Doxycycline Hyclate (Page 6 of 6)

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 are 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)
150 mg treatment
(click image for full-size original)
  • 100 mg treatment (two thirds of the tablet or two 50 mg tablet segments are taken)
100 mg treatment
(click image for full-size original)
  • 50 mg treatment (one third of the tablet is taken)
50 mg treatment
(click image for full-size original)

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

D oxycycline hyclate delayed-release tablets, USP, 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 tabletsto 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 table)
image description
(click image for full-size original)
  • 100 mg treatment (take two thirds of the tablet or two 50 mg tablet segments)
image description
(click image for full-size original)
  • 50 mg treatment (take one third of the tablet)
image description
(click image for full-size original)

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).

Manufactured for:
Solco Healthcare US, LLC
Cranbury, NJ 08512, USA

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China

Revised: 10/2016

17431-01

NDC 69668-515-30 Rx Only

Doxycycline Hyclate

Delayed-Release

Tablets, USP

150 mg

Do not chew or crush tablets.

30 Tablets

69668515 Label
(click image for full-size original)
DOXYCYCLINE HYCLATE doxycycline hyclate tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69668-515(NDC:43547-324)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 150 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM CHLORIDE
TALC
CROSPOVIDONE
MAGNESIUM STEARATE
POVIDONE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
HYPROMELLOSE, UNSPECIFIED
TRIETHYL CITRATE
MANNITOL
Product Characteristics
Color white Score 3 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code P;0;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69668-515-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207494 11/28/2016
Labeler — Sonoma Pharmaceuticals, Inc. (081642964)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (69668-515)

Revised: 05/2018 Sonoma Pharmaceuticals, Inc.

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