Each capsule contains:
Composition:
Lincomycine Hydrochloride
..............................................500
mg
I.P equivalent to Lincomycin
base....................................500
mg
Indications :
Lincomycin has been used in the
treatment of serious skin infections
caused by susceptible strains of
streptococci, pneumococci, and
staphylococci.
Description and Clinical Pharmacology:
The mode of action of lincomycin is the
inhibition of protein synthesis by the
inhibition of the binding of
aminoacyl sRNA to the messenger ribosome
complex at the 50S ribosomal unit.
Lincomycin is absorbed rapidly after
oral administration, reaching peak
levels in 2 to 4 hours. Levels above the
minimum inhibitory concentration for
most gram-positive organisms are
maintained for 6 to 8 hours. I.M.
administration of lincomycin produces
peak serum levels in 30 minutes with
detectable levels persisting for 24
hours after a 600 mg dose.
I.V. infusions of lincomycin over a 2
hour interval yield therapeutic levels
for 14 hours.
Precautions: General: Should be used with caution in those patients with
a history of gastrointestinal disease,
specifically colitis.
Lincomycin is not indicated for use in
the treatment of meningitis as the
levels within the cerebral spinal fluid
do not reach an adequate concentration
to combat this infection.
No serious renal or neurologic
abnormalities have been reported to
date. No ototoxicity has been
demonstrated in any of a large number of
patients treated with lincomycin.
Pregnancy: Limited experience with 322
women receiving lincomycin orally at a
dosage of 500 mg 4 times/day for 7 days
during pregnancy revealed no ill effect
in the mother or the fetus. One hundred
and ten of these patients were treated
in the first trimester of pregnancy, 105
in the second trimester and 107 in the
third trimester. All were suffering from
cervicitis and/or vaginitis of bacterial
origin in conjunction with their
pregnancy. One hundred and twelve of the
children, ages 6 1/2 to 7 1/2 years,
from these patients have been examined
and compared with a control group of 65
children born at the same time in the
same hospital. Lincomycin treatment did
not result in any drug related
abnormalities (physical, dental or
developmental) when compared with the
control group.
Since safe conditions for the parenteral
use of lincomycin in pregnancy have not
been established, its use in such
patients should involve careful
consideration of expected benefits and
possible risks.
Lactation: Lincomycin has been reported
in breast milk at concentrations of 0.5
to 2.4 µg/mL.
Patients with Special Diseases and
Conditions: The serum half-life of
lincomycin is increased in those
patients with impaired renal or hepatic
function. Therefore, consideration
should be given to reducing the
frequency of administration in these
patients.
Since adequate data are not yet
available in patients with pre-existing
endocrine or metabolic diseases, its use
in such patients is not recommended at
this time unless special clinical
circumstances so indicate. Efficacy of
lincomycin in the prophylactic treatment
of rheumatic fever has not been
established.
Dosage :
As per physician’s advice.
Presentations :
10 caps.
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