product Okebo 0418

Save



OkeboTM (Doxycycline monohydrate USP) Capsules
75 mg and 100 mg

Indication

Okebo™ Capsules are a tetracycline-class antibacterial and can be used as adjunctive therapy in severe acne. Okebo™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Dosage and Administration

The usual dosage and frequency of administration of Okebo differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects.

Important Safety Information Regarding Okebo™ (doxycycline monohydrate) Capsules

Contraindications

  • Okebo™ Capsules are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Warnings & Precautions

  • Tetracycline drugs should not be administered during tooth development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of the teeth (yellow-gray-brown). Enamel hypoplasia has also been reported.
  • Pseudomembranous colitis has been reported with doxycycline and may range from mild to life-threatening. Consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
  • Pseudotumor cerebri (intracranial hypertension, IH) has been associated with the use of doxycycline. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline-associated IH. If visual disturbance occurs, ophthalmologic evaluation is warranted. Monitor patients until they stabilize.
  • Photosensitivity manifested by an exaggerated sunburn has been observed in some individuals taking tetracyclines.
  • Patients are advised to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration.
  • Pregnancy Category D. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus.

Adverse Reactions

Adverse reactions that have been observed in patients receiving tetracyclines include the following: anorexia, nausea, vomiting, diarrhea, esophagitis, rashes, rise in BUN, urticaria, erythema multiforme, toxic epidermal necrolysis, angioneurotic edema, anaphylaxis, hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, serum sickness, exacerbation of systemic lupus erythematosus and intracranial hypertension.

Drug Interactions

  • Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
  • Avoid giving Okebo™ in conjunction with penicillin.
  • Avoid concomitant use of isotretinoin and Okebo™.
  • Some antacids impair tetracycline absorption.
  • Concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal renal toxicity.
  • Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
  • Concurrent use of tetracycline may render oral contraceptives less effective. A second form of birth control should be used while taking doxycycline.

This information is not comprehensive. Please click here for full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, call 1-800-399-2561, Option 2 or This email address is being protected from spambots. You need JavaScript enabled to view it., or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Okebo is a trademark of Encore Dermatology, Inc.

PP-OKE-0021

 

 

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save