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Levosimed 12.5mg Injection 1ml

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Introduction About LEVOSIMED 12.5MG INJECTION

LEVOSIMED 12.5MG INJECTION contains Levosimendan, which belongs to the group of medicines called Calcium Sensitizer. It is used in adults for the management of heart failure, in people who still find it hard to breathe, even though they are taking other medicines to get rid of extra water from the body. It helps to relieve the shortness of breath from severe heart failure.

LEVOSIMED 12.5MG INJECTION should be used in pregnant women only if the benefits for the mother outweigh the possible risks to the foetus. LEVOSIMED 12.5MG INJECTION is not recommended for use in breastfeeding women as it may pass into human breast milk to avoid potential cardiovascular side effects in the infant.

LEVOSIMED 12.5MG INJECTION is not recommended for use if you have severe kidney or liver disease, very low blood pressure, or an abnormally fast heartbeat (Torsade’s de Pointes) or have heart disease that makes filling or emptying of the heart harder.

LEVOSIMED 12.5MG INJECTION should be used with caution if you have mild to moderate kidney or liver disease, chest pain, low blood pressure, an abnormally fast heartbeat, or an abnormal heart rhythm called ‘atrial fibrillation’. Consult your doctor before receiving it.

LEVOSIMED 12.5MG INJECTION is not recommended for use in children and adolescents under 18 years of age. The most common side effects of receiving LEVOSIMED 12.5MG INJECTION are headache, abnormally fast heartbeat, and drop in blood pressure. Consult your doctor if any of the side effects worsen.

Uses Of LEVOSIMED 12.5MG INJECTION

  • It helps to relieve the shortness of breath from severe heart failure.

How LEVOSIMED 12.5MG INJECTION Works

LEVOSIMED 12.5MG INJECTION works by increasing the pumping force of the heart and allows blood vessels to relax. Levosimendan will lessen the congestion in your lungs and make it easier for blood and oxygen to go through your body. Thus, LEVOSIMED 12.5MG INJECTION will help to relieve the shortness of breath from severe heart failure.

How to use LEVOSIMED 12.5MG INJECTION

LEVOSIMED 12.5MG INJECTION will be administered only by a doctor or a nurse into the veins as an intravenous infusion. Your doctor will decide the correct dose and duration for you depending on your age, body weight, and disease condition.

Side Effects Of LEVOSIMED 12.5MG INJECTION

Common

  • Headache
  • Abnormally fast heartbeat
  • Drop in blood pressure

Uncommon

  • Low amount of potassium in your blood
  • Insomnia
  • Dizziness
  • An abnormal heartbeat called ‘atrial fibrillation’ (a part of the heart flutters instead of beating properly)
  • Increased heart rate
  • Extra heartbeats
  • Heart failure
  • Your heart doesn’t get enough oxygen
  • Nausea, constipation, diarrhea, vomiting
  • Low blood counts

Rare

Stop receiving LEVOSIMED 12.5MG INJECTION and inform your doctor immediately if you experience any of the following side effects:

  • Abnormally fast heartbeat
  • Headache
  • Drop in blood pressure
  • Low amount of potassium in your blood
  • Insomnia
  • Dizziness
  • An abnormal heartbeat called atrial fibrillation (a part of the heart flutters instead of beating properly)
  • Extra heartbeats
  • Heart failure
  • Your heart doesn’t get enough oxygen
  • Low blood counts

How To Manage Side Effects

Constipation

Take fiber-rich foods in your diets, such as fresh fruits, vegetables, and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Contact your doctor if constipation persists.

Diarrhea

Drink lots of fluids, such as water, to keep yourself hydrated. Try to avoid taking any medicine on your own to manage diarrhea and consult your doctor if the diarrhea gets worse.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Headache

Rest and relax. Keep yourself hydrated by drinking plenty of fluids, such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Nausea And Vomiting

Take LEVOSIMED 12.5MG INJECTION with or just after meals. Stick to simple meals. Avoid eating oil-rich or spicy foods. Consult your doctor if your nausea and vomiting worsen.

Warning & Precautions

Pregnancy

Monitoring required

LEVOSIMED 12.5MG INJECTION should be used in pregnant women only if the benefits for the mother outweigh the possible risks to the foetus. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before this medicine is given to you.

Breastfeeding

Contraindicated

LEVOSIMED 12.5MG INJECTION is not recommended for use in breastfeeding women as it may pass into human breast milk to avoid potential cardiovascular side effects in the infant. Your doctor will have to decide if the benefits to the mother outweigh the possible risk to a baby.

Driving and Using Machines

Use with Caution

LEVOSIMED 12.5MG INJECTION can affect your ability to drive or operate any machinery.

Alcohol

Consult your doctor

Inform your doctor if you have alcohol addiction before using this medicine.

Kidney

Consult your doctor

LEVOSIMED 12.5MG INJECTION is not recommended for use if you have severe kidney disease. It should be used with caution if you have mild to moderate kidney disease. Consult your doctor before receiving it.

Liver

Consult your doctor

LEVOSIMED 12.5MG INJECTION is not recommended for use if you have severe liver disease. It should be used with caution if you have mild to moderate liver disease. Consult your doctor before receiving it.

Allergy

Contraindicated

LEVOSIMED 12.5MG INJECTION is not recommended for use if you are allergic to Levosimendan or to any other ingredients of this medicine.

Heart Disease

Consult your doctor

LEVOSIMED 12.5MG INJECTION is not recommended for use if you have very low blood pressure or an abnormally fast heartbeat (Torsade’s de Pointes) or have heart disease that makes filling or emptying of the heart harder. Inform your doctor if you have chest pain, low blood pressure, an abnormally fast heartbeat, or an abnormal heart rhythm called ‘atrial fibrillation’. Consult your doctor before receiving it.

Use In Pediatrics

Contraindicated

LEVOSIMED 12.5MG INJECTION is not recommended for use in children and adolescents under 18 years of age.

Use In Geriatrics

Consult your doctor

There is no specific dose recommendation for elderly patients. Consult your doctor for advice.

Others

LEVOSIMED 12.5MG INJECTION is not recommended for use if you have:

NA

Before receiving LEVOSIMED 12.5MG INJECTION, inform your doctor if you:

  • low blood counts (anemia)
  • or an abnormally low amount of potassium in your blood
  • severe decrease of blood volume in your body (hypovolaemia)
  • epilepsy

Interactions

A. Drug-Drug Interactions:

Inform your physician if you are taking any of the following drugs before using LEVOSIMED 12.5MG INJECTION:

  • isosorbide mononitrate (used to manage angina (chest pain))

Overdose:

LEVOSIMED 12.5MG INJECTION will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to result in an overdose. However, if you are given too much of this medicine, your blood pressure may drop and your heartbeat may get faster; then please consult your doctor or nurse immediately.

Synopsis

Drug :   Levosimendan
Pharmacological Category :   Calcium Sensitizer
Therapeutic Indication :   Heart failure
Dosage Forms :   Injection

More Information

Storage

  • Keep LEVOSIMED 12.5MG INJECTION out of reach of children
  • Store LEVOSIMED 12.5MG INJECTION in a refrigerator (2 °C–8 °C)

FAQs About LEVOSIMED 12.5MG INJECTION

Q: What is LEVOSIMED 12.5MG INJECTION used for?

A: LEVOSIMED 12.5MG INJECTION is used in adults for the management of heart failure, in people who still find it hard to breathe, even though they are taking other medicines to get rid of extra water from the body. It helps to relieve the shortness of breath from severe heart failure.

Q: What are the side effects of LEVOSIMED 12.5MG INJECTION?

A: The most common side effects of receiving LEVOSIMED 12.5MG INJECTION are headache, abnormally fast heartbeat, and drop in blood pressure. Consult your doctor if any of the side effects worsen.

Q: How does LEVOSIMED 12.5MG INJECTION work?

A: LEVOSIMED 12.5MG INJECTION works by increasing the pumping force of the heart and allows blood vessels to relax. Levosimendan will lessen the congestion in your lungs and make it easier for blood and oxygen to go through your body. Thus, LEVOSIMED 12.5MG INJECTION will help to relieve the shortness of breath from severe heart failure.

Q: Is LEVOSIMED 12.5MG INJECTION safe for pregnant women?

A: LEVOSIMED 12.5MG INJECTION should be used in pregnant women only if the benefits for the mother outweigh the possible risks to the foetus. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before this medicine is given to you.

Q: Who should avoid using LEVOSIMED 12.5MG INJECTION?

A: LEVOSIMED 12.5MG INJECTION is not recommended for use if you have severe kidney disease, severe liver disease, are allergic to Levosimendan, have very low blood pressure or an abnormally fast heartbeat (Torsade’s de Pointes), or have heart disease that makes filling or emptying of the heart harder.

Q: What precautions must be taken while using LEVOSIMED 12.5MG INJECTION?

A: Before using LEVOSIMED 12.5MG INJECTION, inform your doctor if you have mild to moderate kidney, liver disease, chest pain, low blood pressure, an abnormally fast heartbeat, an abnormal heart rhythm called ‘atrial fibrillation, low blood counts (anemia), or an abnormally low amount of potassium in your blood, a severe decrease in blood volume in your body (hypovolaemia), and epilepsy.

Q: Is LEVOSIMED 12.5MG INJECTION safe for kids?

A: LEVOSIMED 12.5MG INJECTION is not recommended for use in children and adolescents under 18 years of age.

Q: How LEVOSIMED 12.5MG INJECTION is given?

A: LEVOSIMED 12.5MG INJECTION will be administered only by a doctor or a nurse into the veins as an intravenous infusion. Your doctor will decide the correct dose and duration for you depending on your age, body weight, and disease condition.

Q: How long does LEVOSIMED 12.5MG INJECTION last?

A: The effect on your heart will last for at least 24 hours after LEVOSIMED 12.5MG INJECTION is stopped. The effect may continue for 7–10 days after the infusion is stopped.

Q: Can I take other medicines while using LEVOSIMED 12.5MG INJECTION?

A: Inform your physician if you are taking any of the following drugs before using LEVOSIMED 12.5MG INJECTION, such as isosorbide mononitrate (used to manage angina (chest pain), as LEVOSIMED 12.5MG INJECTION may increase the drop of your blood pressure when getting up.

References

1. Nieminen MS, Fruhwald S, Heunks LM, Suominen PK, Gordon AC, Kivikko M, Pollesello P. Levosimendan: current data, clinical use, and future development. NIH, National Library of Medicine. National Centre for Biotechnology Information. PubMed Central. 2013. [Accessed on 30th August 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868185/

2. AS KALCEKS. Health Products Regulatory Authority (HPRA). [Revised in February 2022] [Accessed on 30th August 2024] https://www.hpra.ie/img/uploaded/swedocuments/f255c6f4-40a8-4c0f-b034-e20069403900.pdf

3. SIMDAX. [Revised in June 2010] [Accessed on 30th August 2024] https://www.simdax.com/siteassets/simdax-spc.pdf

4. AROMA ILAÇ SAN. LTD. STI. SIMENDAN. [Revised July 2021] [Accessed on 30th August 2024] https://www.polifarma.com.tr/media/2635/simendan-pil-rev00.pdf

5. Drug bank. Levosimendan. [Accessed on 30th August 2024] https://go.drugbank.com/drugs/DB00922

Useful Diagnostic Tests

  • Complete Blood Count (CBC)/ Hemogram
  • Serum Electrolytes/ Electrolytes Profile
  • Cardiac Risk Profile
  • Basic Heart Care
  • Comprehensive Heart Care
  • Lipid Profile Test/Cholesterol-Total, Serum
  • Healthians Extended Heart Care Package
  • Jaanch Healthy Heart Advanced
  • Cardiac Risk Markers - Advanced
  • Jaanch Healthy Heart Basic

Author Details

Written By Dr. N. Sai Swaroop - Pharm.D
Reviewed For Accuracy By Dr. Venkatesh Poludasu - MBBS
Last updated on 31 Aug 2024 | 05:47 PM(IST)
Lab updated