DORYX (Page 4 of 4)

ADVERSE REACTIONS

Due to oral doxycycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhoea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines:

Gastrointestinal: Anorexia, nausea, vomiting, diarrhoea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (see DOSAGE AND ADMINISTRATION).

Skin: Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above (see WARNINGS).

Renal toxicity: Rise in BUN has been reported and is apparently dose related. (see WARNINGS).

Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

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

Other: Bulging fontanels in infants and benign intracranial hypertension in adults (See PRECAUTIONSGeneral).

When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discolouration of thyroid glands. No abnormalities of thyroid functions are known to occur.

OVERDOSAGE

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.

DOSAGE AND ADMINISTRATION

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 pounds, the usual adult dose should be used.

The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.

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

Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS).

If gastric irritation occurs, doxycycline may be given with food or milk. Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.

Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twiceaday for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.

Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg by mouth, twice a day for 7 days.

Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for 7 days.

Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice a day for 2 weeks.

Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice a day for 4 weeks.

Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twiceaday for at least 10 days.

Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.

For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1-2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveller leaves the malarious area.

Inhalation anthrax (post-exposure):

ADULTS: 100 mg of doxycycline, by mouth twiceaday for 60 days.

CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twiceaday for 60 days. Children weighing 100 lb or more should receive the adult dose.

Sprinkling the Capsule Contents on Apple-sauce

DORYX Capsules may also be administered by carefully opening the capsules and sprinkling the capsule contents on a spoonful of applesauce. However, any loss of pellets in the transfer would prevent using the dose. The applesauce should be swallowed immediately without chewing and followed with a cool 8-ounce glass of water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. In the event that a prepared dose of applesauce / DORYX pellets cannot be taken immediately, the mixture should be discarded and not stored for later use.

HOW SUPPLIED

DORYX® (doxycycline hyclate) Delayed-Release Capsules, 100 mg have a dark yellow transparent body with light blue opaque cap; the capsule bearing the inscription “DORYX” and “WC” in a circle, printed in white. Pellets are coloured yellow. Each capsule contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline, supplied in:

Bulk containers of 60,000 capsules (NDC 50546-400-01).

DORYX® (doxycycline hyclate) Delayed-Release Capsules, 75 mg have an orange transparent body with opaque green cap; the capsule bearing the inscription “DORYX” on the cap and “75mg” on the body, printed in black. Pellets are coloured yellow. Each capsule contains specially coated pellets of doxycycline hyclate equivalent to 75 mg doxycycline, supplied in:

Bulk containers of 60,000 capsules (NDC 50546-550-01).

STORAGE CONDITIONS

Store at controlled room temperature below 25˚C (77˚F).

ANIMAL PHARMACOLOGY AND 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. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests , Fourth Edition. Approved Standard NCCLS Document M2-A4, Vol. 10, No.7 NCCLS Villanova, PA, April 1990.
  2. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically , Second Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8 NCCLS, Villanova, PA, April 1990.
  3. Friedman JM and Polifka JE. Teratogenic Effects of Drugs: A Resource for Clinicians (TERIS). Baltimore, MD; The Johns Hopkins University Press; 2000: 149-195.
  4. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89:524-528.
  5. Horne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25:315-317
  6. Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX:Pharmasoft Publishing 2000; 225-226.

RX only

Revised March 2007

Manufactured by:

Mayne Pharma International Pty Ltd

1538 Main North Road

Salisbury South, SA 5106

Australia

Marketed by:

Warner Chilcott (US), Inc.

Rockaway, NJ 07866 USA

443271/9

DORYX doxycycline hyclate capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50546-400
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
doxycycline hyclate (doxycycline) doxycycline 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSIC POLYMER COATING
D & C YELLOW NO. 10
FD & C BLUE NO. 1
FD & C YELLOW NO. 6
GELATIN
LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALINE CELLULOSE
POVIDONE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH WHEAT
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (dark) , BLUE (light) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code DORYX;WC
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50546-400-01 1 BAG (1 BAG) in 1 DRUM contains a BAG
1 60000 CAPSULE, DELAYED RELEASE PELLETS (60000 CAPSULE) in 1 BAG This package is contained within the DRUM (50546-400-01)
DORYX doxycycline hyclate capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50546-550
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
doxycycline hyclate (doxycycline) doxycycline 75 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSIC POLYMER COATING
D & C YELLOW NO. 10
FD & C BLUE NO. 1
FD & C YELLOW NO. 6
GELATIN
LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALINE CELLULOSE
POVIDONE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH WHEAT
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE, GREEN Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code DORYX;75mg
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50546-550-01 1 BAG (1 BAG) in 1 DRUM contains a BAG
1 60000 CAPSULE, DELAYED RELEASE PELLETS (60000 CAPSULE) in 1 BAG This package is contained within the DRUM (50546-550-01)
Labeler — Warner Chilcott (US), Inc.

Revised: 08/2007 Warner Chilcott (US), Inc.

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