Novelta
Generic Name
Artemether + Lumefantrine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| novelta 480 mg suspension | ৳ 120.00 | N/A |
Description
Overview of the medicine
Novelta 480 mg Suspension is a potent antimalarial drug combining Artemether and Lumefantrine, primarily used for the treatment of uncomplicated Plasmodium falciparum malaria, including infections from multi-drug resistant strains.
Uses & Indications
Dosage
Adults
For adults and children weighing 35 kg or more: 1 bottle (Artemether 80 mg + Lumefantrine 480 mg) administered orally twice daily (morning and evening) for 3 days, totaling 6 doses. Doses should be taken at 0, 8, 24, 36, 48, and 60 hours.
Elderly
No specific dose adjustment required for elderly patients, but caution is advised due to potential comorbidities and polypharmacy.
Renal_impairment
No dose adjustment necessary for mild to moderate renal impairment. Caution with severe renal impairment due to limited data.
How to Take
Shake the suspension well before each use. Administer orally, preferably with food or a fatty meal (e.g., milk, peanut butter) to enhance absorption. If vomiting occurs within 1 hour of dosing, repeat the dose.
Mechanism of Action
Artemether is a fast-acting blood schizonticide that rapidly reduces parasite biomass by inhibiting nucleic acid and protein synthesis and forming free radicals. Lumefantrine is a slower-acting, longer-lasting blood schizonticide that interferes with heme detoxification and forms cytotoxic complexes within the parasite, clearing residual parasites and preventing recrudescence.
Pharmacokinetics
Onset
Rapid onset of action due to Artemether, typically within hours.
Excretion
Excretion is predominantly fecal, with very little (<1%) renal excretion for both components.
Half life
Artemether has a short elimination half-life (2-3 hours), while its active metabolite dihydroartemisinin has a half-life of 2-4 hours. Lumefantrine has a much longer elimination half-life of 3-5 days.
Absorption
Artemether is rapidly absorbed with peak plasma concentrations occurring within approximately 2 hours. Lumefantrine absorption is slower and highly variable, significantly increased by co-administration with fatty food, with peak concentrations observed 6-8 hours post-dose.
Metabolism
Both Artemether and Lumefantrine are extensively metabolized in the liver, primarily by the cytochrome P450 enzyme CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Artemether, Lumefantrine, or any components of the suspension.
- Severe malaria (parenteral treatment is indicated).
- Patients with a known history of prolonged QT interval or family history of sudden death.
- Concomitant use with drugs known to prolong the QT interval (e.g., certain antiarrhythmics, antipsychotics, antidepressants).
- Electrolyte disturbances (hypokalemia, hypomagnesemia).
Drug Interactions
Ritonavir, Saquinavir, Nelfinavir (HIV protease inhibitors)
May significantly alter drug levels. Close monitoring required.
CYP3A4 Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin)
May decrease plasma concentrations of Artemether and Lumefantrine, leading to reduced efficacy. Avoid concomitant use if possible.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Grapefruit juice)
May increase plasma concentrations of Artemether and Lumefantrine. Monitor for adverse effects.
Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, certain antipsychotics)
Concomitant use is contraindicated due to increased risk of cardiac arrhythmias.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, symptomatic and supportive treatment should be initiated. Monitor cardiac function, including ECG, and electrolyte levels. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use in the first trimester is generally not recommended unless the potential benefits outweigh the risks due to limited data. In the second and third trimesters, it can be considered when other suitable antimalarials are not available or are ineffective. For lactation, consult a doctor; generally, it is not recommended as components may pass into breast milk.
Side Effects
Contraindications
- Hypersensitivity to Artemether, Lumefantrine, or any components of the suspension.
- Severe malaria (parenteral treatment is indicated).
- Patients with a known history of prolonged QT interval or family history of sudden death.
- Concomitant use with drugs known to prolong the QT interval (e.g., certain antiarrhythmics, antipsychotics, antidepressants).
- Electrolyte disturbances (hypokalemia, hypomagnesemia).
Drug Interactions
Ritonavir, Saquinavir, Nelfinavir (HIV protease inhibitors)
May significantly alter drug levels. Close monitoring required.
CYP3A4 Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin)
May decrease plasma concentrations of Artemether and Lumefantrine, leading to reduced efficacy. Avoid concomitant use if possible.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Grapefruit juice)
May increase plasma concentrations of Artemether and Lumefantrine. Monitor for adverse effects.
Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, certain antipsychotics)
Concomitant use is contraindicated due to increased risk of cardiac arrhythmias.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, symptomatic and supportive treatment should be initiated. Monitor cardiac function, including ECG, and electrolyte levels. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use in the first trimester is generally not recommended unless the potential benefits outweigh the risks due to limited data. In the second and third trimesters, it can be considered when other suitable antimalarials are not available or are ineffective. For lactation, consult a doctor; generally, it is not recommended as components may pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture when stored under recommended conditions.
Availability
Available in pharmacies, hospitals, and health centers
Approval Status
Approved by major regulatory bodies for malaria treatment
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the high efficacy and safety of Artemether-Lumefantrine in treating uncomplicated P. falciparum malaria, including in areas with high resistance to conventional antimalarials. Ongoing surveillance and post-marketing studies continue to monitor its effectiveness and safety profile globally.
Lab Monitoring
- ECG monitoring (especially in patients with pre-existing cardiac conditions or those on QT-prolonging drugs).
- Electrolyte levels (potassium, magnesium) if abnormalities are suspected or with concomitant diuretic use.
- Liver function tests in patients with severe hepatic impairment or if jaundice develops.
Doctor Notes
- Ensure patients complete the full 3-day treatment course.
- Stress the importance of taking the medication with fatty food for optimal absorption, especially for Lumefantrine.
- Monitor for signs of recrudescence, especially in areas of emerging resistance.
- Caution in patients with cardiac conditions or those on QT-prolonging drugs.
Patient Guidelines
- Complete the entire 3-day course of treatment, even if you feel better, to prevent recurrence and drug resistance.
- Always take the medicine with food or a fatty meal (e.g., milk, yogurt, peanut butter) to ensure proper absorption.
- Shake the suspension well before each dose.
- If vomiting occurs within 1 hour after taking a dose, repeat the dose.
- Inform your doctor about all other medications you are taking, including herbal supplements and over-the-counter drugs.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness or lightheadedness. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Ensure adequate rest during the treatment period.
- Stay well-hydrated by drinking plenty of fluids.
- Maintain good personal hygiene to prevent other infections.
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