Dynacin (Page 4 of 4)

Skin

Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions have been rarely reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and rarely Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS). Pigmentation of the skin and mucous membranes has been reported.

Renal toxicity

Elevations in BUN have been reported and are apparently dose related (see WARNINGS). Acute renal failure has been rarely reported and, in most cases, has been reversible.

Hypersensitivity reactions

Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus and rarely pulmonary infiltrates with eosinophilia have been reported. A lupus-like syndrome and serum sickness-like reactions also have been reported.

Blood

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

Central Nervous System

Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults (see PRECAUTIONS-General) have been reported. Headache has also been reported.

Other

When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid glands. Very rare cases of abnormal thyroid function have been reported.

Tooth discoloration in pediatric patients less than 8 years of age (see WARNINGS) and also, rarely, in adults has been reported.

Tinnitus and decreased hearing have been rarely reported in patients on minocycline hydrochloride.

OVERDOSAGE

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

DOSAGE AND ADMINISTRATION

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

Minocycline hydrochloride capsules may be taken with or without food. (see CLINICAL PHARMACOLOGY.)

For Pediatric Patients Above 8 Years of Age

The usual dosage of minocycline hydrochloride capsules is 4 mg/kg initially followed by 2 mg/kg every 12 hours.

Adults

The usual dosage of minocycline hydrochloride is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule four times daily.

Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of four days, with post-therapy cultures within 2 to 3 days.

In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for five days is recommended.

For the treatment of syphilis, the usual dosage of minocycline hydrochloride capsules should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.

In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for five days.

Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases.

Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least seven days.

Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.

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

HOW SUPPLIED

DYNACIN® (MINOCYCLINE HCl CAPSULES, USP) equivalent to 50 mg minocycline are opaque white capsules imprinted “0487” and “DYNACIN® 50 mg” and are supplied as follows:

NDC 99207-487-10 Bottles of 100

NDC 99207-487-11 Bottle of 1000.

DYNACIN® (MINOCYCLINE HCl CAPSULES, USP) equivalent to 75 mg minocycline are light gray opaque capsules imprinted “0489” and “DYNACIN® 75 mg” and are supplied as follows:

NDC 99207-489-10 Bottles of 100

NDC 99207-489-11 Bottle of 1000.

DYNACIN® (MINOCYCLINE HCl CAPSULES, USP) equivalent to 100 mg minocycline are opaque dark gray and opaque white capsules imprinted “0488” and “DYNACIN® 100 mg” and are supplied as follows:

NDC 99207-488-05 Bottles of 50

NDC 99207-488-11 Bottle of 1000.

Dispense in tight, light-resistant container with child-resistant closure.

Store at 20º–25ºC (68º–77ºF). [See USP Controlled Room Temperature].

Protect from light, moisture and excessive heat.

ANIMAL PHARMACOLOGY AND TOXICOLOGY

Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs and monkeys). In the rat, chronic treatment with minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake, and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs.

REFERENCES

  1. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fourth Edition; Approved Standard. NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA. January 1997.
  2. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disks Susceptibility Tests – Sixth Edition; Approved Standard. NCCLS Document M2-A5, Vol. 17, No. 1, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA. January 1997.
  3. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests – Eighth Edition; Approved Standard. NCCLS Document M100-S8, Vol. 18, No. 1, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA. January 1998

Manufactured for:
MEDICIS, The Dermatology Company®
Scottsdale, AZ 85258

IN-5178/S
Prescribing Information as of February 2004

DYNACIN
minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:99207-487
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
minocycline hydrochloride (minocycline) minocycline 50 mg
Inactive Ingredients
Ingredient Name Strength
magnesium stearate
starch (corn)
gelatin
silicon dioxide
sodium lauryl sulfate
titanium dioxide
Product Characteristics
Color WHITE (Opaque white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 0487;DYNACIN;50;mg
Contains
Coating false Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:99207-487-10 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
2 NDC:99207-487-11 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
DYNACIN
minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:99207-489
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
minocycline hydrochloride (minocycline) minocycline 75 mg
Inactive Ingredients
Ingredient Name Strength
magnesium stearate
starch (corn)
Product Characteristics
Color GRAY (light, opaque gray) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 0489;DYNACIN;75;mg
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:99207-489-10 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
2 NDC:99207-489-11 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
DYNACIN
minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:99207-488
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
minocycline hydrochloride (minocycline) minocycline 100 mg
Inactive Ingredients
Ingredient Name Strength
magnesium stearate
starch (corn)
Product Characteristics
Color GRAY (dark, opaque gray) , WHITE (WHITE) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 0488;DYNACIN;100;mg
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:99207-488-05 50 CAPSULE (50 CAPSULE) in 1 BOTTLE None
2 NDC:99207-488-11 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Labeler — MEDICIS, The Dermatology Company

Revised: 11/2006 MEDICIS, The Dermatology Company

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