Orion Pharma Ltd.

Terbiderm 250 mgTerbinafine tablet: This tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).Terbinafine granules: This is indicated in Tinea Capitis.Terbinafine cream: Fungal ... Read moreTerbinafine tablet: This tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).Terbinafine granules: This is indicated in Tinea Capitis.Terbinafine cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbicular (also known as Malassezia furfur).Terbinafine 1% Spray: This spray is indicated in the treatment of tinea infections of the skin. This spray is also indicated in the treatment of pityriasis (tinea) versicolor due to Malassezia furfur.Theropeutic ClassDrugs for subcutaneous and mycoses, Topical Antifungal preparationsPharmacologyTerbinafine is an allylamine with a range of antifungal activity. It is fungicidal against dermatophytes, moulds and certain dimorphic fungi. Terbinafine is either fungicidal or fungistatic against yeasts, depending on the species. Terbinafine interferes with fungal ergosterol biosynthesis by inhibiting squalene epoxidase in the fungal cell membrane at an early stage. This leads to a deficiency in ergosterol and to intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine is highly effective in fungal infections of the skin, hair and nails caused by Trichophyton spp., Microsporum spp. and Epidermophyton floccosum. It is also effective against yeast infections of the skin, principally those caused by the genus candida. Topical terbinafine appears to be effective in pityriasis versicolor due to Pityrosporum arbiculare.Dosage & Administration of Terbiderm 250 mgTopical application: Terbinafine cream to affected areas once or twice daily for 1-2 weeks may be adequate for fungal infections of the skin but certain infections may require oral Terbinafine tablet therapy.Usual duration of treatment of Terbinafine cream: In Tinea corporis and Tinea cruris: 1-2 weeks. In Tinea pedis: 2-4 weeks (One week of treatment will normally suffice if the cream is applied twice daily.). In Cutaneous candidiasis: 1-2 weeks In Pityriasis (tinea) versicolor: 2 weeks. To prevent relapses in fungal infection, treatment should be continued for a adequate length of time. To apply Terbinafine cream clean and dry the affected areas thoroughly and apply the cream once or twice a day to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections the application may be covered with a gauze strip, especially at night. Oral administration: Terbinafine tablet is essential for hair or nail infections: The usual oral dose: Terbinafine 250 mg daily for 2 to 12 weeks depending upon the infection. Finger nail onychomycosis: Terbinafine 250 mg once daily for 6 weeks. Toe nail onychomycosis: Terbinafine 250 mg once daily for 12 weeks. Dosage of Terbiderm 250 mgTerbinafine tablet: For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks. For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for the outgrowth of healthy nail. Terbinafine granules: Body Weight: 35 kg: 250 mg/day up to 6 weeks Terbinafine cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. The likely durations of treatment are as follows: Tinea corporis, cruris: 1 to 2 weeks Tinea pedis: 1 week Cutaneous candidiasis: 2 weeks Pityriasis versicolor: 2 weeks Relief of the clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly. Tinea pedis: once a day,1 week Tinea corporis/cruris: once a day,1 week Pityriasis versicolor: twice a day, 1 week Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after two weeks the diagnosis should be verified.Interaction of Terbiderm 250 mgIn vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.ContraindicationsTerbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.Side Effects of Terbiderm 250 mgThe adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation. Adverse events, based on worldwide experience with terbinafine use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.Pregnancy & LactationTerbinafine tablet: There are no adequate and well controlled?studies in pregnant women. Because animal reproduction studies are not always predictive of?human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy.?After oral administration, terbinafine is present in breast milk of nursing mothers. Treatment with?terbinafine in not recommended in nursing mothers. Terbinafine cream: Foetal toxicity and?fertility studies in animals suggest no adverse effects. There is no clinical experience with?terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential?risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore?mothers should not receive terbinafine treatment whilst breast-feeding.Precautions & WarningsWarnings- Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued. Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided. Precautions: Terbinafine are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) teste are advised for all patients before taking terbinafine tablets.Overdose Effects of Terbiderm 250 mgClinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 gm (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.Storage ConditionsStore in a cool and dry place, below 30?C, protect from light.Use In Special PopulationsUse in Children: Terbinafine cream appears to be an effective and well-tolerated treatmenr of tinea corposis and tinea cruris in children.Use in Elderly: Terbinafine appears to be safe in the elderly. The dose should be reduced by half if significant hepatic or renal impairment is present.Drug ClassesOther Antifungal preparations, Topical Antifungal preparationsMode Of ActionTerbinafine, an Allylamine antifungal, inhibits biosynthesis of Ergosterol (an essential component of fungai cell membrane) via inhibition of Squalene Epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Tricophyton Mentagrophyte, Trichophyton Rubrum.PregnancyTerbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers. Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.Pediatric UsesPediatric use: The safety and efficacy of terbinafine have not been established in pediatric patients.Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Torped 500 mg/10 mlTorped 500 mg/10 ml is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis ... Read moreTorped 500 mg/10 ml is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections Bone and Joint Infections such as osteomyelitis, septic arthritis Obstetric and gynaecological infections: such as pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy Prophylaxis: The administration of Torped 500 mg/10 ml prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.Theropeutic ClassThird generation CephalosporinsPharmacologyTorped 500 mg/10 ml binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Torped 500 mg/10 ml is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Torped 500 mg/10 ml is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.Dosage & Administration of Torped 500 mg/10 mlAdults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be requiredChildren: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.Dosage in gonorrhoea: 500 mg as a single dose.Dosage of Torped 500 mg/10 mlAdults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be requiredChildren: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.Dosage in gonorrhoea: 500 mg as a single dose.Interaction of Torped 500 mg/10 mlIncreased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.ContraindicationsTorped 500 mg/10 ml is contraindicated in patients who have shown hypersensitivity to Torped 500 mg/10 ml or the cephalosporin group of antibiotics.Side Effects of Torped 500 mg/10 mlAdverse reactions to Torped 500 mg/10 ml have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Torped 500 mg/10 ml. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.Pregnancy & LactationAlthough studies in animals have not shown any adverse effect on the developing foetus, the safety of Torped 500 mg/10 ml in human pregnancy has not been established. Consequently, Torped 500 mg/10 ml should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Torped 500 mg/10 ml is excreted in the milk.Precautions & WarningsTorped 500 mg/10 ml should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Torped 500 mg/10 ml is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Torped 500 mg/10 ml in patients with even profound renal dysfunction.Storage ConditionsStore below 25?C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2? to 8?C.Use In Special PopulationsDosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Torped 500 mg/10 ml in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.Drug ClassesThird generation CephalosporinsMode Of ActionTorped 500 mg/10 ml binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Torped 500 mg/10 ml is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Torped 500 mg/10 ml is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.PregnancyAlthough studies in animals have not shown any adverse effect on the developing foetus, the safety of Torped 500 mg/10 ml in human pregnancy has not been established. Consequently, Torped 500 mg/10 ml should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Torped 500 mg/10 ml is excreted in the milk.Pediatric UsesDosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Torped 500 mg/10 ml in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.

Truso 37.5 mlCefixime is an orally active cephalosporin antibiotic which has marked in-vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organism. Truso 37.5 ml indicated for the treatment of the following acute infections when caused by susceptible microorganisms.Upper Respiratory Tract Infections (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk. Lower Respiratory Tract Infections-e.g. bronchitis.Urinary Tract Infections:?e.g. cystitis, cystourethritis, pyelonephritis. Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumonia, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. Cefixime is highly stable in the presence of beta-lactamase enzymes.Theropeutic ClassThird generation CephalosporinsPharmacologyCefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.Dosage & Administration of Truso 37.5 mlThe usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following ?-1 year: 75 mg daily. 1-4 years: 100 mg daily. 5-10 years: 200 mg daily. 11-12 years: 300 mg daily In typhoid fever, dosage should be 10 mg/kg/day for 14 days. Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.Dosage of Truso 37.5 mlAbsorption of Cefixime is not significantly modified by the presence of food. The usual course of treatment is 7 days. This may be continued for up to 14 days if required. Adults and children over 10 years: The recommended adult dosage is 200-400 mg daily according to the severity of the infection, given either as a single dose or in two divided doses. Elderly: Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment. Children: The recommended dosage for children is 8 mg/kg/day administered as a single dose or in two divided doses. As a general guide for prescribing in children the following daily doses in terms of volume of suspension are suggested: 6 months up to 1 year: 3.75 ml daily Children 1-4 years: 5 ml daily Children 5-10 years: 10 ml daily In typhoid: the recommended children dose is 5 mg/kg body weight twice daily for 10-14 days. Children weighing more than 50 kg or older than 10 years: Should be treated with the recommended adult dose 200-400 mg daily depending on the severity of infection. Children aged less than 6 months: The safety and efficacy of Cefixime has not been established in children aged less than 6 months.Dosage in Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 ml/min or greater. In patients whose creatinine clearance is less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 ml/min.Interaction of Truso 37.5 mlIn common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulant therapy.ContraindicationsPatients with known hypersensitivity to cephalosporin antibiotics.Side Effects of Truso 37.5 mlCefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self limiting in nature. Gastrointestinal disturbances: The most frequent side-effects seen with Cefixime are diarrhoea and stool changes; diarrhoea has been more commonly associated with higher doses. Other gastrointestinal side-effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembraneous colitis has been reported. Central nervous system: headache and dizziness. Hypersensitivity reactions: allergies in the form of rash, pruritis, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy. Hematological and clinical chemistry: thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were infrequent and reversible. Mild transient change in liver and renal function tests have been observed. Miscellaneous: other possible reactions include genital pruritis and vaginitis.Pregnancy & LactationThere are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.Precautions & WarningsCefixime should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporin should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient treated with appropriate agents if necessary. Cefixime should be administered with caution in patients with markedly impaired renal function. Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhoea. Use in pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.Overdose Effects of Truso 37.5 mlGastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.Storage ConditionsKeep below 30?C temperature, protected from light & moisture. Keep out of the reach of children.Drug ClassesThird generation CephalosporinsMode Of ActionCefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.PregnancyThere are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Vertex 2 gm/vialVertex 2 gm/vial is indicated for the treatment of the following major infections: Lower respiratory tract infections Acute Bacterial Otitis Media Skin and skin structure infections Urinary tract infections Gonorrhea Bacterial Septicemia Bone and joint infections Meningitis Prevention of postoperative infections Perioperative prophylaxis of infections associated with surgery Theropeutic ClassThird generation CephalosporinsPharmacologyVertex 2 gm/vial is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Vertex 2 gm/vial kills bacteria by interfering with the synthesis of the bacterial cell wall. Vertex 2 gm/vial has a high degree of stability in the presence of beta lactamases. A remarkable feature of Vertex 2 gm/vial is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Vertex 2 gm/vial is not metabolized in the body. About 40-65% of a dose of Vertex 2 gm/vial is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).Dosage of Vertex 2 gm/vialAdult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day). Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day Uncomplicated gonococcal infections: 250 mg IM as a single dose Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day). Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.Administration of Vertex 2 gm/vialPreparation of Solutions for Intramuscular / Intravenous Injections: For Intramuscular Injection: 250 mg or 500 mg Vertex 2 gm/vial should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Vertex 2 gm/vial in 3.5 ml of Lidocaine HCI 1% injection. For Intravenous Injection: 250 mg or 500 mg Vertex 2 gm/vial should be dissolved in 5 ml of Water for injection or 1 g Vertex 2 gm/vial in 10 ml of Water for injection USP or 2 g Vertex 2 gm/vial in 20 ml of Water for injection. The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Vertex 2 gm/vial injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5?C).Interaction of Vertex 2 gm/vialNo drug interactions have been reported.ContraindicationsVertex 2 gm/vial should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.Side Effects of Vertex 2 gm/vialVertex 2 gm/vial is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.Pregnancy & LactationIts safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Vertex 2 gm/vial are excreted in human milk. Caution should be exercised when Vertex 2 gm/vial is administered to a lactating mother.Precautions & WarningsAs with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Vertex 2 gm/vial therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.Overdose Effects of Vertex 2 gm/vialThere is no specific antidote. Treatment of overdosage should be symptomatic.Storage ConditionsVial store in a cool, dry place (below 30? C), away from light & moisture. Keep out of the reach of children.Use In Special PopulationsVertex 2 gm/vial must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).