Demeclocycline Hydrochloride (Page 3 of 3)

ADVERSE REACTIONS

The following reactions have been reported in patients receiving tetracyclines:

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis and inflammatory lesions (with monilial overgrowth) in the anogenital region, increases in liver enzymes, and hepatic toxicity has been reported rarely.

Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines.

Instances of esophageal ulcerations have been reported in patients receiving oral tetracyclines. Most of the patients were reported to have taken the medication immediately before lying down. (See DOSAGE AND ADMINISTRATION.)

Skin: Maculopapular and erythematous rashes, erythema multiforme. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions and Stevens-Johnson syndrome have been reported rarely. Lesions occurring on the glans penis have caused balanitis. Pigmentation of the skin and mucous membranes has also been reported. Photosensitivity is discussed above. (See WARNINGS.)

Renal toxicity: Acute renal failure. Rise in BUN has been reported and is apparently dose related. Nephrogenic diabetes insipidus. (See WARNINGS.)

Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis exacerbation of systemic lupus erythematosus, lupus-like syndrome, pulmonary infiltrates with eosinophilia.

Hematologic: Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have been reported.

CNS: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants (see PRECAUTIONS – General). Dizziness, headache, tinnitus and visual disturbances have been reported. Myasthenic syndrome has been reported rarely.

Other: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur. Very rare cases of abnormal thyroid function have been reported.

Tooth discoloration has occurred in pediatric patients less than 8 years of age (see WARNINGS), and has been reported rarely in adults.

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 tetracyclines 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 HCl tablets, USP, 150 mg, are supplied as round, convex, red, film-coated tablets, debossed with “AN 54” on one side and plain on the other side.

They are available as follows:

Bottles of 100: NDC 65162-554-10

Demeclocycline HCl tablets, USP, 300 mg, are supplied as round, convex, pink, film-coated tablets, debossed with “AN 55” on one side and plain on the other side.

They are available as follows:

Bottles of 48: NDC 65162-555-48

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP. Protect from light.

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

ANIMAL PHARMACOLOGY & OR 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.

Manufactured by:

Amneal Pharmaceuticals

Paterson, NJ 07504

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 02-2013

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

d94687e9-figure-02
(click image for full-size original)
d94687e9-figure-03
(click image for full-size original)
DEMECLOCYCLINE HYDROCHLORIDE
demeclocycline tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-554
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
ALGINIC ACID
STARCH, CORN
ETHYLCELLULOSES
FD&C RED NO. 40
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
D&C RED NO. 27
Product Characteristics
Color RED Score no score
Shape ROUND Size 9mm
Flavor Imprint Code AN;54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-554-10 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065425 02/27/2008
DEMECLOCYCLINE HYDROCHLORIDE
demeclocycline tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-555
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
ALGINIC ACID
STARCH, CORN
ETHYLCELLULOSES
FD&C RED NO. 40
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 20mm
Flavor Imprint Code AN;55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-555-48 48 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065425 02/27/2008
Labeler — Amneal Pharmaceuticals of New York, LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals, LLC 968119730 ANALYSIS (65162-554), ANALYSIS (65162-555), LABEL (65162-554), LABEL (65162-555), MANUFACTURE (65162-554), MANUFACTURE (65162-555), PACK (65162-554), PACK (65162-555), REPACK (65162-554), REPACK (65162-555)

Revised: 12/2012 Amneal Pharmaceuticals of New York, LLC

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