Potassium lactate Monico

Package leaflet: Information for the user

POTASSIUM LACTATE MONICO

2 mEq/ml Concentrate for solution for infusion
Lactic acid and potassium hydroxide
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What POTASSIUM LACTATE MONICO is and what it is used for
2. What you need to know before using POTASSIUM LACTATE MONICO
3. How to use POTASSIUM LACTATE MONICO
4. Possible side effects
5. How to store POTASSIUM LACTATE MONICO
6. Contents of the pack and other information

1. What POTASSIO LATTATO MONICO is and what it is used for

POTASSIO LATTATO MONICO contains two active substances: lactic acid and potassium hydroxide.
This medicinal product is indicated:

• in the treatment of potassium deficiency, when this mineral cannot be administered orally;
• in cases of mild increase in acidic substances in the blood (moderate acidosis).

2. What you need to know before using POTASSIUM LACTATE MONICO

Do not use POTASSIUM LACTATE MONICO

• if you are allergic to lactic acid, potassium hydroxide, or any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of potassium in the blood (hyperkalemia) or reduced potassium excretion from the body (potassium retention);
• if you have severe kidney problems (severe renal insufficiency);
• if your blood shows an accumulation of lactic acid (lactic acidosis);
• if you suffer from heart problems (cardiac failure, shock, hypoxemia, or other disorders affecting oxidative processes or tissue perfusion that prevent lactate utilization);
• if you have an accumulation of basic substances in the blood (metabolic and respiratory alkalosis);
• if you have diseases characterized by increased deposition of glucose as glycogen;
• if you have low levels of calcium in the blood (hypocalcemia);
• if your body temperature is very low (hypothermia);
• if you have untreated adrenal gland disease (Addison's disease);
• if you have acute dehydration;
• if you experience painful, short-lived muscle cramps (heat cramps).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using POTASSIUM LACTATE MONICO.
This medicine must not be administered undiluted, as it is lethal if given without dilution.
This medicine must be administered, after dilution with a compatible solution, by very slow intravenous infusion (intravenous infusion), because potassium intoxication may occur, which could lead to death due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to complete cessation of heart activity (cardiac arrest).
During treatment with this medicine, your doctor must monitor:

• heart activity through specific tests (serial electrocardiograms);
• levels of fluids, electrolytes, and blood pH.

This medicine should be administered with caution in the following cases:

• if you have kidney problems (renal insufficiency), as administration of solutions containing potassium ions may cause excessive accumulation of potassium (potassium retention);
• if you have heart problems (cardiac failure), especially if you are being treated with certain heart medications (digitalis);
• if you have adrenal gland problems (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if you have periodic familial paralysis (occasional episodes of muscle weakness);
• if you have congenital myotonia (a serious condition characterized by prolonged muscle contraction);
• if you have recently undergone surgery (early post-operative phase).

Children
The safety and efficacy of potassium lactate in children have not been established.
Other medicines and POTASSIUM LACTATE MONICO
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Use caution and inform your doctor, who must closely monitor your blood potassium levels, if you are taking:

• medicines that increase urine output and reduce potassium loss (potassium-sparing diuretics), as they may cause increased potassium levels in the blood (hyperkalemia), especially if you have kidney problems (renal dysfunction);
• medicines used to lower blood pressure (ACE inhibitors) that reduce aldosterone levels, because they may decrease potassium excretion (potassium retention).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
This medicine should not be used during pregnancy or breastfeeding unless absolutely necessary.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use POTASSIO LATTATO MONICO

This medicinal product must always be administered exactly according to the instructions given by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Before being injected intravenously (intravenous infusion), POTASSIO LATTATO MONICO must be appropriately diluted, as undiluted administration may result in death.
Mix thoroughly during the preparation of the dilution and before administration.

The dose will be determined by the doctor based on your age, body weight, and health condition, taking into account the daily potassium requirement for an adult (40–80 mEq per day). The total daily dose must not exceed 200 mEq. Furthermore, the doctor or nurse will determine the infusion rate (not exceeding 10 mEq of potassium per hour), since too rapid infusions may cause pain at the infusion site.

Use in children
The safety and efficacy of this medicinal product in children have not been established.

Use in patients with kidney problems
This medicinal product must only be administered if renal function is intact.

If you use more POTASSIO LATTATO MONICO than you should
If you suspect that an excessive dose of this medicinal product has been administered, contact your doctor or nurse immediately.

In case of accidental overdose of this medicinal product, stop treatment immediately and seek medical advice without delay from your doctor or the nearest hospital.

If you forget to use POTASSIO LATTATO MONICO
Do not use a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects that may occur are listed below:
Frequency not known (frequency cannot be estimated from the available data)

• stomach and intestinal disorders (gastrointestinal disturbances);
• nerve and muscle disorders (neuromuscular disturbances);
• altered sensation in arms, legs or other body parts (paraesthesiae);
• loss of muscle tone (flaccid paralysis), weakness, mental confusion;
• low blood pressure (hypotension);
• irregular heartbeat (arrhythmias);
• heart disorders (conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram);
• cessation of heart activity (cardiac arrest);
• increased blood volume (hypervolemia);
• fever (febrile reactions), injection site infections, formation of blood clots in veins (venous thrombosis), inflammation of veins (phlebitis), leakage of medicine into surrounding tissues at the injection site (extravasation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store POTASSIUM LACTATE MONICO

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP.”. The expiry date refers to the last day of that month.
Store this medicine in its original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What POTASSIO LATTATO MONICO contains

• The active substances are lactic acid and potassium hydroxide. 10 ml of solution contain 1.80 g of lactic acid and 1.12 g of potassium hydroxide (each ml contains 2 mEq of potassium and lactate). pH: 6.5 ÷ 8.5.
• The other component is water for injections.

Description of the appearance of POTASSIO LATTATO MONICO and contents of the pack
POTASSIO LATTATO MONICO 2 mEq/ml Concentrate for solution for infusion, sterile and pyrogen-free:
pack containing 5 glass vials of 10 ml each.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

The following information is intended exclusively for physicians or healthcare professionals

Dosage and administration
The medicinal product must not be injected undiluted. It is fatal if administered without dilution.
The medicinal product must be administered intravenously only after dilution in 5% glucose solution,
0.9% sodium chloride solution (physiological saline), or other compatible solutions.
Dilute the solution immediately after opening the container; the diluted solution must be used
immediately. The solution must be clear, colourless, and free from visible particles. It is intended for single
and uninterrupted administration; any remaining solution must not be reused. All standard precautions
should be taken to maintain sterility before and during intravenous infusion.
Shake well during preparation of the dilution and before administration.
The dose depends on the patient's age, body weight, and clinical condition, taking into account that the
usual daily requirement of potassium is as follows:

• Adults: 40–80 mEq per day. The total daily dose must not exceed 200 mEq.
• Children: 2–3 mEq/kg per day. In children, the safety and efficacy of potassium lactate have not been established. The medicinal product must be administered only when renal function is normal and at a rate not exceeding 10 mEq of potassium per hour. In emergency situations (serum potassium levels ≤ 2 mEq/L with electrocardiographic changes and muscle paralysis), the infusion rate must not exceed 40 mEq/hour, under continuous electrocardiographic monitoring, and the total dose must not exceed 400 mEq within 24 hours. Infusions that are too rapid may cause local pain; therefore, the infusion rate should be adjusted according to patient tolerance.

Overdose
In case of overdose, immediately discontinue the infusion and initiate corrective therapy to reduce elevated
plasma potassium levels and, if necessary, restore acid-base balance.
Incompatibilities
Unless otherwise indicated, and except for the solutions listed below, mixing potassium lactate solution
with other medicinal products is not recommended.
Solutions to be used for dilution of potassium lactate MONICO:
5% glucose solution or 0.9% sodium chloride solution (physiological saline).
For further information, please refer to the Summary of Product Characteristics.