Lonart, Lonart Forte, Lonart DS Tablets

Class: Antimalarial

Manufacturer: Bliss GVS Pharma Ltd.

Dosage Form: Tablet

Similar Brands:

Uses:

For the treatment of acute uncomplicated plasmodium falciparum malaria in adults, children and infants of 5kg and above.

Dosage:

LONART TABLETS

Weight in Kg	Total tablets	Dosage Regimen
		Day-1		Day-2		Day-3
		0 Hour	8 Hours	24 Hour	36 Hours	48 Hours	60 Hour
5-14	6	1	1	1	1	1	1
15-24	12	2	2	2	2	2	2
25-34	18	3	3	3	3	3	3
35 – and more(Adults)	24	4	4	4	4	4	4

 

LONART FORTE TABLET

Weight in Kg	Total tablets	Dosage Regimen
		Day-1		Day-2		Day-3
		0 Hour	8 Hours	24 Hour	36 Hours	48 Hours	60 Hour
5-14	3	½	½	½	½	½	½
15-24	6	1	1	1	1	1	1
25-34	9	1½	1½	1½	1½	1½	1½
35 – and more(Adults)	12	2	2	2	2	2	2

 

LONART DS TABLETS

Weight in Kg	Total tablets	Dosage Regimen
		Day-1		Day-2		Day-3
		0 Hour	8 Hours	24 Hour	36 Hours	48 Hours	60 Hour
(Adults) 35Kg and above	6	1	1	1	1	1	1

 

Second dose to be taken strictly after 8 hours of first dose. After each dose eat or drink something or take fatty meal.

If there is vomiting within one hour of taking LONART/LONART FORTE/LONART DS, repeat the dosel.

Take dosage exactly as recommended, otherwise infection may return.

Method of administration

Tablet for oral administration

To increase absorption, Lonart should be taken with food or a milky drink. If patients are unable to tolerate food, Lonart should be administered with water, but the systemic exposure may be reduced. Patients who vomit within 1 hour of taking the medication should repeat the dose

Side Effects:

The commonly reported adverse effects with artemether-lumefantrine are decreased appetite, psychiatric disorders, sleep disorders, insomnia, headache, dizziness, paraesthesia, clonus, palpitation, electrocardiogram QT prolonged, cough, vomiting, abdominal pain, nausea, diarrhea, liver function tests increased, rash, pruritis, arthralgia, myalgia, asthenia, fatigue and gait disturbances.

Warnings & Precautions:

• Lonart must not be used in the first trimester of pregnancy in situations where other suitable and effective antimalarials are available.
• Lonart has not been evaluated for the treatment of severe malaria, including cases of celebral malaria or other severe manifestations such as pulmonary oedema or renal failure.
• Due to limited data on safety and efficacy, lonart should not be given concurrently with any other antimalarial agent unless there is no other treatment option.
• If a patient deteriorates whilst taking lonart, alternative treatment for malaria should be started without delay. In such cases, monitoring of the ECG is recommended and and steps should be taken to correct any electrolyte disturbances.
• The long elimination half-life of lumefantrine must be taken into account when administering quinine in patients previously treated with lonart.
• If quinine is given is given after lonart, close monitoring of the ECG is advised.
• If lonart is given after mefloquine, close monitoring of food intake is advised.
• In patients previously treated with halofantrine, lonart should not be administered earlier than one month after the halofantrine dose.
• Lonart is not indicated and has not been evaluated for prophylaxis of malaria.
• Lonart should be used cautiously in patients on anti-retroviral drugs (ARTs) since decreased artemether, DHA, and/or lumefantrine concentration may result in a decrease of antimalarial efficacy of lonart.
• Like other antimalarials (e.g. halofantrine, quinine and quinidine) lonart has the potential to cause QT prolongation.
• Caution is recommended when combining lonart with drugs exhibiting variable patterns or inhibition, moderate induction or competition for CYP3A4 as the therapeutic effects of some drugs could be altered.
• Caution is recommended when combining lonart with hormonal contraceptives.
• Patients who remain averse to food during treatment should be closely monitored as the risk of recrudescence may be greater.
• Renal impairment

No dose adjustment for the use of lonart in patients with renal impairment recommended. Caution is advised when administering lonart to patients with severe renal impairment. In these patients, ECG and blood potassium monitoring is advised

• Hepatic impairment

Caution should be exercised in dosing patients with severe hepatic impairment. In these patients, ECG and blood potassium monitoring is advised. No dose adjustment is recommended for patients with mild to moderate hepatic impairment.

• Older people

There is no information suggesting that the dosage in patients over 65 years of age should be different that in younger adults.

• New infections

Data for a limited number of patients in a malaria endemic area show that new infections can be treated with a second course of lanart. In the absence of carcinogenicity study data, and due to lack of clinical experience, more than two coursed of lonart cannot be recommended.

Pregnancy & Lactation:

Lonart treatment must not be used during the first trimester of pregnancy in situations where other suitable effective antimalarials are available. However, it should not be withheld in life-threatening situations, where no other effective antimalarials are available. During the second and third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the foetus.

Breast-feeding should not resume until at least one week after the last dose of lonart unless potential benefits to the mother and child outweigh the risks of lonart treatment.

Drug Interactions:

• If lonart is given following administration of mefloquine or quinine, close monitoring of food intake (for mefloquine) or of the ECG (for quinine) is advised.
• Lonart should be used cautiously with drugs that inhibit CYP3A4 and are contraindicated with drugs which additionally are known to prolong QTc
• Lonart should be used cautiously in patients on ARTs since decreased artemether, DHA, and /or lumefantrine concentrations may result in a decrease of antimalarial efficacy of lonart, and increased lumefantrine concentrations may cause QT prolongation.
• Interaction with drugs metablolized by CYP2D6 e.g. neuroleptics, metoprolol, and tricyclic antidepressants such as imipramine, amitriptyline, clomipramine
• Grapefruit juice should be used cautiously during lonart treatment.

Contraindications:

• Patients with known hypersensitivity to the active substances or to any of the excipients of this formulation.
• Patients with severe malaria according to WHO definition*
• Patients who are taking any drug which is metabolized by the cytochrome enzyme CYP2D6 (e.g. metoprolol, imipramine, amitriptyline, clomipramine).
• Patients with a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical known to prolong the QTc interval.
• Patients taking drugs that are known to prolong the QTc interval (proarrythmic). These drugs include: antiarrythmic of classes IA and III, Neuroleptics antidepressant agents, Certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines(terfenadine, astemizole), Cisapride, flecainide
• Patients with a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by left ventricle ejection fraction.
• Patients with disturbances of electrolyte balance e.g. hypokalemia or hypomagnesimia.
• Patients taking drugs that are strong inducers of CYP3A4 such as rifampicin, carbamzepine, phenytoin, St John’s wort (Hypericum perforatum).
• Presence of one or more of the following clinical or laboratory features.

Clinical manifestations: prostration; impaired consciousness or unarousable coma; failure to feed; deep breathing, respiratory distress (acidotic breathing); multiple convulsions, circulatory collapse or shock; pulmonary edema (radiological); abnormal bleeding; clinical jaundice; hemoglobinuria

Laboratory test: severe mormocytic anemia; hemoglobuniuria; metabolic acidosis; renal impairment; hyperlactatemia; hyperparasitemia

Price: Ksh 150

Notes:

Pack Size: 24s, 12s & 6s

Price for lonart 24s is Ksh100/-

price for lonart 6S is Ksh 200/-

Overdose

In cases of suspected over dosage symptomatic and supportive therapy should be given as appropriate, which should include ECG and blood potassium monitoring.

Date of publication/review: 04/2021

Effects on ability to drive and use machines

Patients receiving lonart should be warned that dizziness or fatigue/asthenia may occur in which cse they should not drive or use machines.