Le Gami
Le Gami Uses, Dosage, Side Effects, Food Interaction and all others data.
Le Gami is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Le Gami acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV (TOPO IV) which are both essential for bacterial growth.
Le Gami is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that gemifloxacin is distributed rapidly into target tissues and body fluids such as the lung (epithelial lining fluid, alveolar macrophages, bronchial tissue) and nasal secretions.
Following oral administration of gemifloxacin, approximately 36% and 61% of the dose is excreted in the urine and feces, respectively, as unchanged drug and metabolites. AUC values were generally only slightly higher (approx. 10%) in women than in men. No dose adjustment is required based on gender
Le Gami is a quinolone/fluoroquinolone antibiotic. Le Gami 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. Le Gami is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.
| Trade Name | Le Gami |
| Availability | Prescription only |
| Generic | Gemifloxacin |
| Gemifloxacin Other Names | Gemifloxacin |
| Related Drugs | amoxicillin, doxycycline, ciprofloxacin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin |
| Type | Tablet |
| Formula | C18H20FN5O4 |
| Weight | Average: 389.3809 Monoisotopic: 389.149932358 |
| Protein binding | 60-70% |
| Groups | Approved, Investigational |
| Therapeutic Class | 4-Quinolone preparations |
| Manufacturer | Lexus India Organics |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Le Gami is used for the treatment of the following bacterial infections in adults caused by sensitive organisms as follows-
Acute bacterial exacerbation of chronic bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Community-acquired pneumonia (of mild to moderate severity): caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.
Le Gami is also used to associated treatment for these conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Bacterial Infections, Community Acquired Pneumonia (CAP), Gonorrhea, Multidrug resistant Streptococcus pneumoniae infection, Bacterial rhinosinusitis
How Le Gami works
The bactericidal action of gemifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.
Dosage
Le Gami dosage
Side Effects
The general adverse events include abdominal pain, diarrhea, headache, nausea, rash and vomiting. Some side effects have been infrequently reported such as fungal overgrowth in body, dizziness and insomnia, urticaria, pruritis and a maculopapular erythmatous skin rash.
Precaution
Precautions: For patients with severe impairment of renal function, alteration of the dosage regimen to 160 mg once daily is necessary. Adequate hydration of patients receiving Le Gami should be maintained to prevent the formation of a highly concentrated urine and crystalluria. Le Gami may cause dizziness; if this occurs, patients should not operate an automobile or machinery or engage in activities requiring mental alertness or co-ordination.
Warning: Tendinitis and tendon ruptures may occur in any age group during treatment with quinolones, including Le Gami, but particularly in elderly patients or when corticosteroids are being co-administered. Le Gami should be discontinued if tendinitis is suspected or at the first sign of pain or inflammation and the affected limb should be rested. In clinical studies with Le Gami a small mean increase in QTc interval was observed. Le Gami should be used with caution in patients predisposed to QTc interval prolongation or in patients taking other medications that are known to prolong the QTc interval. Le Gami should be used with caution in patients with epilepsy.
Interaction
Le Gami absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Le Gami should be taken at least 2 hours before or 3 hours after these agents. Le Gami should be taken at least 2 hours before sucralfate administration. No clinically significant interactions have been observed when Le Gami was co-administered with omeprazole theophylline, digoxin, warfarin and oral contraceptives.
Food Interaction
- Take with or without food. The absorption is unaffected by food.
Le Gami multivitamins interaction
[Moderate] ADJUST DOSING INTERVAL: Oral preparations that contain magnesium, aluminum, or calcium may significantly decrease the gastrointestinal absorption of quinolone antibiotics.
Absorption may also be reduced by sucralfate, which contains aluminum, as well as other polyvalent cations such as iron and zinc.
The mechanism is chelation of quinolones by polyvalent cations, forming a complex that is poorly absorbed from the gastrointestinal tract.
The bioavailability of ciprofloxacin has been reported to decrease by as much as 90% when administered with antacids containing aluminum or magnesium hydroxide.
When coadministration cannot be avoided, quinolone antibiotics should be dosed either 2 to 4 hours before or 4 to 6 hours after polyvalent cation-containing products to minimize the potential for interaction.
When coadministered with Suprep Bowel Prep (magnesium Please consult individual product labeling for specific recommendations.
Le Gami Drug Interaction
Moderate: citric acid / potassium bicarbonate / sodium bicarbonate, citric acid / potassium bicarbonate / sodium bicarbonateMinor: sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprimUnknown: 5-hydroxytryptophan, 5-hydroxytryptophan, contained in alcoholic beverages , contained in alcoholic beverages , amoxicillin / clavulanate, amoxicillin / clavulanate, diphenhydramine, diphenhydramine, diphenhydramine, diphenhydramine, acetaminophen, acetaminophen, penicillin v potassium, penicillin v potassium, cholecalciferol, cholecalciferol
Le Gami Disease Interaction
Major: colitis, CNS disorders, myasthenia gravis, peripheral neuropathy, QT interval prolongation, tendonitisModerate: crystalluria, diabetes, renal dysfunction
Volume of Distribution
- 1.66 to 12.12 L/kg
Elimination Route
Rapidly absorbed from the gastrointestinal tract. The absolute bioavailability averages approximately 71%.
Half Life
7 (± 2) hours
Clearance
- renal cl=11.6+/- 3.9 L/hr [Healthy subjects receiving repeat doses of 320 mg orally]
Elimination Route
Le Gami and its metabolites are excreted via dual routes of excretion.Following oral administration of gemifloxacin to healthy subjects, a mean (± SD) of 61 ± 9.5% of the dose was excreted in the feces and 36 ± 9.3% in the urine as unchanged drug and metabolites. The mean (± SD) renal clearance following repeat doses of 320 mg was approximately 11.6 ± 3.9 L/hr (range 4.6-6 L/hr), which indicates active secretion is involved in the renal excretion of gemifloxacin.
Pregnancy & Breastfeeding use
Le Gami should not be used in pregnant or lactating women. The safety and efficacy of Le Gami in pregnant or lactating women have not been established.
Contraindication
Known hypersensitivity to Le Gami and other quinolones, Patients who have previously suffered tendon damage with fluoroquinolones. Le Gami should not be used in children under 18 years of age.
Special Warning
Renal impairment: Dose adjustment in patients with mild/moderate renal impairment is not required. Some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
Creatinine Clearance (>40 ml/min): See usual dosage
Creatinine Clearance (<40 ml/min): 160 mg once daily
Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily
Hepatic impairment: Le Gami may be given to patients with hepatic impairment, with no requirement for dose adjustment.
Elderly patients: Dose adjustment is not required.
Acute Overdose
No specific antidote is known. Dialysis does not remove Le Gami sufficiently to be useful in overdose. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed, treated symptomatically and adequate hydration should be maintained.
Storage Condition
Store in a cool and dry place, protected from light and moisture. Keep out of reach of children.
Innovators Monograph
You find simplified version here Le Gami
Le Gami contains Gemifloxacin see full prescribing information from innovator Le Gami Monograph, Le Gami MSDS, Le Gami FDA label
FAQ
What is Le Gami used for?
Le Gami used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. Le Gami belongs to the class of medicines known as quinolone antibiotics.
How does Le Gami work?
Le Gami works by killing bacteria or preventing their growth.
What are the common side effects of Le Gami?
Common side effects of Le Gami are include;
- severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
- rash
- hives
- itching
- peeling or blistering of the skin
- fever
- swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles, or lower legs
- hoarseness or throat tightness
- difficulty breathing or swallowing
- ongoing or worsening cough
- yellowing of the skin or eyes; pale skin; dark urine; or light colored stool
- extreme thirst or hunger; pale skin; feeling shaky or trembling; fast or fluttering heartbeat; sweating; frequent urination; trembling; blurred vision; or unusual anxiety
- fainting or loss of consciousness
- sudden pain in the chest, stomach, or back
Is Le Gami safe during pregnancy?
The manufacturer makes no recommendation regarding use during pregnancy.
Is Le Gami safe during breastfeeding?
You should not breast-feed while using Le Gami.
When should be taken of Le Gami?
Le Gami is usually taken with or without food.
How do I take Le Gami?
Swallow the tablet whole with liquid. Do not break, crush, or chew it. Drink plenty of fluids while you are using this medicine. Drinking extra water will help prevent some unwanted effects of Le Gami.
How many time can I take Le Gami daily?
Le Gami usually taken once daily.
Can I drink alcohol with Le Gami?
Using alcohol or tobacco with certain Le Gami may also cause interactions to occur.
What is the half life of Le Gami?
The elimination half-life of Le Gami is 6-8 hours in patients with normal renal function, supporting once-daily dosing.
How long can I take Le Gami?
Le Gami taken once a day for 5 or 7 days.
How do I use Le Gami?
Use the medicine exactly as directed. Take Le Gami with water, and drink extra fluids to keep your kidneys working properly while taking Le Gami.
Who should not take Le Gami?
Le Gami should not be given to children younger than 18 years of age. Le Gami may cause other side effects. You should not use this medicine if you are allergic to Le Gami or other fluoroquinolones.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
When should not I take Le Gami?
If you experience any of the following symptoms, stop taking Le Gami and call your doctor immediately: seizures; tremors; dizziness; lightheadedness; headaches that won't go away (with or without blurred vision); difficulty falling asleep or staying asleep; nightmares.
What happen if I overdose on Le Gami?
If you think you or someone else may have overdosed on: Le Gami, call your doctor or the Poison Control center. If someone collapses or isn't breathing after taking Le Gami.
What happen If I stop taking Le Gami?
Skipping doses can increase your risk of infection that is resistant to medication.
Can Le Gami affects my heart ?
Le Gami may cause a condition that affects the heart rhythm. Le Gami can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
Can Le Gami affects my liver?
Le Gami may cause serious liver problems.
