Gate P
Gate P Uses, Dosage, Side Effects, Food Interaction and all others data.
Gatifloxacin is a fluoroquinolone antibacterial which acts by inhibiting DNA synthesis in susceptible organisms via inhibition of both DNA gyrase (essential for bacterial reproduction) and topoisomerase IV (essential during bacterial cell division).
Gatifloxacin is a synthetic broad-spectrum 8-methoxyfluoroquinolone antibacterial agent for oral or intravenous administration. is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. Gatifloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. It should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Prednisolone is a glucocorticoid similar to cortisol used for its anti-inflammatory, immunosuppressive, anti-neoplastic, and vasoconstrictive effects.
Prednisolone was granted FDA approval on 21 June 1955.
Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Prednisolone has a short duration of action as the half life is 2.1-3.5 hours. Corticosteroids have a wide therapeutic window as patients make require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.
| Trade Name | Gate P |
| Generic | Prednisolone + Gatifloxacin |
| Weight | 1% |
| Type | Eye Drops |
| Therapeutic Class | |
| Manufacturer | Ajanta Pharma Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Gatifloxacin is used for the following infections:
- Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus.
- Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.
- Community-acquired pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.
- Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus or Streptococcus pyogenes.
- Uncomplicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
- Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
- Pyelonephritis due to Escherichia coli.
- Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.
- Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae.
Prednisolone is a glucocorticoid used to treat adrenocortical insufficiency, inflammatory conditions, and some cancers.
Prednisolone is indicated to treat endocrine, rheumatic, and hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, and gastrointestinal diseases; allergic and edematous states; and other conditions like tuberculous meningitis.
Gate P is also used to associated treatment for these conditions: Bacterial Conjunctivitis, Ocular Infections, Irritations and InflammationsAcne Rosacea, Acute Gouty Arthritis, Allergic Bronchopulmonary Aspergillosis, Allergic Contact Dermatitis, Allergic corneal marginal ulcers, Alveolitis, Extrinsic Allergic, Anal Fissures, Ankylosing Spondylitis (AS), Aspiration Pneumonitis, Atopic Dermatitis (AD), Bell's Palsy, Berylliosis, Bullous dermatitis herpetiformis, Burns, Chorioretinitis, Choroiditis, Chronic Obstructive Airways Disease Exacerbated, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Conjunctivitis, Corneal Inflammation, Corneal injuries, Corneal ulceration, Crohn's Disease (CD), Cyclitis, Dermatitis exfoliative generalised, Dermatitis, Contact, Dermatomyositis, Dermatosis of the Ear Canal, Drug hypersensitivity reaction, Edema of the cerebrum, Epicondylitis, Erythroblastopenia, Exacerbation of asthma, Eye inflammation caused by Cataract Surgery, Eye inflammation caused by Infection, Herpes Zoster Keratitis, Hot Water Burns (Scalds), Hypercalcemia of Malignancy, Idiopathic Pulmonary Fibrosis (IPF), Idiopathic Thrombocytopenic Purpura, Inflamed External Hemorrhoid, Inflamed Hemorrhoids, Internal, Inflammatory Reaction caused by susceptible Bacterial Infections, Iridocyclitis, Iritis, Itching caused by susceptible Bacterial Infections, Leukemia, Acute, Loeffler's syndrome, Malignant Lymphomas, Multiple sclerosis exacerbation, Mycosis Fungoides (MF), Ocular Inflammation, Ophthalmia, Sympathetic, Optic Neuritis, Otic Eczema, Pemphigus, Perennial Allergic Rhinitis (PAR), Pericarditis, Pneumocystis Jirovecii Pneumonia, Pneumonia, Aspiration, Polymyalgia Rheumatica, Post-traumatic Osteoarthritis, Proctitis, Proteinuria, Pruritus, Pruritus Ani, Psoriatic Arthritis, Pulmonary Tuberculosis (TB), Pure Red Cell Aplasia, Rash, Rejection, Transplant, Relapsing Polychondritis, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Seasonal Allergic Conjunctivitis, Seasonal Allergic Rhinitis, Secondary Adrenal Insufficiency, Secondary thrombocytopenia, Serum Sickness, Severe Asthma, Sjögren's Syndrome, Skin Infections, Bacterial, Stevens-Johnson Syndrome, Superficial punctate keratitis, Synovitis, Systemic Lupus Erythematosus (SLE), Trichinosis, Tuberculosis (TB), Tuberculous Meningitis, Ulcerative Colitis, Uveitis, Vasculitis, Acquired immune hemolytic anemia, Acute Bursitis, Acute Rheumatic heart disease, unspecified, Acute Tenosynovitis, Allergic skin manifestations, Anal eczema, Exfoliative erythroderma, Idiopathic Bronchiolitis obliterans with organizing pneumonia, Idiopathic eosinophilic pneumonias, Non-suppurative Thyroiditis, Primary adrenocoritical insufficiency, Severe Psoriasis, Severe Seborrhoeic dermatitis, Severe alcoholic liver disease, Steroid-responsive inflammation of the eye, Subacute Bursitis, Susceptible Bacterial Infections, Symptomatic Sarcoidosis, Varicella-zoster virus acute retinal necrosis
How Gate P works
The bactericidal action of Gatifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.
The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.
Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10.
Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.
Dosage
Gate P dosage
Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg 5 days
Acute Sinusitis: 400 mg 10 days
Community-acquired Pneumonia: 400 mg 7-14 days
Uncomplicated Skin and Skin Structure Infections: 400 mg 7-10 days
Uncomplicated Urinary Tract Infections: 400 mg Single Dose or 200 mg 3 days
Complicated Urinary Tract Infections: 400 mg 7-10 days
Acute Pyelonephritis: 400 mg 7-10 days
Uncomplicated Urethral Gonnorrhea in Men: 400 mg Single dose
Gatifloxacin can be administered without regard to food.
Side Effects
Gatifloxacin is generally well tolerated. The most common side effects that can occur while taking this drug are usually mild and include nausea, vomiting, stomach pain, diarrhea, dizziness,and headache .
Toxicity
The intraperitoneal LD50 in rats is 2g/kg and 65mg/kg in mice. The subcutaneous LD50 in rats is 147mg/kg and >3500mg/kg in mice. The oral LD50 in mice is 1680mg/kg. In humans, the oral TDLO in men is 9mg/kg/2W and in women is 14mg/kg/13D.
Patients experiencing an overdose of prednisolone may present with gastrointestinal disturbances, insomnia, and restlessness. Overdose of oral prednisolone may be treated by gastric lavage or inducing vomiting if the overdose was recent, as well as supportive and symptomatic therapy. Chronic overdosage may be treated by dose reduction or treating patients on alternate days. An overdose by the ophthalmic route is not expected to cause problems.
Precaution
Gatifloxacin should be administered with caution in the presence of renal insufficiency.
Volume of Distribution
A 0.15mg/kg dose of prednisolone has a volume of distribution of 29.3L, while a 0.30mg/kg dose has a volume of distribution of 44.2L.
Elimination Route
Well absorbed from the gastrointestinal tract after oral administration with absolute bioavailability of gatifloxacin is 96%
Oral prednisolone reaches a Cmax of 113-1343ng/mL with a Tmax of 1.0-2.6 hours. Oral prednisolone is approximately 70% bioavailable.
Half Life
7-14 hours
Prednisolone has a plasma half life of 2.1-3.5 hours. This half life is shorter in children and longer in those with liver disease.
Clearance
A 0.15mg/kg dose of prednisolone has a clearance of 0.09L/kg/h, while a 0.30mg/kg dose has a clearance of 0.12L/kg/h.
Elimination Route
Prednisolone is over 98% eliminated in urine.
Pregnancy & Breastfeeding use
Pregnancy: Gatifloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Lactation: It is not known whether Gatifloxacin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when gatifloxacin is administered to a nursing woman.
Contraindication
Gatifloxacin is contraindicated in patients with a history of hypersensitivity of Gatifloxacin, quinolone antimicrobial agents, or any other components of this product.
Special Warning
Renal Impaired patient:
- Creatinine Clearance 40 mL/min: 400 mg every day.
- Creatinine Clearance < 40 mL/min: 400 mg 200 mg every day.
Dialysis patients:
- Hemodialysis: 400 mg 200 mg every day.
- Continuous peritoneal dialysis: 400 mg 200 mg every day.
Pediatric use: The safety and effectiveness of Gatifloxacinacin in pediatric populations (<18 years of age) have not been established.
Acute Overdose
Gatifloxacin exhibits a low potential for acute toxicity in animal studies. In the event of acute oral overdose, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed (including ECG monitoring) and given symptomatic and supportive treatment. Adequate hydration should be maintained.
Innovators Monograph
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