Tetracycline Hydrochloride (Page 3 of 3)

Dosage and Administration:

Adults:

Usual daily dose, 1 gram as 500 mg b.i.d. or 250 mg q.i.d. Higher doses such as 500 mg q.i.d. may be required for severe infections or for those infections which do not respond to the smaller doses.

Children above eight years of age:

Usual daily dose, 10 to 20 mg/lb (25 to 50 mg/kg) body weight divided in four equal doses.

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

For the treatment of brucellosis, 500 mg tetracycline q.i.d. for three weeks should be accompanied by streptomycin, 1 gram intramuscularly twice daily the first week and once daily the second week.

For the treatment of syphilis in patients allergic to penicillin, the following dosage of tetracycline is recommended: early syphilis (less than one year’s duration) —500 mg q.i.d. for 15 days. Syphilis of more than one year’s duration (except neurosyphilis)—500 q.i.d. for 30 days.

For treatment of gonorrhea, the recommended dose is 500 mg by mouth four times a day for seven days.

In cases of moderate to severe acne which, in the judgement of the clinician, require long-term treatment, the recommended initial dosage is 1 gram daily in divided doses. When improvement is noted, dosage should be gradually reduced to maintenance levels ranging from 125 mg to 500 mg daily. In some patients it may be possible to maintain adequate remission of lesions with alternate day or intermittent therapy. Tetracycline therapy of acne should augment the other standard measures known to be of value. Duration of long-term treatment which can safely be recommended has not been established (see WARNINGS and Carcinogenesis, Mutagenesis , Impairment of Fertilit y).

Concomitant Therapy:

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc or sodium bicarbonate.

Food and some dairy products also interfere with absorption.

In the treatment of streptococcal infections, a therapeutic dose of tetracycline should be administered for at least ten days.

In patients with renal impairment (see WARNINGS) total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis: 500 mg, by mouth, four times a day for at least seven days.

Administration of adequate amounts of fluid with the capsule formulation of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS).

How Supplied:

Tetracycline Hydrochloride Capsules, USP are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0877-2 500 mg 60 Capsules in a Blister Pack Yellow Opaque Body 0591-2475

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

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 accomplished 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.

Manufactured By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA
Distributed By:
Watson Pharma, Inc.
Corona, CA 92880 USA

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

PACKAGE LABEL

Label Image for 53808-0877 500mg

Label Image for 500mgLabel Image for 500mg
TETRACYCLINE HYDROCHLORIDE
tetracycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0877(NDC:0591-2475)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE) TETRACYCLINE HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
TITANIUM DIOXIDE
BENZYL ALCOHOL
BUTYLPARABEN
EDETATE CALCIUM DISODIUM
FD&C YELLOW NO. 6
METHYLPARABEN
PROPYLPARABEN
COLLOIDAL SILICON DIOXIDE
SODIUM PROPIONATE
DIMETHICONE
WATER
ALCOHOL
ETHYLENE GLYCOL MONOETHYL ETHER
SHELLAC
LECITHIN, SOYBEAN
Product Characteristics
Color YELLOW (Yellow Opaque Body) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code WPI;2235
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-0877-2 60 CAPSULE (CAPSULE) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061837 01/01/2013
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-0877)

Revised: 09/2013 State of Florida DOH Central Pharmacy

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