Brioschi

Generic Name: sodium bicarbonate (Oral route, Intravenous route, Subcutaneous route)

SOE-dee-um bye-KAR-bo-nate

Commonly used brand name(s):

In the U.S.

• Brioschi
• Neut

In Canada

• Sellymin
• Sodium Bicarbonate

Available Dosage Forms:

• Tablet
• Solution
• Powder
• Granule
• Capsule

Therapeutic Class: Antacid, Sodium Bicarbonate Containing

Uses For Brioschi

Sodium bicarbonate , also known as baking soda, is used to relieve heartburn, sour stomach, or acid indigestion by neutralizing excess stomach acid. When used for this purpose, it is said to belong to the group of medicines called antacids. It may be used to treat the symptoms of stomach or duodenal ulcers. Sodium bicarbonate is also used to make the blood and urine more alkaline in certain conditions.

Antacids should not be given to young children (up to 6 years of age) unless prescribed by their doctor. Since children cannot usually describe their symptoms very well, a doctor should check the child before giving this medicine. The child may have a condition that needs other treatment. If so, antacids will not help and may even cause unwanted effects or make the condition worse.

Sodium bicarbonate for oral use is available without a prescription.

Before Using Brioschi

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

Antacids should not be given to young children (up to 6 years of age) unless prescribed by a physician. This medicine may not help and may even worsen some conditions, so make sure that your child's problem should be treated with this medicine before you use it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of sodium bicarbonate in the elderly with use in other age groups.

Pregnancy

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

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.

• Dasatinib
• Itraconazole

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:

• Appendicitis or
• Intestinal or rectal bleeding—Oral forms of sodium bicarbonate may make these conditions worse

• Edema (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure (hypertension) or
• Kidney disease or
• Liver disease or
• Problems with urination or
• Toxemia of pregnancy—Sodium bicarbonate may cause the body to retain (keep) water, which may make these conditions worse

Proper Use of sodium bicarbonate

This section provides information on the proper use of a number of products that contain sodium bicarbonate. It may not be specific to Brioschi. Please read with care.

For safe and effective use of sodium bicarbonate:

• Follow your doctor's instructions if this medicine was prescribed.
• Follow the manufacturer's package directions if you are treating yourself.

For patients taking this medicine for a stomach ulcer :

• Take it exactly as directed and for the full time of treatment as ordered by your doctor, to obtain maximum relief of your symptoms.
• Take it 1 and 3 hours after meals and at bedtime for best results, unless otherwise directed by your doctor.

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 sodium bicarbonate effervescent powder:
  • To relieve heartburn or sour stomach:
    • Adults and teenagers—3.9 to 10 grams (1 to 2½ teaspoonfuls) in a glass of cold water after meals. However, the dose is usually not more than 19.5 grams (5 teaspoonfuls) a day.
    • Children up to 6 years of age—Dose must be determined by your doctor.
    • Children 6 to 12 years of age—1 to 1.9 grams (¼ to ½ teaspoonful) in a glass of cold water after meals.
• For sodium bicarbonate powder:
  • To relieve heartburn or sour stomach:
    • Adults and teenagers—One-half teaspoonful in a glass of water every two hours. Your doctor may change the dose if needed.
    • Children—Dose must be determined by your doctor.
  • To make the urine more alkaline (less acidic):
    • Adults and teenagers—One teaspoonful in a glass of water every four hours. Your doctor may change the dose if needed. However, the dose is usually not more than 4 teaspoonfuls a day.
    • Children—Dose must be determined by your doctor.
• For sodium bicarbonate tablets:
  • To relieve heartburn or sour stomach:
    • Adults and teenagers—325 milligrams (mg) to 2 grams one to four times a day.
    • Children up to 6 years of age—Dose must be determined by your doctor.
    • Children 6 to 12 years of age—The dose is 520 mg. The dose may be repeated in thirty minutes.
  • To make the urine more alkaline (less acidic):
    • Adults and teenagers—At first, four grams, then 1 to 2 grams every four hours. However, the dose is usually not more than 16 grams a day.
    • Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 23 to 230 mg per kilogram (kg) (10.5 to 105 mg per pound) of body weight a day. Your doctor may change the dose if needed.

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.

Precautions While Using Brioschi

If this medicine has been ordered by your doctor and if you will be taking it regularly for a long time, your doctor should check your progress at regular visits. This is to make sure the medicine does not cause unwanted effects.

Do not take sodium bicarbonate:

• Within 1 to 2 hours of taking other medicine by mouth. To do so may keep the other medicine from working properly.
• For a long period of time. To do so may increase the chance of side effects.

For patients on a sodium-restricted diet:

• This medicine contains a large amount of sodium. If you have any questions about this, check with your health care professional.

For patients taking this medicine as an antacid:

• Do not take this medicine if you have any signs of appendicitis (such as stomach or lower abdominal pain, cramping, bloating, soreness, nausea, or vomiting). Instead, check with your doctor as soon as possible.
• Do not take this medicine with large amounts of milk or milk products. To do so may increase the chance of side effects.
• Do not take sodium bicarbonate for more than 2 weeks or if the problem comes back often. Instead, check with your doctor. Antacids should be used only for occasional relief, unless otherwise directed by your doctor.

Brioschi Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although the following side effects occur very rarely when this medicine is taken as recommended, they may be more likely to occur if it is taken: in large doses, for a long time, or by patients with kidney disease.

Check with your doctor as soon as possible if any of the following side effects occur:

• Frequent urge to urinate
• headache (continuing)
• loss of appetite (continuing)
• mood or mental changes
• muscle pain or twitching
• nausea or vomiting
• nervousness or restlessness
• slow breathing
• swelling of feet or lower legs
• unpleasant taste
• unusual tiredness or weakness

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:

• Increased thirst
• stomach cramps

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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