DOXYCYCLINE
Generic: DOXYCYCLINE
Basic Information
Manufacturer
Lupin Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
81c5a7fc-3fe0-40b2-bae0-c79eb0b27697
Indications & Usage
1 INDICATIONS AND USAGE Doxycycline capsules are a tetracycline- class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients ( 1.1 ) Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections.
Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
( 1.2 ).
Doxycycline capsules have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.( 1.2 ).
1.1 Indication Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.
1.2 Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections.
Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, doxycycline capsules should be used only as indicated.
Doxycycline capsules USP, have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.
Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
( 1.2 ).
Doxycycline capsules have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.( 1.2 ).
1.1 Indication Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.
1.2 Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections.
Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, doxycycline capsules should be used only as indicated.
Doxycycline capsules USP, have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.
Adverse Reactions
6 ADVERSE REACTIONS Some of the most common adverse reactions (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Clinical Trials of Doxycycline Capsules In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received doxycycline capsules or placebo over a 16-week period.
The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥ 1% for the active arm: Note: Percentages based on total number of study participants in each treatment group.
Table 1: Incidence (%) of Selected Adverse Reactions in Clinical Trials of Doxycycline Capsules (n=269) vs.
Placebo (n=268) Doxycycline Capsules Placebo Nasopharyngitis 13 (5) 9 (3) Pharyngolaryngeal Pain 3 (1) 2 (1) Sinusitis 7 (3) 2 (1) Nasal Congestion 4 (2) 2 (1) Fungal Infection 5 (2) 1 (0) Influenza 5 (2) 3 (1) Diarrhea 12 (5) 7 (3) Abdominal Pain Upper 5 (2) 1 (0) Abdominal Distention 3 (1) 1 (0) Abdominal Pain 3 (1) 1 (0) Stomach Discomfort 3 (1) 2 (1) Dry Mouth 3 (1) 0 (0) Hypertension 8 (3) 2 (1) Blood Pressure Increase 4 (2) 1 (0) Aspartate Aminotransferase Increase 6 (2) 2 (1) Blood Lactate Dehydrogenase Increase 4 (2) 1 (0) Blood Glucose Increase 3 (1) 0 (0) Anxiety 4 (2) 0 (0) Pain 4 (2) 1 (0) Back Pain 3 (1) 0 (0) Sinus Headache 3 (1) 0 (0) Adverse Reactions for Tetracyclines : The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region.
Hepatotoxicity.
Esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class.
Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [ see Dosage and Administration ( 2 ) ].
Renal toxicity: Rise in BUN has been reported and is apparently dose-related [ see Warnings and Precautions ( 5.4 ) ].
Skin: maculopapular and erythematous rashes.
Exfoliative dermatitis.
Photosensitivity is discussed above [ see Warnings and Precautions ( 5.5 ) ].
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.
6.2 Postmarketing Adverse Reactions Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post approval use of doxycycline capsules.
Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.
Skin: fixed drug eruption Psychiatric: depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Clinical Trials of Doxycycline Capsules In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received doxycycline capsules or placebo over a 16-week period.
The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥ 1% for the active arm: Note: Percentages based on total number of study participants in each treatment group.
Table 1: Incidence (%) of Selected Adverse Reactions in Clinical Trials of Doxycycline Capsules (n=269) vs.
Placebo (n=268) Doxycycline Capsules Placebo Nasopharyngitis 13 (5) 9 (3) Pharyngolaryngeal Pain 3 (1) 2 (1) Sinusitis 7 (3) 2 (1) Nasal Congestion 4 (2) 2 (1) Fungal Infection 5 (2) 1 (0) Influenza 5 (2) 3 (1) Diarrhea 12 (5) 7 (3) Abdominal Pain Upper 5 (2) 1 (0) Abdominal Distention 3 (1) 1 (0) Abdominal Pain 3 (1) 1 (0) Stomach Discomfort 3 (1) 2 (1) Dry Mouth 3 (1) 0 (0) Hypertension 8 (3) 2 (1) Blood Pressure Increase 4 (2) 1 (0) Aspartate Aminotransferase Increase 6 (2) 2 (1) Blood Lactate Dehydrogenase Increase 4 (2) 1 (0) Blood Glucose Increase 3 (1) 0 (0) Anxiety 4 (2) 0 (0) Pain 4 (2) 1 (0) Back Pain 3 (1) 0 (0) Sinus Headache 3 (1) 0 (0) Adverse Reactions for Tetracyclines : The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region.
Hepatotoxicity.
Esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class.
Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [ see Dosage and Administration ( 2 ) ].
Renal toxicity: Rise in BUN has been reported and is apparently dose-related [ see Warnings and Precautions ( 5.4 ) ].
Skin: maculopapular and erythematous rashes.
Exfoliative dermatitis.
Photosensitivity is discussed above [ see Warnings and Precautions ( 5.5 ) ].
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.
6.2 Postmarketing Adverse Reactions Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post approval use of doxycycline capsules.
Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.
Skin: fixed drug eruption Psychiatric: depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination