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Oracea
Overview
What is Oracea?
ORACEA (doxycycline, USP) capsules 40 mg are hard gelatin capsule
shells filled with two types of doxycycline beads (30 mg immediate release and
10 mg delayed release) that together provide a dose of 40 mg of anhydrous
doxycycline (CHNO).
The structural formula of doxycycline, USP is:
with an empirical formula of CHNO•HO and a molecular weight of 462.46. The chemical designation
for doxycycline is 2-Naphthacenecarboxamide,
4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,
[4S-(4aα, 4aα, 5α, 5aα, 6a,12aα)]-, monohydrate. It is very slightly soluble in
water.
Inert ingredients in the formulation are: hypromellose, iron oxide red, iron
oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80,
sugar spheres, talc, titanium dioxide, and triethyl citrate. Active ingredients:
Each capsule contains doxycycline, USP in an amount equivalent to 40 mg of
anhydrous doxycycline.
What does Oracea look like?
What are the available doses of Oracea?
Sorry No records found.
What should I talk to my health care provider before I take Oracea?
Sorry No records found
How should I use Oracea?
ORACEA 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. ORACEA
has not been evaluated for the treatment of the erythematous, telangiectatic, or
ocular components of rosacea. Efficacy of ORACEA beyond 16 weeks and safety
beyond 9 months have not been established.
This formulation of doxycycline has not been evaluated in the treatment or
prevention of infections. ORACEA should not be used 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, ORACEA should be used only as
indicated.
THE DOSAGE OF ORACEA DIFFERS FROM THAT OF
DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY
RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF
RESISTANT MICROORGANISMS.
One ORACEA Capsule (40 mg) should be taken once daily in the morning on an
empty stomach, preferably at least one hour prior to or two hours after
meals.
Efficacy beyond 16 weeks and safety beyond 9 months have not been
established.
Administration of adequate amounts of fluid along with the capsules is
recommended to wash down the capsule to reduce the risk of esophageal irritation
and ulceration. (see section).
What interacts with Oracea?
This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
What are the warnings of Oracea?
The benefits of immediate-release oral isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use isosorbide dinitrate in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.
Results of animal studies indicate that tetracyclines cross the
placenta, are found in fetal tissues, and can cause retardation of skeletal
development on the developing fetus. Evidence of embryotoxicity has been noted
in animals treated early in pregnancy (see section).
Pseudomembranous colitis has been reported with
nearly all antibacterial agents and may range from mild to
life-threatening.
Therefore, it is important to consider this diagnosis in
patients who present with diarrhea subsequent to the administration of
antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and
may permit overgrowth of clostridia. Studies indicate that a toxin produced by
Clostridium difficile is a primary cause of "antibiotic-associated colitis".
If a diagnosis of pseudomembranous colitis has been established, therapeutic
measures should be initiated. Mild cases of pseudomembranous colitis usually
respond to discontinuation of the drug alone. In moderate to severe cases,
consideration should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug clinically
effective against Clostridium difficile colitis.
The anti-anabolic action of the tetracyclines may cause an
increase in BUN. While this is not a problem in those with normal renal
function, in patients with significantly impaired function, higher serum levels
of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and
acidosis. If renal impairment exists, even usual oral or parenteral doses may
lead to excessive systemic accumulations of the drug and possible liver
toxicity. Under such conditions, lower than usual total doses are indicated, and
if therapy is prolonged, serum level determinations of the drug may be
advisable.
Photosensitivity manifested by an exaggerated sunburn reaction
has been observed in some individuals taking tetracyclines. Although this was
not observed during the duration of the clinical studies with ORACEA, patients
should minimize or avoid exposure to natural or artificial sunlight (tanning
beds or UVA/B treatment) while using ORACEA. If patients need to be outdoors
while using ORACEA, they should wear loose-fitting clothes that protect skin
from sun exposure and discuss other sun protection measures with their
physician.
What are the precautions of Oracea?
Safety of ORACEA beyond 9 months has not been established.
As with other antibiotic preparations, use of ORACEA may result in overgrowth
of non-susceptible microorganisms, including fungi. If superinfection occurs,
ORACEA should be discontinued and appropriate therapy instituted. Although not
observed in clinical trials with ORACEA, the use of tetracyclines may increase
the incidence of vaginal candidiasis.
ORACEA should be used with caution in patients with a history of or
predisposition to candidiasis overgrowth.
Bacterial resistance to tetracyclines may develop in patients using ORACEA.
Because of the potential for drug-resistant bacteria to develop during the use
of ORACEA, it should be used only as indicated.
Tetracyclines have been associated with the development of
autoimmune syndromes. Symptoms may be manifested by fever, rash, arthralgia, and
malaise. In symptomatic patients, liver function tests, ANA, CBC, and other
appropriate tests should be performed to evaluate the patients. Use of all
tetracycline-class drugs should be discontinued immediately.
Tetracycline class antibiotics are known to cause
hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many
organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity
(teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral
pigmentation has been reported to occur independently of time or amount of drug
administration, whereas other pigmentation has been reported to occur upon
prolonged administration. Skin pigmentation includes diffuse pigmentation as
well as over sites of scars or injury.
Bulging fontanels in infants and benign intracranial hypertension
in adults have been reported in individuals receiving tetracyclines. These
conditions disappeared when the drug was discontinued.
See Patient Package Insert that accompanies this
Package Insert for additional information to give patients.
Periodic laboratory evaluations of organ systems, including
hematopoietic, renal and hepatic studies should be performed. Appropriate tests
for autoimmune syndromes should be performed as indicated.
False elevations of urinary catecholamine levels may occur due to
interference with the fluorescence test.
Doxycycline was assessed for potential to induce carcinogenesis
in a study in which the compound was administered to Sprague-Dawley rats by
gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased
incidence of uterine polyps was observed in female rats that received 200
mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline
approximately 12.2 times that observed in female humans who use ORACEA (exposure
comparison based upon area under the curve (AUC) values). No impact upon tumor
incidence was observed in male rats at 200 mg/kg/day, or in either gender at the
other dosages studied. Evidence of oncogenic activity was obtained in studies
with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors) and
minocycline (thyroid tumors).
Doxycycline demonstrated no potential to cause genetic toxicity in an point mutation study with mammalian cells
(CHO/HGPRT forward mutation assay) or in an
micronucleus assay conducted in CD-1 mice. However, data from an assay with CHO cells for potential to cause
chromosomal aberrations suggest that doxycycline is a weak clastogen.
Oral administration of doxycycline to male and female Sprague-Dawley rats
adversely affected fertility and reproductive performance, as evidenced by
increased time for mating to occur, reduced sperm motility, velocity, and
concentration, abnormal sperm morphology, and increased pre- and
post-implantation losses. Doxycycline induced reproductive toxicity at all
dosages that were examined in this study, as even the lowest dosage tested (50
mg/kg/day) induced a statistically significant reduction in sperm velocity. Note
that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained
in the recommended daily dose of ORACEA for a 60-kg human when compared on the
basis of AUC estimates. Although doxycycline impairs the fertility of rats when
administered at sufficient dosage, the effect of ORACEA on human fertility is
unknown.
(see
section). Results from animal studies indicate that doxycycline crosses the
placenta and is found in fetal tissues.
(see
section).
The effect of tetracyclines on labor and delivery is
unknown.
Tetracyclines are excreted in human milk. Because of the
potential for serious adverse reactions in infants from doxycycline, ORACEA
should not be used in mothers who breastfeed. (see section).
ORACEA should not be used in infants and children less than 8
years of age (see
section). ORACEA has not been studied in children of any age with regard to
safety or efficacy, therefore use in children is not recommended.
What are the side effects of Oracea?
In controlled clinical trials of adult patients with mild to
moderate rosacea, 537 patients received ORACEA or placebo over a 16-week period.
The most frequent adverse reactions occurring in these studies are listed in
Table 3.
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 has been reported rarely. Rare instances of
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 section).
Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been
reported but is uncommon. Photosensitivity is discussed above. (see section).
Renal toxicity:
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis,
anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of
systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have
been reported.
| ORACEA | Placebo | ||
| Nasopharyngitis | 13 (4.8) | 9 (3.4) | |
| Pharyngolaryngeal Pain | 3 (1.1) | 2 (0.7) | |
| Sinusitis | 7 (2.6) | 2 (0.7) | |
| Nasal Congestion | 4 (1.5) | 2 (0.7) | |
| Fungal Infection | 5 (1.9) | 1 (0.4) | |
| Influenza | 5 (1.9) | 3 (1.1) | |
| Diarrhea | 12 (4.5) | 7 (2.6) | |
| Abdominal Pain Upper | 5 (1.9) | 1 (0.4) | |
| Abdominal Distention | 3 (1.1) | 1 (0.4) | |
| Abdmonial Pain | 3 (1.1) | 1 (0.4) | |
| Stomach Discomfort | 3 (1.1) | 2 (0.7) | |
| Dry Mouth | 3 (1.1) | 0 (0) | |
| Hypertension | 8 (3.0) | 2 (0.7) | |
| Blood Pressure Increase | 4 (1.5) | 1 (0.4) | |
| Aspartate Aminotransferase Increase | 6 (2.2) | 2 (0.7) | |
| Blood Lactate Dehydrogenase Increase | 4 (1.5) | 1 (0.4) | |
| Blood Glucose Increase | 3 (1.1) | 0 (0) | |
| Anxiety | 4 (1.5) | 0 (0) | |
| Pain | 4 (1.5) | 1 (0.4) | |
| Back Pain | 3 (1.1) | 0 (0) | |
| Sinus Headache | 3 (1.1) | 0 (0) |
What should I look out for while using Oracea?
This drug is contraindicated in persons who have shown hypersensitivity to
doxycycline or any of the other tetracyclines.
Results of animal studies indicate that tetracyclines cross the
placenta, are found in fetal tissues, and can cause retardation of skeletal
development on the developing fetus. Evidence of embryotoxicity has been noted
in animals treated early in pregnancy (see section).
Pseudomembranous colitis has been reported with
nearly all antibacterial agents and may range from mild to
life-threatening.
Therefore, it is important to consider this diagnosis in
patients who present with diarrhea subsequent to the administration of
antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and
may permit overgrowth of clostridia. Studies indicate that a toxin produced by
Clostridium difficile is a primary cause of "antibiotic-associated colitis".
If a diagnosis of pseudomembranous colitis has been established, therapeutic
measures should be initiated. Mild cases of pseudomembranous colitis usually
respond to discontinuation of the drug alone. In moderate to severe cases,
consideration should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug clinically
effective against Clostridium difficile colitis.
The anti-anabolic action of the tetracyclines may cause an
increase in BUN. While this is not a problem in those with normal renal
function, in patients with significantly impaired function, higher serum levels
of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and
acidosis. If renal impairment exists, even usual oral or parenteral doses may
lead to excessive systemic accumulations of the drug and possible liver
toxicity. Under such conditions, lower than usual total doses are indicated, and
if therapy is prolonged, serum level determinations of the drug may be
advisable.
Photosensitivity manifested by an exaggerated sunburn reaction
has been observed in some individuals taking tetracyclines. Although this was
not observed during the duration of the clinical studies with ORACEA, patients
should minimize or avoid exposure to natural or artificial sunlight (tanning
beds or UVA/B treatment) while using ORACEA. If patients need to be outdoors
while using ORACEA, they should wear loose-fitting clothes that protect skin
from sun exposure and discuss other sun protection measures with their
physician.
What might happen if I take too much Oracea?
In case of overdosage, discontinue medication, treat
symptomatically, and institute supportive measures. Dialysis does not alter
serum half-life and thus would not be of benefit in treating cases of
overdose.
How should I store and handle Oracea?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 ().All products are to be stored at controlled room temperatures of l5°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.Patent Information: U.S. Patents 5,789,395; 5,919,775 and patents pending.Manufactured by:CardinalHealthWinchester, KY 40391Marketed by:CollaGenex Pharmaceuticals, Inc.Newtown, PA 18940May 26, 2006ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 ().All products are to be stored at controlled room temperatures of l5°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.Patent Information: U.S. Patents 5,789,395; 5,919,775 and patents pending.Manufactured by:CardinalHealthWinchester, KY 40391Marketed by:CollaGenex Pharmaceuticals, Inc.Newtown, PA 18940May 26, 2006ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 ().All products are to be stored at controlled room temperatures of l5°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.Patent Information: U.S. Patents 5,789,395; 5,919,775 and patents pending.Manufactured by:CardinalHealthWinchester, KY 40391Marketed by:CollaGenex Pharmaceuticals, Inc.Newtown, PA 18940May 26, 2006ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 ().All products are to be stored at controlled room temperatures of l5°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.Patent Information: U.S. Patents 5,789,395; 5,919,775 and patents pending.Manufactured by:CardinalHealthWinchester, KY 40391Marketed by:CollaGenex Pharmaceuticals, Inc.Newtown, PA 18940May 26, 2006ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 ().All products are to be stored at controlled room temperatures of l5°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.Patent Information: U.S. Patents 5,789,395; 5,919,775 and patents pending.Manufactured by:CardinalHealthWinchester, KY 40391Marketed by:CollaGenex Pharmaceuticals, Inc.Newtown, PA 18940May 26, 2006ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 ().All products are to be stored at controlled room temperatures of l5°C-30°C (59°F-86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.Patent Information: U.S. Patents 5,789,395; 5,919,775 and patents pending.Manufactured by:CardinalHealthWinchester, KY 40391Marketed by:CollaGenex Pharmaceuticals, Inc.Newtown, PA 18940May 26, 2006
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ORACEA capsules are not bioequivalent to other doxycycline products. The
pharmacokinetics of doxycycline following oral administration of ORACEA was
investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic
parameters for ORACEA following single oral doses and at steady-state in healthy
subjects are presented in Table 1.
In a single-dose food-effect study involving administration of
ORACEA to healthy volunteers, concomitant administration with a 1000 calorie,
high-fat, high-protein meal that included dairy products, resulted in a decrease
in the rate and extent of absorption (Cmax and AUC) by about 45% and 22%,
respectively, compared to dosing under fasted conditions. This decrease in
systemic exposure can be clinically significant, and therefore if ORACEA is
taken close to meal times, it is recommended that it be taken at least one hour
prior to or two hours after meals.
Doxycycline is greater than 90% bound to plasma proteins.
Major metabolites of doxycycline have not been identified.
However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin
decrease the half-life of doxycycline.
Doxycycline is excreted in the urine and feces as unchanged drug.
It is reported that between 29% and 55.4% of an administered dose can be
accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours
in subjects receiving a single dose of ORACEA.
Doxycycline pharmacokinetics have not been evaluated in geriatric
patients.
Doxycycline pharmacokinetics have not been evaluated in pediatric
patients (see
section).
The pharmacokinetics of ORACEA were compared in 16 male and 14
female subjects under fed and fasted conditions. While female subjects had a
higher Cmax and AUC than male subjects, these differences were thought to be due
to differences in body weight/lean body mass.
Differences in doxycycline pharmacokinetics among racial groups
have not been evaluated.
Studies have shown no significant difference in serum half-life
of doxycycline in patients with normal and severely impaired renal function.
Hemodialysis does not alter the serum half-life of doxycycline.
Doxycycline pharmacokinetics have not been evaluated in patients
with hepatic insufficiency.
In a study in healthy volunteers (N=24) the bioavailability of
doxycycline is reported to be reduced at high pH. This reduced bioavailability
may be clinically significant in patients with gastrectomy, gastric bypass
surgery or who are otherwise deemed achlorhydric.
(see section)
Non-Clinical Toxicology
This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy (see section).
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening.
Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis".
If a diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with ORACEA, patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using ORACEA. If patients need to be outdoors while using ORACEA, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.
Safety of ORACEA beyond 9 months has not been established.
As with other antibiotic preparations, use of ORACEA may result in overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, ORACEA should be discontinued and appropriate therapy instituted. Although not observed in clinical trials with ORACEA, the use of tetracyclines may increase the incidence of vaginal candidiasis.
ORACEA should be used with caution in patients with a history of or predisposition to candidiasis overgrowth.
Bacterial resistance to tetracyclines may develop in patients using ORACEA. Because of the potential for drug-resistant bacteria to develop during the use of ORACEA, it should be used only as indicated.
Tetracyclines have been associated with the development of autoimmune syndromes. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.
Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.
Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued.
See Patient Package Insert that accompanies this Package Insert for additional information to give patients.
Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use ORACEA (exposure comparison based upon area under the curve (AUC) values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/day, or in either gender at the other dosages studied. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors).
Doxycycline demonstrated no potential to cause genetic toxicity in an point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an micronucleus assay conducted in CD-1 mice. However, data from an assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline is a weak clastogen.
Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre- and post-implantation losses. Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of ORACEA for a 60-kg human when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of ORACEA on human fertility is unknown.
(see section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.
(see section).
The effect of tetracyclines on labor and delivery is unknown.
Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in infants from doxycycline, ORACEA should not be used in mothers who breastfeed. (see section).
ORACEA should not be used in infants and children less than 8 years of age (see section). ORACEA has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.
In controlled clinical trials of adult patients with mild to moderate rosacea, 537 patients received ORACEA or placebo over a 16-week period. The most frequent adverse reactions occurring in these studies are listed in Table 3.
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 has been reported rarely. Rare instances of 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 section).
Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (see section).
Renal toxicity:
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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