Trade name of the drug: CLINDOX Active substance (INN): CLINDAMYCIN, CLOTRIMAZOLE AND TINIDAZOLE Dosage form: Soft gelatin vaginal capsule
structure Each vaginal soft gelatin capsule contains: Clindamycin Phosphate BP Clindamycin equivalent .................. 100 mg Clotrimazole BP ................................ 100 mg Tinidazole BP.......... ......................... .100 mg Fillers ------------------------
PHARMACEUTICAL FORM Soft gelatin capsule
PHARMACOTHERAPEUTIC CATEGORY Antibacterial and antifungal drug PBX Code: Clindamycin Phosphate-G01AA10, Clotrimazole-D01AC01, Tinidazole- P01AB02
PHARMACODYNAMICS Clindamycin: Clindamycin is an antibiotic, an analogue and derivative of lincomycin. Clindamycin can be used for local or systemic treatment. It is effective as an anti-anaerobic and antiprotozoal antibiotic. Clotrimazole: Clotrimazole, an imidazole derivative with a wide spectrum of antifungal activity, inhibits the biosynthesis of ergostole sterol, an important component of the fungal cell membrane. Its action leads to an increase in the permeability of the membrane and an obvious violation of the enzyme systems associated with the membrane. Betamethasone and clotrimazole are used together to treat skin infections of shingles. In studies of fungal cultures, the minimal fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the environment with concomitant decay of cellular nucleic acids and accelerated potassium etflux. Both of these events started quickly and widely after the drug was added to the cultures. The main action of clotrimazole is against division and growth of the body. Tinidazole: Tinidazole is a synthetic antiprotozoal agent. Tinidazole is active both in vitro and against clinical infections against the following protozoa: Trichomonas vaginalis, Giardia duodenalis (also called G.lamblia) and Entamoeba histolytica. Tinidazole does not appear to have activity against most strains of vaginal lactobacilli.
PHARMACOKINETICS Clindamycin: Clindamycin. The absolute bioavailability of a vaginal egg with clindamycin phosphate compared to the reference treatment of a sterile clindamycin phosphate solution, as well as the relative bioavailability of an egg compared to a vaginal cream with clindamycin phosphate was evaluated in 12 healthy adult female volunteers. Subjects were randomly assigned to receive an egg or cream composition intravaginally for 3 consecutive days during the two-hour crossover portion of the study. During the third treatment period, all subjects received 100 mg of clindamycin in the form of a 4-minute intravenous infusion of a sterile solution of clindamycin phosphate (10 mg/ml). Clindamycin concentrations in blood serum were determined by high-performance liquid chromatography with mass spectrometry detection. Pharmacokinetic analysis of serum data showed low systemic absorption of clindamycin from vaginal cream (about 4%), which is consistent with the results of previous bioavailability studies. After intra-vaginal administration of an egg with clindamycin phosphate, systemic absorption averaged 30%, which was about seven times more than after the introduction of a vaginal cream. A higher absorption of the drug for the egg may be associated with differences in the effect of the drug on the vaginal membrane. Nevertheless, the systemic effect of clindamycin from the egg is still significantly lower than from the therapeutic oral dose. It is rapidly absorbed after oral administration with peak serum concentrations observed after about 45 minutes. Oral dose absorption is almost complete (90%), and simultaneous food intake does not lead to a significant change in serum concentration; serum levels were uniform and predictable from person to person and from dose to dose. Clindamycin does not penetrate the blood-brain barrier. Binding to proteins: 92-94% Metabolism: hepatic Method of excretion: approximately 10% of biological activity is excreted in urine and 3.6% in feces; the remainder is excreted as bioactive metabolites. Half-life: 2.4 hours Clotrimazole: Clotrimazole absorption after vaginal administration was estimated in the range of 3 to 10%. To study the fate of clotrimazole reaching systemic circulation, pharmacokinetic studies were conducted after oral and intravenous administration. Clotrimazole concentrations in vaginal fluid and in blood plasma after vaginal administration of 200 and 500 mg were determined using a special analysis using quantitative thin-layer chromatography. Fungicidal concentrations of clotrimazole were detected in the vaginal fluid within 3 days after the use of one vaginal tablet containing 500 mg. In contrast, clotrimazole plasma levels were below 0.01 mcg/ml, indicating that clotrimazole is rapidly metabolized. Poorly and randomly absorbed orally, minimal vaginal or local absorption. Binding to proteins: 92-94% Metabolism: hepatic Half-life: 2.0 hours Tinidazole: Tinidazole is a potent nitroimidazole compound active and used to treat infections of Trichomonas vaginalis (vaginal trichomoniasis) for men and women. There are suggestions in the literature that the observed differences in plasma concentrations of tinidazole in men and women may be related to sex-mediated sex differences in pharmacokinetics. To investigate this phenomenon, a study was developed to determine the pharmacokinetics of tinidazole in men and women. Each of the six male and six female volunteers was administered a single oral dose of tinidazole of 2 gm. Plasma and urine samples collected within 72 hours were analyzed using sensitive and specific HPLC analysis. The results demonstrate a significant correlation between oral clearance of tinidazole and body weight and the apparent volume of distribution of tinidazole and body weight for male and female subjects, respectively. There were no obvious gender-mediated differences in weight-normalized pharmacokinetic parameters, which is confirmed by statistically equivalent mean values of oral plasma purification (36.1 and 35.4 ml / kg/hour), visible volumes of distribution (0.65 and 0.63 liters /kg) and half-life (12.3 and 12.3 hours, men and women, respectively). The average area under the curve of the dependence of the concentration of tinidazole in plasma on time and the average peak concentration of tinidazole in plasma in women was 1.3 times larger than in men, apparently due to the lower average body weight in women and, consequently, 1.3 times the administered dose for women. based on weight. It is quickly and completely absorbed in starvation conditions. Administration with food leads to a delay of Tmax by about 2 hours and a decrease in Cmax by about 10% and AUC of 901.6 ± 126.5 mcg h / ml. Distribution volume: 50 L Protein binding: Binding to plasma proteins of tinidazole is 12%. Metabolism: hepatic, mainly through CYP3A4. Tinidazole, like metronidazole, is significantly metabolized in humans before excretion. Tinidazole is partially metabolized by oxidation, hydroxylation and conjugation. Tinidazole is the main drug-relateda component in plasma after human treatment, along with a small amount of 2-hydroxymethylmetabolites. Method of isolation: tinidazole penetrates the placental barrier and is excreted in breast milk. Tinidazole is excreted from the body by the liver and kidneys. Tinidazole is excreted in the urine mostly unchanged (approximately 20-25% of the administered dose). Approximately 12% of the drug is excreted in the feces.
INDICATIONS FOR USE Clindamycin: for the treatment of serious infections caused by susceptible anaerobic bacteria, including Bacteroides spp., Peptostreptococcus, anaerobic streptococci, Clostridium spp. and microaerophilic streptococci. It can be useful for polymicrobial infections such as intra-abdominal or pelvic infections, osteomyelitis, diabetic foot ulcer, aspiration pneumonia and dental infections. It can also be used to treat MSSA and respiratory infections caused by S.pneumoniae and S.pyogenes in patients who do not tolerate other specified antibiotics or are infected with a resistant organism. It can be used vaginally to treat vaginosis caused by Gardnerella vaginosa. Clindamycin reduces the toxic effects of S.aureus and S.pyogenes and, as such, may be particularly useful for the treatment of necrotic fasciitis. It can be used topically to treat acne. Clotrimazole: for topical treatment of oropharyngeal candidiasis and yeast infections of the vagina, it is also used for fungal skin infections such as ringworm, athlete's feet and itching. Tinidazole: for the treatment of trichomoniasis caused by T.vaginalis in both women and men. Also for the treatment of giardiasis caused by G.duodenalis, both in adults and in children over three years old, as well as for the treatment of intestinal amoebiasis and amoebic liver abscess caused by E.stolytica, both in adults and in children over three years of age.
METHOD OF ADMINISTRATION AND DOSAGE Intravaginal. In the supine position, insert the capsule as deep as possible into the vagina. Treatment should not coincide with the period of menstruation. Treatment of bacterial vaginosis and other gynecological infections: one capsule per day for 7 days, before bedtime. Prevention before gynecological procedures: one capsule once every three days before the planned procedure and four days after it.
contraindications Clindamycin: contraindicated in persons with a history of hypersensitivity to clindamycin, lincomycin or any of the components of this vaginal cream. Clindamycin is also contraindicated in persons with a history of regional enteritis, ulcerative colitis or "antibiotic-associated" colitis. Clotrimazole: hypersensitivity to imidazole. First trimester of pregnancy, hypersensitivity. preparation / class / component. be careful when using latex or rubber contraceptives. Tinidazole: Reduction of leukocyte-type neutrophils, peripheral neuropathy, seizures, a mother who produces milk and breast-feeding and nitroimidazoles.
DRUG INTERACTIONS Clindamycin: It is always important to inform your doctor and pharmacist about all your treatment methods. Not only prescription medications, but also things that may not look like medications, such as: over-the-counter (OTC) medications; vitamins, nutritional shakes, protein powders and other supplements; herbal treatments or other alternative medications; and any illegal or recreational drugs. The following drugs are known to interact with clindamycin: Keep a list of all the products you use. Share this list with your doctor and pharmacist to reduce the risk of serious problems with taking medications. Tinidazole: Drug interactions can change the way your medications work or increase the risk of serious side effects. This document does not contain all possible drug interactions. Save a list of all the products you use (including prescription/over-the-counter medications and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medications without your doctor's permission. Some products that may interact with this drug include: alcohol-containing products (such as cough and cold syrups, aftershave), products containing propylene glycol, lopinavir / ritonavir-containing solution, lithium. Do not take tinidazole if you are taking disulfiram or if you have been taking disulfiram for the last 2 weeks. Although most antibiotics are unlikely to affect hormonal birth control, such as pills, a patch or a ring, some antibiotics (such as rifampin, rifabutin) can reduce their effectiveness. This can lead to pregnancy. If you are using hormonal birth control, ask your doctor or pharmacist for more details. This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure that the laboratory staff and all your doctors know that you are using this drug.
SIDE EFFECTS Clindamycin: contraindicated in persons with a history of hypersensitivity to clindamycin, lincomycin or any of the components of this vaginal cream. Clindamycin is also contraindicated in persons with a history of regional enteritis, ulcerative colitis or "antibiotic-associated" colitis. Clotrimazole: hypersensitivity to imidazole. First trimester of pregnancy, hypersensitivity. preparation / class / component. be careful when using latex or rubber contraceptives. Tinidazole: Reduction of leukocyte-type neutrophils, peripheral neuropathy, seizures, mother who produces milk and breast-feeding and nitroimidazoles
WARNINGS AND PRECAUTIONS If the patient has symptoms of candida vaginitis for the first time, you should consult a doctor. Before using a SOFT GELATIN CAPSULE OF CLINDAMYCIN, CLOTRIMAZOLE AND TINIDAZOLE, it is necessary to consult a doctor if there are any of the following cases: - more than two infections of candida vaginitis in the last 6 months. - previous history of sexually transmitted diseases or contact with a sexually transmitted partner. pregnancy or presumed pregnancy. - age under 16 or over 60. - known hypersensitivity to imidazoles or other vaginal antifungal drugs.
CLINDAMYCIN, CLOTRIMAZOLE AND TINIDAZOLE SOFT GELATIN CAPSULES should not be used if the patient has any of the following symptoms for which medical attention should be sought: - irregular vaginal bleeding. - abnormal vaginal bleeding or spotting. - vaginal or vaginal ulcers, blisters or ulcers. - pain in the lower abdomen or dysuria. - any adverse events, such as redness, irritation or swelling associated with treatment. - fever or chills. - nausea or vomiting. - diarrhea. - unpleasant odors from the vagina.
Patients should be advised to consult a doctor if symptoms have not been eliminated within one week using a SOFT GELATIN CAPSULE of CLINDAMYCIN, CLOTRIMAZOLE AND TINIDAZOLE. SOFT GELATIN CAPSULES CLINDAMYCIN, CLOTRIMAZOLE AND TINIDAZOLE can be used again if the candida infection recurs after 7 days.However, if the candida infection recurs more than twice within six months, patients should consult a doctor. > Botulinum toxin A. > Many contraceptive medications, including those containing the following: desogestrel, dienogest, drospirenone, estradiol, ethinodiol, levonorgestrel, mestranol, norelgestromine, norgestimate and norgestrel > Mycophenolate mofetil (Cellcept, Myfortic) > Many medications that are used during surgery, such as muscle-controlling drugs Atracurium (Tacrum), Cisatrcurium (Nimbex), Pancuronium (Pavulon), Rocuronium (Zemuron, Esmeron) and Vecuronium (Norcuron) > Sodium Picosulfate Clindamycin and grapefruit juice You should avoid eating grapefruit and drinking grapefruit juice while taking clindamycin. Grapefruit juice reduces the body's ability to break down clindamycin, which can lead to a dangerous increase in the level of the drug in the blood. Clindamycin and other interactions You should not take clindamycin if you are taking the Calmette-Guerin bacillus (known as BCG or Theracys), a treatment for tuberculosis, leprosy, bladder cancer and other conditions. Clotrimazole: The effect of some medications may change if you take other medications or herbal products at the same time. This may increase the risk of serious side effects or may cause your medications to malfunction. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or control interactions by changing the way medications are administered or by careful monitoring. To help your doctor and pharmacist provide you with the best possible care, be sure to inform your doctor and pharmacist about all the products you use (including prescription, over-the-counter and herbal products) before starting treatment with this product. When using this product, do not start, stop, or change the dosage of any other medications you use without your doctor's permission. Some foods that may increase the risk of vaginal yeast infections include antibiotics, corticosteroids (such as prednisone) and medications that suppress the immune system (such as cyclosporine, methotrexate).
PREGNANCY AND LACTATION A soft gelatin capsule can interact with other medications, herbs and vitamins and affect the work of the medicine. Make sure your doctor is aware of all your other medications before prescribing you a dose of Mymazole Soft Gelatin Capsules. Mymazole Soft gelatin capsules are generally safe during pregnancy, but consult your doctor before taking them. Clindamycin was detected in breast milk after oral or parenteral administration. It is not known if clindamycin is excreted in breast milk after using clindamycin phosphate vaginally. Due to the possibility of serious adverse reactions in infants from clindamycin phosphate, a decision should be made to stop feeding or discontinue taking the drug, taking into account the importance of the drug for the mother.
OVERDOSE If you think an overdose has occurred, call a poison control center or seek medical help immediately. Be ready to tell or show what was taken, how much and when it happened.
INTRODUCTION MODE vaginal
expiration date 24 months from the date of manufacture.
SALE MODE by prescription
STORAGE CONDITIONS Store in a dry place protected from light at a temperature not higher than 25 C. The drug should be kept out of the reach of children
presentation 7 capsules packed in a blister, for example 1 blister packed in a cardboard box with instructions
PRODUCED BY: Applied Communication & Controls 122, Selakui Industrial Area Dehradun, (UK)
IMPLEMENTED: HARASHA PHARMA PVT. LTD. DG-II / 159 A, Vikaspuri, Block-D, New Delhi, India.
