Store at 15° to 25☌ (59° to 77☏) in a dry place and protect from light.ĭistributed by: Turing Pharmaceuticals LLC New York, New York 10036. White, scored tablets containing 25 mg pyrimethamine, imprinted with “DARAPRIM” and “A3A” in bottles of 100 ( NDC 69413-330-10) and bottles of 30 ( NDC 69413-330-30). Infants and children under 4 years – 6.25 mg (¼ tablet) once weekly. For Chemoprophylaxis of MalariaĪdults and pediatric patients over 10 years – 25 mg (1 tablet) once weekly Children 4 through 10 years – 12.5 mg (½ tablet) once weekly Regimens which include suppression should be extended through any characteristic periods of early recrudescence and late relapse, i.e., for at least 10 weeks in each case. In any event, clinical cure should be followed by the once-weekly regimen described below for chemoprophylaxis. Should circumstances arise wherein DARAPRIM must be used alone in semi- immune persons, the adult dosage for acute malaria is 50 mg for 2 days children 4 through 10 years old may be given 25 mg daily for 2 days. DARAPRIM is only recommended for patients infected in areas where susceptible plasmodia exist. However, DARAPRIM at a dosage of 25 mg daily for 2 days with a sulfonamide will initiate transmission control and suppression of non- falciparum malaria. Fast-acting schizonticides, such as chloroquine or quinine, are indicated for treatment of acute malaria. For Treatment of Acute MalariaĭARAPRIM is NOT recommended alone in the treatment of acute malaria. The usual pediatric sulfonamide dosage is used in conjunction with DARAPRIM. The pediatric dosage of DARAPRIM is 1 mg/kg/day divided into 2 equal daily doses after 2 to 4 days this dose may be reduced to one half and continued for approximately 1 month. The dosage may then be reduced to about one half that previously given for each drug and continued for an additional 4 to 5 weeks. This dosage is ordinarily continued for 1 to 3 weeks, depending on the response of the patient and tolerance to therapy. The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a sulfonamide of the sulfapyrimidine type, e.g. Concurrent administration of folinic acid is strongly recommended in all patients. Young patients may tolerate higher doses than older individuals. At the dosage required, there is a marked variation in the tolerance to the drug. The dosage of DARAPRIM for the treatment of toxoplasmosis must be carefully adjusted so as to provide maximum therapeutic effect and a minimum of side effects. Pyrimethamine, known chemically as 5-(4- chlorophenyl)-6-ethyl-2, 4-pyrimidinediamine, has the following structural formula:ĭOSAGE AND ADMINISTRATION For Treatment of Toxoplasmosis Each scored tablet contains 25 mg pyrimethamine and the inactive ingredients corn and potato starch, lactose, and magnesium stearate. DESCRIPTIONĭARAPRIM (pyrimethamine) is an antiparasitic compound available in tablet form for oral administration.
You may report side effects to FDA at 1-80. For more information, ask your doctor or pharmacist.Ĭall your doctor for medical advice about side effects. These are not all the possible side effects of Daraprim. Tell the doctor if you have any side effect that bothers you or that does not go away. The most common side effects of Daraprim include:
Get medical help right away, if you have any of the symptoms listed above.
#Prim and serious skin
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