Tetracycline Hydrochloride (Page 3 of 3)

Pediatric Use

See WARNINGS and DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS

Gastrointestinal:

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

Esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines. Most of the patients were reported to have taken medication immediately before going to bed (see DOSAGE AND ADMINISTRATION).

Teeth:

permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has been reported (see WARNINGS).

Skin:

maculopapular and erythematous rashes. Exfoliative dermatitis has been reported. Onycholysis and discoloration of the nails have been reported. Photosensitivity is discussed in WARNINGS.

Renal Toxicity:

an increase in BUN has been reported and is dose related.

Liver:

hepatotoxicity and liver failure have been observed in patients receiving 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.

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.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

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 twice a day or 250 mg four times a day. Higher doses such as 500 mg four times a day may be required for severe infections or for those infections which do not respond to the smaller doses.

For pediatric patients above eight years of age: Usual daily dose, 10 mg/lb to 20 mg/lb (25 mg/kg to 50 mg/kg) body weight divided in four equal doses.

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).

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.

When used in streptococcal infections, therapy should be continued for 10 days.

For treatment of brucellosis, 500 mg tetracycline four times a day for three weeks 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 four times a day for 15 days. Syphilis of more than one year’s duration (except neurosyphilis), 500 mg four times a day for 30 days.

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

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.

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, reduce dosage gradually 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).

Use in Specific Population

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

HOW SUPPLIED

Tetracycline Hydrochloride Capsules USP are available as:
250 mg: Orange/yellow capsules, imprinted with “WPI ” on cap and “2234 ” on body. Available in bottles of 100 (NDC 0591-2474-01).

500 mg: Black/yellow capsules, imprinted with “WPI ” on cap and “2235 ” on body. Available in bottles of 100 (NDC 0591-2475-01).

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].

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL MEDICATIONS 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, 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 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:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 11/2018

PRINCIPAL DISPLAY PANEL

NDC 0591-2474-01

Tetracycline
Hydrochloride
Capsules, USP
250 mg

100 Capsules Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0591-2475-01
Tetracycline
Hydrochloride
Capsules, USP
500 mg

100 Capsules Rx Only

TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2474 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE) TETRACYCLINE HYDROCHLORIDE 250 mg

Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE SODIUM LAURYL SULFATE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN TITANIUM DIOXIDE BENZYL ALCOHOL BUTYLPARABEN D&C RED NO. 22 EDETATE CALCIUM DISODIUM METHYLPARABEN PROPYLPARABEN SILICON DIOXIDE SODIUM PROPIONATE SHELLAC FERROSOFERRIC OXIDE D&C YELLOW NO. 10 ALUMINUM LAKE DIMETHICONE WATER ETHYLENE GLYCOL MONOETHYL ETHER FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2–ALUMINUM LAKE FD&C RED NO. 40 LECITHIN, SOYBEAN BUTYL ALCOHOL ALCOHOL

Product Characteristics Color orange, yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code WPI;2234 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0591-2474-01 100 CAPSULE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA061837 08/15/2011

TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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, UNSPECIFIED FORM 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 SILICON DIOXIDE SODIUM PROPIONATE DIMETHICONE WATER ALCOHOL ETHYLENE GLYCOL MONOETHYL ETHER SHELLAC LECITHIN, SOYBEAN

Product Characteristics Color black, yellow Score no score Shape CAPSULE Size 22mm Flavor Imprint Code WPI;2235 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0591-2475-01 100 CAPSULE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA061837 08/15/2011

Labeler — Actavis Pharma, Inc. (119723554)

Revised: 11/2018 Actavis Pharma, Inc.