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SODIUM BICARBONATE 2.74% SOLUTION FOR INFUSION - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - SODIUM BICARBONATE 2.74% SOLUTION FOR INFUSION

2. what you need to know before you are given sodium bicarbonate infusion

You should not receive Sodium Bicarbonate Infusion if you:

  • suffer from high blood pressure (hypertension)
  • suffer from kidney disease

HUH I

  • suffer from heart disease
  • have fluid in the lungs (pulmonary oedema)
  • have above normal pH levels in your body (respiratory or metabolic alkalosis)
  • are overbreathing (hyperventilating)
  • have high levels of sodium in your blood (hypernatraemia)
  • have complications in your pregnancy called eclampsia (symptoms include: convulsions, increased blood pressure, circulatory problems, severe headaches, vision problems, pain in the upper abdomen, vomiting, sudden swelling of your feet, ankles, face and hands and excessive weight gain).

Tell your doctor if you:

  • suffer from acute illness, pain, post-operative stress, infections, burns, or disease of the central nervous system.
  • have any type of liver disease.
  • have been treated with a medicine increasing the effect of vasopressin (a hormone regulating the body's water retention) because this may increase the risk of hospital-acquired low sodium levels in the blood (hyponatraemia)
  • heat cramp
  • have sickle cell disease ( a condition affecting the red blood cells)
  • have excess fluids build up around the brain (cerebral oedema)
  • have meningitis (swelling of the protective membranes covering brain and spinal cord)
  • have any brain injury.

Warnings and precautions

Sodium Bicarbonate Infusion must be given directly into a vein and not into body tissue.

Patients receiving resuscitation may risk the possibility of fluid in their lungs if they are given Sodium Bicarbonate Infusion.

Prolonged use of sodium bicarbonate should be avoided because it may cause hypokalaemia (condition in which the body fails to retain sufficient potassium levels)

The doctor or nurse will check that the solution is free from particles before use.

Other Medicines and Sodium Bicarbonate Infusion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following drugs should not be mixed with Sodium Bicarbonate Infusion:

  • Vitamin c (ascorbic acid)
  • benzylpenicillin, oxytetracycline, tetracycline, streptomycin, vancomycin (antibiotics)
  • calcium chloride
  • calcium gluconate (used in effervescent calcium tablets)
  • calcium salts of drugs
  • carmustine, cisplatin (used in chemotherapy)
  • codeine phosphate (painkiller, anti-diarrhoea)
  • adrenaline, corticotrophin, noradrenaline (hormone)
  • dobutamine (used for heart disease)
  • insulin (used in treatment of diabetes)
  • labetalol (high blood pressure)
  • levorphanol, pethidine, morphine sulphate (used to treat severe pain)
  • magnesium salts
  • methadone (used in the treatment of drug addiction)
  • pentobarbitone (tranquilizer and anticonvulsive medicine)
  • procaine (a local anesthetic drug)
  • suxamethonium (muscle relaxant)
  • vitamin B complex with C
  • lithium (used in the treatment of mania, antidepressant)
  • hexamine based drugs (urinary antiseptics)
  • amphetamine (prescription stimulant used to treat attention-deficit hyperactivity disorder (ADHDD)
  • quinidine (antiarrhythmic agent)
  • quinine (fever-reducing, painkiller and anti-inflammatory medicine)
  • Medicines leading to an increased vasopressin effect e.g.:
  • Medicines stimulating vasopressin release (e.g. chlorpropamide. clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics)
  • Medicines potentiating vasopressin action (e.g. non-steroidal anti-inflammatory drugs, chlorpropamide, cycophosphamide)
  • Medicines acting as vasopressin, so called vasopressin analogues e.g.: Desmopressin, oxytocin, vasopressin, terlipressin
  • other medicinal products increasing the risk of hyponatraemia including diuretics in general and antiepiliptics e.g. oxcarbazepine

If you are unsure whether you are taking one of the above drugs, ask your doctor or pharmacist. These medicines may be affected by sodium bicarbonate or may affect how well it works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Sodium Bicarbonate Infusion is considered safe to use during pregnancy and breastfeeding.

Sodium Bicarbonate infusion should be given with special caution for pregnant women during labour, if given in combination with oxytocin this may cause low sodium concentration in the blood.

Driving and using machines

Sodium Bicarbonate Infusion should not affect your ability to drive or operate machinery.

  • 3. How you are given Sodium Bicarbonate Infusion

Sodium Bicarbonate Infusion will be given to you in hospital by a healthcare professional via intravenous infusion (into a vein).

The amount and rate at which the infusion is given depends on your requirements.

Your doctor will decide on the correct dose for you

If you receive more Sodium Bicarbonate Infusion than you should It is very unlikely that you will receive more infusion than you should. If you suspect that you received too much sodium bicarbonate you should immediately inform your doctor describing the symptoms.

Excessive amounts of infused Sodium Bicarbonate Infusion may result in:

  • abnormally fast breathing (hyperpnoea)
  • nausea (feeling sick)
  • convulsions (fits)

If Sodium Bicarbonate Infusion is administered too quickly it may result in chemical imbalance in the body (hyperosmolarity).

Dosage System

Fluid balance, glucose and salts along with other electrolytes found within your blood may need to be monitored before and during administration, especially if you are at risk of high blood pressure or kidney problems.

Monitoring of your salt levels is important for this type of infusion solution (hypotonic fluid), as it may become very hypotonic after administration due to glucose utilisation in the body.

4. possible side effects

Like all medicines, Sodium Bicarbonate Infusion can cause side effects, although not everybody gets them.

Thrombosis (the formation of a clot) may occur in the vein where the infusion is given. The symptoms of thrombosis include:

  • pain, swelling and redness at the blood clot site.
  • an itchy rash at the clot site
  • warm skin around the clot
  • a mild fever
  • major veins that stand out from your skin.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

  • 5. How Sodium Bicarbonate Infusion is stored

6. contents of the pack and other information

What Sodium Bicarbonate Infusion contains

Sodium Bicarbonate Infusions contain:

Sodium Bicarbonate

The concentration of sodium bicarbonate in the infusion can be seen in the name of the product. The following concentrations are available: Sodium Bicarbonate 1.26% solution for infusion

Sodium Bicarbonate 1.4% solution for infusion

Sodium Bicarbonate 2.74% solution for infusion

Sodium Bicarbonate 4.2% solution for infusion

Sodium Bicarbonate 8.4% solution for infusion

The infusions also contain water for injections, disodium edetate, carbon dioxide.

What Sodium Bicarbonate Infusions look like and contents of the pack

Sodium Bicarbonate Infusions come in a sealed semi-rigid, cylindrical plastic container with a ‘Twist-off’ seal at one end and a ring tab at the opposite end. The solutions are available in 500ml size. Sodium Bicarbonate Intravenous Infusion BP 8.4% is available in 200 ml size.

Marketing authorisation holder

Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Manor Park

Runcorn

Cheshire

WA7 1NT

UK

Manufacturer:

Terumo BCT Limited,

Old Belfast Road, Millbrook, Larne, Co. Antrim, BT40 2SH. UK.

This leaflet was last revised in April 2020.

Wx FRESENIUS KABI

LEAF/BICAR/0

V004/TM

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Sodium Bicarbonate 2.74% Solution for Infusion used for?

Sodium Bicarbonate 2.74% Solution is primarily used to treat conditions related to acidosis, such as metabolic acidosis, and to help alkalinize urine.

How does Sodium Bicarbonate work in the body?

Sodium Bicarbonate helps balance the pH levels in your body by neutralizing excess acids, which can help relieve symptoms associated with acidosis.

Who can receive Sodium Bicarbonate infusions?

Patients who have metabolic acidosis or those undergoing certain medical treatments that lead to acid buildup may receive Sodium Bicarbonate infusions, but it should be administered under medical supervision.

What are the common side effects of Sodium Bicarbonate infusion?

Common side effects may include headache, nausea, vomiting, and swelling at the injection site. Consult your doctor if you experience any severe reactions.

Can Sodium Bicarbonate be used during pregnancy?

Sodium Bicarbonate should only be used during pregnancy if prescribed by a healthcare provider who will evaluate the benefits against potential risks.

Is Sodium Bicarbonate 2.74% Solution safe for children?

The safety of Sodium Bicarbonate infusions in children depends on their specific health conditions and should only be administered by a qualified healthcare professional.

How is Sodium Bicarbonate administered?

Sodium Bicarbonate 2.74% Solution is typically administered through an intravenous (IV) infusion in a clinical setting by healthcare professionals.

What precautions should I take before receiving Sodium Bicarbonate?

Before receiving Sodium Bicarbonate, inform your doctor about any allergies, existing medical conditions, medications you are currently taking, and whether you are pregnant or breastfeeding.

Can I drink water after receiving Sodium Bicarbonate infusion?

Yes, drinking water after receiving a Sodium Bicarbonate infusion is generally acceptable unless advised otherwise by your healthcare provider.

What happens if I miss a dose of Sodium Bicarbonate infusion?

If a dose is missed, your healthcare provider will determine the best course of action. Do not attempt to self-administer or adjust your treatment.

Are there any dietary restrictions while using Sodium Bicarbonate 2.74% Solution for Infusion?

While using this solution, it’s advisable to follow any dietary guidelines provided by your healthcare provider to support treatment efficacy.

Can I take other medications with Sodium Bicarbonate infusion?

Some medications may interact with Sodium Bicarbonate. Always inform your doctor about all medications you are taking, including over-the-counter drugs and supplements.

How long does the infusion take?

The duration of a Sodium Bicarbonate infusion can vary based on the individual’s condition and medical guidance but typically lasts from several minutes to hours.

What should I do if I experience severe side effects after the infusion?

If you experience severe side effects like difficulty breathing or chest pain after receiving the infusion, seek immediate medical attention.

Can I receive other treatments while on Sodium Bicarbonate therapy?

Other treatments can often continue during therapy; however, discuss with your healthcare provider to ensure safety and proper management of your treatment plan.

Does Sodium Bicarbonate affect my blood pressure?

Sodium Bicarbonate may affect blood pressure levels; monitor your blood pressure regularly and report any significant changes to your doctor.

Is it normal to feel bloated after receiving this infusion?

Some patients may feel bloated or have increased gas after an infusion due to changes in electrolyte levels; consult with your doctor if symptoms persist.

What should I tell my doctor before starting treatment with this solution?

Inform your doctor about any history of heart disease, kidney problems, or fluid retention before starting treatment with Sodium Bicarbonate solution.

How is my progress monitored while on Sodium Bicarbonate therapy?

Your healthcare provider will monitor your blood pH levels and overall health status regularly during treatment to ensure effectiveness and safety.

Where can I find more information about Sodium Bicarbonate 2.74% Solution for Infusion?

For more information about this medication, consult with your pharmacist or healthcare provider for further resources and guidance tailored to your needs.