Demeclocycline Hydrochloride (Page 4 of 4)

OVERDOSAGE

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracyclines are not removed in significant quantities by hemodialysis or peritoneal dialysis.

DOSAGE AND ADMINISTRATION

Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.

Concomitant Therapy

Absorption of tetracycline is impaired by antacids containing aluminum, calcium, or magnesium, and by iron-containing preparations. Foods and some dairy products also interfere with absorption. Oral forms of tetracycline should be given at least 1 hour before or 2 hours after meals.

In Patients With Renal Impairment

(See WARNINGS). Tetracyclines should be used cautiously in patients with impaired renal function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

In Patients With Liver Impairment

Tetracyclines should be used cautiously in patients with impaired liver function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. Administration of adequate amounts of fluid with the oral formulations of tetracyclines is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS).

Adults

Usual Daily Dose

Four divided doses of 150 mg each or two divided doses of 300 mg each.

For Pediatric Patients Above Eight Years of Age

Usual daily dose, 7 to 13 mg per kg body weight per day, depending upon the severity of the disease, divided into two to four doses not to exceed adult dosage of 600 mg per day.

Gonorrhea patients sensitive to penicillin may be treated with demeclocycline administered as an initial oral dose of 600 mg followed by 300 mg every 12 hours for four days to a total of 3 grams.

HOW SUPPLIED

Demeclocycline Hydrochloride Tablets USP, 150 mg are available as pink, round, biconvex, film-coated, unscored tablets, debossed with b 701 on one side and 150 on the other, packaged in bottle of 100 tablets.

Demeclocycline Hydrochloride Tablets USP, 300 mg are available as pink, round, biconvex, film-coated, unscored tablets, debossed with b 702 on one side and 300 on the other, packaged in bottle of 48 tablets.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4 , methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline), and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI.) Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. Approved Standard – 9th Edition. CLSI document M7-A9, 950 West Valley Rd. Suite 2500,.Wayne, PA 19087, 2012.
  2. CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 22nd Informational Supplement. CLSI document M100-S22. Wayne, PA, 2012.
  3. CLSI. Methods or Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria: Approved Guideline — 2nd Edition. CLSI document M45-A2. CLSI, Wayne, PA, 2011.
  4. CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests. Approved Standard — 11th Edition. CLSI document M2-A11. Wayne, PA, 2012.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 9/2012

PRINCIPAL DISPLAY PANEL

Demeclocycline Hydrochloride Tablets USP 150 mg 100s Label
(click image for full-size original)

Demeclocycline Hydrochloride Tablets USP 150 mg 100s Label Text

NDC 0555-0701- 02

DEMECLOCYCLINE
HYDROCHLORIDE
Tablets USP
150 mg

Rx only

100 TABLETS

TEVA

PRINCIPAL DISPLAY PANEL

Demeclocycline Hydrochloride Tablets USP 300 mg 48s Label
(click image for full-size original)

Demeclocycline Hydrochloride Tablets USP 300 mg 48s Label Text

NDC 0555-0702- 84

DEMECLOCYCLINE
HYDROCHLORIDE
Tablets USP
300 mg

Rx only

48 TABLETS

TEVA

DEMECLOCYCLINE HYDROCHLORIDE
demeclocycline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-0701
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) DEMECLOCYCLINE HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K29/32
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9mm
Flavor Imprint Code b;701;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0555-0701-02 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065171 01/04/2005
DEMECLOCYCLINE HYDROCHLORIDE
demeclocycline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-0702
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) DEMECLOCYCLINE HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POVIDONE K29/32
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 11mm
Flavor Imprint Code b;702;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0555-0702-84 48 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065171 01/04/2005
Labeler — Barr Laboratories Inc. (802716563)

Revised: 12/2012 Barr Laboratories Inc.

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