Zwraf 150 in< 300 (rMltldkw kydncMorhli) Tttliti, USP BRIEF SUMMARY atmr 150 ii* 3« (nwltldnn hydrocMorUe) GEUow" Ctenikn ZmlK*150(niillMliiiky|-rwMDril'l)EFFEMMi»TilMi Zntii* 150 (nifflUlM hvfroellorldi) EFKIUni 1 * Gnwiln Zutfu' (ruttUlM hverortlKlde) Syrup. USP The following is a brief summary only. Before prescribing, see complete prescribing Information in Zantac' product labeling. INDICATIONS AND USAGE: Zantac' is indicated In: 1. Short-term treatment of active duodenal ulcer. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage alter healing of acute ulcers. 3. The treatment of pathological hypersecretory conditions (e.g., Zolllnger-EUison syndrome and systemic mastocytosB). 4. short-term treatment of active, benign gastric ulcer. 5. Maintenance therapy for gastnc ulcer patients at reduced dosage after healing of acute ulcers. 6. Treatment of gastroesophageal reflux disease (GERD). 7.Treatmemofendoscoplcalfydlagiio^err)srifeesoprwltls.8.to erosive esophagltis. Concorntent antacids should be given as needed for pain relief to patlertewMi active duodenal ulcer active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagltis. CONTRAINDICATIONS: Zantac- Is contralndicated for patients known to have hypersensl- tivity to the drug or any of the Ingredients (see PRECAUTIONS). PRECAUTIONS: G«*nl: 1. Symptomatic response to Zantac' therapy does not preclude the presence of gastric malgnancy. 2. Since Zintac is excreted primarily by the kidney, dosaoe should be adjusted In patients with Impaired renal function (see DOSAGE AND ADMINISTRATION). Caution should be observed In patients with hepatic dysfunction since Zantac Is metabolized in the liver. 3. Rare reports suggest that Zantac may precipitate acute porphyric attacks In patients with acute porphyria. Zantac should therefore be avoided In patients with a history of acute porphyria. WormitlMi«Pltl*iltc m»rttMc«»to:Zantac' 150 EffERdose" Tablets and Zantac- 150EffERdo«™Gr3mitec«italnr^enyUlanlne16.Mmgper150moofranllkllne. Utwatwy Tests: False-positive tests for urine protein with Multistlx* may occur during Zantac therapy, and therefore testing with sultosalicylic acid is recommended. On) MincUM*: Although Zantac has been reported to bind weakly to cytochrome P- 450 /n MD, recommended doses of the drug do not Inhibit the action of the cytochrome P-450-linked oxygenase enzymes In the liver. However, there have been isolated reports of drug Interactions that suggest that Zantac may affect the bloavaUabHlty of certain drugs by some mechanism as yet unidentified (e.g., a pH-dependent effect on absorption or a change In volume of distribution). Increased or decreased prolhrombln times have been reported during concurrent use of ranltidine and warfarin. However, In human phamucokinetic studies with dosages of ranl- tidine up to 400 mg per day, no Interaction occurred: ranltidine had no effect on warfarin clearance or prothrombln time. The possibility of an interaction with warfarin at dosages of ranltidine higher than 400 mgperday has not been Investigated. CirtiMMMsH, Mutagmnri. Impalmtetrt of FiUHKy. There was no Indication ol tu- mortoenlc or carcinogenic effects In life-span studies in mice and rats at dosages up to 2,000 mg/kg per day. Ranrtidine was not mutagenic in standard bacterial tests (Salmonella, Eschoichla col!) fornvrtag^nlr^atconcentrjBonsuptoltiernaxirnumnKomrnendedfortheseusays. In a dominant lethal assay, a single oral dose of 1,000 mg/kg to mate rats was without eflect on the outcome of two matlnasper week for the next 9 weeks. performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Zantac. There are, however, no adequate and well-controlled studies In pregnant women. Because animal reproduction studies an not always predictive ol human response, this drug should be used during pregnancy only If dearly needed. NiinlM Milton: Zantac Is secreted in human milk. Caution should be exercised when Zantac is administered to a nursing mother. PHIitric DM: Safely and effectiveness In pediatricpatients have not been established. Use ki Ek4*rty HIMr. Ulcer healing rates in eldetfy patients (65 to 82 years ol age) were no different from those in younger age-groups. The Incidence rates for adverse events and laboratory abnormalities were also not different from those seen In other age-groups. ADVERSE REACTIONS: The following have been reported as events In clinical trials or in the routine management of patients treated with Zantac'. The relationship to Zantac therapy has been unclear to rrany cases. Headacte, sometimes severe, seems to be related to Zantac administration. Cntnl Nervous SntttK Rarely, malaise, dizziness, somnolence, Insomnia, and vertigo. Rare cases ol reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly In severely III elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible Involuntary motor disturbances have been received. CiriiOMsaiku: As with other Hj-blockers, rare reports of arrhythmias such as tachycar- dia, bradycardla, atfoveritricularolock, and premature ventricular beats. GntrtWitUul: Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis Huatte: In normal volunteers, SGPT values were Increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg qid. Intravenously for 7 d»ys, and In 4 of 24 subjects receiving 50 mg qJ.d. Intravenously lor 5 days. There have been occasional reports of hepatitis, hepatocellular or hepatoonalicular or mixed, with or without jaundice. In such circumstances, ranltidine should be immediately discontinued. These events are usually reversible, but to exceedingly rare circumstances death has occurred. MualaskHtral:Rare reports of arthralgtas and myalgias. Hmntologlc: Blood count changes (teukooenia. grmdocytopenia, and rhrombocytopenia) have occurred In a few patients. These were usually reversible. Rare cases of agranulocyrosis, ca«»topenia, sometimes with nwrowliyiMplasia, art cases ofiacquired immune hemotytic anemia have been reported. FjfKrun: Controlled studies in animals and man have shown no stimulation of any pituitary hormone by Zantac and no antiandrogenlc activity, and dmetidlne-lnduced gyneco- mastia and impotence in hypersecretory patients have resolved when Zantac has been substituted. However, occasional cases of gynecomastia. impotence, and loss of libido have been reported In male patients receiving Zantac, but the Incidence did not differ from that in the general population. InMguiBMlirr- R«*. Including rare cases of erythema multtforme, and. rarely, alopecia. Otkir: Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosin optima), anaphylaxis, angioneurotic edema, and small increases In serum creatinine. OVEROOSABRThere has been limited experience with overdosage. Reported acute inges- tions of up to 18 g orally have been associated with transient adverse effects similar to those encountered In normal clinical experience (see ADVERSE REACTIONS). In addition, abnormalities of gait and hypotension have been reported. When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed. Studies in dogs receiving dosages of Zantac' In excess of 225 mo/kg per day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1.000 mg/kg In mice and rats were not lethal. Intravenous liSo values in mice and rats were 77 and 83 mg/kg, respectively. DOSAGE AND ADMINISTRATION: (See complete prescribing information In Zantac- prod- Doo|i ftiintmHl IN PiUirt Witt ImMlrH Dual Fuictlon: On me basts of experience with a group of subjects with severely Impaired renal function treated with Zantac, the recommended dosage in patients with a creanntoe clearance <50 ml per minuteito 150 mg or 10 mL (2 leaspoontuis equivalent to 150 mg of ranitidine) every 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces me level of ctaJatta ra^lnijdealry, the dosing schedule should be adjusted so that the timing ol a scheduled dose coincides GlaxoWellcome OltxoWeUeomelne. Zantac' 150 Tablett/Zafflac' 300 Tablets: Glaxo Wellcome, Research Triangle Park, NC 2770* Zantac- 150 EFFERdose" TabWs/Zintac- 150 EFFEHdose™ Granules: Glaxo Wellcome, Research Triangle Park, NC 27709, Manufactured In France; Zantac; 150 Nothing seemed to help my heartburn. And it kept getting worse. ACID REFLUX DISEASE / TRIED OVER-THE-COUNTER MEDICINES. BUT THEY DIDN'T REALLY HELP MY HEARTBURN PAIN. As time went by. my symptoms got worse. I started getting heartburn pain 3 to 4 times a week. The burning sensation in my chest was so painful, I would often wake up at night. I didn't realize my symptoms might be a sign of a serious medical condition. / SHOULD HAVE SEEN MY DOCTOR SOONER. But between working at the surgicenter, taking care of my family, running a hot line for troubled teens, K. and helping out at church events, I never seemed •» to find the time. One afternoon, my heartburn pain was so bad, I just had to call my doctor. MY DOCTOR SAID MY FREQUENT . HEARTBURN WAS CAUSED BY ACID REFLUX DISEASE. , He explained that lifestyle changes plus I prescription medication could help me. I He advised me to avoid certain foods and » bedtime snacks, and to elevate the head P of my bed. And he prescribed ZANTAC... i* which relieved my heartburn pain. When / finally went to my doctor, he prescribed ZANTAC. And now, I'm pain free. ZANTAC IS AVAILABLE ONLY BY PRESCRIPTION. The following side effects have been most frequently reported by patients being treated with ZANTAC: headache, sometimes severe; abdominal discomfort/pain; nausea and vomiting; constipation: and diarrhea. Your doctor or other health care professional can provide you with more information on other possible side effects. FOR ME, ONLY ZANTAC IS ZANTAC ^ Zantac GELdose ^' ranitidine HCI150 m? capsules , Research Triangle Park, NC 27709 by Banner Gelatin Products Corp., Chatsworth, CA 91313 and/or Banner Gelatin Products (Canada) UdJIds, Wberta, Canada TOM 1PO, Manufactured in Canada: Zantac' Syrup: Manufactured for Glaxo Wellcome, Research Triangle Park, NC 27709 by Roxane Laboratories, Inc., Columbus. OH 43216 e Copyright 1995, Glaxo Wellcome Inc. All rights reserved. ZA3500RO Printed In USA September 1995 To receive more information about heartburn and acid reflux disease, call toll free: 1-800-GLAXO RX (452-9679) See additional important information next to thib ad'.orlisement.
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