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Nizatidine

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Overview

What is Nizatidine Solution?

Nizatidine Oral Solution

15 mg/mL

Rx only

Description:

Nizatidine (USP) is a histamine H2-receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine.

The structural formula is as follows:

Nizatidine has the empirical formula C12H21N5O2S2 representing a molecular weight of 331.47. It is an off-white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor.

Nizatidine oral solution is a clear, pale-yellow, peppermint flavored solution and each 1 mL contains 15 mg of nizatidine. Nizatidine oral solution also contains the inactive ingredients anhydrous citric acid, glycerin, magnasweet, methylparaben, natural peppermint extract, povidone, propylparaben, purified water, saccharin sodium, sodium chloride, sodium citrate, sucrose and xanthan gum.



What does Nizatidine Solution look like?



What are the available doses of Nizatidine Solution?

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What should I talk to my health care provider before I take Nizatidine Solution?

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How should I use Nizatidine Solution?

Indications and Usage:

Nizatidine oral solution is indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known.

Nizatidine oral solution is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.

Nizatidine oral solution is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.

In pediatric patients, nizatidine oral solution is indicated for ages 12 years and older. Nizatidine oral solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.

Dosage and Administration:

Active Duodenal Ulcer—The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

Maintenance of Healed Duodenal Ulcer—The recommended oral dosage for adults is 150 mg once daily at bedtime.

Gastroesophageal Reflux Disease—The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

Active Benign Gastric Ulcer—The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

Each mL of nizatidine oral solution contains 15 mg of nizatidine. In adults, nizatidine oral solution may be substituted for any of the above indications using equivalent doses of the oral solution.

Pediatric Dosing—Each mL of oral solution contains 15 mg of nizatidine. Nizatidine oral solution is indicated for pediatric patients 12 years of age or older. For pediatric patients 12 years of age and older, the dosage of nizatidine is 150 mg b.i.d. (2 tsp, b.i.d.)

The following dosage recommendations are provided:

Erosive Esophagitis—For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.

Gastroesophageal Reflux Disease—For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.

Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency—The dose for patients with renal dysfunction should be reduced as follows:

Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

Based on the pharmacokinetic data in elderly patients with renal impairment, pediatric patients with creatinine clearances less than 50 mL/min, should have their dose of nizatidine reduced accordingly. The clinical effects of this dose reduction in pediatric patients with renal failure have not been evaluated.


What interacts with Nizatidine Solution?

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What are the warnings of Nizatidine Solution?

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What are the precautions of Nizatidine Solution?

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What are the side effects of Nizatidine Solution?

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What should I look out for while using Nizatidine Solution?

Contraindication


What might happen if I take too much Nizatidine Solution?

Overdosage:

Overdoses of nizatidine have been reported rarely. The following is provided to serve as a guide should such an overdose be encountered.

Signs and Symptoms—There is little clinical experience with overdosage of nizatidine in humans. Test animals that received large doses of nizatidine have exhibited cholinergic-type effects, including lacrimation, salivation, emesis, miosis, and diarrhea. Single oral doses of 800 mg/kg in dogs and of 1,200 mg/kg in monkeys were not lethal. Intravenous median lethal doses in the rat and mouse were 301 mg/kg and 232 mg/kg respectively.

In the two 8-week pediatric exposure trials of nizatidine in 256 pediatric patients, there were no cases of deliberate overdosage. In one study of nizatidine 10 mg/kg/day, drug compliance rates up to 7.5% above 100% compliance were not associated with clinically significant adverse events.

Treatment—To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

If overdosage occurs, use of activated charcoal, emesis, or lavage should be considered along with clinical monitoring and supportive therapy. The ability of hemodialysis to remove nizatidine from the body has not been conclusively demonstrated; however, due to its large volume of distribution, nizatidine is not expected to be efficiently removed from the body by this method.


How should I store and handle Nizatidine Solution?

StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See .] StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See .] How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00How Supplied:Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available asBottles of 480 mL – NDC 60846-301-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENRx onlyDistributed by:Gemini Laboratories, LLCBridgewater, NJ 08807www.gemini-labs.comRev. 06-2016-00301-219Nizatidine Oral Solution 15 mg/mLRx OnlyRev. 06-2016-00


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Clinical Pharmacology in Adults

Antisecretory Activity—1. Effects on Acid Secretion: Nizatidine significantly inhibited nocturnal gastric acid secretion for up to 12 hours. Nizatidine also significantly inhibited gastric acid secretion stimulated by food, caffeine, betazole, and pentagastrin (Table 1).

2. Effects on Other Gastrointestinal Secretions—Pepsin: Oral administration of 75 to 300 mg of nizatidine did not affect pepsin activity in gastric secretions. Total pepsin output was reduced in proportion to the reduced volume of gastric secretions.

Intrinsic Factor: Oral administration of 75 to 300 mg of nizatidine increased betazole-stimulated secretion of intrinsic factor.

Serum Gastrin Concentration: Nizatidine had no effect on basal serum gastrin concentration. No rebound of gastrin secretion was observed when food was ingested 12 hours after administration of nizatidine.

3. Other Pharmacologic Actions—

a. Hormones: Nizatidine was not shown to affect the serum concentrations of gonadotropins, prolactin, growth hormone, antidiuretic hormone, cortisol, triiodo-thyronine, thyroxin, testosterone, 5 α-dihydro-testosterone, androstenedione, or estradiol.

b. Nizatidine had no demonstrable antiandrogenic action.

4. Pharmacokinetics—The absolute oral bioavailability of nizatidine exceeds 70%. Peak plasma concentrations (700 to 1,800 mcg/L for a 150-mg dose and 1,400 to 3,600 mcg/L for a 300-mg dose) occur from 0.5 to 3 hours following the dose. Plasma concentrations 12 hours after administration are less than 10 mcg/L. The elimination half-life is 1 to 2 hours, plasma clearance is 40 to 60 L/h, and the volume of distribution is 0.8 to 1.5 L/kg. Because of the short half-life and rapid clearance of nizatidine, accumulation of the drug would not be expected in individuals with normal renal function who take either 300 mg once daily at bedtime or 150 mg twice daily. Nizatidine exhibits dose proportionality over the recommended dose range.

The oral bioavailability of nizatidine is unaffected by concomitant ingestion of the anticholinergic propantheline. Antacids consisting of aluminum and magnesium hydroxides with simethicone decrease the absorption of nizatidine by about 10%. With food, the AUC and Cmax increase by approximately 10%. In humans, less than 7% of an oral dose is metabolized as N2-monodesmethylnizatidine, an H2-receptor antagonist, which is the principal metabolite excreted in the urine. Other likely metabolites are the N2-oxide (less than 5% of the dose) and the S-oxide (less than 6% of the dose).

More than 90% of an orally administered dose of nizatidine is excreted in the urine within 12 hours. About 60% of an oral dose is excreted as unchanged drug. Renal clearance is about 500 mL/min, which indicates excretion by active tubular secretion. Less than 6% of an administered dose is eliminated in the feces.

Moderate to severe renal impairment significantly prolongs the half-life and decreases the clearance of nizatidine. In individuals who are functionally anephric, the half-life is 3.5 to 11 hours, and the plasma clearance is 7 to 14 L/h. To avoid accumulation of the drug in individuals with clinically significant renal impairment, the amount and/or frequency of doses of nizatidine should be reduced in proportion to the severity of dysfunction (see Dosage and Administration).

Approximately 35% of nizatidine is bound to plasma protein, mainly to α1-acid glycoprotein. Warfarin, diazepam, acetaminophen, propantheline, phenobarbital, and propranolol did not affect plasma protein binding of nizatidine in vitro.

At a dose of 150 mg, the nizatidine oral solution (15 mg/mL) is bioequivalent to nizatidine capsules.

Clinical Pharmacology in Pediatric Patients:

Pharmacokinetics

Table 2 presents pharmacokinetic data of nizatidine administered orally to adolescents with gastroesophageal reflux (GER) and healthy adults. Pharmacokinetic parameters for adolescent patients ages 12 to 18 years are comparable to those obtained for adults.

Administration of nizatidine capsules in apple juice results in 27% reduction of nizatidine bioavailability.

Pharmacodynamics

Pharmacodynamics of nizatidine was evaluated in 48 pediatric patients. These data suggest that gastric acid suppression is similar to that observed in adult studies (Table 3).

Non-Clinical Toxicology
Contraindication

Cyclobenzaprine HCl may have life-threatening interactions with MAO inhibitors (see ).  Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).

Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.

Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.

____________________________________________________________________ ULTRAM (tramadol HCl tablets, Ortho-McNeil Pharmaceutical) ULTRACET (tramadol HCl and acetaminophen tablets, Ortho-McNeil Pharmaceutical)_____________________________________________________________________

Precautions:

General—

1. Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy.

2. Because nizatidine is excreted primarily by the kidney, dosage should be reduced in patients with moderate to severe renal insufficiency (see Dosage and Administration).

3. Pharmacokinetic studies in patients with hepatorenal syndrome have not been done. Part of the dose of nizatidine is metabolized in the liver. In patients with normal renal function and uncomplicated hepatic dysfunction, the disposition of nizatidine is similar to that in normal subjects.

Laboratory Tests—False-positive tests for urobilinogen with Multistix® may occur during therapy with nizatidine.

Drug Interactions—No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. Nizatidine does not inhibit the cytochrome P-450-linked drug-metabolizing enzyme system; therefore, drug interactions mediated by inhibition of hepatic metabolism are not expected to occur. In patients given very high doses (3,900 mg) of aspirin daily, increases in serum salicylate levels were seen when nizatidine, 150 mg b.i.d., was administered concurrently.

Carcinogenesis, Mutagenesis, Impairment of Fertility—A 2-year oral carcinogenicity study in rats with doses as high as 500 mg/kg/day (about 13 times the recommended human dose based on body surface area) showed no evidence of a carcinogenic effect. There was a dose-related increase in the density of enterochromaffin-like (ECL) cells in the gastric oxyntic mucosa. In a 2-year study in mice, there was no evidence of a carcinogenic effect in male mice; although hyperplastic nodules of the liver were increased in the high-dose males as compared with placebo. Female mice given the high dose of nizatidine (2,000 mg/kg/day, about 27 times the recommended human dose based on body surface area) showed marginally statistically significant increases in hepatic carcinoma and hepatic nodular hyperplasia with no numerical increase seen in any of the other dose groups. The rate of hepatic carcinoma in the high-dose animals was within the historical control limits seen for the strain of mice used. The female mice were given a dose larger than the maximum tolerated dose, as indicated by excessive (30%) weight decrement as compared with concurrent controls and evidence of mild liver injury (transaminase elevations). The occurrence of a marginal finding at high dose only in animals given an excessive and somewhat hepatotoxic dose, with no evidence of a carcinogenic effect in rats, male mice, and female mice (given up to 360 mg/kg/day, about 5 times the recommended human dose based on body surface area), and a negative mutagenicity battery are not considered evidence of a carcinogenic potential for nizatidine.

Nizatidine was not mutagenic in a battery of tests performed to evaluate its potential genetic toxicity, including bacterial mutation tests, unscheduled DNA synthesis, sister chromatid exchange, mouse lymphoma assay, chromosome aberration tests, and a micronucleus test.

In a 2-generation, perinatal and postnatal fertility study in rats, doses of nizatidine up to 650 mg/kg/day (about 17.5 times the recommended human dose based on body surface area) produced no adverse effects on the reproductive performance of parental animals or their progeny.

Pregnancy—Teratogenic Effects—Pregnancy Category B—Oral reproduction studies in pregnant rats at doses up to 1500 mg/kg/day (about 40.5 times the recommended human dose based on body surface area) and in pregnant rabbits at doses up to 275 mg/kg/day (about 14.6 times the recommended human dose based on body surface area) have revealed no evidence of impaired fertility or harm to the fetus due to nizatidine. 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.

Nursing Mothers—Studies conducted in lactating women have shown that 0.1% of the administered oral dose of nizatidine is secreted in human milk in proportion to plasma concentrations. Because of the growth depression in pups reared by lactating rats treated with nizatidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Use of nizatidine in pediatric patients from 12 to 18 years of age is supported by evidence from published pediatric literature, adequate and well-controlled published studies in adults, and by the following adequate and well-controlled studies in pediatric patients: (see Dosage and Administration)

Adverse Reactions in Adults

Incidence in Placebo-Controlled Clinical Trials in the United States and Canada—Table 7 lists adverse events that occurred at a frequency of 1% or more among nizatidine-treated patients who participated in placebo-controlled trials. The cited figures provide some basis for estimating the relative contribution of drug and non-drug factors to the side-effect incidence rate in the population studied.

A variety of less common events were also reported; it was not possible to determine whether these were caused by nizatidine.

Hepatic—Hepatocellular injury, evidenced by elevated liver enzyme tests (SGOT [AST], SGPT [ALT], or alkaline phosphatase), occurred in some patients and was possibly or probably related to nizatidine. In some cases, there was marked elevation of SGOT, SGPT enzymes (greater than 500 IU/L) and, in a single instance, SGPT was greater than 2,000 IU/L. The overall rate of occurrences of elevated liver enzymes and elevations to 3 times the upper limit of normal, however, did not significantly differ from the rate of liver enzyme abnormalities in placebo-treated patients. All abnormalities were reversible after discontinuation of nizatidine. Since market introduction, hepatitis and jaundice have been reported. Rare cases of cholestatic or mixed hepatocellular and cholestatic injury with jaundice have been reported with reversal of the abnormalities after discontinuation of nizatidine.

Cardiovascular—In clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in 2 individuals administered nizatidine and in 3 untreated subjects.

CNS—Rare cases of reversible mental confusion have been reported.

Endocrine—Clinical pharmacology studies and controlled clinical trials showed no evidence of antiandrogenic activity due to nizatidine. Impotence and decreased libido were reported with similar frequency by patients who received nizatidine and by those given placebo. Rare reports of gynecomastia occurred.

Hematologic—Anemia was reported significantly more frequently in nizatidine- than in placebo-treated patients. Fatal thrombocytopenia was reported in a patient who was treated with nizatidine and another H2-receptor antagonist. On previous occasions, this patient had experienced thrombocytopenia while taking other drugs. Rare cases of thrombocytopenic purpura have been reported.

Integumental—Sweating and urticaria were reported significantly more frequently in nizatidine- than in placebo-treated patients. Rash and exfoliative dermatitis were also reported. Vasculitis has been reported rarely.

Hypersensitivity—As with other H2-receptor antagonists, rare cases of anaphylaxis following administration of nizatidine have been reported. Rare episodes of hypersensitivity reactions (eg, bronchospasm, laryngeal edema, rash, and eosinophilia) have been reported.

Body as a Whole—Serum sickness-like reactions have occurred rarely in conjunction with nizatidine use.

Genitourinary—Reports of impotence have occurred.

Other—Hyperuricemia unassociated with gout or nephrolithiasis was reported. Eosinophilia, fever, and nausea related to nizatidine administration have been reported.

Adverse Reactions (Pediatric):

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).