CLINDALIV [Clindamycin] 0.2 g Gel
instructions
for the medical use of the medicinal product
CLINDALIV
Tradename
Сlindaliv, Клиндалив
International non-proprietary name
or generic name
Clindamycin, Клиндамицин
Dosage form
Gel for
external use.
Composition
for 20 g of gel
active substance: clindamycin phosphate 0.24 g equivalent to
clindamycin 0.2 g;
excipients: propylene glycol, macrogol 400, methylparaben,
carbomer, lavender hydrolate, sodium hydroxide, purified water.
Pharmacotherapeutic group
Antibacterial agents,
lincosamides.
АТХ Code: D07AD01
Pharmacological properties
Pharmacodynamics
Clindamycin phosphate is a
semi-synthetic antibiotic from the lincosamide group, is a phosphate ester of clindamycin,
a derivative of lincomycin. Clindamycin phosphate is inactive in vitro, but
after application to the skin it is rapidly hydrolyzed by phosphatases in the
ducts of the sebaceous glands to form clindamycin, which has antibacterial
activity.
Clindamycin acts
bacteriostatically on gram-positive aerobic bacteria, as well as on many
anaerobic bacteria. It is active against all strains of Propionibacterium
acnes, the minimum inhibitory concentration (MIC) is 0.4 μg / ml.
Inhibits protein synthesis in
the microbial cell due to interaction with the 50S subunits of ribosomes.
Clindamycin stops the proliferation of Propionibacterium acnes, thereby
reducing the release of fatty acids, which in turn inhibits chemotaxis, and
this leads to the suppression of inflammatory processes.
Pharmacokinetics
Clindamycin quickly
accumulates in comedones, where it exhibits antibacterial activity. The average
concentration of the antibiotic in the contents of comedones after application
of the gel significantly exceeds the minimum inhibitory concentration for all
strains of Propionibacterium acnes, the causative agent of acne. After
application of clindamycin gel to the skin, very low concentrations of
clindamycin are detected in the blood plasma and urine.
Indications for
use
For the treatment of
acne vulgaris.
• hypersensitivity to
clindamycin or lincomycin, as well as other components of the drug;
• Crohn's disease;
• ulcerative and
pseudomembranous (antibiotic-associated) colitis (including history);
• children under 12 years of
age.
Should be used with caution in patients with
allergies, as well as when taking muscle relaxants at the same time.
Method of administration and dosage
Externally.
Apply a thin layer of gel to the
affected area of previously cleaned and dried skin 2 times a day.
To obtain satisfactory results,
treatment should be continued for 6-8 weeks. If necessary, the course of
treatment can be extended to 6 months.
If after using the drug for several
months, the effectiveness of the treatment decreases, then you should take a
break for 4 weeks and consult a doctor.
Special instructions and precautions
Before using the drug,
consult a doctor.
Avoid contact with
eyes and mucous membranes of the nose and mouth, as well as wound skin
surfaces. If the drug accidentally gets into the eyes or on the mucous
membranes, rinse them with plenty of cold water.
After prolonged use,
clindamycin may be present in small concentrations in the blood serum and
urine.
Long-term treatment
with clindamycin in high doses may lead to the growth of insensitive flora.
Influence on the ability to drive
vehicles and mechanisms
There is no data on the
adverse effects of the drug on the ability to drive vehicles and operate
machinery.
Use during pregnancy
and breastfeeding
During
pregnancy, the drug should be used only if clearly necessary, when the benefit
of its use for the mother outweighs the potential risk to the fetus.
Due
to the potential for serious adverse reactions in breast-fed infants due to the
action of clindamycin, a decision should be made to discontinue breastfeeding
or discontinue the drug taking into account the importance of its use for the
mother in each individual case.
Side effect
The drug Clindaliv is usually well tolerated,
however, when using the gel locally, irritation (at the site of application),
burning, itching, dry skin, erythema, peeling, increased sebum secretion,
contact dermatitis are possible.
With resorption, there is a risk of
developing pseudomembranous enterocolitis.
If any of the side effects listed in the
instructions worsen, or you notice any other side effects not listed in the
instructions, tell your doctor.
Interaction with
other medicinal products
There is cross-resistance of microorganisms
to clindamycin and lincomycin.
Antagonism between clindamycin
and erythromycin has been noted.
It has been established that
clindamycin, when administered systemically, disrupts neuromuscular
transmission and, therefore, can enhance the effect of other peripherally
acting muscle relaxants, so the drug should be used with caution in patients
receiving drugs of this group.
When applied topically, clindamycin may
be absorbed in amounts that cause systemic effects. Possible systemic side
effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous
colitis. In case of overdose, symptomatic and supportive therapy is indicated.
Storage conditions
Store
at a temperature not exceeding 30°C. Keep out of reach of children.
Shelf life
2 years. Do not use
after the expiration date stated on the package.
Vacation
conditions
Dispensed by
prescription.
Release
form
20 g of gel in an aluminum tube together with
instructions for medical use in a cardboard box.
Manufacturer
The holder of trade mark and Marketing Authorization
is:
«LIVE MEDICINE ILAÇ VE TIC. LTD.
ŞTI.», Gökevler Mah.2312. Sk. Burc Istanbul 18 Esenyurt, ISTANBUL, TURKEY.
Produced by
«Amriya Pharmaceuticals Industries», Alexandria-Cairo
Desert Road, km 25, Amriya, Alexandria, Egypt.