Clindamax (Solution, Cream) Instructions for Use
ATC Code
D10AF01 (Clindamycin)
Active Substance
Clindamycin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
A drug with antibacterial action for the treatment of acne
Pharmacotherapeutic Group
Drugs for the treatment of acne; drugs for the treatment of acne for topical use; antimicrobial agents for the treatment of acne
Pharmacological Action
An antibiotic of the lincosamide group. In therapeutic doses, it has a bacteriostatic effect; in high doses, it has a bactericidal effect on susceptible strains. It disrupts intracellular protein synthesis at an early stage by binding to the 50S subunit of bacterial ribosomes.
Clindamycin is active against most aerobic gram-positive bacteria, including Staphylococcus spp. (including strains producing penicillinase); Streptococcus spp., Bacillus anthracis, Corynebacterium diphtheriae.
Clindamycin is also active against anaerobic gram-positive bacteria, including Eubacterium, Propionibacterium, Peptococcus, Peptostreptococcus spp., many strains of Clostridium perfringens and Clostridium tetani.
Among gram-negative anaerobes, Fusobacterium spp. (excluding F. varium, which is usually resistant), Veillonella, Bacteroides spp. (including B. fragilis) are susceptible to clindamycin.
Against Mycoplasma spp., Clindamycin is usually less active than erythromycin.
Some strains of Actinomyces spp. and Nocardia asteroides are susceptible to clindamycin.
Some antiprotozoal activity against Toxoplasma gondii and Plasmodium spp. has been reported.
Enterococcus spp., methicillin-resistant strains of Staphylococcus aureus, most gram-negative aerobic bacteria (including Enterobacteriaceae spp.), Neisseria gonorrhoeae, Neisseria meningitidis and Haemophilus influenzae, as well as fungi (including yeasts) and viruses are resistant to clindamycin.
Pharmacokinetics
After oral administration, about 90% of the clindamycin dose is absorbed from the gastrointestinal tract. After a dose of 150 mg, the plasma concentration of clindamycin is 2-3 mcg/ml after 1 hour, and about 0.7 mcg/ml after 6 hours. After doses of 300 mg and 600 mg, Cmax in plasma is 4 mcg/ml and 8 mcg/ml, respectively. Concurrent food intake reduces the rate of absorption, while the extent of absorption changes insignificantly.
After intramuscular injection of a 300 mg dose, the average Cmax in plasma is 6 mcg/ml and is reached within 3 hours; with a 600 mg dose, it is 9 mcg/ml.
In children, Cmax in plasma is reached within 1 hour. When the same doses are administered intravenously, Cmax in plasma is 7-10 mcg/ml and is reached at the end of the infusion.
Clindamycin is absorbed in small amounts from the skin surface.
With intravaginal administration, systemic absorption can be about 5%.
Clindamycin is widely distributed in body tissues and fluids, including bones, but does not reach significant concentrations in the CNS. High concentrations of clindamycin are found in bile. Clindamycin accumulates in leukocytes and macrophages.
About 90% of clindamycin is bound to plasma proteins.
Clindamycin is metabolized, mainly in the liver, to form N-demethylated and sulfoxide metabolites, as well as inactive metabolites.
T1/2 is 2-3 hours, increased in patients with severe kidney disease and in premature newborns.
About 10% of the dose is excreted in the urine as unchanged drug and metabolites and about 4% in the feces. The remainder is excreted as inactive metabolites. Excretion is slow, over 7 days.
Not removed from the blood by dialysis.
Indications
For systemic use: severe infectious and inflammatory diseases caused by microorganisms susceptible to clindamycin: pneumonia, lung abscess, pleural empyema, osteomyelitis, endometritis, adnexitis, purulent infections of the skin, soft tissues, wounds, peritonitis. Prevention of peritonitis and intra-abdominal abscesses after intestinal perforation or trauma (in combination with aminoglycosides). As a reserve antibiotic for infections caused by strains of staphylococcus and other gram-positive microorganisms resistant to penicillin. As a prophylactic agent for tooth extraction.
For external use: acne vulgaris.
For topical use: vaginosis caused by susceptible microorganisms.
ICD codes
| ICD-10 code | Indication |
| J15 | Bacterial pneumonia, not elsewhere classified |
| J85 | Abscess of lung and mediastinum |
| J86 | Pyothorax (pleural empyema) |
| K65.0 | Acute peritonitis (including abscess) |
| L01 | Impetigo |
| L02 | Cutaneous abscess, furuncle and carbuncle |
| L03 | Cellulitis |
| L08.0 | Pyoderma |
| L08.8 | Other specified local infections of skin and subcutaneous tissue |
| L70 | Acne |
| M86 | Osteomyelitis |
| N70 | Salpingitis and oophoritis |
| N71 | Inflammatory disease of uterus, excluding cervix (including endometritis, myometritis, metritis, pyometra, uterine abscess) |
| N72 | Inflammatory disease of cervix uteri (including cervicitis, endocervicitis, exocervicitis) |
| N73.0 | Acute parametritis and pelvic cellulitis |
| N76 | Other inflammatory diseases of vagina and vulva |
| T79.3 | Posttraumatic wound infection, not elsewhere classified |
| Z29.2 | Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes) |
| ICD-11 code | Indication |
| 1B70.1 | Streptococcal cellulitis of the skin |
| 1B70.2 | Staphylococcal cellulitis of the skin |
| 1B70.Z | Bacterial cellulitis or lymphangitis caused by unspecified bacterium |
| 1B72.0 | Bullous impetigo |
| 1B72.1 | Nonbullous impetigo |
| 1B72.Z | Impetigo, unspecified |
| 1B75.0 | Furuncle |
| 1B75.1 | Carbuncle |
| 1B75.2 | Furunculosis |
| 1B75.3 | Pyogenic skin abscess |
| 1B7Y | Other specified pyogenic bacterial infections of skin or subcutaneous tissue |
| 1C44 | Non-pyogenic bacterial infections of skin |
| CA40.0Z | Bacterial pneumonia, unspecified |
| CA43.Z | Abscess of lung or mediastinum, unspecified |
| CA44 | Pyothorax |
| DC50.0 | Primary peritonitis |
| DC50.2 | Peritoneal abscess |
| DC50.Z | Peritonitis, unspecified |
| EA50.3 | Staphylococcal scarlet fever |
| EB21 | Pyoderma gangrenosum |
| ED80.Z | Acne, unspecified |
| FB84.Z | Osteomyelitis or osteitis, unspecified |
| GA00 | Vulvitis |
| GA01.Z | Inflammatory diseases of uterus, except cervix, unspecified |
| GA02.Z | Unspecified vaginitis |
| GA05.0 | Acute inflammatory disease of female pelvic organs |
| GA07.Z | Salpingitis and oophoritis, unspecified |
| GA0Z | Inflammatory diseases of female genital tract, unspecified |
| NF0A.3 | Posttraumatic wound infection, not elsewhere classified |
| QC05.Y | Other specified prophylactic measures |
| GA0Z | Inflammatory diseases of female genital tract, unspecified |
| XA5WW1 | Cervix uteri |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
Orally for adults – 150-450 mg every 6 hours. For tooth extraction prophylaxis, a single dose is 600 mg in 1-2 doses according to the scheme.
Orally for children – 3-6 mg/kg every 6 hours.
For intramuscular or intravenous administration to adults – 0.6-2.7 g/day in divided doses. For very severe infections, up to 4.8 g/day can be administered intravenously. Maximum doses for intramuscular injection: single dose – 600 mg; for intravenous infusion lasting 1 hour – 1.2 g.
For intramuscular or intravenous administration to children over 1 month of age – 15-40 mg/kg/day in divided doses. For severe infections, the total dose should be at least 300 mg/day.
Topically – apply to the affected area 2-3 times/day.
Intravaginally – 100 mg at night for 3-7 days.
Cream
Intravaginally 100 mg for 3-7 days.
Adverse Reactions
From the digestive system nausea, vomiting, abdominal pain, diarrhea, after intravenous administration in high doses – unpleasant metallic taste; after oral administration – symptoms of esophagitis; transient increase in the activity of liver transaminases and bilirubin in blood plasma; in isolated cases – jaundice and liver disease.
From the hematopoietic system rarely – reversible leukopenia, neutropenia, thrombocytopenia, agranulocytosis.
Allergic reactions urticaria; rarely – erythema multiforme; in some cases – angioedema, fever, anaphylactic shock.
From the cardiovascular system with rapid intravenous administration – decreased blood pressure, dizziness, weakness.
Local reactions with intravenous administration in high doses – phlebitis; with intramuscular administration rarely – irritation at the injection site, development of infiltration, abscess.
With external use irritation at the application site, contact dermatitis. Due to slight systemic absorption, there is a possibility of systemic side effects.
With topical use cervicitis, vaginitis or vulvovaginal irritation.
Effects due to chemotherapeutic action pseudomembranous colitis, candidiasis.
Contraindications
Hypersensitivity to clindamycin or lincomycin.
For systemic use: severe impairment of liver or kidney function, myasthenia gravis, bronchial asthma, ulcerative colitis (in history), pregnancy, lactation, children under 1 month of age, elderly age.
Use in Pregnancy and Lactation
Clindamycin crosses the placental barrier into the fetal bloodstream. It is excreted in breast milk.
Clindamycin for oral and parenteral administration is contraindicated during pregnancy and lactation.
Intravaginal use of clindamycin during pregnancy is possible if the intended benefit to the mother outweighs the potential risk to the fetus; during lactation – only for strict indications.
Use in Hepatic Impairment
Systemic use is contraindicated in severe liver dysfunction.
Use in Renal Impairment
Systemic use is contraindicated in severe kidney dysfunction.
Pediatric Use
Systemic use is contraindicated in children under 1 month of age.
Geriatric Use
Systemic use is contraindicated in elderly age.
Special Precautions
Use with caution in patients with a history of gastrointestinal diseases.
If diarrhea or symptoms of colitis appear, Clindamycin should be discontinued.
Pseudomembranous colitis can occur both during clindamycin use and 2-3 weeks after treatment cessation. Drugs that inhibit intestinal peristalsis should not be used.
It is not recommended to use Clindamycin concurrently with drugs that slow neuromuscular transmission.
Intravaginally, it is not recommended to use concurrently with other intravaginal agents.
Drug Interactions
Clindamycin enhances the effect of drugs blocking neuromuscular transmission.
With concurrent use with opioids, an increase in the depressant effect on respiration is possible. Clindamycin may exhibit antagonism to the activity of sympathomimetics.
Synergism regarding the antibacterial action on some anaerobes between clindamycin and ceftazidime, metronidazole, ciprofloxacin has been noted.
There is evidence that Clindamycin inhibits the bacterial activity of aminoglycosides. Due to the similarity of binding sites on ribosomes, Clindamycin may competitively inhibit the action of macrolides and chloramphenicol.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for external use 10 mg/1 ml: fl. 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml or 100 ml with dropper.
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
 |
Clindamax | Solution for external use 10 mg/1 ml: fl. 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml or 100 ml with dropper. |
Dosage Form, Packaging, and Composition
Solution for external use in the form of a colorless, transparent liquid, with a characteristic odor.
| 1 ml | |
| Clindamycin hydrochloride | 11.5 mg, |
| Equivalent to clindamycin content | 10 mg |
Excipients : ethanol 96% (ethyl alcohol 96%) – 608 mg, propylene glycol – 86.9 g, purified water – 173.6 g.
10 ml – dark glass bottles (1) with a dropper – cardboard boxes.
20 ml – dark glass bottles (1) with a dropper – cardboard boxes.
30 ml – dark glass bottles (1) with a dropper – cardboard boxes.
40 ml – dark glass bottles (1) with a dropper – cardboard boxes.
50 ml – dark glass bottles (1) with a dropper – cardboard boxes.
60 ml – dark glass bottles (1) with a dropper – cardboard boxes.
70 ml – dark glass bottles (1) with a dropper – cardboard boxes.
80 ml – dark glass bottles (1) with a dropper – cardboard boxes.
90 ml – dark glass bottles (1) with a dropper – cardboard boxes.
100 ml – dark glass bottles (1) with a dropper – cardboard boxes.
Vaginal cream 2%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, or 100 g with applicators
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
 |
Clindamax | Vaginal cream 2%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, or 100 g with applicators |
Dosage Form, Packaging, and Composition
Vaginal cream from white to white with a yellowish or creamy tint, homogeneous; a faint specific odor may be present.
| 1000 mg | |
| Clindamycin phosphate | 23.8 mg, |
| Equivalent to clindamycin content | 20 mg |
Excipients : mineral oil – 64.2 mg, polysorbate 60 – 50 mg, propylene glycol – 50 mg, cetearyl alcohol – 32.1 mg, cetyl palmitate – 32.1 mg, stearic acid – 21.4 mg, sorbitan stearate – 20 mg, benzyl alcohol – 10 mg, purified water – up to 1000 mg.
20 g – tubes (1) with applicators – cardboard boxes.
25 g – tubes (1) with applicators – cardboard boxes.
30 g – tubes (1) with applicators – cardboard boxes.
35 g – tubes (1) with applicators – cardboard boxes.
40 g – tubes (1) with applicators – cardboard boxes.
50 g – tubes (1) with applicators – cardboard boxes.
60 g – tubes (1) with applicators – cardboard boxes.
70 g – tubes (1) with applicators – cardboard boxes.
80 g – tubes (1) with applicators – cardboard boxes.
100 g – tubes (1) with applicators – cardboard boxes.
![Clindamax [Solution, Cream] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Clindamax [Solution, Cream] 2")