Regulatory Information
PHARMAFORTE SINGAPORE PTE LTD
PHARMAFORTE SINGAPORE PTE LTD
Therapeutic
Prescription Only
Formulation Information
CAPSULE
**DOSAGE AND ADMINISTRATION** Children 13 Years of Age or Older: The usual dosage of AA PHARMA MINOCYCLINE (minocycline hydrochloride) is 4 mg/kg initially followed by 2 mg/kg every 12 hours. Tetracyclines are not recommended in children under 13 years of age (see Warnings – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Adults: The usual oral dosage of AA PHARMA MINOCYCLINE is 100 mg or 200 mg initially, followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg doses may be given initially, followed by one 50 mg dose every 6 hours. Therapy should be continued for 1 or 2 days beyond the time when characteristic symptoms or fever have subsided. For treatment of syphilis, AA PHARMA MINOCYCLINE therapy should be administered over a period of 10 or 15 days. Close follow-up, including laboratory tests, is recommended. Concomitant therapy: Antacids containing aluminum, calcium or magnesium and/or iron preparations impair absorption and should not be given to patients taking minocycline.
ORAL
Medical Information
**INDICATION AND CLINICAL USES** AA PHARMA MINOCYCLINE (minocycline hydrochloride) may be indicated for the treatment of the following infections due to susceptible strains of the designated organisms: Gallbladder infections caused by Escherichia coli; Urinary tract infections: cystitis, gonorrhea, pyelonephritis caused by Escherichia coli, Proteus species, Klebsiella species, Enterobacter aerogens, Neisseria gonorrhoeae. When penicillin is contraindicated, minocycline may be employed as an alternative drug in the treatment of anal and pharyngeal gonorrhea and syphilis. Skin and soft tissue infections: Abscess cellulities, furunculosis, impetigo and pyoderma caused by: Staphylococcus epidermidis, Staphylococcus aureus, Streptococcus pyogenes, Proteus species, Escherichia coli. Although tetracyclines are not the drugs of choice in any staphylococcal or streptococcal infection, minocycline could be useful in circumstances where these organisms are shown to be resistant to other agents but sensitive to minocycline. Bacterial evaluation of clinical cases involving proteus suggests a relatively lower success rate may be expected where these organisms are concerned. Respiratory tract infections: bronchitis, pharyngitis, pneumonia, bronchopneumonia, sinusitis and tonsillitis caused by: Haemophilus Influenzae, Klebsiella species, Enterobacter species. Tetracyclines should not be prescribed for acute throat infections.
**CONTRAINDICATIONS** History of hypersensitivity to minocycline or any other tetracyclines.
J01AA08
minocycline
Manufacturer Information
PHARMAFORTE SINGAPORE PTE LTD
APOTEX INC
Active Ingredients
Documents
Package Inserts
AA Pharma Minocycline PI - proposed clean IR 220301.pdf
Approved: March 10, 2022