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Dalatsin C 300 mg capsules 16’s

$26.40

af80643e9d58

Description

The instruction for medical use

of PHOSPHATE DALATsIN® DALATsIN® medicine Ts

the Trade name

of DALATsIN® DALATsIN® of C PHOSPHATE

the International unlicensed

name Clindamycin Dosage Form
of the Capsule on 150 mg and 300 mg
Solution for injections 300mg/2ml, 600mg/4ml

Structure
of Dalatsin® of the capsule on 150 mg and 300 mg:
One capsule contains
active agent – clindamycin (in the form of hydrochloride clindamycin) 150 mg and 300 mg,
excipients: lactose, magnesium stearate, corn starch, talc, gelatin, titanium dioxide.
Далацин® C phosphate solution for injections:
1 ml of solution contains
active agent – clindamycin (in the form of phosphate clindamycin) 150 mg,
excipients: benzyl alcohol, edetat dinatrium, water for injections.

The description
Solid gelatin capsules of white color with the inscription Clin 150 and Pfizer (for a dosage of 150 mg) or Clin 300 and Pfizer (for a dosage of 300 mg) Contents of capsules – homogeneous powder of white color.
Далацин® C phosphate solution for injections: transparent colourless solution.

Pharmacotherapeutic group
Antibacterial drugs of systemic action. Linkozamida.
The code of automatic telephone exchange J01FF01

the Pharmacological

Pharmacokinetics Absorption Later properties of oral administration happens almost full (90%) clindamycin absorption. At adults after oral administration of clindamycin in a dose of 150 mg the maximum level of drug in blood serum (2.5 mkg/ml) is reached in 45 minutes. In 3 hours after oral administration the concentration of drug in blood serum makes 1.5 mkg/ml, and in 6 hours makes 0.7 mkg/ml.
After intramuscular introduction of 600 mg of clindamycin of phosphate the maximum concentration of drug in blood serum (9mkg/ml) is reached in 1-3 hours from the introduction moment. After intravenous infusion of 300 mg of drug within 10 minutes or 600 mg of drug within 20 minutes the maximum concentration of drug which makes 7 mkg/ml and 10mkg/ml, respectively, is reached at the end of administration of drug. Clindamycin phosphate is appointed the adult every 8-12 hours, to children – every 6-8 hours, or in the form of continuous intravenous infusion that provides concentration of clindamycin in blood serum which exceeds the minimum concentration of the drug in vitro necessary for suppression of the microorganisms, most sensitive to clindamycin. Constant level of drug in an organism is reached after the third dose.
Distribution
of 40-90% of the administered drug contacts in an organism blood proteins. After oral administration the accumulation of drug in an organism is not noted. Clindamycin easily gets into the majority of fabrics and liquids of an organism. Concentration of clindamycin in a bone tissue reaches about 40% (20-75%) of concentration of drug in blood serum. In maternal milk the concentration of drug makes 50-100% of concentration in blood serum, in synovial fluid of 50%, in blood of a fruit of 40%, in pus of 30%, in pleural liquid of 50-90% of concentration in blood serum. Clindamycin does not get through a blood-brain barrier, even in case of meningitis.
Metabolism
Time of semi-removal of clindamycin is + 1.5-3.5 hours. At patients with heavy abnormal liver functions and/or kidneys this period can be extended. In the presence of an easy or severe form of diseases of kidneys or a liver the scheme of treatment does not need to be changed. Clindamycin is almost completely metabolized.
Removal
In an active form is brought out of an organism by 10-20% of drug kidneys, 4% – with a stake. Other quantity is removed in the form of inactive metabolites, mainly with bile and a stake.

The pharmacodynamics
Active agent of drug is clindamycin – semi-synthetic substance with antimicrobic activity which is formed of lincomycin at substitution 7-(R) – hydroxyl group on 7-(S) – chlorine.
Depending on sensitivity of a microorganism and concentration of drug, clindamycin can work bakteritsidno or bacteriostatically. In vitro clindamycin has effect on the following isolated forms of microorganisms:
1) Aerobic gram-positive cocci, including:
· Golden staphylococcus
· Epidermal staphylococcus (the strains which are developing and not producing penicillinase). When carrying out the researches in vitro the fast development of stability to clindamycin in some staphylococcal strains resistant to erythromycin was noted.
· Streptococci (except for a fecal streptococcus)
· Pneumococci
2) Anaerobic gram-negative bacilli, including:
· Bacteroides species (including the B.fragilis group and the B.meleninogenicus group)
·
Fusobacterium species 3) the Anaerobic gram-positive bacilli which are not forming spores including:
· Propionibacterium
· Eubacterium
·
Actinomyces species 4) Anaerobic and mikroaerofilny gram-positive cocci, including:
· Peptococcus species
· Peptostreptococcus species
· Mikroaerofilny streptococci
· Clostridiums: clostridiums show big resistance to clindamycin, than the majority of other anaerobe bacterias. The majority of Clostridium perfringens are sensitive to clindamycin, but other types, such as C.sporogenes and C.tertium, are often resistant to effect of clindamycin. Therefore it is necessary to carry out sensitivity tests.
5) Various organisms, including Chlamidia trachomatis, Toxoplasma gondii, Plasmodium falciparum and Pneumocystis carinii (in combination with Primachinum), Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, Mycoplasma hominis.
The following organisms usually rezistentna to clindamycin:
· Aerobic gram-negative bacilli
· Streptococcus faecalis
· Nocardia species
· Neisseria meningitidis
· Strains Methicillinum – resistant Staphylococcus aureus and Haemophilus influenzae strains
Between lincomycin and clindamycin exists cross resistance. There is an antagonism between clindamycin and erythromycin.
Though clindamycin the hydrochloride is active both in vitro, and in vivo, clindamycin phosphate and clindamycin palmitate in vitro are inactive. However both in Vivo connections are quickly hydrolyzed to the active basis.

Indications
of Dalatsin® is an effective remedy at treatment of the following infections if they are caused by anaerobic bacteria or strains of gram-positive aerobic bacteria, sensitive to it, such as streptococci, staphylococcus and pneumococci and also types of Chlamidia trachomatis, sensitive to clindamycin:
– upper respiratory tract infections, including: tonsillitis, pharyngitis, sinusitis, inflammation of a middle ear and scarlet fever
– infections of lower parts of airways, including: bronchitis, pneumonia, an empyema of a pleura and abscess of a lung
– infectious diseases of skin and soft tissues, including: eels, furuncles, cellulitis, impetigo, the abscesses, contaminated wounds, specific infectious processes of skin and soft tissues caused by activators, sensitive to this drug, such as ugly face and paronychia (felon)
– infectious diseases of bones and joints, including: osteomyelitis and septic arthritis
– gynecologic infections, including an endometritis, abscesses of a pipe and ovaries, a salpingitis and inflammatory diseases of bodies of a basin if it is appointed in combination with the suitable antibacterial drug active concerning gram-negative aerobic activators. In case of the infections of a neck of the uterus caused by Chlamidia trachomatis it was shown that medicinal therapy only the drug Dalatsin® is effective for full treatment
– infectious diseases of an abdominal cavity, including: peritonitis and abscesses of an abdominal cavity (in combination with other antibacterial drugs which affect gram-negative aerobic bacteria)
– a septicaemia and an endocarditis. The efficiency of the drug Dalatsin® in certain cases of an endocarditis is proved: drug has bactericidal effect on in vitro contagium at use of such concentration of drug which are reached in blood serum of the person.
– oral cavity infections, such as periodontal abscess and periodontitis
– toksoplazmenny encephalitis at patients with AIDS. The efficiency of drug in combination with Pyrimethaminum at patients with intolerance of standard therapy
– pneumocystic pneumonia at patients with AIDS was proved. At patients with intolerance or resistant to standard therapy of Dalatsin® it can be used in a combination with Primachinum
– the malaria including caused by multi-drug resistant Plasmodium falciparum both in the form of monotherapy, and in combination with quinine or chloroquine
– prevention of an endocarditis at patients with hypersensitivity to penicillin
– prevention of infections at operations in the head and a neck. Далацин® the phosphate divorced in normal saline solution is applied by C in surgery to irrigation of an operational wound
– early prescribing of drug Dalatsin® Ts phosphate in combination with antibacterial drug from group of aminoglycosides, for example gentamycin or Tobramycinum, with success prevents development of peritonitis or abscess of an abdominal cavity after a perforation of intestines or as a result of traumatic infection
In the researches in vitro was shown that the following strains of microorganisms are sensitive to clindamycin: B.melaninogenicus, B.disiens, B.bivius, Peptostreptococcus spp., G.vaginalis, M.mulieris, M.curtisii, Mycoplasma hominis
in order to avoid complications to apply strictly on doctor’s orders.

The route of administration and doses
Adults and children are more senior than 12 years
of Dalatsin® of C phosphate (intravenously or intramusculary): For treatment of infectious diseases of an abdominal cavity, inflammatory diseases of bodies of a small pelvis at women and also in other complicated or heavy infections it is usually appointed 2400-2700mg drug in day, divided into 2, 3 or 4 equal doses. At easier forms of an infection and in the presence of the activator, more sensitive to therapy, the medical effect is reached also when assigning smaller doses of drug – 1200-1800 mg/day divided into 3 or 4 equal doses.
With success the drug doses reaching 4800 mg/day were applied. Purpose intramusculary of the single dose exceeding 600 mg is not recommended.
Далацин® capsules (inside): 600-1800 mg/day in 2, 3 or 4 receptions (equal doses). In order to avoid irritation of the mucous capsule of a gullet it is necessary to accept, washing down with a full glass of water.
Children are more senior than 1 month
of Dalatsin® of C phosphate (intravenously or intramusculary): 20-40 mg/kg of weight body/day divided into 3 or 4 equal doses. Solvent – normal saline solution is entered in the form of infusion.
Newborns (is younger than 1 month)
Dalatsin® of C phosphate (intravenously or intramusculary): 15-20 mg/kg of weight body/day divided into 3 or 4 equal doses. Solvent – normal saline solution is entered in the form of infusion.
For premature children there can be sufficient a smaller dose of drug.
The separate indications
of the Infection caused by a beta and hemolytic streptococcus: doses are stated above, it is necessary to continue treatment not less than 10 days.
Inflammatory diseases of bodies of a basin: 900 mg of drug Dalatsin® Ts phosphate in in each 8 hours + in/in the suitable antibacterial agent active concerning gram-negative aerobic activators (for example, gentamycin in a dose of 2.0 mg/kg with the subsequent introductions of 1.5 mg/kg every 8 hours for patients with normal function of kidneys). To continue administration of drugs in/in within not less than 4 days and then within not less than 48 hours after approach of improvement of a condition of the patient. Then to accept inside on 450-600 mg of the drug Dalatsin® each 6 hours before end 10-14 day courses of therapy.
The infections of a neck of the uterus caused by Chlamidia trachomatis: on 450-600 mg of the drug Dalatsin® in 4 times a day within 10-14 days.
Toksoplazmenny encephalitis at patients with AIDS: at patients with intolerance of standard therapy of Dalatsin® of C phosphate or Dalatsin® is applied in combination with Pyrimethaminum according to the following scheme: Далацин® C phosphate in/in or Dalatsin® inside in a dose of 600-1200 mg each 6 hours within 2 weeks, and Pyrimethaminum in a dose of 25-75 mg inside every day. Usually the course of therapy makes 8-10 weeks. At use of higher doses of Pyrimethaminum it is necessary to appoint foliniyevy acid in a dose of 10-20 mg/day.
Pneumocystic pneumonia at patients with AIDS: Далацин® C phosphate in/in 600-900 mg each 6 hours or 900 mg in in each 8 hours, or Dalatsin® on 300-450 mg inside each 6 hours within 21 days and Primachinum of 15-30 mg inside once a day within 21 days.
Acute streptococcal tonsillitis / pharyngitis: Далацин® on 300 mg in 2 times a day within 10 days.
Malaria: Далацин® capsules on 10-20 mg/kg/day for adults and 10 mg/kg/day for children each 12 hours equal doses within 7 days in the form of monotherapy, or in combination with quinine (12mg/kg each 12 hours) or chloroquine (to 15-25 mg there are each 24 hours) within 3-5 days.
Prevention of an endocarditis at patients with hypersensitivity to penicillin: in the capsule on 600 mg for adults and 20 mg/kg for children in 1 hour prior to intake of penicillin, or Dalatsin® of C phosphate in/in in a dose of 600 mg in 1 hour prior to administration of penicillin.
Prevention of infections at operations in a neck and the head: Далацин® C use phosphate (900 mg in 1 l of normal saline solution) during operation for irrigation of the polluted wounds of the head and neck before closing of a wound.
Cultivation and speed of infusion
Concentration of clindamycin in solution for infusions should not exceed 18 mg/ml and the speed of infusion should not exceed 30 mg/min. Usually use the following speeds of infusion:

The clindamycin dose

the Volume of normal saline solution

Time

of 300

mg 600 mg 900 mg 1200 mg 50 ml 50 ml 50-100 ml 100 ml

of 10

min. 20 min. 30 min. 40 min.

Introduction over 1200 mg for one infusion lasting 1 hour is not recommended.

Side effects
– an abdominal pain, nausea, vomiting and diarrhea, and at oral administration – the esophagitis (in addition to above-mentioned reactions)
– hypersensitivity reactions
is In certain cases noted makulopapulezny rash and a small tortoiseshell. Generalized korepodobny rash of easy and average degree of manifestation – the most frequent side reaction. Exceptional cases of the multiformny erythema reminding Stephens-Johnson’s syndrome and also cases of anaphylactoid reactions.
– the phenomena of jaundice and an abnormal liver function
– an itching, a vaginitis and also exceptional cases of exfoliative and vezikulo-bulezny dermatitis
– the neutropenia (leukopenia) and an eosinophilia of the passing character and also cases of an agranulocytosis and thrombocytopenia, but at the same time was not succeeded to establish etiological connection between these phenomena and the carried-out therapy by the drug Dalatsin®
– at too fast intravenous administration of drug cases of an apnoea and warm activity and also development of hypotonia were noted
– at intramuscular administration of drug such phenomena as local irritation, morbidity and formation of abscesses in the field of introduction can be noted. At intravenous administration sometimes there were thrombophlebitis phenomena. Frequency of emergence of such phenomena decreases at administration of drug deeply intramusculary and at as much as possible rare use of constant intravenous catheters.

Contraindications
– hypersensitivity to clindamycin, lincomycin or any component of drug

Medicinal interactions
the Following drugs are physically incompatible with drug Dalatsin® Ts phosphate in solution for infusions: ampicillin, sodium Phenytoinum, barbiturates, Aminophyllinum, calcium gluconate, magnesium sulfate, tseftriakson sodium, ciprofloxacin.
It was established that in vitro is shown antagonism between clindamycin and erythromycin. As this antagonism can be clinically significant, these two drugs should not be administered at the same time.
It is established that clindamycin breaks neuromuscular transfer therefore it can strengthen action of other muscle relaxants of peripheral action. Therefore, it has to be used with care at the patients receiving drugs of this group.

The special
instructions Solution for injections of Dalatsin® of C phosphate contains benzyl alcohol. There are messages that benzyl alcohol can cause development of deadly Gasping Syndrome (the disturbances from a respiratory system which are shown in the form of suffocation) in premature newborns. Cases of pseudomembranous colitis of varying severity up to life-threatening were observed at use practically of all antibacterial agents, including Dalatsin®. Therefore in all cases of diarrhea after intake of antibacterial drugs it is necessary to consider the possibility of this diagnosis.
Antibacterial drugs suppress normal flora of intestines that can promote the strengthened reproduction of clostridiums. It is proved that the toxins produced by Clostridium difficile are a basic reason of the colitis connected with antibiotic treatment. After diagnosis of pseudomembranous colitis it is necessary to take the following measures: in cases of an easy course it is usually enough to cancel antibacterial agent, in moderately severe cases and in hard cases it is necessary to consider expediency of input of the fluid, electrolytes, protein and prescribing of the antibacterial drug effective concerning Clostridium difficile. Далацин® it is not necessary to appoint for treatment of meningitis as clindamycin badly gets through a blood-brain barrier.
If treatment is carried out during the long span, then it is regularly necessary to conduct researches of function of a liver and kidneys.
At use of antibacterial agents, including Dalatsin® the excess growth of microorganisms, insensitive to this drug, especially yeast-like mushrooms is possible.
Далацин® the C phosphate should not be entered intravenously in not divorced look and it is one-stage. Injection needs to be carried out within not less than 10-60 minutes.
Patients have no recommendations about a drug Dalatsin® dose decline with an abnormal liver function and kidneys.
Pregnancy and feeding by a breast
Klindamitsin gets through a placenta. After introduction of several doses of drug the concentration in amniotic liquid made about 30% of concentration in mother’s blood. Далацин® it is necessary to apply at pregnant women only according to absolute indications i.e. when the potential advantage of therapy by drug exceeds potential risk.
It was reported that clindamycin is found in maternal milk in concentration of 0.7-3.8 mkg/ml.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
were not studied.

Overdose
Symptoms: strengthening of side effects.
Treatment: symptomatic and supporting.

Form of release and packing
of Dalatsin® of the capsule:
· blisters on 8 capsules
· 2 blisters and an iinstruktion on use are packed into a cardboard pack.
Далацин® C phosphate solution for injections:
· ampoules from transparent glass on 2 ml, 4 ml,
· 1 ampoule and an iinstruktion on use are packed into a cardboard pack.

To Store storage conditions at a temperature not above +25os.
To store out of children’s reach!

The Capsule period of storage – 5 years
– 2 years
not to apply Solution to injections after expiry date.

Prescription status
According to the prescription

the Producer
of the Capsule:

Pfizer PGM Zone Industrielle – 29

route des Industries 37530 Poce-sur-Cisse France
Solution for injections:

To Develop Pfizer of MFG Belgium H. B. Rijksweg 12, 2870 Puurs Belgium

Additional information

Ingredient

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