DOXYCYCLINE capsule DOXYCYCLINE MONOHYDRATE capsule
DOXYCYCLINE MONOHYDRATE by
Drug Labeling and Warnings
DOXYCYCLINE MONOHYDRATE by is a Prescription medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- CLINICAL PHARMACOLOGY PART 2
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- ANIMAL PHARMACOLOGY AND OR TOXICOLOGY
- STORAGE AND HANDLING
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HOW SUPPLIED
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
NDC: 68382-782-18 in bottle of 50 capsules
NDC: 68382-782-16 in bottle of 90 capsules
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
NDC: 68382-706-18 in bottle of 50 capsules
NDC: 68382-706-16 in bottle of 90 capsules
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
NDC: 68382-707-18 in bottle of 50 capsules
NDC: 68382-707-16 in bottle of 90 capsules
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.
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SPL UNCLASSIFIED SECTION
Manufactured by:
Cadila Healthcare Limited
Ahmedabad, India.
Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
Rev.: 02/18
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.
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REFERENCES
Clinical and Laboratory Standards Institute (CLSI). Methods for Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard – Second Edition. CLSI document M24-A2 [2011], Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA.
Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195.
Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997;89:524-528.
Horne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25:315-317.
Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing 2000; 225-226.Please address medical inquiries to, MedicalAffairs@zydususa.com Tel.: 1-877-993-8779.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOXYCYCLINE
doxycycline capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 61919-276(NDC:43386-792) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 100 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow (Opaque Body) , brown (Opaque Cap) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code NL792;100mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 61919-276-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 03/17/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204446 03/17/2016 DOXYCYCLINE MONOHYDRATE
doxycycline monohydrate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 61919-624(NDC:68382-707) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS 100 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE RED (UNII: 1K09F3G675) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AMMONIA (UNII: 5138Q19F1X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM LAURYL SULFATE (UNII: 368GB5141J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SHELLAC (UNII: 46N107B71O) Product Characteristics Color yellow (OPAQUE YELLOW) , orange (OPAQUE ORANGE) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 707 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 61919-624-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2019 2 NDC: 61919-624-14 14 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205115 04/05/2019 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-276, 61919-624)
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