Lincomycin 30% zoetis

Overdose

Serum levels of Lincomycin 30% Zoetismycin are not appreciably affected by hemodialysis and peritoneal dialysis.

Contraindications

This drug is contraindicated in patients previously found to be hypersensitive to Lincomycin 30% Zoetismycin or clindamycin.

Undesirable effects

The following reactions have been reported with the use of Lincomycin 30% Zoetismycin and are listed by System Organ Class.

Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort1 , anal pruritus

1Event has been reported with intravenous injection.

Rash, urticaria, pruritus, Stevens-Johnson syndrome, erythema multiforme (see WARNINGS), dermatitis bullous, dermatitis exfoliative

Vaginal infection, pseudomembranous colitis, Clostridium difficile colitis (see WARNINGS)

Pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura

Anaphylactic reaction (see WARNINGS), angioedema, serum sickness

Jaundice, liver function test abnormal, transaminases increased

Renal impairment, oliguria, proteinuria, azotemia

Cardio-respiratory arrest (see DOSAGE AND ADMINISTRATION)

Hypotension (see DOSAGE AND ADMINISTRATION), thrombophlebitis1

Vertigo, tinnitus

Headache, dizziness, somnolence

Injection site abscess sterile2 , injection site induration2 , injection site pain2 , injection site irritation2

2 Reported with intramuscular injection.

Therapeutic indications

Lincomycin 30% ZoetisCIN Sterile Solution is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial associated pseudomembranous colitis, as described in the WARNING box, before selecting Lincomycin 30% Zoetismycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).

Indicated surgical procedures should be performed in conjunction with antibacterial therapy.

The drug may be administered concomitantly with other antimicrobial agents when indicated.

Lincomycin 30% Zoetismycin is not indicated in the treatment of minor bacterial infections or viral infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin 30% ZoetisCIN and other antibacterial drugs, Lincomycin 30% ZoetisCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Name of the medicinal product

Qualitative and quantitative composition

Special warnings and precautions for use

see BOX WARNING.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomycin 30% Zoetismycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Serious hypersensitivity reactions, including anaphylaxis and erythema multiforme, have been reported with use of Lincomycin 30% ZoetisCIN. If an allergic reaction to Lincomycin 30% ZoetisCIN occurs, discontinue the drug. (see ADVERSE REACTIONS)

This product contains benzyl alcohol as a preservative.

The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.

Use in Meningitis — Although Lincomycin 30% Zoetismycin appears to diffuse into cerebrospinal fluid, levels of Lincomycin 30% Zoetismycin in the CSF may be inadequate for the treatment of meningitis.

Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When Lincomycin 30% ZoetisCIN is indicated in these patients, they should be carefully monitored for change in bowel frequency.

Lincomycin 30% ZoetisCIN should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Lincomycin 30% ZoetisCIN should be used with caution in patients with a history of asthma or significant allergies.

Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibacterial therapy.

The use of Lincomycin 30% ZoetisCIN may result in overgrowth of nonsusceptible organisms— particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing monilial infections require therapy with Lincomycin 30% ZoetisCIN, concomitant antimonilial treatment should be given.

The serum half-life of Lincomycin 30% Zoetismycin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function.

Patients with severe impairment of renal function and/or abnormal hepatic function should be dosed with caution and serum Lincomycin 30% Zoetismycin levels monitored during high-dose therapy. (see DOSAGE AND ADMINISTRATION)

Lincomycin 30% Zoetismycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the DOSAGE AND ADMINISTRATIONSection.

Prescribing Lincomycin 30% ZoetisCIN in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

During prolonged therapy with Lincomycin 30% ZoetisCIN, periodic liver and kidney function tests and blood counts should be performed.

The carcinogenic potential of Lincomycin 30% Zoetismycin has not been evaluated.

Lincomycin 30% Zoetismycin was not found to be mutagenic in the Ames Salmonella reversion assay or the V79 Chinese hamster lung cells at the HGPRT locus. It did not induce DNA strand breaks in V79 Chinese hamster lung cells as measured by alkaline elution or chromosomal abnormalities in cultured human lymphocytes. In vivo, Lincomycin 30% Zoetismycin was negative in both the rat and mouse micronucleus assays and it did not induce sex-linked recessive lethal mutations in the offspring of male Drosophila. However, Lincomycin 30% Zoetismycin did cause unscheduled DNA syntheses in freshly isolated rat hepatocytes.

Impairment of fertility was not observed in male or female rats given oral 300 mg/kg doses of Lincomycin 30% Zoetismycin (0.36 times the highest recommended human dose based on mg/m2 ).

Lincomycin 30% ZoetisCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See WARNINGS.

Teratogenic Effects

There are no studies on the teratogenic potential of Lincomycin 30% Zoetismycin in animals or adequate and wellcontrolled studies of pregnant women.

Nonteratogenic Effects

Reproduction studies have been performed in rats using oral doses of Lincomycin 30% Zoetismycin up to 1000 mg/kg (1.2 times the maximum daily human dose based on mg/m2 ) and have revealed no adverse effects on survival of offspring from birth to weaning.

Lincomycin 30% Zoetismycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 μg/mL. Because of the potential for serious adverse reactions in nursing infants from Lincomycin 30% ZoetisCIN, a decision should be made whether to discontinue nursing, or to discontinue the drug, taking into account the importance of the drug to the mother.

Lincomycin 30% ZoetisCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants. See WARNINGS. Safety and effectiveness in pediatric patients below the age of one month have not been established. (see DOSAGE AND ADMINISTRATION)

Dosage (Posology) and method of administration

If significant diarrhea occurs during therapy, this antibacterial should be discontinued. (see BOX WARNING.)

Serious infections—600 mg (2 mL) intramuscularly every 24 hours. More severe infections—600 mg (2 mL) intramuscularly every 12 hours or more often.

Serious infections—one intramuscular injection of 10 mg/kg (5 mg/lb) every 24 hours. More severe infections—one intramuscular injection of 10 mg/kg (5 mg/lb) every 12 hours or more often.

The intravenous dose will be determined by the severity of the infection. For serious infections doses of 600 mg of Lincomycin 30% Zoetismycin (2 mL of Lincomycin 30% ZoetisCIN) to 1 gram are given every 8 to 12 hours. For more severe infections these doses may have to be increased. In life-threatening situations daily intravenous doses of as much as 8 grams have been given. Intravenous doses are given on the basis of 1 gram of Lincomycin 30% Zoetismycin diluted in not less than 100 mL of appropriate solution (see Physical Compatibities) and infused over a period of not less than one hour.

These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 grams of Lincomycin 30% Zoetismycin.

10 to 20 mg/kg/day (5 to 10 mg/lb/day) depending on the severity of the infection may be infused in divided doses as described above for adults.

Reported with intramuscular injection.

NOTE: Severe cardiopulmonary reactions have occurred when this drug has been given at greater than the recommended concentration and rate.

0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid levels of antibacterial (lasting for at least 5 hours) with MICs sufficient for most susceptible pathogens.

When therapy with Lincomycin 30% ZoetisCIN is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys.

Physically compatible for 24 hours at room temperature unless otherwise indicated.

5% Dextrose Injection
10% Dextrose Injection
5% Dextrose and 0.9% Sodium Chloride Injection
10% Dextrose and 0.9% Sodium Chloride Injection
Ringer’s Injection

1/6 M Sodium Lactate Injection
Travert 10%-Electrolyte No. 1
Dextran in Saline 6% w/v

B-Complex
B-Complex with Ascorbic Acid

Penicillin G Sodium (Satisfactory for 4 hours)
Cephalothin
Tetracycline HCl
Cephaloridine
Colistimethate (Satisfactory for 4 hours)
Ampicillin
Methicillin
Chloramphenicol
Polymyxin B Sulfate

Novobiocin
Kanamycin

IT SHOULD BE EMPHASIZED THAT THE COMPATIBLE AND INCOMPATIBLE DETERMINATIONS ARE PHYSICAL OBSERVATIONS ONLY, NOT CHEMICAL DETERMINATIONS. ADEQUATE CLINICAL EVALUATION OF THE SAFETY AND EFFICACY OF THESE COMBINATIONS HAS NOT BEEN PERFORMED.