Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany
Therapy and chemoprophylaxis of malaria.
Lariam is especially indicated for therapy of P. falciparum malaria in which the pathogen has become resistant to other antimalarial agents.
Following treatment of P. vivax malaria with Lariam, relapse prophylaxis with an 8-amino-quinoline derivative, for example primaquine, should be considered in order to eliminate parasites in the hepatic phase.
Malaria chemoprophylaxis with Lariam is particularly recommended for travellers to malarious areas in which multiply resistant P. falciparum strains occur.
Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration. Official guidelines will normally include WHO and public health authorities. For current advice on geographical resistance patterns and appropriate chemoprophylaxis, current guidelines or the National Travel Health Network and Centre (NaTHNaC) should be consulted, which can be found at http://travelhealthpro.org.uk/diseases/malaria.
When chemoprophylaxis with Lariam fails, physicians should carefully evaluate which antimalarial to use for therapy. Regarding the use of halofantrine, see sections 4.3, 4.4 and 4.5.
For malaria prophylaxis the stated dose of Lariam should be given once weekly, always on the same day.
In order to ensure, before arrival in endemic area, that Lariam administration is well tolerated, it is recommended to start chemoprophylaxis with Lariam 10 days before departure (i.e. first intake 10 days before departure and 2nd intake 3 days before departure). Subsequent doses should be taken once a week (on a fixed day).
Treatment should be continued for 4 weeks after leaving a malarious area (minimum treatment period 6 weeks). The maximum recommended duration of administration of Lariam is 12 months.
The recommended chemoprophylactic dose of Lariam is approximately 5 mg/kg bodyweight once weekly. The following dosage schedule is given as a guide:
| Dosage | |
|---|---|
| Adults and children of more than 45 kg bodyweight | 1 tablet |
| Children and adults weighing less than 45 kg | |
| 5–19 kg | ¼ tablet |
| 20–30 kg | ½ tablet |
| 31–45 kg | ¾ tablet |
The tablets should be swallowed whole preferably after a meal with plenty of liquid.
The recommended total therapeutic dose of Lariam is 20–25 mg/kg.
The recommended total therapeutic dosages of Lariam tablets relative to body weight are presented in the following table:
| Body Weight | Total dose |
|---|---|
| <20 kg* | ¼ tablet/2.5–3 kg |
| 1 tablet/10–12 kg | |
| 20–30 kg | 2–3 tablets |
| >30–45 kg | 3–4 tablets |
| >45–60 kg | 4–5 tablets |
| >60 kg** | 6 tablets |
* Experience with Lariam in infants less than 3 months old or weighing less than 5 kg is limited.
** There is no specific experience with total dosages of more than 6 tablets in very heavy patients.
In order to limit the occurrence and severity of adverse reactions, the total therapeutic dose may be split into 2–3 doses (e.g. 3 + 1, 3 + 2 or 3 + 2 + 1 tablets) taken 6–8 hours apart.
A second full dose should be given to patients who vomit less than 30 minutes after receiving the drug. If vomiting occurs 30–60 minutes after a dose, an additional half-dose should be given.
If a full treatment course with Lariam does not lead to improvement within 48–72 hours, alternative treatments should be considered.
Lariam can be given for severe acute malaria after an initial course of intravenous quinine lasting at least 2–3 days. Interactions leading to adverse events can largely be prevented by allowing an interval of at least 12 hours after the last dose of quinine (see section 4.5).
Artemisinin combination therapy (ACT) is recommended as the standard of care for treatment of P. falciparum malaria, regardless of region of acquisition. Mefloquine is a recommended partner molecule for inclusion in ACT.
No specific adaptation of the usual adult dosage is required for elderly patients.
In cases of overdosage with mefloquine, the symptoms mentioned under section 4.8 may be more pronounced.
Patients should be managed by symptomatic and supportive care following mefloquine overdose. There are no specific antidotes. The use of oral activated charcoal to limit mefloquine absorption may be considered within one hour of ingestion of an overdose. Monitor cardiac function (if possible by ECG) and neuropsychiatric status for at least 24 hours. Provide symptomatic and intensive supportive treatment as required, particularly for cardiovascular disorders. Elimination of mefloquine and its metabolites is limited by haemodialysis.
Shelf life: 3 years.
Do not store above 30°C, store in the original package in order to protect from moisture.
Aluminium foil packs containing 8 tablets.
Not applicable.
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