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ATOVAQUONE/PROGUANIL HYDROCHLORIDE is a brand name for Atovaquone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for: • Prophylaxis of Plasmodium falciparum malaria in adults and in children weighing…
Verbatim from this product's MHRA label. Tap a section to expand.
Method of administration The daily dose should be taken with food or a milky drink (to ensure maximum absorption ) at the same time each day. The tablets should preferably not be crushed. If patients are unable to tolerate food, Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets should be administered, but systemic exposure of atovaquone will be reduced.
In the event of vomiting within 1 hour of dosing a repeat dose should be taken.
Posology Prophylaxis:
Prophylaxis should: • commence 24 to 48 hours prior to entering a malaria-endemic area , • continue during the period of the stay, • continue for 7 days after leaving the area. In residents (semi-immune subjects) of endemic areas, the safety and effectiveness of Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets has been established in studies of up to 12 weeks.
In non-immune subjects, the average duration of exposure in clinical studies was 27 days.
Dosage in adults and adolescents more than 40 kg bodyweight:
One Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablet daily. Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets are not recommended for malaria prophylaxis in persons under 40 kg bodyweight.
Treatment:
Dosage in adults Four Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets as a single dose for three consecutive days. Dosage in Children weighing 11 kg or more 11 to 20 kg bodyweight. One tablet daily for three consecutive days.
21 to30 kg bodyweight. Two tablets as a single dose for three consecutive days. 31 to 40 kg bodyweight. Three tablets as a single does for three consecutive days. ≥40 kg bodyweight. Dose as for adults. 2). Dosage in hepatic impairment A pharmacokinetic study indicates that no dosage adjustments are needed in patients with mild to moderate hepatic impairment.
2). Dosage in renal impairment Pharmacokinetic studies indicate that no dosage adjustments are needed in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatine clearance <30 mL/min) alternatives to Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film- coated tablets for treatment of acute P.
In clinical trials of atovaquone-proguanil in the treatment of malaria the most commonly reported adverse reactions were abdominal pain, headache, anorexia, nausea, vomiting, diarrhoea and coughing. In clinical trials of atovaquone-proguanil for prophylaxis of malaria, the most commonly reported adverse reactions were headache, abdominal pain and diarrhoea.
The following table provides a summary of adverse reactions that have been reported to have a suspected (at least possible) causal relationship to treatment with atovaquone-proguanil in clinical trials and spontaneous post-marketing reports.
The following convention is used for the classification of frequency: very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1,000 to <1/100); not known (cannot be estimated from the available data). There are limited long term safety data in children.
In particular, the long-term effects of Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets on growth, puberty and general development have not been studied. 4) Vasculitis3 Metabolism and nutrition disorders Hyponatraemia1 Anorexia Elevated amylase levels1 Psychiatric disorders Abnormal dreams Depression Anxiety Hallucinations Panic attack Crying Nightmares Psychotic disorder Nervous system disorders Headache Insomnia Dizziness Seizure Cardiac disorders Palpitations1 Tachycardia Gastrointestinal disorders Nausea1 Vomiting Diarrhoea Abdominal pain Stomatitis Gastric intolerance3 Oral ulceration3 Hepatobiliary disorders Elevated liver enzymes1 Hepatitis Cholestasis Skin and subcutaneous tissue disorders Pruritus Rash Hair loss Urticaria Stevens- Johnson syndrome Erythema multiforme Blister Skin exfoliation Photosensitivity reactions General disorders and administration Fever site conditions Respiratory, thoracic and mediastinal disorders Cough 1.
Frequency taken from atovaquone label. Patients participating in clinical trials with atovaquone have received higher doses and have often had complications of advance Human Immunodeficiency Virus (HIV) disease. Therefore, the causal relationship between the adverse experiences and atovaquone is difficult to evaluate.
Persons taking Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets for prophylaxis or treatment of malaria should take a repeat dose if they vomit within 1 hour of dosing. In the event of diarrhoea, normal dosing should be continued.
Absorption of atovaquone may be reduced in patients with diarrhoea or vomiting, but , diarrhoea or vomiting was not associated with reduced efficacy in clinical trials of Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets for malaria prophylaxis.
However, as with other antimalarial agents, subjects with diarrhoea or vomiting should be advised to continue with malaria measures by complying with personal protection measures (repellants, bednets). In patients with acute malaria who present with diarrhoea or vomiting, alternative therapy should be considered.
If Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets are used to treat malaria in these patients, parasitaemia and the patient’s clinical condiion should be closely monitored. Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets have not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria including hyperparasitaemia, pulmonary oedema or renal failure.
Occasionally, severe allergic reactions (including anaphylaxis) have been reported in patients taking Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets. 8) Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets should be discontinued promptly and appropriate treatment initiated.
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets has been shown to have no efficacy against hypnozoites of Plasmodium vivax as parasite relapse occurred commonly when P. vivax malaria was treated with Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets alone.
1. Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2). For prophylaxis of P. 3
These events may have been seen at a lower frequency or not at all in clinical trials with atovaquone-proguanil. 2. Observed from post-marketing spontaneous reports. The frequency is unknown 3. Observed with proguanil. 4. Clinical trial data for atovaquone-proguanil indicated that abnormalities in liver function tests were reversible and not associated with untoward clinical events.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
Travellers with intense exposure to P. vivax or P. ovale, and those who develop malaria caused by either of these parasites, will require additional treatment with a drug that is active against hypnozoites. In the event of recrudescent infections due to P.
falciparum after treatment with Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets, or failure of to chemoprophylaxis with Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets, patients should be treated with a different blood schizonticide as such events can reflect a resistance of the parasite.
5). 5). 5). Concurrent use of metoclopramide is not recommended. 5). 5). 5). In patients with severe renal impairment (creatinine clearance <30 mL/min) alternatives to Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets for treatment of acute P.
2) The safety and effectiveness of Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film- coated tablets has not been established for prophylaxis of malaria in patients who weigh less than 40kg, or in the treatment of malaria in paediatric patients who weigh less than 11kg.