Arigem
Arigem Uses, Dosage, Side Effects, Food Interaction and all others data.
Arigem is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Arigem 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.
Arigem 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
Arigem is a quinolone/fluoroquinolone antibiotic. Arigem 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. Arigem is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.
| Trade Name | Arigem |
| Availability | Prescription only |
| Generic | Gemifloxacin |
| Gemifloxacin Other Names | Gemifloxacin |
| Related Drugs | amoxicillin, doxycycline, ciprofloxacin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin |
| Weight | 320mg |
| Type | Tablet |
| Formula | C18H20FN5O4 |
| Weight | Average: 389.3809 Monoisotopic: 389.149932358 |
| Protein binding | 60-70% |
| Groups | Approved, Investigational |
| Therapeutic Class | 4-Quinolone preparations |
| Manufacturer | Aries Pharmaceuticals (pvt) Ltd |
| Available Country | Pakistan |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Arigem 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.
Arigem 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 Arigem 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
Arigem 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 Arigem should be maintained to prevent the formation of a highly concentrated urine and crystalluria. Arigem 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 Arigem, but particularly in elderly patients or when corticosteroids are being co-administered. Arigem 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 Arigem a small mean increase in QTc interval was observed. Arigem 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. Arigem should be used with caution in patients with epilepsy.
Interaction
Arigem absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Arigem should be taken at least 2 hours before or 3 hours after these agents. Arigem should be taken at least 2 hours before sucralfate administration. No clinically significant interactions have been observed when Arigem was co-administered with omeprazole theophylline, digoxin, warfarin and oral contraceptives.
Food Interaction
- Take with or without food. The absorption is unaffected by food.
Arigem 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.
Arigem 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
Arigem 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
Arigem 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
Arigem should not be used in pregnant or lactating women. The safety and efficacy of Arigem in pregnant or lactating women have not been established.
Contraindication
Known hypersensitivity to Arigem and other quinolones, Patients who have previously suffered tendon damage with fluoroquinolones. Arigem 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: Arigem 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 Arigem 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 Arigem
Arigem contains Gemifloxacin see full prescribing information from innovator Arigem Monograph, Arigem MSDS, Arigem FDA label
FAQ
What is Arigem used for?
Arigem used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. Arigem belongs to the class of medicines known as quinolone antibiotics.
How does Arigem work?
Arigem works by killing bacteria or preventing their growth.
What are the common side effects of Arigem?
Common side effects of Arigem 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 Arigem safe during pregnancy?
The manufacturer makes no recommendation regarding use during pregnancy.
Is Arigem safe during breastfeeding?
You should not breast-feed while using Arigem.
When should be taken of Arigem?
Arigem is usually taken with or without food.
How do I take Arigem?
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 Arigem.
How many time can I take Arigem daily?
Arigem usually taken once daily.
Can I drink alcohol with Arigem?
Using alcohol or tobacco with certain Arigem may also cause interactions to occur.
What is the half life of Arigem?
The elimination half-life of Arigem is 6-8 hours in patients with normal renal function, supporting once-daily dosing.
How long can I take Arigem?
Arigem taken once a day for 5 or 7 days.
How do I use Arigem?
Use the medicine exactly as directed. Take Arigem with water, and drink extra fluids to keep your kidneys working properly while taking Arigem.
Who should not take Arigem?
Arigem should not be given to children younger than 18 years of age. Arigem may cause other side effects. You should not use this medicine if you are allergic to Arigem 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 Arigem?
If you experience any of the following symptoms, stop taking Arigem 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 Arigem?
If you think you or someone else may have overdosed on: Arigem, call your doctor or the Poison Control center. If someone collapses or isn't breathing after taking Arigem.
What happen If I stop taking Arigem?
Skipping doses can increase your risk of infection that is resistant to medication.
Can Arigem affects my heart ?
Arigem may cause a condition that affects the heart rhythm. Arigem can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
Can Arigem affects my liver?
Arigem may cause serious liver problems.
