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doxycycline hyclate

DOXYCLYCLINE HYCLATE

Manufacturer: Lupin Pharmaceuticals, Inc.

Score: 142.0

Quick Summary

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 the prophylaxis of malaria. The drug has several important safety considerations, including the potential for tooth discoloration and inhibition of bone growth in pediatric patients, and the risk of adverse reactions such as anorexia, nausea, vomiting, and diarrhea. The recommended dosage varies depending on the condition being treated, with typical adult doses ranging from 100 mg to 200 mg per day, and pediatric doses ranging from 2.2 mg/kg to 4.4 mg/kg per day. Special population considerations include the use of the drug during pregnancy, nursing, and in pediatric and geriatric patients.

Key Clinical Findings and Indications

  • Rickettsial infections
  • Sexually transmitted infections
  • Respiratory tract infections
  • Specific bacterial infections
  • Anthrax, including inhalational anthrax (post-exposure)
  • Alternative treatment for selected infections when penicillin is contraindicated
  • Prophylaxis of malaria

Important Safety Information

Warning

The use of doxycycline hyclate during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of the teeth.

Contraindications

  • Hypersensitivity to any of the tetracyclines

Adverse Reactions

  • Anorexia
  • Nausea
  • Vomiting
  • Diarrhea
  • Rash
  • Photosensitivity
  • Urticaria
  • Hemolytic anemia

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal impairment.

Adults

Adult Dose

200 mg on the first day of treatment, followed by a maintenance dose of 100 mg daily

Pediatric Dose

2.2 mg/kg every 12 hours for pediatric patients weighing less than 45 kg

Pediatric patients

Adult Dose

Not applicable

Pediatric Dose

4.4 mg/kg divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg/kg daily

Special Population Considerations

Pregnancy

  • The use of doxycycline hyclate during pregnancy may cause tooth discoloration and inhibition of bone growth in the fetus.

Nursing Mothers

  • Doxycycline hyclate is excreted in human milk, and the potential for adverse reactions in the infant should be considered.

Pediatric Use

  • The use of doxycycline hyclate in pediatric patients is not recommended, except in severe or life-threatening conditions, due to the potential for tooth discoloration and inhibition of bone growth.

Geriatric Use

  • Clinical studies of doxycycline hyclate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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