Ammonium Chloride

Dosage Forms & Strengths

injectable solution

• 5 mEq/mL

Hypochloremic States & Metabolic Alkalosis

mEq of chloride ion (as ammonium chloride-NH4Cl) = [0.2 L/kg X BW (kg)] X [103 - observed serum chloride]; administer 50% of dose over 12 hr and reevaluate

103 is the average normal serum chloride concentration (mEq/L) and 0.2 L/kg is the estimated chloride volume of distribution

Dosage Forms & Strengths

injectable solution

• 5 mEq/mL

Hypochloremic States & Metabolic Alkalosis

mEq of chloride ion (as ammonium chloride-NH4Cl) = [0.2 L/kg X BW (kg)] X [103 - observed serum chloride]; administer 50% of dose over 12 hr and reevaluate

103 is the average normal serum chloride concentration (mEq/L) and 0.2 L/kg is the estimated chloride volume of distribution

Pregnancy Category: C

Lactation: N/A

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Ammonium Chloride is available in the following forms:

• Injectable Solution
• Oral Powder
• Oral Solution
• Oral Tablet

• Tell all of your health care providers that you take ammonium chloride. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Ammonium Chloride Injection, USP, 100 mEq, is a sterile, nonpyrogenic solution of Ammonium Chloride (NH4Cl) in water for injection administered (after dilution) by the intravenous route. Each mL contains 267.5 mg of Ammonium Chloride 5 mEq of ammonium and 5 mEq of chloride) and edetate disodium (anhydrous) 2 mg added as a stabilizer. pH 4.4 (4.0 to 6.0). May contain hydrochloric acid for pH adjustment. 10 mOsmol/mL (calc.). It is intended to be used only after dilution in a larger volume of isotonic (0.9%) sodium chloride injection.

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for dilution as a single-dose additive. When smaller doses are required the unused portion should be discarded with the entire additive unit.

Ammonium Chloride Injection, USP is an electrolyte replenisher and systemic acidifier.

Ammonium Chloride, USP is chemically designated NH4Cl, colorless crystals or white granular powder freely soluble in water.

The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

The ammonium ion (NH4+) in the body plays an important role in the maintenance of acid-base balance. The kidney uses ammonium (NH4+) in place of sodium (Na+) to combine with fixed anions in maintaining acid-base balance, especially as a homeostatic compensatory mechanism in metabolic acidosis.

When a loss of hydrogen ions (H+) occurs and serum chloride (Cl–) decreases, sodium is made available for combination with bicarbonate (HCO3–). This creates an excess of sodium bicarbonate (NaHCO3) which leads to a rise in blood pH and a state of metabolic alkalosis.

The therapeutic effects of Ammonium Chloride depend upon the ability of the kidney to utilize ammonia in the excretion of an excess of fixed anions and the conversion of ammonia to urea by the liver, thereby liberating hydrogen (H+) and chloride (Cl–) ions into the extracellular fluid.

Ammonium Chloride is contraindicated in patients with severe impairment of renal or hepatic function.

Ammonium Chloride should not be administered when metabolic alkalosis due to vomiting of hydrochloric acid is accompanied by loss of sodium (excretion of sodium bicarbonate in the urine).

Overdosage of Ammonium Chloride has resulted in a serious degree of metabolic acidosis, disorientation, confusion and coma. Should metabolic acidosis occur following overdosage, the administration of an alkalinizing solution such as sodium bicarbonate or sodium lactate will serve to correct the acidosis.