Vonoprazan + Amoxicillin + Clarithromycin
Vonoprazan + Amoxicillin + Clarithromycin Uses, Dosage, Side Effects, Food Interaction and all others data.
Each Vonokit blister strip contains- One Vonoprazan 20 mg tablet (as Vonoprazan Fumarate INN) Two Amoxicillin 500 mg capsules (as Amoxicillin Trihydrate BP) One Clarithromycin 500 mg tablet (as Clarithromycin USP) Each Vonocab Trio blister strip contains- Two Vonoprazan 20 mg tablet (as Vonoprazan Fumarate INN) Four Amoxicillin 500 mg capsules (as Amoxicillin Trihydrate BP) Two Clarithromycin 500 mg tablet (as Clarithromycin USP) Each Vonolend kit contains- Two Vonoprazan 20 mg Tablets (Each film coated tablet contains Vonoprazan Fumarate INN equivalent to Vonoprazan 20 mg) Four Amoxicillin 500 mg Capsules (Each capsule contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 500 mg) Two Clarithromycin 500 mg Tablets (Each film coated tablet contains Clarithromycin USP 500 mg Each Helicon V kit contains- One Vonoprazan INN 20 mg Tablet Two Amoxicillin BP 500 mg Capsules One Clarithromycin USP 500 mg Tablet| Trade Name | Vonoprazan + Amoxicillin + Clarithromycin |
| Generic | Vonoprazan + Amoxicillin + Clarithromycin |
| Type | |
| Therapeutic Class | Anti H. pylori drugs |
| Manufacturer | |
| Available Country | Bangladesh |
| Last Updated: | September 24, 2024 at 5:38 am |
Uses
The standard triple therapy regimen is indicated in the eradication of H. pylori in active chronic gastritis, duodenal and gastric ulcers.Vonoprazan + Amoxicillin + Clarithromycin 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 infectionsAcute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Acute maxillary sinusitis, Bacterial Infections, Bartonellosis, Community Acquired Pneumonia (CAP), Duodenal ulcer caused by helicobacter pylori, Infective Endocarditis, Lyme Disease, Mycobacterial Infections, Otitis Media (OM), Pertussis, Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated skin and subcutaneous tissue bacterial infectionsDuodenal Ulcer, Gastric Ulcer, Gastric or Duodenal Ulcers Caused by Low-dose Aspirin, Helicobacter Pylori Infection, NSAID Associated Gastric Ulcers, Reflux Esophagitis (RE)
How Vonoprazan + Amoxicillin + Clarithromycin 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.
Clarithromycin is first metabolized to 14-OH clarithromycin, which is active and works synergistically with its parent compound. Like other macrolides, it then penetrates bacteria cell wall and reversibly binds to domain V of the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome, blocking translocation of aminoacyl transfer-RNA and polypeptide synthesis. Clarithromycin also inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein, an energy-dependent drug efflux pump.
Dosage
Vonoprazan + Amoxicillin + Clarithromycin dosage
The recommended dosage regimen is- Vonoprazan 20 mg Amoxicillin 1000 mg Clarithromycin 500 mg Each given twice daily (morning and evening, 12 hours apart), with or without food, for 14 days.Geriatrics: The standard triple therapy regimen increased risk of torsade de pointes due to the clarithromycin component.Renal Impairment: Avoid use in severe renal impairment.Hepatic Impairment: Avoid use in moderate and severe hepatic impairment.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.
This may be given with or without meals.
The usual duration of treatment is 6 to 14 days.
Children older than 12 years: As for adults.
Eradication of H. pylori in patients with duodenal ulcers: Adults: The usual duration of treatment is 6 to 14 days.
45 ml of water is to be added to the granules in the bottle and shaken to yield 70 ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125 mg per 5 ml.
Side Effects
Most common adverse reactions (>2%) were dysgeusia, diarrhea, vulvovaginal candidiasis, headache, abdominal pain, hypertension and nasopharyngitis.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.
Symptoms of toxicity include diarrhea, nausea, abnormal taste, dyspepsia, and abdominal discomfort. Transient hearing loss with high doses has been observed. Pseudomembraneous colitis has been reported with clarithromycin use. Allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis and Stevens-Johnson syndrome have also occurred. Rare cases of severe hepatic dysfunctions also have been reported. Hepatic failure is usually reversible, but fatalities have been reported. Clarithromycin may also cause tooth decolouration which may be removed by dental cleaning. Fetal abnormalities, such as cardiovascular defects, cleft palate and fetal growth retardation, have been observed in animals. Clarithromycin may cause QT prolongation.
Precaution
Hypersensitivity Reactions: Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of this triple pack. If hypersensitivity reactions occur, discontinue and institute immediate therapy (e.g., anaphylaxis management).Severe Cutaneous Adverse Reactions (SCAR): Discontinue this pack at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation.Clostridioides difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs with this pack and Due to the Clarithromycin Component:QT Prolongation: Avoid this pack in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia (torsades de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics.Hepatotoxicity: Discontinue if signs and symptoms of hepatitis occur with this pack.Serious adverse reactions due to concomitant use with other drugs: Serious adverse reactions can occur with this pack due to drug interactions of clarithromycin with colchicine, some lipid lowering agents, some calcium channel blockers, and other drugs.Embryo-Fetal Toxicity: Based on the findings from animal studies and human observational studies in pregnant women treated with clarithromycin, this pack is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate.Myasthenia Gravis: Exacerbation of myasthenia gravis can occur with this pack since it has been reported in patients receiving clarithromycin tablets.Interaction
Triple therapy regimen should be used with caution when co-administrated with following drugs: Tacrolimus, cyclosporine, clopidogrel, citalopram, cilostazol, probenecid, allopurinol, itraconazole, ketoconazole, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, saquinavir, ritonavir, etravirine, rilpivirine-containing products, atazanavir, nelfinavir.Volume of Distribution
The central volume of distribution of amoxicillin is 27.7L.
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.
Clarithromycin is well-absorbed, acid stable and may be taken with food.
Half Life
The half life of amoxicillin is 61.3 minutes.
3-4 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.
After a 250 mg tablet every 12 hours, approximately 20% of the dose is excreted in the urine as clarithromycin, while after a 500 mg tablet every 12 hours, the urinary excretion of clarithromycin is somewhat greater, approximately 30%.
Pregnancy & Breastfeeding use
Based on findings from animal studies and observational studies in pregnant women with use of clarithromycin, use of this triple pack is not recommended in pregnant women except in clinical circumstances where no alternative therapy is appropriate. There are no data regarding the presence of vonoprazan in human milk, the effects on the breastfed infant or the effects on milk production. Vonoprazan and its metabolites are present in rat milk.Contraindication
The standard triple therapy regimen is contraindicated in patients with known hypersensitivity to vonoprazan, amoxicillin or any other betalactams, clarithromycin or any other macrolide antimicrobialsSpecial Warning
Clarithromycin may be used in neonates and children in appropriate doses.
Acute Overdose
If overdose occurs, should consult with doctor immediately.Storage Condition
Do not store above 30°C. Keep in a dry place. Protect from light and keep out of the reach of children.Innovators Monograph
You find simplified version here Vonoprazan + Amoxicillin + Clarithromycin
