NODOSIS is Sodium bicarbonate tablets which is used as an alkalinizing agent in the treatment of metabolic acidosis. Sodium bicarbonate also may be used as an alkalinizing agent in advanced cardiovascular life support (ACLS) during cardiopulmonary resuscitation (CPR) and in the treatment of certain intoxications (e.g., methyl alcohol, phenobarbital, salicylates) to decrease renal reabsorption of the drug or to correct acidosis.

Sodium bicarbonate also is used to increase urinary pH in order to increase the solubility of certain weak acids (e.g., cystine, sulfonamides, uric acid) or in the treatment of hemolytic reactions requiring alkalinization of the urine to diminish the nephrotoxic effects of blood pigments. In addition, the drug is used in the treatment of severe diarrhea accompanied by substantial GI bicarbonate loss and as an adjunct in the treatment of hyperkalemia to induce the cellular uptake of potassium and return the ratio of intracellular to extra cellular potassium concentration toward normal.

Composition

Each film-coated tablet of NODOSIS contains Sodium Bicarbonate USP 500 mg

Each film-coated tablet of NODOSIS-DS contains Sodium Bicarbonate USP 1000 mg

Pharmacology

Sodium Bicarbonate (NODOSIS) therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis. Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered "labile" since at a proper concentration of hydrogen ion (H+) it may be converted to carbonic acid (H2CO3) and thence to its volatile form, carbon dioxide (CO2) excreted by the lung. Normally a ratio of 1:20 (carbonic acid; bicarbonate) is present in the extra cellular fluid. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine

Indications

Sodium Bicarbonate (NODOSIS) is indicated in the treatment of metabolic acidosis; promotion of gastric, systemic, and urinary alkalinization; replacement therapy in severe diarrhea; used to reduce incidence of chemical phlebitis

Contraindications

Sodium Bicarbonate (NODOSIS) is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis, metabolic and respiratory alkalosis; hypocalcemia in which alkalosis may produce tetany, hypertension, convulsions, or CHF; when administration of sodium could be clinically detrimental.

Precautions

Sodium Bicarbonate should not be used if you have certain medical conditions. Before using this product, consult your doctor if you have: a certain breathing problem (pulmonary edema), congestive heart failure, severe kidney disease (e.g., inability to make urine), severe liver disease (e.g., ascites, cirrhosis), high sodium levels, and swollen ankles/legs/feet due to retaining water (peripheral edema). If you have any of the following health problems, consult your doctor before using Sodium Bicarbonate: low calcium levels, high blood pressure, heart problems (e.g., irregular heartbeat), and kidney disease.

Because this medication contains salt (sodium), do not use if you are on a salt-restricted diet. During pregnancy, this medication should be used only when clearly needed. This medication may worsen high blood pressure during pregnancy (toxemia of pregnancy). Discuss the risks and benefits with your doctor.

Side Effects and Adverse Reactions

Some of the side effects although may occur rarely with Sodium Bicarbonate (NODOSIS) are nausea or vomiting, headache, muscle pain, swelling of feet, ankles or legs, decreased appetite, unusual tiredness, constipation, dry mouth or increased thirst or increased urination.

Some of the common adverse reactions which may occur with Sodium Bicarbonate (NODOSIS Exacerbation of CHF. Rebound hyperacidity, milk-alkali syndrome, Hypernatremia, alkalosis, Extravasation with cellulitis, tissue necrosis, ulceration, venous irritation, tetany or edema.

Dosage and Administration

The dose of sodium bicarbonate will be different for different patients. Usual Adult Dose for Moderate metabolic acidosis is 325 to 2000 mg orally 1 to 4 times a day. (patients younger than 60?yr of age, max dose 16 g/day; patients older than 60 yr of age max dose 8 g/day).

Concomitant Therapy

Sodium bicarbonate can decrease elimination of Amphetamine, dextroamphetamine, ephedrine, flecainide, mecamylamine, methamphetamine, pseudoephedrine, quinidine, thus increasing their therapeutic effects.

Sodium bicarbonate can increase elimination of Chlorpropamide, lithium, methotrexate, salicylates, tetracyclines, thus decreasing their therapeutic effect

Overdosage

Sodium bicarbonate should be stopped should alkalosis result, manage the patient according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis

Storage

Store in a cool, dry place. Protect from light and moisture

Presentation

NODOSIS is available as tablets in a blister of 20 tablets and 10 such blisters in a box

NODOSIS-DS is available as tablets in a blister of 15 tablets and 10 such blisters in a box