such as NaCl. The word aqueous means pertaining to, related to, similar to, or dissolved in water...
s for intravenous therapy
Intravenous therapy
Intravenous therapy or IV therapy is the infusion of liquid substances directly into a vein. The word intravenous simply means "within a vein". Therapies administered intravenously are often called specialty pharmaceuticals...
.
Side-effects and removal from the market
A Canadian study published in the New England Journal of MedicineNew England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
in March 2006 claims Tequin can have "life threatening" side effects
Adverse drug reaction
An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs...
including serious diabetes. An editorial
Editorial
An opinion piece is an article, published in a newspaper or magazine, that mainly reflects the author's opinion about the subject. Opinion pieces are featured in many periodicals.-Editorials:...
by
Dr. Jerry Gurwitz in the same issue called for the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) to consider giving Tequin a black box warning
Black box warning
In the United States, a black box warning is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects...
. This editorial followed distribution of a letter dated February 15 by Bristol-Myers Squibb to health care providers indicating action taken with the FDA to strengthen warnings for the medication. Subsequently it was reported on May 1, 2006 that Bristol-Myers Squibb would stop manufacture of Tequin, end sales of the drug after existing stockpiles were exhausted, and return all rights to Kyorin.
Other serious side effects reported with gatifloxacin include hallucinations, liver damage and purpura
Purpura
Purpura is the appearance of red or purple discolorations on the skin that do not blanch on applying pressure. They are caused by bleeding underneath the skin...
.
Union Health and Family Welfare Ministry of India on 18 march 2011 banned the manufacture, sale and distribution of Gatifloxacin as it caused certain adverse side effects
Availability
Gatifloxacin is currently available only in the US and Canada as an ophthalmic solution.In China it is sold in tablet as well as in eye drop formulations.
Gatifloxacin was banned in India on the 18th of March along with Tegaserod. A statement from the health ministry said: 'The use of the following drugs is likely to involve certain risks to human beings, whereas safer alternatives to the said drugs are available.' The move comes after international studies revealed that Gatifloxacin posed 17 times higher risk of developing serious hyperglycemia (high blood sugar) than other antibiotics in elderly patients.
gatifloxacin
The Ministry of Health and Family Welfare, Govt of India in the Gazette notification dated on 16th March 2011, has prohibited the manufacture, sale and distribution of two drugs; Gatifloxacin for systemic use and Tegaserod. The prohibitory order on Gatifloxacin is applicable only for its systemic use as mentioned in the Gazette notification and does not apply to any topical formulations of Gatifloxacin.
Ophthalmic anti-infectives are generally well tolerated. The concentration of the drug observed following oral administration of 400 mg Gatifloxacin systemically is approximately 800 times higher than that of the 0.5% Gatifloxacin eye drop. Given as an eye drop, Gatifloxacin Ophthalmic Solution 0.3% & 0.5% cause very low systemic exposures. Therefore, the systemic exposures resulting from the gatifloxacin ophthalmic solution are not likely to pose any risk for systemic toxicities.