Brioschi

• Brioschi Pharmaceuticals International, LLC

Brioschi is part of the drug classes:

• Electrolyte solutions

• Salt solutions

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. 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.

• Amphetamine
• Benzphetamine
• Dextroamphetamine
• Digoxin
• Elvitegravir
• Gefitinib
• Ketoconazole
• Ledipasvir
• Lisdexamfetamine
• Mefenamic Acid
• Memantine
• Methamphetamine
• Pazopanib

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

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

Parenteral:
If acid-base status is available, dosages should be calculated as follows: 0.2 x weight (kg) x base deficit.

Alternatively:

HCO3 (mEq) required = 0.5 x weight (kg) x [24 - serum HCO3 (mEq/L)].

or

Moderate metabolic acidosis: 50 to 150 mEq sodium bicarbonate diluted in 1 L of D5W to be intravenously infused at a rate of 1 to 1.5 L/hour during the first hour.

Severe metabolic acidosis: 90 to 180 mEq sodium bicarbonate diluted in 1 L of D5W to be intravenously infused at a rate of 1 to 1.5 L/hour during the first hour.

If acid-base status is not available, dosages should be calculated as follows: 2 to 5 mEq/kg IV infusion over 4 to 8 hours; subsequent doses should be based on patient's acid-base status.

Oral:

Moderate metabolic acidosis: 325 to 2000 mg orally 1 to 4 times a day. One gram provides 11.9 mEq (mmoL) each of sodium and bicarbonate.

Although sodium bicarbonate is approved for the treatment of metabolic acidosis, data have shown that the use of this drug may be harmful in certain clinical settings such as lactic acidosis, acidosis with tissue hypoxia, uremia, severe cardiac dysfunction or arrest, and diabetic ketoacidosis.

Most experts only allow for its use when tissue perfusion and ventilation are maximized and the arterial pH is 7.1 or lower.

If sodium bicarbonate is used to treat diabetic ketoacidosis, the initial dosage is 50 mEq sodium bicarbonate in 1 L of appropriate IV solution to be given once.

Insulin therapy may obviate the need for bicarbonate therapy since it will promote glucose utilization and decrease the production of ketoacids.

0 to 12 years:

Parenteral:
120 to 200 mEq/m2/day diluted in maintenance IV fluids of 3000 mL/m2/day; titrate to maintain urine pH between 6 and 7.

Oral:
12 g/m2/day divided into 4 doses; titrate to maintain urine pH between 6 and 7.

1 mEq/kg slow IV initially, may repeat with 0.5 mEq/kg 10 minutes later one time, or as indicated by the patient acid-base status.

Due to the risk of hypernatremia, electrolyte shifts, and systemic pH changes, it is recommended that sodium bicarbonate be used with caution due to the patient's liver disease. Close monitoring of this patient's plasma electrolytes and bicarbonate is recommended, particularly if dose increments are considered.

Due to the undesirable side effects of sodium loading--edema and weight gain--the use of alternative antacids has been advocated by some experts. In one unblinded, controlled study of the maternal and fetal effects of 150 mEq of sodium bicarbonate, use of the drug was associated with significantly elevated maternal arterial pH, pC02, and base excess and significantly elevated umbilical arterial pH, p02, and base excess at delivery. There were apparent adverse effects of the infusion on the mothers, and no mention of adverse effects on the fetuses or newborns.

Sodium bicarbonate has been assigned to pregnancy category C by the FDA. There are no animal or human reproductive data. Some experts consider the use of sodium bicarbonate as an antacid during human pregnancy to be relatively contraindicated because of the availability of preferable therapeutic agents. Sodium bicarbonate should only be given during pregnancy when benefit outweighs risk.

There are no data on the excretion of sodium bicarbonate into human milk.