Rx Item-Trimethoprim 100MG 100 Tab by Mayne Pharma USA , Clinical Information:
Generic Code And Description: 9497 Trimethoprim Oral Tablet 100 Mg
Strength: 100 Mg
Dose Form: Tablet
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 8360000 Urinary Anti-Infectives
Active Ingredients: 2873 Trimethoprim 738705
Inactive Ingredients: Drug Class: Drug Class: 8360000 Urinary Anti- Infectives, OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 100 , Brand Label Flag: GENERIC , Storage Temperature Zone: 10 Room Temperature, Item Size Code:100 , Item Strength Code:100MG , Item Abbreviation: Trimethoprim , Generic Form: TAB
SPL UNCLASSIFIED SECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to ...
DESCRIPTION
Trimethoprim is a synthetic antibacterial available in tablet form for oral administration. Each scored white tablet contains 100 mg trimethoprim. Trimethoprim is ...
CLINICAL PHARMACOLOGY
Trimethoprim is rapidly absorbed following oral administration. It exists in the blood as unbound, protein-bound, and metabolized forms. Ten to twenty percent of trimethoprim is metabolized ...
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to ...
CONTRAINDICATIONS
Trimethoprim is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.
WARNINGS
Serious hypersensitivity reactions have been reported rarely in patients on trimethoprim therapy. Trimethoprim has been reported rarely to interfere with hematopoiesis, especially when ...
PRECAUTIONS
General - Prescribing trimethoprim tablets, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and ...
ADVERSE REACTIONS
The adverse effects encountered most often with trimethoprim were rash and pruritus. Dermatologic - Rash, pruritus, and phototoxic skin eruptions. At the recommended dosage regimens of 100 mg ...
OVERDOSAGE
Acute - Signs of acute overdosage with trimethoprim may appear following ingestion of 1 gram or more of the drug and include nausea, vomiting, dizziness, headaches, mental depression, confusion ...
DOSAGE AND ADMINISTRATION
The usual oral adult dosage is 100 mg of trimethoprim every 12 hours or 200 mg of trimethoprim every 24 hours, each for 10 days. The use of trimethoprim in patients with a creatinine clearance of ...
HOW SUPPLIED
Trimethoprim tablets, USP, 100 mg: White, round, convex tablet, debossed "9", scored, "3" on one side and debossed "21 58" on the other, in bottles of 100. NDC 51862-486-01 - Store at 20° to 25°C ...
REFERENCES
1. Brumfitt W, Pursell R. Trimethoprim-sulfamethoxazole in the treatment of bacteriuria in women. J Infect Dis. 1973;128(suppl): S657-S663. 2. Lacey RW, Simpson MHC, Fawcett C, et al. Comparison ...
SPL UNCLASSIFIED SECTION
Distributed by: Mayne Pharma - Greenville, NC 27834 - Rev. 09/2020
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
NDC 51862-486-01 - Trimethoprim - Tablets USP - 100 mg - Rx Only - 100 Tablets - mayne pharma
INGREDIENTS AND APPEARANCE
Product Information
