Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/134
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ZANTAC (Tablet, Film Coated)
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Active Duodenal Ulcer: The current recommended adult oral dosage of ZANTAC
for duodenal ulcer is 150 mg or 10 mL of syrup (2 teaspoonfuls
of syrup equivalent to 150 mg of ranitidine) twice daily. An
alternative dosage of 300 mg or 20 mL of syrup (4 teaspoonfuls
of syrup equivalent to 300 mg of ranitidine) once daily after
the evening meal or at bedtime can be used for patients in whom dosing
convenience is important. The advantages of one treatment regimen
compared to the other in a particular patient population have yet
to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective
in inhibiting gastric acid secretionin US studies, and several foreign
trials have shown that 100 mg twice daily is as effective as
the 150-mg dose. Antacid should be given
as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).<br/>Maintenance of Healing of
Duodenal Ulcers: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) at bedtime.<br/>Pathological Hypersecretory
Conditions (such as Zollinger-Ellison syndrome): The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) twice a day. In some patients it may be
necessary to administer ZANTAC 150-mg doses more frequently. Dosages
should be adjusted to individual patient needs, and should continue
as long as clinically indicated. Dosages up to 6 g/day have been
employed in patients with severe disease.<br/>Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) twice a day.<br/>Maintenance of Healing of
Gastric Ulcers: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) at bedtime.<br/>GERD: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) twice a day.<br/>Erosive Esophagitis: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) 4 times a day.<br/>Maintenance of Healing of
Erosive Esophagitis: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) twice a day.<br/>Pediatric Use: The safety and effectiveness of ZANTAC have been
established in the age-group of 1 month to 16 years. There
is insufficient information about the pharmacokinetics of ZANTAC in
neonatal patients (less than 1 month of age) to make dosing recommendations. The following 3 subsections provide dosing information
for each of the pediatric indications. Also, see the subsection on
Preparation of ZANTAC 25 EFFERdose Tablets, below.<br/>Treatment of Duodenal and
Gastric Ulcers: The recommended oral dose for the treatment of active
duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a
maximum of 300 mg/day. This recommendation is derived from adult
clinical studies and pharmacokinetic data in pediatric patients.<br/>Maintenance of Healing of
Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of
healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily
to a maximum of 150 mg/day. This recommendation is derived from
adult clinical studies and pharmacokinetic data in pediatric patients.<br/>Treatment of GERD and Erosive
Esophagitis: Although limited data exist for these conditions
in pediatric patients, published literature supports a dosage of 5
to 10 mg/kg per day, usually given as 2 divided doses.<br/>Dosage Adjustment for Patients
With Impaired Renal Function: On the basis of experience with a group of subjects
with severely impaired renal function treated with ZANTAC, the recommended
dosage in patients with a creatinine clearance<50 mL/min
is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup
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 the level of circulating ranitidine. Ideally, the dosing schedule
should be adjusted so that the timing of a scheduled dose coincides
with the end of hemodialysis. Elderly patients
are more likely to have decreased renal function, therefore caution
should be exercised in dose selection, and it may be useful to monitor
renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics
and PRECAUTIONS: Geriatric Use).<br/>Preparation of ZANTAC 25 EFFERdose
Tablets: Tablets should
not be chewed, swallowed whole, or dissolved on the tongue. Dissolve
1 tablet in no less than 5 mL (1 teaspoonful) of water in an
appropriate measuring cup. Wait until the tablet is completely dissolved
before administering the solution to the infant/child. The solution
may be administered by medicine dropper or oral syringe for infants.
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The active ingredient in ZANTAC 150 Tablets,
ZANTAC 300 Tablets, ZANTAC 25 EFFERdose Tablets, and ZANTAC Syrup
is ranitidine hydrochloride (HCl), USP, a histamine H-receptor
antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N���-methyl-2-nitro-1,1-ethenediamine,
HCl. It has the following structure: The empirical formula is CHNOS���HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular
substance that is soluble in water. It has a slightly bitter taste
and sulfurlike odor. Each ZANTAC 150 Tablet
for oral administration contains 168 mg of ranitidine HCl equivalent
to 150 mg of ranitidine. Each tablet also contains the inactive
ingredients FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium
stearate, microcrystalline cellulose, titanium dioxide, triacetin,
and yellow iron oxide. Each ZANTAC 300 Tablet
for oral administration contains 336 mg of ranitidine HCl equivalent
to 300 mg of ranitidine. Each tablet also contains the inactive
ingredients croscarmellose sodium, D&C Yellow No. 10 Aluminum
Lake, hypromellose, magnesium stearate, microcrystalline cellulose,
titanium dioxide, and triacetin. ZANTAC
25 EFFERdose Tablets for oral administration is an effervescent formulation
of ranitidine that must be dissolved in water before use. Each individual
tablet contains 28 mg of ranitidine HCl equivalent to 25 mg
of ranitidine and the following inactive ingredients: aspartame, monosodium
citrate anhydrous, povidone, and sodium bicarbonate. Each tablet also
contains sodium benzoate. The total sodium content of each tablet
is 30.52 mg (1.33 mEq) per 25 mg of ranitidine. Each 1 mL of ZANTAC Syrup contains 16.8 mg
of ranitidine HCl equivalent to 15 mg of ranitidine. ZANTAC Syrup
also contains the inactive ingredients alcohol (7.5%), butylparaben,
dibasic sodium phosphate, hypromellose, peppermint flavor, monobasic
potassium phosphate, propylparaben, purified water, saccharin sodium,
sodium chloride, and sorbitol.
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ZANTAC is a competitive, reversible inhibitor
of the action of histamine at the histamine H-receptors,
including receptors on the gastric cells. ZANTAC does not lower serum
Ca++ in hypercalcemic states. ZANTAC is not an anticholinergic agent.<br/>Pharmacokinetics:<br/>Absorption: ZANTAC is 50% absorbed after oral administration,
compared to an intravenous (IV) injection with mean peak levels of
440 to 545 ng/mL occurring 2 to 3 hours after a 150-mg dose.
The syrup and EFFERdose formulations are bioequivalent to the tablets.
Absorption is not significantly impaired by the administration of
food or antacids. Propantheline slightly delays and increases peak
blood levels of ZANTAC, probably by delaying gastric emptying and
transit time. In one study, simultaneous administration of high-potency
antacid (150 mmol) in fasting subjects has been reported to decrease
the absorption of ZANTAC.<br/>Distribution: The volume of distribution is about 1.4 L/kg.
Serum protein binding averages 15%.<br/>Metabolism: In humans, the N-oxide is the principal metabolite
in the urine; however, this amounts to<4% of the dose. Other metabolites
are the S-oxide (1%) and the desmethyl ranitidine (1%). The remainder
of the administered dose is found in the stool. Studies in patients
with hepatic dysfunction (compensated cirrhosis) indicate that there
are minor, but clinically insignificant, alterations in ranitidine
half-life, distribution, clearance, and bioavailability.<br/>Excretion: The principal route of excretion is the urine, with
approximately 30% of the orally administered dose collected in the
urine as unchanged drug in 24 hours. Renal clearance is about
410 mL/min, indicating active tubular excretion. The elimination
half-life is 2.5 to 3 hours. Four patients with clinically significant
renal function impairment (creatinine clearance 25 to 35 mL/min)
administered 50 mg of ranitidine intravenously had an average
plasma half-life of 4.8 hours, a ranitidine clearance of 29 mL/min,
and a volume of distribution of 1.76 L/kg. In general, these
parameters appear to be altered in proportion to creatinine clearance
(see DOSAGE AND ADMINISTRATION).<br/>Geriatrics: The plasma half-life is prolonged and total clearance
is reduced in the elderly population due to a decrease in renal function.
The elimination half-life is 3 to 4 hours. Peak levels average
526 ng/mL following a 150-mg twice daily dose and occur in about
3 hours (see PRECAUTIONS: Geriatric Use and DOSAGE AND ADMINISTRATION:
Dosage Adjustment for Patients With Impaired Renal Function).<br/>Pediatrics: There are no significant differences in the pharmacokinetic
parameter values for ranitidine in pediatric patients (from 1 month
up to 16 years of age) and healthy adults when correction is
made for body weight. The average bioavailability of ranitidine given
orally to pediatric patients is 48% which is comparable to the bioavailability
of ranitidine in the adult population. All other pharmacokinetic parameter
values (t, Vd, and CL) are similar to those observed
with intravenous ranitidine use in pediatric patients. Estimates of
Cand Tare displayed in Table 1. Plasma clearance measured in 2 neonatal patients
(less than 1 month of age) was considerably lower (3 mL/min/kg)
than children or adults and is likely due to reduced renal function
observed in this population (see PRECAUTIONS: Pediatric Use and DOSAGE
AND ADMINISTRATION: Pediatric Use).<br/>Pharmacodynamics: Serum concentrations necessary to inhibit 50% of
stimulated gastric acid secretion are estimated to be 36 to 94 ng/mL.
Following a single oral dose of 150 mg, serum concentrations
of ZANTAC are in this range up to 12 hours. However, blood levels
bear no consistent relationship to dose or degree of acid inhibition. In a pharmacodynamic comparison of the EFFERdose with
the ZANTAC Tablets, during the first hour after administration, the
EFFERdose tablet formulation gave a significantly higher intragastric
pH, by approximately 1 pH unit, compared to the ZANTAC tablets.<br/>Antisecretory Activity:<br/>Other Pharmacologic Actions:<br/>Pediatrics: Oral doses of
6 to 10 mg/kg per day in 2 or 3 divided doses maintain gastric
pH>4 throughout most of the dosing interval.<br/>Clinical Trials:<br/>Active Duodenal Ulcer: In a multicenter, double-blind, controlled, US study
of endoscopically diagnosed duodenal ulcers, earlier healing was seen
in the patients treated with ZANTAC as shown in Table 3. *All patients were permitted p.r.n. antacids for
relief of pain. P<0.0001. In
these studies, patients treated with ZANTAC reported a reduction in
both daytime and nocturnal pain, and they also consumed less antacid
than the placebo-treated patients. Foreign studies have shown that patients heal
equally well with 150 mg b.i.d. and 300 mg h.s. (85% versus
84%, respectively) during a usual 4-week course of therapy. If patients
require extended therapy of 8 weeks, the healing rate may be
higher for 150 mg b.i.d. as compared to 300 mg h.s. (92%
versus 87%, respectively). Studies have
been limited to short-term treatment of acute duodenal ulcer. Patients
whose ulcers healed during therapy had recurrences of ulcers at the
usual rates.<br/>Maintenance Therapy in Duodenal
Ulcer: Ranitidine has been found to be effective as maintenance
therapy for patients following healing of acute duodenal ulcers. In
2 independent, double-blind, multicenter, controlled trials, the number
of duodenal ulcers observed was significantly less in patients treated
with ZANTAC (150 mg h.s.) than in patients treated with placebo
over a 12-month period. % = Life table estimate. * = P<0.05 (ZANTAC versus comparator). RAN = ranitidine (ZANTAC). PLC = placebo. As with other H-antagonists, the factors
responsible for the significant reduction in the prevalence of duodenal
ulcers include prevention of recurrence of ulcers, more rapid healing
of ulcers that may occur during maintenance therapy, or both.<br/>Gastric Ulcer: In a multicenter,
double-blind, controlled, US study of endoscopically diagnosed gastric
ulcers, earlier healing was seen in the patients treated with ZANTAC
as shown in Table 6. *All patients were permitted
p.r.n. antacids for relief of pain. P = 0.009. In this
multicenter trial, significantly more patients treated with ZANTAC
became pain free during therapy.<br/>Maintenance of Healing of
Gastric Ulcers: In 2 multicenter, double-blind, randomized, placebo-controlled,
12-month trials conducted in patients whose gastric ulcers had been
previously healed, ZANTAC 150 mg h.s. was significantly more
effective than placebo in maintaining healing of gastric ulcers.<br/>Pathological Hypersecretory
Conditions (such as Zollinger-Ellison syndrome): ZANTAC inhibits gastric acid secretion and reduces
occurrence of diarrhea, anorexia, and pain in patients with pathological
hypersecretion associated with Zollinger-Ellison syndrome, systemic
mastocytosis, and other pathological hypersecretory conditions (e.g.,
postoperative, "short-gut" syndrome, idiopathic). Use of ZANTAC was
followed by healing of ulcers in 8 of 19 (42%) patients who were
intractable to previous therapy.<br/>Gastroesophageal Reflux Disease
(GERD): In 2 multicenter, double-blind, placebo-controlled,
6-week trials performed in the United States and Europe, ZANTAC 150 mg
b.i.d. was more effective than placebo for the relief of heartburn
and other symptoms associated with GERD. Ranitidine-treated patients
consumed significantly less antacid than did placebo-treated patients. The US trial indicated that ZANTAC 150 mg b.i.d.
significantly reduced the frequency of heartburn attacks and severity
of heartburn pain within 1 to 2 weeks after starting therapy.
The improvement was maintained throughout the 6-week trial period.
Moreover, patient response rates demonstrated that the effect on heartburn
extends through both the day and night time periods. In 2 additional US multicenter, double-blind, placebo-controlled,
2-week trials, ZANTAC 150 mg b.i.d. was shown to provide relief
of heartburn pain within 24 hours of initiating therapy and a
reduction in the frequency of severity of heartburn. In these trials,
ZANTAC EFFERdose Tablets were shown to provide heartburn relief within
45 minutes of dosing.<br/>Erosive Esophagitis: In 2 multicenter, double-blind, randomized, placebo-controlled,
12-week trials performed in the United States, ZANTAC 150 mg
q.i.d. was significantly more effective than placebo in healing endoscopically
diagnosed erosive esophagitis and in relieving associated heartburn.
The erosive esophagitis healing rates were as follows: *All patients were permitted
p.r.n. antacids for relief of pain. P<0.001 versus placebo. No
additional benefit in healing of esophagitis or in relief of heartburn
was seen with a ranitidine dose of 300 mg q.i.d.<br/>Maintenance of Healing of
Erosive Esophagitis: In 2 multicenter, double-blind, randomized, placebo-controlled,
48-week trials conducted in patients whose erosive esophagitis had
been previously healed, ZANTAC 150 mg b.i.d. was significantly
more effective than placebo in maintaining healing of erosive esophagitis.
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ZANTAC is contraindicated for patients known
to have hypersensitivity to the drug or any of the ingredients (see
PRECAUTIONS).
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ZANTAC 150 Tablets (ranitidine HCl equivalent
to 150 mg of ranitidine) are peach, film-coated, 5-sided tablets
embossed with "ZANTAC 150" on one side and "Glaxo" on the other. They
are available in bottles of 60 (NDC 0173-0344-42), 180 (NDC 0173-0344-17),
and 500 (NDC 0173-0344-14) tablets. ZANTAC
300 Tablets (ranitidine HCl equivalent to 300 mg of ranitidine)
are yellow, film-coated, capsule-shaped tablets embossed with "ZANTAC
300" on one side and "Glaxo" on the other. They are available in bottles
of 30 (NDC 0173-0393-40) tablets. Store between 15��and 30��C (59��and
86��F) in a dry place. Protect from light. Replace cap securely
after each opening. ZANTAC 25 EFFERdose
Tablets (ranitidine HCl equivalent to 25 mg of ranitidine) are
white to pale yellow, round, flat-faced, bevel-edged tablets embossed
with���GS���on one side and���25C���on the
other side. They are packaged in foil strips and are available in
a carton of 60 (NDC 0173-0734-00) tablets. Store between 2��and 30��C (36��and
86��F). ZANTAC Syrup, a clear,
pale yellow, peppermint-flavored liquid, contains 16.8 mg of
ranitidine HCl equivalent to 15 mg of ranitidine per 1 mL
(75 mg/5 mL) in bottles of 16 fluid ounces (one pint)
(NDC 0173-0383-54). Store between 4��and 25��C (39��and 77��F). Dispense
in tight, light-resistant containers as defined in the USP/NF. GlaxoSmithKline Research
Triangle Park, NC 27709 ZANTAC and EFFERdose
are registered trademarks of Warner-Lambert Company, used under license. ��2008, GlaxoSmithKline. All rights reserved. March 2008 ZNT:2PI
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General:<br/>Information for Patients:<br/>Phenylketonurics: ZANTAC 25 EFFERdose Tablets contain phenylalanine
2.81 mg per 25 mg of ranitidine. ZANTAC EFFERdose Tablets should
not be chewed, swallowed whole, or dissolved on the tongue.<br/>Laboratory Tests: False-positive tests for urine protein with MULTISTIX may occur during ZANTAC therapy, and therefore testing
with sulfosalicylic acid is recommended.<br/>Drug Interactions: Ranitidine has the potential to affect the absorption,
metabolism, or renal excretion of other drugs. The altered pharmacokinetics
may necessitate dosage adjustment of the affected drug or discontinuation
of ranitidine. Interactions may occur by several mechanisms including: Inhibition of Cytochrome P450-linked Mixed Function Oxygenase System: Ranitidine at usual therapeutic doses does not potentiate
the actions of drugs which are inactivated by this enzyme system such
as diazepam, lidocaine, phenytoin, propranolol, and theophylline.
There have been reports of altered prothrombin time with coumarin
anticoagulants (e.g., warfarin). Due to the narrow therapeutic index,
close monitoring of increased or decreased prothrombin time is recommended
during concurrent treatment with ranitidine. Competition
for Renal Tubular Secretion: Since ranitidine
is partially eliminated by the cationic system, it may affect the
clearance of other drugs eliminated by this route. High doses of ranitidine
(such as those used in the treatment of Zollinger-Ellison syndrome)
may reduce the excretion of procainamide and N-acetylprocainamide
resulting in increased plasma levels of these drugs. Alteration
of Gastric pH: The bioavailability of certain
drugs may be affected. This can result in either an increase in absorption
(e.g., triazolam, midazolam) or a decrease in absorption (e.g., ketoconazole,
atazanavir, glipizide, delaviridine, gefitnib). In a ranitidine-triazolam drug-drug interaction study, triazolam
plasma concentrations were higher during b.i.d. dosing of ranitidine
than triazolam given alone. The mean area under the triazolam concentration-time
curve (AUC) values in 18- to 60-year-old subjects were 10% and 28%
higher following administration of 75-mg and 150-mg ranitidine tablets,
respectively, than triazolam given alone. In subjects older than 60 years
of age, the mean AUC values were approximately 30% higher following
administration of 75-mg and 150-mg ranitidine tablets. It appears
that there were no changes in pharmacokinetics of triazolam and��-hydroxytriazolam,
a major metabolite, and in their elimination. Reduced gastric acidity
due to ranitidine may have resulted in an increase in the availability
of triazolam. The clinical significance of this triazolam and ranitidine
pharmacokinetic interaction is unknown.<br/>Carcinogenesis, Mutagenesis, Impairment
of Fertility: There was no indication of tumorigenic or carcinogenic
effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg
per day. Ranitidine was not mutagenic in standard
bacterial tests (Salmonella, Escherichia
coli) for mutagenicity 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 2 matings per week for the
next 9 weeks.<br/>Pregnancy:<br/>Teratogenic Effects:: Pregnancy Category B. Reproduction studies have
been 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 are not always predictive of human response, this drug should
be used during pregnancy only if clearly needed.<br/>Nursing Mothers: ZANTAC is secreted in human milk. Caution should
be exercised when ZANTAC is administered to a nursing mother.<br/>Pediatric Use: The safety and effectiveness of ZANTAC have been
established in the age-group of 1 month to 16 years for
the treatment of duodenal and gastric ulcers, gastroesophageal reflux
disease and erosive esophagitis, and the maintenance of healed duodenal
and gastric ulcer. Use of ZANTAC in this age-group is supported by
adequate and well-controlled studies in adults, as well as additional
pharmacokinetic data in pediatric patients and an analysis of the
published literature (see CLINICAL PHARMACOLOGY: Pediatrics and DOSAGE
AND ADMINISTRATION: Pediatric Use). Safety
and effectiveness in pediatric patients for the treatment of pathological
hypersecretory conditions or the maintenance of healing of erosive
esophagitis have not been established. Safety
and effectiveness in neonates (less than 1 month of age) have not
been established (see CLINICAL PHARMACOLOGY: Pediatrics).<br/>Geriatric Use: Of the total number of subjects enrolled in US and
foreign controlled clinical trials of oral formulations of ZANTAC,
for which there were subgroup analyses, 4,197 were 65 and over, while
899 were 75 and over. No overall differences in safety or effectiveness
were observed between these subjects and younger subjects, and other
reported clinical experience has not identified differences in responses
between the elderly and younger patients, but greater sensitivity
of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney and
the risk of toxic reactions to this drug may be greater in patients
with impaired renal function. Because elderly patients are more likely
to have decreased renal function, caution should be exercised in dose
selection, and it may be useful to monitor renal function (see CLINICAL
PHARMACOLOGY: Pharmacokinetics: Geriatrics and DOSAGE AND ADMINISTRATION:
Dosage Adjustment for Patients With Impaired Renal Function).
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There has been limited experience with overdosage.
Reported acute ingestions 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 mg/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 LDvalues in mice and rats were 77 and
83 mg/kg, respectively.
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| dailymed-instance:genericMe... |
ranitidine hydrochloride
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| dailymed-instance:fullName |
ZANTAC (Tablet, Film Coated)
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| dailymed-instance:adverseRe... |
The following have been reported as events in
clinical trials or in the routine management of patients treated with
ZANTAC. The relationship to therapy with ZANTAC has been unclear in
many cases. Headache, sometimes severe, seems to be related to administration
of ZANTAC.<br/>Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia,
and vertigo. Rare cases of reversible mental confusion, agitation,
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 been reported. Rare reports
of reversible involuntary motor disturbances have been received.<br/>Cardiovascular: As with other H-blockers, rare reports
of arrhythmias such as tachycardia, bradycardia, atrioventricular
block, and premature ventricular beats.<br/>Gastrointestinal: Constipation, diarrhea, nausea/vomiting, abdominal
discomfort/pain, and rare reports of pancreatitis.<br/>Hepatic: There have been occasional reports of hepatocellular,
cholestatic, or mixed hepatitis, with or without jaundice. In such
circumstances, ranitidine should be immediately discontinued. These
events are usually reversible, but in rare circumstances death has
occurred. Rare cases of hepatic failure have also been reported. In
normal volunteers, SGPT values were increased to at least twice the
pretreatment levels in 6 of 12 subjects receiving 100 mg
q.i.d. intravenously for 7 days, and in 4 of 24 subjects
receiving 50 mg q.i.d. intravenously for 5 days.<br/>Musculoskeletal: Rare reports of arthralgias and myalgias.<br/>Hematologic: Blood count changes (leukopenia, granulocytopenia,
and thrombocytopenia) have occurred in a few patients. These were
usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes
with marrow hypoplasia, and aplastic anemia and exceedingly rare cases
of acquired immune hemolytic anemia have been reported.<br/>Endocrine: Controlled studies in animals and man have shown
no stimulation of any pituitary hormone by ZANTAC and no antiandrogenic
activity, and cimetidine-induced gynecomastia 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.<br/>Integumentary: Rash, including rare cases of erythema multiforme.
Rare cases of alopecia and vasculitis.<br/>Respiratory: A large epidemiological study suggested an increased
risk of developing pneumonia in current users of histamine-2���receptor
antagonists (HRAs) compared to patients who had stopped
HRA treatment, with an observed adjusted relative risk
of 1.63 (95% CI, 1.07���2.48). However, a causal relationship
between use of HRAs and pneumonia has not been established.<br/>Other: Rare cases of hypersensitivity reactions (e.g.,
bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic
edema, acute interstitial nephritis, and small increases in serum
creatinine.
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| dailymed-instance:indicatio... |
ZANTAC is indicated in: Concomitant antacids should be given as needed
for pain relief to patients with active duodenal ulcer; active, benign
gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
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ZANTAC
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