500 mg + 100 mg + 150 Million Spores
For the use of a Registered Medical Practitioner or a Hospital or a Institution only.
Off-white coloured elongated uncoated tablets, having one end flat and depressed and the other end circular.
Each uncoated tablet contains :
Metronidazole USP 500 mg
Clotrimazole USP 100 mg
Lactic Acid Bacillus 150 million spores
(Earlier known as Lactobacillus Sporogenes)
(Lactose Monohydrate USP-NF, Microcrystalline Cellulose USP–NF, Dibasic Calcium Phosphate USP, Corn Starch USP–NF, Hypromellose 15 CPS USP, Colloidal Silicon Dioxide USP-NF, Gelatin USP-NF, Methylparaben USP–NF, Propylparaben USP–NF, Talc USP, Croscarmellose Sodium USP-NF, Sodium Starch Glycolate USP-NF, Kyron 314)
CLOGINAL is a combination of antifungal, antibacterial & anti-infective drugs locally acting on urethra and vagina.
Clotrimazole : is a broad spectrum imidazole antifungal with antimicrobial activity. It acts effectively against yeasts (Candida albicans and other candida species) and other fungi (Trichophyton, Epidermophyton, Microsporum), gram (+) bacteria and protozoa (Trichomonas vaginalis, Gardrenella vaginalis, Staphylococcus aureus, Streptococcus pyogenes, Hemophilus vaginalis). The mechanism of action of clotrimazole is to destroy fungal membrane by inhibiting 14α-demethylase and then inhibit the biosynthesis of ergosterol in fungi, a main component in the fungal membrane.
Metronidazole : is an 5-nitroimidazole derivative acting as an antiprotozoal and antibacterial agent such as anaerobic bacteria both gram (-) and gram (+), Trichomonas vaginalis, Gardrenella vaginalis. It is also active against several protozoa including Balantidium coli, Blastocystis hominis, Entamoeba histolytica, Giardia intestinalis (Giardia lamblia), and Trichomonas vaginalis. Most obligate anaerobic bacteria, including Bacteroides and Clostridium spp., are sensitive in vitro to metronidazole. It is bactericidal. It also has activity against the facultative anaerobes Gardnerella vaginalis and Helicobacter pylori and against some spirochaetes. The mode of action of metronidazole is not entirely clear, but is thought to involve reduction by bacterial ‘nitroreductases’ to an unstable intermediate which interacts with DNA, effectively preventing further replication.
Lactic acid bacillus : is a gram-positive, spore-forming, lactic-acid producing bacillus. The mechanism of the action of lactic acid bacillus is presumed to be results of improving gastrointestinal ecology by replenishing the quantity of desirable obligate microorganisms and antagonizing pathogenic microbes. This produces shift in the environment in the support of complex gastrointestinal flora. They are also capable of protecting from pathogenic invasion into intestinal tract and help to restore the normal balance of the intestinal flora after antimicrobial drugs treatment.
In clinical reality, vaginitis is often due to a combination of pathogens such as Trichomonas, Candida albicans, gram (-) and gram (+) bacteria that makes the treatment complicated. Therefore, it is required to have drugs of combination that have good treatment against Trichomonas, fungi and bacteria at the same time. CLOGINAL can meet this requirement.
CLOGINAL is active against sensitive aerobic bacteria both gram (+) and gram (-), sensitive anaerobic bacteria both gram (+) and gram (-), fungi, and protozoa. Therefore, it is indicated for the treatment of vaginitis due to one or a combination of the above pathogens such as Bacterial vaginitis due to banal pyogenic germs, vaginitis due to Trichomonas and Gardnerella vaginalis, Fungal (Monilial) vaginitis due to Candida albicans, vaginitis with desquamative leucorrhoea, mixed vaginitis due to Trichomonas and Yeast or a combination of the pathogens.
By vaginal route. NOT FOR ORAL USE. ONLY FOR ADULTS.
Special directions for using applicator :
1. Prior to application, cut out one tablet from the aluminium foil.
2. Moisten the tablet by immersing them in water for 2 to 3 seconds before insertion. insertion.
3. Pull out plunger A until it stops. Place one vaginal tablet into the applicator B.
4 .Insert applicator containing the tablet carefully as deep as possible into the vagina (this is done best by lying on the back).
5. Push plunger A until it stops, thereby depositing the tablet into the vagina. Withdraw the applicator.
6. After use, remove plunger A completely by pulling it out of the applicator B.
Thereafter wash both A & B in warm (not boiling) soapy water and dry completely. The applicator is ready for next use. Insert the tablet deeply in the vagina, 1 tablet daily. The recommended treatment duration is 8 days. Patients should take the medicine before going to bed. Your partner should also be treated. Symptomatic relief may occur in a few days but continue full course of treatment as advised by the physician.
Contraindicated in the patients with hypersensitivity (allergy) to any component in the composition of the product. Take the medicine with disulfiram only if indicated by the physician. Please consult your physician in case of any doubt.
If irritation, sensitisation, pull brained or moving unregulation is found discontinue the treatment and consult your physician. Use of alcohol containing drinks should be reduced during the treatment with this drug (risk to reactions of red face, getting hot in the face, vomit and increase in heart rhythm). The patients should be instructed not to engage in vaginal intercourse during the treatment with this product. The treatment should not be carried out during menstruation but should be completed before this begins.
The drug is not indicated during pregnancy in the first trimester and lactation. If you are found to be pregnant in the first three months during the treatment of this medicine, please inform your physician for suitable treatment. However, pregnant women in the second and third trimester, lactating women can take this medicine if prescribed by doctor.
ABILITY TO DRIVE AND OPERATE MACHINE :
Patient should be cautious because CLOGINAL may cause dizziness.
If irritation or sensitivity develops treatment should be discontinued and appropriate therapy instituted. In case of renal dysfunction or a history of serious nervous disease, please inform your physician. In case of history of leucocyte related haematological dysfunction, please consult your physician. Intractable candidiasis may be a symptom of unrecognized diabetes mellitus. Perform urine and blood glucose studies on patients who do not respond to treatment. A persistently resistant infection may actually be due to reinfection, evaluate a source of reinfection.
Laboratory test :
If there is lack of response, repeat microbiological studies to confirm diagnosis and rule out other pathogens before reinstituting antimycotic therapy.
INTERACTIONS WITH OTHER MEDICINES :
Metronidazole increases effects of some drugs as warfarin, phenytoin and lithium, ciclosporin, and fluorouracil, therefore, do not take those drugs together with CLOGINAL. Acute psychoses or confusion have been associated with the use of metronidazole and disulfiram together. When given with alcohol, metronidazole may provoke a disulfiram-like reaction in some patients. The medicine deactivates contraceptive method of spermicide. In order to avoid interactions, especially disulfiram, please inform your physician about all medicines you are taking. Plasma concentrations of metronidazole are decreased by phenobarbital, with a consequent reduction in the effectiveness of metronidazole. Cimetidine has increased plasma concentrations of metronidazole and might increase the risk of neurological side-effects.
SIDE EFFECTS :
Gastro intestinal dysfunction, vomit, nausea, diarrhoea, belly cramp, dizziness, headache, urticaria, pruritus, glossitis hot face, recoverable pancreatitis, confusion, convulsive seizures, vertigo, irritability, depression, weakness, incordination. Peripheral neuropathy, usually presenting as numbness or tingling in the extremities, and epileptiform seizures have been associated with high doses of metronidazole or prolonged treatment. A brown colouring of the urine frequently occurs.
Local side effects :
symptoms in the form of local prickling or irritation during the first day of treatment have been reported in rare instances. Inform the physician for any adverse effect.
OVERDOSAGE AND TREATMENT OF OVERDOSAGE :
High dose and/or long term therapy can cause decrease in leucocyte numbers.
If a large amount of this medicine is taken by oral route, it is advised to use stomach washing method if necessary. It is also advised to treat overdosage if metronidazole taken by oral route exceeds over 12 g. There is no anti-dote and hence symptomatic treatments are applied. Overdosage symptoms are vomit, nausea, diarrhoea, stomachache, pruritus, convulsive seizures, decrease of leucocyte numbers, metallic taste, incordination, brown colouring of the urine.
Store below 30°C (86°F), protected from moisture. Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may break down the medicine. Do not refrigerate.
SHELF LIFE :
36 months from date of manufacture.
1 Strip of 6 tablets, with an applicator per box.
Disclaimer : For the use of a Registered Medical Practitioner or a Hospital or a Institution only. Also it is not intended to be used by healthcare professionals or patients for the purpose of prescribing or administering these products. Questions regarding the complete and current content of product labeling / specification / presentation should be directed to SGPharma.