Pylotrip R Kit
Amoxicillin + Clarithromycin + Rabeprazole Sodium kit
20 mg + 500 mg + 1 gm
Square Pharmaceuticals PLC.
| Pack size | 14's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 55.00 AED |
Indications
Pylotrip R Kit is used for:
H. pylori infection, Peptic ulcer disease
Adult Dose
Oral
Eradication of H. pylori infection:
One strip twice daily for 7-14 days.
Child Dose
Renal Dose
Severe renal impairment (CrCl <30 mL/min): Do not use
Administration
Contra Indications
Rabeprazole
Hypersensitivity to Rabeprazole or other proton pump inhibitors
Amoxicillin
History of severe hypersensitivity reactions (eg, anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or other beta-lactam antibiotics (eg, penicillins and cephalosporins)
Infectious mononucleosis (relative)
Clarithromycin
Documented hypersensitivity
Clarithromycin/ranitidine bicitrate contraindicated in: severe renal impairment (CrCl<25 mL/min); history of acute porphyria
QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes
Concomitant administration with HMG-CoA reductase inhibitors
History of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin
Coadministration with colchicine in patients with renal or hepatic impairment
Precautions
Severe hepatic impairment, and gastric malignancy. May increase the risk of GI infections due to acid-suppressive effects. Pregnancy.
Amoxicillin
Allergy to cephalosporins, carbapenems
Endocarditis prophylaxis: use only for high risk pts, per recent AHA Guidelines
High doses may cause false urine glucose test by some methods
Clarithromycin
Caution in severe renal or hepatic impairment; in presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals of clarithromycin may be appropriate
Do not refrigerate oral solution
Endocarditis prophylaxis: use only for high risk patients, per recent AHA Guidelines
Drug has been associated with prolongation of QT interval and infrequent cases of arrhythmia; cases of torsades de pointes spontaneously reported during postmarketing surveillance; fatalities reported; avoid therapy in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents; elderly patients may be more susceptible to drug-associated effects on the QT interval
Concomitant use of clarithromycin and oral hypoglycemic agents and/or insulin can result in significant hypoglycemia
There is a risk of serious hemorrhage and significant elevations in INR and prothrombin time when clarithromycin is co-administered with warfarin; monitor INR and prothrombin times
Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, reported with drug; hepatic dysfunction may be severe and usually reversible; in some instances, hepatic failure with fatal outcome reported and generally associated with serious underlying diseases and/or concomitant medications; symptoms of hepatitis can include anorexia, jaundice, dark urine, pruritus, or tender abdomen; discontinue clarithromycin immediately if signs and symptoms of hepatitis occur
Pregnancy-Lactation
Pregnancy
There were no adequate and well-controlled studies of in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk of the mother. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug therapy, taking into account the importance of the therapy to the mother.
Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
Amoxicillin is excreted in human milk in very small amounts.
There are no available human data on Rabeprazol use in pregnant women to inform the drug associated risk.
Lactation: Not recommended
Interactions
Amoxicillin: May reduce the efficacy of OC. May increase the effect of anticoagulants. Increased risk of allergic reactions w/ allopurinol. Increased and prolonged blood levels w/ probenecid. Chloramphenicol, macrolides, sulfonamides and tetracyclines may interfere w/ the bactericidal effect of amoxicillin.
Clarithromycin: Serious adverse reactions have been reported in patients taking Clarithromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension and acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine). Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 involved elderly patients 65 years of age or older.
Rabeprazole: May decrease serum concentration of ketoconazole, itraconazole and clopidogrel. Increased risk of hypomagnesaemia w/ diuretics and digoxin. May increase prothrombin time and INR of warfarin. May increase plasma concentration of saquinavir and methotrexate. Decreased serum levels w/ sucralfate.
Potentially Fatal: May decrease plasma concentrations and pharmacological effects of rilpivirine and atazanavir.
Adverse Effects
Side effects of Amoxicillin + Clarithromycin + Rabeprazole Sodium kit :
>10%
Clarithromycin
GI effects, general (13%)
1-10%
Clarithromycin
Headache (6%),Rash (children 3%),Abdominal pain (adults 2%, children 3%),Abnormal taste (adults 3-7%),Diarrhea (3-6%),Dyspepsia (2%),Heartburn (adults 2%),GI intolerance (oral-dose related),Nausea (adults 3-6%),Vomiting (adults 1%; children 6%),Decreased WBC, elevated BUN (4%), elevated PT (1%)
Rabeprazole
Headache (2-10%),Constipation (2%),Diarrhea (2-5%),Flatulence (3%),Pain (3%),Pharyngitis (3%),Abdominal pain (4%)
<1%
Clarithromycin
QT prolongation,Anxiety, dizziness, hallucinations, manic behavior, neuromuscular blockade, psychosis, seizures,Anorexia, glossitis, pancreatitis,AST increased, bilirubin increased, elevated LFTs, hepatic dysfunction, hepatitis, increased alkaline phosphate, jaundice,Hypoglycemia, leukopenia, neutropenia, thrombocytopenia,Increased serum creatinine,Dyspnea,Anaphylaxis, C Diff colitis, Stevens-Johnson syndrome
Rabeprazole
Agitation,Agranulocytosis,Alopecia,Anemia,Angioedema,Chest pain,Delirium,Erythema,Hypokalemia,Hypomagnesemia,Hyponatremia,Jaundice,Leukocytosis,Leukopenia,Migraine,Osteoporosis related fracture,Rhabdomyolysis,Stevens-Johnson syndrome,Sudden death,Toxic epidermal necrolysis,Abnormal taste
Frequency Not Defined
Amoxicillin
Headache,Rash,Diarrhea, nausea, vomiting,Anemia,AST/ALT elevation,Acute exanthematous pustulosis,Exfoliative dermatitis
Seizure,Insomnia,Hemorrhagic colitis,Toxic epidermal necrolysis,Urticaria,Stevens-Johnson syndrome,Anaphylaxis,Candidiasis (mucocutaneous), pseudomembranous colitis, serum sickness
Clarithromycin
Torsade de pointes (rare),Allergic reactions: urticaria & skin eruptions, leukocytoclastic vasculitis, toxic epidermal necrolysis, pruritus, rash
Transient CNS effects: psychosis, anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, nightmares, tinnitus, tremor, and vertigo,Hepatic failure,Stomatitis,Acute renal failure,Reversible hearing loss (hypoacusis)
Potentially Fatal: Anaphylaxis, agranulocytosis.
Mechanism of Action
Amoxicillin: Inhibits bacterial cell wall synthesis by binding to one or more penicillin binding proteins that in turn inhibit the final transpeptidation step of peptoglycan synthesis in cell wall biosynthesis.
Clarithromycin: Inhibits protein synthesis by binding to 50S ribosomal subunit causing antibacterial activity.
Rabeprazole: Proton pump inhibitor (PPI); binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, blocking acid secretion.
Note
Pylotrip R 20 mg + 500 mg + 1 gm Kit manufactured by Square Pharmaceuticals PLC.. Its generic name is Amoxicillin + Clarithromycin + Rabeprazole Sodium kit. Pylotrip R is availble in Bangladesh.
Farmaco BD drug index information on Pylotrip R Kit is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.