近日，美国制药公司Pernix Therapeutics宣布，Omeclamox-Pak已在美国上市，该药用于幽门螺旋杆菌（Helicobacter pylori）感染及十二指肠溃疡，以根治成人中幽门螺旋杆菌感染。
Omeclamox-Pak是服药期为10天的三重组合口服药，包括奥美拉唑（omeprazole）缓释胶囊（20 mg）、克拉霉素（clarithromycin）片剂（500 mg）及阿莫西林（amoxicillin）胶囊（500 mg）。
Omeclamox-Pak是第一个可在10天内根除幽门螺旋杆菌感染的三重组合药物。现行幽门螺旋杆菌感染治疗方法包括双重疗法（含一种质子泵抑制剂及一种抗生素药物）及每日两次、共需服用14天的三重组合疗法。
Omeprazole是一种抗分泌药，通过降低胃酸的分泌量而发挥药效。2011年，FDA批准组合药Omeclamox-Pak在美上市。
Omeclamox-Pak禁用于对奥美拉唑、大环内酯类抗生素及盘尼西林过敏人群
ufacturer:
Pernix Therapeutics
Pharmacological Class:
Proton pump inhibitor + antibiotics (macrolide + penicillin).
Active Ingredient(s):
Omeprazole 20mg (2 del-rel caps containing enteric-coated granules), clarithromycin 500mg (2 tabs), amoxicillin 500mg (4 caps); per daily administration card.
Indication(s):
Treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori.
Pharmacology:
Omeprazole, an antisecretory drug with the substituted benzimidazoles, suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.
Clarithromycin exerts its antibacterial activity by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis.
Amoxicillin acts through the inhibition of biosynthesis of cell wall mucopeptide.
Clinical Trials:
Three U.S., randomized, double-blind clinical studies in patients with H. pylori infection and duodenal ulcer disease (n = 558) compared omeprazole plus clarithromycin plus amoxicillin with clarithromycin plus amoxicillin. Two studies (1 and 2) were conducted in patients with an active duodenal ulcer, and the other study (3) was conducted in patients with a history of a duodenal ulcer in the past 5 years but without an ulcer present at the time of enrollment. The dose regimen in the studies was omeprazole 20mg twice daily plus clarithromycin 500mg twice daily plus amoxicillin 1g twice daily for 10 days; or clarithromycin 500mg twice daily plus amoxicillin 1g twice daily for 10 days. In Studies 1 and 2, patients who took the omeprazole regimen also received an additional 18 days of omeprazole 20mg once daily. Endpoints studied were eradication of H. pylori and duodenal ulcer healing (Studies 1 and 2 only). H. pylori status was determined by CLOtest, histology and culture in all three studies. For a given patient, H. pylori was considered eradicated if at least two of these tests were negative and none was positive.
The combination of omeprazole plus clarithromycin plus amoxicillin, was effective in eradicating H. pylori.
Legal Classification:
Rx
Adults:
Swallow whole. Take on an empty stomach. Omeprazole 20mg + clarithromycin 500mg + amoxicillin 1g, all twice daily (AM + PM) for 10 days.
Children:
Not established.
Contraindication(s):
Concomitant ergots, pimozide.
Warnings/Precautions:
Hepatic impairment, Asian patients: avoid. Myasthenia gravis (monitor). Mononucleosis. Renal impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interaction(s):
See Contraindications. Clarithromycin: cardiac arrhythmias possible with concomitant pimozide. Vasospasm and ischemia with ergots. Colchicine toxicity (esp. in elderly). Torsades de pointes with quinidine, disopyramide. Potentiates digoxin, theophylline, carbamazepine, sildenafil, statins (lovastatin, simvastatin). Monitor QT prolongation with concomitant antiarrhythmics. May potentiate oral anticoagulants. CNS effects with triazolobenziodidiazepines (eg, triazolam, alprazolam) and benzodiazepines (eg, midazolam). Omeprazole: Increased INR and PT with concomitant warfarin. Antagonizes atazanavir, nelfinavir: not recommended. Consider dose reduction of concomitant saquinavir, cilostazol. Potentiates tacrolimus; monitor. May interfere with absorption of drugs for which gastric pH is important (eg, ketoconazole, ampicillin esters, iron salts). Amoxicillin: Potentiated by probenecid. May interfere with testing for glucose in urine using Clinitest, Benedict's or Fehling's Solution.
Adverse Reaction(s):
Diarrhea, taste perversion, headache; superinfection (discontinue if occurs), C. difficile-associated diarrhea.
How Supplied:
Daily administration card—1, 10
Last Updated:
6/11/2012
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