DOXYCYCLINE HYCLATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Available from:

Zydus Pharmaceuticals (USA) Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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: -   Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. -   Respiratory tract infections caused by Mycoplasma pneumoniae. -   Lymphogranuloma venereum caused by Chlamydia trachomatis . -   Psittacosis (ornithosis) caused by Chlamydophila psittaci . -   Trachoma caused by Chlamydia trachomatis , although the infectiou

Product summary:

Doxycycline hyclate capsules, USP contain doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg. Doxycycline hyclate capsules USP, 50 mg are yellowish powder filled in size '3' hard gelatin capsule with light blue opaque cap imprinted with 'CHL' in white ink and white opaque body imprinted with 'D75' in black ink. NDC 68382-221-18 in bottle of 50 capsules with child-resistant closure NDC 68382-221-01 in bottle of 100 capsules NDC 68382-221-05 in bottle of 500 capsules NDC 68382-221-10 in bottle of 1000 capsules NDC 68382-221-77 in cartons of 100 capsules (10 x 10 unit-dose) Doxycycline hyclate capsules USP, 100 mg contains yellowish powder filled in size '1' hard gelatin capsule with light blue opaque cap imprinted with 'CHL' in white ink and light blue opaque body imprinted with 'D76' in black ink. NDC 68382-222-18 in bottle of 50 capsules with child-resistant closure NDC 68382-222-01 in bottle of 100 capsules NDC 68382-222-05 in bottle of 500 capsules NDC 68382-222-10 in bottle of 1000 capsules NDC 68382-222-77 in cartons of 100 capsules (10 x 10 unit-dose) Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
ZYDUS PHARMACEUTICALS (USA) INC.
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DOXYCYCLINE HYCLATE CAPSULES
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
hyclate and other antibacterial drugs, doxycycline hyclate should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Doxycycline hyclate is an antibacterial drug synthetically derived
from oxytetracycline, and is available
as doxycycline hyclate capsules for oral administration.
The chemical designation for doxycyclin is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide
monohydrate.
The structural formula of doxycycline hyclate is
Doxycycline hyclate, USP is yellow to light yellow powder. It is
freely soluble in water and methanol,
sparingly soluble in alcohol; practically insoluble in chloroform and
in ether. It dissolves in aqueous
solution of alkali hydroxides and carbonates.
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.
Each capsule contains doxycycline hyclate equivalent to doxycycline 50
mg or 100 mg and inactive
ingredients: anhydrous lactose, croscarmellose sodium, D&C red 28, FD
& C blue 1, gelatin,
microcrystalline cellulose, magnesium stearate and sodium lauryl
sulfate and titanium dioxide. Each
capsule cap is printed with white pharmaceutical ink and capsule body
is printed with black
pharmaceutical ink which contains following ingredient butyl alcohol,
dehydrated alcohol, isopropyl
alcohol, potassium hydroxide, propylene glycol, strong ammonia
solution, and shellac. Additionally
black pharmaceutical ink also contains black iron oxide.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degree. They are
concentrated by the liver in the bile and excreted in t