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The following is a brief summary only. Before prescribing, see corn plata prescdbing information in Zantea ~ I njeation/Zautac ~ injection Pre@xed product labeling. INDICATIONS AND USAG E: Zantac ~' [njeation and Zastac ~ Injection Premixed are indicated in some hospitalized patients wdb pathological hypersecretory conditions or intractable duodenal ulcers, or as an alternative to the oral dosage form for short-tsrm usa in patients who are unable to take oral medicnt[on. CONTRAINDICATIONS: Zantac ~ Injection and Zantac * Injection Premixed are contraindicated for patients known to have hyper-sensitivit7 to the drug. PRECAUTIORS: General: 1. Symptomatic response to Zantac ~ therapy does not precludethe presence of gastric malignancy. 2. Since Zantac is excreted primarily by the kidney, dosage she uld be adjusted in patients with impaired renal function (sea DOSAG E AND ADMINISTRATION). Caution should be observed in patients with hepatic dysfunction since Zantac is metabolized in the liver. 3. in co strolled studiea in normal volunteers, elevations in SG PT have been observed when H2-antagonists have been administered intravenously at gmatar than recommended dosages for 5 days or Iongen Therefore, it seems prudent in patients raceMng intravenous (IV) ranhidine at dosages greater than or equal to 1 O0 mg q.i.d for pebods rd 5 days or longer to mongor SG PT daily (from day 5) forthe remainder of IVtherapy. 4, Stadycardia in association with rapid ad ministration of Za stea~ I njestio n has been reported rarely, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded (see DOSAGE AND ADMINISTRATION). Laboratory Tests: Fatse-posgive tests for u rine protein wi~h Multistix" may occur dubng Zantac therapy, and therefore testing with suecoalicylie acid is recommended. Drug Interactions: Although Zantac has been reported to bind weakly to cytochrome P-450 in vitro, recommended doses of the drug do not inhibit the action of the cytochrome P-45g-linked oxygenase enzymes in the liver. However, there have been isolated reports of drug interactions that suggest that Zantac may affect the bioavailabildy of certain drugs by some mechanism as yet unidentified (e.g., a pH-dependest effect o n absorption o r a change in vatu me of distd b ution).
Increased or decreased prothrombin times have been reported during concurrent use of rangidiee and warfarin. Howeven in human pharmacok[nctic studies with dosages of rangidine up to 400 rag per day, no fnteraction occurred; rangidine had no effect on vcafiadn clearance or protbrem big time. The possib;[~ of an interaction with warfarin at dosages of ranitidine higher than 400 mg per day has not been investigated.
There was no indication of tumorigenic or carcinogen ic effects in lifespan studies in mice and rats at rma[ dosages up to 2,000 mg/kg per day, Ranitidine was not mstagenic in standard bacteria[ tests (Salmonella, Escherichia coh) for mstagenicity at concentrations up to the maximum recommended for these assays, in a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of two matings per weak for the next 9weeks, Pregnancy: Teratogenic Effects: Pregnancy CategotyB: Reproduction studies have been peflormed in rats and rabbits at oral doses up to 160 times the human oral dose and have reveated no evidence of impaired ferdbiv or harm to the fetus due to Zardac. There are, however, no adequate and werl-controlled studies in pregnant women. Because animaI reproduction studies are not always p redictive of human response, this d rug should be used du ring preg nancy only if clearly needed. Nursing Mothers: Zantac is secreted in human milk. Caution should be exercised when Zantac is administered to a nursing mother. Pediatric Use: Safety and effectiveness in children have not been established. Use in Elderly Patients: Ulcer heating rates in elderly patients (65 -82 years of age) trusted with oral Zantec were no d gferent from those in YS under age-groups. The inc[decoe rates for adverse events and laboratory abnormaldice were also n ot different from those seen in other age-groups. ADVERSE REACTIONS: Transient pain at the site of IM iniection has been reported. Transient local burning or itching has bcee reported with IV administration of Zantac ".
The following have been reported as events in clinical trials or in the routine management of patients treated with oral or pareateral Zantec. The reletioea hip to Zantac therapy has been u nclear in many cases. Headache, somet[mea severe, seems to be related to Zastac ad minist rstion. Cenlral Nervous System: Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agita6o n, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have bean reported. Cardieveeaular: As with other H2-itlcokere, ra re reports of arrhythmias such as taehycardia, b radycardia, acystnle, st rioventricular block, and premature ventricurar beats. Gastrointestinal: Constipation, diarrhea, nausea/vomiting, and abdominal discomfor@ain, and rare reports of pancrestitis. Hepatic: In normal velunteers, SGPT velues we re increased to at least twice tha pretreatment levels in 6 of 12 su bjeuts receiving 1 O0 mg q.Ld. intravenously for 7 days, and in 4 of 24 subjects receiving 50 mg q.i.d, intravenously for 5 days. There have been occasional reports of hepatitis, hepatocellular or hepstocanalicular or mixed, with or wgho ut jau ndice. ]n such cJ~umstacoea, ranitidine should be immediately discostin ued. These events are usually reversible, but in exceedingly rare circumstances death has cccu rind. Musculoskeletal: Rare reports of arthralgias. Hematologic; Blood co unt changes (leakopenia, granulocytopenia, and throm bocyLopenia) have occurred in a few patients. These were usually reversible. Rare cases of ag ranulocytosis, pancytopenia, so mstimes with marrow hypoplasia, and apJastic anemia and exceedingly rare cases of acquired imrnune hemolytic anemfa have been reported. Endocrine: Controlled studies in animals and man have shown no stimulation of any pituitary hormone by Zantac and no antiand rogeaic activity, and cimetidinednd uced gynecomastia and impotence in hypersecretory patio sts have resolved when Zautac has been subst~sted. However, oeaeaiona[ cases of gysecomastia, impotence, and loss of libido have been reported in male patients receMng Zaatac, butthe incidence did not differ from that in the general population. Integumentary:. Rash, including rare cases suggestive of mild arytbema mu giforrna, and, rarely, alopecia. Other: Rare cases of hypersensitivity reactions (e.g., bronehospasm, fever, rash, eosJnephilia), anaphylaxis, angioneurutic edema, and small increases in serum ernatieine. OVERDOSAGE: Information concerning possible overdosage and its treatment appears in the full prescribing information, DOSAGE AND ADMINISTRATION: (See complete preecr[bing information in Zantac" I njestionfZastac ~ Injection Pramixed product laboring.) Intramuscular lejecfio n: 50 mg (2 rsL) every 6-B hours. (No dilution necessary.) Intermittent Intravenous Injection: a. IntetmitteMBolus: 50 mg (2 m L) every 6-3 hours. Dilute Zantac Injection, 50 rug, in 0.9% sodium chloride injection or other compatible IV solution (see Stability) to a concentration no greater than 2.5 mg/mL (20 m L). In]est at a rate no greater , than 4 mL per minute (5 minutes).
& Intermittentlnlusien:5O mg (2 mL) every 6-8 hours. Dbute Zantae Injection, 50 rag, in 5% dextrose iniectirm or other compatible/V solution (see StabiPty) to a co eaeatrstion no greatar then 0.5 mg/mL (10O m L). Infuse at a rate no greater than 5-7 mL per minute (15 -20 minutes), Zantae [njestion Pramiรed solution, 50 rag, in 0.45 % sodium oHoride, 100 m L, requires no dilution and s hould be istu sod over 15-20 minutes. in some patients it may be necessaryto increase dosage. When this is necessary, the increases should be made by more frequent administration of the dose, but generally should not exceed 400 mg per day Continuous Intravenous Infusion: Add Zantac I njectio n to 5 % dextrose injection or other compa6 ble IV solution (see Stab[$y). DaIiver at a rate of 6.25 m9 per hour (e.g., 150 mg [6 m L Zantac Injection in 250 mL of 5% deatrose injection at 10,7 mL per hour).
For Zo nger-EI][son pat ants, d ute Zantac I njectiotl n 5% dextrose n ection or other compat[b e IVsolution sea Stab ty) to a concentration no g reate r than 2.5 m g/mL. Start th e infusion at a rate of f ,0 m g/kg per he u [ If after 4 hours e~ther a meas ured gastric acid output is greater than 10 mEq p er he ur o r the pntJaut beco re es symptomatic, the dose should be adjusted upward in O.5-mg/kg per hour incremants, and the acid output should be remeasured. Dosages up to 2.5 mg/kg per hoar and infusion rates as high as 220 mg per hour have been used.
๐ SIMILAR VOLUMES
## PediaProfenยฎ Ibuprofen Suspension 100 rag/5 ml The following is a brief summary only Before prescribing, see complete prescribing information in PediaProfen labeling. INOICATIONS AND USAGE: PediaProfea is indicated for the reduction of fever in patients aged 6 months and older, and for the re