Doxycycline

Oracea

• ORACEA 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 ORACEA for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
• ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.

Doryx MPC

• DORYX MPC is a tetracycline class drug indicated for: Rickettsial Infections
• Sexually Transmitted Infections
• Respiratory Tract Infections
• Specific Bacterial Infections
• Ophthalmic Infections
• Anthrax, Including Inhalational Anthrax (Post-Exposure)

Oracea

40 mg beige opaque capsule imprinted with "GLD 40" 40 mg capsule.

Doryx MPC

• DORYX MPC (doxycycline hyclate delayed-release tablets), 60 mg are white, oval tablets containing yellow pellets and debossed with "D6" on one face and plain on the other.
• Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg).
• DORYX MPC Delayed-Release Tablets 60 mg

Oracea

• Take one ORACEA capsule (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals.
• Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant microorganisms.

Doryx MPC

• Important Dosage and Administration Instructions: DORYX MPC is not substitutable on a mg per mg basis with other oral doxycyclines.
• Do not chew or crush tablets.
• Dosage in Adult Patients The usual dosage of DORYX MPC is 240 mg on the first day of treatment (administered 120 mg every 12 hours) followed by a maintenance dose of 120 mg daily.
• In the management of more severe infections (particularly chronic infections of the urinary tract), 120 mg every 12 hours is recommended.
• Dosage in Pediatric Patients For all pediatric patients weighing less than 45 kg with severe or life threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage of DORYX MPC is 2.6 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose.
• For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule of DORYX MPC is 5.3 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.6 mg per kg of body weight (given as a single daily dose or divided into twice daily doses).

Oracea

most common adverse reactions (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase.

Doryx MPC

The following adverse reactions have been identified during post-approval use of doxycycline. 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.

Oracea

• The use of ORACEA 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.
• Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile. If C. difficile associated diarrhea occurs, discontinue ORACEA.
• If renal impairment exists, ORACEA doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver injury.
• Photosensitivity can occur with ORACEA; Patients should minimize or avoid exposure to natural or artificial sunlight.
• Tetracyclines have been associated with the development of autoimmune syndromes; if symptoms develop, discontinue ORACEA immediately.
• ORACEA may cause pseudotumor cerebri (benign intracranial hypertension). Discontinue ORACEA if symptoms occur.
• Bacterial resistance to tetracyclines may develop in patients using ORACEA. It should only be used as indicated.

Doryx MPC

• The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
• Clostridioides difficile -Associated Diarrhea. Evaluate patients if diarrhea occurs.
• Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Limit sun exposure.
• Overgrowth of non-susceptible organisms, including fungi, may occur. If such infections occur, discontinue use and institute appropriate therapy.

Oracea

• ​This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
• ORACEA is contraindicated in persons who have shown hypersensitivity to doxycycline or other tetracyclines.

Doryx MPC

• DORYX MPC is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
• Doxycycline is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Oracea

• Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
• Some bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.
• The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Doryx MPC

• Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage
• Avoid co-administration of tetracyclines with penicillin
• Absorption of tetracyclines, including DORYX MPC is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron-containing preparations
• Concurrent use of tetracyclines, including DORYX MPC may render oral contraceptives less effective
• Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline

Oracea

Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of ORECEA during the second and third trimester of pregnancy.

Doryx MPC

There are no adequate studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for the treatment of anthrax exposure.