Dalacin® vaginal suppositories (suppositories). Dalatsin: instructions for use, analogues and reviews, prices in pharmacies in Russia Dalatsin ear drops

Antibiotic of the lincosamide group

Release form, composition and packaging

Capsules hard gelatinous, with lid and body white, with the inscription "P&U 225"; the contents of the capsules are white powder.

Excipients:

Capsules hard gelatinous, with a white lid and body, with the inscription "P&U 395"; the contents of the capsules are white powder.

Excipients: lactose, magnesium stearate, corn starch, talc, gelatin, titanium dioxide.

8 pcs. - blisters (2) - cardboard packs.
10 pieces. - blisters (10) - cardboard packs.

pharmachologic effect

Clindamycin is a semisynthetic antibiotic lincosamide, formed from the substitution of 7- (R) -hydroxyl group by 7- (S) -chlorine, active against aerobic gram-positive microorganisms and a wide range of anaerobic bacteria. Most gram-negative aerobic bacteria, including Enterobacteriaceae, are resistant to clindamycin.

Lincosamides like macrolides (for example) bind to the 50S-subunit of the bacterial ribosome and inhibit protein synthesis by early stages... Depending on the sensitivity of the microorganism and the concentration of the drug, clindamycin can act bacteriostatic (mainly) or bactericidal (in high concentrations).

To clindamycin sensitive in vitro the following microorganisms:

1. Aerobic gram-positive cocciincluding: Staphylococcus aureus; Staphylococcus epidermidis (strains that produce and do not produce penicillinase). The rapid development of resistance to clindamycin was noted (in vitro) in some staphylococcal strains resistant to erythromycin. Streptococcus spp. (excluding Streptococcus faecalis), Pneumococcus spp.

2. Anaerobic gram-negative bacilliincluding: Bacteroides spp. (including the group B.fragilis, B.disiens, B.bivius and B.melaninogenicus), Fusobacterium spp.

3. Anaerobic gram-positive bacillinon-spore forming, including Propionibacterium spp., Eubacterium spp., Actinomyces spp.

4. Anaerobic and microaerophilic gram-positive cocci, including Peptococcus spp., Peptostreptococcus spp., microaerophilic Streptococcus spp., Clostridia spp .: Clostridia show greater resistance to clindamycin than most other anaerobes. Most Clostridium perfringens are susceptible to clindamycin, but other species, such as C. sporogenes and C. tertium, are often resistant to clindamycin and sensitivity testing is necessary.

5. Various organisms, including Chlamydia trachomatis, Toxoplasma gondii, Plasmodium falciparum and Pneumocystis carinii (in combination with primaquine), Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, Mycoplasma hominis.

The following microorganisms are usually resistantto clindamycin: aerobic gram-negative bacilli Streptococcus faecalis, Nocardia spp., Neisseria meningitidis, strains of methicillin-resistant Staphylococcus aureus and strains of Haemophilus influenzae. Cross-resistance exists between lincomycin and clindamycin.

Pharmacokinetics

Suction

After oral administration, there is a rapid and almost complete (90%) absorption of clindamycin. In adults, after taking clindamycin orally at a dose of 150 mg Cmax of the drug in serum (2.5 μg / ml) is achieved after 45 minutes, after 3 hours, the concentration of the drug in serum is 1.5 μg / ml, and after 6 hours - 0.7 μg / ml ... When taken orally, the absorption of clindamycin (in quantitative terms) does not depend to a large extent on the simultaneous intake of food, but intake with food can slow down absorption. There is a linear relationship between the serum concentration of clindamycin and the dose taken. Serum concentrations of clindamycin exceed the minimum inhibitory concentration (MIC) for most susceptible microorganisms for at least 6 hours after taking the drug at the usual recommended doses.

Distribution

40-90% of the administered drug binds to proteins in the body. After oral administration for at least 14 days, the accumulation of the drug in the body is not observed. Clindamycin is readily absorbed into most tissues and body fluids. The concentration of clindamycin in bone tissue reaches approximately 40% (20-75%) of its concentration in blood serum. In breast milk, the concentration of the drug is 50-100% of its concentration in serum, in synovial fluid - 50%, in sputum - 30-75%, in peritoneal fluid - 50%, in fetal blood - 40%, in pus - 30% , in pleural fluid - 50-90% concentration in blood serum. Clindamycin does not penetrate the intact BBB (even with inflammation meninges permeability increases slightly).

Metabolism

Clindamycin is almost completely metabolized, mainly in the liver to form N-demethyl and sulfoxide active metabolites, as well as some inactive metabolites.

Withdrawal

T 1/2 of clindamycin in adults averages about 2.4 hours (with severe hepatic or renal failure, slightly lengthens to 3-5 hours), age does not affect the pharmacokinetics of clindamycin.

In unchanged form, about 10% of the drug is excreted from the body by the kidneys, 3.6% - with feces. The rest is excreted as inactive metabolites, mainly in the bile and feces. Clindamycin is not excreted by hemodialysis and peritoneal dialysis.

Indications

Infectious and inflammatory diseases caused by anaerobic bacteria sensitive to clindamycin or strains of gram-positive aerobic bacteria, such as Streptococcus spp., Staphylococcus spp. and Pneumococcus spp., as well as clindamycin-sensitive Chlamydia trachomatis serovars:

- upper respiratory tract infections, incl. tonsillitis, pharyngitis, sinusitis;

- inflammation of the middle ear, scarlet fever;

- infections of the lower respiratory tract, incl. bronchitis, pneumonia, pleural empyema and lung abscess;

- infectious diseases of the skin and soft tissues, incl. acne, furunculosis, infection of the subcutaneous fatty tissue, impetigo, abscesses, infected wounds, specific infections in the skin and soft tissues caused by pathogens sensitive to this drug, such as erysipelas and paronychia (panaritium);

- infectious diseases of bones and joints, incl. osteomyelitis and septic arthritis;

- gynecological infectious diseases, including endometritis, infections of the subcutaneous fatty tissue, infections of the tissues surrounding the vagina, abscesses of the fallopian tubes and ovaries, salpingitis and pelvic inflammatory disease, in combination with an antibacterial drug active against gram-negative aerobic pathogens (for example);

- monotherapy of infectious diseases of the cervix caused by Chlamydia trachomatis;

- infectious diseases abdominal, including: peritonitis and abdominal abscesses (in combination with other antibacterial drugs that act on gram-negative aerobic bacteria);

- septicemia and endocarditis;

- infections of the oral cavity, such as: periodontal abscess and periodontitis;

- toxoplasmotic encephalitis in AIDS patients (in combination with pyrimethamine in patients with intolerance to standard therapy);

- Pneumocystis pneumonia in AIDS patients (in combination with primaquine in patients with intolerance or resistant to standard therapy);

- malaria, incl. caused by multidrug-resistant Plasmodium falciparum, both as monotherapy and in combination with quinine or chloroquine;

- prevention of endocarditis in patients with increased sensitivity to penicillins.

Contraindications

- hypersensitivity to clindamycin, lincomycin or any component of the drug.

FROM caution: gastrointestinal diseases (in history), especially ulcerative colitis, myasthenia gravis (clindamycin can interfere with neuromuscular transmission), severe liver failure.

Dosage

To avoid complications, use strictly as directed by your doctor.

Adults: 600-1800 mg / day by mouth in 2, 3 or 4 divided doses (equal doses).

Children: 8-25 mg / kg body weight / day by mouth in 3-4 divided doses (equal doses).

To avoid irritation of the esophageal mucosa, capsules should be taken with a full glass of water.

If the calculated dose per dose is lower than the content of clindamycin in the capsule or there are swallowing disorders, the use of parenteral forms of the drug should be recommended.

Infections caused by beta-hemolytic streptococcus: doses are indicated above, treatment should be continued for at least 10 days.

Infectious and inflammatory diseases of the pelvic organs: 900 mg IV clindamycin every 8 hours + IV a suitable antibacterial agent active against gram-negative aerobic pathogens (e.g. gentamicin 2.0 mg / kg followed by 1.5 mg / kg every 8 hours for patients with normal kidney function), for at least 4 days, and after the onset of improvement in the patient's condition - for at least 48 hours. Then they switch to taking clindamycin by mouth at 450-600 mg every 6 hours daily. The full course of therapy is 10-14 days.

Chlamydia trachomatis cervical infections: 450-600 mg orally 4 times a day daily for 10-14 days.

Toxoplasmotic encephalitis in AIDS patients: in patients with intolerance to standard therapy, clindamycin is used in combination with pyrimethamine according to the following scheme: 600-1200 mg orally every 6 hours for 2 weeks, then 300-600 mg orally every 6 hours. Pyrimethamine is prescribed at a dose of 25-75 mg orally every day ... Usually the course of therapy is 8-10 weeks. When using higher doses of pyrimethamine, folinic acid should be given at a dose of 10-20 mg / day.

Pneumocystis pneumonia in AIDS patients: 300-450 mg orally every 6 hours for 21 days and primaquine 15-30 mg orally 1 time / day for 21 days.

Acute streptococcal tonsillitis / pharyngitis: 300 mg orally 2 times a day for 10 days.

Malaria: 10-20 mg / kg / day by mouth for adults and 10 mg / kg / day for children every 12 hours in equal doses for 7 days as monotherapy, or in combination with quinine (12 mg / kg every 12 hours) or chloroquine (15-25 mg every 24 hours) for 3-5 days.

Prevention of endocarditis in patients with hypersensitivity to penicillins: 600 mg orally for adults and 20 mg / kg for children 1 hour before minor surgery or dental intervention or any other procedure associated with the risk of endocarditis.

Elderly patients: there is no need to modify the dose if liver and kidney function is normal (for a given age).

Patients with impaired renal and liver function: there is no need to modify the dose.

Side effects

From the side digestive system: abdominal pain, nausea, vomiting and diarrhea, esophagitis, esophageal ulcer, pseudomembranous colitis, dysbiosis, jaundice, liver dysfunction, incl. hyperbilirubinemia.

Allergic reactions: maculopapular rash, urticaria, itching, most often a generalized measles-like rash of mild to moderate severity; rarely - erythema multiforme, exfoliative and vesicular-bullous dermatitis and toxic epidermal necrolysis, anaphylactoid reactions.

Hematopoiesis: cases of neutropenia (leukopenia) and eosinophilia of a passing nature, as well as cases of agranulocytosis and thrombocytopenia, have been noted, however, the relationship between these phenomena and clindamycin therapy has not been established.

Others:vaginitis.

In the reference literature there are data on the possibility of the development of the following side effects against the background of the use of clindamycin: impaired neuromuscular transmission, the development of superinfection.

Overdose

In case of overdose, symptomatic and supportive treatment should be carried out. Clindamycin is not excreted by hemodialysis and peritoneal dialysis.

Drug interactions

It has been found that in vitro antagonism between clindamycin and erythromycin is manifested. Because this antagonism may be clinically relevant, these drugs should not be taken at the same time. There is evidence of a similar interaction with chloramphenicol.

It has been established that clindamycin disrupts neuromuscular transmission and, therefore, may enhance the action of other peripheral action, therefore, the drug should be used with caution in patients receiving drugs of this group.

Simultaneous use with opioid (narcotic) analgesics, which have a central inhibitory effect on respiratory function, can lead to more pronounced respiratory depression up to apnea.

Simultaneous administration with antidiarrheal drugs that reduce gastrointestinal motility increases the risk of developing pseudomembranous colitis.

Aminoglycosides expand the spectrum of action of clindamycin.

special instructions

For Chlamydia trachomatis cervical infections, clindamycin monotherapy is effective for complete cure.

Cases of pseudomembranous colitis of varying severity up to life-threatening have been observed with the use of almost all antibacterial agents, including clindamycin, therefore, in all cases of diarrhea after taking antibacterial drugs, the possibility of this diagnosis should be considered. Antibacterial drugs suppress the normal flora of the intestine, which can increase the proliferation of Clostridia. The toxins produced by Clostridium difficile have been shown to be the main cause of antibiotic-associated colitis. Pseudomembranous colitis can appear both while taking clindamycin and 2-3 weeks after stopping treatment; manifested by diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by the release of blood and mucus with feces). After the diagnosis of pseudomembranous colitis in mild cases, it is sufficient to discontinue treatment and use ion exchange resins (colestyramine, colestipol), in cases of moderate and severe cases, it is shown that the loss of fluid, electrolytes and protein is replaced, the appointment of an antibacterial drug effective against Clostridium difficile, for example, at a dose of 125-500 mg, or bacitracin at a dose of 25,000 IU orally 4 times / day. within 7-10 days, or metronidazole 250-500 mg 3 times / day. Drugs that reduce gastrointestinal motility should not be administered concomitantly with clindamycin.

With the use of all antibacterial agents, including clindamycin, excessive growth of microorganisms insensitive to this drug is possible, especially yeast-like fungi. With the development of superinfection, appropriate measures should be taken depending on the clinical situation.

Clindamycin should not be prescribed for the treatment of meningitis, as it does not penetrate the BBB well.

When prescribing the drug in high doses, it is necessary to control the concentration of clindamycin in plasma. If the treatment is carried out over an extended period of time, then liver and kidney function tests should be carried out regularly.

In patients with impaired liver and kidney function, there is no need to modify the dose of the drug, since clindamycin practically does not accumulate in the body if the drug is taken orally with an interval of 8 hours.

Pregnancy and lactation

Clindamycin crosses the placenta. After the administration of several doses of the drug, the concentration in the amniotic fluid was approximately 30% of the concentration in the mother's blood. Clindamycin should be used in pregnant women only when the intended benefit to the mother outweighs the potential risk to the fetus. Clindamycin is found in human milk at a concentration of 0.7-3.8 μg / ml.

If necessary, the appointment during lactation should stop breastfeeding.

Pediatric use

See section "Dosing regimen".

In case of impaired renal function

List B. At a temperature not higher than 25 ° C. Keep out of the reach of children.

The shelf life is 5 years. Do not use after the expiration date printed on the package.

**** * ECZACIBASI * PFIZER PHARMACIA & UPJOHN UPJOHN CO. UPJOHN PUURS S.A Pfizer MFG Belgium N.V. Saniko N.B. (B) Pharmacy and Upjohn Company Pharmacy and Upjohn N.V. / S.A Pharmacy N.V. / S.A (Belgium), produced by Wetter Pharm

Country of origin

Belgium UNITED STATES

Product group

Antibacterial drugs

Topical antibiotic in gynecology

Release forms

  • 3 - strips (1) complete with a plastic applicator - cardboard packs. 30 g - (1) - cardboard packs. Vaginal cream 2% - 20 g of cream in a tube. 1 tube of 20 g, complete with 3 applicators with instructions for use in a cardboard box. Vaginal cream 2% - 40 g of cream in a tube. 1 tube of 40 g, complete with 7 applicators with instructions for use in a cardboard box.

Description of the dosage form

  • White cream. White cream. Gel for external use 1% Solid vaginal suppositories

pharmachologic effect

An antibiotic of the lincosamide group for topical use. The mechanism of action is associated with the suppression of protein synthesis in the microbial cell due to interaction with the 50S-subunit of ribosomes. Has a bacteriostatic effect; in higher concentrations against some microorganisms - bactericidal. The drug is active against microorganisms that cause bacterial vaginosis: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Peptostreptococcus spp., Bacteroides spp.

Pharmacokinetics

After applying clindamycin intravaginally at a dose of 100 mg per day, once (in the form of 2% clindamycin phosphate cream) for 7 days, the serum concentration reaches a maximum after about 10 hours (4-24 hours) after administration and is on the first day an average of 18 ng / ml (4-47 ng / ml), and on the seventh day - 25 ng / ml (6-61 ng / ml), while systemic absorption is about 4% (0.6-11%) of the administered dose. In women with bacterial vaginosis, with a similar dosing regimen, about 4% of clindamycin is absorbed (with a smaller spread of 2-8%), the serum concentration reaches a maximum after about 14 hours (4-24 hours) after administration and on the first day averages 13 ng / ml (6-34 ng / ml), and on the seventh day -16 ng / ml (7-26 ng / ml). The systemic effect of clindamycin when administered intravaginally is weaker than when administered orally or intravenously. After intravaginal administration of repeated doses, clindamycin hardly accumulates in the blood. The systemic elimination half-life is 1.5-2.6 hours. Use in elderly patients B clinical research clindamycin 2% vaginal cream involved an insufficient number of patients aged 65 and over to assess the difference in clinical response to therapy between this age group and younger patients. In the available reports from clinical experience, there was no difference in response between older patients and younger patients.

Special conditions

Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus, which often cause vulvovaginitis, must be excluded by appropriate laboratory methods before prescribing the drug. Intravaginal use of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi. The use of clindamycin (as well as almost all antibiotics) orally or parenterally is associated with the development of severe diarrhea and, in some cases, pseudomembranous colitis. With the development of severe or prolonged diarrhea, the drug should be discontinued and, if necessary, appropriate diagnostic and therapeutic measures... Patients should be warned that during drug therapy they should not have sexual intercourse, as well as use other means for intravaginal administration (tampons, douching). It is not recommended to use the drug Dalacin® cream during menstruation. The initiation of therapy should be postponed until the end of menstruation. The drug contains components that can reduce the strength of latex or rubber products, so the use of condoms, vaginal contraceptive diaphragms and other latex products for intravaginal use during drug therapy and within 72 hours after use is not recommended. Impact on the ability to drive vehicles. Wed and fur .: There is no reason to believe that the use of the drug Dalacin® vaginal cream can affect the ability to drive a car and use mechanisms.

Composition

  • 1 g clindamycin (in the form of phosphate) 20 mg Excipients: sorbitan monostearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, mineral oil, benzyl alcohol, purified water. clindamycin (in the form of phosphate) 20 mg Excipients: sorbitan monostearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, mineral oil, benzyl alcohol, purified water. clindamycin (in the form of phosphate) 100 mg Excipients: solid fat (Witepsol H-32, a mixture of triglycerides, diglycerides and monoglycerides). clindamycin 10 mg

Dalacin indications for use

  • - bacterial vaginosis.

Dalacin contraindications

  • - a history of hypersensitivity to clindamycin or lincomycin. Precautions: age up to 12 years (no data on safety and effectiveness).

Dalacin dosage

  • 1% 100mg 150mg / ml 2% 300mg / 2ml, 600mg / 4ml, 900mg / 6ml

Dalatsin side effects

  • The incidence of the following side effects is less than 10%. From the reproductive system: irritation of the mucous membrane of the vulva and vagina, pain in the vagina, vaginal discharge, vaginal candidiasis, vulvovaginitis, trichomonas vaginitis, vaginal infections, disorders menstrual cycle, uterine bleeding, abnormal labor, endometriosis. From the urinary system: dysuria, infections urinary tract (including pyelonephritis), proteinuria. From the digestive system: generalized abdominal pain, localized abdominal pain, abdominal cramps, bloating, dyspepsia, nausea, vomiting, diarrhea, constipation, flatulence, bad breath, taste perversion. From the side of the central nervous system: dizziness, headache. Dermatological reactions: rash, pruritus, maculopapular rash, erythema, skin candidiasis. Allergic reactions: urticaria. From the side endocrine system: glucosuria, hyperthyroidism. From the side of the body as a whole: fungal infections, fever, side pain, back pain, lower abdominal pain, generalized pain, bacterial infections, inflammatory edema, upper respiratory tract infections, nosebleeds, abnormal microbiological test results. Local reactions: itching and pain at the injection site.

Drug interactions

There is cross-resistance between clindamycin and lincomycin. Antagonism between clindamycin and erythromycin has been demonstrated under in vitro conditions. It has been established that systemic use of clindamycin disrupts neuromuscular transmission and, therefore, can enhance the effect of peripheral muscle relaxants, so the drug should be used with caution in patients receiving drugs of this group. Combined use with other drugs for intravaginal administration is not recommended.

Overdose

With intravaginal use of Dalacin® cream, absorption of clindamycin is possible in quantities sufficient for the development of systemic reactions. Accidental ingestion of the drug into the gastrointestinal tract can also cause systemic effects similar to those that occur after oral administration of clindamycin in therapeutic doses... Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis (see sections " Side effect"and" Special instructions "). Treatment: symptomatic and supportive.

Storage conditions

  • keep away from children
Information provided by the State Register of Medicines.

Synonyms

  • Dalacin, Dalacin C, Dalacin C phosphate, Klimycin, Clindamycin, Clindafer

DALACIN ®

Registration number: P N011553 / 03

Trade name of the drug: DALACIN ®

International non-proprietary name (INN): clindamycin

Chemical name: (2S-trans) -methyl-7-chloro-6,7,8-trideoxy-6 - [[(1-methyl-4-propyl-2-pyrrolidine) -carbonyl] -amino] -1-thio-L - treo-α-D- galacto-octopyranoside 2- (dihydrogen phosphate).

Dosage form: gel for external use

Composition (for 1 g of gel):
Active substance : clindamycin (as clindamycin phosphate) 10 mg;
Excipients: allantoin, methylparaben, propylene glycol, polyethylene glycol, carbomer 934P, sodium hydroxide, purified water.

Description: transparent colorless viscous mass

Pharmacotherapeutic group: antibiotic - lincosamide
ATX code D10AF01

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Clindamycin phosphate is inactive in vitro, but after application to the skin, it is rapidly hydrolyzed by phosphatases in the ducts sebaceous glands with the formation of clindamycin, which has antibacterial activity. The sensitivity of all tested strains has been shown Propionibacterium acnes to clindamycin in vitro (MIC 0.4 μg / ml), which explains the effectiveness of the drug in the treatment of acne vulgaris.
After applying clindamycin to the skin, the amount of free fatty acids on the skin surface decreases from about 14% to 2%.

Pharmacokinetics
After external application of 1% gel of clindamycin phosphate, very low concentrations of clindamycin are determined in blood serum and urine.
The activity of clindamycin in comedones has been shown in patients with acne vulgaris. The average concentration of antibiotic in the comedone content after applying a solution of clindamycin in isopropyl alcohol and water (10 mg / ml) for 4 weeks averaged 597 mg / g of comedone content (0-1490 mg / g).

INDICATIONS FOR USE
Acne vulgaris

CONTRAINDICATIONS

History of hypersensitivity to clindamicia or lincomycin.

CAREFULLY
age up to 12 years (data on safety and effectiveness are not available).

APPLICATION DURING PREGNANCY OR BREASTFEEDING
In animal studies, when clindamycin was administered at doses of 100-600 mg / kg / day subcutaneously or orally, impairment of fertility, as well as any teratogenic effects, was not found. There are no adequate controlled studies in pregnant women. Since the results of animal studies cannot always be extrapolated to humans, the drug should be prescribed during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
It is not known whether clindamycin is excreted in breast milk after external use.
Clindamycin is found in breast milk following oral administration or parenteral administration, therefore, caution should be exercised when prescribing the drug during breastfeeding.

DOSAGE AND APPLICATION
Outwardly. A thin layer of gel is applied to the affected area of \u200b\u200bclean, dry skin 2 times a day. Treatment course: in order to obtain satisfactory results, treatment should be continued for 6-8 weeks, and if necessary, it can be continued up to 6 months.

SIDE EFFECT
The most common is dry skin.
Less commonly: abdominal pain, skin irritation, gastrointestinal disorders (diarrhea, nausea, vomiting), contact dermatitis, burning sensation in the eyes, folliculitis caused by gram-negative flora, increased production of the sebaceous glands.
In extremely rare cases, colitis may develop.
When applied topically, clindamycin phosphate can be absorbed in amounts causing systemic effects.

INTERACTION WITH OTHER MEDICINAL PRODUCTS
There is cross-resistance of microorganisms to clindamycin and lincomycin.
Antagonism between clindamycin and erythromycin.
It has been established that clindamycin disrupts neuromuscular transmission and, therefore, may enhance the action of other muscle relaxants of peripheral action, therefore, the drug should be used with caution in patients receiving drugs of this group.

SPECIAL INSTRUCTIONS
Avoid getting the drug on the mucous membrane of the eyes and in the oral cavity. After applying the gel, wash your hands thoroughly. In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes), rinse the area with copious amounts of cool water.
The use of clindamycin (as well as other antibiotics) orally or parenterally in some cases is associated with the development of severe diarrhea and pseudomembranous colitis. With the external use of clindamycin, cases of diarrhea and colitis are rare, nevertheless, caution should be exercised, and if severe or prolonged diarrhea develops, the drug should be discontinued and, if necessary, appropriate diagnostic and therapeutic measures should be taken. In the case of severe diarrhea, a colonoscopy should be considered.

Influence on the ability to drive a car and use mechanisms
There is no reason to believe that the use of DALACIN may affect the ability to drive a car and use mechanisms.

RELEASE FORM
Gel for external use 1% in tubes of 30 g; 1 tube with instructions for use is placed in a cardboard box.

SHELF LIFE:
2 years.
Do not use after the expiry date stated on the package!

STORAGE CONDITIONS:
List B
At a temperature not exceeding 25 ° C, out of the reach of children. Do not freeze.

HOLIDAY FROM PHARMACIES
over the counter.

MANUFACTURING COMPANY:
Pharmacy and Upjohn Company, USA.
Representative office address: 109147 Moscow, st. Taganskaya, 21,

Content

With increased activity of gram-positive, anaerobic bacteria or strains, doctors prescribe broad-spectrum antibiotics. Among these is the medical product Dalacin, which has several forms of release. The drug is characterized by a systemic effect in the body, for medical reasons it is recommended for patients over 18 years of age. Self-medication is contraindicated.

Composition and form of release

The antibiotic Dalacin is available in the form of capsules for oral use, a gel for external use, a solution for intravenous and intramuscular injection, vaginal suppositories and a cream. Features of the chemical composition:

Release form

Active ingredients

Excipients

Characteristics of the release form

Equipment

vaginal cream

clindamycin phosphate (20 mg in 1 g of the composition)

polysorbate 60, cetyl palmitate, sorbitan monostearate, cetostearyl alcohol, benzyl alcohol, propylene glycol, stearic acid, mineral oil; purified water

homogeneous composition of white color with a specific odor

aluminum tubes with an applicator of 20 or 40 grams (1 tube, 3 or 7 applicators)

vaginal suppositories

clindamycin phosphate (100 mg)

a mixture of diglycerides, triglycerides, monoglycerides

torpedo-shaped white candles

3 pcs. on strips, applicator included

gel for external use

clindamycin phosphate (10 mg)

Methylparaben, Carbomer 934R, sodium hydroxide solution 40%, propylene glycol, polyethylene glycol, allantoin, purified water.

colorless, transparent, viscous mass

30 g in aluminum tubes

capsules for oral administration

clindamycin hydrochloride (150 or 300 mg)

magnesium stearate, lactose, talc, corn starch, gelatin, titanium dioxide

gelatin capsules, hard, with white body and lid

8 or 10 pcs. on blisters, 2 or 10 blisters in 1 carton box

Pharmacodynamics and pharmacokinetics

Dalacin is an antibacterial drug from the lincosamide group. Clindamycin, being a synthetic antibiotic, is active against gardnerella (Gardnerellavaginali), mycoplasma (Mycoplasmahomini), Mobiluncusspp, trichomonads, peptostreptococci, actinomycetes, bacteroids, all types of Propioni bacteriumacnes strains. The component is slowly released in the body, violates the integrity of the membranes of pathogenic flora and blocks metabolic processes, which leads to the death of harmful microorganisms.

When the antibiotic is taken orally, there is a high degree of adsorption, not associated with food intake. The component reaches the maximum concentration in plasma 1 hour after the application of a single dose. A high rate of clindamycin is recorded in bone tissue. Metabolism occurs in the liver, inactive metabolites are excreted in the urine, in small quantities with feces. With long-term treatment, cumulation is excluded. With the introduction of suppositories, the maximum concentration of the active substance is observed after 5 hours, when using the cream - after 4-24 hours.

Indications for use

The antibiotic Dalacin participates in the scheme complex therapy... Indications for use are described in the instructions, depending on the form of release of the medication. Capsules and solution are prescribed for the following diagnoses:

  • malaria;
  • endocarditis, abscess of the peritoneal region, septicemia, peritonitis;
  • pneumonia, otitis media, bronchitis, sinusitis, lung abscess;
  • periodontitis and periodontal abscess (infections oral cavity);
  • endometritis, colpitis, salpingitis;
  • furunculosis, infected wounds, acne, abscesses, erysipelas, osteomyelitis, purulent arthritis;
  • as a reliable prevention of chronic endocarditis.

Cream and suppositories for vaginal administration are recommended for bacterial vaginitis, colpitis, vaginal dysbiosis. The therapeutic gel is prescribed as part of the complex therapy of acne, folliculitis, staphyloderma, and acne. With external use of Dalacin, the action of clindamycin is local, directed to the focus of pathology. The positive dynamics of treatment is observed after 7-10 days of regular home procedures. When using tablets much earlier - 2-3 days.

Method of administration and dosage

The doctor determines the daily doses and duration of drug therapy on an individual basis. The method of application depends on the form of release of the drug and the diagnosis. The drug is prescribed orally or vaginally for up to 7 days, used externally for up to 6-8 weeks without interruption. Toxic effect on soft tissues, internal organs is absent.

Dalatsin cream

In addition to the cream, the carton contains disposable applicators, instructions for use. The course of treatment for bacterial vaginitis is from 3 to 7 days. For the procedure, the applicator is screwed onto a tube with cream, after which it is inserted deep into the vagina and a single dose is squeezed out using a piston. The patient should be in a horizontal position with legs bent at the knees. The procedure is carried out 1 time per day - before bedtime, after completion it is advisable not to get out of bed. When treating, it is important to temporarily abandon sexual intercourse, skip sessions during menstruation.

Capsules

A single dose of medication is taken orally with meals, without chewing and drinking plenty of water. Adults are prescribed 150 mg four times a day, with complicated clinical cases - 300-450 mg with the same number of doses. For chlamydial infections, the recommended dose is 450 mg. IN childhood the optimal daily dosage is 8-25 mg / kg of body weight for 4 approaches. According to the instructions, the course is determined individually, on average, it lasts 5-10 days.

Dalacin C Phosphate

This is a solution for intravenous and intramuscular injections required for the treatment of infectious and inflammatory diseases of the pelvic organs. According to the instructions, the initial dose is 900 mg every 8 hours along with antibiotics for 4 days. With the onset of stable positive dynamics, doctors continue therapy for another 2 days, after which Dalacin is prescribed in the form of capsules with a single dosage of 450–600 mg with an interval of 6 hours. According to the instructions, the course lasts 10–14 days.

Candles

Detailed instructions for the use of Dalacin describe the recommended dosages and features of the use of vaginal suppositories. The patient is prescribed 1 suppository intravaginally 1 time per day. The suppository is inserted in a horizontal position, deep into the vagina. The procedure is carried out before bedtime, after completion they do not get up. The course is 3 days. In the absence of positive dynamics, it is extended up to 7 days.

Dalacin gel

This form of drug release is used for effective treatment acne vulgaris. Before applying the composition, problem areas are thoroughly cleaned and dried. The gel is applied in a thin layer in the morning and in the evening, after which you cannot wash. The course is 6-8 weeks, if necessary, it can be extended to 6 months. If, after a few weeks, there is no positive dynamics, drug therapy is stopped for 4 weeks, then resumed again.

Dalatsin and Dalatsin T - what is the difference

Only vaginal cream and suppositories have the name "Dalatsin". In each form of release, the concentration of the active substance is different. "Dalatsin T" is tradename gel 1% for the treatment of acne. It is important not to confuse the indicated medicines (names). Often, cream and gel are combined under the general name "Dalatsin ointment", but this is wrong. The capsules have the trade name "Dolocin C".

special instructions

Before starting treatment with Dalacin, you need to contact a gynecologist and undergo an examination for the detection of a pathogenic pathogen to determine the body's sensitivity to clindamycin. If a long time use vaginal cream or suppositories, prolonged thrush develops. The addition of a secondary bacterial infection is not excluded. The instructions for use indicate other recommendations:

  1. For the period of treatment, it is required to temporarily avoid sexual intercourse. It is important to remember that Dalatsin contains components that violate the integrity of latex products. As a result, the risk of an unplanned pregnancy increases.
  2. During menstruation, it is not recommended to use forms of Dalacin for vaginal administration. It is necessary to resume the course 1–2 days after the end of monthly bleeding.
  3. Additionally, douching, using tampons is highly undesirable, since in such cases the therapeutic effect of clindamycin is reduced.
  4. For cervical infections provoked by increased activity of Chlamydia trachomatis, monotherapy with Dalacin capsules is effective for final recovery.
  5. With prolonged therapy with capsules, it is required to regularly carry out laboratory research to assess the functions of the liver and kidneys, to respond promptly to alarming symptoms.
  6. It is important to avoid getting the gel for external use on the mucous membranes of the mouth and eyes. If contact occurs, be sure to rinse affected areas with water. After using the specified medication, wash your hands thoroughly.
  7. Clindamycin does not inhibit the work of the nervous system (organs of the central nervous system in the future), therefore, during drug therapy, it is allowed to administer vehicle, engage in intellectual activity and other types of work associated with increased concentration of attention.

Dalacin during pregnancy

When carrying a fetus, not all patients can use Dalacin. For example, in the 1st trimester, this medication is categorically contraindicated, since the active substance provokes extensive intrauterine pathologies. In the 2nd and 3rd trimesters, treatment proceeds under strict medical supervision. The instructions for use say that during lactation it is advisable to abandon such a pharmaceutical appointment or temporarily transfer the child to artificial mixtures.

Drug interactions

Since the medication is used as part of a complex treatment, it is important to exclude complications from the interaction of synthetic components. The instructions for use say:

  1. Clindamycin enhances the effect of muscle relaxants, has a cross-reaction with lincomycin.
  2. Capsules are not recommended to be combined with barbiturates, Erythromycin, Ampicillin, Magnesium sulfate, Calcium gluconate, Aminophylline.
  3. The substance clindamycin inhibits the activity of aminoglycosides, macrolides and chloramphenicol.
  4. With simultaneous use with opioids, respiratory depression is observed.

Dalatsin and alcohol

According to the instructions for use, it is categorically contraindicated to combine the indicated medication with alcoholic beverages. 3 days before the start of the course, it is required to stop drinking alcohol, after the completed treatment - for another 1 month. Otherwise, the risk of intoxication of the body increases, followed by the need for resuscitation at home or in a hospital.

Side effects

Since the drug is characterized by a systemic effect in the body (especially when it comes to capsules), side effects affect all internal organs, systems. The instructions for use describe how the patient's condition may worsen. Side effects of capsules and solution:

  • from the digestive system: signs of dyspepsia, esophagitis (inflammation of the mucous membrane), abdominal pain, esophageal ulcer, nausea;
  • from the hematopoietic organs: leukopenia, eosinophilia, agranulocytosis, thrombocytopenia;
  • from the side skin: epidermal necrolysis, urticaria, skin rash, edema and hyperemia of the epidermis;
  • with rapid intravenous administration - anaphylactic shock, arterial hypertension, dizziness, weakness; intravenous local reactions.

Preparations for vaginal and external use have fewer side effects. After using suppositories and cream, the following pathologies may develop:

  • vaginal candidiasis;
  • fungal bacterial infections;
  • trichomonas vaginitis;
  • bleeding;
  • violation of the menstrual cycle;
  • migraines, dizziness, weakness;
  • dysuria, lower abdominal pain, bloating, constipation and diarrhea.

The gel is well tolerated by the body. Side effects are rare, described in detail in the instructions:

  • folliculitis;
  • contact dermatitis;
  • irritation and dryness of the skin;
  • nausea, vomiting;
  • colitis.

Contraindications

The antibacterial drug Dalacin is not allowed to be used by all patients. The instructions for use provide a list of medical contraindications:

  • hepatic, renal failure chronic form;
  • antibiotic-associated colitis;
  • hypersensitivity of the body to lincosamides;
  • age up to 1 month;
  • lactation period.

Terms of sale and storage

Dalacin is a prescription drug that can be purchased over the counter. The shelf life of the medicine is 2 years from the date of manufacture indicated on the package. It is required to store the medication in a dry, dark place at temperatures up to 20 degrees, out of the reach of small children:

Analogs

If the antibiotic is not suitable: causes side effects or does not work, the doctor suggests a replacement. When choosing an analogue of Dalacin, it is recommended to pay attention to such effective antibiotics:

  1. Clindovite. This is a gel for external use in tubes of 30 g. According to the instructions, the medicine is used to treat acne, it is applied in a thin layer to the foci of pathology in the morning and in the evening. The course is 6-8 weeks.
  2. Klindatop. Gel in aluminum tubes of 15 and 30 g. According to the instructions, the medicine is used for moderate acne, comedones, similar to the above drug, for a course of several months.
  3. Clindacin. A medication with an active substance of the same name in the form of suppositories and a cream for intravaginal administration. Not effective for fungal infections.
  4. Klindes. The drug has several forms of release, it works similarly to Dalatsin. With renal and liver failure the antibiotic is contraindicated, for pregnant and lactating women the same.
  5. Clindamycin. According to the instructions, the drug suppresses protein production in pathogenic microorganisms, is effective against gram-positive and microaerophilic cocci, anaerobic gram-positive bacilli without spores.

Dalatsin price

The average cost of a medication depends on the configuration and form of release. The price of a vaginal cream (tube 2% 20 g) is 200–650 rubles.

Tradename
Dalacin C ™ (DALACIN C ™)

International name
clindamycin

Latin name
DALACIN C

general characteristics
basic physical and chemical properties: capsules of 150 mg: capsules with a lime tree body and a dark red cap with the inscription P&U 225, filled with white powder; capsules of 300 mg: capsules with a lilac body and a cap with the inscription P&U 395, filled with white powder; composition: Dalacin C ™ capsules 150 mg: One capsule contains clindamycin (in the form of clindamycin hydrochloride) -150 mg; excipients: starch, lactose, talc, magnesium stearate, sodium erythrosine, sodium indigotin sulfonate, titanium dioxide, gelatin. Dalacin C ™ 300 mg capsules: One capsule contains clindamycin (in the form of clindamycin hydrochloride) - 300 mg; excipients: starch, lactose, talc, magnesium stearate, sodium erythrosine, sodium indigotin sulfonate, titanium dioxide, gelatin.

Release form
Dalacin C ™ capsules 150 mg: Dalacin C ™ capsules 300 mg:

Pharmgroup
Antibacterial agents for systemic use. Macrolides and lincosamides. ATC: J01F F01.

Pharmacological properties
The active ingredient of the drug is clindamycin, a semi-synthetic antibiotic synthesized from lincomycin by replacing the 7- (I) -hydroxy group with 7- (S) -xnop. Clindamycin can act bactericidal or bacteriostatic, depending on the sensitivity of the microorganism and the concentration of the antibiotic. In vitro clindamycin acts on such isolated forms of microorganisms: 1. Aerobic gram-positive cocci, including: - Staphylococcus aureus; - Staphylococcus epidermidis (strains that produce and do not produce penicillinase). During in vitro studies, there was a rapid development of resistance to clindamycin in some strains of staphylococci resistant to erythromycin; - streptococci (with the exception of fecal streptococcus); - pneumococci. 2. Aerobic gram-negative bacteria, including: - Bacteroides spp. (Including the B. fragilis group and the B. melaninogenicus group) - Fusobacterium spp. 3. Aerobic gram-positive bacteria that do not form spores, including: - Peptococcus spp .; - Eubacterium spp .; - Actinomycs spp. 4. Anaerobic and microaerophilic gram-positive cocci, including: - Peptococcus spp .; - Peptostreptococcus spp .; - Microarophilic streptococci; - Clostridium spp. (Clostridia are more resistant to cpindamycin than most other anaerobes). Most species of Clostridia, in particular Clostridium perfringens, are susceptible to cpindamycin, but some species, such as C.sporogenes and C.tetrium, are often resistant to clindamycin. Therefore, sensitivity tests should be performed. 5. Various microorganisms, including: - Chlamidia trachomatis; - Toxoplasma gondii; - Plasmodium falciparum and Pneumocystis carinii (in combination with primaquine); - Gardnerella vaginalis; - Mobilicus mulieris, Mobilincus curtisii; - Mycoplasma hominis. The following microorganisms are usually resistant to clindamycin: 1. Aerobic gram-negative bacteria: - Spreptococcus feacalis; - Nocardia spp .; - Neisseria meningitidis; - stamp of penis-resistant Staphylococcus aureus; - stamp of Haemophilis influenzae. Clindamycin hydrochloride is active both in vitro and in vivo.

Pharmacokinetics
Absorption After oral administration, almost complete (90%) absorption of clindamycin occurs. In adults, after oral administration of clindamycin at a dose of 150 mg, the maximum serum level of the drug (2.5 μg / ml) is reached after 45 minutes. 3 hours after oral administration, the concentration of the drug in the serum is 1.5 μg / ml, and after 6 hours - 0.7 μg / ml. When taken orally, the absorption of clindamecin (in quantitative terms) does not largely depend on the simultaneous intake of food, but in this case, the absorption of the drug may occur more slowly. Distribution of the drug in the body 40 - 90% of the administered drug binds to proteins in the body. After oral administration, the accumulation of the drug in the body is not observed. Clindamycin is readily absorbed into most tissues and body fluids. The concentration of clindamycin in bone tissue reaches approximately 40% (20 - 75%) of the concentration of the drug in serum. In breast milk, the concentration of the drug is 50-100% in serum, in synovial fluid - 50%, in sputum - 30-75%, in peritoneal fluid - 50%, in fetal blood - 40%, in pus - 30% and in pleural fluid - 50 (90% concentration in blood serum). Clindamycin does not enter the cerebrospinal fluid, even in the case of meningitis. Biotransformation of the drug The half-life of clindamycin is (1.5 - 3.5 hours). In patients with severely impaired renal or hepatic function, the elimination half-life is somewhat lengthened. If you have a mild to moderate form of kidney or liver disease, you do not need to change the liver regimen. Clindamycin is almost completely metabolized. o Excretion from the body 10 - 20% of the drug is excreted from the body by the kidneys in a microbiologically active form, 4% - with feces. The rest is excreted as inactive metabolites, mainly in bile and feces.

Indications for use
Clindamycin is effective remedy for the treatment of the following infections, if they are caused by susceptible to it anaerobic bacteria or strains of gram-positive aerobic bacteria, such as streptococci and pneumococci, as well as species of Chlamidia trachomatis sensitive to cpindamycin: 1. Upper respiratory tract infections, including: tonsillitis, sinus pharyngitis , otitis media and scarlet fever. 2. Infections of the lower respiratory tract, including: bronchitis, pneumonia, pleural empyema and lung abscess. 3. Infectious diseases of the skin and soft tissues, including: acne, boils, cellulitis, impetigo, infected wounds, specific infections of the skin and soft tissues caused by pathogens sensitive to the drug, such as erysipelas and paronychia (panaritium). 4. Infectious diseases of bones and joints, including: osteomyelitis and septic arthritis. 5. Clindamycin is indicated in the treatment of gynecological infections, including endometritis, cellulitis, vaginal cuff infections, tubal and ovarian abscesses, salpingitis, and pelvic inflammatory disease, when given in combination with a suitable antibacterial agent active against gram-negative pathogens. In the case of Chlamidia trachomatis cervical infections, therapy with clindamycin has been shown to be effective for complete recovery. 6. Infectious diseases of the abdominal cavity, including: peritonitis and abdominal abscesses (in combination with antibiotics acting on gram-negative bacteria). 7. Septicemia and endocarditis. The effectiveness of clindamycin in certain cases of endocarditis has been proven: the drug has a bactericidal effect on the causative agent of infection in vitro when using such concentrations of the drug that are reached in human blood. 8. Oral cavity infections such as periodontal abscess and periodontitis. 9. Toxoplasmic encephalitis in patients with AIDS. The effectiveness of clindamycin in combination with pyrimethamine has been proven in patients with intolerance to standard therapy. 10. Pneumocystis pneumonia in patients with AIDS. In patients with intolerance or resistance to standard therapy, clindamycin can be used in combination with primaquine. 11. Malaria, including those caused by multidrug-resistant Plasmodium falciparum, both as monotherapy and in combination with quinine or chloroquine. 12. Prevention of endocarditis in patients with hypersensitivity to penicillins.

Method of administration and dosage
Doses of the drug depend on the severity of the disease, the patient's condition and the sensitivity of the infectious agent to the prescribed drug. For adults: 600 - 1800 mg per day, divided into 3 - 4 equal doses. For children over 1 month old: 8 - 25 mg / kg / day, divided into 3 - 4 doses. To avoid irritation of the esophageal mucosa, clindamycin capsules should be taken with a full glass of water. Treatment of infections caused by beta-hemolytic streptococcus. The doses indicated above should be used. Treatment should be continued for at least 10 days. Treatment of inflammatory diseases pelvic organs After parenteral administration of the drug for 6 days, therapy with clindamycin hydrochloride at a dose of 450 mg every 6 hours should be continued until the end of the 10-14 day course of therapy. Treatment of cervical infections, 450 mg of clindamycin hydrochloride orally 4 times a day for 10 -14 days. Treatment of toxopasmic encephalitis in AIDS patients. 600-1200 mg every 6 hours for 2 weeks, then 300-600 mg every 6 hours. The course of treatment usually lasts 8-10 weeks. The dose of pyrimethamine is 25 to 75 mg orally daily for 8 to 10 weeks. Folic acid 1–20 mg / day should be given when higher doses of pyrimethamine are used. Treatment of Pneumocystis pneumonia in AIDS patients, 300 - 450 mg of clindamycin hydrochloride orally every 6 hours for 21 days and primaquine 15 - 30 mg orally once a day for 21 days. Treatment of acute streptococcal tonsillitis / pharyngitis The oral dose of clindamycin is 300 mg twice daily for 10 days. Malaria treatment. Adults: 10 to 20 mg / kg / day; children: 10 mg / kg / day in equal doses every 12 hours for 7 days as monotherapy or in combination with quinine (12 mg / kg every 12 hours) or chloroquine (15 to 25 mg every 24 hours) for 3 to 5 days. Prevention of endocarditis in patients with hypersensitivity to penicillins. For adults: 600 mg each; for children: 20 mg / kg 1 hour before the administration of penicillin.

Side effects
1. Gastrointestinal tract Abdominal pain, nausea, vomiting and diarrhea (see Section "Peculiarities of use"), esophagitis. 2. Hypersensitivity Reactions In some cases, maculopapular rash and urticaria are noted. Mild to moderate generalized measles rash is the most common adverse reaction. Rare cases of erythema multiforme resembling Stevens-Johnson syndrome, as well as cases of anaphylactoid reactions. 3. Liver During treatment with the drug, jaundice and liver dysfunction were observed. 4. Skin and mucous membranes Itching, vaginitis, as well as rare cases of exfoliative and vesiculobullous dermatitis. 5. Hematopoiesis There were cases of transient neutropenia (leukopenia), as well as cases of agranulocytosis and thrombocytopenia, but it was not possible to establish an etiological relationship between these phenomena and therapy with Dalacin C.

Contraindications
The appointment of clindamycin is contraindicated in patients with hypersensitivity to clindamycin, lincomycin, or to any of the components of the drug. Dalacin C capsules should also not be prescribed to patients with thyroid pathology.

Interacting with others medicines
Cross-resistance exists between lincomycin and clindamycin. There is also an antagonism between clindamycin and erythromycin. It has been established that clindamycin has an effect on neuromuscular transmission, therefore, it should be prescribed with caution in patients receiving peripheral muscle relaxants.

Overdose
In case of overdose, there is no specific treatment. The serum half-life of clindamycin is 24 hours. Kpindamycin cannot be easily eliminated from serum by dialysis or peritoneal dialysis. In case of allergic adverse reactions, standard therapy for such conditions should be carried out, including the use of corticosteroids, epinephrine and antihistamines.

Application features
The use of clindamycin, like the use of almost all other antibiotics, can be accompanied by the development of severe colitis, which can lead to the death of the patient. Clinical picture colitis, which develops during treatment with clindamycin, can be different, starting with watery stools and ending with severe persistent diarrhea, accompanied by leukocytosis, chills, severe cramping abdominal pain with possible bloody-mucous discharge. With further deterioration of the condition, peritonitis, shock and toxic megacolon may develop. The clinical picture usually allows a diagnosis of pseudomembranous colitis. The diagnosis is confirmed by endoscopic examination, as well as by detection of Clostridium difficile or its toxins in the feces. The development of colitis caused by antibiotics is noted both during treatment and 2 to 3 weeks after the withdrawal of antibiotics. This complication is especially difficult in elderly and malnourished patients. When development of easy forms of colitis caused by antibiotics, it is recommended to stop treatment with clindamycin and prescribe cholestyramine or cholestepol, which, as shown by in vitro studies, can bind toxins. The recommended doses of cholestyramine and cholestepol are 5 g 3 times a day and 4 g 3 times a day, respectively. If severe antibiotic-induced colitis develops, appropriate therapy, including fluids, proteins, and electrolytes, is necessary. Studies have shown that toxins produced by Clostridia, especially Clostridium difficile, are the most important and direct cause of colitis. In addition, in vitro studies have shown that these toxigenic clostridia are generally susceptible to vancomycin. With the appointment of vancomycin in a dose of 125 - 500 mg 4 times a day, there is a rapid disappearance of the toxin from the feces with a simultaneous cessation of diarrhea. Occasionally, after discontinuation of vancomycin, relapses of colitis are noted. Cholestyramine and cholestepol bind vancomycin in vitro. With the simultaneous use of these drugs and vancomycin, it is recommended to divide the time of their administration. As an alternative treatment for colitis, bacitracin can be administered orally at a dose of 25,000 IU 5 times a day for 7-10 days. Avoid prescribing drugs that inhibit intestinal peristalsis. When prescribing the drug to patients who have a history of gastrointestinal diseases, especially colitis, the dose of clindamycin should be selected with caution. Clindamycin should not be used to treat meningitis because the drug does not cross the blood-brain barrier well. In vitro, it has been proven that clindamycin and erythromycin are antagonists, and therefore the simultaneous administration of these drugs is not recommended. If the treatment is carried out for a long time, then it is necessary to monitor the function of the liver and kidneys. Clindamycin treatment can lead to the activation of other flora insensitive to the drug, especially yeast fungi. Pregnancy and lactation. The safety of systemic use during pregnancy has not been established. The appearance of clindamycin in breast milk at a concentration of 0.7 to 3.8 μg / ml has been reported.

Storage conditions and periods
Store at room temperature (20-25 ° C) out of reach of children. The date of manufacture and shelf life are indicated on the packaging.

Vacation conditions
On prescription.

Packaging
16 capsules per pack.

Manufacturer and its address
Pharmacia N. V./S. A. Address. Rijksweg 12, 2870, Puurs - Belgium.

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