Detailed information
COMPOSITION:
Each capsule contains minocyclin hydrochloride equivalent to 50mg or l00mg minocyclin.
CLINICAL AND PHARMACOLOGICAL PROPERTIES:
Minocyclin hydrochloride, a semi synthetic derivative of tetracycline, is rapidly absorbed from the gastrointestmal tract following oral administration, maximum serum concentrations are attained in 2 hours, the serum half-life is attainde in 15 hours.
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect to the inhibition of protein synthesis. The tetracyclines, including minocycline, have similarly antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracycline is common, while vitro studies have demonstrated me susceptibility of most strains of the following microorganisms clinical efficacy for infections other than those included in the indications and usage section which have not been documented.
Gram-negative bacteria:
Bartonella baeilliforms, Brucella specie, Haemophilus influenzae, Haemoph-ilus ducreyi, Listeria monocytogenes, Neisseria gonorrhoeae. Vibrio cholera, Yersinia pestis.
Because many strains of the following groups of gram-negative microorga isms have been shown to be resistant to tetracyclines, culture and susceptibility tests are especially recommended :
Acinetobacter species, Bacteroides species, Enterobacter aerogenes, Esheri-chia coli, Klebsiella species, Shigella species,
Gram-positive bacteria:
Because many strains of the following groups of gram-negative micro-organisms have been shown to be resistant to tetracyclines, culture and susceptibility tests are especially recommended. Up to 44% of streptococcus pyogenes strains have been found to be resistant to tetracyclines drugs. Therefore tetracyclines should not be used for streptococcal diseases imless me organism has been demonstrated to be susceptible Enterococcus faecalis and Enterococcus faecium. Streptococcus Pneumoniae, Steptococcus pyogenes, Viridans group streptococci.
Other microorganisms:
Bacillus anthracis, Chlamydia trchomatis, Clostridium species, Entamoeba species, Mycoplasma pneumoniae, Treponemaicketesia pallidium.and Ureaplasma urealyticum.
INDICATIONS AND USAGE:
Capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganism:
Typhus fever, tick fevers caused by rickettsiae. Respiratory tract infections caused by chlamydia trachomatis. Lymphogranuloma venereum caused by chlamydia trachomatis. Trachoma caued by chlamydia tracho' iatis inclusion. Conjunctivitivitis caused by chlamydia trachomatis. Nongonococcal urethritis in adults caused by ureaplasma '.realyticum or chlamydia trachomatis. Chancroid caused by haemophilus du reyi. Pague due plague to yesinia pestis. Cholera caused by vbrio cholerae. Brucellosis due to brucella species. It is indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.
Skin and skin structure infections and soft tissue infections caused by staphylococcus aureus. Central nervous system side effects including light headiness, dizziness or vertigo have been reported with minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued. Patients who experience central nervous system symptoms should be cautioned about driving vehiclesorusing hazardous machinery while on minocycline therapy.
As with other antibiotic preparations, use of this drug results in overgrowth of non-susceptible organisms, including fungi. If super infection occurs, the antibiotic should be discontinued and appropriate therapy instituted. Paseudotumor cerebri (benign intracranial hypertension ) in adults has been associated with the use of tetracycline. The usual clinical manifestations (headache and blurred vison bulging fontanels) have been associated with the use of tetracyclines in infants, while both of these conditions and related symptoms usually resolve after discontinuation of the tetracycline, the possibility for permanent sequelae exists .
Nursing Mothers:
Tetracyclines are exerted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
DRUG INTERACTION:
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of tetracyclines is impaired by anticids containing aluminum, calcium or magnesium, and iron-containing preparation. Concurrent use of tetracyclines with oral contraceptives may make render oral contraceptive less effective.
ADVERSE REACTIONS:
The following adverse reactions have been observed in patients receiving tetracyclines :
Gastrointestmal: anorexia, nausea, vomiting, dianhea, glossitis, dysphagia, enterocelitis, pancreatitis, rarely hepatitis, and liver failure have been reported.
Rare instances ofesophagitis and esopha^eal ulceration have been reported in patients taking the tetracyclines-class antibiotics in capsules and tabfets, most of these patients took the medication immediately before going to bed.
Skin: maculopapular and erythematous rashes, balanitis, pigmentation of the skin and mucous membranes have been reported.
Renal toxicity : elevations in BUN have been reported and are apparently dose related.
Hypersensitivity reactions : urticaria, angioneurotic edema, polyarthragia, and pericarditis.
Blood : hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
Central nervous system : bulging fontanels in infants and benign intraci mial hypertension (pseudotumor cerebri in adults) have been reported, hea' che has also been reported, decreosein hearing has been reported in patients.
OVERDOSAGES:
In case of overdose, discontinue medication, treat symptomatically, and institute supportive measures.
DOSAGE AND ADMINISTRATION:
The usual dosage and frequency of administration of die drug differs from that of other tetracyclines .Exceedingthe recommended dosage may result in an increased incidence of side effects. Capsules may be taken with or without food.
Adults:
The usual dosage of capsules is 200mg initially followed by 100mg every 12 hours.
Alternatively, if more frequent doses are preferred, two or four 50mg capsule may be given initially followed by one 50mg capsule four times daily.
For children above 8 years of age the usual dosage of capsules is 4 mg/kg initially followed by 2 mg/kg every 12 hours. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men 200mg initially, followed by l00mg every 12 hours for a minimum of four days, with post therapy cultures within 2-3 days. In the treatment of uncomplicated gonococcal urethritis in men, l00mg every 12 hours for five days is recommended. For the treatment of syphilis, the usual dosage of the drug 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 l00mg every 12 hours for five days.
Uncomplicated nongonococcal urethral infection in adults caused by clamy-dia trachomat or ureaplasma : l00mg every 12 hours for at least 7 days. Ingestion of adequate amounts of fluids along with drugs in the tetracyclin-class is recommended to reduce the risk of easophageal irritation and ulceration.
In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual dose and or by extending the time intervals between doses .
HOW SUPPLIED:
20 capsules, each one contains 50mg minocycline hydrochloride
20 capsules, each one contains l00mg minocycline hydrochloride |
