Apmod 25/67.5: Your Guide to Antimalarial Medication

What is Apmod 25/67.5 and Its Use

Apmod 25/67.5 is an antimalarial medication, which means it is a drug specifically designed to combat certain types of malaria infections. This medication combines two antimalarial agents, artesunate and amodiaquine, to effectively eliminate the malaria parasite residing within red blood cells.

Your healthcare provider has prescribed Apmod 25/67.5 for you because you have been diagnosed with malaria. It is important to note that this medication is indicated for the treatment of uncomplicated malaria attacks caused by Plasmodium falciparum, a specific malaria parasite against which this medication is effective. To ensure a complete cure, it is crucial to follow the prescribed dose as instructed by your doctor, pharmacist, or healthcare provider.

Before Taking Apmod 25/67.5

Before you start taking Apmod 25/67.5, there are some important considerations you should be aware of:

Do Not Take Apmod 25/67.5 If:

  • You are allergic to amodiaquine, artesunate, or any of the other components listed in Apmod 25/67.5 (refer to section 6 for a detailed list of ingredients).
  • You have experienced liver problems while using amodiaquine.
  • You have previously had sudden high fevers, shaking, severe sore throat, or ulcers in your mouth, which are symptoms suggesting harm to white blood cells while taking amodiaquine.
  • You have an eye disease that has caused damage to your retina.

In case of any doubt regarding your eligibility to use this medication, consult your doctor, pharmacist, or healthcare provider.

Warnings and Precautions:

  • Apmod 25/67.5 can potentially cause liver and blood damage, which can sometimes be severe or fatal. If you experience significant fatigue, gastrointestinal disturbances, jaundice, sore throat, or mouth ulcers, stop the treatment immediately and consult your doctor. They may need to take a blood sample.
  • Inform your healthcare provider if you have recently used amodiaquine-containing medications, as this could increase the likelihood of side effects.
  • This medication may lead to abnormal movements of the head, tongue, or neck (refer to section 4 for possible side effects). If you encounter these symptoms, discontinue the treatment and consult your doctor. These symptoms can often be reversed by stopping the treatment, and your doctor might recommend an alternative antimalarial treatment.
  • If you have a history of heart rhythm problems, low levels of potassium or magnesium in your blood, or issues with your liver or kidneys, let your doctor know.

Other Medications: Please notify your doctor or pharmacist about any other medications you are taking or have recently taken, including those obtained without a prescription. Some medications can interact with Apmod 25/67.5, potentially leading to adverse effects.

Pregnancy and Breastfeeding: Avoid using this drug during the first three months of pregnancy without medical advice. If you become pregnant during treatment, consult your doctor for guidance. When it comes to breastfeeding, seek medical advice before proceeding.

Driving and Using Machinery: If you experience dizziness or fatigue after taking Apmod 25/67.5, refrain from driving or operating machinery.

How to Take Apmod 25/67.5

Always follow your doctor’s instructions for taking Apmod 25/67.5. If you have any uncertainties, consult your healthcare provider or pharmacist.

Dosage Adjustment Based on Weight/Age:

  • Weight Range (Approximate Age Range): On three consecutive days
    • ≥4.5 kg to < 9 kg (2 to 11 months): 25 mg artesunate + 67.5 mg amodiaquine/day (1 tablet of Apmod 25/67.5 in one intake per day)
    • ≥9 kg to <18 kg (1 to 5 years): 50 mg artesunate + 135 mg amodiaquine/day (2 tablets of Apmod 25/67.5 in one intake per day)
    • ≥18 kg to <36 kg (6 to 13 years): 100 mg artesunate + 270 mg amodiaquine/day (4 tablets of Apmod 25/67.5 in one intake per day)
    • ≥ 36 kg (14 years and above): 200 mg artesunate + 540 mg amodiaquine/day (8 tablets of Apmod 25/67.5 in one intake per day)

For very young children or patients unable to swallow tablets whole, you can crush the tablets and add them to a small amount of semi-solid food or liquid, which should be consumed immediately.

If you vomit within half an hour of taking the tablets, take another dose as soon as possible. Then, contact your doctor for a prescription for more tablets and inform them about your vomiting.

Overdose: In the event of accidental overdose, contact a doctor or the nearest hospital emergency department immediately. Symptoms of overdose may include headaches, dizziness, visual disturbances, convulsions, or abnormal movements of the head, tongue, or neck.

Missed Dose: Try to ensure that you do not miss any dose. However, if you forget a dose, take the missed dose as soon as you remember. Then take the next dose at the prescribed interval. Do not double the dose to compensate for a missed tablet.

Completing the Treatment: To achieve the best results, take the medicine regularly as prescribed by your doctor, and for the full duration they recommend. Even if your fever or other symptoms improve, this does not necessarily mean you are completely cured. Any sensations of fatigue, nausea, or vomiting may be due to the infection itself, and reducing or discontinuing your treatment will only delay your recovery.

Possible Side Effects

As with any medication, Apmod 25/67.5 may lead to side effects, although not everyone will experience them. Possible side effects include:

Common Side Effects (Affecting 1 to 10 users in 100):

  • Loss of appetite.
  • Difficulty sleeping.
  • Sleepiness.
  • Cough.
  • Nausea.
  • Abdominal pain.
  • Weakness.
  • Tiredness.

Uncommon Side Effects (Affecting 1 to 10 users in 1,000):

  • Acute bronchitis.
  • Gastroenteritis.
  • Oral thrush.
  • Decrease in red blood cell count (anemia).
  • Low blood sugar (hypoglycemia).
  • Hallucination.
  • Tingling and numbness of the limbs.
  • Yellowing of the eyes.
  • Dizziness.
  • Heart rhythm disorders.
  • Diarrhea.
  • Vomiting.
  • Itching.
  • Rashes.
  • Swelling of the face.
  • Skin disorders.
  • Joint pain.
  • Swelling of the limbs (edema).
  • Fever.

Some side effects are specifically associated with amodiaquine, one of the active ingredients in Apmod 25/67.5, including a low count of white blood cells (increasing susceptibility to infections), severe liver function disturbances, eye disorders like slate-grey pigmentation (particularly in the fingers and mucous membranes), and nervous system and muscle impairment.

In post-marketing experience, additional side effects have been reported, including headache, cold symptoms, flu, rhinitis, shivering, sore throat, spleen enlargement, convulsions, yellowing of the skin, and allergic reactions. For some of these events, it is unclear whether they are related to amodiaquine/artesunate or to the underlying malaria disease.

Moreover, side effects known as extrapyramidal symptoms have been documented, which may involve abnormal movements of the head, tongue, or neck (e.g., facial spasms, tongue protrusion, difficulties in speaking), and generalized rigidity, even after a single dose.

If any side effect becomes severe or if you notice any side effects not listed in this leaflet, contact your doctor, pharmacist, or healthcare provider.

How to Store Apmod 25/67.5

Keep Apmod 25/67.5 out of reach and sight of children. Store the medication below 30°C. Do not use it after the expiry date indicated on the blister and the outer packaging. Do not dispose of unused medication in wastewater or household waste; consult your pharmacist for proper disposal methods to help protect the environment.

Contents of the Pack and Additional Information

Ingredients in Apmod 25/67.5:

  • Active ingredients: 25 mg artesunate and 67.5 mg amodiaquine (as hydrochloride)
  • Other ingredients: calcium carbonate, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, maize starch, microcrystalline cellulose, and povidone.

Appearance and Packaging:

  • Apmod 25/67.5 is a circular, bilayered, bevel-edged tablet. One layer is yellow with a scoreline, while the other layer is white to slightly yellow. The tablet is debossed with ‘A’ on one side of the scoreline and ‘1’ on the other side of the scoreline. The scoreline is intended to facilitate breaking for easier swallowing, not to divide into equal doses.
  • Packaging:
    • A carton contains 1 blister (Alu-OPA/Alu/PVC) of 3 tablets. Pack size: 1×3.
    • A carton contains 25 blisters (Alu-OPA/Alu/PVC) of 3 tablets each, along with 25 patient information leaflets. Pack size: 25×3.

Supplier and Manufacturer Information:

  • Supplier: Ajanta Pharma Ltd.
    • Address: Ajanta House, Charkop, Kandivli (West), Mumbai – 400 067, India
    • Phone: +9122 66061000
    • Fax: +9122 66061200
    • Email: info@ajantapharma.com
  • Manufacturer: Ajanta Pharma Limited
    • Address: B-4-5-6, MIDC Industrial Area, Paithan, Aurangabad, 431148, Dist: Aurangabad, Maharashtra, India.
    • Tel: +91-2431-664000
    • Fax: +91-2431-664100

This leaflet was prepared in September 2014, and Section 6 was updated in February 2019. For further information on this medication, you can visit the World Health Organization (WHO) website.

Please remember to follow your healthcare provider’s guidance for the proper use of Apmod 25/67.5, and consult them or your pharmacist for any questions or concerns. Your health and safety are of the utmost importance.