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DARAPRIM
Malaria
Protozoal infections
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Drug Name:

DARAPRIM Rx

Generic Name and Formulations:
Pyrimethamine 25mg; scored tabs.

Company:
Turing Pharmaceuticals LLC

Therapeutic Use:

Indications for DARAPRIM:

Treatment of acute malaria in combination with other antimalarials only. Chemoprophylaxis of malaria due to susceptible strains of plasmodia.

Adults and Children:

Acute treatment: Monotherapy not recommended, must give with concomitant fast-acting schizonticides (eg, chloroquine, quinine). 25mg daily for 2 days with a sulfonamide. Monotherapy in semi-immune adult patients (should circumstances arise): 50mg daily for 2 days; children 4–10yrs: 25mg daily for 2 days. Chemoprophylaxis: <4yrs: 6.25mg once weekly. 4–10yrs: 12.5mg once weekly. >10yrs: 25mg once weekly. Regimens which include suppression should be extended through any characteristic periods of early recrudescence and late relapse, for at least 10 weeks in each case.

Contraindications:

Megaloblastic anemia due to folate deficiency.

Warnings/Precautions:

Renal or hepatic impairment. Folate deficiency (eg, malabsorption syndrome, alcoholism, pregnancy, concomitant phenytoin). Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Increased risk of bone marrow suppression with concomitant antifolic drugs or agents associated with myelosuppression (eg, sulfonamides, trimethoprim-sulfamethoxazole combinations, proguanil, zidovudine, methotrexate). Mild hepatotoxicity with lorazepam.

Pharmacological Class:

Folic acid antagonist.

Adverse Reactions:

Hypersensitivity reactions (may be severe: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, anaphylaxis; discontinue if occurs), hyperphenylalaninemia, hematologic effects; rare: pulmonary eosinophilia. May be carcinogenic.

Generic Availability:

NO

How Supplied:

Tabs—30, 100

Indications for DARAPRIM:

Treatment of toxoplasmosis when used conjointly with a sulfonamide.

Adult:

Give concomitant folinic acid. Initially 50–75mg daily, together with 1–4g daily of a sulfonamide of the sulfapyramidine type (eg, sulfadoxine). Continue for 1–3 weeks depending on response and tolerance. May reduce dose by ½ and continue for additional 4–5 weeks.

Children:

Give concomitant folinic acid and usual pediatric sulfonamide dose. 1mg/kg divided into 2 equal doses; after 2–4 days, may reduce dose by ½ and continue for 1 month.

Contraindications:

Megaloblastic anemia due to folate deficiency.

Warnings/Precautions:

Renal or hepatic impairment. Folate deficiency (eg, malabsorption syndrome, alcoholism, pregnancy, concomitant phenytoin); reduce dose or discontinue drug if develops. Seizure disorders: give small starting dose to avoid CNS toxicity. Obtain semi-weekly blood counts, including platelets. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Increased risk of bone marrow suppression with concomitant antifolic drugs or agents associated with myelosuppression (eg, sulfonamides, trimethoprim-sulfamethoxazole combinations, proguanil, zidovudine, methotrexate). Mild hepatotoxicity with lorazepam.

Pharmacological Class:

Folic acid antagonist.

Adverse Reactions:

Hypersensitivity reactions (may be severe: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, anaphylaxis; discontinue if occurs), hyperphenylalaninemia, hematologic effects (eg, megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia), atrophic glossitis, hematuria, cardiac rhythm disorders; rare: pulmonary eosinophilia. May be carcinogenic.

Generic Availability:

NO

How Supplied:

Tabs—30, 100

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