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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