Tetracycline Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Tetracycline Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx only


TETRACYCLINE HYDROCHLORIDE DESCRIPTION


Tetracycline Hydrochloride



CLINICAL PHARMACOLOGY



Microbiology
INDICATIONS AND USAGEsection has not been documented.








































Susceptibility Testing

INDICATIONS & USAGE






























TETRACYCLINE HYDROCHLORIDE CONTRAINDICATIONS


WARNINGS







PRECAUTIONS

General





INFORMATION FOR PATIENTS


LABORATORY TESTS



DRUG INTERACTIONS






CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




PREGNANCY




WARNINGS)


WARNINGS)

LABOR & DELIVERY


NURSING MOTHERS


PEDIATRIC USE

WARNINGSandDOSAGE AND ADMINISTRATION.

TETRACYCLINE HYDROCHLORIDE ADVERSE REACTIONS

Gastrointestinal:anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region.

DOSAGE AND ADMINISTRATION).
Teeth:permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has also been reported (seeWARNINGS).
Skin:maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Onycholysis and discoloration of the nails have been reported rarely. Photosensitivity is discussed inWARNINGS.
Renal toxicity:rise in BUN has been reported and is apparently dose related.
Liver:hepatotoxicity and liver failure have been observed in patients receiving large doses of tetracycline and in tetracycline-treated patients with renal impairment.
Hypersensitivity reactions:urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, and serum sickness-like reactions, as fever, rash, and arthralgia.
Blood:hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported.
Other:bulging fontanels in infants and intracranial pressure in adults (see PRECAUTIONS, General).

OVERDOSAGE


DOSAGE & ADMINISTRATION

Adults


Children above eight years of age





WARNINGSand Carcinogenesis, Mutagenesis, Impairment of Fertility).

Concomitant therapy



WARNINGS): total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

ADVERSE REACTIONS).

HOW SUPPLIED



STORAGE AND HANDLING



ANIMAL PHARMACOLOGY & OR TOXICOLOGY




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Tetracycline Hydrochloride


Tetracycline Hydrochloride

Tetracycline Hydrochloride

TETRACYCLINE HYDROCHLORIDE CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:24236-404(NDC:0172-2416)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE 250 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
GELATIN
propylene glycol
SHELLAC
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
titanium dioxide
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
yellow 19 mm Z;2416 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24236-404-03 20 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075659 2012-08-28


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