Doxycycline Hyclate (Page 5 of 6)

15 REFERENCES

1. Friedman JM, Polifka JE. Teratogenic Effects of Drug s. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195.

2. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524-528.

3. Horne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315-317.

4. Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); [Last Revision Date 2015 March 10; cited 2016 Jan]. Doxycycline; LactMed Record Number: 100; [about 3 screens]. Available from: http://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm .

16 HOW SUPPLIED/STORAGE AND HANDLING

Doxycycline hyclate delayed-release tablets, USP, 50 mg are white, oval tablets containing yellow pellets and debossed with “DV” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 50 mg of doxycycline.

Bottles of 120 tablets
NDC 51862-709-12

Doxycycline hyclate delayed-release tablets, USP, 75 mg are white, oval scored tablets containing yellow pellets and debossed with “D|5” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 75 mg of doxycycline.

Bottles of 60 tablets
NDC 68308-775-60

Doxycycline hyclate delayed-release tablets, USP, 80 mg are white, oval scored tablets containing yellow pellets and debossed with “D|8” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 80 mg of doxycycline.

Bottles of 30 tablets
NDC 51862-571-30

Doxycycline hyclate delayed-release tablets, USP, 100 mg are white, oval scored tablets containing yellow pellets and debossed with “D|0” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline.

Bottles of 100 tabletsNDC 68308-710-10

Doxycycline hyclate delayed-release tablets, USP, 150 mg are white, rectangular dual-scored tablets containing yellow pellets and debossed with “D|l|l” on one face and dual-scored on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 150 mg of doxycycline.

Bottles of 30 tablets Bottles of 100 tablets
NDC 68308-715-30 NDC 68308-715-10

Doxycycline hyclate delayed-release tablets, 200 mg are white, oval scored tablets containing yellow pellets and debossed with “D|D” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 200 mg of doxycycline.

Bottles of 30 tablets Bottles of 60 tablets
NDC 68308-716-30 NDC 68308-716-60

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

17 PATIENT COUNSELING INFORMATION

Patients taking doxycycline for malaria prophylaxis should be advised:

  • that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.
  • to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (for example, staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent).
  • that doxycycline prophylaxis:
    • should begin 1 to 2 days before travel to the malarious area,
    • should be continued daily while in the malarious area and after leaving the malarious area,
    • should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area,
    • should not exceed 4 months.

All patients taking doxycycline should be advised:

  • to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (for example, skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered [see Warnings and Precautions (5.3) ].
  • to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6.1) ].
  • that the absorption of tetracyclines is reduced when taken with foods, especially those that contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk [see Drug Interactions (7.3) ].
  • that the absorption of tetracyclines is reduced when taken with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations [see Drug Interactions (7.3) ].
  • that the use of doxycycline might increase the incidence of vaginal candidiasis.

Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of antibacterial. If this occurs, patients should contact their physician as soon as possible.

Patients should be counseled that antibacterial drugs including doxycycline hyclate delayed-release tablets should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When doxycycline hyclate delayed-release tablets is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Doxycycline hyclate delayed-release tablets or other antibacterial drugs in the future.

17.1 Instructions for Breaking the 150 mg Doxycycline Hyclate Delayed-Release Dual-Scored Tablet

The tablet is marked with separation lines (score lines) and may be broken at these score lines to provide any of the following doses.

  • 150 mg treatment (the entire tablet is taken)

    Image

  • 100 mg treatment (two thirds of the tablet or two 50 mg tablet segments are taken)

    Image

  • 50 mg treatment (one third of the tablet is taken)

    Image

To break the tablet, the tablet is held between the thumbs and index fingers close to the appropriate score line. Then, with the score line facing the patient, enough pressure is applied to snap the tablet segments apart (segments that do not break along the score line should not be used).

FDA-Approved Patient Labeling Doxycycline hyclate delayed-release tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg and 200 mg

Instructions for Breaking the 150 mg Doxycycline hyclate delayed-release dual-scored tablet

Your doctor may find it necessary to adjust your dosage of doxycycline hyclate delayed-release tablets to obtain the proper treatment response. The tablet is marked with separation lines (score lines) and may be broken at these score lines to provide any of the following doses. If your doctor prescribed:

  • 150 mg treatment (take the entire tablet)

    Image

  • 100 mg treatment (take two thirds of the tablet or two 50 mg tablet segments)

    Image

  • 50 mg treatment (take one third of the tablet)

    Image

To break the tablet, hold the tablet between your thumbs and index fingers close to the appropriate score line. Then, with the score line facing you, apply enough pressure to snap the tablet segments apart (do not use segments that do not break along the score line).

Rx only

Distributed by:
Mayne Pharma
Greenville, NC 27834

Manufactured by:
Mayne Pharma International Pty Ltd
Salisbury South, SA 5106
Australia

61449

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