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ATOVAQUONE PROGUANIL is a brand name for Atovaquone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Each ATOVAQUONE PROGUANIL (atovaquone and proguanil hydrochloride) Tablet contains 250 mg of atovaquone and 100 mg proguanil hydrochloride. The daily dose should be taken with food or a milky drink (to ensure maximum absorption) at the same time each day (see PRECAUTIONS, General).
In the event of vomiting within 1 hour of dosing a repeat dose should be taken. Should vomiting continue, alternative therapy should be considered or the patient’s parasitemia should be monitored. ATOVAQUONE PROGUANIL Tablets (adult strength) should preferably be swallowed whole.
Either tablet may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing tablets. ). Prophylaxis should be continued daily throughout the stay and for 7 additional days after leaving the area of concern.
Dosage in Adults One ATOVAQUONE PROGUANIL Tablet (adult strength = 250 mg atovaquone and 100 mg proguanil hydrochloride) daily. Dosage in Children (see PRECAUTIONS, Use in Children, and CLINICAL PHARMACOLOGY, Special Populations, Pediatrics) The dosage for prevention of malaria in children is based upon body weight.
> 40 kg body weight: One ATOVAQUONE PROGUANIL Tablet (adult strength) daily. ATOVAQUONE PROGUANIL is not recommended for malaria prophylaxis in children weighing less than 11 kg. Page 20 of 42 TREATMENT Dosage in Adults Four ATOVAQUONE PROGUANIL Tablets (adult strength) as a single dose for three consecutive days.
Dosage in Children (see PRECAUTIONS, Use in Children, and CLINICAL PHARMACOLOGY, Special Populations, Pediatrics) The dosage for treatment of acute malaria in children is based upon body weight. 11-20 kg body weight: One ATOVAQUONE PROGUANIL Tablet (adult strength) daily for three consecutive days.
21-30 kg body weight: Two ATOVAQUONE PROGUANIL Tablets (adult strength) as a single dose for three consecutive days. 31-40 kg body weight: Three ATOVAQUONE PROGUANIL Tablets (adult strength) as a single dose for three consecutive days.
> 40 kg body weight: Dose as for adults.
SPECIAL POPULATIONS Patients with Renal Impairment:
There are no studies in children with renal impairment. However, pharmacokinetic studies in adults indicate that no dosage adjustments are needed in patients with mild to moderate renal impairment. ATOVAQUONE PROGUANIL should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance < 30 mL/min), and alternatives to ATOVAQUONE PROGUANIL should be recommended for treatment of acute P.
falciparum malaria whenever possible (see CONTRAINDICATIONS, PRECAUTIONS, Renal Impairment, and CLINICAL PHARMACOLOGY, Special Populations).
Page 21 of 42 Patients with Hepatic Impairment:
As ATOVAQUONE PROGUANIL contains atovaquone and proguanil hydrochloride, the type and severity of adverse reactions associated with each of the compounds may be expected. At the doses employed for the treatment and prophylaxis of malaria, adverse reactions have generally been mild and of limited duration.
There has been no evidence of increased toxicity following concurrent administration of the two compounds. A summary of adverse events associated with the use of ATOVAQUONE PROGUANIL, atovaquone, or proguanil hydrochloride is provided below.
Blood and Lymphatic:
Anemia, neutropenia.
Pancytopenia in patients with severe renal impairment Endocrine and Metabolic:
Anorexia, hyponatremia Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhoea, gastric intolerance, oral ulceration, stomatitis Hepatobiliary Tract and Pancreas: Elevated liver enzyme levels and reports of hepatitis, cholestasis, elevated amylase levels.
Clinical trial data for ATOVAQUONE PROGUANIL indicated that abnormalities in liver function tests (elevated bilirubin and transaminases) were reversible and not associated with untoward clinical events.
Immune System/Hypersensitivity:
Allergic reactions: including rash, urticaria, pruritus, angioedema, isolated reports of anaphylaxis, and vasculitis Lower Respiratory: Cough Neurology: Headache, insomnia, dizziness, asthenia Non-Site Specific: Fever Skin: Rash, hair loss Other events seen in clinical trials with ATOVAQUONE PROGUANIL include: Body as a Whole: Back pain, lethargy Cardiovascular: Hypotension, palpitations Page 14 of 42 Erythropoietic: Splenomegaly Gastrointestinal: Hepatomegaly, constipation, dyspepsia Musculoskeletal: Myalgia Neurology: Strange or vivid dreams, visual difficulties, depression, anxiety Of the seven severe or treatment-limiting adverse experiences reported in clinical trials with atovaquone and proguanil hydrochloride, three were considered to be treatment related; two were reports of nausea and/or vomiting and one, a report of an anaphylactic reaction (see WARNINGS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There are no studies in children with hepatic impairment. However, a pharmacokinetic study in adults indicates that no dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see PRECAUTIONS, Hepatic Impairment, and CLINICAL PHARMACOLOGY, Special Populations).
2 Page 23 of 42 Description: Atovaquone: Atovaquone is a yellow crystalline solid with a melting point of ≈ 221°C. 7 mg/mL).
Proguanil Hydrochloride:
A white crystalline powder, odorless or almost odorless with a melting point of 243°C to 244°C. It is slightly soluble in water, more soluble in hot water and sparingly soluble in 96% ethanol. It is practically insoluble in chloroform and in ether.
4 mg proguanil base). The non-medicinal ingredients in both tablets are low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30 and sodium starch glycollate. The tablet coating contains hypromellose, macrogol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide.
Stability and Storage Recommendations Store between 15°C - 30°C. AVAILABILITY OF DOSAGE FORMS ATOVAQUONE PROGUANIL (atovaquone and proguanil hydrochloride) Tablets are branded GX CM3, pink, round biconvex film-coated tablets available in blister packs of 12.
Page 24 of 42 ATOVAQUONE PROGUANIL INFORMATION FOR THE PATIENT Please read this information carefully before taking your medication. If you have any questions ask your doctor or pharmacist. What is malaria? Malaria is a disease that is caused by the presence of very small organisms (malaria parasites called plasmodia) in the blood.
Malaria is a serious but preventable disease spread by the bite of an infected mosquito. Anyone, of any age, can get malaria. Human malaria is caused by four species of protozoa belonging to the genus Plasmodium: P. vivax, P. ovale, P.
malariae and P. falciparum. Malaria deaths are frequently the results of delays in the diagnosis and treatment of the infection. Malaria is widespread in tropical and subtropical areas of Africa, Latin America, Asia and the Pacific. Several different types of malaria may exist within one area, each type requiring its own protective medication.
Malaria is […]
Two subjects, one adult and one 4-year-old child, receiving atovaquone/proguanil hydrochloride for the treatment of malaria had seizures; the child successfully continued treatment. Both subjects had a prior history of seizures and the investigators did not consider the events to be exacerbated by treatment with ATOVAQUONE PROGUANIL.
During clinical trials, two adult subjects receiving atovaquone monotherapy experienced psychiatric symptoms. One subject had a history of psychiatric illness and the other a history of drug and alcohol abuse. Studies of this size and design would only be able to detect adverse events at a rate of 1:150 (95% CI).
Treatment Table 2 provides a summary of the adverse events considered by investigators to be attributable to study medication and reported in clinical trials for the treatment of malaria with ATOVAQUONE PROGUANIL Tablets. Abdominal pain, headache, anorexia, nausea, vomiting, diarrhoea, asthenia and abnormal liver function tests were the most commonly reported adverse experiences.
Page 15 of 42 Table 2 Adverse Events Considered by Investigators to be Attributable to Study Medication, Occurring in ≥ 1% of Adults with Malaria in Completed Phase III Treatment Studies Adverse Event ATOVAQUONE PROGUANIL (n = 304) PYR + S (n = 81) MFQ (n = 91) ADQ (n = 71) C±PYR+S* (n = 55) Gastrointestinal Abdominal Pain 15% (45) 21% (17) 0% 8% (6) 0% Vomiting 12% (35) 15% (12) 0% 25% (18) 2% (1) Nausea 11% (32) 14% (11) 2% (2) 21% (15) 2% (1) Diarrhoea 8% (25) 11% (9) 0% 7% (5) 2% (1) Anorexia 5% (15) 5% (4) 1% (1) 13% (9) 2% (1) Hepatomegaly 2% (6) 6% (5) 0% 0% 0% Constipation 1% (2) 0% 0% 0% 0% Dyspepsia 1% (2) 0% 0% 0% 0% Nervous/Psychiatric Headache 8% (25) 31% (25) 1% (1) 7% (5) 0% Dizziness 3% (8) 11% (9) 0% 11% (8) 2% (1) Insomnia 1% (3) 4% (3) 0% 25% (18) 0% Body as a Whole Asthenia 7% (20) 16% (13) 0% 3% (2) 0% Back Pain 1% (2) 4% (3) 0% 0% 0% Abnormal liver function tests ALT 6% (18) 6% (5) 7% (6) 0% 0% AST 5% (16) 5% (4) 7% (6) 0% 0% Bilirubin 2% (7) 0% 1% (1) 0% 0% Cardiovascular Hypotension, postural 2% (6) 17% (14) 0% 0% 0% Palpitations 2% (5) 0% 0% 6% (4) 0% Cutaneous Pruritus 2% (6) 2% (2) 0% 46% (33) 0% Rash 1% (2) 0% 0% 0% 0% Musculoskeletal Myalgia 3% (8) 6% (5) 0% 4% (3) 0% Erythropoietic Splenomegaly 1% (4) 2% (2) 0% 0% 0% Respiratory Coughing 1% (3) 0% 0% 2% (2) 0% PYR = pyrimethamine S = sulfadoxine MFQ = mefloquine ADQ = amodiaquine C= chloroquine * Data for both comparator groups of chloroquine alone plus pyrimethamine and sulfadoxine.
A similar profile of clinical adverse events was reported in children with malaria treated with atovaquone and proguanil hydrochloride in phase III trials as occurred in the adult studies. Page 16 of 42 Prophylaxis In clinical trials of ATOVAQUONE PROGUANIL for prophylaxis of malaria in adults weighing above 40 kg, the most commonly reported adverse events, independent of attributability, were headache, abdominal pain and diarrhoea, and were reported in a similar proportion of subjects receiving ATOVAQUONE PROGUANIL Tablets or placebo.
Table 3 provides a summary of the most common drug-related adverse events reported in clinical trials of ATOVAQUONE PROGUANIL Tablets for the prophylaxis of malaria in non- immune travellers weighing above 40 kg. Page 17 of 42 Table 3 Common Drug-Related, Treatment-Emergent Adverse Events (≥5%) in Non-Immune Travellers Weighing Above 40 kg (ATOVAQUONE PROGUANIL Tablets vs Mefloquine and ATOVAQUONE PROGUANIL Tablets vs Chloroquine/Proguanil) Adverse Event ATOVAQUONE PROGUANIL 1 (n=993) Mefloquine2 (n=471) Chloroquine3/ Proguanil4 (n=511) Active5 n (%) All6 n (%) Active5 n (%) All6 n (%) Active5 n (%) All6 n (%) Any Adverse Event 256 (26) 336 (34) 204 (43) 205 (44) 142 (28) 142 (28) Digestive System 135 (14) 173 (17) 94 (20) 96 (20) 100 (20) 100 (20) Neuro-Psychiatric* 117 (12) 165 (17) 139 (30) 139 (30) 53 (10) 54 (11) Body as a Whole 55 (6) 84 (8) 58 (12) 58 (12) 34 (7) 34 (7) […]