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