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Introduction About SIMENDA 12.5MG INJECTION
SIMENDA 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.
SIMENDA 12.5MG INJECTION should be used in pregnant women only if the benefits for the mother outweigh the possible risks to the foetus. SIMENDA 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.
SIMENDA 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.
SIMENDA 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.
SIMENDA 12.5MG INJECTION is not recommended for use in children and adolescents under 18 years of age. The most common side effects of receiving SIMENDA 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 SIMENDA 12.5MG INJECTION
- It helps to relieve the shortness of breath from severe heart failure.
How SIMENDA 12.5MG INJECTION Works
SIMENDA 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, SIMENDA 12.5MG INJECTION will help to relieve the shortness of breath from severe heart failure.
How to use SIMENDA 12.5MG INJECTION
SIMENDA 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 SIMENDA 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 SIMENDA 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 SIMENDA 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 requiredSIMENDA 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
ContraindicatedSIMENDA 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 CautionSIMENDA 12.5MG INJECTION can affect your ability to drive or operate any machinery.
Alcohol
Consult your doctorInform your doctor if you have alcohol addiction before using this medicine.
Kidney
Consult your doctorSIMENDA 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 doctorSIMENDA 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
ContraindicatedSIMENDA 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 doctorSIMENDA 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
ContraindicatedSIMENDA 12.5MG INJECTION is not recommended for use in children and adolescents under 18 years of age.
Use In Geriatrics
Consult your doctorThere is no specific dose recommendation for elderly patients. Consult your doctor for advice.
Others
SIMENDA 12.5MG INJECTION is not recommended for use if you have:
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Before receiving SIMENDA 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 SIMENDA 12.5MG INJECTION:
- isosorbide mononitrate (used to manage angina (chest pain))
Overdose:
SIMENDA 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 SIMENDA 12.5MG INJECTION out of reach of children
- Store SIMENDA 12.5MG INJECTION in a refrigerator (2 °C–8 °C)
FAQs About SIMENDA 12.5MG INJECTION
Q: What is SIMENDA 12.5MG INJECTION used for?
A: SIMENDA 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 SIMENDA 12.5MG INJECTION?
A: The most common side effects of receiving SIMENDA 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 SIMENDA 12.5MG INJECTION work?
A: SIMENDA 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, SIMENDA 12.5MG INJECTION will help to relieve the shortness of breath from severe heart failure.
Q: Is SIMENDA 12.5MG INJECTION safe for pregnant women?
A: SIMENDA 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 SIMENDA 12.5MG INJECTION?
A: SIMENDA 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 SIMENDA 12.5MG INJECTION?
A: Before using SIMENDA 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 SIMENDA 12.5MG INJECTION safe for kids?
A: SIMENDA 12.5MG INJECTION is not recommended for use in children and adolescents under 18 years of age.
Q: How SIMENDA 12.5MG INJECTION is given?
A: SIMENDA 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 SIMENDA 12.5MG INJECTION last?
A: The effect on your heart will last for at least 24 hours after SIMENDA 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 SIMENDA 12.5MG INJECTION?
A: Inform your physician if you are taking any of the following drugs before using SIMENDA 12.5MG INJECTION, such as isosorbide mononitrate (used to manage angina (chest pain), as SIMENDA 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
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