Lincomycin - Lincobiotic ampoule

Lincomycin - Lincobiotic ampoule

Lincobiotic ampoule

"Lincomycin hydrochloride monohydrate 340.22 mg

(equivalent to Lincomycin base 300 mg)

Company Name

Memphis

Therapeutic Group

MACROLIDES & SIMILAR TYPE

Pharmaceutical form

Ampoule for intramuscular injection or intravenous administration after dissolution.

Package
Carton box containing 3 ampoules each of 2 ml for I.M and I.V injection.

Indications

"Lincomycin is indicated in the treatment of serious infections, when caused by lincomycin susceptible strains of gram positive aerobes such as streptococci, pneumococci and staphylococci, or by susceptible anaerobic bacteria:

1-Upper respiratory infections: chronic sinusitis caused by anaerobic strains. Lincomycin can be used for selected cases of chronic suppurative otitis media or as adjunctive therapy along with an antibiotic active against aerobic gram-negative organisms. Infections caused by H. influenzae are no indication (see under Properties).

2-Lower respiratory infections including infectious exacerbation of chronic bronchitis and pneumonia.

3-Serious skin and soft tissue infections caused by susceptible organisms, when penicillins are not indicated.

4-Bone and joint infections including osteomyelitis and septic arthritis.

5-Septicemia and endocarditis. Selected cases of septicaemia and/or endocarditis due to susceptible organisms have responded well to lincomycin. However, bactericidal drugs are often preferred for these infections.

Warning & Precautions

"Special precautions: The injectable form of this product contains benzylalcohol. Benzylalcohol has been reported to be associated with a fatal ""Gasping Syndrome"" (respiratory disorder characterized by a persistent gasping for breath) in premature infants. As no clinical experience is available, LINCOBIOTIC is not recommended in newborn babies. Caution should be exercised in prescribing lincomycin doses in patients with a history of GI disease, particularly colitis. Every diarrhea should be observed until two or three weeks after the therapy. Although lincomycin appears to diffuse into cerebrospinal fluid, levels of lincomycin in the CSF may be inadequate for the treatment of meningitis. Thus, the drug should not be used in the treatment of meningitis. In vitro, antagonism has been demonstrated between lincomycin and erythromycin and chemical related macrolides. Because of possible clinical significance, these two drugs should not be administered concurrently. If lincomycin antibiotic therapy is prolonged, liver and kidney function tests should be performed. The use of lincomycin may result in overgrowth of non susceptible organisms, particularly yeasts. Lincomycin should NEVER be injected intravenously undiluted as a bolus, but should be infused over at least 10 60 minutes as directed in the Dosage and administration section. Lincomycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Lincomycin should be administered with caution in atopic individuals. Patients with very severe renal disease and/or very severe hepatic disease accompanied by severe metabolic aberrations should be dosed with caution. During high dose therapy the serum lincomycin levels should be monitored as serum half life may be 2 to 3 fold longer in these patients. Warnings This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissue. This product is contraindicated for use in premature infants because the formulation contains benzyl alcohol. Pregnancy and lactation: Do not administer injections preserved with benzyl alcohol to pregnant women or nursing mothers. Injections preservative free should be used in these populations

Product Type

Human

Dosage

"Dosage and route of administration should be determined by the severity of the infection, the condition of the patient, and the susceptibility of the causative microorganisms.

Lincobiotic has to be administered by way of a deep intra-muscular injection.

Lincomycin should never be injected intravenously undiluted as a bolus, but should be infused over at least 10 60 minutes

ADULTS

A-Intramuscular injection

600 mg every 24 hours or more often

B-Intravenous injection (see dilution and infusion rates)

600 mg to 1 gram every 8 to 12 hours.

These doses may be increased, dependent on the degree of the infection.

In life-threatening situations, daily intravenous doses of as much as 8 grams are given.

CHILDREN

A-Intramuscular injection

10 mg/kg/day or more often

B-Intravenous injection

10 to 20 mg/kg/day depending on the severity of the infection may be infused in divided doses as described in the section on dilution and infusion rates.

DOSAGE IN DISTURBED RENAL AND/OR LIVER FUNCTION

When therapy with lincomycin is required in individuals with severe impairment of renal AND/OR LIVER function, an appropriate dose is 25 to 30 % of that recommended for patients with normally functioning KIDNEYS/LIVER.

DILUTION AND INFUSION RATES

Intravenous doses are given on the basis of 1 gram of lincomycin diluted in not less than 100 ml of appropriate solution (such as 5 % glucose or 0.9 % sodium chloride) and infused over a period of not less than one hour.

Dose Vol. diluent Time

600 mg 100 ml 1 hr

1 gram 100 ml 1 hr

2 grams 200 ml 2 hr

3 grams 300 ml 3 hr

4 grams 400 ml 4 hr

These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 grams of lincomycin.

Note:

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

Adverse Reactions

"1-Gastrointestinal Nausea, vomiting, abdominal distress and persistent diarrhea (see Special precautions).

Almost all antibiotics, among which penicillins, cephalosporins and the lincosamides, can give rise to severe diarrhea (sometimes after a latency period), colitis and pseudomembranous colitis, caused by toxins of Clostridium difficile. If severe or prolonged diarrhea occurs, the drug should be discontinued. Colitis has to be treated specifically, for instance with vancomycin (orally), combined with appropriate fluid, electrolyte and protein supplementation. Drugs which cause bowel stasis should be avoided.

2-Hematopoietic Neutropenia, leukopenia, agranulocytosis and thrombocytopenic purpura have been reported. There have been rare reports of aplastic anemia and pancytopenia in which lincomycin could not be ruled out as the causative agent.

3-Hypersensitivity reactions Hypersensitivity reactions such as angioneurotic edema, serum sickness and anaphylaxis have been reported, some of these in patients sensitive to penicillin. Rare instances of erythema multiforme, sometimes resembling the Stevens Johnson syndrome, have been associated with lincomycin administration.

Serious anaphylactoid reactions require immediate emergency treatment with epinephrine, oxygen, and intravenous steroids. Airway management, including intubation, should also be administered if indicated.

4-Skin and mucous membranes Pruritus, skin rashes, urticaria, vaginitis and rare instances of exfoliative and vesiculobullous dermatitis have been reported.

5-Liver Jaundice and abnormal liver function tests (particularly elevation of serum transaminase) have been observed during lincomycin therapy.

6-Cardiovascular Instances of hypotension following parenteral administration have been reported, particularly after too rapid administration. Rare instances of cardiopulmonary arrest have been reported after too rapid intravenous administration (see Dosage and administration section).

7-Local reactions Local irritation, pain, induration and sterile abscess formation have been seen with I.M. injection. Thrombophlebitis has been reported with I.V. injection. These reactions can be minimized by deep I.M. injection and avoidance of indwelling I.V. catheters.

8-The use of lincomycin can cause an overgrowth of non-sensitive organisms, particularly yeasts.

Contra Indications

"Lincomycin is contraindicated in patients previously found sensitive to lincomycin or clindamycin AND WITH MENINGEAL INFECTIONS.

Pregnancy, Nursing mothers& Pediatric use

Do not administer injections preserved with benzyl alcohol to neonates, infants, pregnant women or nursing mothers. Benzyl alcohol has been associated with serious adverse events & death, particularly in pediatric patients. Injections preservative free should be used in these populations.

Drug Interactions

"The action of neuromuscular blockers can be increased.

In vitro, antagonism has been demonstrated between lincomycin, erythromycin and chemical related macrolides. Because of possible

clinical significance, these two drugs should not be administered concurrently.

Lincomycin can interfere with the dosage of alkaline phosphatase in plasma. Consequently the obtained values can be erroneously elevated.

Search Post

Label :