Aminocaproic Acid (Amicar)- FDA

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Cyanocobalamin (Vitamin B-12) DeficiencyGenerally, daily treatment with any acid-suppressing medications over a long period of time Aminocaproic Acid (Amicar)- FDA. HypomagnesemiaHypomagnesemia, training games and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. TumorigenicityDue to the chronic nature of GERD, there may be a potential for prolonged administration of PROTONIX.

Fundic Gland PolypsPPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Interference Читать полностью Investigations For Neuroendocrine TumorsSerum chromogranin Aminocaproic Acid (Amicar)- FDA (CgA) levels increase secondary to drug-induced decreases in gastric acidity.

Patient Counseling InformationAdvise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). PregnancyAdvise a pregnant woman of the potential risk to a fetus. AdministrationDo not split, crush, or chew PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets.

PROTONIX oral suspension packet is a fixed dose and cannot be divided to make a smaller dose. Take PROTONIX For Delayed-Release Oral Suspension approximately 30 minutes before a meal. Administer PROTONIX For Delayed-Release Oral Suspension in apple juice or applesauce, as described in the Instructions for Use. Do not administer in water, other liquids, or foods. For patients with a nasogastric Aminocaproic Acid (Amicar)- FDA or gastrostomy tube, PROTONIX For Delayed-Release Oral Suspension can be administered with apple juice, as described in the Instructions for Use.

Nonclinical ToxicologyCarcinogenesis, Mutagenesis, Impairment Of FertilityIn a 24-month carcinogenicity study, Sprague-Dawley Aminocaproic Acid (Amicar)- FDA were treated Aminocaproic Acid (Amicar)- FDA with pantoprazole doses of 0. Use In Specific PopulationsPregnancyRisk SummaryAvailable data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole.

DataHuman DataAvailable data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use.

LactationRisk SummaryPantoprazole has been detected in breast milk of a nursing mother after a single 40 mg oral dose of pantoprazole.

DataThe breast milk of a 42-year-old woman receiving 40 mg of oral pantoprazole, at 10 months postpartum, was studied for 24 hours, to demonstrate low levels of pantoprazole present in the breast milk. Pantoprazole was not detectable (Pediatric UseThe safety and effectiveness of PROTONIX for short-term treatment (up to eight weeks) of EE associated with GERD have been established in pediatric patients 1 year through 16 years of age.

Antisecretory ActivityUnder maximal acid stimulatory conditions using pentagastrin, нажмите для продолжения dose-dependent decrease in gastric acid output occurs after a single dose of oral (20-80 mg) or a single dose of intravenous (20-120 mg) pantoprazole in healthy subjects. Table 5: Effect of Single Daily Doses of Oral Pantoprazole on Intragastric pHTimeMedian pH on day 7Placebo20 mg40 mg80 mg8 a.

Enterochromaffin-Like (ECL) Cell EffectsIn 39 patients treated with oral pantoprazole 40 mg to 240 mg daily (majority receiving 40 mg to 80 mg) for up to 5 years, there was Minocycline Topical Foam (Zilxi)- FDA moderate increase in ECL-cell density, starting after the first year of use, which appeared to plateau Aminocaproic Acid (Amicar)- FDA 4 years.

Endocrine EffectsIn a clinical Aminocaproic Acid (Amicar)- FDA study, PROTONIX 40 mg given once daily for 2 weeks had no effect on the levels of the following hormones: cortisol, testosterone, triiodothyronine (T3), thyroxine (T4), thyroid-stimulating hormone (TSH), thyronine-binding protein, parathyroid hormone, insulin, glucagon, renin, aldosterone, follicle-stimulating hormone, luteinizing hormone, prolactin, and growth hormone.

PharmacokineticsPROTONIX Delayed-Release Tablets are prepared as enteric-coated tablets so that absorption of pantoprazole begins only after the tablet leaves the stomach. AbsorptionAfter Aminocaproic Acid (Amicar)- FDA of a single or multiple oral 40 mg doses of PROTONIX Delayed-Release Tablets, the peak plasma concentration of pantoprazole was Aminocaproic Acid (Amicar)- FDA in approximately 2.

DistributionThe apparent volume of distribution of pantoprazole is approximately 11 to 23. EliminationMetabolismPantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. Patients With Renal ImpairmentIn patients with severe renal impairment, pharmacokinetic parameters for pantoprazole Aminocaproic Acid (Amicar)- FDA similar to those of healthy subjects.

Patients With Hepatic ImpairmentIn patients with mild to severe hepatic impairment (Child-Pugh A to C cirrhosis), maximum pantoprazole concentrations increased only slightly (1.

Drug Interaction StudiesEffect Of Other Drugs On PantoprazolePantoprazole is metabolized mainly by CYP2C19 and to minor extents by CYPs 3A4, 2D6, and 2C9. Effect Of Pantoprazole On Other DrugsClopidogrelClopidogrel is metabolized to its active metabolite in part by CYP2C19.

AntacidsThere was also no interaction with concomitantly administered antacids. PharmacogenomicsCYP2C19 displays узнать больше здесь known genetic polymorphism due to its deficiency in some subpopulations (e.

For known pediatric poor metabolizers, a dose reduction should be considered. Clinical StudiesPROTONIX Delayed-Release Tablets were Aminocaproic Acid (Amicar)- FDA in the following clinical trials. Erosive Esophagitis (EE) Associated With Gastroesophageal Reflux Disease (GERD)Adult PatientsA US multicenter, double-blind, placebo-controlled study of PROTONIX 10 mg, 20 mg, or 40 mg once правы.

ultra пойму Aminocaproic Acid (Amicar)- FDA conducted in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above (Hetzel-Dent scale).

Pediatric Patients Ages 5 Years Through 16 YearsThe efficacy of PROTONIX in the treatment of EE associated with GERD in pediatric patients ages 5 years through 16 years is extrapolated from adequate and well-conducted trials in adults, as the pathophysiology is thought to be the same. Long-Term Maintenance Of Healing Of Erosive EsophagitisTwo independent, multicenter, randomized, double-blind, comparator-controlled trials of identical design were conducted in adult GERD patients with endoscopically confirmed healed EE to demonstrate efficacy of PROTONIX in long-term maintenance of healing.

You should take PROTONIX exactly as prescribed, at the lowest источник статьи possible and for the shortest time needed.

PROTONIX can cause serious side effects, including:A type Aminocaproic Acid (Amicar)- FDA kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute Aminocaproic Acid (Amicar)- FDA nephritis that can happen Aminocaproic Acid (Amicar)- FDA any time during treatment with PROTONIX. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call Aminocaproic Acid (Amicar)- FDA doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.



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