Description
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.
This product is available in the following dosage forms:
- Tablet
- Capsule
Before Using
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 nizatidine capsules in children and oral liquid in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
- Fosphenytoin
- Gefitinib
- Infigratinib
- Ketoconazole
- Ledipasvir
- Levoketoconazole
- Methylphenidate
- Neratinib
- Nilotinib
- Nirogacestat
- Octreotide
- Pazopanib
- Phenytoin
- 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
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 erosive and ulcerative esophagitis, and heartburn caused by gastroesophageal reflux disease (GERD):
- 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.
- For erosive and ulcerative esophagitis, and heartburn caused by gastroesophageal reflux disease (GERD):
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
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
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.
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