Nitrostat

Pronunciation: NYE-troe-GLIS-er-in
Generic Name: Nitroglycerin
Brand Name: Nitrostat

Nitrostat is used for:

Preventing or relieving a sudden attack of angina (chest pain) caused by heart disease. It may also be used for other conditions as determined by your doctor.

Nitrostat is a nitrate. It works by dilating (widening) blood vessels. Chest pain occurs when the heart needs more oxygen than it can get. Dilating blood vessels allows blood to flow more easily. This reduces the heart's workload and the amount of oxygen needed by the heart.

Do NOT use Nitrostat if:

• you are allergic to any ingredient in Nitrostat


• you have increased pressure in the head


• you have severe anemia


• you are also taking a phosphodiesterase type 5 (PDE5) inhibitor (eg, sildenafil, tadalafil, vardenafil)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nitrostat:

Some medical conditions may interact with Nitrostat. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you drink alcoholic beverages


• if you have a history of other heart problems (eg, heart failure, an enlarged heart, a heart attack), an overactive thyroid, a stroke or other bleeding in the brain, or a recent head injury


• if you have anemia, low blood pressure, dehydration, or low blood volume

Some MEDICINES MAY INTERACT with Nitrostat. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, PDE5 inhibitors (eg, sildenafil), or phenothiazines (eg, thioridazine) because the risk of low blood pressure and dizziness when standing may be increased


• Salicylates (eg, aspirin) because they may increase the risk of Nitrostat's side effects


• Long-acting nitrates (eg, nitroglycerin patch) because they may decrease Nitrostat's effectiveness


• Ergot alkaloids (eg, dihydroergotamine, ergotamine) because the risk of their side effects may be increased by Nitrostat


• Alteplase because its effectiveness may be decreased by Nitrostat

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitrostat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitrostat:

Use Nitrostat as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do NOT swallow, chew, or crush this tablet. Dissolve the tablet under the tongue or between the cheek and gum.


• To treat an angina attack, use Nitrostat at the first sign of chest pain. Sit quietly while the tablet is dissolving. The dose may be repeated every 5 minutes until you get relief or as directed by your doctor. Do not use more than 3 tablets in 15 minutes. If chest pain continues after a total of 3 tablets, seek medical attention at once, unless your doctor gives you different instructions.


• If you use Nitrostat to prevent angina caused by physical activity, use it 5 to 10 minutes before activity unless your doctor tells you otherwise.


• If you miss a dose of Nitrostat and you are still having chest pain, contact your doctor right away. Ask your health care provider any questions you may have about the proper use of Nitrostat.

Ask your health care provider any questions you may have about how to use Nitrostat.

Important safety information:

• Nitrostat may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nitrostat with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol while you are using Nitrostat. Drinking alcohol may increase the risk of low blood pressure with Nitrostat.


• Nitrostat may cause dizziness, lightheadedness, or fainting. Sit down while taking Nitrostat. When you return to a standing position, stand slowly using caution to avoid falling caused by lightheadedness or dizziness.


• Nitrostat can cause tingling or burning when you put it under your tongue. However, lack of tingling or burning does not mean the medicine is not working.


• Contact your doctor right away if you develop slow heartbeat or new or worsening chest pain after you take Nitrostat.


• Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.


• Keep medicine in the original glass bottle with the cap tightly closed. Throw away the cotton inside once the bottle is opened.


• Tell your doctor or dentist that you take Nitrostat before you receive any medical or dental care, emergency care, or surgery.


• Nitrostat may interfere with certain lab tests, including certain cholesterol tests. Be sure your doctor and lab personnel know you are using Nitrostat.


• Lab tests, including heart function, blood pressure, and blood electrolyte levels, may be performed while you take Nitrostat. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Nitrostat with caution in the ELDERLY; they may be more sensitive to its effects.


• Nitrostat should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Nitrostat while you are pregnant. It is not known if Nitrostat is found in breast milk. If you are or will be breast-feeding while you are taking Nitrostat, check with your doctor. Discuss any possible risks to your baby.

When used at higher doses or more often than prescribed, Nitrostat may not work as well. This is known as TOLERANCE. Tolerance to other nitrates and nitrites may also occur. Increasing the dose is not effective in managing tolerance to Nitrostat. Talk with your doctor if Nitrostat stops working well. Do not take more than prescribed.

Possible side effects of Nitrostat:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning or tingling sensation; dizziness, lightheadedness, or fainting when sitting up or standing; flushing of the face and neck; headache; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; new, abnormal, or worsening chest pain; pale skin; pounding in the chest; severe dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; slow or irregular heartbeat; swelling of the hands, ankles, or feet; unusual weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nitrostat side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold or blue skin; confusion; diarrhea; excessive sweating; fainting; fast, slow, or irregular heartbeat; fever; inability to move; loss of consciousness; persistent throbbing headache; seizures; severe dizziness, nausea, or vomiting; trouble breathing; vision problems.

Proper storage of Nitrostat:

Store Nitrostat in the original glass container, tightly closed, at or below 77 degrees F (25 degrees C). Protect from heat, moisture, and light. Do not store in bathroom. Keep Nitrostat out of the reach of children and away from pets.

General information:

• If you have any questions about Nitrostat, please talk with your doctor, pharmacist, or other health care provider.


• Nitrostat is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nitrostat. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nitrostat resources

• Nitrostat Side Effects (in more detail)
• Nitrostat Use in Pregnancy & Breastfeeding
• Drug Images
• Nitrostat Drug Interactions
• Nitrostat Support Group
• 1 Review for Nitrostat - Add your own review/rating

• Nitrostat Advanced Consumer (Micromedex) - Includes Dosage Information


• Nitrostat Prescribing Information (FDA)


• Nitroglycerin Monograph (AHFS DI)


• Nitroglycerin Professional Patient Advice (Wolters Kluwer)


• Minitran Prescribing Information (FDA)


• Minitran Advanced Consumer (Micromedex) - Includes Dosage Information


• Nitro-Bid Advanced Consumer (Micromedex) - Includes Dosage Information


• Nitro-Bid Prescribing Information (FDA)


• Nitro-Dur Prescribing Information (FDA)


• Nitro-Time Prescribing Information (FDA)


• NitroMist Consumer Overview


• NitroMist Prescribing Information (FDA)


• Nitrolingual Prescribing Information (FDA)


• Rectiv Consumer Overview


• Rectiv Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Nitrostat with other medications

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Nizatidine

Nizatidine Capsules USP

Rx only

Nizatidine 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 331.46. It is an off-white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor.

Each capsule for oral administration contains Nizatidine 150 mg (0.45 mmol) or 300 mg (0.91 mmol), pregelatinized starch, povidone, corn starch, talc, croscarmellose sodium, dimethicone, gelatin, titanium dioxide, pharmaceutical glaze (modified), synthetic black iron oxide, propylene glycol, FD&C blue No. 2 aluminum lake, FD&C red No. 40 aluminum lake, FD&C blue No. 1 aluminum lake, and D&C yellow No. 10 aluminum lake. The 150 mg capsule also contains yellow iron oxide, and the 300 mg capsule also contains D&C red No. 28, FD&C blue No. 1, and FD&C yellow No. 6.

Nizatidine - Clinical Pharmacology

Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-receptors, particularly those in the gastric parietal cells.

Antisecretory Activity

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).

Table 1: Effect of Oral Nizatidine on Gastric Acid Secretion

	Time After Dose (h)	% Inhibition of Gastric Acid Output by Dose (mg)
		20 - 50	75	100	150	300
Nocturnal	Up to 10	57	---	73	---	90
Betazole	Up to 3	---	93	---	100	99
Pentagastrin	Up to 6	---	25	---	64	67
Meal	Up to 4	41	64	---	98	97
Caffeine	Up to 3	---	73	---	85	96

Effects on Other Gastrointestinal Secretions

 Pepsin

 Oral administration of 75 mg 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 mg to 300 mg of Nizatidine increased betazole-stimulated secretion of intrinsic factor.

Serum Gastrin

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.

Other Pharmacologic Actions

 Hormones

Nizatidine was not shown to affect the serum concentrations of gonadotropins, prolactin, growth hormone, antidiuretic hormone, cortisol, triiodothyronine, thyroxin, testosterone, 5α-dihydrotestosterone, androstenedione, or estradiol.

Nizatidine had no demonstrable antiandrogenic action.

Pharmacokinetics

 The absolute oral bioavailability of Nizatidine exceeds 70%. Peak plasma concentrations (700 mcg/L to 1800 mcg/L for a 150 mg dose and 1400 mcg/L to 3600 mcg/L for a 300 mg dose) occur from 0.5 to 3 hours following the dose. A concentration of 1000 mcg/L is equivalent to 3 μmol/L; a dose of 300 mg is equivalent to 905 μmoles. 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 L/h to 60 L/h, and the volume of distribution is 0.8 L/kg 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 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 oral 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 L/h 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.

Clinical Trials

1. Active Duodenal Ulcer

 In multicenter, double-blind, placebo-controlled studies in the United States, endoscopically diagnosed duodenal ulcers healed more rapidly following administration of Nizatidine, 300 mg h.s. or 150 mg b.i.d., than with placebo (Table 2). Lower doses, such as 100 mg h.s., had slightly lower effectiveness.

Table 2: Healing Response of Ulcers to Nizatidine

* P<0.01 as compared with placebo. † P<0.05 as compared with placebo.
	Nizatidine				Placebo
	300 mg h.s.		150 mg b.i.d.
	Number Entered	Healed/ Evaluable	Number Entered	Healed/ Evaluable	Number Entered	Healed/ Evaluable
STUDY 1
Week 2			276	93/265 (35%)*	279	55/260 (21%)
Week 4				198/259 (76%)*		95/243 (39%)
STUDY 2
Week 2	108	24/103 (23%)*	106	27/101 (27%)*	101	9/93 (10%)
Week 4		65/97 (67%)*		66/97 (68%)*		24/84 (29%)
STUDY 3
Week 2	92	22/90 (24%)†			98	13/92 (14%)
Week 4		52/85 (61%)*				29/88 (33%)
Week 8		68/83 (82%)*				39/79 (49%)

2. Maintenance of Healed Duodenal Ulcer

 Treatment with a reduced dose of Nizatidine has been shown to be effective as maintenance therapy following healing of active duodenal ulcers. In multi-center, double-blind, placebo-controlled studies conducted in the United States, 150 mg of Nizatidine taken at bedtime resulted in a significantly lower incidence of duodenal ulcer recurrence in patients treated for up to 1 year (Table 3).

Table 3: Percentage of Ulcers Recurring by 3, 6, and 12 Months in Double-Blind Studies Conducted in the United States

* P<0.001 as compared with placebo.
Month	Nizatidine, 150 mg h.s.	Placebo
3	13% (28/208)*	40% (82/204)
6	24% (45/188)*	57% (106/187)
12	34% (57/166)*	64% (112/175)

3. Gastroesophageal Reflux Disease (GERD)

 In 2 multi-center, double-blind, placebo-controlled clinical trials performed in the United States and Canada, Nizatidine was more effective than placebo in improving endoscopically diagnosed esophagitis and in healing erosive and ulcerative esophagitis.

In patients with erosive or ulcerative esophagitis, 150 mg b.i.d. of Nizatidine given to 88 patients compared with placebo in 98 patients in Study 1 yielded a higher healing rate at 3 weeks (16% vs 7%) and at 6 weeks (32% vs 16%, P<0.05). Of 99 patients on Nizatidine and 94 patients on placebo, Study 2 at the same dosage yielded similar results at 6 weeks (21% vs 11%, P< 0.05) and at 12 weeks (29% vs 13%, P<0.01).

In addition, relief of associated heartburn was greater in patients treated with Nizatidine. Patients treated with Nizatidine consumed fewer antacids than did patients treated with placebo.

4. Active Benign Gastric Ulcer

 In a multicenter, double-blind, placebo-controlled study conducted in the United States and Canada, endoscopically diagnosed benign gastric ulcers healed significantly more rapidly following administration of Nizatidine than of placebo (Table 4).

Table 4

* P-values are one-sided, obtained by Chi-square test, and not adjusted for multiple comparisons.
Week	Treatment	Healing Rate	vs. Placebo p-value*
4	Nizatidine 300 mg h.s.	52/153 (34%)	0.342
	Nizatidine 150 mg b.i.d.	65/151 (43%)	0.022
	Placebo	48/151 (32%)
8	Nizatidine 300 mg h.s.	99/153 (65%)	0.011
	Nizatidine 150 mg b.i.d.	105/151 (70%)	<0.001
	Placebo	78/151 (52%)

In a multicenter, double-blind, comparator-controlled study in Europe, healing rates for patients receiving Nizatidine (300 mg h.s. or 150 mg b.i.d.) were equivalent to rates for patients receiving a comparator drug, and statistically superior to historical placebo control rates.

Indications and Usage for Nizatidine

Nizatidine capsules USP are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.

Nizatidine capsules USP are 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 capsules USP for longer than 1 year are not known.

Nizatidine capsules USP are 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 capsules USP are 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.

Contraindications

Nizatidine is contraindicated in patients with known hypersensitivity to the drug. Because cross- sensitivity in this class of compounds has been observed, H2-receptor antagonists, including Nizatidine, should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.

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 (3900 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 80 times the recommended daily therapeutic dose) 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 (2000 mg/kg/day, about 330 times the human dose) 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 60 times the human dose), 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 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 (9000 mg/m2/day, 40.5 times the recommended human dose based on body surface area) and in pregnant rabbits at doses up to 275 mg/kg/day (3245 mg/m2/day, 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

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the 955 patients in clinical studies who were treated with Nizatidine, 337 (35.3%) were 65 and older. No overall differences in safety or effectiveness were observed between these and younger subjects. 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, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION).

Adverse Reactions

Worldwide, controlled clinical trials of Nizatidine included over 6,000 patients given Nizatidine in studies of varying durations. Placebo-controlled trials in the United States and Canada included over 2,600 patients given Nizatidine and over 1,700 given placebo. Among the adverse events in these placebo-controlled trials, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the Nizatidine group.

Incidence in Placebo-Controlled Clinical Trials in the United States and Canada

Table 5 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 nondrug factors to the side effect incidence rate in the population studied.

Table 5: Incidence of Treatment-Emergent Adverse Events in Placebo-Controlled Clinical Trials in the United States and Canada

* Events reported by at least 1% of Nizatidine-treated patients are included.
	Percentage of Patients Reporting Event
Body System/ Adverse Event*	Nizatidine (N=2,694)	Placebo (N=1,729)
Body as a Whole
Headache	16.6	15.6
Abdominal Pain	7.5	12.5
Pain	4.2	3.8
Asthenia	3.1	2.9
Back Pain	2.4	2.6
Chest Pain	2.3	2.1
Infection	1.7	1.1
Fever	1.6	2.3
Surgical Procedure	1.4	1.5
Injury, Accident	1.2	0.9
Digestive
Diarrhea	7.2	6.9
Nausea	5.4	7.4
Flatulence	4.9	5.4
Vomiting	3.6	5.6
Dyspepsia	3.6	4.4
Constipation	2.5	3.8
Dry Mouth	1.4	1.3
Nausea and Vomiting	1.2	1.9
Anorexia	1.2	1.6
Gastrointestinal Disorder	1.1	1.2
Tooth Disorder	1.0	0.8
Musculoskeletal
Myalgia	1.7	1.5
Nervous
Dizziness	4.6	3.8
Insomnia	2.7	3.4
Abnormal Dreams	1.9	1.9
Somnolence	1.9	1.6
Anxiety	1.6	1.4
Nervousness	1.1	0.8
Respiratory
Rhinitis	9.8	9.6
Pharyngitis	3.3	3.1
Sinusitis	2.4	2.1
Cough, Increased	2.0	2.0
Skin and Appendages
Rash	1.9	2.1
Pruritus	1.7	1.3
Special Senses
Amblyopia	1.0	0.9

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 2000 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 (e.g., 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.

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 1200 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.

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.

Nizatidine 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.

Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

The dose for patients with renal dysfunction should be reduced as follows:

Active Duodenal Ulcer, GERD and Benign Gastric Ulcer
Ccr	Dose
20-50 mL/min	150 mg daily
<20 mL/min	150 mg every other day
Maintenance Therapy
Ccr	Dose
20-50 mL/min	150 mg every other day
<20 mL/min	150 mg every 3 days

 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 t

Nitroglycerin Tablets

Generic Name: Nitroglycerin (nye-troe-GLIH-suh-rin)
Brand Name: Nitrogard

Nitroglycerin is used for:

Preventing chest pain caused by heart disease. It may also be used to treat other conditions as determined by your doctor.

Nitroglycerin is a nitrate. It works by widening blood vessels in the body, which allows more blood to flow more easily through them and reduces the work the heart has to do to pump blood. This reduces the oxygen need of the heart, and helps prevent chest pain.

Do NOT use Nitroglycerin if:

• you are allergic to any ingredient in Nitroglycerin


• you suspect your are having a heart attack


• you have increased pressure inside the head


• you have severe anemia


• you are currently taking a phosphodiesterase type 5 inhibitor (eg, sildenafil), a medicine used frequently for sexual dysfunction

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nitroglycerin:

Some medical conditions may interact with Nitroglycerin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you drink alcoholic beverages


• if you have a history of heart failure, overactive thyroid, recent head trauma, recent heart attack, recent stroke, head injury, or low blood pressure

Some MEDICINES MAY INTERACT with Nitroglycerin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), phenothiazines (eg, thioridazine), or phosphodiesterase type 5 inhibitors (eg, sildenafil) because side effects such as severely low blood pressure may occur


• Alteplase or heparin because the effectiveness of these medicines may be decreased


• Salicylates (eg, aspirin) because the effectiveness of nitroglycerin may be altered. Control of blood pressure may be impaired and your doctor may need to adjust your dose.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitroglycerin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitroglycerin:

Use Nitroglycerin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not crush, chew, or swallow the tablet, or place it under the tongue.


• Place tablet(s) under the upper lip or between the gum and cheek and allow it to dissolve slowly over a 3 to 5 hour period or as directed by your health care provider. If you wear dentures, place the tablet between the cheek and gum above the denture plate. Touching the tablets with the tongue or drinking hot liquids will help the tablets dissolve faster.


• If you accidentally swallow a tablet, replace it with another one, unless otherwise advised by your doctor.


• If you miss a dose of Nitroglycerin and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nitroglycerin.

Important safety information:

• Nitroglycerin may cause dizziness or blurred vision. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.


• Nitroglycerin may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.


• To avoid tooth and gum decay, vary location sites and brush your teeth after the tablet has completely dissolved.


• Do not fall asleep with a tablet in your mouth.


• LAB TESTS, including blood electrolytes and blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Nitroglycerin is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Nitroglycerin during pregnancy. It is unknown if Nitroglycerin is excreted in breast milk. If you are or will be breast-feeding while you are using Nitroglycerin, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Nitroglycerin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning or tingling in the mouth; dizziness; flushing; headache; heavy sweating; lightheadedness; nausea; pale skin; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; fainting; increased chest pain; pounding in the chest; slow heartbeat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Nitroglycerin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately. Symptoms may include: changes in vision; confusion and difficulty breathing; excessive sweating; fast heartbeat; flushing; low blood pressure; pounding in the chest.

Proper storage of Nitroglycerin:

Store between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in bathroom. Keep Nitroglycerin out of the reach of children and away from pets.

General information:

• If you have any questions about Nitroglycerin, please talk with your doctor, pharmacist, or other health care provider.


• Nitroglycerin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Nitroglycerin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nitroglycerin resources

• Nitroglycerin Side Effects (in more detail)
• Nitroglycerin Use in Pregnancy & Breastfeeding
• Drug Images
• Nitroglycerin Drug Interactions
• Nitroglycerin Support Group
• 6 Reviews for Nitroglycerin - Add your own review/rating

Compare Nitroglycerin with other medications

• Anal Fissure and Fistula
• Angina
• Angina Pectoris Prophylaxis
• Heart Attack
• Heart Failure
• High Blood Pressure
• Raynaud's Syndrome

Nitropress

Generic Name: nitroprusside (nye troe PRUS ide)

Brand Names: Nitropress

What is Nitropress (nitroprusside)?

Nitroprusside is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). This lowers blood pressure and allows blood to flow more easily through your veins and arteries.

Nitroprusside is used to treat congestive heart failure and life-threatening high blood pressure (hypertension). Nitroprusside is also used to keep blood pressure low during a surgery.

Nitroprusside may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Nitropress (nitroprusside)?

You should not receive this medication if you are allergic to nitroprusside, or if you have hereditary vision loss (Leber's disease), vision problems caused by smoking, or a history of blood clot in your brain.

Before receiving nitroprusside, tell your doctor if you have high blood pressure, kidney or liver disease, anemia (a lack of red blood cells), a seizure disorder, or a history of head injury or brain tumor.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast-feeding. Make sure any doctor caring for you afterward knows that you have received this medication.

Tell your caregivers right away if you have a serious side effect such as breathing problems, tremors or twitching, numbness or cold feeling in your arms and legs, confusion, ringing in your ears, or feeling like you might pass out.

What should I discuss with my health care provider before receiving Nitropress (nitroprusside)?

You should not receive this medication if you are allergic to nitroprusside, or if you have:

• 
  

  hereditary vision loss (Leber's disease);

  
  


• 
  

  vision problems caused by smoking; or

  
  


• 
  

  a history of blood clot in your brain.

  
  

If possible before you receive nitroprusside, tell your doctor if you have:

• 
  

  high blood pressure (hypertension);

  
  


• kidney disease;


• liver disease;


• 
  

  anemia (a lack of red blood cells);

  
  


• 
  

  epilepsy or other seizure disorder; or

  
  


• 
  

  a history of head injury or brain tumor.

  
  

FDA pregnancy category C. It is not known whether nitroprusside will harm an unborn baby. Tell your doctor if you are pregnant. It is not known whether nitroprusside passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

In an emergency situation, it may not be possible before you are treated with nitroprusside to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

How is nitroprusside given?

Nitroprusside is injected into a vein through an infusion pump. You will receive this injection in a clinic or hospital setting.

Nitroprusside is usually given for as long as needed until your body responds to the medication. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving nitroprusside. Your blood and urine may also need to be tested during treatment.

What happens if I miss a dose?

Since nitroprusside is given as needed by a healthcare professional, you are not likely to miss a dose.

What happens if I overdose?

Tell your caregivers at once if you think you have received too much of this medicine. Overdose symptoms may include extreme dizziness, nausea and vomiting, muscle twitching, rapid breathing, fast or pounding heartbeat, and feeling like you might pass out.

What should I avoid after receiving Nitropress (nitroprusside)?

Follow your doctor's instructions about any restrictions on food, beverages, activity, or other medications.

Nitropress (nitroprusside) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

• 
  

  feeling like you might pass out, even while lying down;

  
  


• 
  

  gasping, struggling to breathe, or shallow breathing;

  
  


• 
  

  confusion, ringing in your ears;

  
  


• 
  

  dizziness with nausea and vomiting, rapid breathing, seizure (convulsions);

  
  


• 
  

  fast, slow, or uneven heart rate;

  
  


• 
  

  numb or cold feeling in your arms and legs; or

  
  


• 
  

  chills, sweating, tremors, twitching, overactive reflexes.

  
  

Less serious side effects may include:

• 
  

  mild skin rash;

  
  


• 
  

  mild stomach pain or nausea;

  
  


• 
  

  warmth, redness, or tingly feeling under your skin;

  
  


• 
  

  darkening or deeper color of veins through your skin; or

  
  


• 
  

  irritation around the IV needle.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Nitropress (nitroprusside)?

Tell your doctor if you take any type of blood pressure medication.

There may be other drugs that can interact with nitroprusside. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Nitropress resources

• Nitropress Side Effects (in more detail)
• Nitropress Use in Pregnancy & Breastfeeding
• Nitropress Drug Interactions
• Nitropress Support Group
• 0 Reviews for Nitropress - Add your own review/rating

• Nitropress Prescribing Information (FDA)


• Nitropress Monograph (AHFS DI)

Compare Nitropress with other medications

• Heart Failure
• Hypertensive Emergency

Where can I get more information?

• Your doctor or pharmacist can provide more information about nitroprusside.

See also: Nitropress side effects (in more detail)

Nicotine Lozenges

Pronunciation: NIK-oh-teen
Generic Name: Nicotine
Brand Name: Commit

Nicotine Lozenges are used for:

Helping you to quit smoking.

Nicotine Lozenges are a smoking deterrent. It works by providing low levels of nicotine, which may help you to quit smoking by lessening the physical symptoms of withdrawal.

Do NOT use Nicotine Lozenges if:

• you are allergic to any ingredient in Nicotine Lozenges


• you have had a recent heart attack


• you have severe or worsening chest pain or a severely irregular heartbeat


• you continue to smoke, chew tobacco, use snuff, or use any other nicotine-containing products

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nicotine Lozenges:

Some medical conditions may interact with Nicotine Lozenges. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are on a low-sodium diet or if you have phenylketonuria (PKU)


• if you have chest pain (eg, angina), heart problems (eg, coronary artery disease, irregular heartbeat), high blood pressure, or you have had a heart attack


• if you have an ulcer, diabetes, an overactive thyroid, blood vessel problems (eg, Buerger disease, Raynaud phenomena), or an adrenal gland tumor (pheochromocytoma)


• if you take medicine for asthma or depression, or if you are using another medicine to stop smoking

Some MEDICINES MAY INTERACT with Nicotine Lozenges. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acetaminophen, adrenergic antagonists (eg, prazosin), beta-blockers (eg, labetalol, propranolol), caffeine, insulin, oxazepam, pentazocine, theophylline, or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased when you stop smoking


• Adrenergic agonists (eg, isoproterenol, phenylephrine) because their effectiveness may be decreased when you stop smoking

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nicotine Lozenges may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nicotine Lozenges:

Use Nicotine Lozenges as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Nicotine Lozenges. Talk to your pharmacist if you have questions about this information.


• Do not eat or drink for 15 minutes before taking Nicotine Lozenges or when it is in your mouth.


• Do NOT chew or swallow the lozenge whole. Place the lozenge in your mouth and allow it to slowly dissolve. Occasionally move the lozenge from one side of your mouth to the other. Try not to swallow very often while Nicotine Lozenges are dissolving. It may take 20 to 30 minutes for Nicotine Lozenges to completely dissolve.


• To improve your chances of quitting smoking, take at least 9 lozenges per day for the first 6 weeks unless your doctor tells you otherwise.


• Do not take more than 1 lozenge at a time or continuously take one lozenge after another. Hiccups, heartburn, nausea, or other effects may occur.


• Do NOT take more than 5 lozenges in 6 hours. Do NOT take more than 20 lozenges each day.


• If you cannot finish a lozenge, wrap it in paper and dispose of it in the trash out of the reach of children and away from pets.


• If you miss a dose of Nicotine Lozenges, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Nicotine Lozenges.

Important safety information:

• The dose of Nicotine Lozenges that you take is determined by how soon after waking you would normally smoke your first cigarette of the day. If you are not sure what dose of Nicotine Lozenges to take, ask your doctor or pharmacist.


• Do not smoke or use tobacco products while taking Nicotine Lozenges.


• Do NOT use Nicotine Lozenges for longer than 12 weeks. If you still feel the need to take Nicotine Lozenges after 12 weeks, check with your doctor.


• Nicotine Lozenges should be used as part of a larger program to help you stop smoking. If you need help choosing a program, talk with your health care provider.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Do not use Nicotine Lozenges in CHILDREN younger than 18 years old without first talking with the child's doctor.


• PREGNANCY and BREAST-FEEDING: Nicotine Lozenges may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Nicotine Lozenges while you are pregnant. Nicotine Lozenges are found in breast milk. If you are or will be breast-feeding while you take Nicotine Lozenges, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Nicotine Lozenges. This is known as DEPENDENCE or addiction.

Do not suddenly stop taking Nicotine Lozenges without your doctor's approval. Stopping Nicotine Lozenges suddenly may cause serious WITHDRAWAL symptoms. These may include anxiety, craving, impaired concentration, increased appetite, irritability, nervousness, sleep disturbances, and weight gain.

Possible side effects of Nicotine Lozenges:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Warm or tingling sensation in the mouth.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; mouth problems (eg, mouth pain, sores, or swelling); persistent indigestion; severe sore throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nicotine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold and clammy skin; confusion; diarrhea; difficulty breathing; dizziness; excessive drooling; fainting; fast, weak, or irregular heartbeat; headache; hearing and vision problems; nausea; seizures; stomach pain; sweating; tremor; vomiting; weakness.

Proper storage of Nicotine Lozenges:

Store Nicotine Lozenges at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Store Nicotine Lozenges in the original blister pack. Once removed from the blister, use immediately. Do not store in the bathroom. Keep Nicotine Lozenges out of the reach of children and away from pets.

General information:

• If you have any questions about Nicotine Lozenges, please talk with your doctor, pharmacist, or other health care provider.


• Nicotine Lozenges are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nicotine Lozenges. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nicotine resources

• Nicotine Side Effects (in more detail)
• Nicotine Use in Pregnancy & Breastfeeding
• Nicotine Drug Interactions
• Nicotine Support Group
• 42 Reviews for Nicotine - Add your own review/rating

Compare Nicotine with other medications

• Smoking Cessation

Noroxin

Generic Name: Norfloxacin
Class: Quinolones
VA Class: AM900
Chemical Name: 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
CAS Number: 70458-96-7

• 
  

  Fluoroquinolones, including norfloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.^{1 372 373} This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.^{1 372 373} (See Tendinopathy and Tendon Rupture under Cautions.)

  
  

REMS:

FDA approved a REMS for norfloxacin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of norfloxacin and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antibacterial; fluoroquinolone.^{1 17 18 20}

Uses for Noroxin

Urinary Tract Infections (UTIs) and Prostatitis

Treatment of uncomplicated UTIs (including cystitis) caused by susceptible Citrobacter freundii, Enterobacter aerogenes, E. cloacae, Escherichia coli, Klebsiella pneumoniae, Morganella morganii†, Proteus mirabilis, P. vulgaris, Providencia rettgeri†, Pseudomonas aeruginosa, or Serratia marcescens†.^{1 107 114 115 116 117 118 123 124 127 128 129 134 135 201 230 231 280 283 309} Also used for treatment of uncomplicated UTIs caused by susceptible Staphylococcus aureus, S. epidermidis, S. saprophyticus, or Streptococcus agalactiae (group B streptococci), or Enterococcus faecalis.^{1 107 116 117 118 124 127 129 134 135 201 230 231}

Treatment of complicated UTIs caused by susceptible E. coli, K. pneumoniae, P. mirabilis, Ps. aeruginosa, S. marcescens, or E. faecalis.¹

Treatment of prostatitis caused by E. coli.¹

Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria; generally not recommended for uncomplicated UTIs (e.g., acute cystitis) unless more commonly employed urinary anti-infectives are contraindicated or not tolerated.^{111 251 253}

GI Infections

Treatment of gastroenteritis† caused by susceptible enterotoxigenic E. coli,^{71 193 232} Aeromonas hydrophila,^{193 232} Plesiomonas shigelloides,⁷¹ Salmonella,^{71 193 232} or Shigella (including Sh. boydii,⁷¹ Sh. dysenteriae,^{36 71 131 193} Sh. flexneri,^{71 193} Sh. sonnei).⁷¹

Treatment of cholera†, including infections caused by Vibrio cholerae serotypes 01 or 0139.^{310 311 341 344} Tetracyclines generally are drugs of choice when an anti-infective is indicated as an adjunct to fluid and electrolyte replacement;^{43 309 311 334} alternative agents for V. cholerae resistant to tetracyclines include co-trimoxazole, fluoroquinolones, or furazolidone.^{43 309 311 334 341}

Treatment of travelers’ diarrhea†.^{210 301 304 305 306 335 374} Replacement therapy with oral fluids and electrolytes may be sufficient for mild to moderate disease.^{210 304 305 335} Generally self-limited and may resolve within 3–4 days without anti-infective treatment;^{210 304 305 334} if diarrhea is moderate or severe, persists for >3 days, or is associated with fever or bloody stools, short-term (1–3 days) anti-infective treatment may be indicated.^{210 304 305 334 374} Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, is indicated.^{304 305 312 335 337 374} Azithromycin is a treatment alternative for those who should not receive fluoroquinolones (e.g., children, pregnant women) and may be a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., Thailand, India) or those who have not responded after 48 hours of fluoroquinolone treatment.^{304 305 334 374} Rifaximin is another alternative for treatment of travelers' diarrhea caused by noninvasive E. coli.^{304 305 374}

Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug.^{109 131 193 301 304 307 308 335 337 374} CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk;^{210 304 305 308 312 334 374} the principal preventive measures are prudent dietary practices.^{210 304 329 330} If anti-infective prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is recommended for nonpregnant adults,^{304 305 374} although the increasing incidence of quinolone resistance in pathogens that cause travelers' diarrhea (e.g., Campylobacter) should be considered.^{304 305}

Gonorrhea and Associated Infections

Has been used for treatment of uncomplicated urethral, endocervical, or rectal† gonorrhea caused by susceptible Neisseria gonorrhoeae.^{1 17 18 21 71 111 119 132 193 195 196 229 297 298 301 319}

Although fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin) were previously considered drugs of choice for treatment of uncomplicated gonorrhea,^{319 358} CDC currently states that fluoroquinolones should not be used for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).^{328 358 359 360}

Quinolone-resistant N. gonorrhoeae (QRNG) has been reported with increasing frequency worldwide and is widespread in the US.^{319 320 328 338 358 359 360} (See Resistance in Neisseria gonorrhoeae under Cautions.)

For treatment of uncomplicated cervical, urethral, or rectal gonorrhea, CDC and others recommend IM ceftriaxone or oral cefixime; IM ceftriaxone is drug of choice for pharyngeal infections.^{319 328 358 359}

Noroxin Dosage and Administration

Administration

Oral Administration

Administer orally.¹

Give tablets with a glass of water at least 1 hour before or at least 2 hours after a meal or dairy products (e.g., milk, yogurt).^{1 2} (See Pharmacokinetics.)

Patients receiving norfloxacin should be well hydrated and should be instructed to drink fluids liberally.^{1 240} (See Renal Effects under Cautions.)

Dosage

Adults

Urinary Tract Infections (UTIs) and Prostatitis

Uncomplicated UTIs

Oral

400 mg every 12 hours.^{1 17 114 116 117 118 124 127 128 201 205} Usual duration is 3 days for treatment of uncomplicated UTIs caused by susceptible E. coli, K. pneumoniae, or P. mirabilis or 7–10 days for treatment of uncomplicated UTIs caused by other susceptible bacteria.¹

Complicated UTIs

Oral

400 mg every 12 hours.^{1 17 114 116 128 135 201 205} Usual duration is ≥10–21 days.^{1 17 135}

Acute or Chronic Prostatitis Caused by E. coli

Oral

400 mg every 12 hours for 28 days.¹

GI Infections†

Gastroenteritis Caused by Susceptible Bacteria†

Oral

400 mg twice daily for 5 days.^{36 71 131 193} A duration of 3 days may be sufficient for some infections, including shigellosis or some E. coli infections.⁴³

Cholera†

Oral

400 mg twice daily for 3 days in conjunction with fluid and electrolyte replacement.^{341 344} A single 800-mg dose has been used in adults, but there is some evidence that a multiple-dose regimen is more effective than a single-dose regimen for treatment of severe cholera caused by V. cholerae 0139.³⁴¹

Treatment of Travelers’ Diarrhea†

Oral

400 mg twice daily for 1–3 days.^{305 306 374}

Prevention of Travelers’ Diarrhea†

Oral

400 mg once daily.^{305 329 330 335 374}

Although anti-infective prophylaxis generally is discouraged,^{210 304 305 308 312 334 337 374} some clinicians state that it can be given during the period of risk (for ≤3 weeks) beginning the day of travel and continuing for 1 or 2 days after leaving the area of risk.^{329 330 335 374}

Gonorrhea

Uncomplicated Urethral, Endocervical, or Rectal† Gonorrhea

Oral

A single 800-mg dose.^{1 319}

Because of increased prevalence of quinolone-resistant Neisseria gonorrhoeae (QRNG), CDC no longer recommends fluoroquinolones for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., PID, epididymitis).^{328 358 359 360} (See Gonorrhea and Associated Infections under Uses.)

Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients being treated for gonorrhea should also receive an anti-infective regimen effective for presumptive treatment of chlamydia (e.g., a single dose of oral azithromycin or a 7-day regimen of oral doxycycline).³¹⁹

Prescribing Limits

Adults

Oral

Maximum 400 mg twice daily because of the risk of crystalluria.¹

Special Populations

Renal Impairment

Dosage adjustments necessary in patients with severe renal impairment.^{1 2 7 8 17 143}

Adults with Cl_cr ≤30 mL/minute per 1.73 m² should receive 400 mg once daily.¹

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Select dosage with caution because of possible age-related decreases in renal impairment.¹

Cautions for Noroxin

Contraindications

• 
  

  Hypersensitivity to norfloxacin or any quinolone.^{1 240}

  
  


• 
  

  History of tendinitis or tendon rupture with norfloxacin or any quinolone.¹

  
  

Warnings/Precautions

Warnings

Tendinopathy and Tendon Rupture

Fluoroquinolones, including norfloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups.^{1 372 373} This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.^{1 372 373}

Other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.^{1 372 373} Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any of these risk factors.¹

Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon and may require surgical repair.¹ Tendinitis and tendon rupture in the rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites also reported.¹

Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.¹

Discontinue if pain, swelling, inflammation, or rupture of a tendon occurs.^{1 372 373} Advise patients to rest and refrain from exercise and contact a clinician at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint).^{1 372 373} (See Advice to Patients.)

Musculoskeletal Effects

Fluoroquinolones, including norfloxacin, cause arthropathy and osteochondrosis in immature animals of various species.^{1 2 233 240 362 363 364 365 366 369 370} Relevance of these adverse effects in immature animals to use in humans unknown.^{213 241 361 367 368 369} Safety and efficacy of norfloxacin not established in children and adolescents <18 years of age (see Pediatric Use under Cautions) or in pregnant or lactating women (see Pregnancy and see Lactation under Cautions).¹

CNS Effects

Possibility of seizures, increased intracranial pressure, toxic psychoses, and CNS stimulation leading to tremors, restlessness, lightheadedness, confusion, and hallucinations.^{1 21 233 240 257 258}

Use with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy).¹

If a severe adverse CNS reaction (e.g., seizures, increased intracranial pressure, CNS stimulation, toxic psychosis) occurs, discontinue the drug and institute appropriate therapeutic measures.¹

Peripheral Neuropathy

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with quinolones, including norfloxacin.¹

To prevent development of an irreversible condition, discontinue norfloxacin if symptoms of neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur or if there are deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength.¹

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.¹ Institute appropriate therapy if superinfection occurs.¹

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.^{1 345 346 347 348 349 354} C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including norfloxacin, and may range in severity from mild diarrhea to fatal colitis.^{1 242 267 345 346 347 348 349 351 355 356} Outbreaks of severe CDAD caused by fluoroquinolone-resistant C. difficile have been reported with increasing frequency over the last several years.^{350 351 352 353 355} Hyper toxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.¹

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.^{1 345 346 347 348 349 354} Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.^{1 345 346 347 348 349}

If CDAD is suspected or confirmed, norfloxacin may need to be discontinued.^{1 345 346 347 348 349} Some mild cases may respond to discontinuance alone.^{345 346 347 348 349} Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, appropriate anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.^{1 345 346 347 348 349}

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal (anaphylactic) hypersensitivity reactions, which may occur following first dose, reported with some quinolones, including norfloxacin.^{1 193 293 294 295}

Some reactions have been accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.^{1 293 294 295}

In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported, most frequently after multiple doses.¹ These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia, and/or other hematologic effects.¹

Discontinue norfloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).¹

Photosensitivity Reactions

Moderate to severe photosensitivity/phototoxicity reactions have been reported with fluoroquinolones, including norfloxacin.¹

Phototoxicity may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) on areas exposed to sun or artificial ultraviolet (UV) light (usually the face, neck, extensor surfaces of forearms, dorsa of hands).¹

Relative potential of the various fluoroquinolones to cause photosensitivity/phototoxicity unclear.²⁹² Factors that contribute to susceptibility to this adverse effect during fluoroquinolone therapy include patient's skin pigmentation, frequency and duration of exposure to sun and UV light, use of protective clothing and sunscreen, concomitant use of other drugs, and dosage and duration of fluoroquinolone therapy.²⁹²

Avoid unnecessary or excessive exposure to sunlight or artificial UV light (tanning beds, UVA/UVB treatment) while receiving norfloxacin.¹ If patient needs to be outdoors, they should wear loose-fitting clothing that protects skin from sun exposure and use other sun protection measures (sunscreen).¹

Discontinue norfloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.¹

General Precautions

Renal Effects

Possible crystalluria;^{1 2 21 71 138 193} generally associated with alkaline urine and high dosage.^{21 138 193 221}

Adequate fluid intake necessary to ensure proper hydration and adequate urinary output;^{1 2 240} avoid alkaline urine and do not exceed usual dosage.^{1 2 240}

Hematologic Effects

Hemolytic reactions reported rarely in patients with latent or actual defects in glucose-6-phosphate dehydrogenase (G-6-PD).¹

Prolongation of QT Interval

Prolonged QT interval and ventricular arrhythmias (including torsades de pointes) reported with some fluoroquinolones, including norfloxacin.¹

Avoid or use with caution in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents or other drugs that may affect QT interval (e.g., cisapride [available in the US only under a limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants) and in patients with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia).¹

Myasthenia Gravis Patients

Possible exacerbation of signs of myasthenia gravis, which may lead to life-threatening weakness of respiratory muscles, reported with quinolones, including norfloxacin; use with caution in patients with myasthenia gravis.¹

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.¹

Selection and Use of Anti-infectives

When prescribing a fluoroquinolone, consider potential benefits and risks for the individual patient.^{372 373} Most patients tolerate the drugs, but serious adverse reactions (e.g., CNS effects, QT prolongation, C. difficile-associated diarrhea and colitis, damage to liver, kidneys, or bone marrow, alterations in glucose homeostatis) may occur rarely.^{372 373}

To reduce development of drug-resistant bacteria and maintain effectiveness of norfloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹

Resistance in Neisseria gonorrhoeae

N. gonorrhoeae with decreased susceptibility to norfloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) has been reported with increasing frequency over the past several years.^{319 320 322 323 324 325 326 327 328 336 358}

Recent US data indicate that QRNG has continued to increase among men who have sex with men and among heterosexual males and is now present in all regions of the country.³⁵⁸

CDC states that fluoroquinolones should not be used to treat proven or suspected gonorrhea,^{328 358 359 360} including infections acquired within the US or acquired while traveling abroad.³¹⁹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether distributed into milk;¹ other quinolones are distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children and adolescents <18 years of age.¹ Norfloxacin causes arthropathy in juvenile animals.^{1 233} (See Musculoskeletal Effects under Cautions.)

AAP states use of fluoroquinolones may be justified in children <18 years of age in special circumstances after careful assessment of the risks and benefits for the individual patient and after these benefits and risks have been explained to the parents or caregivers.³³⁴

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased risk of some adverse effects cannot be ruled out.¹

Risk of severe tendon disorders, including tendon rupture, is increased in geriatric adults >60 years of age.^{1 372 373} This risk is further increased in those receiving concomitant corticosteroids.^{1 372 373} (See Tendinopathy and Tendon Rupture under Cautions.) Use caution in geriatric adults, especially those receiving concomitant corticosteroids.¹

Risk of QT interval prolongation leading to ventricular arrhythmias may be increased in geriatric patients, especially those receiving concurrent therapy with other drugs that can prolong QT interval (e.g., class IA or III antiarrhythmic agents) or with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia).¹ (See Prolongation of QT Interval under Cautions.)

Substantially eliminated by the kidney and age-related decline in renal function may increase risk of adverse reactions.¹

Consider age-related decreases in renal function when selecting dosage; renal function monitoring may be useful.¹

Renal Impairment

Increased norfloxacin serum concentrations and prolonged half-life.^{1 17 18}

Dosage adjustments necessary in patients with severe renal impairment.^{1 2 7 8 17 143} (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (nausea, abdominal cramping);^{1 17 18 21 71 116 124 193 205 233} CNS effects (headache, dizziness, asthenia);^{1 17 18 21 71 116 124 193 205 233} rash.¹

Interactions for Noroxin

Drugs Metabolized by Hepatic Microsomal Enzymes

Inhibits cytochrome P-450 (CYP) isoenzyme 1A2.¹ Potential pharmacokinetic interaction with CYP1A2 substrates (e.g., caffeine, clozapine, ropinirole, tacrine, theophylline, tizanidine) resulting in increased drug concentrations if given in usual dosages.¹ Carefully monitor patients receiving norfloxacin concomitantly with drugs metabolized by CYP1A2.¹

Drugs that Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation).¹ Avoid or use with caution in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents or other drugs that may affect QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants).¹ (See Prolongation of QT Interval under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Aminoglycosides	In vitro evidence of additive or synergistic antibacterial effects against some Enterobacteriaceae and Ps. aeruginosa;150 155 177 synergism unpredictable and indifference or antagonism also has been reported48 155
Antacids (aluminum- or magnesium-containing)	Decreased absorption of norfloxacin1 2 18 71 240 266	Administer norfloxacin tablets at least 2 hours before or after such antacids1 219
Anticoagulants, oral (warfarin)	Potential for enhanced warfarin effects1 276 289	Use with caution;276 289 monitor PT or other appropriate coagulation tests1
β-lactam antibiotics	No in vitro evidence of synergism or antagonism against gram-positive or -negative bacteria when used with ampicillin, cefotaxime, or cefoxitin48
Caffeine	Possible prolonged half-life of caffeine with some quinolones (e.g., ciprofloxacin)241 244 269 270 271 272 273	The possibility of exaggerated or prolonged effects of caffeine during concomitant use with a quinolone should be considered244 270
Corticosteroids	Increased risk of tendinitis or tendon rupture, especially in patients >60 years of age1 372 373
Cyclosporine	Possible increased concentrations of cyclosporine1	Monitor cyclosporine concentrations and adjust cyclosporine dosage if needed1
Didanosine	Decreased absorption of norfloxacin with buffered didanosine preparations1	Administer norfloxacin tablets at least 2 hours before or after buffered didanosine preparations (pediatric oral solution admixed with antacid)1
Glyburide	Severe hypoglycemia reported1	Monitor blood glucose1
Iron preparations	Decreased absorption of norfloxacin1	Administer norfloxacin tablets at least 2 hours before or after ferrous sulfate and dietary supplements containing iron1
Multivitamins and mineral supplements	Decreased absorption of norfloxacin1	Administer norfloxacin tablets at least 2 hours before or after supplements containing zinc or iron1
Nitrofurantoin	Some in vitro evidence of antagonism between norfloxacin and nitrofurantoin1	Clinical importance unknown; should not be used concomitantly1
NSAIAs	Increased risk of CNS stimulation and convulsive seizures1 Animal studies suggest norfloxacin may have greater convulsant activity than some other fluoroquinolones (e.g., levofloxacin) and the potential risk associated with concomitant therapy may vary depending on the specific NSAIA357	Use with caution1
Probenecid	Decreased clearance of norfloxacin;1 2 3 139 serum concentrations139 and half-life of norfloxacin generally not affected2 3
Sucralfate	Possible decreased GI absorption of norfloxacin1 333	Some clinicians suggest that concomitant use should be avoided; if used concomitantly, give norfloxacin tablets at least 2 hours before or after sucralfate1 333
Theophylline	Possible increased theophylline concentrations and increased risk of theophylline-related adverse effects1 18 21 205 216 224 225 234 244 245 246 255 Although risk of norfloxacin inducing substantial alterations in theophylline pharmacokinetics appears to be less than with some other quinolones (e.g., ciprofloxacin),244 245 246 255 256 theophylline-related adverse effects have been reported in patients receiving norfloxacin concomitantly1	Some clinicians suggest that the interaction between norfloxacin and theophylline may not be clinically important in most patients;234 255 256 275 287 others suggest that norfloxacin should be used with caution in patients receiving theophylline205 219 244 246 255 Manufacturer of norfloxacin states that consideration should be given to monitoring plasma theophylline concentrations and theophylline dosage should be adjusted as required1

Noroxin Pharmacokinetics

Absorption

Bioavailability

Rapidly, but incompletely, absorbed from GI tract following oral administration.^{1 2 3 4 17 18 21 22 136 142 205}

At least 30–50% of an oral dose is absorbed from GI tract;^{1 2 4} peak serum concentrations generally attained within 1–2 hours