DOXYCYCLINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

DOXYCYCLINE

Composition:

DOXYCYCLINE ANHYDROUS 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP 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 capsules, USP are 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 infectious agent i

Product summary:

Doxycycline Capsules USP, 50 mg are light yellow to yellow powder filled in hard gelatin capsule shell having an opaque yellow cap and an opaque white body printed with 782 on cap with black ink and are supplied as follows: NDC 68382-782-06 in bottle of 30 capsules with child-resistant closure NDC 68382-782-18 in bottle of 50 capsules with child-resistant closure NDC 68382-782-16 in bottle of 90 capsules with child-resistant closure NDC 68382-782-01 in bottle of 100 capsules NDC 68382-782-05 in bottle of 500 capsules NDC 68382-782-10 in bottle of 1000 capsules NDC 68382-782-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Doxycycline Capsules USP, 75 mg are light yellow to yellow powder filled in hard gelatin capsule shells having an opaque orange cap and an opaque white body printed with 706 on cap in black ink and are supplied as follows: NDC 68382-706-06 in bottle of 30 capsules with child-resistant closure NDC 68382-706-18 in bottle of 50 capsules with child-resistant closure NDC 68382-706-16 in bottle of 90 capsules with child-resistant closure NDC 68382-706-01 in bottle of 100 capsules NDC 68382-706-05 in bottle of 500 capsules NDC 68382-706-10 in bottle of 1000 capsules NDC 68382-706-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Doxycycline Capsules USP, 100 mg are light yellow to yellow powder filled in hard gelatin capsule shells having an opaque yellow cap and an opaque orange body printed with 707 on cap in black ink and are supplied as follows: NDC 68382-707-06 in bottle of 30 capsules with child-resistant closure NDC 68382-707-18 in bottle of 50 capsules with child-resistant closure NDC 68382-707-16 in bottle of 90 capsules with child-resistant closure NDC 68382-707-01 in bottle of 100 capsules NDC 68382-707-21 in bottle of 250 capsules NDC 68382-707-05 in bottle of 500 capsules NDC 68382-707-10 in bottle of 1000 capsules NDC 68382-707-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline. Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet. Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline) and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE - DOXYCYCLINE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
----------
DOXYCYCLINE CAPSULES, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline capsules and other antibacterial drugs, doxycycline
capsules should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
DESCRIPTION
Doxycycline is a broad-spectrum antibacterial synthetically derived
from oxytetracycline.
Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain
doxycycline
monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline
for oral
administration. The chemical designation of the light-yellow to pale
yellow powder is
alpha-6-deoxy-5-oxytetracycline.
Structural formula:
C
H
N O • H O M.W. = 462.45
Doxycycline has a high degree of lipid 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 doxycycline capsule, USP intended for oral administration
contains 50 mg or 75
mg or 100 mg of doxycycline. In addition, each capsule contains the
following inactive
ingredients: colloidal silicon dioxide, gelatin, magnesium stearate,
microcrystalline
cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium
dioxide.
Additionally, each 50 and 100 mg capsule shell contains iron oxide
yellow, each 75 mg
22
24
2
8
2
and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1,
FD & C red # 3
and FD & C yellow # 6 and each 100 mg capsule shell contains iron
oxide red. The
capsule is printed with black pharmaceutical ink which contains
following ingredients:
black iron oxide, potassium hydroxide, propylene glycol, shellac and
strong ammonia
solution.
The Product meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degrees.
They are concentrated by the liver in the bile and excreted in the
urine and feces at high
concentrations in a biologically