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Description
The instruction
for medical use
of MS Deriva-S medicine
the Trade name
Deriva
the International unlicensed name
Is not present C MS
the Dosage form
Gel for external use, 30 g
Structure
of 1 g of gel contain
active agents: adapalen microspherical 1.0 mg,
clindamycin phosphate
(it is equivalent to clindamycin) 10.0 mg
excipients: dinatrium edetat, carbomer 940 (karbopol 940), propylene glycol monostearate, methylparahydroxybenzoate, phenoxyethanol, half-oxameasures 407, sodium hydroxide, water purified.
Description
Uniform gel of yellow-white color.
Pharmacotherapeutic group
Drugs for treatment of acne rash. Drugs for topical treatment of acne rash. Antimicrobial drugs for treatment of acne rash. Clindamycin, combinations.
The ATX D10AF51 code
The pharmacological
Pharmacokinetics Absorption properties of an adapalen through skin happens slowly. After prolonged topical administration of an adapalen only a small amount of initial substance was revealed (& lt, 0.25 ng/ml). Drug removal generally happens to bile.
At topical administration about 3-12 g of clindamycin a day, within 5 days, peak plasma concentration of clindamycin less than 5.5 ng/ml were reached. With urine less than 0.04% of the general dose are removed.
Gel Eliminirutsya in mainly biliary way.
The pharmacodynamics
Adapalen is the synthetic retinoid derivative of naphthoic acid, possesses komedonolitichesky and anti-inflammatory action. Drug affects a follicular hyperkeratosis, regulating process of keratinization and desquamation, affects the opened and closed comedones, preventing formation of microcomedones. The main mechanism of action selection linking with nuclear RAq-receptors of cells of epidermis in which result there is a decrease in a stseplennost of epithelial cells to the mouth of a grease and hair follicle and reduction, prerequisites for formation of microcomedones. This mechanism regulates a final differentiation of keratinotsit that provides normalization of process of keratinization and reduction of prerequisites for forming of microcomedones. Has anti-inflammatory effect by inhibition of metabolism of arikhidonovy acid and migration of leukocytes in the inflammation center.
Clindamycin a bacteriostatic antibiotic from group of linkozamid, possesses a broad spectrum of activity, contacts 23S a subunit of a ribosomalny membrane and suppresses synthesis of protein in a microbic cell. Concerning a number of gram-positive cocci perhaps bactericidal action. It is active concerning Staphylococcus spp. (excepting Enterococcus faecalis), Streptococcus pneumoniae, Corynebacterium diphtheriae, Mycoplasma spp., anaerobic and mikroaerofilny gram-positive cocci (including Peptococcus spp. and Peptostreptococcus spp.), Clostridium perfringens, Clostridium tetani, Vacteroides spp. (including Bacteroides fragilis and Prevotella melaninogenica), Fusobacterium spp., Propionibacterium spp., eubakterium and Actinomyces israelli. The majority of strains of Clostridium perfringens are sensitive to clindamycin, but other types of Clostridium spp. (including Clostridium sporogenes, Clostridium tertium) are resistant to its action in this connection in the infections caused by Clostridium spp. the definition of an antibiotikogramma is recommended.
Indications
– acne rash
the Route of administration and doses
Outwardly. Before use of MS Deriva-S gel it is necessary to clean and dry up skin. Evenly to apply with light touch gel on affected areas of skin once a day before going to bed, avoiding hit of drug in eyes, on lips and other mucous membranes. Duration of treatment is determined by the doctor.
The repeated course of treatment is possible after consultation with the doctor.
Side effects
Often:
– reddening, peeling, dryness, an itching and burning of integuments
– a peristatic hyperemia of skin eels
– contact dermatitis
– an abdominal pain
– the folliculitis caused by gram-negative microflora.
Seldom:
– the irritation of skin, pricking, strengthening of acne rash
– sunblisters
– diarrhea, a melena, colitis
– a photosensitization
– an acne
Is unknown:
– an erythema, an itching a century, the century swelled, persons
In the first weeks of treatment there can be a short-term irritation of skin. This effect is connected with effect of drug on the hidden skin damages and is not the basis for the treatment termination.
Contraindications
– hypersensitivity to drug components
– hypersensitivity to lincomycin
– a renal and liver failure
– the expressed lipidemia
– regional enteritis or ulcer colitis
– an antibiotic – the associated colitis
– children’s age up to 12 years
– pregnancy and the period of a lactation
Medicinal interactions
As adapalen can cause local irritation of skin in some patients, in order to avoid cumulative effect the simultaneous use with other means having the drying-up or irritating effect is not recommended (medical or abrasive мылá, and detergents, мылá, and the cosmetics having the drying effect, spirits, ethanol the containing means, etc.).
With extra care it is necessary to use in a combination with adapaleny the means containing sulfur, resorcin, salicylic acid. If these means were used earlier, it is reasonable not to begin therapy adapaleny until effects of these drugs on skin do not disappear.
It is incompatible with the solutions containing a complex of vitamins of group B, aminoglycosides, ampicillin, calcium a gluconate and magnesium sulfate. Shows antagonism with erythromycin.
As system absorption of drug at external use is insignificant, any medicinal interactions with the drugs used systemically are improbable. Drug can strengthen action of other means blocking neuromuscular transmission therefore to be careful at combined use of gel with such means.
The special
instructions Impact of Sunlight, including suntan, it is necessary to minimize during a usage time of an adapalen. Extreme weather events, such as wind or cold, can cause irritation of skin in patients.
To avoid contact of Deriva-S of MS with eyes, lips, corners of a nose and mucous membranes. The product should not be applied on cuts, grazes, eczemas or suntanned skin, it is not necessary to apply at patients with heavy acne rash, with dermatitis, with seborrhea, to treatment of burns.
As a part of drug there is methylparahydroxybenzoate which can cause allergic reactions of the slowed-down type. Filler propylene glycol can cause irritation of skin.
Pregnancy and the period of a lactation
is not recommended. Throughout all course of treatment drug and 1 month later after treatment, it is necessary to use reliable means of contraception. It is not recommended to use drug in case of pregnancy planning.
The feature of influence of drug on ability to run the vehicle or potentially
the C MS dangerous Deriva mechanisms does not affect ability to run motor transport or potentially dangerous mechanisms
Overdose
Excessive putting gel does not result in faster or best result.
Symptoms: the significant skin reactions reddening, peeling and also burning, diarrhea, a bloody chair and colitis (including pseudomembranous).
Treatment: symptomatic, local removal of gel.
A form of release and packing
On 30 g of gel in the laminated tuba.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature not higher than 25 C. Not to freeze.
To store out of children’s reach!
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
the Name and the country
of the Glenmark Pharmasyyutikalz Ltd manufacturing organization, India
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