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KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATIONTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Do not wear tight-fitting clothing around the stomachAvoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables Serum hormone levels, including prolactin, cortisol, thyroxine (T4), and testosterone, were not altered after treatment with famotidine.Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 to 13 years of age using the sigmoid Emax model. The bioavailability of oral doses is 40 to 45%. endobj 0000011256 00000 n
In the 106-week study in rats and the 92-week study in mice at oral doses of up to 2000 mg/kg/day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis), there was no evidence of carcinogenic potential for famotidine.Famotidine was negative in the microbial mutagen test (Ames test) using In studies with rats given oral doses of up to 2000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg per day) fertility and reproductive performance were not affected.In a U.S. multicenter, double-blind trial in adult outpatients with endoscopically confirmed duodenal ulcer (DU), orally administered famotidine was compared to placebo.
It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome.. Famotidine also treats gastroesophageal reflux disease and other conditions in which acid backs up …
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There is limited experience on the usefulness of hemodialysis as a treatment for famotidine tablets overdosage.The active ingredient in Famotidine Tablets USP is a histamine-2 (HFamotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.Famotidine is a competitive inhibitor of histamine-2 (HFamotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. ��F���L�����c1��lB+�`�
0000015109 00000 n After oral doses, peak plasma levels occur in 1-3 hours.
0000005339 00000 n famotidine tablets, including 302 treated with40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily. While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher.
In patients with moderate renal impairment (creatinine clearance between 30 to 60 mL/minute), the AUC of famotidine increased at least 2-fold Carcinogenic potential of famotidine was assessed in a 106-week oral carcinogenicity study in rats and a 92-week oral carcinogenicity study in mice.
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Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahabubnagar (Dt)-509302, India.
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4 0 obj /Type /ExtGState 20 0 obj to relieve symptoms, swallow 1 tablet with a glass of water. Famotidine tablets and famotidine for oral suspension are bioequivalent. 0000083230 00000 n [/Pattern /DeviceRGB] Packaging: Commercial Package Size. endobj 0172-5728-70, Do not lie flat or bend over after … >> /ColorSpace << 0000006046 00000 n It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome.. Famotidine also treats gastroesophageal reflux disease and other conditions in …
Plasma levels after multiple dosages are similar to those after single doses.Fifteen to 20% of famotidine in plasma is protein bound.Famotidine undergoes minimal first-pass metabolism. As shown in Table 6, patients treated with famotidine 20 mg twice daily had greater improvement in symptomatic GERD than patients treated with 40 mg at bedtime or placebo.Healing of endoscopically verified erosion and symptomatic improvement were studied in a U.S. and an international double-blind trials. Updated
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Product Characteristics: Not Actual Size. TEVA-FAMOTIDINE TABLETS (famotidine tablets, USP) 20 mg and 40 mg FAMOTIDINE IV INJECTION (famotidine injection) 10 mg/mL Histamine H2 Receptor Antagonist Teva Canada Limited.
If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness.
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Famotidine tablets and famotidine for oral suspension are bioequivalent.
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%PDF-1.4 0000083497 00000 n Last updated on Mar 25, 2020. There were no effects on the breastfed infant. Usual Adult Dose for: Duodenal Ulcer; Peptic Ulcer; Gastric …
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