Capitals indicate lifethreatening, underlines indicate most frequent. Those allergic to atovaquone should not use this medication. Fda for atovaquone oral suspension usp, 750 mg5 ml, a generic version of mepron1 oral. Mepron atovaquone is a semithick bright yellow suspension liquid that is taken orally. When atovaquone is used to treat pneumonia, it is usually taken with meals twice a day for 21 days. Instruct patient and familycaregivers to report other troublesome side effects such as severe or prolonged headache, sleep loss, skin rash, fever, or gi problems diarrhea, nausea, vomiting. Atovaquone oral suspension drug information, side effects, faqs. Atovaquone suspension compared with aerosolized pentamidine. Information for the user wellvone 750 mg5 ml oral suspension. Mepron oral suspension is contraindicated in patients who develop or have a history of. Mepron atovaquone dose, indications, adverse effects. This ed material has been downloaded from a licensed data provider and is not for distribution, except. Selected from data included with permission and ed by first databank, inc. List of drug master files dmf of atovaquone active pharmaceutical ingredient api submitted to the u.
Information from its description page there is shown below. Atovaquone oral suspension, usp is a formulation of microfine particles of atovaquone, usp. Atovaquone oral suspension is a quinone antimicrobial drug. Atovaquone oral suspension, usp is for oral administration and is bright yellow with a citrus flavor. The other ingredients are benzyl alcohol, xanthan gum, poloxamer 188, saccharin sodium, purified water, tutti frutti flavouring sweet orange oil. Incidences of pcp and death were higher in subjects receiving 750 mg of atovaquone than in subjects receiving 1500 mg. Pdf relative bioavailability of atovaquone suspension when. The usual dosage of atovaquone suspension is 750mg 1 teaspoon or 5ml two times daily or 1500 mg 2 teaspoons or 10 ml once daily.
It is used to prevent and to treat pneumocystis carinii pneumonia pcp. For example, rifabutin mycobutin or rifampin rifadin, rofact should not be taken together with atovaquone. Atovaquone side effects, dosage, interactions drugs. This file contains additional information, probably added from the digital camera or scanner used to create or digitize it. Each 5 ml of atovaquone oral suspension, usp contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, flavor natural citrus, poloxamer 188, purified water, saccharin sodium, and xanthan gum. A phase i doseescalating safety and pharmacokinetic study evaluated an oral suspension of micronized atovaquone m atovaquone in infants and children stratified into age groups from 1 month to 12 years of age. Public assessment report scientific discussion atovaquon.
This medication works best when the amount of medicine in your body is kept at a constant level. Atovaquone compared with dapsone for the prevention of pneumocystis carinii pneumonia in patients with hiv infection who cannot tolerate trimethoprim, sulfonamides, or both. Atovaquone usp is a yellow colored powder that is freely soluble in tetrahydrofuran, soluble in chloroform and sparingly soluble in acetone. Atovaquone must be administered with meals as failure to do so may reduce therapeutic efficacy. Atovaquone nanosuspensions show excellent therapeutic effect. Atovaquone is 99% protein bound and is eliminated almost exclusively by biliary excretion. Read more about the prescription drug atovaquone suspension oral. Aug 07, 2019 mepron atovaquone is supplied in strength of 750 mg atovaquone in each teaspoonful 5 ml. Atovaquone oral what should i tell my health care suspension. Depending on the infection that is being treated, higher doses may be needed. If the file has been modified from its original state, some details may not fully reflect the modified file.
Atovaquone does not cause bone marrow suppression, and because it lacks antibacterial activity, it should not affect the gastrointestinal flora. Taking atovaquone with dietary fat increases its absorption, and therefore tablets should be taken with a meal or a milky beverage. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Mepron is supplied in 210ml bottles or 5ml foil pouches. Mepron suspension is a formulation of microfine particles of atovaquone. Mepron oral suspension is a quinone antimicrobial drug indicated for. Indications, dose, contraindications, sideeffects, interactions, cautions, warnings and other safety information for atovaquone. May 21, 20 this study will be a singlecenter, phase i, randomized, open, in fed condition, parallel, single dose study to evaluate the pharmacokinetics and the safety, tolerability of atovaquone proguanil combination tablets and atovaquone suspension in japanese healthy male subjects. Glenmark pharmaceuticals receives anda approval for atovaquone oral suspension usp, 750 mg5 ml mumbai, india, november 22, 2018. Aug 07, 2019 mepron suspension is a formulation of microfine particles of atovaquone each 5 ml of mepron suspension contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum. Atovaquone is an alternative oral agent for the treatment of mildtomoderate p. Atovaquone compared with dapsone for the prevention of. Mepron suspension is for oral administration and is bright yellow with a citrus flavor. For children, the dosage is also based on age and weight.
Atovaquone lyme inside living with late stage lyme disease. Prevention of pneumocystis jirovecii pneumonia pcp in adults and adolescents aged. Pdf atovaquone compared with dapsone for the prevention of. Find patient medical information for atovaquone oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Dosing varies for adults and pediatric patients and is determined by the prescribing doctor. Medicare coverage and pricing details for atovaquone. When atovaquone is used to prevent pneumonia, it is usually taken with a meal once a day. Atovaquone comes as a suspension liquid to take by mouth. Each teaspoonful 5 ml contains 750 mg of atovaquone and the inactive.
Read all of this leaflet carefully before you start taking this medicine because it contains. Mepron oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions e. Information for the user atovaquone glenmark 750 mg5 ml oral. Nov 09, 2018 atovaquone is a medication that interferes with the reproduction of protozoa singlecell organisms that can cause disease in the body. The suspension should be taken twice daily at a dose of 750mg.
The liquid resembles paint and us lymies call it by a few nicknames such as yellow paint. For information on changes after this date please refer to the steps taken after finalisation at the end of this par. Atovaquone was detected by hplc in the sera, brains, livers, and lungs of mice treated with ans 1 and 10 mgkg and atovaquone suspension 100 mgkg. Atovaquone suspension fda prescribing information, side. Atovaquone must be taken with food so your body can absorb as much of the medication as possible so it can work well. Mepron can temporally stain clothing, kitchen sinks, counter tops or just about anything it touches. Note that failure to administer mepron suspension with meals may limit response to therapy. Jul 29, 2019 atovaquone oral suspension, usp is a formulation of microfine particles of atovaquone, usp. The chemical name of atovaquone is 1,4naphthalenedione, 244chlorophenylcyclohexyl3hydroxy, trans. Plasma concentrations do not increase proportionally with dose after ascending repeatdose administration of atovaquone oral suspension. Atovaquone is a highly lipophilic compound with poor bioavailability. Atovaquone suspension at 1500 mg once a day has an efficacy similar to that of aerosolized pentamidine for prevention of pcp in hivinfected subjects and is a safe, effective alternative in those who are intolerant to. Atovaquone has also been used with azithromycin in the treatment of babesiosis. Atovaquone suspension may cause a yellow staining of clothing so care should be taken to avoid spillage.
The atovaquone particles, reduced in size to facilitate absorption, are significantly smaller than those in the previously marketed tablet formulation. Certain drugs can increase or decrease the effect of atovaquone. Learn more about medicare prescription drug plans and savings with goodrx. The demonstration of atovaquone in brain tissue at low but measurable concentrations is particularly important.
Atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions e. Atovaquone medicare coverage and copay details goodrx. Atovaquone is a highly lipophilic compound with low aqueous solubility. Each 5 ml spoonful of wellvone suspension contains 750 mg of the active ingredient atovaquone 1 ml of wellvone contains 150 mg atovaquone. Pdf atovaquone compared with dapsone for the prevention. Atovaquone a toe va kwone is an antiinfective medicine. Atovaquone suspension oral mepron side effects, medical. Existing route of synthesis of atovaquone strategy adopted in the literature for synthesis of atovaquone i. Mepron is a bright yellow, citrusflavored, oral suspension containing 750 mg of atovaquone per 5 ml. Ultraperformance lcmsms method for the quantification of.
Dosages of 10, 30, and 45 mgkg of body weightday were evaluated as single daily doses over a period of 12 days. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Overdoses of atovaquone suspension in three patients did not result in permanent injury t. Atovaquone api dmfs us drug master file dmf details. Read all of this leaflet carefully before you start taking this medicine because it contains important. Consumer information about the medication atovaquone suspension oral mepron, includes side effects, drug interactions, recommended dosages, and storage information. Single oral dose study of atovaquoneproguanil hydrochloride. Atovaquone take atovaquone for the duration of suspension. We conducted a multicenter, openlabel, randomized trial comparing daily atovaquone 1500mg suspension with daily dapsone 100 mg for the prevention of p. Pdf to compare the relative bioavailability of a single atovaquone 750 mg suspension oral dose when administered in the fasting state, after a normal. If you have questions about this medicine talk to your doctor, pharmacist, or health care provider. Remind patient to take this drug as directed for the full course of treatment even if feeling better.
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