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 Lifesciences Limited

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 65841-821-06 in bottle of 30 capsules NDC 65841-821-18 in bottle of 50 capsules NDC 65841-821-16 in bottle of 90 capsules NDC 65841-821-01 in bottle of 100 capsules NDC 65841-821-05 in bottle of 500 capsules NDC 65841-821-10 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 65841-822-06 in bottle of 30 capsules NDC 65841-822-18 in bottle of 50 capsules NDC 65841-822-16 in bottle of 90 capsules NDC 65841-822-01 in bottle of 100 capsules NDC 65841-822-05 in bottle of 500 capsules NDC 65841-822-10 in bottle of 1000 capsules NDC 65841-822-77 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 65841-823-06 in bottle of 30 capsules NDC 65841-823-18 in bottle of 50 capsules NDC 65841-823-16 in bottle of 90 capsules NDC 65841-823-01 in bottle of 100 capsules NDC 65841-823-21 in bottle of 250 capsules NDC 65841-823-05 in bottle of 500 capsules NDC 65841-823-10 in bottle of 1000 capsules NDC 65841-823-77 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 LIFESCIENCES LIMITED
----------
DOXYCYCLINE CAPSULES, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-821-01 in bottle of 100 Capsules
Doxycycline Capsules USP, 50 mg
Rx Only
100 Capsules
NDC 65841-822-01 in bottle of 100 Capsules
Doxycycline Capsules USP, 75 mg
Rx Only
100 Capsules
NDC 65841-823-01 in bottle of 100 Capsules
Doxycycline Capsules USP, 100 mg
Rx Only
100 Capsules
DOXYCYCLINE
doxycycline capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-821
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS -
UNII:334895S862)
DOXYCYCLINE
ANHYDROUS
50 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (OPAQUE YELLOW) , WHITE (OPAQUE WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
16mm
FLAVOR
IMPRINT CODE
782
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
821-06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
03/14/2016
2
NDC:65841-
821-18
50 in 1 BOTTLE; Type 0: Not a Combination
Product
03/14/2016
3
NDC:65841-
821-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
03/14/2016
4
NDC:65841-
821-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
03/14/2016
5
NDC:65841-
821-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
03/14/2016
6
NDC:65841-
821-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
03/14/2016
7
NDC:65841-
821-77
10 in 1 CART