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Doxycycline hyclate

DOXYCYCLINE HYCLATE

Manufacturer: Ajanta Pharma USA Inc.

Score: 142.0

Quick Summary

Acticlate CAP (Doxycycline Hyclate) is a tetracycline-class antimicrobial drug used to treat various infections, including rickettsial infections, sexually transmitted infections, respiratory tract infections, and specific bacterial infections. It is also used as an alternative treatment for selected infections when penicillin is contraindicated and for adjunctive therapy in acute intestinal amebiasis and severe acne. The drug has several important safety considerations, including contraindications in persons with hypersensitivity to tetracyclines, and warnings regarding photosensitivity, intracranial hypertension, and tooth discoloration. Dosage recommendations vary depending on the condition being treated, with typical adult doses ranging from 100 mg to 200 mg per day. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Rickettsial infections
  • Sexually transmitted infections
  • Respiratory tract infections
  • Specific bacterial infections
  • Ophthalmic infections
  • Anthrax, including inhalational anthrax (post-exposure)
  • Alternative treatment for selected infections when penicillin is contraindicated
  • Adjunctive therapy for acute intestinal amebiasis and severe acne
  • Prophylaxis of malaria

Important Safety Information

Warning

Contraindicated in persons with hypersensitivity to tetracyclines

Contraindications

  • Hypersensitivity to tetracyclines

Adverse Reactions

  • Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions
  • Hepatotoxicity
  • Superficial discoloration of the adult permanent dentition
  • Permanent tooth discoloration and enamel hypoplasia
  • Esophagitis and esophageal ulcerations
  • Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme
  • Photosensitivity
  • Renal: Rise in BUN
  • Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus
  • Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia
  • Intracranial Hypertension

Dosing Recommendations

General Guidance

Dosage adjustments may be necessary in patients with renal impairment

Rickettsial infections

Adult Dose

200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily

Pediatric Dose

2.2 mg per kg of body weight administered every 12 hours for pediatric patients weighing less than 45 kg

Sexually transmitted infections

Adult Dose

100 mg by mouth twice-a-day for 7 days

Pediatric Dose

4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg per kg of body weight (given as a single daily dose or divided into twice daily doses) for pediatric patients weighing less than 45 kg

Special Population Considerations

Pregnancy

  • Teratogenic effects: Pregnancy Category D
  • Use during pregnancy only when the potential benefits are expected to outweigh the risks

Nursing Mothers

  • Tetracyclines are excreted in human milk
  • Short-term use by lactating women is not necessarily contraindicated
  • Decision should be made whether to discontinue nursing or to discontinue the drug

Pediatric Use

  • Use in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions
  • Dosage recommendations vary depending on the condition being treated and the weight of the pediatric patient

Geriatric Use

  • Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
  • Other reported clinical experience has not identified differences in responses between the elderly and younger patients

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