NITROFURANTOIN capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L), NITROFURANTOIN MONOHYDRATE (UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L)

Sẵn có từ:

BluePoint Laboratories

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) and other antibacterial drugs,Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals)  should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribut

Tóm tắt sản phẩm:

Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) is available as 100 mg opaque yellowish brown and pale yellow capsules imprinted “101” on both cap and body. Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.] Rx Only CLINICAL STUDIES Controlled clinical trials comparing Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) 100 mg p.o. q12h and nitrofurantoin (macrocrystals) capsule 50 mg p.o. q6h in the treatment of acute uncomplicated urinary tract infections demonstrated approximately 75% microbiologic eradication of susceptible pathogens in each treatment group. Mfg. by: Swiss Pharmaceutical Co. Ltd. Tainan City, 74442 Taiwan For BluePoint Laboratories Rev.: 10/2019

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

NITROFURANTOIN- NITROFURANTOIN CAPSULE
BLUEPOINT LABORATORIES
----------
NITROFURANTOIN CAPSULES, USP (MONOHYDRATE/MACROCRYSTALS)-
NITROFURANTOIN AND NITROFURANTOIN
MONOHYDRATE CAPSULE
NITROFURANTOIN CAPSULES, USP (MONOHYDRATE/MACROCRYSTALS)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Nitrofurantoin
Capsules, USP (monohydrate/macrocrystals) and other antibacterial
drugs, Nitrofurantoin Capsules,
USP (monohydrate/macrocrystals) should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Nitrofurantoin is an antibacterial agent specific for urinary tract
infections. Nitrofurantoin Capsules ,
USP (monohydrate/macrocrystals)is a hard gelatin capsule shell
containing the equivalent of 100 mg of
nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals
and 75 mg of nitrofurantoin
monohydrate.
The chemical name of nitrofurantoin macrocrystals is
1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-
imidazolidinedione. The chemical structure is the following:
Molecular Weight: 238.16
The chemical name of nitrofurantoin monohydrate is
1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-
imidazolidinedione monohydrate. The chemical structure is the
following:
Molecular Weight: 256.17
INACTIVE INGREDIENTS: Each capsule contains carbomer 974P,
pregelatinized starch, sucrose, FD&C
Blue No.1, FD&C Yellow No. 6, D&C Yellow No. 10, FD&C Red No.40,
gelatin, titanium dioxide,
lactose, magnesium stearate, povidone, talc, sodium lauryl sulfate,
colloidal silicon dioxide and
Opacode® black ink S-1-17843 (consist of shellac, ferrosoferric
oxide, butyl alcohol, propylene
glycol, isopropyl alcohol and ammonia).
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY
Each Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals)
contains two forms of nitrofurantoin.
Twenty-five percent is macrocrystalline nitrofurantoin, which has
slower dissolution and absorption
than nitrofurantoin monohydrate. The remaini