RIFAMPIN capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

RIFAMPIN (UNII: VJT6J7R4TR) (RIFAMPIN - UNII:VJT6J7R4TR)

Sẵn có từ:

A-S Medication Solutions

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide [e.g., RIFATER® ]1 is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, th

Tóm tắt sản phẩm:

Product: 50090-0964 NDC: 50090-0964-0 30 CAPSULE in a BOTTLE NDC: 50090-0964-3 60 CAPSULE in a BOTTLE

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

RIFAMPIN- RIFAMPIN CAPSULE
A-S MEDICATION SOLUTIONS
----------
RIFAMPIN CAPSULES, USP
RX ONLY
REV. 11/18
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
rifampin capsules USP and other antibacterial drugs, rifampin should
be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by
bacteria.
DESCRIPTION
Rifampin capsules, USP for oral administration contain 150 mg or 300
mg rifampin per
capsule. The 150 mg and 300 mg capsules also contain, as inactive
ingredients: colloidal
silicon dioxide, corn starch, FD&C Blue No. 1, FD&C Red No. 40,
gelatin, lactose
monohydrate, magnesium stearate, sodium lauryl sulfate, talc, and
titanium dioxide.
The printing ink contains ammonium hydroxide, isopropyl alcohol,
n-butyl alcohol,
pharmaceutical glaze, propylene glycol, simethicone, and titanium
dioxide
Rifampin is a semisynthetic antibiotic derivative of rifamycin SV.
Rifampin is a red-brown
crystalline powder very slightly soluble in water at neutral pH,
freely soluble in
chloroform, soluble in ethyl acetate and in methanol. Its molecular
weight is 822.95 and
its chemical formula is C
H
N O
.
The chemical name for rifampin is either:
3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin
5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-
1-piperazinyl)formimidoyl]-2,7-
(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-_b_]furan-1,11(2H)-dione
21-acetate.
Its structural formula is:
CLINICAL PHARMACOLOGY
43
58
4
12
or
ORAL ADMINISTRATION
Rifampin is readily absorbed from the gastrointestinal tract. Peak
serum concentrations
in healthy adults and pediatric populations vary widely from
individual to individual.
Following a single 600 mg oral dose of rifampin in healthy adults, the
peak serum
concentration averages 7 mcg/mL but may vary from 4 to 32 mcg/mL.
Absorption of
rifampin is reduced by about 30% when the drug is ingested with food.
Rifampin is widely distributed throughout the body. It is present in
effective
concentrations