VIBRAMYCIN MONOHYDRATE- doxycycline powder, for suspension VIBRAMYCIN CALCIUM- doxycycline calcium syrup VIBRAMYCIN HYCLATE- doxycycline hyclate capsule VIBRA-TABS- doxycycline hyclate tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Διαθέσιμο από:

Pfizer Laboratories Div Pfizer Inc

INN (Διεθνής Όνομα):

DOXYCYCLINE

Σύνθεση:

DOXYCYCLINE ANHYDROUS 25 mg in 5 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Vibramycin and other antibacterial drugs, Vibramycin 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. Doxycycline is indicated for the treatment of the following infections: Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Περίληψη προϊόντος:

Vibramycin Hyclate (doxycycline hyclate) Capsules Aqua blue capsule imprinted with "VIBRA" on one half and "PFIZER 095" on the other half. NDC 0069-0950-50 100 mg doxycycline bottles of 50 Vibra-Tabs (doxycycline hyclate) Tablets Salmon colored film-coated tablets, imprinted on one side with "VIBRA-TABS" and "PFIZER 099" on the other side. NDC 0069-0990-50 100 mg doxycycline bottles of 50 PRODUCT DISCONTINUED Vibramycin Calcium (doxycycline calcium) Syrup-oral suspension Raspberry-apple flavored oral suspension. NDC 0069-0971-93 50 mg/5mL: 1 pint (473 mL) bottle or NDC 0069-0971-74 NDC 0069-0971-95 50 mg/5mL: 1 pint (473 mL) bottle (with carton) Vibramycin Monohydrate (doxycycline monohydrate) Oral suspension Raspberry-flavored, dry powder for oral suspension. NDC 0069-0970-65 25 mg/5mL, 2 oz (60 mL) bottles All products are to be stored below 86°F (30°C) and dispensed in tight, light-resistant containers (USP).

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

VIBRAMYCIN MONOHYDRATE- DOXYCYCLINE POWDER, FOR SUSPENSION
VIBRAMYCIN CALCIUM- DOXYCYCLINE CALCIUM SYRUP
VIBRAMYCIN HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
VIBRA-TABS- DOXYCYCLINE HYCLATE TABLET, FILM COATED
PFIZER LABORATORIES DIV PFIZER INC
----------
VIBRAMYCIN
CALCIUM
(DOXYCYCLINE CALCIUM ORAL SUSPENSION, USP)
ORAL SUSPENSION
SYRUP
VIBRAMYCIN
HYCLATE
(DOXYCYCLINE HYCLATE CAPSULES, USP)
CAPSULES
VIBRAMYCIN
MONOHYDRATE
(DOXYCYCLINE MONOHYDRATE)
FOR ORAL SUSPENSION
VIBRA-TABS
(DOXYCYCLINE HYCLATE TABLETS, USP)
FILM COATED TABLETS
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Vibramycin and other antibacterial drugs, Vibramycin should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Vibramycin is an antibacterial drug synthetically derived from
oxytetracycline, and is
available as Vibramycin Monohydrate (doxycycline monohydrate);
Vibramycin Hyclate
and Vibra-Tabs (doxycycline hydrochloride hemiethanolate hemihydrate);
and
Vibramycin Calcium (doxycycline calcium) for oral administration.
The structural formula of doxycycline monohydrate is
®
®
®
®
®
with a molecular formula of C
H
N O ∙H O and a molecular weight of 462.46. The
chemical designation for doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-
naphthacenecarboxamide monohydrate. The molecular formula for
doxycycline
hydrochloride hemiethanolate hemihydrate is (C
H
N O ∙HCl) ∙C H O∙H O and the
molecular weight is 1025.89. Doxycycline is a light-yellow crystalline
powder. Doxycycline
hyclate is soluble in water, while doxycycline monohydrate is very
slightly soluble in
water.
Doxycycline has a high degree of lipoid solubility and a low affinity
for calcium binding. It
is highly stable in normal human serum. Doxycycline will not degrade
into an epianhydro
form.
Inert ingredients in the syrup formulation are: apple flavor;
butylparaben; calcium
chloride; carmine; glycerin; hydr