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SPC-MINOCYCLINE is a brand name for Minocycline, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Children 13 Years of Age or Older:
The usual dosage of SPC-MINOCYCLINE (minocycline hydrochloride) is 4 mg/kg initially followed by 2 mg/kg every 12 hours. Tetracyclines is contraindicated in children under 13 years of age (see CONTRAINDICATIONS).
Adults:
The usual oral dosage of SPC-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, SPC-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. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
SPC-MINOCYCLINE (minocycline hydrochloride) Prescribing Information Page 12 of 32 PHARMACEUTICAL INFORMATION Drug Substance: Proper Name: minocycline hydrochloride Chemical Name: 4, 7-Bis(dimethylamino)-l, 4, 4a, 5, 5a, 6, 11,12a-octahydro- 3,10,12, 12a-tetrahydroxy-1, 11-dioxo-2-naphthacene- carboxamide monohydrochloride.
94 g/mol Description: Minocycline hydrochloride, USP is a yellow crystalline powder which is sparingly soluble in water; soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol; practically insoluble in chloroform and in ether.
Composition: 50 mg Capsule:
Corn Starch, FD&C Yellow # 6, Gelatin, Iron Oxide Black, Magnesium Stearate, Propylene Glycol, Shellac Glaze and Titanium dioxide. 100 mg Capsule: All ingredients of the 50 mg Capsule, FD&C Blue #1, FD&C Red #3, Potassium Hydroxide and Shellac.
Stability and Storage Recommendations Store at 15 to 30°C. Protect from moisture. SPC-MINOCYCLINE (minocycline hydrochloride) Prescribing Information Page 13 of 32 AVAILABILITY OF DOSAGE FORMS Capsules - 50 mg Light orange opaque cap/light orange opaque body, hard gelatin size ‘4’ capsules imprinted with ‘rbx’ on cap and ‘M 50’ on body in black ink containing yellow color powder.
Capsules –100 mg Purple opaque cap/light orange opaque body, hard gelatin size ‘2’ capsules imprinted with ‘rbx’ on cap and ‘M 100’ on body in black ink containing yellow powder.
• Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see the Dosage Forms section. • History of hypersensitivity to minocycline or any other tetracycline. • Pregnancy and lactation (see WARNINGS, Pregnancy and Lactation) • Children under 13 years (see WARNINGS, Newborns, Infants and Children) • Complete renal failure • Severe liver disease • Myasthenia gravis WARNINGS Anaphylactic/Anaphylactoid Reactions: Rarely, anaphylactic/anaphylactoid reactions including shock and fatalities have been associated with the administration of minocycline hydrochloride.
Gastrointestinal:
Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with the use of many antibacterial agents, including minocycline (see ADVERSE REACTIONS). CDAD may range in severity from mild diarrhea to fatal colitis.
It is important to consider this diagnosis in patients who present with diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory, to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile. Surgical evaluation should be instituted as clinically indicated since surgical intervention may be required in certain severe cases.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Package Sizes:
SPC-MINOCYCLINE 50 mg & 100 mg Capsules are available in bottles of 10 and 500. ) was conducted in 24 healthy, adult, male subjects under fasting conditions. ) were purchased in Canada § Expressed as the median (range) only € Expressed as the arithmetic mean (CV %) only SPC-MINOCYCLINE (minocycline hydrochloride) Prescribing Information Page 14 of 32 MICROBIOLOGY This survey of the in vitro activity of minocycline against clinical isolates was compiled from data presented in 130 articles published from 1967 to 1980.
The MICs of minocycline against clinical isolates representing gram-positive, gram-negative, actinomycetes, acid-fast and anaerobic bacteria and mycoplasma, were recorded and entered into a computer data-base file. The percent of clinical isolates inhibited at various antibiotic concentrations was determined directly from the total number of isolates tested by a computer-assisted statistical analysis system program.
BACTERIA No. of Strains Tested Cumulative Strains Inhibited at the Indicated Concentrations of Minocycline (mg/L) ≤1 ≤4 ≤8 ≤16 GRAM-POSITIVE Staphylococcus aureus 3301 77 91 96 98 Staphylococcus aureus − methicillin resistant 13 38 100 Staphylococcus aureus – penicillin resistant 100 100 Staphylococcus aureus – tetracycline resistant 736 50 75 84 93 Staphylococcus epidermidis 577 89 94 95 98 Staphylococcus epidermidis − methicillin resistant 19 21 89 95 95 Staphylococcus species 775 82 89 96 99 Staphylococcus species – tetracycline resistant 46 48 100 Staphylococcus beta hemolytic 654 73 83 95 99 Streptococcus – Enterococcus group 844 18 23 28 46 Streptococcus pneumonia 508 78 88 96 99 Streptococcus pneumoniae − tetracycline resistant 70 27 57 96 100 BACTERIA No.
of Strains Tested Cumulative Strains Inhibited at the Indicated Concentrations of Minocycline (mg/L) ≤1 ≤4 ≤8 ≤16 GRAM-NEGATIVE Acinetobacter calcoaceticus 456 95 99 100 Acinetobacter species 56 96 100 Bordetella pertussis 23 100 Brucella species 127 75 100 Citrobacter species 37 8 81 81 84 Enterobacter aerogenes 130 0 13 35 61 Enterobacter cloacae 131 0 9 18 44 Enterobacter species 310 7 78 91 95 Escherichia coli 1538 33 56 69 78 Haemophilus influenzae 385 62 90 98 100 Haemophilus species 182 89 98 99 100 Klebsiella-Enterobacter group 309 30 48 59 68 Klebsiella […]
Newborns, Infants and Children:
Minocycline s contraindicated in children under 13 years of age (see CONTRAINDICATIONS). The use of tetracycline including minocycline during tooth development (last half of pregnancy infancy and childhood under the age of thirteen years) has been shown to cause permanent tooth discolouration (yellow-grey-brown).
This is more common during long-term use, but has been observed following short-term courses. Enamel hypoplasia has also been reported. All tetracyclines including minocycline administered during the last trimester form a stable calcium complex throughout the human fetal skeleton.
A decrease in the fibula growth rate has been observed in SPC-MINOCYCLINE (minocycline hydrochloride) Prescribing Information Page 4 of 32 premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This appeared to be reversible when the drug was discontinued.
Congenital anomalies including limb reductions have been reported in postmarketing experience.
Pregnancy and lactation:
Tetracyclines including minocycline, are contraindicated during pregnancy and lactation (see CONTRAINDICATIONS) because of possible adverse effects on developing bones and teeth of the fetus and neonate. 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).
If minocycline hydrochloride is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.
The safety of Minocycline for use during pregnancy has not been established. Tetracyclines, including minocycline, are excreted in the milk of lactating women; therefore, a decision should be made whether to discontinue breast-feeding or to discontinue minocycline.
Fertility There are no relevant data available.
Elderly:
Clinical studies of Minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Penicillins:
It is advisable to avoid giving minocycline in conjunction with penicillin since some bacteriostatic drugs may interfere with the bactericidal action of penicillin.
Treatment of Streptococcal Infections:
Minocycline should not be used for the treatment of streptococcal diseases unless the organism is demonstrated to be sensitive, since most streptococci have been found to be resistant to tetracycline drugs. If it is deemed necessary that infection due to Group A beta-hemolytic streptococci be treated with minocycline, then such treatment should be continued for at least ten days.
Renal Impairment:
In the presence of significant renal impairment, usual oral doses may lead to excessive systemic accumulations of minocycline and possible liver toxicity. Under such conditions, lower than usual SPC-MINOCYCLINE (minocycline hydrochloride) Prescribing Information Page 5 of 32 doses may be indicated.
After initial therapy, and if therapy is prolonged, serum level determinations of the drug are advisable. The anti-anabolic action of tetracyclines can also produce dose-related increases in BUN; consequently, in patients with significant renal impairment, elevated serum minocycline levels can lead to azotemia, hypophosphatemia and acidosis.
Renal failure, including interstitial nephritis, has been reported rarely.
Auto-immune Disorders:
Rare cases of auto-immune hepatotoxicity and isolated cases […]