Potassium Chloride Concentrate for Injection 15% w/v Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Potassium Chloride Concentrate for Injection 15% w/v Taj Pharma
Potassium Chloride Concentrate for Injection 40mEq/20ml Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 10ml contains:
Potassium Chloride……… 15% w/v (1.5g)

  1. PHARMACEUTICAL FORM

Concentrate for Solution for Infusion

Clear, colorless, sterile, aqueous solution for infusion.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

For use in patients requiring supplemental potassium therapy.

4.2 Posology and method of administration

Route of administration: Intravenous, after dilution.

Before administering Sterile Potassium Chloride Concentrate:

1.) This solution must be diluted with not less than 50 times its volume of sodium chloride solution or other suitable diluent.

2.) The solution should be carefully mixed with the infusion fluid.

During administration:

1.) The diluted injection should be administered by slow intravenous infusion at a maximal rate of 20mmol of potassium per hour.

2.) The ECG should be monitored continuously.

The goal of potassium replacement therapy is to elevate the plasma concentration of the ion to within the normal range.

Dose per hour: The maximal rate of intravenous infusion is 20mmol/hour.

Dose per day: Since the normal dietary intake of potassium is 50 to 100mmol daily, it is rare that a larger amount is required during potassium replacement therapy.

4.3 Contraindications

1.) Sterile Potassium Chloride Concentrate should never be used undiluted.

2.) Hyperkalaemia (plasma-potassium concentration above 5 mmol/litre).

3.) Hyperchloraemia,

4.) Impaired renal function with oliguria, anuria or azotaemia

5.) Addison’s disease,

6.) Acute dehydration

7.) Heat cramps.

4.4 Special warnings and precautions for use

Administration – see also section 4.2

  • Only use with specialist advice
  • ECG should be used throughout and monitored continuously
  • High concentrations of potassium cause serious cardiotoxicity, so the concentration of the solution should not exceed 3g (40mmol)/L and the diluted solution given slowly (maximal rate 20mmol/L)
  • Initially do not use with glucose infusions – glucose may further decrease potassium levels

Other concurrent treatment – also see section 4.5

  • Extreme caution in patients on potassium sparing diuretics and other drugs that may increase potassium
  • Glucose infusion – see above Administration

Monitoring

  • Continuous ECG monitoring – see above Administration
  • Regular potassium levels especially in patients with renal impairment (see section 4.3)

Underlying conditions – see also section 4.3

  • Dehydration must be corrected to ensure adequate urinary output (and potassium excretion)
  • Where renal excretion of potassium or cellular uptake deficient – life threatening hyperkalaemia can occur with standard doses
  • Extreme caution with extensive tissue destruction (eg burns)
  • Extreme caution in cardiac disease

4.5 Interaction with other medicinal products and other forms of interaction

Increased risk of severe hyperkalaemia with the following

  • ACE-inhibitors
  • Aliskerin
  • Angiotensin-II receptor anatagonists
  • Potassium sparing diuretics such as: amiloride, spironolactone and triamterene and aldosterone antagonists
  • Ciclosporin
  • Tacrolimus (not topical formulations)

Particularly close monitoring required with these (see section 4.4) and any other medicines or conditions that may increase potassium levels

Further reductions in potassium occurs with glucose infusions – see also section 4.4

4.6 Pregnancy and lactation

Potassium chloride should be used during pregnancy or lactation only under the supervision of the prescribing physician if considered essential by the physician.

4.7 Effects on ability to drive and use machines

Nil.

4.8 Undesirable effects

Excessive intake of potassium may cause hyperkalaemia, with paraesthesia, muscle weakness, paralysis, hypotension, cardiac arrhythmias and cardiac arrest.

Pain at the injection site and phlebitis may occur during IV administration of solutions containing 30 mmol potassium or more per litre.

4.9 Overdose

Clinical signs and symptoms of potassium overdosage include:

Paraesthesia of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, flaccid paralysis, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, cardiac arrhythmias and heart block, due to which patients may deteriorate rapidly.

Extremely high plasma potassium concentrations (8-11 mmol/litre) may cause death from cardiac depression, arrhythmias or arrest.

All drugs containing potassium should be withdrawn and potassium-sparing diuretics discontinued.

Treatment:

Serum concentrations may be reduced by infusion of 300 – 500 mls per hour of 10% – 25% glucose solutions containing up to 10 units of insulin for each 20 g of glucose, or by the infusion of sodium bicarbonate solution.

Cardiac arrhythmias or a serum concentration above 6.5 mmol/litre, require immediate attention and may be treated by intravenous injection over 1 – 5 minutes of 10 – 20 ml of 10% Calcium Gluconate Injection B.P. with E.C.G. monitoring. Mild hyperkalaemia may be treated with sodium polystyrene sulphonate, a cation-exchange resin administered by mouth or as an enema. If the above measures fail, haemodialysis or peritoneal dialysis may be required.

Monitoring

  • Measure urea, electrolytes and creatinine
  • Monitor potassium levels regularly (2 to 3 hourly if raised )
  • Continuous 12 lead ECG
  • Observe asymptomatic patients for at least 6 hours
  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Active ion transport by the sodium-potassium ATP ASE carrier maintains a high gradient of potassium across the plasma membrane. Intracellular concentrations of potassium are about 150 mEq per litre while the plasma concentration is in the range of 3.5 to 5 mEq per litre, although there is a modest variation from one cell type to another.

Potassium plays a vital physiological role in maintenance of normal electrical excitability of nerve and muscle. It is also important in the genesis and correction of imbalances of acid-base metabolism.

In acute hypokalaemia, parenteral administration of potassium chloride promptly corrects the deficit in plasma potassium concentration and restores normal physiological function to potassium-dependent systems.

5.2 Pharmacokinetic properties

Potassium is an essential dietary constituent and is readily absorbed from the gastro-intestinal tract. Accumulation of potassium by cells occurs via an energy-dependent mechanism that extrudes sodium. Active ion transport systems maintain a high gradient of potassium across the plasma membrane, resulting in plasma concentrations of about 3.5 to 5 mEq per litre and intracellular concentrations of approximately 150 mEq per litre.

Potassium is excreted mainly by the kidneys. It is freely filtered at the glomerulus and is mainly absorbed in the proximal tubules, so that by the time the tubuler fluid reaches the late distal tubules, it contains less than 10% of the amount of potassium in the original glomerular filtrate. Normally, considerable amounts of potassium are secreted into the distal tubules and secretory transport is extremely important for the control of plasma potassium concentration.

As a consequence of the large volume of distribution and the rapid response of the kidney, intracellular and extracellular concentrations of potassium are normally maintained within relatively narrow limits. However, when potassium is administered as a drug, the factors that govern the rate and extent of its distribution are of critical importance. Although administration of potassium will not significantly increase the total body content of the ion, it may easily raise the extracellular concentration excessively. Because it is the extracellular concentration of potassium that determines life-threatening toxicity, awareness of the transient concentration achieved in plasma should govern the use of potassium therapy.

5.3 Preclinical safety data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for Injections BP.

6.2 Incompatibilities

Incompatibilities have been reported with dobutamine hydrochloride, amphotericin, amikacin sulphate and fixed oil emulsions.

6.3 Shelf life

5 years (60 months).

6.4 Special precautions for storage

Keep in outer carton

Do not store above 25°C.

6.5 Nature and contents of container

10ml, clear Open point cut (OPC) glass ampoules, glass type 1 Ph.Eur. packed in cardboard cartons to contain 10 x 10ml ampoules.

6.6 Special precautions for disposal and other handling

Warning: Must be diluted before use.

Dilute before use with not less than 50 times its volume of Sodium Chloride Injection or another suitable diluent. Discard if cloudy or deposit present.

Use as directed by the physician.

If only part used, discard the remaining solution.

Keep out of reach of children.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

PATIENT INFORMATION LEAFLET

POTASSIUM CHLORIDE CONCENTRATE FOR INJECTION
15% W/V / 40MEQ/20ML
TAJ PHARMA

Potassium Chloride

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Potassium Chloride 15% w/v Concentrate for Solution for Infusion but will be referred to as ‘Potassium chloride concentrate’ throughout the remainder of this leaflet.

IN THIS LEAFLET:

  1. What Potassium chloride concentrate is and what it is used for
    2. Before you are given Potassium chloride concentrate
    3. How you are given Potassium chloride concentrate
    4. Possible side effects
    5. How to store Potassium chloride concentrate
    6. Further information

 

  1. WHAT POTASSIUM CHLORIDE CONCENTRATE AND WHAT IT IS USED FOR

Potassium chloride concentrate belongs to a group of medicines called electrolyte replacement solutions.

Electrolytes are a group of chemicals and salts that are in the body fluids.

Potassium chloride concentrate is used in patients needing additional amounts of potassium.

  1. BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE CONCENTRATE

You should not be given Potassium chloride concentrate if :

  • you have hyperkalaemia (high levels of potassium in your blood – your doctor will advise you)
  • you suffer from impaired kidney function (you may produce little or no urine)
  • you suffer from Addison’s disease (a hormonal disorder where you may feel weak, lose weight and have a darkened skin)
  • you are very dehydrated
  • you suffer from heat cramps
  • you suffer from Hyperchloraemia (electrolyte disturbance in which there is an abnormally elevated level of the chloride ion in the blood).

Make sure your doctor knows if you suffer from the above.

Take special care with Potassium chloride concentrate if you:

  • have heart disease
  • have had a recent severe injury involving a large area of skin such as a burn.

Make sure your doctor is aware of these situations if it is not already obvious.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

  • Diuretics (“water tablets”) like amiloride, spironolactone and triamterene
  • Other medicines containing potassium
  • ACE inhibitors, and angiotensin II antagonists, aliskerin (used to treat high blood pressure)
  • Ciclosporin, Tacrolimus (used to supress the immune system following transplants)
  • Glucose infusions (used in patients who have low levels of sugar in their blood or are dehydrated).

Pregnancy and breast feeding

Do not have Potassium chloride concentrate if you are pregnant (or think you may be), or breast feeding unless your doctor has decided that it is in your best interests.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Potassium chloride concentrate should not interfere with your ability to drive or use machines but consult your doctor first.

  1. HOW YOU ARE GIVEN POTASSIUM CHLORIDE CONCENTRATE

Potassium chloride concentrate is diluted and then slowly dripped through a needle into a vein. The process may take an hour or more depending on your dose. Your doctor will decide the best dose for you.

While this medicine is being injected, your ECG (electrocardiogram, measuring the heart) should be monitored continuously.

If you are given more Potassium chloride concentrate than you should

As Potassium chloride concentrate is administered by a healthcare professional it is unlikely that you will be given too much. If you think you have been given too much medicine, tell your doctor. The likely signs of an overdose are the occurrence of side-effects as listed below.

In this event, you will be treated in the hospital and you will be given the necessary treatment.

If you miss a dose of Potassium chloride concentrate

This is unlikely as the injection is given by a healthcare professional but if you are concerned about missing a dose speak to your doctor.

  1. POSSIBLE SIDE EFFECTS

Like all medicines Potassium chloride concentrate can sometimes cause side-effects, although not everybody gets them.

The most likely side-effects are:

  • Tingling or other odd sensations
  • Muscle weakness or loss of movements
  • Faintness or irregular heart beats, or heart attack
  • Hyperkalaemia (too much potassium in the blood which would be identified by a blood test)
  • Hypotension (low blood pressure causing dizziness on standing)
  • Pain at the site of injection
  • Inflammation of the vein into which the solution is injected.

Please tell your doctor as soon as possible if you experience any of the above or are concerned they may have occurred.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor (GP or hospital doctor) or pharmacist.

  1. HOW TO STORE POTASSIUM CHLORIDE CONCENTRATE

These instructions apply mainly to the healthcare professional administering the injection.

Keep this medicine out of the sight and reach of children

This medicine should be stored out of the light at a maximum temperature of 25°C. Do not use after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month.

Do not use if the ampoule is damaged or if the solution is cloudy or has solids in it. If only part of the ampoule is used, throw away the rest of the solution

  1. FURTHER INFORMATION

The active substance is potassium chloride.

Each 10ml contains:
Potassium Chloride……… 15% w/v (1.5g)

The other ingredient is water for injections.

Potassium chloride concentrate must be diluted before use to not less than fifty times its volume of sodium chloride injection or other suitable liquids for dilution.

What Potassium chloride concentrate looks like and contents of pack

Potassium chloride concentrate is a clear, colourless, sterile aqueous solution for injection. Each 10ml glass ampoule contains 15%w/v (1.5g) of active ingredient, potassium chloride. Potassium chloride concentrate is supplied in pack of 10 ampoules.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

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