In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births.

Food also increases the Clarithromycin peak plasma concentration by about 24%, but does not affect the extent of Clarithromycin bioavailability.

Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. Thrombophlebitis was the only new adverse reaction identified with PROTONIX I.V.Additional adverse reactions that were reported for oral PROTONIX in US clinical trials with a frequency of ≤2% are listed below by body system:In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients administered PROTONIX I.V. Change in MAC bacteremia or blood cultures negative for 2. The study is created by eHealthMe based on reports of 1,050 people who take Clarithromycin and Pantoprazole from the Food and Drug Administration (FDA), and is updated regularly. These highlights do not include all the information needed to use PROTONIX I.V. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. Patients (n=45, median age 56 years, 21 males and 24 females) with acute endoscopically proven reflux esophagitis (Savary/Miller Stage II or III) with at least 1 of 3 symptoms typical for reflux esophagitis (acid eructation, heartburn, or pain on swallowing) were randomized to receive either 40 mg PROTONIX I.V. Once gastric acid secretion was controlled, there was no evidence of tolerance during this 7 day study. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy.

were assessed in a single-dose, open-label, placebo-controlled, dose-response study. A repeat endoscopy after 8 weeks of treatment revealed that 20 out of 23 (87%) patients treated with PROTONIX I.V. Trials Recurrence at 12 Months in Trial 14Risk of Mortality in Patients with Coronary Disease Years After Clarithromycin TreatmentWe comply with the HONcode standard for trustworthy health information - Administer intravenously over a period of at least 2 minutes.The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. If Clarithromycin is used during pregnancy, Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving Clarithromycin therapy.Prescribing Clarithromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.The following serious adverse reactions are described below and elsewhere in the labeling:Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.Based on pooled data across all indications, the most frequent adverse reactions for both adult and pediatric populations observed in clinical trials are abdominal pain, diarrhea, nausea, vomiting and dysgeusia. have not been established in pediatric patients.In a pre- and post-natal development toxicity study in rats, the pups were administered oral doses of pantoprazole at 5, 15, and 30 mg/kg/day on postnatal day (PND 4) through PND 21, in addition to lactational exposure through milk. 0000021887 00000 n 0000004553 00000 n The recommended adult dosage is 500 mg Clarithromycin tablets, 30 mg lansoprazole, and 1 gram amoxicillin, all given every 12 hours for 10 or 14 days The recommended adult dosage is 500 mg Clarithromycin tablets, 20 mg omeprazole, and 1 gram amoxicillin; all given every 12 hours for 10 days. PROTONIX ® (pantoprazole sodium) ... midazolam, clarithromycin, naproxen, piroxicam, and oral contraceptives [levonorgestrel/ethinyl estradiol]) metabolized by CYPs 2C19, 3A4, 2C9, 2D6, and 1A2. Adverse Reactions with an Incidence of 3% or GreaterLess Frequent Adverse Reactions Observed During Clinical Trials of ClarithromycinGeneral Disorders and Administration Site Conditions:All-Cause Mortality in Patients with Coronary Artery Disease 1 to 10 Years Following Clarithromycin ExposureTable 8: Clinically Significant Drug Interactions with ClarithromycinDrug(s) with Pharmacokinetics Affected by ClarithromycinLovastatin, Simvastatin, Atorvastatin, Pravastatin, FluvastatinNateglinide, Pioglitazone, Repaglinide, RosiglitazoneDrug(s) that Affect the Pharmacokinetics of ClarithromycinClarithromycin Tissue Concentrations 2 hours after Dose (mcg/mL)/(mcg/g)Figure 3. There was no significant difference in symptom relief between PROTONIX I.V. is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal.

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