Brand Information

Strength	Rate	Packing Style
0.3%w/v	25.67	5ml eye drops

Drug Interaction:

Fluoroquinolones include the following :

Ciprofloxacin, Norfloxacin, Lomefloxacin, Ofloxacin, Pefloxacin, Enoxacin Refer Ciprofloxacin

Interacting drugs

Antipsychotics, Cisapride, Possible prolongation of QTc interval. Use with Erythromycin, Tricyclic caution antidepressants

Class IA antiarrhythmics Potential for QTc prolongation. Avoid (Quinidine, Procainamide) concomittant use Class III antiarrhythmics (Amiodrone, Solatol)

Digoxin- Possible increase in digoxin levels. Watch for toxicity

NSAIDs- Potential for incresed risk of CNS stimulation and seizures. Use together cautiously

Probenecid- Increase in Gatifloxacin levels and prolongation of its half life

Warfarin- Possible enhanced effects of warfarin. Monitor PT and INR

Indication:

U.S FDA. APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

165. Gatifoxacin 0.3% 24-07-08

Ketorolac Tramthamine 0.4% eye drops

For reduction of post operative inflammatory condition

of the eyes

Chronic bronchitis, pneumonia

U.S.FDA APPROVED DRUGS DURING 2004

207. FDC of Gatifloxacin 0.3% + 15-06-2004

Dexamethasone Phos. 0.1% w/w Eye drops

For post-operative inflammatory and bacterial

infection of eyes

245. Gatifloxacin Eye Ointment (1%) 06-10-2004 Ophthalmic use

259 FDC of Gatifloxacin (400mg)+ 21-12-2004

Ambroxol HCL (75mg) tablet

RTI in adults

U.S.FDA APPROVED DRUGS DURING 2006

56. Gatifloxacin(0.3% ) + 02-06-2006

Prednisolone Acetate (1%) eye drops

For Ophthalmic use

U.S.FDA APPROVED DRUGS DURING 2007

176. Gatifloxacin sequihydrate 3mg+ 29-11-07

Flurbiprofen sod. 0.3mg/ml eye drops For reduction of post operative inflammatory

conditions of eye,when bacterial infection exists

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Gatifloxacin Anti-Bacterial 03-10-2001

2.Gatifloxacin 0.3% 020-06-2006

+ Prednisolone acetate 1& eye drops

For Ophthalmic use

3.Gatifloxacin sequihydrare 3mg 29-11-2007

+ Fluribiprofen sodium 0.3mg/ml eye drops

For reduction of post-operative inflamatory conditions of eye

when bacterial infection exists

4.Gatifloxacin 0.3% 24-07-2008

+ Ketoroloac tramthane 0.4% eye drops

For the reduction of part operative inflammatory condition of the eyes

5.Gatifloxacin 0.3% 19-05-2011

+Lotprednol etabonate 0.5%

+ Benzalkonium chloride 0.01% w/v ophthalmic suspn.

For post-operative steroid repulsive inflammatory ocular conditions

when ocular bacterial infections or a risk of bacterial infection exists

6.Gatifloxacin eye drop 5mg/ml 21-12-2011

For the treatment of bacterial conjuntivitis caused by susceptible

strains

7.Gatifloxacin Eye ointment 1% 06-01-2004

Ophthalmic use

FIXED DOSE COMBINATIONS APPROVED BY DCG(I)

FROM JANUARY 1961 TILL NOVEMBER 2014

Name of Drug Indication Date of Approval

1.Gatifloxacin 0.3% + 06-02-2006

Prednisolone Acetate 1% eye drops

For Ophthalmic use

2.Gatifloxacin 200mg + 06-06-2005

Omnidazole 500mg tablet

For diarrhoea of mixed infection in adults

3.Gatifloxacin Sequihydrate 3mg+ 29-11-2007

Flurbiprofen Sodium 0.3mg/ml eye drops

For the reduction of post-operative inflammatory

conditions of eye, when bacterial infection exists

4.Gatifloxacin 0.3% + 24-07-2008

Ketorolac Trathamine 0.4% eye drops

For reduction of part operative inflammatory condition

of eyes

5.Gatifloxacin 0.3% + 19-05-2011

Loteprednol Etabonate 0.5% +

Benzalkonium Chloride 0.01%w/v Ophthalmic suspn

For Post-operative Steroid repulsive iflammatory

Ocular conditions when Ocular bacterial infections

or a risk of bacterial infection exists

6.Gatifloxacin 3mg + 18-06-2004

Dexamethasone 1mg Eye Drops

For post operative steroid responsive inflammatory

Ocular conditions when bacterial Ocular infection or

a risk of bacterial Ocular infectons exiists

7.Gatifloxacin IP eq.to Gatifloxacin anhydrous 3mg+ 24-10-2011

Difluprednate 0.5mg+

Benzalkonium Chloride IP as preservative

0.01% w/v Eye drops

For the treatment in the patients with inflammatory

Ocular conditions where bacterial infection or a

risk of Occular infection exists

8.Gatifloxacin sequihydrate 24-12-2004

eq.to Gatofloxacin 400mg+

Ambroxol Hcl SR 75mg film coated bilayered

tablets

For the treatment of respiratory tract infection by

suceptible organism in adults

Patent Expiry Date of drugs (Ref - IDMA Publication)

Chemical Category Manufacturer/ US Patent

Ingredient- Marketer Expiration Date

Gatifloxacin Antibiotics Bristol- Meyers 25-12-2007

& antifungals

Fluoroquinolones include the following :

Ciprofloxacin, Norfloxacin, Lomefloxacin, Ofloxacin, Pefloxacin, Enoxacin Refer Ciprofloxacin

Adverse Reaction:

Sun exposure-

Photosensitivity reactions may occur.

CNS- Headache, dizziness, abnormal dreams, insomnia, paraesthesia, tremor, vertogo, CV- Palpitation, chest pain

ENT- Tinntus, abnormal vision, parryngitis

GI- nausea, diarrhoea, abdominal pain, constipatiom, dyspepsia, oral candidiasis, glossitis, mouth ulcer, vomiting, taste disturbances. GU- Dysuria, haematuria, vaginitis

Musculoskeletal-

Arthralgia, myalgia, back pain

Respiratory- Dysponea

Skin- Rash, sweating

Others- Redness at injection site, chills, fever, peripheal oedema.

Contra-Indications:

Contraindicated in patients with hypersensitivity to fluroquinolones.

Special Precautions:

Do not use in patients with prolongation of QTc interval or in patients with uncorrected hypokalemia.

Use with caution in patients with clinically significant bradycardia, acute mycardial ischemia, known or suspected CNS disorders, or renal insufficiency

Safety and effectiveness in children , adolescents (less than 18 years) pregnant women and breast feeding mothers have not been established,

Dosages/ Overdosage Etc:

Indication-

Chronic bronchitis, pneumonia.

Dosage-

Recommened daily dose 400mg orally or I.V. daily and subsequent doses are 200mg orally or I.V. daily.

Patient Information:

Fluoroquinolones include the following :

Ciprofloxacin, Norfloxacin, Lomefloxacin, Ofloxacin, Pefloxacin, Enoxacin Refer Ciprofloxacin

Pharmacology/ Pharmacokinetics:

Pharmacology:

Gatifloxacin inhibits bacterial topisomerase II (DNA gyrase) and topisomerase IV which are esstential enzymes for duplication, transcription, and repair of bacterial DNA. Gatifloxacin acts against a wide range of gram- positive and and gram negative organisms both in vivo and in clinical infections.

There are no reported cross-resitence between gatofloxacin and penicillns, cephalosporins, aminoglycosides, macrolides and tetracyclines. It can ocur with other fluroquinolones.

Pharmacokinetics:

Following oral administration, Gatifloxacin is well absorbed with an absolute bioavailability of 96%. The drug can be administered without regard to food. Peak plasma levels occur within 1 - 2 hours after oral dose.

Gatifloxacin is excreted as unchanged drug via the kidney through glomerular filtration. More than 70% of the administred dose was recovered as unchanged drug in the urine within 48 hours after oral administration.

Interaction with Food:

The drug can be administered without regard to food.

Pregnancy and lactation:

Safety and effectiveness in children , adolescents (less than 18 years) pregnant women and breast feeding mothers have not been established,

GATT DPS

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation

Drug Interaction:

Indication:

Adverse Reaction:

Contra-Indications:

Dosages/ Overdosage Etc:

Patient Information:

Pharmacology/ Pharmacokinetics:

Interaction with Food:

Pregnancy and lactation:

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