Adult Dosing

H. pylori Eradication

• Lansoprazole 30 mg + amoxicillin 1g + clarithromycin 500 mg PO administered together bid for 10 or 14 days

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• H. pylori eradication to reduce the risk of recurrent duodenal ulcer

• Hypersensitivity to any of the ingredients of the product
• History of allergic reaction penicillins
• Hypersensitivity to macrolide antibiotics
• Concomitant use alprazolam, astemizole, atazanavir, BCG live intravesical, cisapride, conivaptan, dronedarone, dutasteride/tamsulosin, eletriptan, eplerenone, ergot alkaloids, ergotamine/caffeine, lurasidone, mefloquine, midazolam, nelfinavir, phenothiazines, pimozide, ranolazine, saquinavir, silodosin, tamsulosin,terfenadine, tolvaptan, toremifene, triazolam

• N/A

Renal Dose Adjustment

• CrCl <30: Not recommended

Hepatic Dose Adjustment

• Severe hepatic impairment: Consider dose reduction; dose adjustments not defined

• Therapy may cause serious and occasionally fatal hypersensitivity reactions in patients with history of hypersensitivity or sensitivity to multiple allergens
• If serious anaphylactic reaction occurs, immediately treat with epinephrine, oxygen, IV steroids and airway management including intubation
• Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate
• Deaths have been reported in some patients when clarithromycin and colchicine used concomitantly
• Therapy may cause Clostridium difficile associated diarrhea (CDAD) ranging from mild diarrhea to fatal colitis which may alter the normal flora of the colon leading to overgrowth of C. difficile
• Suspend therapy if CDAD is suspected or confirmed. Start with fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile
• Symptomatic response to therapy does not preclude the presence of gastric malignancy
• Clarithromycin therapy may cause exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome
• Superinfections with mycotic or bacterial pathogens may occur during the therapy. If superinfections occur, suspend therapy and institute appropriate therapy
• Avoid prescribing therapy in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication as it may increase the risk of the development of drug-resistant bacteria

Cautions: Use cautiously in

• Hypersensitivity
• Renal impairment
• QT prolongation
• Risk factors for QT prolongation
• Electrolyte disturbances
• Hypokalemia
• Hypomagnesemia
• Myasthenia gravis
• Hepatic impairment
• Prolonged therapy
• Elderly patients

Pregnancy Category:C

Breastfeeding: Safety unknown; due to the potential for possible serious adverse reactions in nursing infants a decision should be made for discontinuation of breastfeeding or discontinuation of the drug (taking into account the importance of the drug to the mother).

• CNS: Headache
• NEURO: Myasthenia gravis exacerbation
• CV: QT prolongation, ventricular arrhythmias, torsades de pointes
• GI: Clostridium difficile associated diarrhea, taste changes, nausea, dyspepsia abdominal pain
• EENT: Reversible hearing loss
• HEMA: Agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura
• DERM: Exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis, rash, urticaria
• HEPA: Hepatic impairment, hepatitis
• GU: Interstitial nephritis, vulvovaginal candidiasis, elevated liver transaminases
• MISC: Anaphylaxis, superinfection, serum sickness-like reaction, fractures

Amoxicillin

• Aminopenicillin; binds to bacterial cell wall, causing cell death
• Metabolized by liver; CYP450: unknown
• Renally excreted: 60-75% unchanged
• Half-life: 1.1 hrs; severe renal impairment: 12 hrs

Clarithromycin

• Macrolide; inhibits protein synthesis at the level of the 50S bacterial ribosome
• Primarily metabolized by liver; CYP450: 3A4 substrate/inhibitor
• Renally excreted: 20-40% unchanged
• Half-life: 5-7 hrs (500 mg q8-12 hrs); 22 hrs (CrCl<30 mL/min)

Lansoprazole

• Proton pump inhibitor; binds to an enzyme in the presence of acidic gastric pH, preventing the final transport of hydrogen ions into the gastric lumen
• Absolute bioavailability >80%
• Extensively metabolized by liver; CYP450: 2C19, 3A4 substrate
• Primarily excreted in bile/feces: urine (<1% unchanged);
• Half-life: <2 hrs

US Trade Name(s)

• PrevPac

US Availability

amoxicillin/clarithromycin/lansoprazole (generic)

• CARD: 500 mg (4 caps)/500 mg (2 tabs)/30 (2 caps)mg

PrevPac (amoxicillin/clarithromycin/lansoprazole)

• CARD: 500 mg (4 caps)/500 mg (2 tabs)/30 (2 caps)mg

Canadian Trade Name(s)

• HP-Pac

Canadian Availability

PrevPac (amoxicillin/clarithromycin/lansoprazole)

• CARD: 500 mg (4 caps)/500 mg (2 tabs)/30 (2 caps)mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

H. Pylori Eradication Agents

Gastrointestinal

H. Pylori Eradication Agents

Infectious Disease

H. Pylori Eradication Agents

Pricing data from www.DrugStore.com in U.S.A.

• Prevpac MISC [Box] (TAKEDA PHARMACEUTICALS)
  14 = $427.99
  28 = $854.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Prevpac Kit

Ingredient(s): Amoxicillin mixture with Clarithromycin and lansoprazole

Imprint: KL

Color(s): Yellow

Shape: Oval

Size (mm): 18.00

Score: 1

Inactive Ingredient(s): hypromellose / hydroxypropyl cellulose / silicon dioxide / croscarmellose sodium / d&c yellow no. 10 / magnesium stearate / cellulose, microcrystalline / povidone / propylene glycol / sorbic acid / sorbitan monooleate / titanium dioxide / vanillin

Drug Label Author:
Takeda Pharmaceuticals America, Inc.

DEA Schedule:
Non-Scheduled