DRUGS & SUPPLEMENTS
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Ofacin-M is an anti protozoal agent. It is believed that the mechanism of action is associated with DNA damage-sensitive microorganisms. Active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, and obligate anaerobic bacteria (including Bacteroides spp., Fusobacterium spp.).
Aerobic bacteria are resistant to Ofacin-M (Metronidazole Benzoate).
In combination with amoxicillin Ofacin-M (Metronidazole Benzoate) is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to Ofacin-M (Metronidazole Benzoate).
Ofacin-M (Metronidazole Benzoate) well absorbed after oral administration. The bioavailability is 80%. Ofacin-M (Metronidazole Benzoate) is distributed in tissues and body fluids. This medication crosses the placental barrier and the BBB. Binding to plasma proteins is 20%. Ofacin-M (Metronidazole Benzoate) is metabolized in the liver by oxidation and binding to glucuronic acid. T1/2 is 8 hours. This drug is excreted in the urine (60-80%) and feces (6-15%).
Trichomonazice vaginitis and urethritis in women, trichomonazice urethritis in men, giardiasis, amoebic dysentery, anaerobic infections caused by metronidazole-sensitive organisms, combination therapy of severe mixed aerobic-anaerobic infections. Preventing anaerobic infection in surgery (particularly abdominal, urinary tract). Chronic alcoholism.
Ofacin-M (Metronidazole Benzoate) in combination with amoxicillin: chronic gastritis in acute phase, gastric ulcer and duodenal ulcer in acute phase, associated with Helicobacter pylori.
For external and topical use: treatment of acne vulgaris and pink, bacterial vaginosis, treatment of long-term healing of wounds and trophic ulcers.
Ofacin-M is administered for oral use for adults and children over 12 years in 7.5 mg / kg every 6 h or 250-750 mg 3-4 times / day. For children up to 12 years the dose is 5-16.7 mg / kg 3 times / day. For IV injections for adults and children over 12 years starting dose is 15 mg / kg, followed by 7.5 mg / kg every 6 hours or depending on the etiology of the disease - by 500-750 mg every 8 hours. The duration of treatment and frequency of tests is determined individually.
Intravaginally - 500 mg 1 time a night.
In combination with amoxicillin (2.25 g / day) daily dose of Ofacin-M (Metronidazole Benzoate) is 1.5 g; multiplicity of admission - 3 times / day. For patients with severe renal impairment (creatinine clearance less than 30 ml / min) and / or liver daily dose of Ofacin-M (Metronidazole Benzoate) is 1 g (amoxicillin - 1.5 g / day), the multiplicity of the reception is 2 times / day. This medication takes for external and local use 2 times / day, doses are determined individually.
The maximum daily dose for adults when taken orally and IV is 4 g.
Digestive system: nausea, vomiting, anorexia, metallic taste in the mouth.
CNS and peripheral nervous system: headache, nervousness, irritability, insomnia, dizziness, ataxia, weakness, confusion, depression, peripheral neuropathy, seizures, hallucinations.
Allergic reactions: skin rash, itching, hives.
Hemopoietic system: leucopenia.
Local reactions: irritation.
Other: arthralgia, burning sensation in the urethra.
Organic CNS lesions, blood diseases, liver problems, I trimester of pregnancy, hypersensitivity to Ofacin-M (Metronidazole Benzoate).
Ofacin-M is rapidly crosses the placental barrier. In II and III trimester of pregnancy Ofacin-M (Metronidazole Benzoate) is used only for health reasons.
Ofacin-M (Metronidazole Benzoate) is excreted in breast milk. If necessary, use during lactation should solve the issue of termination of breastfeeding.
Patients should with careful use of Ofacin-M (Metronidazole Benzoate) in liver diseases.
In combination with amoxicillin this medication is not recommended for patients younger than 18 years. During the treatment period it is necessary the regular control of pattern of peripheral blood.
During the treatment of Trichomonas vaginitis in women and Trichomonas urethritis in men patients should refrain from sexual activity, simultaneous treatment of both partners is mandatory.
During the taking of Ofacin-M (Metronidazole Benzoate) there is a more dark staining of urine.
During treatment with Ofacin-M (Metronidazole Benzoate) should avoid alcohol because to violations of the oxidation of alcohol can accumulate acetaldehyde. As a result may develop reactions similar to those characteristic of disulfiram (abdominal cramps, nausea, vomiting, headache, a sudden rush of blood to the face).
Simultaneous administration of Ofacin-M (Metronidazole Benzoate) with:
Symptoms: nausea, vomiting, ataxia, in severe cases - peripheral neuropathy and seizures.
Treatment: symptomatic, there is no specific antidote.
Ofacin-M is an antimicrobial agents of broad-spectrum action type from fluoroquinolone group. Bactericidal action of Ofacin-M (Ofloxacin) is due to blockage of the enzyme DNA gyrase in bacterial cells. This medication is highly active against most of gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., and Chlamydia spp.
Ofacin-M (Ofloxacin) is active against some gram-positive bacteria (including Staphylococcus spp., Streptococcus spp., especially beta-hemolytic streptococci).
Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp. are moderately susceptible to Ofacin-M (Ofloxacin).
Anaerobic bacteria (except Bacteroides ureolyticus) are insensitive to Ofacin-M (Ofloxacin).
This drug is resistant to beta-lactamases.
After oral administration Ofacin-M (Ofloxacin) is rapidly and completely absorbed from the gastrointestinal tract. Ingestion has a little effect on the extent of absorption but may slow its speed. Cmax plasma levels reached in 2 hours.
The protein binding is 25%. Ofacin-M (Ofloxacin) is widely distributed in tissues and body fluids (organs of urinary system, reproductive organs, prostate, lung, ENT organs, gall bladder, bone, skin).This medicine is excreted in the urine in unchanged form (about 80% in 24 h). A small portion of the active substance (4%) is excreted in the feces. T1/2 is 6 h.
Infectious-inflammatory diseases caused by microorganisms sensitive to Ofacin-M (Ofloxacin), including: diseases of the lower respiratory tract, ear, nose, throat, skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal organs (except bacterial enteritis) and pelvic infection, kidney and urinary tract, prostatitis, gonorrhea.
Dosing regimen of Ofacin-M is individual. Daily dose of 200-800 mg, the multiplicity of application 2 times / day. For patients with impaired renal function (creatinine clearance 20-50 ml / min), the first dose is 200 mg, then 100 mg every 24 hours. When CC is less than 20 ml / min, the first dose is 200 mg, then 100 mg every 48 hours.
Digestive system: nausea, vomiting, diarrhea, abdominal pain and cramps, appetite loss, dry mouth, flatulence, gastrointestinal dysfunction, constipation; rarely - liver damage, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, bleeding from the gastrointestinal tract, disorders of the oral mucosa, heartburn, elevated liver enzymes, including GGT and LDH, increased serum bilirubin.
CNS and peripheral nervous system: insomnia, dizziness, fatigue, drowsiness, nervousness; rarely - convulsions, anxiety, cognitive changes, depression, abnormal dreams, euphoria, hallucinations, paresthesia, syncope, tremor, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggressiveness, emotional instability, peripheral neuropathy, ataxia, incoordination, exacerbation of extrapyramidal disorders, speech disorder.
Allergic reactions: skin rash, itching, rarely - angioedema, urticaria, vasculitis, allergic pneumonitis, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, conjunctivitis.
Sexual system: an itch on the external genitalia in women, vaginitis, vaginal discharge; rare - burning, irritation, pain and rash in the genital area of women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis.
Cardiovascular system: rarely - heart failure, edema, hypertension, hypotension, palpitation, vasodilatation, cerebral thrombosis, pulmonary edema, and tachycardia.
Urinary system: rarely - dysuria, urinary frequency, urinary retention, anuria, polyuria formation of kidney stones, kidney failure, nephritis, hematuria, albuminuria, candiduria.
Musculoskeletal system: rarely - arthralgia, myalgia, tendonitis, muscle weakness, exacerbation of myasthenia gravis.
Metabolism: rarely - thirst, weight loss, hyper- or hypoglycemia (especially in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents), acidosis, increase in serum triglycerides, cholesterol, potassium.
Respiratory system: rarely - cough, runny nose, respiratory failure, dyspnea, bronchospasm, stridor.
Sensory organs: rarely - hearing loss, tinnit, diplopia, nystagmus, impaired clarity of vision, disturbances of taste, smell, photophobia.
Dermatological reactions: rarely - photosensitivity, hyperpigmentation, vesicle-bullous eruption.
Hematopoietic system: rarely - anemia, hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible suppression of bone marrow hematopoiesis, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymosis, increased prothrombin time.
Other: chest pain, sore throat, fever, body aches, rarely - fatigue, chills, malaise, epistaxis, increased sweating.
Pregnancy, lactation, childhood and adolescence to 18 years, increased sensitivity to Ofacin-M (Ofloxacin) or other quinolone derivatives.
Ofacin-M is contraindicated during pregnancy and lactation.
Category effects on the fetus by FDA - C.
Use with caution in patients with impaired renal function and liver.
During the period of treatment required to conduct monitoring of blood glucose. Long-term therapy is necessary to periodically monitor the kidney function, liver and peripheral blood picture.
When using Ofacin-M (Ofloxacin) it should be ensure adequate hydration of the body, the patient should be subjected to ultraviolet irradiation.
In experimental studies the mutagenic potential was not been identified. Long-term studies to determine the carcinogenicity of Ofacin-M (Ofloxacin) were not conducted.
Safety and efficacy in children and adolescents under the age of 18 is not defined.
Use with caution in patients whose activities are connected with the necessity of high concentration of attention and quickness of psychomotor reactions.
Simultaneous administration of Ofacin-M (Ofloxacin) with:
Symptoms: drowsiness, nausea, vomiting, dizziness, disorientation, lethargy, confusion.
Treatment: gastric lavage, maintenance of vital functions.
Depending on the reaction of the Ofacin-M after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ofacin-M not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Ofacin-M addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology