Tetracycline Hydrochloride (Page 3 of 3)

OVERDOSAGE

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracycline is not dialyzable.

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 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 mg 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 Fertility).

Concomitant therapy

Absorption of tetracycline 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, 250 mg are available as orange opaque and yellow opaque capsules, imprinted with “Z” and “2416” in black ink, containing 250 mg of tetracycline hydrochloride, packaged in bottles of 100 and 1000 capsules, and unit-dose boxes of 100 capsules.

Tetracycline Hydrochloride Capsules USP, 500 mg are available as black and yellow capsules, imprinted with “Z” and “2407” in white ink, containing 500 mg of tetracycline hydrochloride, packaged in bottles of 100 and 1000 capsules, and unit-dose boxes of 100 capsules.


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


Store at 20° to 25°C (68° to 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, minocycline, 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 HCI and tetracycline HCI 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.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. B 3/2011

PRINCIPAL DISPLAY PANEL

55289446 Label
(click image for full-size original)

PDRx Label

Tetracycline Hydrochloride Capsules USP 500 mg 100s Label Text

0172-2407-60

TETRACYCLINE

HYDROCHLORIDE

Capsules USP

500 mg

Rx only

100 CAPSULES

TEVA

TETRACYCLINE HYDROCHLORIDE
tetracycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-446(NDC:0172-2407)
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
AMMONIA
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color BLACK, YELLOW Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code Z;2407
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55289-446-10 10 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:55289-446-12 12 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:55289-446-20 20 BOTTLE, PLASTIC (CAPSULE) in 1 BOTTLE, PLASTIC contains a BOTTLE, PLASTIC (55289-446-16)
3 NDC:55289-446-16 16 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC This package is contained within the BOTTLE, PLASTIC (55289-446-20)
4 NDC:55289-446-28 28 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
5 NDC:55289-446-30 30 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
6 NDC:55289-446-40 40 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
7 NDC:55289-446-56 56 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
8 NDC:55289-446-60 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
9 NDC:55289-446-01 100 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA060704 03/23/2010
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack

Revised: 05/2011 PD-Rx Pharmaceuticals, Inc.

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