Tetracycline-class Drug

Oracea

Approved 26 May 2006OralCapsule

Indications

Doxycycline is 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 for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.

( 1.2 ) Doxycycline has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. ( 1.2 )

1.1Indication

Doxycycline is 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.

1.2Limitations of Use

This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use Doxycycline 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 should be used only as indicated.

Doxycycline has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.

Contraindications

This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines. Doxycycline is contraindicated in persons who have shown hypersensitivity to doxycycline or other tetracyclines. ( 4 )

Warnings and precautions

The use of Doxycycline during tooth development (the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.1 , 5.2 , 8.1 , 8.4 ) Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile . If C. difficile associated diarrhea occurs, discontinue Doxycycline.

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 Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received Doxycycline 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: Table 1. Incidence (%) of Selected Adverse Reactions in Clinical Trials of Doxycycline (n=269) v.s. Placebo (n=268) Doxycycline 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) Note: Percentages based on total number of study participants in each treatment group.

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.

6.2Postmarketing 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. Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache. Skin : fixed drug eruption Psychiatric : depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination

Oracea

Indications

1.1Indication

1.2Limitations of Use

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Inhibition of Bone Growth During Fetal and Pediatric Development

5.2Tooth Discoloration During Fetal and Pediatric Development

5.4Metabolic Effects

5.5Photosensitivity

5.6Autoimmune Syndromes

5.7Tissue Hyperpigmentation

5.8Pseudotumor Cerebri

5.9Development of Drug Resistant Bacteria

5.11Laboratory Monitoring

5.12Fixed Drug Eruptions

Interactions

7.1Anticoagulants

7.2Penicillin

7.3Methoxyflurane

7.4Antacids and Iron Preparations Absorption

7.5Oral Retinoids

7.6Barbiturates and Anti-epileptics

7.7Drug/Laboratory Test Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Adverse Reactions

Composition

Official product information

At a glance

Guidelines