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Atovaquone + proguanil

آتوواکون + پروگوانیل

⚠ Unverified

🪱 Antiparasitic Products, Insecticides And RepellentsAntimalarial

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 2 contraindications 🇺🇸 FDA approved (NDA) NDA021078 ATC P01AX06

Market / country: 🇺🇸 USA

Malarone (US)

🧮 Dose calculator

Disease / regimen

Malaria (prophylaxis and treatment) · Regimen source: FDA Malarone · 2.1, Table 1

• Shown as the atovaquone component. Start 1–2 days before entering the area, daily during the stay and for 7 days after return; with food or a milky drink. Over 40 kg: one adult tablet. FDA Malarone · 2.1 FDA Malarone · 2

Formulation

Age *

Weight (kg) *

Enter age and weight.

🛡️ Safety & information

Contraindications

⛔ Hypersensitivity to atovaquone or proguanil. FDA Malarone · 4
⛔ Prophylaxis contraindicated in severe renal impairment (CrCl <30). FDA Malarone · 4 FDA Malarone · 2.3

Formulations

Adult tablet: atovaquone 250 mg + proguanil 100 mg — tablet 🇺🇸 USA FDA Malarone · 3
Pediatric tablet: atovaquone 62.5 mg + proguanil 25 mg — tablet 🇺🇸 USA FDA Malarone · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Malarone · 8.1
“Risk Summary Available data from published literature and postmarketing experience with use of MALARONE in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes .”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Malarone · 8.2
“Risk Summary There are no data on the presence of atovaquone in human milk; however, proguanil is present in human milk.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Malarone · 8.4
“The efficacy and safety of MALARONE have been established for the prophylaxis of malaria in controlled trials involving pediatric patients weighing 11 kg or more [see Clinical Studies ( 14.1 )] .”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Malarone · 8.5
“In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, the higher systemic exposure to cycloguanil, and the greater frequency of concomitant disease or other drug therapy.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA021078
DailyMed (FDA label)FDA Malarone
MedlinePlus (NIH)Atovaquone
WHO ATC/DDDP01AX06
Darooyab (Iran)Atovaquone

🇮🇷 Not found in Iran list Darooyab · G-1100/Atovaquone

Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Malarone · 3 FDA Malarone · 2.1, Table 1 FDA Malarone · 2.1 FDA Malarone · 2 FDA Malarone · 2.2, Table 2 FDA Malarone · 2.2 FDA Malarone · 4 FDA Malarone · 2.3 FDA Malarone · 8.1 FDA Malarone · 8.2 FDA Malarone · 8.4 FDA Malarone · 8.5 FDA Malarone · SPL approval / marketing category
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-1100/Atovaquone
Clinical review⚠ Unverified