Dalacin c - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Clindamycin

DALACIN C 150 mg hard capsules
DALACIN C 300 mg hard capsules

Why is Dalacin c used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Systemic antibiotic.

THERAPEUTIC INDICATIONS

DALACIN C capsule is indicated in the treatment of severe infections caused by susceptible anaerobic germs, as well as in the treatment of severe infections caused by staphylococci, streptococci and pneumococci.

DALACIN C capsules have been shown to be effective in the treatment of infections caused by staphylococci resistant to other antibiotics: however, since strains of staphylococci resistant to clindamycin have been isolated, sensitivity tests should be performed during therapy with this antibiotic.

Oral clindamycin can be used in gynecological and pelvic infections due to Chlamydia trachomatis only as maintenance therapy in subjects already treated intravenously.

Clindamycin is also effective in the treatment of opportunistic Toxoplasma gondii and Pneumocystis jiroveci infections in immunocompromised patients.

The use of clindamycin should be reserved for patients allergic to penicillin or for patients for whom, in the judgment of the physician, penicillin is not indicated.

The drug can be administered together with other antibiotics if needed.

In consideration of the possible onset of severe colitis, the doctor, before starting a therapy with DALACIN C capsules, should carefully evaluate the possibility, also in relation to the nature of the infection to be treated, to use less toxic drugs as an alternative.

Contraindications When Dalacin should not be used c

Clindamycin is contraindicated in patients who have previously shown sensitivity to clindamycin, lincomycin or any of the other components of this medicinal product.

Feeding time.

Dalacin C must not be administered to patients with diarrhea or inflammatory bowel disease (see SPECIAL WARNINGS section).

Precautions for use What you need to know before you take Dalacin c

The data available so far show that elderly and / or seriously ill patients tolerate diarrhea less well; should these patients be treated with clindamycin, particular attention should be paid to changes in the frequency of bowel movements.

DALACIN C capsules should be prescribed with caution to individuals with a history of gastrointestinal diseases, particularly colitis, and to atopic individuals.

Sometimes the use of antibiotics can cause the development of resistant germs, especially yeasts. Should superinfection occur, take appropriate therapeutic measures. During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

Impaired liver and kidney function

The half-life of the drug was only slightly modified in hepatonephro patients. Therefore, in cases of mild to medium severity of hepatic and renal impairment, a reduction in the dose is not usually necessary, which may be required in cases of severe deterioration of the function of the drug. liver and kidney In case of prolonged therapy, liver and kidney function tests should be performed.

Significant levels of clindamycin are not reached in the cerebrospinal fluid, therefore the drug should not be used for the treatment of meningitis.

Data on the use of Dalacin C in pregnant women are limited therefore its use should only be made if strictly necessary (see section: Fertility, pregnancy and lactation).

Interactions Which drugs or foods can modify the effect of Dalacin c

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

Warfarin or similar medicines used to thin the blood. You may be more at risk of bleeding. Your doctor may need to have regular blood tests to check the ability of your blood to clot.

Clindamycin has been shown to induce neuromuscular blockade which may enhance the activity of other neuromuscular blocking drugs (eg ether, tubocurarine, pancuronium). It should therefore be used with caution in patients taking such drugs.

A synergistic action has been reported with metronidazole against Bacteroides fragilis.

The association with gentamicin can occasionally determine a synergism and never an antagonism.

Cross-reactivity between clindamycin and lincomycin has been demonstrated.

In vitro antagonism between clindamycin and erythromycin has been demonstrated, therefore due to possible clinical relevance the two medicinal products should not be administered concomitantly.

Administration of clindamycin and primakin to HIV-positive volunteers did not significantly affect the pharmacokinetic parameters of zidovudine.

Some antibiotics may reduce the effectiveness of oral contraceptive pills. Additional contraceptive precautions should be considered during treatment.

Warnings It is important to know that:

In case of ascertained intolerance to sugars, contact your doctor before taking the medicine.

Treatment with antibiotics alters the normal flora of the colon and leads to an overgrowth of Clostridium difficile. This has been reported with the use of almost all antibiotics, including clindamycin. Clostridium difficile produces toxins A and B which contribute to the development of Clostridium difficile associated diarrhea (CDAD) and is a primary cause of antibiotic-induced colitis. A careful medical history is also required as cases of C. difficile associated diarrhea have been reported even more than two months after antibiotic administration.

In patients who present with diarrhea following antibiotic administration, it is important to consider the diagnosis of CDAD. It can progress to colitis, including pseudomembranous colitis (see section UNDESIRABLE EFFECTS), the severity of which can range from mild to fatal colitis. Colitis is usually characterized by severe and persistent diarrhea with abdominal cramps and there may be blood and mucus in the stool. If not diagnosed and treated promptly, colitis can progress to peritonitis, shock and toxic megacolon. Endoscopic examination may reveal pseudomembranous colitis. If colitis is suspected a rectosigmoidoscopic examination is recommended. The presence of colitis can be further confirmed by stool culture for Clostridium difficile in a selective medium and by the toxin test. Clostridium difficile. If antibiotic-induced diarrhea or antibiotic-induced colitis is suspected or confirmed, ongoing treatment with antibiotics, including clindamycin, should be discontinued and appropriate therapeutic measures taken immediately. In this situation, drugs that inhibit peristalsis are contraindicated.

Antiperistaltics, opiates and diphenoxylate plus atropine can prolong and / or worsen conditions.

Vancomycin was found to be effective in the treatment of antibiotic-dependent pseudomembranous colitis produced by Clostridium difficile. The dosage for adults is 500 mg to 2 g / day of oral vancomycin in three to four doses over a period of 7-10 days.

Cholestyramine binds to the toxin in vitro, but this resin also binds to vancomycin. Therefore, in the case of simultaneous administration of cholestyramine and vancomycin it is advisable to administer each drug at different times.

Some rare cases of relapse after treatment with vancomycin have been described.

Fertility, pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Reproductive toxicity studies conducted in rats and rabbits following oral and subcutaneous administration have shown no signs of impaired fertility or fetal harm caused by clindamycin, except at doses that induce maternal toxicity. Reproduction studies in animals are not always predictive of the response in humans.

In humans, clindamycin crosses the placenta. After repeated dosing, amniotic fluid concentrations were approximately 30% of maternal blood concentrations.

In clinical studies in pregnant women, systemic administration of clindamycin in the second and third trimesters was not associated with an increase in the frequency of congenital anomalies. There are no adequate and well-controlled studies in women in the first trimester of pregnancy.

In pregnancy, clindamycin should only be used if strictly necessary.

Feeding time

Orally and parenterally administered clindamycin has been found in breast milk in concentrations ranging from 0.7 to 3.8 μg / ml. Due to possible serious adverse reactions in infants, breastfeeding women should not take clindamycin.

Fertility

Fertility studies in rats treated with oral clindamycin showed no effects on fertility or reproductive capacity.

Effects on ability to drive and use machines

Clindamycin has no or negligible influence on the ability to drive and use machines.

Important information about some of the ingredients:

The medicine contains lactose. If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.

Dosage and method of use How to use Dalacin c: Dosage

Pediatric population: from 8 to 20 mg / kg / day divided into 3 or 4 administrations depending on the severity of the infection.

Adults: 600-1200 mg / day divided into 3 or 4 administrations depending on the severity of the infection.

In maintenance therapy of gynecological and pelvic infections, after intravenous treatment, administer 450 mg every 6 hours for 10-14 days.

Cerebral toxoplasmosis: in immunocompromised patients: 600-1200 mg every 6 hours for two weeks, followed by 300-600 mg every 6 hours until the 8-10 week course is complete.

When clindamycin is combined with pyrimethamine the dose of the latter is 25-75 mg orally for 8-10 weeks. With higher doses of pyrimethamine it is recommended to administer 10-20 mg / day of folinic acid.

Pneumocystis jiroveci pneumonia in immunocompromised patients: 300-450 mg every 6 hours for 21 days combined with 15-30 mg of primachine administered orally once daily for 21 days.

To avoid possible esophageal irritation, DALACIN C capsules should be swallowed with a glass of water.

Note: In case of beta-haemolytic streptococcal infections, it is recommended to continue treatment for at least 10 days to decrease the likelihood of rheumatic fever or glomerulonephritis.

Overdose What to do if you have taken too much Dalacin c

As there are no dose-related side effects, overdose is a rare problem, especially if the drug is administered as directed.

Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from serum.

Side Effects What are the side effects of Dalacin c

The following table presents adverse reactions identified from clinical trials and post-marketing surveillance, sorted by system organ class and frequency. Adverse reactions identified from post marketing experience are shown in italics. Frequency groups are defined using the following convention: very common (≥1 / 10); common (≥1 / 100,

System and organ classification Very common ≥1 / 10 Common ≥1 / 100, Uncommon ≥1 / 1,000, Rare ≥1 / 10,000, Very rare Not known (frequency cannot be estimated from the available data) Infections and infestations Infection of the vagina Disorders of the blood and lymphatic system Agranulocytosis Leukopenia Neutropenia Thrombocytopenia Eosinophilia Disorders of the immune system Anaphylactoid Reaction Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Nervous system disorders Dysgeusia Gastrointestinal disorders Abdominal pain Diarrhea Pseudomembranous colitis (see section: Special warnings) Nausea Vomiting Esophageal ulcer Esophagitis Hepatobiliary disorders Alteration of liver function parameters Jaundice Skin and subcutaneous tissue disorders Maculopapular rash Urticaria Toxic epidermal necrolysis Stevens-Johnson syndrome Acute generalized exanthematous pustulosis (AGEP) Erythema multiforme Exfoliative dermatitis Bullous dermatitis Morbilliform rash Pruritus

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Expiry: see the expiry date printed on the package.

The expiry date indicated refers to the product in intact packaging, correctly stored.

WARNING: do not use the medicine after the expiry date shown on the package.

Do not store above 25 ° C.

DO NOT USE IN CASE OF EVIDENT SIGNS OF DETERIORATION.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Keep this medicine out of the sight and reach of children.

Deadline "> Other information

COMPOSITION

DALACIN C 150 mg hard capsules

Each capsule contains:

  • Active ingredient: clindamycin hydrochloride 162.86 mg (equivalent to clindamycin base 150 mg).
  • Excipients: magnesium stearate, talc, corn starch, lactose monohydrate.
  • Constituents of the capsule: titanium dioxide, gelatin.

DALACIN C 300 mg hard capsules

Each capsule contains:

  • Active ingredient: clindamycin hydrochloride 325.8 mg (equivalent to clindamycin base 300 mg).
  • Excipients: magnesium stearate, talc, corn starch, lactose monohydrate.
  • Constituents of the capsule: titanium dioxide, gelatin.

PHARMACEUTICAL FORM AND CONTENT

Hard capsules - Oral use

DALACIN C 150 mg hard capsules - 12 capsules

DALACIN C 300 mg hard capsules - 24 capsules

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Dalacin c can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

DALACIN C 150 MG HARD CAPSULES

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

DALACIN C 150 mg hard capsules

Each hard capsule contains:

Active ingredient: clindamycin hydrochloride 162.86 mg (equivalent to clindamycin base 150 mg).

Excipients with known effects: lactose.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Hard capsules.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

DALACIN C capsule is indicated in the treatment of severe infections caused by susceptible anaerobic germs, as well as in the treatment of severe infections caused by staphylococci, streptococci and pneumococci.

DALACIN C capsules have been shown to be effective in the treatment of infections caused by staphylococci resistant to other antibiotics: however, since strains of staphylococci resistant to clindamycin have been isolated, sensitivity tests should be performed during therapy with this antibiotic.

Oral clindamycin can be used in gynecological and pelvic infections Chlamydia trachomatis only as maintenance therapy in subjects already treated intravenously.

Clindamycin is effective in the treatment of opportunistic infections Toxoplasma gondii And Pneumocystis jiroveci in immunocompromised patients.

The use of clindamycin should be reserved for patients allergic to penicillin or for patients for whom penicillin is not indicated by the physician.

The drug can be administered together with other antibiotics if needed.

In consideration of the possible onset of severe colitis, the doctor, before starting a therapy with DALACIN C capsules, should carefully evaluate the possibility, also in relation to the nature of the infection to be treated, to use less toxic drugs as an alternative.

04.2 Posology and method of administration -

Dosage

Pediatric population

From 8 to 20 mg / kg / day divided into 3 or 4 administrations depending on the severity of the infection.

Adults

600-1200 mg / day divided into 3 or 4 administrations depending on the severity of the infection.

In maintenance therapy of gynecological and pelvic infections, after intravenous treatment, administer 450 mg every 6 hours for 10-14 days.

Cerebral toxoplasmosis in immunocompromised patients: 600-1200 mg every 6 hours for two weeks, followed by 300-600 mg every 6 hours until the 8-10 week course is complete.

When clindamycin is combined with pyrimethamine the dose of the latter is 25-75 mg orally for 8-10 weeks. With higher doses of pyrimethamine it is recommended to administer 10-20 mg / day of folinic acid.

Pneumonia from Pneumocystis jiroveci in immunocompromised patients: 300-450 mg every 6 hours for 21 days combined with 15-30 mg of primachine administered orally once daily for 21 days.

To avoid possible esophageal irritation, DALACIN C capsules should be swallowed with a glass of water.

Note: In case of beta-haemolytic streptococcal infections, it is recommended to continue treatment for at least 10 days to decrease the likelihood of rheumatic fever or glomerulonephritis.

04.3 Contraindications -

Clindamycin is contraindicated in patients who have previously shown hypersensitivity to the active substance, to lincomycin, to any of the excipients listed in section 6.1.

Feeding time.

DALACIN C should not be administered to patients with diarrhea or inflammatory bowel disease (see section 4.4).

04.4 Special warnings and appropriate precautions for use -

Serious hypersensitivity reactions including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (NET) and exanthematous pustulosis have been reported in patients receiving clindamycin therapy. acute generalized (AGEP). If a hypersensitivity reaction or severe skin reaction occurs, treatment with clindamycin should be discontinued and appropriate therapy instituted (see sections 4.3 and 4.8).

Treatment with antibiotics alters the normal flora of the colon and leads to an overgrowth of Clostridium difficile. This has been reported with the use of nearly all antibiotics, including clindamycin Clostridium difficile produces toxins A and B which contribute to the development of associated diarrhea Clostridium difficile (CDAD) and is a primary cause of "antibiotic-induced colitis". A careful medical history is also required since cases of diarrhea associated with C. difficult they have also been reported over two months after antibiotic administration.

In patients who present with diarrhea following antibiotic administration, it is important to consider the diagnosis of CDAD. It can progress to colitis, including pseudomembranous colitis (see section 4.8), the severity of which can range from mild to fatal colitis. Colitis is usually characterized by severe and persistent diarrhea with abdominal cramps and there may be blood and mucus in the stool. If not diagnosed and treated promptly, colitis can progress to peritonitis, shock and toxic megacolon. Endoscopic examination may reveal pseudomembranous colitis. If colitis is suspected a rectosigmoidoscopic examination is recommended. The presence of colitis can be further confirmed by stool culture examination for Clostridium difficile in a selective media and by the toxin assay Clostridium difficile. If antibiotic-induced diarrhea or antibiotic-induced colitis is suspected or confirmed, ongoing treatment with antibiotics, including clindamycin, should be discontinued and appropriate therapeutic measures taken immediately. In this situation, drugs that inhibit peristalsis are contraindicated.

Antiperistaltics, opiates and diphenoxylate plus atropine can prolong and / or worsen conditions.

Vancomycin was found to be effective in the treatment of antibiotic-dependent pseudomembranous colitis produced by Clostridium difficile. The dosage for adults is 500 mg to 2 g / day of oral vancomycin in three to four doses over a period of 7-10 days.

Cholestyramine binds to the toxin in vitro: however this resin also binds to vancomycin. Therefore, in the case of simultaneous administration of cholestyramine and vancomycin it is advisable to administer each drug at different times.

Some rare cases of relapse after treatment with vancomycin have been described.

The data available so far show that elderly and / or seriously ill patients tolerate diarrhea less well; should these patients be treated with clindamycin, particular attention should be paid to changes in the frequency of bowel movements.

DALACIN C capsules should be prescribed with caution to individuals with a history of gastrointestinal diseases, particularly colitis, and to atopic individuals.

Sometimes the use of antibiotics can cause the development of resistant germs, especially yeasts. Should superinfection occur, take appropriate therapeutic measures. During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

Impaired liver and kidney function

The half-life of the drug was only slightly modified in hepatonephro patients. Therefore, in cases of mild to medium severity of hepatic and renal impairment, a reduction in the dose is not usually necessary, which may be required in cases of severe deterioration of the function of the drug. liver and kidney In case of prolonged therapy, liver and kidney function tests should be performed.

Significant levels of clindamycin are not reached in the cerebrospinal fluid, therefore the drug should not be used for the treatment of meningitis.

Data on the use of DALACIN C in pregnant women are limited therefore its use should only be made if strictly necessary (see section 4.6).

Important information about some of the excipients:

The medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.

04.5 Interactions with other medicinal products and other forms of interaction -

Vitamin K antagonists

Increased coagulation tests (PT / INR) and / or haemorrhages have been reported in patients treated with clindamycin in combination with vitamin K antagonists (e.g. warfarin, acenocoumarol and fluindione). Therefore, coagulation tests in patients treated with vitamin K antagonists should be monitored frequently.

Injected clindamycin has been shown to induce neuromuscular block which may enhance the activity of other neuromuscular blocking drugs (for example: ether, tubocurarine, pancuronium). It should therefore be used with caution in patients taking such drugs. .

A synergistic action has been reported with metronidazole against Bacteroides fragilis.

The association with gentamicin can occasionally determine a synergism and never an antagonism.

Cross-reactivity between clindamycin and lincomycin has been demonstrated.

In vitro antagonism between clindamycin and erythromycin has been demonstrated, therefore due to possible clinical relevance the two medicinal products should not be administered concomitantly.

Administration of clindamycin and primakin to HIV-positive volunteers did not significantly affect the pharmacokinetic parameters of zidovudine.

Some antibiotics may reduce the effectiveness of oral contraceptive pills. Additional contraceptive precautions should be considered during treatment.

04.6 Pregnancy and breastfeeding -

Pregnancy

Reproductive toxicity studies conducted in rats and rabbits following oral and subcutaneous administration have shown no signs of impaired fertility or fetal harm caused by clindamycin, except at doses that induce maternal toxicity. Reproduction studies in animals are not always predictive of the response in humans.

In humans, clindamycin crosses the placenta. After repeated dosing, amniotic fluid concentrations were approximately 30% of maternal blood concentrations.

In clinical studies in pregnant women, systemic administration of clindamycin in the second and third trimesters was not associated with an increase in the frequency of congenital anomalies. There are no adequate and well-controlled studies in women in the first trimester of pregnancy.

In pregnancy, clindamycin should only be used if strictly necessary.

Feeding time

Orally and parenterally administered clindamycin has been found in breast milk in concentrations ranging from 0.7 to 3.8 μg / ml. Due to possible serious adverse reactions in infants, breastfeeding women should not take clindamycin.

Fertility

Fertility studies in rats treated with oral clindamycin showed no effects on fertility or reproductive capacity.

04.7 Effects on ability to drive and use machines -

Clindamycin has no or negligible influence on the ability to drive and use machines.

04.8 Undesirable effects -

The following table presents adverse reactions identified from clinical trials and post-marketing surveillance, sorted by system organ class and frequency. Frequency groups are defined according to the following convention: very common (≥1 / 10); common (≥1 / 100,

System and organ classification Very common ≥ 1/10 Common ≥1 / 100, Uncommon ≥1 / 1,000, Rare ≥1 / 10,000, Moltoraro Not known (frequency cannot be estimated from the available data) Infections and infestations Pseudomembranous colitis * (see section 4.4) Colitis from Clostridium difficile *, Vaginal infection * Disorders of the blood and lymphatic system Agranulocytosis *, Neutropenia *, Thrombocytopenia *, Leukopenia *, Eosinophilia Disorders of the immune system Anaphylactic shock *, Anaphylactoid reaction *, Anaphylactic reaction *, Hypersensitivity * Nervous system disorders Dysgeusia Gastrointestinal pathology Diarrhea, Abdominal pain Vomiting, Nausea Esophageal ulcer *, Esophagitis * Hepatobiliary disorders Jaundice * Skin and subcutaneous tissue disorders Maculo-papular rash, Urticaria Toxic Epidermal Necrolysis (TEN) *, Stevens-Johnson Syndrome (SJS) *, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) *, Acute Generalized Exanthematous Pustulosis (AGE P) *, Angioedema *, Exfoliative Dermatitis *, Bullous Dermatitis *, Erythema multiforme, Pruritus, Rash, morbilliform * Diagnostic tests Abnormal liver function parameters

* Adverse reactions identified in post-marketing experience.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose -

As there are no dose-related side effects, overdose is a rare problem, especially if the drug is administered as directed.

Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from serum.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group: antibacterials for systemic use - lincosamides.

ATC code: J01FF01.

DALACIN C capsules contain clindamycin hydrochloride, a semi-synthetic antibiotic obtained by substitution with a chlorine atom of the 7-hydroxyl group in the lincomycin molecule.

Microbiological activity: clindamycin has an "activity in vitro against isolated strains of the following microorganisms:

Aerobic gram-positive cocci, comprising:

Staphylococcus aureus, Staphylococcus epidermidis (including penicillinase producing strains). When tested in vitro some strains of staphylococci originally resistant to erythromycin rapidly develop resistance to clindamycin, streptococci (excluding S. Faecalis), pneumococci, chlamydia trachomatis (sensitive strains).

Gram-negative anaerobic bacilli, comprising:

Bacteroides spp, fusobacterium spp.

Aerobic gram-positive anaerobic bacilli, comprising:

Propionibacterium, eubacterium, actinomyces spp.

Gram positive anaerobic and microaerophilic cocci, including:

Peptococcus spp, peptostreptococcus spp., Microaerophilic streptococci.

Clostridia: clostridia are more resistant than most anaerobes to clindamycin. Most of the C.perfringens they are sensitive, but other species, for example i C.sporogenes and of C.tertium, are frequently resistant to clindamycin. Sensitivity test is recommended. Cross-resistance between clindamycin and lincomycin as well as antagonism has been demonstrated in vitro between clindamycin and erythromycin, so they should not be administered simultaneously.

Protozoa:

Toxoplasma gondii, Pneumocystis jiroveci

05.2 "Pharmacokinetic properties -

Pharmacokinetic studies conducted in healthy volunteers (24 adult subjects) have shown that after oral administration of a dose of 150 mg of clindamycin hydrochloride, the drug is rapidly absorbed. A mean peak serum of 2.50 mcg / mL was achieved in 45 minutes; the mean serum levels after 3 hours and after 6 hours were 1.51 mcg / ml and 0.70 mcg / ml, respectively.

Absorption

Absorption after oral administration is practically complete (90%) and concomitant food intake does not appreciably change the serum concentrations; blood levels were uniform and predictable in all subjects and at various doses. Repeated administration of DALACIN C capsules for up to 14 days did not show accumulation or changes in drug metabolism. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from serum.

Serum clindamycin concentrations increase linearly with increasing dosage and exceed the MIC (minimum inhibitory concentration) for most of the indicated organisms for a period of at least 6 hours after administration of the indicated therapeutic doses.

Distribution

Clindamycin is widely distributed in body fluids and tissues (including bone tissue). The mean half-life is 2.4 hours.

Elimination

Approximately 10% of the drug is excreted in biologically active form in the urine and 3.6% in the faeces; the remainder is excreted in the form of bioinactive metabolites.

Administration of clindamycin and primakin to HIV-positive volunteers did not significantly affect the pharmacokinetic parameters of zidovudine.

In breast milk, clindamycin is present in quantities between 0.7 and 3.8 mcg / ml.

05.3 Preclinical safety data -

The acute toxicity data relating to the experimental animal are as follows:

Animal species Administration LD50 (mg / kg) Mouse i.p. 361 Mouse e.v. 245 Rat o.s. 2618

Clindamycin hydrochloride administered to the Spartan Sprague Dawley rat and Beagle dog orally for one year at doses of 30-100 and 300 mg / kg / day (3 g / day for the dog) was well tolerated.

Histopathological examination did not reveal significant differences between the groups of animals treated with the drug and the controls.

The dose of 600 mg / kg / day administered per OS for 6 months was well tolerated by the rat while gastrointestinal toxic manifestations (vomiting, anorexia and weight loss) were observed in the dog.

In embryofoetal development studies following oral administration of the product in rats and in embryofoetal development studies following subcutaneous administration of the product in rats and rabbits, no developmental toxicity was observed except at doses that would cause maternal toxicity.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Magnesium stearate, talc, corn starch, lactose monohydrate;

capsule constituents: titanium dioxide, gelatin.

06.2 Incompatibility "-

Not relevant.

06.3 Period of validity "-

5 years.

06.4 Special precautions for storage -

Do not store above 25 ° C.

06.5 Nature of the immediate packaging and contents of the package -

Blister in coupled transparent PVC and aluminum, lacquered with heat-sealing paint.

"DALACIN C 150 mg hard capsules" 12 capsules.

06.6 Instructions for use and handling -

Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

PFIZER ITALIA S.r.l.

via Isonzo, 71 - 04100 Latina (LT)

08.0 MARKETING AUTHORIZATION NUMBER -

022633059 "DALACIN C 150 mg hard capsules" 12 capsules

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

Date of first authorization: 23 November 1973

Date of most recent renewal: May 31, 2010

10.0 DATE OF REVISION OF THE TEXT -

23 May 2016

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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