ELYZOL DENTAL 25% Gel / Dental
A/S DUMEX (DUMEX LTD.)
|1g Cartridge + Applicator x 2
|GULF DRUG EST.
ELYZOL DENTAL 25% Overview
ELYZOL DENTAL 25% generic name is Metronidazole. Metronidazole is an antibiotic that is used to treat a variety of bacterial and parasitic infections, including certain types of vaginal infections, respiratory tract infections, and skin infections. It works by stopping the growth of the microorganisms that are causing the infection. It is available in both oral and topical forms, and common side effects can include nausea, stomach upset, and a metallic taste in the mouth. It's important to take metronidazole exactly as prescribed by your doctor and to complete the full course of treatment, even if you feel better before the medication is finished.
ELYZOL DENTAL 25% Gel / Dental is used for: Pneumonia, Giardiasis, Peptic ulcer disease, H. pylori infection, Peritonitis, Rosacea, Septicemia, Endometritis, Aspiration pneumonia, Lung abscess, Empyema, Bone and Joint Infections, Surgical Prophylaxis, Amoebiasis, Bacterial vaginosis, Balantidiasis, Blastocystis hominis infection, Trichomoniasis, Acute dental infections, Acute necrotising ulcerative gingivitis, Anaerobic bacterial infections, Antibiotic-associated colitis, Fungating tumours, Leg ulcers and pressure sores, Diverticulitis, Diabetic foot ulcer, Meningitis and brain abscesses, endocarditis
The drug is indicated for:-Amoebiasis: 800mg three times a day for 5 days (intestinal infection); 5-10 days (extra-intestinal infection). Maximum: 2.4g/day. -Trichomoniasis: 2g as a single dose, 200mg three times a day for 7 days or 400mg twice a day for 5-7 days. Sexual partners should also be treated. Repeat treatment 4-6 weeks between courses as necessary. -Giardiasis: 2g once daily for 3 days, 400mg three times a day for 5 days or 500mg twice a day for 7-10 days. -Bacterial vaginosis: 2g as a single dose or 400mg twice a day for 5-7 days. -Acute necrotising ulcerative gingivitis: 200mg three times a day for 3 days. -Anaerobic bacterial infections: Initially, 800mg followed by 400mg 8 hours later. Alternatively, 7.5mg/kg 6-8 hours later. Maximum: 4g/day. Duration of treatment is usually for 7 days depending on the severity of infection. -Prophylaxis of postoperative anaerobic bacterial infections: 400mg 8 hours later 24 hours prior to surgery followed by post-op IV or rectal administration until oral therapy is possible. The eradication of H. pylori associated with peptic ulcer disease is typically done with a combination of antibiotics and proton pump inhibitors (PPIs). The standard regimen is a 400 mg dose of clarithromycin twice daily, in combination with another antibacterial agent and a PPI. If given with omeprazole and amoxicillin, the clarithromycin dose can be increased to 400 mg three times daily. Treatment is usually given for one week. For leg ulcers and pressure sores, the recommended dose of clarithromycin is 400 mg three times daily for seven days. Acute dental infections are usually treated with a 200 mg dose of clarithromycin three times daily for three to seven days. For anaerobic bacterial infections, the recommended dose of clarithromycin is 500 mg infused as 100 mL of a 5 mg/mL solution at 5 mL/min 8 hours apart. Alternatively, a 15 mg/kg dose can be infused over 1 hour, followed by a 7.5 mg/kg dose infused over 1 hour 6 hours apart. The maximum daily dose is 4 g. Substitute oral therapy as soon as possible. Prophylaxis of postoperative anaerobic bacterial infections is typically done with a 500 mg dose of clarithromycin shortly before surgery, followed by another dose 8 hours after the initial dose. Alternatively, a 15 mg/kg dose can be infused over 30-60 minutes and completed approximately one hour before surgery, followed by a 7.5 mg/kg dose infused over 30-60 minutes at 6 and 12 hours after the initial dose. For patients with hepatic impairment, the recommended dose of clarithromycin is one-third of the usual dose once daily.
Oral amoebiasis, the recommended dosage for children 1-3 years old is 100-200 mg three times daily. For children >3-7 years old, the recommended dosage is 100-200 mg four times daily. For children >7-10 years old, the recommended dosage is 200-400 mg three times daily. Doses are given for 5-10 days. For trichomoniasis, the recommended dosage for children 1-10 years old is 40 mg/kg as a single dose or 15-30 mg/kg daily in 2-3 divided doses for 7 days. The maximum dose is 2 g/dose. For giardiasis, the recommended dosage for children 1-3 years old is 500 mg once daily. For children >3-7 years old, the recommended dosage is 600-800 mg once daily. For children >7-10 years old, the recommended dosage is 1 g once daily. Doses are given for 3 days. For acute necrotising ulcerative gingivitis, the recommended dosage for children 1-3 years old is 50 mg tid. For children >3-7 years old, the recommended dosage is 100 mg bid. For children >7-10 years old, the recommended dosage is 100 mg tid. Doses are given for 3 days. For the treatment of anaerobic bacterial infections in children, the recommended dosage is 7.5 mg/kg 12 hours apart, or 15 mg/kg once daily. For children aged 8 weeks to 12 years, the recommended dosage is 7.5 mg/kg 8 hours apart, or 20-30 mg/kg once daily. The duration of treatment is typically 7 days, depending on the severity of the infection. For the prophylaxis of postoperative anaerobic bacterial infections in children, the recommended dosage is 10 mg/kg as a single dose before surgery for children under 40 weeks, or 20-30 mg/kg as a single dose 1-2 hours before surgery for children under 12 years. The recommended intravenous dosage for anaerobic bacterial infections is 22.5-40 mg/kg per day given every 8 hours.
When administering via Oral, Intravenous or Rectal route. Administer after food taken, to minimise GI distress and it's metallic taste Suspension: Metronidazole suspension should be taken one hour before a meal. Tablets: Metronidazole tablets should be swallowed whole with water, during or after a meal. Reconstitution: Add 4.4 mL of sterile or bacteriostatic water for injection, NaCl 0.9% injection, or bacteriostatic NaCl injection to a vial labeled as containing metronidazole 500 mg. The resultant solution contains approximately 100 mg/mL and must be further diluted with NaCl 0.9% injection, dextrose 5% injection, or lactated Ringer's injection to a concentration of 8 mg/mL or less. The reconstituted and diluted solution must then be neutralized by adding approximately 5 mEq of Na bicarbonate injection for each 500 mg.
Pregnancy (First trimester) , Lactation, Hypersensitivity to metronidazole or other nitroimidazole derivatives.
Discontinue IV therapy if abnormal neurologic symptoms occur in patients with CNS diseases.A history of seizure disorders or evidence of blood dyscrasias should be monitored before and after treatment. Severe hepatic impairment may require monitoring of plasma levels. Prolonged use may result in fungal or bacterial superinfection. This product should not be used in patients with a predisposition to oedema because it contains sodium. Excretion into human milk has been reported; therefore, this product is not recommended for use in nursing mothers.
Pregnancy There are no adequate and well-controlled studies of in pregnant women; there are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used metronidazole during pregnancy; many studies included first trimester exposures; one study showed increased risk of cleft lip, with or without cleft palate, in infants exposed to metronidazole in utero; however, these findings were not confirmed Metronidazole crosses placental barrier and its effects on human fetal organogenesis are not known; reproduction studies have been performed in rats, rabbits and mice at doses similar to maximum recommended daily dose based on body surface area comparisons; there was no evidence of harm to fetus due to metronidazole; healthcare provider should carefully consider potential risks and benefits for each specific patient before prescribing therapy Lactation Metronidazole is present in human milk at concentrations similar to maternal serum levels, and infant serum levels can be close to or comparable to infant therapeutic levels Because of potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account importance of drug to mother; alternatively, a nursing mother may choose to pump and discard human milk for duration of metronidazole therapy, and for 24 hours after therapy ends and feed her infant stored human milk or formula
Metronidazole may increase the risk of psychotic reactions when used with disulfiram. Concurrent use of metronidazole and oral anticoagulants may potentiate the effects of the latter. Metronidazole may also increase the risk of lithium toxicity. The renal clearance may be reduced, resulting in increased toxicity of 5-fluorouracil. Metronidazole may also increase serum levels of ciclosporin. Busulfan toxicity may be increased when metronidazole is used concurrently with busulfan, due to increased plasma levels of the latter. Metronidazole may enhance the metabolism of phenobarbital and phenytoin, resulting in decreased serum concentrations of these drugs.
Side effects of Metronidazole : GI disturbances e.g. nausea, unpleasant metallic taste, vomiting, diarrhoea or constipation. Glossitis, furred tongue, and stomatitis due to overgrowth of Candida. Rarely, antibiotic-associated colitis. Weakness, dizziness, headache, ataxia, insomnia, drowsiness, changes in mood or mental state. Numbness or tingling in the extremities, epileptiform seizures (high doses or prolonged treatment). Transient leucopenia and thrombocytopenia. Hypersensitivity reactions. Urethral discomfort and darkening of urine. Raised liver enzyme values, cholestatic hepatitis, jaundice. Thrombophlebitis (IV). Potentially Fatal: Anaphylaxis.
Mechanism of Action
Metronidazole is converted to reduction products that interact w/ DNA to cause destruction of helical DNA structure and strand which leads to a protein synthesis inhibition and cell death in susceptible organisms. It is active against most anaerobic protozoa, some gm+ve, gm-ve and facultative anaerobes.
ELYZOL DENTAL 25% 250mg/g Gel / Dental manufactured by A/S DUMEX (DUMEX LTD.). Its generic name is Metronidazole. ELYZOL DENTAL 25% is availble in United Arab Emirates. Farmaco UAE drug index information on ELYZOL DENTAL 25% Gel / Dental is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
Some other brands of Metronidazole :
Suprazole Paediatric 125mg/5ml _ 125mg/5ml
Kuwait Saudi Pharmaceutical Industries Co. (KSPICO)
Riazole 125mg/5ml 125mg/5ml
Riyadh Pharma (Medical and Cosmetic Products Company Ltd.)
Julphar (Gulf Pharmaceutical Industries)
Tablets / Film-coated
Stragyl 250 mg
Tablets / Film-coated
Stragyl 500 mg