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Lincover INJECTION 600mg 2ml SOL 3 Vials, Lincomycin

INDICATIONS: Brand Names Libiocid injectable solution is indicated for the treatment of upper respiratory tract infections and lower infection of the skin and soft tissues, bone and joint infections, in other infections such as septicemia and endocarditis, bacillary dysentery and infections caused by susceptible organisms.

Pharmacokinetics in Humans: Lincomycin is an antibiotic that is active against Gram-positive, has a similar but not identical to macrolide antibiotics. No cross-resistance, except with clindamycin and erythromycin. Binds to 50S ribosomes unit and suppresses bacterial protein synthesis.

Bile is an important means of excretion appeared the antibiotic into the active form in feces after being administered orally or parenterally, which suggests excretion with bile or through the intestinal wall or both modes.

Intramuscularly, 600 mg of lincomycin hydrochloride produce a plasma concentration from one to two hours after administration (12 mcg / ml), remaining blood levels up to 24 hours for intravenous, 300 mg of lincomycin generate 15 mcg / ml immediately. It is distributed to all organs and body fluids, such as pleural and peritoneal bile, but the LCR entry is limited, unless there meningitis, in which case, you get to
reach 40% of the plasma concentration. Cross the placenta and pass into the fetus, as well as breast milk, but not in great concentration. Lincomycin is partially inactivated in the liver. A good part is excreted via the kidneys within 24 hours. The half-life is about 4.5 hours. In renal failure, the half-life is prolonged, and could reach 12 hours in severe cases.

Contraindications: It is contraindicated in patients with a history of sensitivity to lincomycin or clindamycin is also contraindicated in neonates while not having more clinical experience in children less than one month, kidney, liver, and the gestational process.

WARNINGS: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including lincomycin and may range in severity from mild to life-threatening. Therefore, it is important in diagnosing patients with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis". After it has been established that the primary diagnosis of pseudomembranous colitis, therapeutic measures should be initiated. In moderate to severe cases, consideration should be given management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. Although lincomycin appears that diffuses into the cerebrospinal fluid, levels of lincomycin to herein may not be suitable for the treatment of meningitis. Therefore, the drug should not be used in such treatment. If lincomycin therapy is prolonged, tests for liver and kidney function. The use of antibiotics may result in an overgrowth of non-susceptible organisms, particularly fungi.

Lincomycin not be injected I.V. bolus but must be infused as described in Dosage and administration.

RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION: The safety of use during pregnancy and lactation has not been established. Lincomycin crosses the placenta and can concentrate in the fetal liver, nevertheless, no problems have been reported in humans. Also excreted in breast milk with no apparent problems arise from this cause, but no data to ensure the harmlessness of lincomycin at this stage.

ADVERSE REACTIONS: There may be cramping, abdominal pain, bloating or watery diarrhea that can be bloody or accompanied by fever, increased thirst, increased weight loss, nausea, vomiting and weakness. Other reactions include glossitis, stomatitis, enterocolitis, anal pruritus, rash, urticaria, generalized pruritus and vaginitis, effects that disappear after stopping treatment. Hypotension may occur when injected intravenously lincomycin as a bolus.

DRUG INTERACTIONS AND OTHER GENDER been shown to have properties
neuromuscular blocker, which can increase the action of other neuromuscular blocking agents, may interact with volatile anesthetics. Its action can be antagonized by chloramphenicol or erythromycin, should not be administered same time. The May potentiate the action of some neurotoxic. Also not be administered concurrently with novobiocin and kanamycin.

CHANGES OF LABORATORY TESTS found transient increase in serum bilirubin, alkaline phosphatase and transaminase and glutamic oxaloacetic acids. It can interfere with normal values ​​creatininfosfocinasa, asfaltato and alaninaminotransferasas.

PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: Its use during pregnancy and lactation has not been established.

DOSAGE AND ADMINISTRATION: Intramuscular or intravenous.

Adults:

Intramuscular: 600 mg (2 ml) every 8 or 12 hours or 24 hours, depending on the severity of the infection.

Intravenous infusion: intravenous doses are administered based on 1 g of lincomycin diluted in at least 100 ml of the appropriate solution and infused over a period of one hour.

Note: Severe cardiopulmonary reactions have occurred when this drug is administered in concentrations and infusion rates higher than recommended: 1) 600 mg to 1 g every 8 or 12 hours. 2) For more severe infections, this dose may be increased. 3) In situations of risk to life, were administered daily intravenous doses up to 8 g.

Dilution and infusion rates

Dose
 Volume of diluent
 Time
 
600 mg
 100 ml
 1 hour
 
1 g
 100 ml
 1 hour
 
2 g
 200 ml
 2 hours
 
3 g
 300 ml
 3 hours
 
4 g
 400 ml
 4 hours
 

Such doses may be repeated as often as required until the limit of RDA
8 g of lincomycin.

Children (over 1 month): intramuscular injection. 10 mg / kg / day and intramuscular injection. More severe infections: 10 mg / kg every 12 hours or more often.

Intravenous infusion: can be infused from 10 to 20 mg / kg / day, depending on the severity of the infection, in divided doses as described in dilution and infusion rates.

Patients with impaired renal function: In patients with hepatic or renal impairment, increases serum half-life of lincomycin. Please note the decline in the frequency of administration of lincomycin in patients with impaired hepatic or renal function. When required lincomycin therapy in individuals with severe renal insufficiency, an appropriate dose is 25 to 30% of that recommended for patients with normal renal function.

ß-hemolytic streptococcal infections: Treatment should be continued for at least 10 days.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION Sometimes can develop antibiotic-associated pseudomembranous colitis caused by Candida difficile toxoid during or after administration, have also been reported problems of hypotension and syncope. Treatment in mild cases may require fluid replacement, electrolytes and proteins, in severe cases can be given oral metronidazole or oral bacitracin, and heart problems, specific treatment installed.

PRESENTATIONS:

Box with 3 and 6 vials of 300 mg / ml for retail and export.

Box of 3 vials of 300 mg / ml and 3 disposable syringes retail and export.

Box with 3 and 6 vials with 600 mg / 2 ml for retail and export.

Box of 3 vials with 600 mg / 2 ml and 3 disposable syringes retail and export.

RECOMMENDED STORAGE: Store at room temperature not exceeding 30 ° C.
Drug Name: Libiocid
Comparable patent medicine: Lincocin
Active ingredient: Lincomycin
Presentation: Injectable Sol
Concentration: 600mg/2ml
Prolonged release tablets: No
Laboratory Rayere
Box of 6 vials with 2ml
Made in: MEXICO