Procalamine

DRUG DESCRIPTION

ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is a sterile, nonpyrogenic, moderately hypertonic intravenous injection containing crystalline amino acids, a nonprotein energy substrate and maintenance electrolytes. A 1000 mL unit provides a total of 29 g of protein equivalent (4.6 g N) and 130 nonprotein calories.

All amino acids designated USP are the "L"-isomer with the exception of Glycine USP which does not have an isomer.

Each 100 mL contains:

Nonprotein energy source:

Glycerin USP (glycerol) 3.0 g

Essential amino acids

Isoleucine USP 0.21 g
Leucine USP 0.27 g
Lysine 0.22 g (added as Lysine Acetate USP 0.31 g)
Methionine USP 0.16 g
Phenylalanine USP 0.17 g
Threonine USP 0.12 g
Tryptophan USP 0.046 g
Valine USP 0.20 g

Nonessential amino acids

Alanine USP 0.21 g
Glycine USP 0.42 g
Arginine USP 0.29 g
Histidine USP 0.085 g
Proline USP 0.34 g
Serine USP 0.18 g
Cysteine < 0.014 g (as Cysteine HCl•H2O USP < 0.020 g)
Sodium Acetate•3H2O USP 0.20 g
Magnesium Acetate•4H2O 0.054 g
Calcium Acetate•H2O 0.026 g
Sodium Chloride USP 0.12 g
Potassium Chloride USP 0.15g
Phosphoric Acid NF 0.041 g
Potassium Metabisulfite NF (as an antioxidant) < 0.05 g
Water for Injection USP qs
pH adjusted with Glacial Acetic Acid USP
pH: 6.8 (6.5-7.0), Calculated Osmolarity: 735 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 35; Potassium 24.5; Calcium 3 Magnesium 5; Chloride 41; Phosphate (HPO=4) 7*; Acetate 47**

What are the precautions when taking amino acid and glycerin (Procalamine)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any amino acid or to glycerin; or if you have any other allergies. This product may contain inactive ingredients (such as latex, sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney or liver disease, certain metabolic disorder (impaired nitrogen utilization).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding problems, congestive heart failure, diabetes.

This product contains aluminum which may build up...

Read All Potential Precautions of Procalamine »

What are the precautions when taking amino acid and glycerin (Procalamine)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any amino acid or to glycerin; or if you have any other allergies. This product may contain inactive ingredients (such as latex, sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney or liver disease, certain metabolic disorder (impaired nitrogen utilization).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding problems, congestive heart failure, diabetes.

This product contains aluminum which may build up...

Read All Potential Precautions of Procalamine »


Procalamine Consumer (continued)

SIDE EFFECTS: Flushing, nausea, warm sensation or mild redness/irritation at the IV infusion site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

It is important to keep your IV site clean. Tell your doctor immediately if you notice: any signs of infection (e.g., fever, chills), unusual redness, swelling, or severe pain at the IV site.

Although unlikely to occur, you may develop an imbalance of body fluid, minerals, or nutrients while receiving this medication. Your therapy may need to be changed to correct the imbalance. It is important to keep your medical and laboratory appointments for regular monitoring by your healthcare professional. Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine, increased thirst/urination, mental/mood changes, muscle weakness, slow/irregular heartbeat, swelling of hands/feet/ankles.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to any amino acid or to glycerin; or if you have any other allergies. This product may contain inactive ingredients (such as latex, sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney or liver disease, certain metabolic disorder (impaired nitrogen utilization).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding problems, congestive heart failure, diabetes.

This product contains aluminum which may build up with prolonged use and may have harmful effects in certain patients (e.g., patients with kidney problems including premature newborns and the elderly). Consult your doctor for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.



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