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Aristo Pharmaceuticals Pvt Ltd

Combither 120mg Injection 1ml

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    Introduction About COMBITHER 120MG INJECTION

    COMBITHER 120MG INJECTION is a combination of Artemether and Lumefantrine which belongs to the group of medicines called Antimalarials. It is used for the management of acute uncomplicated malaria (mosquito borne disease with symptoms of fever with chills, tiredness, nausea, vomiting, stomach pain) caused by a parasite called plasmodium falciparum.

    COMBITHER 120MG INJECTION should be used with caution in patients with severe liver or kidney problems or if the patient feels worse or unwell to eat and drink.

    COMBITHER 120MG INJECTION is not recommended for use in patients having severe type of malarial infection affecting the lungs, kidney or brain, heart condition such as changes in the heart rhythm, slow heartbeat or severe heart disease and low levels of electrolytes such as potassium or magnesium in the blood.

    COMBITHER 120MG INJECTION should be used with caution in pregnant and breast-feeding women only if advised by the doctor.

    The most common side effects of receiving COMBITHER 120MG INJECTION are headache, dizziness, vomiting, nausea, muscle pain and loss of appetite. Inform your doctor if any of the side effects worsen.

    Uses Of COMBITHER 120MG INJECTION

    • Manage acute uncomplicated malarial infections (caused by plasmodium falciparum)

    How COMBITHER 120MG INJECTION Works

    COMBITHER 120MG INJECTION effectively manages malarial infections, where artemether effectively kills the malarial parasites by binding to haem (part of molecules that contains iron which is toxic to malarial parasites) which is produced during the breakdown of haemoglobin. Lumefantrine works by binding to hemin where it manages the formation of a toxic malarial pigment called hemozoin, thereby it manages malarial infection. In addition to this artemether and lumefantrine blocks nucleic acid and protein synthesis in parasite that damages the parasitic cell membrane of plasmodium falciparum which leads to the death of parasite. Thus, it helps in managing the malarial infection.

    How to use COMBITHER 120MG INJECTION

    COMBITHER 120MG INJECTION will be administered to you only by a doctor or a nurse. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

    Side Effects Of COMBITHER 120MG INJECTION

    Common

    • headache, dizziness
    • fever
    • feeling tired
    • nausea, vomiting
    • loss of appetite
    • weakness of muscles
    • muscle pain

    Rare

    Stop receiving COMBITHER 120MG INJECTION and contact your doctor immediately if you experience any of the following side effects:

    • signs of severe allergic reactions (such as rashes or reddening of the face)

    How To Manage Side Effects

    Headache:

    Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Inform your doctor if the symptom does not improve.

    Nausea and vomiting:

    Stick to simple meals while receiving this medicine. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Inform your doctor if the symptom does not improve.

    Tiredness:

    Drink plenty of fluid and eat balanced diet and frequent meals. Follow regular sleep schedule. Inform your doctor if the symptom does not improve.

    Warning & Precautions

    Pregnancy

    COMBITHER 120MG INJECTION is generally not recommended for use during the first trimester of pregnancy. It should be used with caution during second and third trimester of pregnancy only if considered clearly necessary. Consult your doctor before receiving COMBITHER 120MG INJECTION.

    Breastfeeding

    COMBITHER 120MG INJECTION should be used with caution in breast feeding women only if considered clearly necessary. Consult your doctor before receiving COMBITHER 120MG INJECTION.

    Driving and Using Machines

    Do not drive or operate any machines if you experience dizziness, sleepiness or weakness after receiving [GBNLKEYWORD].

    Kidney

    COMBITHER 120MG INJECTION is not recommended for use in patients having severe type of malarial infection affecting the kidneys. It should be used with caution in patients with severe kidney problems. Consult your doctor before receiving COMBITHER 120MG INJECTION.

    Liver

    COMBITHER 120MG INJECTION should be used with caution in patients with severe liver problems. Consult your doctor before receiving COMBITHER 120MG INJECTION.

    Allergy

    Do not receive COMBITHER 120MG INJECTION if you are allergic to Artemether, Lumefantrine or any other ingredients of this medicine.

    Lungs

    COMBITHER 120MG INJECTION is not recommended for use in patients having malaria with pulmonary edema or severe type of malarial infection affecting the lungs. Consult your doctor before receiving it.

    Heart Disease

    COMBITHER 120MG INJECTION is not recommended for use in patients with severe heart disease or with heart diseases such as slow heartbeat, changes in the rhythm or rate of the heartbeat or family history of death due to heart problems or born with heart problems. COMBITHER 120MG INJECTION should be used with caution in patients with variations in ECG (prolongation of QTc interval). Consult doctor before receiving COMBITHER 120MG INJECTION.

    Others

    COMBITHER 120MG INJECTION is not recommended for use if you have:

    • severe type of malarial infection that has affected the brain
    • low levels of electrolytes such as potassium or magnesium in blood

    Before receiving COMBITHER 120MG INJECTION, inform your doctor if you:

    • are infected with both the plasmodium falciparum and plasmodium vivax parasites
    • feeling worse or if you feel too unwell to eat and drink

    Use in Pediatrics:

    COMBITHER 120MG INJECTION should be used with caution in children as the dosages of COMBITHER 120MG INJECTION may vary in children according to their body weight. Consult your child’s doctor for advice.

    Use in Geriatrics:

    COMBITHER 120MG INJECTION can be used in elderly patients. However, consult your doctor before receiving this medicine.

    Interactions

    A. Drug-Drug Interactions:

    Before receiving COMBITHER 120MG INJECTION, inform your doctor if you are taking any of the following medicines:

    • medicines used to manage heart rhythm problems (Ex. Flecainide, metoprolol)
    • medicines used to manage depression (Ex. imipramine, amitriptyline, clomipramine, St. John’s wort)
    • medicine used to manage leprosy or tuberculosis (Ex. rifampicin)
    • medicines used to manage bacterial infections (Ex.  fluroquinolones such as ciprofloxacin, levofloxacin, macrolide antibiotics like azithromycin, erythromycin)
    • medicines used to manage fungal infection (Ex. ketoconazole, fluconazole, itraconazole)
    • medicines used to manage allergy (Ex. terfenadine, astemizole)
    • medicine used to manage stomach disturbance (Ex. cisapride)
    • medicines used to manage fits (Ex. carbamazepine, phenytoin)
    • medicines used to manage malaria (Ex.  atovaquone/proguanil, chloroquine)
    • medicines used to manage HIV infection (Ex. indinavir, ritonavir)
    • medicine used to manage pregnancy (Ex. Ethinyl estradiol)

    B. Drug- Food Interactions:

    Drink grapefruit juice with caution while receiving COMBITHER 120MG INJECTION as it may interact with this medicine.

    Overdosage:

    COMBITHER 120MG INJECTION will be given to you only by a doctor or nurse in a hospital and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms, inform your doctor immediately.

    Synopsis

    Drug :   Artemether, Lumefantrine
    Pharmacological Category :   Antimalarials
    Therapeutic Indication :   Manages acute uncomplicated malaria
    Dosage Forms :   Tablet, Dispersible tablet, Injection, Syrup, Oral Suspension, Dry syrup

    More Information

    • Store COMBITHER 120MG INJECTION at room temperature

    FAQs About COMBITHER 120MG INJECTION

    What is COMBITHER 120MG INJECTION used for?

    COMBITHER 120MG INJECTION is used for the management of acute uncomplicated malaria (mosquito born disease with symptoms of fever with chills, tiredness, nausea, vomiting, stomach pain) caused by a parasite called plasmodium falciparum.

    Does COMBITHER 120MG INJECTION helps to manage malaria?

    COMBITHER 120MG INJECTION is not used to manage malaria. It is only used to manage malarial infection caused by a parasite called plasmodium falciparum. Consult your doctor for advice before receiving this medicine.

    Is COMBITHER 120MG INJECTION safe to use in pregnant women?

    COMBITHER 120MG INJECTION is generally not recommended for use during the first trimester of pregnancy. It should be used with caution during second and third trimester of pregnancy only if considered clearly necessary. Consult your doctor before receiving COMBITHER 120MG INJECTION.

    Can COMBITHER 120MG INJECTION be used in patients with kidney problems?

    COMBITHER 120MG INJECTION is not recommended for use in patients having severe type of malarial infection affecting the kidneys. It should be used with caution in patients with severe kidney problems. Consult your doctor before receiving COMBITHER 120MG INJECTION.

    What are the common side effects of COMBITHER 120MG INJECTION?

    The most common side effects of receiving COMBITHER 120MG INJECTION are headache, dizziness, vomiting, nausea, muscle pain and loss of appetite. Inform your doctor if any of the side effects worsen.

    References

    1. KD Tripathi. Antimalarial drugs. Essentials of Medical Pharmacology. Eighth edition. 2019. Page 875-77.

    2. Hill SR, Thakur RK, Sharma GK. Antimalarial Medications. NIH. National Library of medicine. National Biotechnology center for Biotechnology Information. PubMed central August 2022. [Accessed on 5th November 2022] https://www.ncbi.nlm.nih.gov/books/NBK470158/

    3. Warhurst, DC, Adagu, IS Beck HP, Duraisingh MT, Kirby GC, von Seidlein L, Wright, CW. Mode of action of artemether lumefantrine (COARTEM): The sole, fixed, oral ADCC and its role in combatting multidrug resistance. The Southeast Asian journal of tropical medicine and public health. 2001. [Accessed on 5th November 2022] https://researchonline.lshtm.ac.uk/id/eprint/1904

    4. Novartis Ireland Limited. Electronic Medicines Compendium (EMC) [Revised in August 2021] [Accessed on 5th November 2022] https://www.medicines.org.uk/emc/files/pil.1628.pdf

    5. Ajanta Pharma Ltd. Food and Drugs Authority (FDA). [Revised in February 2018] [Accessed on 5th November 2022] https://fdaghana.gov.gh/img/smpc/Artefan%20(Artemether-Lumefantrine%2060mg-360mg)%20Tablets.pdf

    6. Getz pharma ltd. Artheget (Artemether + Lumefantrine). [Accessed on 5th November 2022] https://getzpharma.com/wp-content/uploads/2016/07/Artheget-Range-Leaflet-Pakistan.pdf
     

    Useful Diagnostic Tests

    • Complete blood count

    Author Details

    Written By Dr. R. Dinesh John Rajkumar - Pharm.D
    Reviewed For Accuracy By Dr. Nitin Sattiwale - MBBS
    Last updated on 18 Nov 2022 | 10:39 AM(IST)
    Lab updated