Antara

Pronunciation: FEN-oh-FYE-brate
Generic Name: Fenofibrate
Brand Name: Examples include Antara and Tricor

Antara is used for:

Controlling high cholesterol and triglyceride levels in the blood. It is used in combination with a diet that is low in cholesterol and saturated fat.

Antara is a lipid-lowering agent. It works by lowering elevated blood triglyceride levels by making the liver produce fewer triglycerides and increasing the elimination of triglycerides from the blood stream.

Do NOT use Antara if:

• you are allergic to any ingredient in Antara


• you have gallbladder problems, liver problems (including cirrhosis, hepatitis), or severe kidney problems (eg, kidney failure)


• you are breast-feeding or pregnant

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

Before using Antara:

Some medical conditions may interact with Antara. 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 have diabetes, an underactive thyroid, heart blood vessel problems, gallstones, kidney problems, or certain muscle problems (myopathy)


• if you have a history of pancreatitis or blood clots in your veins (deep vein thrombosis or pulmonary embolism)


• if you are very overweight, have an inactive lifestyle, or you drink large amounts of alcohol


• if you are taking a beta-blocker (eg, propranolol), estrogen, or thiazide diuretic (eg, hydrochlorothiazide)

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

• HMG-CoA reductase inhibitors (eg, simvastatin) because the risk of serious muscle problems leading to kidney failure may be increased


• Immunosuppressants (eg, cyclosporine) or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because they may decrease Antara's excretion and increase the risk of its side effects


• Anticoagulants (eg, warfarin) or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Antara

This may not be a complete list of all interactions that may occur. Ask your health care provider if Antara 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 Antara:

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

• Take Antara by mouth with or without food.


• Swallow Antara whole. Do not break, crush, or chew before swallowing. Do not take chipped or broken tablets.


• Take Antara with a full glass of water (8 oz/240 mL).


• If you also take a bile acid-binding resin (eg, cholestyramine), do not take it within 4 to 6 hours before or 1 hour after taking Antara. Check with your doctor if you have any questions.


• Take Antara on a regular schedule to get the most benefit from it.


• If you miss a dose of Antara, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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


• Avoid drinking alcohol while you are using Antara.


• Do NOT take more than the recommended dose without checking with your doctor.


• Follow the diet, exercise, and weight reduction program given to you by your health care provider.


• Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.


• Lab tests, including liver function, kidney function, blood cholesterol, and other blood tests, may be performed while you use Antara. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


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


• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using Antara while you are pregnant. It is not known if Antara is found in breast milk. Do not breast-feed while taking Antara.

Possible side effects of Antara:

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:

Headache; nausea.

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); calf pain; chest pain; confusion; dark urine; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased coughing or coughing up blood; muscle pain, tenderness, or weakness (with or without fever and fatigue); pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or lightheadedness; severe or persistent nausea, stomach pain, or vomiting; severe pain or swelling in the ankles, feet, or legs; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

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: Antara 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.

Proper storage of Antara:

Store Antara between 68 and 77 degrees F (20 and 25 degrees C) in a moisture-protective container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Antara out of the reach of children and away from pets.

General information:

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


• Antara 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 Antara. 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 Antara resources

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

• Antara Prescribing Information (FDA)


• Antara Advanced Consumer (Micromedex) - Includes Dosage Information


• Fenofibrate Professional Patient Advice (Wolters Kluwer)


• Fenofibrate Prescribing Information (FDA)


• Fenofibrate Monograph (AHFS DI)


• Fenoglide Prescribing Information (FDA)


• Lipofen Prescribing Information (FDA)


• Lofibra Prescribing Information (FDA)


• Tricor Consumer Overview


• Tricor Prescribing Information (FDA)


• Triglide Prescribing Information (FDA)

Compare Antara with other medications

• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
• Hyperlipoproteinemia Type IV, Elevated VLDL
• Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
• Hypertriglyceridemia

Tylox

acetaminophen and oxycodone hydrochloride

Dosage Form: capsule
Tylox®

(oxycodone and acetaminophen capsules USP)

analgesic CII

For Oral Use

HEPATOTOXICITY

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS).

Tylox Description

Each capsule of Tylox® (oxycodone and acetaminophen capsules USP) contains:

* 5 mg oxycodone hydrochloride is equivalent to 4.4815 mg oxycodone
Oxycodone Hydrochloride USP	5 mg*
Warning — May be habit forming.
Acetaminophen USP	500 mg

Inactive ingredients: docusate sodium, gelatin, magnesium stearate, sodium benzoate, sodium metabisulfite1, corn starch, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, and titanium dioxide.

Acetaminophen occurs as a white, odorless crystalline powder, possessing a slightly bitter taste.

The oxycodone component is 14-hydroxy-dihydrocodeinone, a white, odorless crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

1

See WARNINGS

Tylox - Clinical Pharmacology

The principal ingredient, oxycodone, is a semi-synthetic narcotic analgesic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of the oxycodone in Tylox® (oxycodone and acetaminophen capsules) are analgesia and sedation.

Oxycodone is similar to codeine and methadone in that it retains at least one-half of its analgesic activity when administered orally.

Acetaminophen is a nonopiate, nonsalicylate analgesic and antipyretic.

Indications and Usage for Tylox

Tylox® (oxycodone and acetaminophen capsules) are indicated for the relief of moderate to moderately severe pain.

Contraindications

Tylox® (oxycodone and acetaminophen capsules) should not be administered to patients who are hypersensitive to any component.

Warnings

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products (see Boxed Warning).

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/Anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Tylox® immediately and seek medical care if they experience these symptoms. Do not prescribe Tylox® for patients with acetaminophen allergy.

Tylox® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Drug Dependence

Oxycodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Tylox® (oxycodone and acetaminophen capsules), and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, Tylox® is subject to the Federal Control Substances Act (Schedule II).

Precautions

General

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of Tylox®(oxycodone and acetaminophen capsules) or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Special Risk Patients

Tylox® should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture.

Information for Patients

• Do not take Tylox® if you are allergic to any of its ingredients.


• If you develop signs of allergy such as a rash or difficulty breathing, stop taking Tylox® and contact your healthcare provider immediately.


• Do not take more than 4,000 milligrams of acetaminophen per day. Call your healthcare provider if you took more than the recommended dose.


• Oxycodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Exercise caution until you are reasonably certain that Tylox® does not adversely affect your ability to engage in such activities.

Drug Interactions

Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with Tylox® may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

The concurrent use of anticholinergics with narcotics may produce paralytic ileus.

Usage in Pregnancy

Pregnancy Category C

Animal reproductive studies have not been conducted with Tylox®. It is also not known whether Tylox® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Tylox® should not be given to a pregnant woman, unless in the judgment of the physician, the potential benefits outweigh the possible hazards.

Nonteratogenic Effects

Use of narcotics during pregnancy may produce physical dependence in the neonate.

Labor and Delivery

As with all narcotics, administration of Tylox® to the mother shortly before delivery may result in some degree of respiratory depression in the newborn and the mother, especially if higher doses are used.

Nursing Mothers

It is not known whether the components of Tylox® are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tylox® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, skin rash, and pruritus. At higher doses, oxycodone has most of the disadvantages of morphine including respiratory depression.

Drug Abuse and Dependence

Tylox® capsules are a Schedule II controlled substance.

Oxycodone can produce drug dependence and has the potential for being abused (see WARNINGS).

Overdosage

Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.

Signs and Symptoms

Toxicity from oxycodone poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Serious overdosage with oxycodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

In acetaminophen overdosage: dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment

A single or multiple drug overdose with oxycodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Oxycodone

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including oxycodone. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Acetaminophen

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs early in the course of intoxication.

Tylox Dosage and Administration

Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to oxycodone can develop with continued use and that the incidence of untoward effects is dose related. This product is inappropriate even in high doses for severe or intractable pain.

Tylox® (oxycodone and acetaminophen capsules) are given orally. The usual adult dosage is one Tylox® capsule every 6 hours as needed for pain.

How is Tylox Supplied

Tylox® (oxycodone and acetaminophen capsules USP) contains 5 mg oxycodone and 500 mg acetaminophen. The capsules are red and imprinted with "Tylox" "McNEIL". Tylox® is available as follows:

Bottles of 100 capsules - NDC 50458-526-60

Hospital Unit Dose 100 capsules – NDC 50458-526-79

Dispense in tight, light-resistant container as defined in the official compendium. Store at controlled room temperature (15°–30°C, 59°–86°F). Protect from moisture.

Manufactured by:

Janssen Ortho, LLC

Gurabo, Puerto Rico 00778

Manufactured for:

PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Raritan, NJ 08869

Revised October 2011

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2000

10187201

PRINCIPAL DISPLAY PANEL - 100 Capsule Carton

NSN 6505-01-211-6803

NDC 50458-526-79

CII

Tylox®

(OXYCODONE &

ACETAMINOPHEN CAPSULES USP)

Each capsule contains: Oxycodone Hydrochloride 5 mg†

Acetaminophen 500 mg

† 5 mg oxycodone hydrochloride is equivalent to 4.4815 mg oxycodone.

Rx only.

100 capsules

UNIT DOSE PACK FOR INSTITUTIONAL USE

PriCara®

Division of Ortho-McNeil-Janssen

Pharmaceuticals, Inc.

Tylox  acetaminophen and oxycodone hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50458-526 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength acetaminophen (acetaminophen) acetaminophen 500 mg oxycodone hydrochloride (oxycodone) oxycodone hydrochloride 5 mg

Inactive Ingredients Ingredient Name Strength starch, corn   Docusate sodium   FD&C Blue No. 1   FD&C Red No. 3   FD&C Red No. 40   Gelatin   Magnesium stearate   Sodium benzoate   Sodium metabisulfite   Titanium dioxide

Product Characteristics Color RED Score no score Shape CAPSULE Size 22mm Flavor Imprint Code Tylox;McNEIL Contains

Packaging # NDC Package Description Multilevel Packaging 1 50458-526-60 100 CAPSULE In 1 BOTTLE None 2 50458-526-79 100 CAPSULE In 1 BOX, UNIT-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088790	12/12/1984

Labeler - Ortho-McNeil-Janssen Pharmaceuticals, Inc. (063137772)

Establishment
Name	Address	ID/FEI	Operations
Janssen Ortho, LLC		062191882	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Diosite		409664849	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Ortho-McNeil-Janssen Pharmaceuticals, Inc.		063137772	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt		097722284	ANALYSIS, API MANUFACTURE

Revised: 07/2011Ortho-McNeil-Janssen Pharmaceuticals, Inc.

More Tylox resources

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

• Tylox Advanced Consumer (Micromedex) - Includes Dosage Information


• Tylox Consumer Overview


• Endocet Consumer Overview


• Endocet MedFacts Consumer Leaflet (Wolters Kluwer)


• Roxicet Consumer Overview


• Roxicet Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Tylox with other medications

• Pain

Synvisc Hylan G-F Injection

Generic Name: hylan polymers a and b (Injection route)

HYE-lan POL-a-mers A and B

Commonly used brand name(s)

In the U.S.

• Synvisc


• Synvisc Hylan G-F


• Synvisc One

Available Dosage Forms:

• Injectable


• Solution

Therapeutic Class: Cartilaginous Defect Repair Agent

Uses For Synvisc Hylan G-F

Hylan polymers A and B injection is used to treat knee pain caused by osteoarthritis (OA) in patients who have already been treated with pain relievers (e.g., acetaminophen) and other non-drug treatments that did not work well.

Hylan polymers A and B is similar to a substance that occurs naturally in the joints. It works by acting like a lubricant and shock absorber in the joints and helps the joints to work properly.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Synvisc Hylan G-F

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hylan polymers A and B injection in children up to 21 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of hylan polymers A and B injection in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to bird products such as poultry, feathers, or eggs or


• Lymphatic or venous stasis (severe swelling or blood clots) in the legs—Use with caution. May make these conditions worse.

• Allergy to products containing hyaluronan or sodium hyaluronate or


• Skin or knee joint infections or other problems at the place where the injection is to be given—Should not be given in patients with these conditions.

• Joint effusion (too much fluid in the knees)—Patients with this condition should be treated first before receiving this medicine.

Proper Use of hylan polymers a and b

This section provides information on the proper use of a number of products that contain hylan polymers a and b. It may not be specific to Synvisc Hylan G-F. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into your knee joint. It may take more than one injection for the pain to go away.

Synvisc® is given as a 3-injection regimen. It is usually given once a week and repeated after a week for a total of three injections.

Synvisc-One® is given as a single injection only.

This medicine usually comes with patient information insert. Read the information carefully and make sure you understand it efore receiving this medicine. If you have any questions, ask your doctor.

Precautions While Using Synvisc Hylan G-F

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Temporary pain or swelling in the knee joint may occur after receiving the injection. Call your doctor if the pain or swelling in the knee persists or becomes worse after receiving this medicine.

Do not strain your knee joint for two days after receiving this medicine. Avoid activities such as jogging, soccer, tennis, heavy lifting, or standing on your feet for a long time.

Do not use this medicine with disinfectants containing quaternary ammonium salts (e.g., benzalkonium chloride). This may prevent hylan polymers A and B injection from working properly.

Synvisc Hylan G-F Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Difficulty with moving


• fluid build up around the knee


• muscle pain or stiffness


• pain and stiffness in the joints

Less common

• Bleeding after defecation


• bluish color


• changes in skin color


• fainting


• fast, pounding, or irregular heartbeat or pulse


• pain or aching in the lower legs


• swelling of the ankles, feet, or legs


• tenderness


• uncomfortable swelling around the anus


• warmth or swelling of the joints

Rare

• Redness in the joints


• trouble with walking

Incidence not known

• Black, tarry stools


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chills


• difficulty with breathing


• feeling of warmth


• general feeling of discomfort or illness


• muscle cramps


• pinpoint red spots on the skin


• rapid weight gain


• redness of the face, neck, arms, and occasionally, upper chest


• shortness of breath


• tingling of the hands or feet


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Itching of the skin


• rash


• sprain in the lower back

Rare

• Pain at the injection site

Incidence not known

• Dizziness


• headache


• nausea


• raised red swellings on the skin, lips, tongue, or in the throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

NaFrinse Daily/Neutral

Generic Name: fluoride topical (FLOR ide TOP i kal)

Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N

What is NaFrinse Daily/Neutral (fluoride topical)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

Fluoride may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about NaFrinse Daily/Neutral (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.

Do not eat, drink, or rinse your mouth for 30 minutes after using a fluoride topical. Do not swallow fluoride topical. Spit it out after use. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I discuss with my healthcare provider before using NaFrinse Daily/Neutral (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.

If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.

Talk to your doctor and dentist before using fluoride topical if you are pregnant. Talk to your doctor and dentist before using fluoride topical if you are breast-feeding. The use of fluoride is particularly important in children to protect against tooth decay. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age. The American Academy of Pediatrics recommends fluoride supplementation in children until the age of 16 years old. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

How should I use NaFrinse Daily/Neutral (fluoride topical)?

Use this medication exactly as directed on the label, or as it was prescribed by your dentist or doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.

Swish this medication in your mouth without swallowing. Then spit it out.

Do not eat, drink, or rinse your mouth for 30 minutes after using fluoride topical. Store fluoride topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I avoid while using NaFrinse Daily/Neutral (fluoride topical)?

Do not swallow fluoride topical. Spit it out after use.

NaFrinse Daily/Neutral (fluoride topical) 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. Call your doctor if you have any of the following side effects:

• 
  

  discolored teeth;

  
  


• 
  

  weakened tooth enamel; or

  
  


• 
  

  any changes in the appearance of your teeth.

  
  

Less serious side effects may include:

• 
  

  stomach upset;

  
  


• 
  

  headache; or

  
  


• 
  

  weakness.

  
  

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 NaFrinse Daily/Neutral (fluoride topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More NaFrinse Daily/Neutral resources

• NaFrinse Daily/Neutral Side Effects (in more detail)
• NaFrinse Daily/Neutral Use in Pregnancy & Breastfeeding
• 0 Reviews for NaFrinse Daily/Neutral - Add your own review/rating

• APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information


• EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer)


• Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer)


• Prevident 5000 Booster Prescribing Information (FDA)


• Prevident 5000 Dry Mouth Prescribing Information (FDA)


• Prevident 5000 Enamel Protect Prescribing Information (FDA)


• Prevident 5000 Sensitive Prescribing Information (FDA)

Compare NaFrinse Daily/Neutral with other medications

• Prevention of Dental Caries

Where can I get more information?

• Your pharmacist can provide more information about fluoride topical.

See also: NaFrinse Daily/Neutral side effects (in more detail)

Axid

Generic Name: Nizatidine
Class: Histamine H2-Antagonists
VA Class: GA301
Chemical Name: N - [2 - [[[2 - [(dimethylamino)methyl] - 4 - thiazolyl]methyl]thio]ethyl] - N′ - methyl - 2 - nitro - 1,1 - ethenediamine
Molecular Formula: C₁₂H₂₁N₅O₂S₂
CAS Number: 76963-41-2

Introduction

Histamine H₂ receptor antagonist.^{1 2 3 4 5}

Uses for Axid

Gastroesophageal Reflux (GERD)

Short-term treatment of symptomatic GERD.^{1 2 39 40 41 42 43 44}

Short-term treatment of esophagitis including erosion or ulcers (endoscopically diagnosed) in patients with GERD.^{1 2 39 40 41 42 43 44}

Self-medication as initial therapy to achieve acid suppression, control symptoms, and prevent complications of less severe symptomatic GERD†.¹⁶⁵

Short-term self-medication for relief of heartburn symptoms in adults and adolescents ≥12 years of age.^b

Short-term self-medication for prevention of heartburn symptoms associated with acid indigestion and sour stomach brought on by ingestion of certain foods and beverages in adults and children ≥12 years of age.^b

Duodenal Ulcer

Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).^{1 2 4 5 27 28 29 30 31 32 33 34}

Maintenance of healing and reduction in recurrence of duodenal ulcer.^{1 2 4 5 16 35 36}

Gastric Ulcer

Short-term treatment of active benign gastric ulcer.^{1 4 5 28 45 46 47}

Axid Dosage and Administration

Administration

Oral Administration

Administer orally^{1 2 3 4 5} without regard to meals.^{2 6 12}

Antacids may be used as necessary for pain relief.^{2 5 27 28 29 30 31 32 33 34}

Tablet for self-medication should be administered with a glass of water.^b

For gastroesophageal reflux, once daily dosage not considered appropriate.¹⁶⁵

For duodenal ulcer treatment, the advantage of administration once daily at bedtime (when convenience is important for compliance) over twice-daily administration has not been determined.²

For gastric ulcer treatment in adults, administer in divided doses twice daily or once daily at bedtime.^{1 45 46 47}

Dosage

Pediatric Patients

Erosive Esophagitis or GERD

Oral

Children ≥12 years of age: 150 mg twice daily as oral solution for up to 8 weeks.^c

Gastroesophageal Reflux

Self-medication for Heartburn in Adolescents ≥12 years of Age

Oral

75 mg once or twice daily (maximum 150 mg in 24 hours continuously for 2 weeks) or as directed by clinician.^b

Self-medication for Prevention of Heartburn In Adolescents ≥12 Years of Age

Oral

75 mg once or twice daily (immediately or up to 1 hour before ingestion of causative food or beverage); maximum 150 mg in 24 hours continuously for 2 weeks or as directed by clinician.^b

Adults

Gastroesophageal Reflux

Treatment of Esophagitis

Oral

150 mg twice daily for up to 12 weeks.^{1 2 40 41 42}

300 mg at bedtime also has been used, but is less effective^{2 9 39 130} and not considered appropriate therapy.¹⁶⁵

Self-medication for Heartburn

Oral

75 mg once or twice daily (maximum 150 mg in 24 hours continuously for 2 weeks) or as directed by clinician.^b

Self-medication for Prevention of Heartburn

Oral

75 mg once or twice daily (immediately or up to 1 hour before ingestion of causative food or beverage); maximum 150 mg in 24 hours continuously for 2 weeks or as directed by clinician.^b

Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

300 mg once daily at bedtime, or 150 mg twice daily.^{1 2}

Healing may occur within 2 weeks in some, and within 4 weeks in most patients;^{1 2 27 28 29 30 31 32 33 34} some patients may benefit from an additional 4 weeks of therapy.^{1 2} Occasionally may be necessary to continue full-dose therapy for >6–8 weeks.^{1 2}

Safety and efficacy of continuing full-dose therapy for > 8 weeks have not been established.^{1 2}

Maintenance of Healing of Duodenal Ulcer

Oral

150 mg once daily at bedtime.^{1 2 35 36}

Some clinicians recommend continuing maintenance therapy for at least 1 year.⁴

Safety and efficacy of continuing maintenance therapy beyond 1 year have not been established.¹

Gastric Ulcer

Oral

150 mg twice daily or 300 mg once daily at bedtime for up to 8 weeks.^{1 45 46 47}

Complete healing of gastric ulcers usually occurs within 8 weeks.^{1 4 5 28 45 46 47}

Safety and efficacy for >8 weeks have not been established.^{1 126}

Prescribing Limits

Pediatric Patients

Erosive Esophagitis or GERD

Oral

Maximum 300 mg daily for 8 weeks.^c

Gastroesophageal Reflux

Self-Medication For Heartburn in Adolescents ≥12 years of Age

Oral

Maximum 150 mg in 24 hours continuously for 2 weeks.^b

Self-medication for Prevention of Heartburn in Adolescents ≥12 years of Age

Oral

Maximum 150 mg in 24 hours continuously for 2 weeks.^b

Adults

Gastroesophageal Reflux

Treatment of Esophagitis

Oral

Safety and efficacy for >12 weeks not established.^{1 2 40 41 42}

Self-medication for Heartburn

Oral

Maximum 150 mg in 24 hours continuously for 2 weeks.^b

Self-medication for Prevention of Heartburn

Oral

Maximum 150 mg in 24 hours continuously for 2 weeks.^b

Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

Safety and efficacy for >8 weeks not established.^{1 2}

Maintenance of Healing of Duodenal Ulcer

Oral

Safety and efficacy for >1 year not established.¹

Gastric Ulcer

Short-term treatment of Active Benign Gastric Ulcer

Oral

Safety and efficacy for >8 weeks not established.^{1 126}

Special Populations

Renal Impairment

Modify doses and/or frequency of administration to the degree of renal impairment; clinical efficacy of recommended dosages have not been systematically evaluated.^{1 2 22}

Table 1. Nizatidine Dosage Based on Creatinine Clearance

Creatinine Clearance (mL/minute)	Dosage for Treatment of Esophagitis, Active Duodenal Ulcer, Active Benign Gastric Ulcer1 2 22	Dosage for Maintenance of Healing of Duodenal Ulcer1 2
20–50	150 mg once daily	150 mg once every other day
<20	150 mg once every other day	150 mg once every 3 days

Geriatric Patients

Careful dosage selection recommended due to possible age-related decreases in renal function.^{1 2} (See Renal Impairment under Cautions.) Monitoring renal function may be useful.^a

Cautions for Axid

Contraindications

• 
  

  Known hypersensitivity to nizatidine, any ingredient in the formulation, or to other histamine H₂ antagonists (i.e., cimetidine, famotidine, ranitidine).¹

  
  

Warnings/Precautions

General Precautions

Gastric Malignancy

Response to nizatidine does not preclude presence of gastric malignancy.¹

Respiratory Effects

Administration of H₂-receptor antagonists has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).¹⁷⁵

Specific Populations

Pregnancy

Category B.^{1 10}

Self-medication in pregnant women: consult a clinician before using.¹

Lactation

Distributed into milk.^{1 21} Discontinue nursing or the drug.¹

Self-medication in nursing women: consult a clinician before using.^b

Pediatric Use

Efficacy not established in children <12 years of age.^{1 126}

Safety and efficacy for self-medication not established in children <12 years of age; do not use unless directed by a clinician.^b

Geriatric Use

No substantial differences in safety and efficacy in those ≥65 years of age relative to younger adults, and dosage adjustment solely on the basis of age generally is not required.^{1 2 5}

Possibility exists of greater sensitivity in some geriatric individuals.^a

Substantially eliminated by the kidneys; because geriatric patients are more likely to have decreased renal function, use caution in dosage selection.^a Monitoring of renal function may be useful.^a In geriatric patients with renal impairment, modify dose and frequency of administration in response to the degree of renal impairment.^{1 2} (See Renal Impairment under Dosage and Administration).

Renal Impairment

Use with caution.¹ Dosage adjustments necessary based on degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration).

Common Adverse Effects

Headache, dizziness.^{1 2 5 31 33 34 40 41 46 50}

Interactions for Axid

Does not inhibit hepatic metabolism of drugs by hepatic CYP isoenzymes.^{1 14}

Specific Drugs and Laboratory Tests

Drug/Food/Lab Test	Interaction	Comment
Alcohol	Potential for changes in blood alcohol concentrations, but conflicting data74 75 76 78 79 80 81 82 83 126 129	Potential for psychomotor impairment controversial,74 75 76 77 78 79 80 but use caution during performance of hazardous tasks requiring mental alertness, physical coordination75 76 79 80 126
Antacids	Slight but clinically unimportant decrease in nizatidine bioavailability1 2 4 5 6 9 12	Used concomitantly as necessary for pain relief2 5 27 28 29 30 31 32 33 34
Multistix test for urobilinogen1	False positive1
Salicylate (high-dose aspirin)	Possible inhibition of salicylate excretion and increased serum salicylate concentrations1 2 5 124

Axid Pharmacokinetics

Absorption

Bioavailability

About 70%.^{1 2 9 12 16}

Onset

Gastric acid inhibition within 30 minutes after IV administration.^{6 19}

Duration

Dose dependent.^{2 6 19}

Nocturnal gastric acid secretion is inhibited for 10–12 hours after a single 300-mg dose.^{1 2 4 7 8}

Inhibition of food-stimulated secretion generally persists for up to 4 hours following a 150- or 300-mg dose.^{1 2 20}

Food

May slightly enhance bioavailability.^{1 2 4 5 6 9 12}

Distribution

Extent

Not fully characterized.⁴

Nizatidine crosses the placenta^{5 26} and is distributed into milk.^{1 21}

Plasma Protein Binding

35%, mainly to α₁-acid glycoprotein.^{1 2 3 5 6 15}

Elimination

Metabolism

Metabolized in the liver to active N-desmethylnizatidine (60% as active as nizatidine in blocking acid secretion), and inactive nizatidine N-oxide and nizatidine sulfoxide.^{1 2 5 15 22}

Minimal first pass metabolism.^{1 2}

Elimination Route

Excreted principally in urine^{1 2 3 15} (90%);^{1 5 6 15} about 60–65% is excreted unchanged,^{1 2 5 6 22} 8% is excreted as N-desmethylnizatidine, 6% as nizatidine sulfoxide, 6% as nizatidine N-oxide, and about 15% as unidentified metabolites.^{1 2 5 6 15} <6% of a dose is eliminated in feces.^{1 2 5 6 15}

Half-life

1–2 hours.^{1 2 3 4 5 6 9 12 16 22 23}

Special Populations

In patients with renal impairment, half-life averages 2.1 hours when Cl_cr is 50–75 mL/minute, 4.1 hours when Cl_cr is 10–49 mL/minute, and ranges from 3.5–11 hours in anuric patients.^{1 2 3 5 6 22 23}

Does not appear to be removed appreciably by hemodialysis.^{1 22 23}

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 20–25°C (may be exposed to 15–30°C).^a

Tablets for Self-medication

Tight, light-resistant containers at 20–25°C.^b

ActionsActions

• 
  

  Inhibits daytime, nocturnal basal and stimulated gastric acid secretion.^{1 2 3 5 7 8 19 55 56 57 58}

  
  


• 
  

  Competitively inhibits histamine at parietal cell H₂ receptors.^{1 2 3 5 7 8 19 55 56 57 58}

  
  

Advice to Patients

• 
  

  Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.

  
  


• 
  

  Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.^{1 b}

  
  


• 
  

  Importance of following dosage instructions when nizatidine is administered for self-medication, unless otherwise directed by a clinician.^b

  
  


• 
  

  Importance of promptly informing clinician of persistent abdominal pain or difficulty swallowing.^b

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions).

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Nizatidine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	150 mg	Axid Pulvules	Reliant, (also promoted by Lilly)
		300 mg	Axid Pulvules (with povidone)	Reliant, (also promoted by Lilly)
	Solution	15 mg/mL	Axid	Reliant
	Tablets	75 mg	Axid AR Acid Reducer	Wyeth

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Axid 15MG/ML Solution (BRAINTREE LAB): 480/$409.84 or 1440/$1120.25

Axid 150MG Capsules (GLAXO SMITH KLINE): 60/$172.98 or 180/$499.87

Axid 300MG Capsules (GLAXO SMITH KLINE): 30/$169.98 or 90/$489.97

Axid AR 75MG Tablets (PFIZER CONSUMER HEALTHCARE): 30/$25.99 or 90/$49.97

Nizatidine 15MG/ML Solution (AMNEAL PHARMACEUTICALS): 473/$272 or 1419/$795.98

Nizatidine 150MG Capsules (DR.REDDY'S LABORATORIES INC.): 60/$51.98 or 180/$139.96

Nizatidine 300MG Capsules (DR.REDDY'S LABORATORIES INC.): 30/$53.99 or 90/$138.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Eli Lilly and Company. Axid Pulvules (nizatidine) capsules prescribing information. Indianapolis, IN; 1994 Sep.

2. Eli Lilly and Company. Axid (nizatidine) product information. Indianapolis, IN; 1992. Publication No. 60-NZ-0390-1.

3. Feldman M, Burton ME. Histamine₂-receptor antagonists: standard therapy for acid-peptic diseases. N Engl J Med. 1990; 323:1672-80. [IDIS 274692] [PubMed 1978250]

4. Anon. Nizatidine (Axid). Med Lett Drugs Ther. 1988; 30:77-8. [PubMed 2899835]

5. Price AH, Brogden RN. Nizatidine: a preliminary review of its pharmacodynamic and pharmacokinetic properties, and its therapeutic use in peptic ulcer disease. Drugs. 1988; 36:521-39. [IDIS 249260] [PubMed 2905640]

6. Callaghan JT, Bergstrom RF, Rubin A et al. A pharmacokinetic profile of nizatidine in man. Scand J Gastroenterol. 1987; 22(Suppl 136):9-17.

7. Kovacs TOG, Van Deventer GM, Maxwell V et al. The effect of an oral evening dose of nizatidine on nocturnal and peptone-stimulated gastric acid and gastrin secretion. Scand J Gastroenterol. 1987; 22(Suppl 136):41-6.

8. Dammann HG, Gottlieb WR, Walter TA et al. The 24-hour acid suppression profile of nizatidine. Scand J Gastroenterol. 1987; 22(Suppl 136):56-60.

9. Lin JH. Pharmacokinetic and pharmacodynamic properties of histamine H₂-receptor antagonists. Clin Pharmacokinet. 1991; 20: 218-36. [PubMed 1673880]

10. Morton DM. Pharmacology and toxicology of nizatidine. Scand J Gastroenterol. 1987; 22(Suppl 136):1-8. [IDIS 227436] [PubMed 3551046]

11. Klotz U. Lack of effect of nizatidine on drug metabolism. Scand J Gastroenterol. 1987; 22(Suppl 136):18-23.

12. Knadler MP, Bergstrom RF, Callaghan JT et al. Absorption studies of the H₂-blocker nizatidine. Clin Pharmacol Ther. 1987; 42: 514-20. [IDIS 238317] [PubMed 2890459]

13. Bachmann K, Sullivan TJ, Mauro LS et al. Comparative investigation of the influence of nizatidine, ranitidine, and cimetidine on the steady-state pharmacokinetics of theophylline in COPD patients. J Clin Pharmacol. 1992; 32:476-82. [IDIS 296386] [PubMed 1587967]

14. Hussey EK, Dukes GE. Do all histamine₂-antagonists cause a warfarin drug interaction? Drug Intell Clin Pharm. 1989; 23:675-9.

15. Knadler MP, Bergstrom RF, Callaghan JT et al. Nizatidine, an H₂-blocker: its metabolism and disposition in man. Drug Metabol Dispos. 1986; 14:175-82.

16. Shamburek RD, Schubert ML. Pharmacology of gastric acid inhibition. Bailliére’s Clin Gastroenterol. 1993; 7:23-54.

17. Schneck DW, Callaghan JT, Bergstrom RF et al. Relationship between steady-state plasma nizatidine concentrations and inhibition of basal and stimulated gastric acid secretion. Clin Pharmacol Ther. 1990; 47:499-503. [IDIS 267308] [PubMed 2109665]

18. Cournot A, Berlin I, Sallord JC et al. Lack of interaction between nizatidine and warfarin during chronic administration. J Clin Pharmacol. 1988; 28:1120-2. [IDIS 251308] [PubMed 2907521]

19. Callaghan JT, Bergstrom RF, Obermeyer BD et al. Intravenous nizatidine kinetics and acid suppression. Clin Pharmacol Ther. 1985; 37:162-5. [IDIS 196938] [PubMed 2857117]

20. Vargas R, Ryan J, McMahon G et al. Pharmacokinetics and pharmacodynamics of oral nizatidine. J Clin Pharmacol. 1988; 28:71-5. [IDIS 238443] [PubMed 2895125]

21. Obermeyer BD, Bergstrom RF, Callaghan JT et al. Secretion of nizatidine into human breast milk after single and multiple doses. Clin Pharmacol Ther. 1990; 47:724-30. [IDIS 268712] [PubMed 1972674]

22. Aronoff GR, Bergstrom RF, Bopp RJ et al. Nizatidine disposition in subjects with normal and impaired renal function. Clin Pharmacol Ther. 1988; 43:688-95. [IDIS 243530] [PubMed 2897890]

23. Gladziwa U, Klotz U. Pharmacokinetics and pharmacodynamics of H₂-receptor antagonists in patients with renal insufficiency. Clin Pharmacokinet. 1993; 24:319-32. [PubMed 8098275]

24. Villani P, Regazzi MB, Pecorini M et al. The effect of aging on the pharmacokinetics of nizatidine. Eur J Drug Metab Pharmacokinet. 1991; 3:205-10.

25. Callaghan JT, Rubin A, Knadler MP et al. Nizatidine, an H₂-receptor antagonist: disposition and safety in the elderly. J Clin Pharmacol. 1987; 27:618-24. [IDIS 233536] [PubMed 2888796]

26. Schenker S, Johnson R, Mor L et al. Human placental transport of cimetidine (C), ranitidine (R) and nizatidine (N). Clin Res. 1986; 34:445A.

27. Simon B, Cremer M, Dammann HG et al. 300 Mg nizatidine at night versus 300 mg ranitidine at night in patients with duodenal ulcer. Scand J Gastroenterol. 1987; 22(Suppl 136):61-70.

28. Kuipers EJ, Hazenberg HJA, Quik RFP et al. Nizatidine versus ranitidine in the treatment of peptic ulcer disease: report on the Dutch investigation as part of a European multicentre trial. Neth J Med. 1990; 37:58-62. [PubMed 1977089]

29. Cloud ML, Offen WW, Matsumoto C et al. Healing and recurrence of active duodenal ulcer with nizatidine. Clin Pharmacol Ther. 1989; 46:310-6. [IDIS 259076] [PubMed 2570656]

30. Cherner JA, Cloud ML, Offen WW et al. Comparison of nizatidine and cimetidine as once-nightly treatment of acute duodenal ulcer. Am J Gastroenterol. 1989; 84:769-74. [IDIS 256736] [PubMed 2568086]

31. Pace F, Colombo E, Ferrara A et al. Nizatidine and ranitidine in the short-term treatment of duodenal ulcer: a cooperative double-blind study of once-daily bedtime administration. Am J Gastroenterol. 1988; 83: 643-5. [IDIS 242444] [PubMed 2897784]

32. Levendoglu H, Mehta B, Wait C et al. Nizatidine: a new histamine receptor blocker in the treatment of active duodenal ulcers. Am J Gastroenterol. 1986; 81:1167-70. [IDIS 223762] [PubMed 2878607]

33. Cloud ML, Offen WW, Matsumoto C et al. Healing and subsequent recurrence of duodenal ulcer in a clinical trial comparing nizatidine 300-mg and 100-mg evening doses and placebo in the treatment of active duodenal ulcer. Curr Ther Res. 1989; 45:359-67.

34. Bovero E, Poletti M, Boero A et al. Nizatidine in the short-term treatment off duodenal ulcer—an Italian multicenter study. Hepatogastroenterology. 1987; 34:269-72. [PubMed 2892768]

35. Cerulli MA, Cloud ML, Offen WW et al. Nizatidine as maintenance therapy of duodenal ulcer disease in remission. Scand J Gastroenterol. 1987; 22(Suppl 136):79-83.

36. Hentschel E, Schütze K, Reichel W et al. Nizatidine versus ranitidine in the prevention of duodenal ulcer relapse: six-month interim results of a European multicentre study. Scand J Gastroenterol. 1987; 22(Suppl 136):84-8.

37. Desager JP, Harvengt C. Oral bioavailability of nizatidine and ranitidine concurrently administered with antacid. J Int Med Res. 1989; 17:62-7. [PubMed 2565267]

38. Probst KS, Higdon GL, Fisher LF et al. Preclinical toxicology studies with nizatidine, a new H₂-receptor antagonist: acute, subchronic, and chronic toxicity evaluations. Fundament Appl Toxicol. 1989; 13: 778-92.

39. Sontag SJ. The medical management of reflux esophagitis: role of antacids and acid inhibition. Gastroenterol Clin N Amer. 1990; 19: 683-712.

40. Cloud ML, Offen WW, Nizatidine Gastroesophageal Reflux Disease Study Group. Nizatidine versus placebo in gastroesophageal reflux disease: a six-week, multicenter, randomized, double-blind comparison. Dig Dis Sci. 1992; 37:865-74. [IDIS 297691] [PubMed 1587191]

41. Cloud ML, Offen WW, Robinson M. Nizatidine versus placebo in gastroesophageal reflux disease: a 12-week, multicenter, randomized, double-blind study. Am J Gastroenterol. 1991; 86:1735-42. [IDIS 292298] [PubMed 1962618]

42. Quik RFP, Cooper MJ, Gleeson M et al. A comparison of two doses of nizatidine versus placebo in the treatment of reflux oesophagitis. Aliment Pharmacol Ther. 1990; 4:201-11. [PubMed 1983322]

43. Hixson LJ, Kelley CL, Jones WN et al. Current trends in the pharmacotherapy for gastroesophageal reflux disease. Arch Intern Med. 1992; 152:717-23. [IDIS 295735] [PubMed 1558428]

44. Garnett WR. Efficacy, safety, and cost issues in managing patients with gastroesophageal reflux disease. Am J Hosp Pharm. 1993; 50:S11-8. [PubMed 8097363]

45. Naccaratto R, Cremer M, Dammann HG et al. Nizatidine versus ranitidine in gastric ulcer disease. Scand J Gastroenterol. 1987; 22(Suppl 136):71-8.

46. Cloud ML, Enas N, Offen WW et al. Nizatidine versus placebo in active benign gastric ulcer disease: an eight-week, multicenter, randomized, double-blind comparison. Clin Pharmacol Ther. 1992; 52:307-13. [IDIS 302463] [PubMed 1526089]

47. Di Mario F, Battaglia G, Naccarato R et al. Comparison of 150 mg nizatidine BID or 300 mg at bedtime, and 150 mg ranitidine BID in the treatment of gastric ulcer—an 8-week randomized, double-blind multicentre study. Hepatogastroenterology. 1990; 37(Suppl II):62-5. [PubMed 1982108]

48. Secor JW, Speeg KV Jr, Meredith CG et al. Lack of effect of nizatidine on hepatic drug metabolism in man. Br J Clin Pharmacol. 1985; 20: 710-3. [IDIS 210882] [PubMed 2868746]

49. Van Thiel DH, Gavaler JS, Heyl A et al. An evaluation of the anti-androgen effects associated with H₂ antagonist therapy. Scand J Gastroenterol. 1987; 22(Suppl 136):24-8. [IDIS 227439] [PubMed 3563408]

50. Cloud ML. Safety of nizatidine in clinical trials conducted in the USA and Europe. Scand J Gastroenterol. 1987; 22(Suppl 136):29-36. [PubMed 3563409]

51. Aymard JP, Aymard B, Netter P et al. Haematological adverse effects of histamine H₂-receptor antagonists. Med Toxicol Adverse Drug Exp. 1988; 3: 430-48. [IDIS 250046] [PubMed 2905759]

52. Cantü TG, Korek JS. Central nervous system reactions to histamine-2 receptor blockers. Ann Int Med. 1991; 114:1027-34. [IDIS 281752] [PubMed 1674198]

53. Kassianos GC. Impotence and nizatidine. Lancet. 1989; 1:963. [IDIS 254889] [PubMed 2565456]

54. Lin TM, Evans DC, Warrick MW et al. Actions of nizatidine, a selective histamine H₂-receptor antagonist, on gastric acid secretion in dogs, rats and frogs. J Pharmacol Exp Ther. 1986; 239:406-10. [PubMed 2877081]

55. Lin TM, Evans DC, Warrick MW et al. Actions of nizatidine on the rat uterus, dog stomach and experimentally induced gastric lesions. J Pharmacol Exp Ther. 1986; 239:400-5. [PubMed 3095539]

56. Dammann HG, Gottlieb WR, Walter TA et al. Nocturnal acid suppression with a new H₂ receptor antagonist—nizatidine. Hepatogastroenterology. 1986; 33:217-20. [PubMed 2879782]

57. Danziger L, Furmaga KM, Rodvold KA et al. Nizatidine suppression of basal gastric acid output: a comparison of two intravenous dosage regimens. J Clin Pharmacol. 1989; 29:946-52. [IDIS 260899] [PubMed 2574190]

58. Savarino V, Mela GS, Zentilin P et al. Twenty-four-hour control of gastric acidity by twice-daily doses of placebo, nizatidine 150 mg, nizatidine 300 mg, and ranitidine 300 mg. J Clin Pharmacol. 1993; 33:70-4. [IDIS 308545] [PubMed 8429117]

59. Bemis K, Bendele A, Clemens J et al. General pharmacology of nizatidine in animals. Arzneimittelforschung. 1989; 39:240-50. [PubMed 2567169]

60. Halabi A, Kirch W. Negative chronotropic effects of nizatidine. Gut. 1991; 32:630-4. [IDIS 284150] [PubMed 1676392]

61. Hinrichsen H, Halabi A, Kirch W. Hemodynamic effects of different H₂-receptor antagonists. Clin Pharamcol Ther. 1990; 48: 302-8.

62. Kirch W, Halari H, Ohnhaus EE. Negative inotropic effects of famotidine. Lancet. 1987; 2:684-5. [IDIS 233763] [PubMed 2887963]

63. Tanner LA, Arrowsmith JB. Bradycardia and H₂ antagonists. Ann Intern Med. 1988; 109:434-5. [IDIS 245858] [PubMed 3408059]

64. Hinrichsen H, Halabi A, Fuhrmann G et al. Dose-dependent heart rate reducing effect of nizatidine, a histamine H₂-receptor antagonist. Br J Clin Pharmacol. 1993; 35:461-6. [IDIS 314431] [PubMed 8099802]

65. Laine-Cessac P, Turcant A, Premel-Cabic A et al. Inhibition of cholinesterases by histamine 2 receptor antagonist drugs. Res Comm Chem Pathol Pharmacol. 1993; 79:185-93.

66. Bonfils S. Nizatidine versus ranitidine: evolution of drug antisecretory efficacy over a 28-day period. Curr Ther Res. 1992; 52:859-62.

67. Fullarton GM, McLauchlan G, MacDonald A et al. Rebound nocturnal hypersecretion after four weeks treatment with an H₂ receptor antagonist. Gut. 1989; 30:449-54. [IDIS 253725] [PubMed 2565860]

68. Fullarton GM, MacDonald AMI, McColl KEL. Rebound hypersecretion after H₂-antagonist withdrawal—a comparative study with nizatidine, ranitidine and famotidine. Aliment Pharmacol Ther. 1991; 5:391-8. [PubMed 1685675]

69. Nwokolo CU, Smith JTL, Sawyerr AM et al. Rebound intragastric hyperacidity after abrupt withdrawal of histamine H₂ receptor blockade. Gut. 1991; 32:1455-60. [IDIS 293076] [PubMed 1685465]

70. Lazzaroni M, Sangaletti O, Porro GB. The effect of a single oral morning dose of nizatidine and ranitidine on intragastric pH under basal conditions and after pentagastrin stimulation. J Int Med Res. 1992; 20:454-60. [PubMed 1286739]

71. Savarino V, Mela GS, Zentilin P et al. Lack of gastric acid rebound after stopping a successful short-term course of nizatidine in duodenal ulcer patients. Am J Gastroenterol. 1991; 86:281-4. [IDIS 278990] [PubMed 1671805]

72. Cryer B, Feldman M. Effects of nonsteroidal anti-inflammatory drugs on endogenous gastrointestinal prostaglandins and therapeutic strategies for prevention and treatment of nonsteroidal anti-inflammatory drug-induced damage. Arch Intern Med. 1992; 152:1145-55. [IDIS 298397] [PubMed 1599341]

73. Klotz U, Gottlieb W, Keohane PP et al. Nocturnal doses of ranitidine and nizatidine do not affect the disposition of diazepam. J Clin Pharmacol. 1987; 27:210-2. [IDIS 227677] [PubMed 2890666]

74. Raufman JP, Notar-Francesco V, Raffaniello RD et al. Histamine-2 receptor antagonists do not alter serum ethanol levels in fed, nonalcoholic men. Ann Intern Med. 1993; 118:488-94. [IDIS 311490] [PubMed 8095127]

75. Lewis JH, McIsaac RL. H₂ antagonists and blood alcohol levels. Dig Dis Sci. 1993; 38:569-71. [IDIS 311762] [PubMed 8095199]

76. Roine R, Hernández-Mu˜noz R, Baraona E et al. H₂ antagonists and blood alcohol levels. Dig Dis Sci. 1993; 38:572-3.

77. Levine LR, Cloud ML, Enas NH. Nizatidine prevents peptic ulceration in high-risk patients taking nonsteroidal anti-inflammatory drugs. Arch Intern Med. 1993; 153:2449-54. [IDIS 321821] [PubMed 8215749]

78. Anon. H₂ blocker interaction with alcohol is not clinically significant, FDA advisory committee concludes March 12; issue may be revisited, agency indicates. FDC Rep Drugs Cosmet. 1993 Mar 22:10.

79. Levitt MD. Do histamine-2 receptor antagonists influence the metabolism of ethanol? Ann Intern Med. 1993; 118:564-5. Editorial.

80. Marshall JM. Interaction of histamine₂-receptor antagonists and ethanol. Ann Pharmacother. 1994; 28:55-6. [IDIS 324482] [PubMed 7907240]

81. Fraser AG, Prewett EJ, Hudson M et al. The effect of ranitidine, cimetidine or famotidine on low-dose post-prandial alcohol absorption. Aliment Pharmacol Ther. 1991; 5:263-72. [PubMed 1888825]

82. Fraser AG, Hudson M, Sawyer AM et al. Short report: the effect of ranitidine on the post-prandial absorption of a low dose of alcohol. Aliment Pharmacol Ther. 1992; 6:267-71. [PubMed 1600045]

83. Palmer RH, Frank WO, Nambi P et al. Effects of various concomitant medications on gastric alcohol dehydrogenase and the first-pass metabolism of ethanol. Am J Gastroenterol. 1991; 86:1749-55. [PubMed 1683743]

84. Ateshkadi A, Lam NP, Johnson CA. Helicobacter pylori and peptic ulcer disease. Clin Pharm. 1993; 12:34-48. [IDIS 307044] [PubMed 8428432]

85. Blaser MJ. Helicobacter pylori: its role in disease. Clin Infect Dis. 1992; 15:386-91. [IDIS 301064] [PubMed 1520782]

86. Murray DM, DuPont HL, Cooperstock M et al. Evaluation of new anti-infective drugs for the treatment of gastritis and peptic ulcer disease associated with infection by Helicobacter pylori. Clin Infect Dis. 1992; 15(Suppl 1):S268-73.

87. Peterson WL. Helicobacter pylori and peptic ulcer disease. N Engl J Med. 1991; 324:1043-8. [IDIS 279263] [PubMed 2005942]

88. Graham DY, Go MF. Evaluation of new antiinfective drugs for Helicobacter pylori infection: revisited and updated. Clin Infect Dis. 1993; 17:293-4. [PubMed 8399892]

89. Labenz J, Borsch G. Evidence for the essential role of Helicobacter pylori in gastric ulcer disease. Gut. 1994; 35:19-22. [IDIS 324883] [PubMed 8307443]

90. Levine TS, Price AB. Helicobacter pylori: enough to give anyon