Pronunciation:

nye-ZA-ti-deen

Brand Names:

• Axid
• Axid AR
• Axid Pulvules

Dosage Forms:

• Tablet
• Capsule

Classifications:

Therapeutic—

Gastric Acid Secretion Inhibitor

Pharmacologic—

Histamine H2 Antagonist

Uses of This Medicine:

Nizatidine is used to treat stomach ulcers (active benign gastric ulcer or duodenal ulcer), erosive and ulcerative esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus.

Nizatidine belongs to the group of medicines known as histamine H2-receptor antagonists or H2-blockers. It works by decreasing the amount of acid produced by the stomach.

This medicine is available with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of nizatidine capsules in children and oral liquid in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nizatidine in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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.

Other 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acalabrutinib
• Atazanavir
• Cefuroxime Axetil
• Dasatinib
• Delavirdine
• Erlotinib
• Gefitinib
• Infigratinib
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Methylphenidate
• Neratinib
• Nilotinib
• Nirogacestat
• Octreotide
• Pazopanib
• Rilpivirine
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• Vismodegib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cefpodoxime Proxetil
• Itraconazole

Other interactions—

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Kidney disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease—Use with caution. May make this condition worse.

• Stomach cancer—Use with caution in patients with stomach ulcers caused by this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Each milliliter (mL) of the oral liquid contains 15 milligrams (mg) of nizatidine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules):
  • For erosive and ulcerative esophagitis, and heartburn caused by gastroesophageal reflux disease (GERD):
    • Adults—150 milligrams (mg) 2 times a day.
    • Children—Use and dose must be determined by your doctor.
  • For stomach ulcers (active benign gastric ulcer or duodenal ulcer):
    • Adults—300 milligrams (mg) once a day at bedtime or 150 mg 2 times a day.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance of healed duodenal ulcer:
    • Adults—150 milligrams (mg) once a day at bedtime.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage forms (solution):
  • For erosive and ulcerative esophagitis, and heartburn caused by gastroesophageal reflux disease (GERD):
    • Adults and children 12 years of age and older—150 milligrams (mg) or 2 teaspoons 2 times a day for up to 8 weeks. Dose is usually not more than 300 mg per day for children.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For stomach ulcers (active benign gastric ulcer or duodenal ulcer):
    • Adults—300 milligrams (mg) or 4 teaspoons once a day at bedtime or 150 mg or 2 teaspoons 2 times a day for up to 8 weeks.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance of healed duodenal ulcer:
    • Adults—150 milligrams (mg) once a day at bedtime.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If your condition does not improve, or if it become worse, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

More common

Headache

Less common

Chest pain

cough or hoarseness

fever or chills

lack or loss of strength

lower back or side pain

painful or difficult urination

Rare

Black, tarry stools

bloody nose

blood in the urine

chest tightness

clay-colored stools

diarrhea

difficulty swallowing

dizziness

heavier menstrual periods

hives, itching, skin rash

loss of appetite

mental confusion

nausea

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

trouble breathing

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Incidence not known

Bleeding gums

dark urine

fainting

fast, pounding, or irregular heartbeat or pulse

general feeling of discomfort or illness

muscle aches and pains

pale skin

runny nose

sweating

swelling of the feet or lower legs

trouble sleeping

upper right abdominal or stomach pain

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:

More common

Diarrhea

irritability

sneezing

stuffy nose

vomiting

Less common

Anxiety

blurred vision

body aches or pain

change in vision

constipation

difficulty in moving

dizziness

dry mouth

impaired vision

joint pain

muscle cramps or stiffness

nervousness

swollen joints

tender, swollen glands in the neck

tooth disorder

trouble in swallowing

trouble sleeping

voice changes

weight loss

Rare

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

swelling of the breasts or breast soreness in both females and males

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.