Dynacin
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Questions & Answers
Side Effects & Adverse Reactions
MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).
This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy.
The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported rarely with minocycline.
Central nervous system side effects including lightheadedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Minocycline Hydrochloride Capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:
- Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by Rickettsiae
- Respiratory tract infections caused by Mycoplasma pneumoniae
- Lymphogranuloma venereum caused by Chlamydia trachomatis
- Psittacosis (Ornithosis) due to Chlamydia psittaci
- Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence
- Inclusion conjunctivitis caused by Chlamydia trachomatis
- Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis
- Relapsing fever due to Borrelia recurrentis
- Chancroid caused by Haemophilus ducreyi
- Plague due to Yersinia pestis
- Tularemia due to Francisella tularensis
- Cholera caused by Vibrio cholerae
-
Campylobacter fetus infections caused by
Campylobacter fetus
Brucellosis due to Brucella species (in conjunction with streptomycin) - Brucellosis due to Bartonella bacilliformis
- Granuloma inguinale caused by Calymmatobacterium granulomatis
Minocycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
- Escherichia coli
- Enterobacter aerogenes
- Shigella species
- Acinetobacter species
- Respiratory tract infections caused by Haemophilus influenzae
- Respiratory tract and urinary tract infections caused by Klebsiella species
Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
- Upper respiratory tract infections caused by Streptococcus pneumoniae
-
Skin and skin structure infections caused by
Straphylococcus aureus.
(Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)
When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:
- Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections when penicillin is contraindicated.
- Infections in women caused by Neisseria gonorrhoeae
- Syphilis caused by Treponema pallidum subspecies pallidum
- Yaws caused by Treponema pallidum subspecies pertenue
- Listeriosis due to Listeria monocytogenes
- Anthrax due to Bacillus anthracis
- Vincent's infection caused by Fusobacteruim fusiforme
- Actinomycosis caused by Actinomyces israelii
- Infections caused by Clostridium species
In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides.
In severe acne, minocycline may be useful adjunctive therapy.
Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.
Oral minocycline is not indicated for the treatment of meningococcal infection.
Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
History
There is currently no drug history available for this drug.
Other Information
Minocycline hydrochloride, a semisynthetic derivative of tetracycline, is 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below:
C23H27N3O7.HCl M. W. 493.94
Each minocycline hydrochloride capsule, for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn).
The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
The 75 mg and 100 mg capsule shells also contain: black iron oxide.
Sources
Dynacin Manufacturers
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Medicis, The Dermatology Company
![Dynacin (Minocycline Hydrochloride) Capsule [Medicis, The Dermatology Company]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dynacin | Medicis, The Dermatology Company
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 AgeThe usual dosage of minocycline hydrochloride capsules is 4 mg/kg initially followed by 2 mg/kg every 12 hours.
AdultsThe 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.
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Par Pharmaceutical, Inc.
Dynacin | Medinatura
General Considerations
• The dosage schedules listed below can be used as a general guide for the administration of Engystol® Injection Solution.
• Engystol® Injection Solution may be administered s.c., i.d., i.m., or i.v.
• The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard any unused ampule contents.
• Draw up required dose into syringe.
• Discard any unused ampule contents. Do not reuse ampule.
Only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer the product.
Standard Dosage:
Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days.
Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days.
Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days.
Acute Dosage:
Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage.
Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage.
Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.
![Dynacin (Minocycline Hydrochloride) Tablet [Par Pharmaceutical, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a05158b5-ae28-4889-881c-6a7883c96f4c&name=EngysolInjectionFGV.7.jpg)
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