{"adverse_reactions":["ADVERSE REACTIONS Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The in vitro and in vivo antibacterial action of paromomycin closely parallels that of neomycin. It is poorly absorbed after oral administration, with almost 100% of the drug recoverable in the stool."],"contraindications":["CONTRAINDICATIONS Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction."],"description":["DESCRIPTION Paromomycin sulfate is a broad spectrum antibiotic produced by Streptomyces riomosus var. paromomycinus . It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate is designated chemically as O -2,6-Diamino-2,6-dideoxy-β-L-idopyranosyl-(1→3)- O -β-D-ribofuranosyl(1→5)- O -[2-amino-2-deoxy-α-D-glucopyranosyl-(1→4)]-2-deoxystreptamine sulfate (salt). The molecular formula is C 23 H 45 N 5 O 14 • xH 2 SO 4 , with a molecular weight of 615.64 (base). Its structural formula is: Each capsule, for oral administration, contains paromomycin sulfate equivalent to 250 mg paromomycin. Each capsule also contains the following inactive ingredients: FD&C Green #3; FD&C Yellow #5 (tartrazine); gelatin, NF; and titanium dioxide, USP. chem-structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Intestinal amebiasis: Adults and Children: Usual dose—25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days. Management of hepatic coma: Adults: Usual dose—4 g daily in divided doses, given at regular intervals for five to six days."],"effective_time":"20140224","how_supplied":["HOW SUPPLIED Paromomycin Sulfate Capsules, each contain paromomycin sulfate equivalent to 250 mg paromomycin. The capsule is green/yellow, imprinted “175” in black ink on the cap and body. bottles of 20 NDC 54868-4815-1 bottles of 60 NDC 54868-4815-0 Store at controlled room temperature 15°-30°C (59°-86°F). Protect from moisture. Caution —Federal law prohibits dispensing without prescription. Manufactured by: C.S. No.: 5106T02 Caraco Pharmaceutical Laboratories, Ltd. Iss.: 11/08 1150 Elijah McCoy Drive Detroit, MI 48202 Distributed by: Physicians Total Care, Inc. Tulsa, OK 74146"],"id":"1f3f2f79-ce65-48f2-a7d6-7b09fd5649d1","indications_and_usage":["INDICATIONS AND USAGE Paromomycin sulfate is indicated for intestinal amebiasis—acute and chronic (NOTE—It is not effective in extraintestinal amebiasis); management of hepatic coma—as adjunctive therapy."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL. PRINCIPAL DISPLAY PANEL – 250 mg Paromomycin Sulfate Capsules, USP 250 mg* Rx Only No Label Available"],"precautions":["PRECAUTIONS The use of this antibiotic, as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patient is essential. If new infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken. The drug should be used with caution in individuals with ulcerative lesions of the bowel to avoid renal toxicity through inadvertent absorption. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity."],"set_id":"345955c8-9df0-4b49-80b1-e30bf396f6af","spl_product_data_elements":["Paromomycin Sulfate Paromomycin Sulfate PAROMOMYCIN SULFATE PAROMOMYCIN FD&C GREEN NO. 3 FD&C YELLOW NO. 5 GELATIN TITANIUM DIOXIDE GREEN YELLOW CAPSULE 175"],"version":"1"}