DRUGS & SUPPLEMENTS

Oftec-M

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Oftec-M uses

Oftec-M consists of Metronidazole, Ofloxacin.

Metronidazole:


Pharmacological action

Oftec-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 Oftec-M (Metronidazole).

In combination with amoxicillin Oftec-M (Metronidazole) is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to Oftec-M (Metronidazole).

Pharmacokinetics

Oftec-M (Metronidazole) well absorbed after oral administration. The bioavailability is 80%. Oftec-M (Metronidazole) is distributed in tissues and body fluids. This medication crosses the placental barrier and the BBB. Binding to plasma proteins is 20%. Oftec-M (Metronidazole) 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%).

Why is Oftec-M prescribed?

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.

Oftec-M (Metronidazole) 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.

Dosage and administration

Oftec-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 Oftec-M (Metronidazole) 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 Oftec-M (Metronidazole) 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.

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Oftec-M (Metronidazole) side effects, adverse reactions

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.

Oftec-M contraindications

Organic CNS lesions, blood diseases, liver problems, I trimester of pregnancy, hypersensitivity to Oftec-M (Metronidazole).

Using during pregnancy and breastfeeding

Oftec-M is rapidly crosses the placental barrier. In II and III trimester of pregnancy Oftec-M (Metronidazole) is used only for health reasons.

Oftec-M (Metronidazole) is excreted in breast milk. If necessary, use during lactation should solve the issue of termination of breastfeeding.

Special instructions

Patients should with careful use of Oftec-M (Metronidazole) 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 Oftec-M (Metronidazole) there is a more dark staining of urine.

During treatment with Oftec-M (Metronidazole) 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).

Oftec-M drug interactions

Simultaneous administration of Oftec-M (Metronidazole) with:

  • antacids that contain aluminum hydroxide, with kolestiraminom slightly decreases absorption of Oftec-M (Metronidazole) from the gastrointestinal tract;
  • Oftec-M (Metronidazole) potentiates the effect of indirect anticoagulants;
  • disulfiram may develop acute psychosis and impaired consciousness;
  • lansoprazole possible glossitis, stomatitis and / or the appearance of dark color language; with lithium carbonate - may increase the concentration of lithium in blood plasma and the development of symptoms of intoxication with prednisone - increased excretion of Oftec-M (Metronidazole) from the body by accelerating its metabolism in the liver under the influence of prednisone. It is possible a decrease the effectiveness of Oftec-M (Metronidazole) AA Pharma.
  • rifampicin increased the clearance of Oftec-M (Metronidazole) from the body, with phenytoin - it is perhaps a slight increase in the concentration of phenytoin in blood plasma, described the case of toxic action;
  • phenobarbital significantly increased excretion of Oftec-M (Metronidazole) from the body, apparently due to acceleration of its metabolism in the liver under the influence of phenobarbital. It is possible a decrease the effectiveness of Oftec-M (Metronidazole) AA Pharma;
  • fluorouracil enhanced the toxic effect but not the effectiveness of fluorouracil;
  • cimetidine may inhibit the metabolism of Oftec-M (Metronidazole) in the liver that can lead to slow its elimination and increase the concentration in blood plasma. It can not be excluded the increase in the concentration of carbamazepine in plasma and increased risk of toxicity with concomitant use of Oftec-M (Metronidazole) AA Pharma. There was described a case of acute dystonia after a single dose of chloroquine in patients treated with Oftec-M (Metronidazole).

    Oftec-M in case of emergency / overdose

    Symptoms: nausea, vomiting, ataxia, in severe cases - peripheral neuropathy and seizures.

    Treatment: symptomatic, there is no specific antidote.

  • Ofloxacin:


    Pharmacological action

    Oftec-M is an antimicrobial agents of broad-spectrum action type from fluoroquinolone group. Bactericidal action of Oftec-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.

    Oftec-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 Oftec-M (Ofloxacin).

    Anaerobic bacteria (except Bacteroides ureolyticus) are insensitive to Oftec-M (Ofloxacin).

    This drug is resistant to beta-lactamases.

    Pharmacokinetics

    After oral administration Oftec-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%. Oftec-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.

    Why is Oftec-M prescribed?

    Infectious-inflammatory diseases caused by microorganisms sensitive to Oftec-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.

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    Dosage and administration

    Dosing regimen of Oftec-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.

    Oftec-M (Ofloxacin) side effects, adverse reactions

    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.

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    Oftec-M contraindications

    Pregnancy, lactation, childhood and adolescence to 18 years, increased sensitivity to Oftec-M (Ofloxacin) or other quinolone derivatives.

    Using during pregnancy and breastfeeding

    Oftec-M is contraindicated during pregnancy and lactation.

    Category effects on the fetus by FDA - C.

    Special instructions

    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 Oftec-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 Oftec-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.

    Oftec-M drug interactions

    Simultaneous administration of Oftec-M (Ofloxacin) with:

  • antacids containing calcium, magnesium or aluminum, with sucralfate, with preparations containing two-and trivalent cations, such as iron, or multivitamins containing zinc it may be in breach absorption of quinolones, resulting in a decrease in their concentration in the body. These medications should not be used for 2 hours before or within 2 hours after taking Oftec-M (Ofloxacin).
  • NSAIDs increases the risk of stimulating effect on the central nervous system and seizures.
  • theophylline may increase its concentration in blood plasma (including the equilibrium state), increasing half-life. This increases the risk of adverse reactions associated with the action of theophylline.
  • beta-lactam antibiotics, aminoglycosides and metronidazole there were observed additive interaction.

    Oftec-M in case of emergency / overdose

    Symptoms: drowsiness, nausea, vomiting, dizziness, disorientation, lethargy, confusion.

    Treatment: gastric lavage, maintenance of vital functions.

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    Oftec-M pharmaceutical active ingredients containing related brand and generic drugs:

    infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


    Oftec-M available forms, composition, doses:

    infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
    Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
    Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


    Oftec-M destination | category:

    infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
    Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


    Oftec-M Anatomical Therapeutic Chemical codes:

    infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


    Oftec-M pharmaceutical companies:

    infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
    Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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    References

    1. Dailymed."OFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. Dailymed."METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    3. Dailymed."BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming Oftec-M?

    Depending on the reaction of the Oftec-M after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Oftec-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 Oftec-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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    Review

    sDrugs.com conducted a study on Oftec-M, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Oftec-M consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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    The information was verified by Dr. Arunabha Ray, MD Pharmacology

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