ACTICLATE® (doxycycline hyclate USP) Tablets are indicated for adjunctive (combination) therapy in severe acne.
Important Safety Information for Patients Regarding ACTICLATE® (doxycycline hyclate USP) Tablets, 150 mg and 75 mg
ACTICLATE® Tablets are an antibiotic in the tetracycline class. ACTICLATE® Tablets should be used only to treat infections caused by bacteria that are killed or inhibited by doxycycline. You should take ACTICLATE® Tablets exactly as your doctor prescribed in order to ensure that it will remain useful as a treatment for this and other appropriate infections.
Who should not take ACTICLATE® Tablets:
You should not take ACTICLATE® Tablets if you have had an allergic or other reaction to doxycycline or another tetracycline antibiotic.
Warnings and Precautions:
- Taking ACTICLATE® Tablets during pregnancy may cause a permanent discoloration in your baby's teeth.
- Children under the age of 8 years may develop a permanent change in color (yellow, gray, brown) in their teeth by taking ACTICLATE® Tablets.
- Diarrhea has been reported with the use of ACTICLATE® Tablets and may range from mild diarrhea to fatal colitis. If you develop watery or bloody stools (with or without stomach cramps and fever), contact your doctor as soon as possible to rule out the possibility of Clostridium difficile-associated diarrhea (CDAD).
- Taking ACTICLATE® Tablets may increase your sensitivity to sunlight and may cause a more severe sunburn-type reaction. You should avoid and/or limit sun exposure while taking ACTICLATE® Tablets.
- Increased pressure in the skull has been reported with the use of tetracycline drugs like ACTICLATE® Tablets. Contact your doctor if you experience headaches, blurred vision, double-vision or vision loss. Overweight women of child-bearing age or those who have ever been diagnosed with Intracranial Hypertension (also known as IH or Pseudotumor Cerebri) are at greater risk for developing this side effect.
- You should drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration.
Some patients taking tetracyclines like ACTICLATE® Tablets have reported side effects including: anorexia (decreased appetite), nausea, vomiting, diarrhea, rash, increased sensitivity to sunlight, hives, and anemia (low red blood cells or hemoglobin). Additional side effects reported with the use of doxycycline hyclate include impaired kidney function, abnormal blood cell counts, swelling, worsening of systemic lupus, and Stevens-Johnson syndrome (a severe inflammatory eruption of the skin and mucous membranes).
- Birth control pills may be less effective while taking ACTICLATE® Tablets.
- Avoid use of tetracyclines while also taking penicillin.
- Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.
Use During Pregnancy and Nursing:
- ACTICLATE® Tablets are considered a Pregnancy Category D, which means there is evidence of risk to fetus, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
- Avoid taking ACTICLATE® Tablets while nursing.
This list of side effects, warnings, and precautions is not complete. You can refer to the attached ACTICLATE® Tablets Prescribing Information or your healthcare provider can discuss with you additional considerations prior to taking ACTICLATE® Tablets.
To report SUSPECTED ADVERSE REACTIONS, contact Aqua Pharmaceuticals at 1-866-665-2782, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.