Acticlate

Name: Acticlate

What are some other side effects of Acticlate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Not hungry.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Acticlate?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Do not take this medicine if it is outdated.
  • Do not take Acticlate if it has not been stored as you have been told.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Acticlate Dosage and Administration

Important Administration Instructions

  • The usual dosage and frequency of administration of Acticlate and Acticlate CAP differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of adverse reactions.
  • Administer Acticlate and Acticlate CAP with adequate amounts of fluid to wash down the drugs and reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].
  • If gastric irritation occurs, Acticlate and Acticlate CAP may be given with food or milk [see Clinical Pharmacology (12.3)]
  • Swallow Acticlate CAP whole. Do not break, open, crush, dissolve or chew the capsule.
  • Acticlate tablets (150 mg) can be broken into two-thirds or one-third to provide a 100 mg and 50 mg strength, respectively [see FDA-approved patient labeling].

Dosage in Adult Patients

  • The usual dosage of Acticlate is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours.
  • In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
  • For certain selected specific indications, the recommended duration or dosage and duration of Acticlate or Acticlate CAP in adult patients are as follows:
    1. Streptococcal infections, therapy should be continued for 10 days.
    2. Uncomplicated urethral, endocervical, or rectal infection caused by Chlamydia trachomatis: 100 mg by mouth twice-a-day for 7 days.
    3. Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice-a-day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.
    4. Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg by mouth twice a day for 7 days.
    5. Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 2 weeks.
    6. Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 4 weeks.
    7. Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg by mouth, twice-a-day for at least 10 days.
    8. Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice-a-day for at least 10 days.

Dosage in Pediatric Patients

  • For all pediatric patients weighing less than 45 kg with severe or life threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage of Acticlate and Acticlate CAP is 2.2 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose [see Warnings and Precautions (5.1)].
  • For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule of Acticlate and Acticlate CAP is 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 over 45 kg, the usual adult dose should be used.

Dosage for Prophylaxis of Malaria

For adults, the recommended dose of Acticlate is 100 mg daily.

For pediatric patients 8 years of age and older, the recommended dosage of Acticlate and Acticlate CAP is 2 mg per kg of body weight administered once daily. Pediatric patients weighing 45 kg or more should receive the adult dose.

Prophylaxis should begin 1 or 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

Dosage for Inhalational Anthrax (Post-Exposure)

For adults, the recommended dosage is 100 mg, of Acticlate, by mouth, twice-a-day for 60 days.

For pediatric patients weighing less than 45 kg, the recommended dosage of Acticlate and Acticlate CAP is 2.2 mg per kg of body weight, by mouth, twice-a-day for 60 days. Pediatric patients weighing 45 kg or more should receive the adult dose.

How Supplied/Storage and Handling

How Supplied

Acticlate (doxycycline hyclate) Tablets, 75 mg are round, convex, light-teal, film-coated, tablets with “75” debossed on one side of the tablet and “AQ101” debossed on the other. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline.
Bottles of 60 tablets:        NDC 16110-501-01

Acticlate (doxycycline hyclate) Tablets, 150 mg are oval-shaped, convex, mossy-green, film-coated tablets. Each side of the functionally scored tablet has two parallel score lines for splitting into 3 equal portions with “A” debossed on each portion of one side of the tablet, and no debossing on the other. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline.
Bottles of 60 tablets:        NDC 16110-502-01

Acticlate CAP (doxycycline hyclate) Capsules, 75 mg, have a navy blue opaque body and cap with the inscription “AQUA 101C75” in black. Each 75 mg capsule contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline.
Bottles of 60 capsules:     NDC 16110-601-01

Storage
Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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