Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)
Zydus Pharmaceuticals USA Inc.
MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE 50 mg
ORAL
PRESCRIPTION DRUG
Minocycline hydrochloride capsules USP 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 Chlamydophila 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
Minocycline hydrochloride capsules, USP are supplied as capsules containing minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, and 100 mg minocycline: Capsules containing minocycline hydrochloride, USP equivalent to 50 mg minocycline. The 50 mg capsule is supplied with a pink body and cap and is imprinted "═" on the cap and "316" on the body, in bottles of 100 (NDC 68382-316-01). Capsules containing minocycline hydrochloride, USP equivalent to 75 mg minocycline. The 75 mg capsule is supplied with a light gray opaque body and white opaque cap and is imprinted "═" on the cap and "317" on the body, in bottles of 100 (NDC 68382-317-01). Capsules containing minocycline hydrochloride, USP equivalent to 100 mg minocycline. The 100 mg capsule is supplied with a pink body and maroon cap and is imprinted "═" on the cap and "318" on the body, in bottles of 50 (NDC 68382-318-18). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE CAPSULE Zydus Pharmaceuticals USA Inc. ---------- PATIENT INFORMATION MINOCYCLINE (mye-no-SYE-kleen) HYDROCHLORIDE CAPSULES USP Rx only Read the Patient Information that comes with minocycline hydrochloride capsules before you or a family member starts taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment. What are minocycline hydrochloride capsules? Minocycline hydrochloride capsules are a tetracycline-class antibiotic medicine. Minocycline hydrochloride capsules are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride capsules may be used along with other treatments for severe acne. Sometimes, other germs, called viruses cause infections. The common cold is a virus. Minocycline hydrochloride capsules, like other antibiotics, do not treat viruses. Who should not use minocycline hydrochloride capsules? Do not take minocycline hydrochloride capsules if you are allergic to minocycline or other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medications if you are not sure. See the end of this leaflet for a complete list of ingredients in minocycline hydrochloride capsules. Minocycline hydrochloride capsules are not recommended for pregnant women or children up to 8 years old because: 1. Minocycline hydrochloride capsules may harm an unborn baby 2. Minocycline hydrochloride capsules may permanently turn a baby's or child's teeth yellow-gray- brown during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years. What should I tell my doctor before starting minocycline hydrochloride capsules? Tell your doctor about all of your medical conditions, including if you: • have liver or kidney problems • are pregnant or planning to Lees het volledige document
MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE CAPSULE ZYDUS PHARMACEUTICALS USA INC. ---------- MINOCYCLINE HYDROCHLORIDE CAPSULES, USP RX ONLY 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 bacteria. DESCRIPTION Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7- Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11- dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: C H N O •HCL M.W. 493.94 Minocycline hydrochloride capsules USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of minocycline. INACTIVE INGREDIENTS _Drug Product:_ corn starch and magnesium stearate. _Capsule Shell:_ Gelatin and titanium dioxide. In addition, the 100 mg capsule shells contain D&C Red #28, FD&C Blue #1, FD&C Red #40, and red iron oxide; the 75 mg capsule shells contain black iron oxide; and the 50 mg capsule shells contain D&C Red #33, FD&C Red #3, and FD&C Yellow #6. _Printing Ink: _black iron oxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake and shellac. In addition, the 50 mg and 100 mg ink contains strong ammonia solution. CLINICAL PHARMACOLOGY Following a single dose of two minocycline hydrochloride capsules, 100 mg administered 23 27 3 7 to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2.1 hours) and ranged from 2.1 to 5.1 mcg/mL (average 3.5 mcg/mL). The serum half-life in the normal volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours). When minocycline hydrochloride capsules were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of minocyc Lees het volledige document