Lansi Kit
Lansi Kit Uses, Dosage, Side Effects, Food Interaction and all others data.
Amoxycillin is a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxycillin is bactericidal against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptides.
Amoxicillin competitively inhibit penicillin binding proteins, leading to upregulation of autolytic enzymes and inhibition of cell wall synthesis. Amoxicillin has a long duration of action as it is usually given twice daily. Amoxicillin has a wide therapeutic range as mild overdoses are not associated with significant toxicity. Patients should be counselled regarding the risk of anaphylaxis, Clostridium difficile infections, and bacterial resistance.
Tinidazole, a 5-nitroimidazole derivative with antimicrobial actions similar to metronidazole, is active against both protozoa (e.g. Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia) and obligate anaerobic bacteria. It damages DNA strands or inhibits DNA synthesis in microorganism.
Tinidazole is a synthetic antiprotozoal agent. Tinidazole demonstrates activity both in vitro and in clinical infections against the following protozoa: Trichomonas vaginalis, Giardia duodenalis (also termed G. lamblia), and Entamoeba histolytica. Tinidazole does not appear to have activity against most strains of vaginal lactobacilli.
Trade Name | Lansi Kit |
Generic | Amoxicillin + Tinidazole |
Type | Tablet |
Therapeutic Class | |
Manufacturer | Zydus Cadila Healthcare Ltd |
Available Country | India |
Last Updated: | September 19, 2023 at 7:00 am |
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Uses
Amoxicillin is used for the treatment of the following bacterial infections when caused by susceptible organisms:
- Respiratory tract, ENT infections: Acute and chronic bronchitis, pneumonia, otitis media, sinusitis, tonsillitis, pharyngitis & laryngitis, lobar & bronchopneumonia, chronic bronchial sepsis.
- Urinary tract infections: Pyelonephritis, cystitis and urethritis.
- Obstetric & gynaecological infections: Bacteriuria in pregnancy, septic abortion, intra-abdominal sepsis and puerperal sepsis.
- Gastro-intestinal infections: Typhoid and paratyphoid.
- Skin & soft tissue infections: Cellulitis, infected wounds and abscesses.
- Generalized infections: Septicemia, bacterial endocarditis, meningitis, peritonitis and osteomyelitis.
- Venereal infections: Gonorrhea and syphilis. Amoxicillin may also be used as prophylactic cover for patients at risk of developing endocarditis when undergoing dental surgery.
Trichomoniasis: Tinidazole is used for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection.
Giardiasis: Tinidazole is used for the treatment of giardiasis caused by Giardia duodenalis in both adults and pediatric patients older than three years of age. Sections or subsections omitted from the full prescribing information are not listed.
Amebiasis: Tinidazole is used for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not used for the treatment of asymptomatic cystpassage.
Bacterial Vaginosis: Tinidazole is used for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.
Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole and other antibacterialdrugs, Tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Lansi Kit is also used to associated treatment for these conditions: Acute Bacterial Sinusitis (ABS), Acute Otitis Media, Acute Otitis Media (AOM), Bacterial Infections, Community Acquired Pneumonia (CAP), Duodenal ulcer caused by helicobacter pylori, Genitourinary infections, Helicobacter Pylori Infection, Lower Respiratory Tract Infection (LRTI), Peptic Ulcer With H. Pylori Infection, Sinusitis, Skin and Subcutaneous Tissue Bacterial Infections, Urinary Tract Infection, Acute, uncomplicated Gonorrhea, Ear, nose, and throat infectionsAmebiasis, Bacterial Vaginosis (BV), Candidal Vulvovaginitis, Giardiasis, Mixed Vaginal Infections, Nongonococcal urethritis, Sexually Transmitted Disease (STD), Trichomonas Vaginalis Infection, Trichomoniasis
How Lansi Kit works
Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin binding proteins. Penicillin bind proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action.
Tinidazole is a prodrug and antiprotozoal agent. The nitro group of tinidazole is reduced in Trichomonas by a ferredoxin-mediated electron transport system. The free nitro radical generated as a result of this reduction is believed to be responsible for the antiprotozoal activity. It is suggested that the toxic free radicals covalently bind to DNA, causing DNA damage and leading to cell death. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known, though it is probably similar.
Dosage
Lansi Kit dosage
Ear/Nose/ThroatInfection (Mild to Moderate):
- Adult:500 mg every 12 hours or 250 mg every 8 hours
- Children:25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Ear/Nose/ThroatInfection (Severe):
- Adult: 875 mg every 12 hours or 500 mg every 8 hours
- Children: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower respiratory tractInfection (Mild/ Moderate/Severe):
- Adult: 875 mg every 12 hours or 500 mg every 8 hours
- Children: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Skin/skin structureInfection (Mild/Moderate):
- Adult: 500 mg every 12 hours or 250 mg every 8 hours
- Children: 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Skin/skin structureInfection (Severe):
- Adult: 875 mg every 12 hours or 500 mg every 8 hours
- Children: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Genitourinary tractInfection (Mild/ Moderate):
- Adult: 500 mg every 12 hours or 250 mg every 8 hours
- Children: 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Genitourinary tractInfection (Severe):
- Adult: 875 mg every 12 hours or 500 mg every 8 hours
- Children: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Gonorrhea, Acute, uncomplicated ano-genital, and urethral infections in males and females:
- Adult: 3 g as single oral dose
- Prepubertal children: 50 mg/Kg/Amoxycillin, combined with 25 mg/kg Probenecid as a single dose. Since Probenecid is contraindicated in children under 2 years, do not use this regimen in these cases.
Prevention of Postoperative Infections :
- Adult: A single oral dose of 2g approximately 12 hours before surgery.
- Children less than 12 years: Data are not available to allow dosage recommendations for children below the age of 12 years in the prophylaxis of anaerobic infections.
Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time Giardiasis:
- Adults: a single 2 g dose taken with food.
- Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food
Amebiasis, Intestinal:
- Adults: 2 g per day for 3 days with food.
- Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3 days with food
Amebic liver abscess:
- Adults: 2 g per day for 3-5 days with food.
- Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3-5 days with food
Bacterial vaginosis: Non-pregnant, adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food.
Suspension: Shake the bottle well before adding water. Then add 12 tea spoonful (60 ml) of boiled and cooled water to the bottle and shake well to make 100 ml suspension.
Amoxycillin 500 mg Injection:
- Intramuscular : Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous : Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
Should be taken with food. Take during or immediately after meals.
Side Effects
Side effects are mild, rare and infrequent. As with other penicillins, it may induce diarrhea, indigestion or skin rashes that usually stop during treatment and rarely calls for discontinuation of therapy.
Reported side effects have generally been infrequent, mild and self-limiting. Side effects from the gastrointestinal tract include nausea, vomiting, anorexia, diarrhoea and metallic taste. Hypersensitivity reactions, occasionally severe, may occur in rare cases in the form of skin rash, pruritis, urticaria and angioneurotic oedema. As with related compounds, tinidazole may produce transient leukopenia. Other rarely reported side-effects are headache, tiredness, furry tongue and dark urine.
Toxicity
Patients experiencing an overdose may present with hematuria, oliguria, abdominal pain, acute renal failure, vomiting, diarrhea, rash, hyperactivity, and drowsiness. Treat overdose with symptomatic and supportive treatment, which may include emesis or hemodialysis.
There are no reported overdoses with tinidazole in humans. In acute studies with mice and rats, the LD 50 for mice was generally > 3,600 mg/kg for oral administration and was > 2,300 mg/kg for intraperitoneal administration. In rats, the LD 50 was > 2,000 mg/kg for both oral and intraperitoneal administration.
Precaution
In renal impairment, the excretion of antibiotic will be delayed and depending on the degree of impairment it may be necessary to reduce the total daily dose.
Compounds of similar chemical structure have produced various neurological disturbances such as dizziness, vertigo, uncoordination, and ataxia. If, during therapy with tinidazole, abnormal neurological signs develop, therapy should be discontinued. Use in Pregnancy & Lactation: Tinidazole is contraindicated during the first trimester of pregnancy. While there is no evidence that tinidazole is harmful during the late stages of pregnancy, its use during the last two trimesters requires that the potential benefits outweigh the possible risk to mother and foetus. Tinidazole is excreted in breast milk in concentrations similar to those seen in serum. Tinidazole can be detected in breast milk for up to 72 hours following administration. Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose.
Interaction
The simultaneous use of Amoxicillin and an oral contraceptive might cause breakthrough bleeding or pregnancy on rare occasions. Concurrent administration of probenecid delays the excretion of Amoxicillin.
The following interactions were reported with metronidazole, which is chemically-related to tinidazole.
Alcohol, disulfiram: Avoid during tinidazole use and for 3 days afterward because cramps, nausea, vomiting, headaches, and flushing may occur.
Anticoagulants, oral (eg, warfarin): Anticoagulant effects may be increased. Anticoagulant dose may need to be adjusted during coadministration and for up to 8 days after discontinuation.
Cholestyramine: Bioavailability of tinidazole may be decreased. Cyclosporine, lithium, tacrolimus: Levels may be elevated by tinidazole, increasing the risk of toxicity.
Drugs that induce CYP3A4 (eg, fosphenytoin, phenobarbital, phenytoin, rifampin): May increase metabolism of tinidazole, decreasing plasma levels and therapeutic effect.
Drugs that inhibit CYP3A4 (eg, cimetidine, ketoconazole): May prolong t½ and decrease tinidazole Cl, increasing plasma levels and risk of adverse reactions.
Fluorouracil: Cl may be decreased by tinidazole, increasing the risk of adverse reactions
Fosphenytoin, phenytoin: The t½ may be prolonged and Cl reduced by tinidazole, increasing the risk of adverse reactions.
Oxytetracycline: Therapeutic effect of tinidazole may be decreased.
Volume of Distribution
The central volume of distribution of amoxicillin is 27.7L.
- 50 L
Elimination Route
Amoxicillin is approximately 60% bioavailable. A 250mg dose of oral amoxicillin reaches a Cmax 3.93±1.13mg/L with a Tmax 1.31±0.33h and an AUC of 27.29±4.72mg*h/L. A 875mg dose of oral amoxicillin reaches a Cmax 11.21±3.42mg/L with a Tmax 1.52±0.40h and an AUC of 55.04±12.68mg*h/L.
Rapidly and completely absorbed under fasting conditions. Administration with food results in a delay in Tmax of approximately 2 hours and a decline in Cmax of approximately 10% and an AUC of 901.6 ± 126.5 mcg hr/mL.
Half Life
The half life of amoxicillin is 61.3 minutes.
The elimination half-life is 13.2±1.4 hours and the plasma half-life is 12 to 14 hours.
Clearance
The mean clearance of amoxicillin is 21.3L/h.
Elimination Route
125mg to 1g doses of amoxicillin are 70-78% eliminated in the urine after 6 hours.
Tinidazole crosses the placental barrier and is secreted in breast milk. Tinidazole is excreted by the liver and the kidneys. Tinidazole is excreted in the urine mainly as unchanged drug (approximately 20-25% of the administered dose). Approximately 12% of the drug is excreted in the feces.
Pregnancy & Breastfeeding use
Because of its lack of teratogenicity, Amoxicillin can beused safely throughout pregnancy at the normal adult dose. The small amount of Amoxicillin secreted in maternal milk rarely causes problem in the infant. It can therefore be used safely during lactation in most instances.
Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Contraindication
Amoxicillin is contraindicated for patients hypersensitive to penicillin, infectious mononucleosis, neonatal period or babies born of mothers hypersensitive to penicillin
As with other compounds of similar structure, tinidazole, is contraindicated in patients having, or with a history of, blood dyscrasias although no persistent haematological abnormalities have been noted in clinical or animal studies. Tinidazole should be avoided in patients with organic neurological disorders. Tinidazole should not be administered to patients with known hypersensitivity to the compound.
Special Warning
Renal Impairment: Haemodialysis: Additional dose equal to half the usual dose at the end of haemodialysis.
Acute Overdose
If encountered, gastro-intestinal symptoms and disturbance of the fluid and electrolyte balance may be evident. They may be treated symptomatically and supportive with attention to the water/ electrolyte balance. In the absence of an adequate fluid intake and urinary output, crystalluria is a possibility and the antibiotic may be removed from the circulation by haemodialysis. Oral administration can cause gastro intestinal symptoms such as transient diarrhoea, nausea and colic which are dose related and a result of local irritation not toxicity.
Storage Condition
Store in a cool & dry place protected from light. Amoxicillin suspension and drops should be freshly prepared, stored in a cool dry place preferably in a refrigerator. Reconstituted suspension and drops should be used within 5 days if kept at room temperature or within 7 days if kept in a refrigerator.
Store at room temperature & protected from light.
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