Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**Dosage and Administration:** Adults : Initial dose is 200mg, followed by 100mg every 12 hours. 1. For gonorrhea patients sensitive to penicillin: 200mg initially, then 100mg every 12 hours for a minimum of 4 days. Post-therapy culture within 2 ~ 3 days is necessary. 2. For Neisseria meningitidis carrier (asymptomatic): 100mg every 12 hours for 5 days. 3. For Mycobcterium marinum infection: 100mg every 12 hours for 6 ~ 8 weeks. Optimal dose is not yet established. 4. For uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis and Ureaplasma urealyticum: 100mg twice daily for at least 7 days. 5. For uncomplicated gonococcal urethritis in men: 100mg twice a day for 5 days. Children over 12 years of age: Initial dose of 4mg/kg of body weight followed by 2mg/kg every 12 hours. Dosage reduction is not necessary in patients with renal impairment. May be taken with food or milk if gastrointestinal irritation occurs. To be dispensed on physician's prescription.
ORAL
Medical Information
**Indication(s):** Borymycin Capsule is indicated in the treatment of the following infection caused by susceptible strains: Respiratory tract infections caused by _Mycoplasma pneumoniae_; Psittacosis 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 in adult caused by _Ureaplasma urealyticum_ or _Chlamydia trachomatis_; Chancroid due to _Haemophilus ducreyi_; Cholera caused by _Vibrio cholerae_. Minocycline is indicated for treatment of infections caused by the following gram-negative microorganism, when bacteriologic testing indicates appropriate susceptibility to the drug: _Escherichia coli_; _Enterobacter aerogenes_; _Shigella species_; _Acinetobacter species_; Respiratory tract infections caused by _Haemophilus influenza_; Respiratory tract and urinary tract infections caused by _Klebsiella species_. Minocycline is indicated for treatment of infection caused by the following gram-positive microorganism, when bacteriologic testing indicates appropriate susceptibility to the drug : Upper respiratory tract infections caused by _Streptococcus pneumoniae_; Skin and skin structure infections caused by Minocycline-sensitive organism; Uncomplicated urethritis in men due to _Neisseria gonorrheae_ and for the treatment of other gonococcal infections when penicillin is contraindicated. Minocycline is an alternative drug in the treatment of the following infections: Infections in women caused by _Neisseria gonorrheae_; Syphilis caused by _Treponema pallidum_; Listeriosis due to _Listeria Monocytogenes_; Anthrax caused by _Bacillus anthracis_; Infections caused by Clostridium species. In severe acne, Minocycline may be used as an adjunct therapy. Oral Minocycline is indicated in the treatment of asymptomatic carriers of _Neisseria meningitidis_ to eliminate meningococci from the nasopharynx. It is recommended that the prophylactic use of Minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral Minocycline also has been used in the treatment of infections caused by Mycobacterium marinum.
**Contraindication(s):** 1. Hypersensitivity to any of the Tetracycline. 2. Minocycline, like other tetracycline-class antibiotics, can caused fetal harm when administered to a pregnant woman. If any Tetracycline is used during pregnancy or if the patients become pregnant while taking these drugs, the patients should be considered of the potential hazard to the fetus. 3. Tetracycline is excreted in human milk. Because of the potential for serious side effects in nursing infants from the tetracycline, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 4. In complete renal failure, Minocycline, like other Tetracycline-class, should be discontinued as systemic accumulation of the drug may lead to liver toxicity. 5. Generally should not be used in children under 12 years of age, unless other drugs are ineffective or are contraindicated, because it may cause permanent discoloration of the teeth, enamel hypoplasia, and inhibition of linear skeletal growth.
J01AA08
minocycline
Manufacturer Information
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Y.S.P. INDUSTRIES (M) SDN. BHD.
Active Ingredients
Documents
Package Inserts
Borymycin Capsule 50mg PI.pdf
Approved: November 26, 2021