Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Zydus Lifesciences Limited
DOXYCYCLINE
DOXYCYCLINE ANHYDROUS 50 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Lestu allt skjalið