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Atovaquone-Pro 250-100 100/Bt

  • Manufacturer Name : Glenmark Generics
  • MFG # : 68462040401
  • NDC : 68462040401
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
424823 100/BT Register For Member Price
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Additional Information

Product NameAtovaquone-Pro 250-100 100/Bt
ApplicationAntimalarial
Generic Drug NameAtovaquone / Proguanil HCl
Mechanism of ActionInhibits Plasmodium mitochondrial function and DNA synthesis
Quantity100 Tablets
Strength250 mg - 100 mg
Tablet CoatingFilm-coated for easy swallowing
Route of AdministrationOral
Side EffectsHeadache, nausea, abdominal pain, diarrhea, and dizziness
PrecautionsUse cautiously in patients with severe renal impairment or liver disease
ContraindicationsHypersensitivity to atovaquone, proguanil, or any formulation component
PackagingBottle with secure cap to prevent contamination
Storage RequirementsStore at 20°C to 25°C (68°F to 77°F); protect from light and moisture
UsesPrevention and treatment of malaria, including chloroquine-resistant strains

Description

Atovaquone-Proguanil 250-100 mg is an oral medication used for the prevention and treatment of malaria. It combines two active ingredients: atovaquone and proguanil hydrochloride, which work synergistically to inhibit the development and replication of Plasmodium parasites, the causative agents of malaria. This combination is effective against chloroquine-resistant and multidrug-resistant strains of Plasmodium falciparum.

Each tablet contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride. The product is typically packaged in bottles containing 100 tablets, ensuring adequate supply for prophylactic or therapeutic regimens. The medication is taken orally, usually once daily for prophylaxis or as a three-day course for treatment, depending on the prescribed regimen.

Atovaquone-Proguanil should be stored at controlled room temperatures, between 20°C and 25°C (68°F to 77°F), in its original container to protect it from light and moisture. Side effects of this medication are generally mild and may include headache, nausea, abdominal pain, and diarrhea. Rare but serious adverse effects include allergic reactions or liver function abnormalities.

Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Type Code 1
FDA Approval Date 01/12/2011
FDA Therap Equiv AB
HCPCS -
Market Entry Date 09/15/2011
Medical Coverage -
Termination Date -
Unit TAB
Units Per Pkg 1
Active Ingredients 2943 proguanil HCl 637321; 4112 atovaquone 95233184
AHFS Class 8300800 ANTIMALARIALS
DEA Class NC
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 45855 atovaquone/proguanil HCl ORAL TABLET 250-100 MG
Inactive Ingredients 2537 povidone 9003398
OMP Family -
Product Category RX Pharmaceuticals
Strength 250-100 MG
Common Brand Name COMMON BRAND NAME(S): Malarone
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: penicillamine, "blood thinners" (such as warfarin), metoclopramide. Other medications can affect the removal of atovaquone/proguanil from your body, which may affect how atovaquone/proguanil works. Examples include efavirenz, rifampin, rifabutin, tetracycline, among others.
Allocation Period -
Case Quantity 48
Drug Form Pack Size 100
Form TABLET
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 100
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication, and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication by mouth with food or a milky drink (such as whole milk, milkshake) that contains fat. If you vomit within 1 hour of taking a dose, repeat the dose. If you have vomiting that doesn't stop after taking atovaquone/proguanil, contact a doctor right away. You may need another medication to prevent vomiting or a different malaria medication. Swallow the tablet whole because of its bitter taste. Do not chew. If you have trouble swallowing tablets, this medication may be crushed and mixed with condensed milk. Take the entire mixture right away. Do not save for future use. Dosage is based on your medical condition, on whether you are preventing or treating the illness, and your response to treatment. Dosage in children is also based on weight. To prevent illness, take atovaquone/proguanil as directed by your doctor, usually once daily. Start this medication 1 to 2 days before you enter the malarious area and continue taking the medication while in the area and for 7 days after leaving. If needed, primaquine can be taken for 14 days starting during the last week of treatment with atovaquone/proguanil or starting immediately after you have finished treatment. To treat malaria, take this medication as directed by your doctor, usually once daily for 3 days. It is very important to continue taking this medication exactly as prescribed by your doctor. To help you remember, take it at the same time each day for the entire prescribed time. Do not take more or less of this drug than prescribed. Do not stop taking this drug before completing the full treatment unless directed to do so by your doctor, even if you feel better or do not feel sick. Skipping or changing your dose without approval from your doctor may cause prevention/treatment to be ineffective, cause the amount of parasite to increase, make the infection more difficult to treat (resistant), or worsen side effects. It is important to prevent mosquito bites (such as by using appropriate insect repellents, wearing clothes that cover most of the body, remaining in air-conditioned or well-screened areas, using mosquito nets and insect-killing sprays). Buy insect repellent before traveling. The most effective insect repellents contain diethyltoluamide (DEET). Ask your doctor or pharmacist to recommend the appropriate strengths of mosquito repellent for you/your children. No drug treatment is completely effective in preventing malaria. Get medical help right away if you develop symptoms of malaria (such as fever, chills, headache, other flu-like symptoms). Malaria can return, even months after completing this prescription. Quick treatment of malaria infection is needed to prevent serious, possibly fatal, outcomes. When using atovaquone/proguanil for treatment, tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as blood cell counts, liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (a-TOE-va-kwone/proe-GWAHN-il)
Precautions PRECAUTIONS: Before taking atovaquone/proguanil, tell your doctor or pharmacist if you are allergic to either atovaquone or proguanil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current diarrhea, current vomiting, kidney problems, liver problems, mental/mood problems, seizures. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. While you are pregnant, traveling to an area with malaria places you and your infant at a much higher risk for death and other problems. Discuss the risks and benefits of malaria prevention with your doctor. It is unknown if atovaquone passes into breast milk. The proguanil in this medication passes into breast milk and the effects of this medication on a nursing infant are not known. The CDC recommends against using this product for malaria prevention if you are breastfeeding an infant weighing less than 11 pounds (5 kilograms). Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also How to Use section. Nausea, vomiting, abdominal pain, headache, diarrhea, weakness, loss of appetite, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of serious liver problems (such as nausea and vomiting that are severe or don't stop, abdominal pain, unexplained tiredness, dark urine, yellowing eyes/skin), signs of anemia (such as worsening tiredness, rapid breathing, pale skin/lips/nails, fast heartbeat while resting), signs of severe infection (such as high fever, severe chills, body aches, sore throat). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication contains 2 medicines: atovaquone and proguanil. It is used to prevent and treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells and other tissues. In some cases, you may need to take a different medication (such as primaquine) to complete your treatment. Both medications may be needed for a complete cure and to prevent the return of infection (relapse). Atovaquone/proguanil belongs to a class of drugs known as antimalarials. The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.

Frequently Asked Questions(FAQs)

The cost of Atovaquone-Pro 250-100 100/Bt is $0.00 .
Atovaquone-Pro 250-100 100/Bt is manufactured by Glenmark Generics.
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