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Elocef

Cephradine
Capsule 250 mg Allopathic First generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
  • Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
  • Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
  • Urinary tract infections: cystitis, urethritis and pyelonephritis.
  • Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
The following microorganisms are susceptible, in vitro to Cephradine:
  • Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
  • Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
Therapeutic classView
First generation Cephalosporins
PharmacologyView
Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
DosageView
For oral administration-
Adults:
  • Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
  • Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
  • Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
Children:
  • Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
  • Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
  • Maximum daily dosage: 4 gm
Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-
  • Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
  • Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
Side effectsView
Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
  • Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
  • Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
  • Psychiatric disorders- Unknown: Confusion, sleep disturbances
  • Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
  • Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
  • Renal and urinary disorders- Unknown: Reversible interstitial nephritis
  • Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
ContraindicationsView
Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
PrecautionsView
  • Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
  • Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
  • Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
  • Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
  • Dosage adjustment is necessary in renal impairment.
  • This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
InteractionsView
The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
Pregnancy & lactationView
Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Pediatric usageView
Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
  • CrCl: >20 ml/min: 500 mg every 6 hours
  • CrCl: 5-20 ml/min: 250 mg every 6 hours
  • CrCl: <5 ml/min: 250 mg every 50-70 hours.
Recommendations for patients on chronic, intermittent haemodialysis:
  • 250 mg at the start of haemodialysis
  • 250 mg 6 to 12 hours after the start
  • 250 mg 36 to 48 hours after the start
  • 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
Overdose effectsView
The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
StorageView
Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Elocef

Cephradine
Powder for Suspension 125 mg/5 ml Allopathic First generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
  • Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
  • Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
  • Urinary tract infections: cystitis, urethritis and pyelonephritis.
  • Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
The following microorganisms are susceptible, in vitro to Cephradine:
  • Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
  • Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
Therapeutic classView
First generation Cephalosporins
PharmacologyView
Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
DosageView
For oral administration-
Adults:
  • Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
  • Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
  • Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
Children:
  • Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
  • Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
  • Maximum daily dosage: 4 gm
Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-
  • Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
  • Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
Side effectsView
Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
  • Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
  • Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
  • Psychiatric disorders- Unknown: Confusion, sleep disturbances
  • Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
  • Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
  • Renal and urinary disorders- Unknown: Reversible interstitial nephritis
  • Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
ContraindicationsView
Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
PrecautionsView
  • Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
  • Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
  • Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
  • Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
  • Dosage adjustment is necessary in renal impairment.
  • This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
InteractionsView
The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
Pregnancy & lactationView
Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Pediatric usageView
Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
  • CrCl: >20 ml/min: 500 mg every 6 hours
  • CrCl: 5-20 ml/min: 250 mg every 6 hours
  • CrCl: <5 ml/min: 250 mg every 50-70 hours.
Recommendations for patients on chronic, intermittent haemodialysis:
  • 250 mg at the start of haemodialysis
  • 250 mg 6 to 12 hours after the start
  • 250 mg 36 to 48 hours after the start
  • 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
Overdose effectsView
The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
StorageView
Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Elocon

Econazole Nitrate + Triamcinolone Acetonide
Cream 1%+0.1% Allopathic Triamcinolone & Combined preparations

Indications

Tinea corporis (ringworm)

Indication detailsView
Econazole Nitrate & Triamcinolone Acetonide indicated for the treatment of:
  • Eczematous Mycoses
  • Psoriasis
  • Tinea Pedis (Athlete’s foot)
  • Tinea Corporis (Ring worm)
  • Tinea Cruris (Jock itch)
  • Inflammatory Intertrigo
  • Diaper Dermatitis
Onychomycoses- for the treatment of onychomycoses, local therapy with Econazole/Triamcinolone cream, combined with an oral antimycotic, is recommended.
Therapeutic classView
Triamcinolone & Combined preparations
DosageView
Adults: This cream should be applied sparingly to the skin lesion no more than 2 times daily, preferably once in the morning and once in the evening. This cream should not be applied with an occlusive dressing, or to large areas of skin on the body. The duration of treatment with this cream should continue until the inflammatory symptoms subside but not longer than 2 weeks; after 2 weeks of therapy with this cream, continue therapy as needed with a preparation containing econazole or econazole nitrate alone.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight. Caution should be exercised.
Side effectsView
Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has the minimal allergenic effect and is well tolerated, even by delicate skin. Adrenal suppression on long term continuous topical steroid therapy may occur, particularly in infants or children, or when occlusive dressings are applied. It should be noted that an infant's napkin may act as an occlusive dressing.
ContraindicationsView
This Cream is contraindicated-
  • In individuals who have shown hypersensitivity to any of its ingredients.
  • Like any other dermatological preparation containing corticosteroids, this Cream is contraindicated in specific skin conditions such as tuberculous, varicella, herpes simplex or other viral infections of the skin, or fresh vaccination sites.
  • Decubitus ulcers: Viral, bacterial or fungal skin infections (e.g. tuberculosis of the skin, syphilis of the skin, herpes simplex, herpes zoster, chickenpox).
  • Rosacea and rosacea-like dermatitis.
PrecautionsView
  • For external use only. This Cream is not for ophthalmic or oral use.
  • If a reaction suggesting hypersensitivity or chemical irritation should occur, use of the medication should be discontinued.
  • Corticosteroids applied to the skin can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. Systemic absorption may be increased by various factors such as application over a large skin surface area, application to damaged skin, application under occlusive skin dressings and prolonged duration of therapy.
  • Topical corticosteroids are associated with skin thinning and atrophy, striae, telangiectasis and purpura.
  • Topical corticosteroids may lead to increased risk of dermatological superinfection or opportunistic infection.
Children: Increased caution is required when treating children. Compared to adults, the nature of a child's skin and the larger skin surface area relative to body weight may lead to an increased absorption of the corticosteroid via the child's skin. This cream should be used in children only for short periods of time (less than 2 weeks) and on small areas (less than 10% of body surface area).

Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).
InteractionsView
Econazole: compound metabolized by CYP3A4/2C9 oral anticoagulants (warfarin & acenocoumarol).

Triamcinolone: lowering of plasma salicylates levels. Increased risk of Gl bleeding and ulceration with NSAIDs. Antagonised blood glucose-lowering effects of the antidiabetics. Increased risk of Hyperkalemia with amphotericin B, beta-blockers, potassium-depleting diuretics, theophylline. Increased clearance of the triamcinolone with ciclosporin, carbamazepine, phenytoin, barbiturate, rifampicin.
Pregnancy & lactationView
Pregnancy: Not the Econazole but the Triamcinolone Acetonide crosses the placenta and topical administration of corticosteroids during pregnancy can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids in large amounts or for prolonged periods
should not be used in pregnancy.

Lactation: Negligible amount of econazole and to some extent Triamcinolone may be excreted in small amounts in breast milk. So this cream should not be prescribed to the lactating mother or if prescribed lactation should be withheld during treatment.
Overdose effectsView
This Cream is for cutaneous application only. Corticosteroids applied to the skin, including triamcinolone, can be absorbed in sufficient amounts to produce systemic effects. In the event of accidental ingestion, treat symptomatically. If this cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.
StorageView
Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.

Elodep

Escitalopram Oxalate
Tablet 10 mg Allopathic SSRIs & related anti-depressant drugs

Indications

Trichotillomania

Indication detailsView
Escitalopram Oxalate is indicated in the-
  • Treatment of major depressive episodes.
  • Treatment of panic disorder with or without agoraphobia.
  • Treatment of social anxiety disorder (social phobia).
  • Treatment of generalised anxiety disorder.
  • Treatment of obsessive-compulsive disorder.
Therapeutic classView
SSRIs & related anti-depressant drugs
PharmacologyView
Escitalopram is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake. Escitalopram has no or very low affinity for serotonergic or other receptors including alpha- and beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.
DosageView
Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.

Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.

Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.
AdministrationView
Escitalopram should generally be administered once daily, morning or evening with or without food.
Side effectsView
SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.
ContraindicationsView
Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.
PrecautionsView
SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.
InteractionsView
As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).
Pregnancy & lactationView
When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.
Pediatric usageView
Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.

Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.

When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Overdose effectsView
Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).

Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.
StorageView
Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.

Elodep

Escitalopram Oxalate
Tablet 5 mg Allopathic SSRIs & related anti-depressant drugs

Indications

Trichotillomania

Indication detailsView
Escitalopram Oxalate is indicated in the-
  • Treatment of major depressive episodes.
  • Treatment of panic disorder with or without agoraphobia.
  • Treatment of social anxiety disorder (social phobia).
  • Treatment of generalised anxiety disorder.
  • Treatment of obsessive-compulsive disorder.
Therapeutic classView
SSRIs & related anti-depressant drugs
PharmacologyView
Escitalopram is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake. Escitalopram has no or very low affinity for serotonergic or other receptors including alpha- and beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.
DosageView
Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.

Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.

Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.
AdministrationView
Escitalopram should generally be administered once daily, morning or evening with or without food.
Side effectsView
SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.
ContraindicationsView
Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.
PrecautionsView
SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.
InteractionsView
As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).
Pregnancy & lactationView
When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.
Pediatric usageView
Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.

Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.

When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Overdose effectsView
Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).

Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.
StorageView
Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.

Elopag

Eltrombopag Olamine
Tablet 50 mg Allopathic Haemostatic drugs

Indications

Idiopathic thrombocytopenic purpura

Indication detailsView
Eltrombopag Olamine is indicated in Chronic Immune (Idiopathic) Thrombocytopenia, Chronic Hepatitis C-associated Thrombocytopenia, Severe Aplastic Anemia.
Therapeutic classView
Haemostatic drugs
PharmacologyView
Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. Eltrombopag is a stimulator of STAT and JAK phosphorylation. Unlike recombinant TPO or romiplostim, Eltrombopag does not activate the AKT pathway in any way. It should be noted that when given to patients with aplastic anemia, other lineages besides platelet count were increased, suggesting that either eltrombopag enhanced the effect of TPO in vivo; or there is a yet uncovered mechanism of action at work.
DosageView
Chronic Immune (Idiopathic) Thrombocytopenia-
  • Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C). For patients of East Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
  • For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A,B,C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.

Chronic Hepatitis C-associated Thrombocytopenia-
  • Initiate Eltrombopag at a dose of 25 mg once daily. Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy. During antiviral therapy, adjust the dose of Eltrombopag to avoid dose reductions of Peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag.

Severe Aplastic Anemia-
  • Initiate Eltrombopag at a dose of 50 mg once daily. For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
Side effectsView
The most common side effects of Eltrombopag in adults when used to treat chronic ITP are: In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia and urinary tract infection. In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis.

In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia and peripheral edema. In patients with severe aplastic anemia, the most common adverse reactions (greater than or equal to 20%) were: nausea, fatigue, cough, diarrhea and headache.
ContraindicationsView
There are no contraindications for Eltrombopag
PrecautionsView
Hepatotoxicity: Monitor liver function before and during therapy.

Thrombotic or Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag. Monitor platelet counts regularly.
InteractionsView
Take Eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods and mineral supplements.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies of Eltrombopag usein pregnancy. In animal reproduction and developmental toxicity studies, there was evidence ofembryolethality and reduced fetal weights at maternally toxic doses. Eltrombopag should beused in pregnancy only if the potential benefit to the mother justifies the potential risk to thefetus.

Nursing Mothers: It is not known whether Eltrombopag is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Eltrombopag, a decision should be made whether to discontinue nursing or to discontinue Eltrombopag taking into account the importance of Eltrombopag to the mother.
Pediatric usageView
Pediatric Use:The safety and efficacy of Eltrombopag in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled. The pharmacokinetics of Eltrombopag has been evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily for dosing recommendations for pediatric patients 1 year and older. The safety and efficacy ofEltrombopag in pediatric patients younger than 1 year with ITP have not yet been established. The safety and efficacy of Eltrombopag in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established.

Geriatric Use: Of the 106 patients in two randomized clinical trials of Eltrombopag 50 mg in chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. In the two randomized clinical trials of Eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while fewer than 1% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: Hepatic impairment influences the exposure of Eltrombopag. Reduce the initial dose of Eltrombopag in patients with chronic ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C). No dosage adjustment is necessary for patients with chronic hepatitis C and hepatic impairment.

Renal Impairment: No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.
Overdose effectsView
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.

In one report, a subject who ingested 5,000 mg of Eltrombopag had a platelet count increase to a maximum of 929 x 109/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue. The patient was treated with gastric lavage, oral Lactulose, Intravenous fluids, Omeprazole, Atropine, Furosemide, Calcium, Dexamethasone, andPlasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months follow-up, all events had resolved without sequelae.

In case of an overdose, consider oral administration of a metal cation-containing preparation, such as Calcium, Aluminum, or Magnesium preparations to chelate Eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with Eltrombopag in accordance with dosing and administration recommendations.
StorageView
Store in a cool and dry place, away from light and moisture. Keep out of the reach of children.

Elopag

Eltrombopag Olamine
Tablet 25 mg Allopathic Haemostatic drugs

Indications

Idiopathic thrombocytopenic purpura

Indication detailsView
Eltrombopag Olamine is indicated in Chronic Immune (Idiopathic) Thrombocytopenia, Chronic Hepatitis C-associated Thrombocytopenia, Severe Aplastic Anemia.
Therapeutic classView
Haemostatic drugs
PharmacologyView
Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. Eltrombopag is a stimulator of STAT and JAK phosphorylation. Unlike recombinant TPO or romiplostim, Eltrombopag does not activate the AKT pathway in any way. It should be noted that when given to patients with aplastic anemia, other lineages besides platelet count were increased, suggesting that either eltrombopag enhanced the effect of TPO in vivo; or there is a yet uncovered mechanism of action at work.
DosageView
Chronic Immune (Idiopathic) Thrombocytopenia-
  • Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C). For patients of East Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
  • For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A,B,C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.

Chronic Hepatitis C-associated Thrombocytopenia-
  • Initiate Eltrombopag at a dose of 25 mg once daily. Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy. During antiviral therapy, adjust the dose of Eltrombopag to avoid dose reductions of Peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag.

Severe Aplastic Anemia-
  • Initiate Eltrombopag at a dose of 50 mg once daily. For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
Side effectsView
The most common side effects of Eltrombopag in adults when used to treat chronic ITP are: In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia and urinary tract infection. In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis.

In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia and peripheral edema. In patients with severe aplastic anemia, the most common adverse reactions (greater than or equal to 20%) were: nausea, fatigue, cough, diarrhea and headache.
ContraindicationsView
There are no contraindications for Eltrombopag
PrecautionsView
Hepatotoxicity: Monitor liver function before and during therapy.

Thrombotic or Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag. Monitor platelet counts regularly.
InteractionsView
Take Eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods and mineral supplements.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies of Eltrombopag usein pregnancy. In animal reproduction and developmental toxicity studies, there was evidence ofembryolethality and reduced fetal weights at maternally toxic doses. Eltrombopag should beused in pregnancy only if the potential benefit to the mother justifies the potential risk to thefetus.

Nursing Mothers: It is not known whether Eltrombopag is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Eltrombopag, a decision should be made whether to discontinue nursing or to discontinue Eltrombopag taking into account the importance of Eltrombopag to the mother.
Pediatric usageView
Pediatric Use:The safety and efficacy of Eltrombopag in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled. The pharmacokinetics of Eltrombopag has been evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily for dosing recommendations for pediatric patients 1 year and older. The safety and efficacy ofEltrombopag in pediatric patients younger than 1 year with ITP have not yet been established. The safety and efficacy of Eltrombopag in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established.

Geriatric Use: Of the 106 patients in two randomized clinical trials of Eltrombopag 50 mg in chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. In the two randomized clinical trials of Eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while fewer than 1% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: Hepatic impairment influences the exposure of Eltrombopag. Reduce the initial dose of Eltrombopag in patients with chronic ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C). No dosage adjustment is necessary for patients with chronic hepatitis C and hepatic impairment.

Renal Impairment: No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.
Overdose effectsView
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.

In one report, a subject who ingested 5,000 mg of Eltrombopag had a platelet count increase to a maximum of 929 x 109/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue. The patient was treated with gastric lavage, oral Lactulose, Intravenous fluids, Omeprazole, Atropine, Furosemide, Calcium, Dexamethasone, andPlasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months follow-up, all events had resolved without sequelae.

In case of an overdose, consider oral administration of a metal cation-containing preparation, such as Calcium, Aluminum, or Magnesium preparations to chelate Eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with Eltrombopag in accordance with dosing and administration recommendations.
StorageView
Store in a cool and dry place, away from light and moisture. Keep out of the reach of children.

Elorim

Eflornithine Hydrochloride
Cream 13.90% Allopathic Hair Growth Inhibitor

Indications

Reduction of unwanted facial hair in women

Indication detailsView
Eflornithine Hydrochloride cream, 13.9% is indicated for the reduction of unwanted facial hair in women. Eflornithine Hydrochloride has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.
Therapeutic classView
Hair Growth Inhibitor
PharmacologyView
Eflornithine prevents hair growth by inhibiting the anagen phase of hair production. This occurs by eflornithine irreversibly binding (also called suicide inhibition) to ornithine decarboxylase (ODC) and physically preventing the natural substrate ornithine from accessing the active site.
DosageView
Adults: Apply a thin layer of Eflornithine cream, 13.9% to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. The patient should continue to use hair removal techniques as needed in conjunction with Eflornithine (Wonica should be applied at least 5 minutes after hair removal). Cosmetics or sunscreens may be applied over treated areas after cream has dried. 

Elderly: No apparent differences in safety were observed between older patients and younger patients. 

Children: The safety and effectiveness of this product have not been established in pediatric patients less than 12 years of age.
Side effectsView
Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of Eflornithine. Side effects can include acne, barbae, pseudofolliculitis, stinging skin, headache, burning skin, dry skin, erythema (redness), pruritus (itching), tingling skin, dyspepsia, skin irritation, rash, alopecia, dizziness, folliculitis, hair ingrown, facial edema, anorexia, nausea, asthenia, vertigo
ContraindicationsView
Eflornithine is contraindicated in patients with a history of sensitivity to any components of the preparation.
PrecautionsView
For external use only. Transient stinging or burning may occur when applied to abraded or broken skin.
InteractionsView
It is not known whether Eflornithine has any interaction with other topically applied drug products.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether or not Eflornithine Hydrochloride is excreted in human milk. Caution should be exercised when Eflornithine is administered to a nursing woman.
Overdose effectsView
Overdosage information with Eflornithine is unavailable. However, if very high topical doses (e.g., multiple tubes per day) or oral ingestion has been encountered (a 30 gm tube contains 4.2 gm of Eflornithine Hydrochloride), the patient should be monitored, and appropriate supportive measures should be administered as necessary.
StorageView
Store at 25°C, excursions permitted to 15°C-30°C. Do not freeze.

Eloxatin

Oxaliplatin
IV Infusion 5 mg/ml Allopathic Cytotoxic Chemotherapy

Indications

Oesophageal cancer

Indication detailsView
Oxaliplatin, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:
  • Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
  • Treatment of advanced colorectal cancer.
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Oxaliplatin, a platinum-containing complex similar to cisplatin, is an alkylating agent. After intracellular hydrolysis, the platinum compound binds to DNA forming cross-links which inhibit DNA replication and transcription, resulting in cell death.
DosageView
Intravenous (Adult)-

Adjuvant therapy in stage III colon cancer: In combination with fluorouracil/ leucovorin: 85 mg/m2 every 2 wk for 12 cycles. Dose to be given by IV infusion over 2-6 hr, dissolved in 250-500 ml of glucose 5%, every 2 wk; given for 12 cycles. After recovery from toxicity, reduce dose to 75 mg/m2. Administer before fluoropyrimidines.

Advanced colorectal cancer: In combination with fluorouracil/ leucovorin: 85 mg/m2 every 2 wk until disease progression or unacceptable toxicity. Dose to be given by IV infusion over 2-6 hr, dissolved in 250-500 ml of glucose 5%, . After recovery from toxicity, reduce dose to 65 mg/m2. Administer before fluoropyrimidines.
Side effectsView
Fatigue, fever, pain, headache, insomnia, nausea, diarrheoa, vomiting, abdominal pain, constipation, anorexia, stomatitis, anemia, thrombocytopenia, leukopenia, aspartate and alanine transaminases increased, total bilirubin increased, peripheral neuropathy, back pain, dyspnoea, cough, oedema, chest pain, peripheral oedema, flushing , thromboembolism, dizziness, rash, alopecia , hand-foot syndrome dehydration, hypokalaemia, dyspepsia, taste perversion, flatulence, mucositis, gastroesophageal reflux, dysphagia, dysuria, neutropenia, inj site reaction, rigors, arthralgia, abnormal lacrimation, serum creatinine increased, rhinitis, epistaxis, pharyngitis, pharyngolaryngeal dysesthesia, allergic reactions, hiccup.
ContraindicationsView
Pregnancy. Peripheral neuropathy with functional impairment. Severe renal impairment.
PrecautionsView
Should be administered under the supervision of an experienced cancer chemotherapy physician. Use appropriate precautions for handling and disposal. Monitor neurological status and dose should be reduced if symptoms are prolonged or severe. Monitor blood counts during treatment and courses should not be repeated until blood counts have recovered. Caution in elderly, moderate degrees of renal impairment. Avoid using aluminum-containing needles or IV admin sets that may come into contact with oxaliplatin as aluminum has been reported to cause degradation of platinum compounds. Lactation.
InteractionsView
May decrease plasma levels of digoxin. May increase risk of toxicity with nephrotoxic drugs. When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before oxaliplatin to limit myelosuppression and enhance efficacy.
Pregnancy & lactationView
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Pediatric usageView
Renal Impairment: Dose adjustment may be needed
Overdose effectsView
Extensions of known adverse reaction (e.g. thrombocytopenia, myelosuppression, nausea, vomiting, neurotoxicity, respiratory symptoms). Treatment is supportive.
ReconstitutionView
Reconstitute with 10 ml (for 50 mg vial) or 20 ml (for 100 mg vial) water for inj or 5% dextrose inj. Reconstituted solution must be further diluted with 250-500 ml of 5% dextrose inj before admin.
StorageView
Store intact vials at 15-30°C; do not freeze. Reconstituted solution: May store at 2-8°C for up to 24 hr. Diluted solutions: Stable up to 6 hr at 20-25°C or up to 24 hr under refrigeration at 2-8°C.

Eltrom

Eltrombopag Olamine
Tablet 50 mg Allopathic Haemostatic drugs

Indications

Idiopathic thrombocytopenic purpura

Indication detailsView
Eltrombopag Olamine is indicated in Chronic Immune (Idiopathic) Thrombocytopenia, Chronic Hepatitis C-associated Thrombocytopenia, Severe Aplastic Anemia.
Therapeutic classView
Haemostatic drugs
PharmacologyView
Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. Eltrombopag is a stimulator of STAT and JAK phosphorylation. Unlike recombinant TPO or romiplostim, Eltrombopag does not activate the AKT pathway in any way. It should be noted that when given to patients with aplastic anemia, other lineages besides platelet count were increased, suggesting that either eltrombopag enhanced the effect of TPO in vivo; or there is a yet uncovered mechanism of action at work.
DosageView
Chronic Immune (Idiopathic) Thrombocytopenia-
  • Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C). For patients of East Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
  • For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A,B,C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.

Chronic Hepatitis C-associated Thrombocytopenia-
  • Initiate Eltrombopag at a dose of 25 mg once daily. Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy. During antiviral therapy, adjust the dose of Eltrombopag to avoid dose reductions of Peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag.

Severe Aplastic Anemia-
  • Initiate Eltrombopag at a dose of 50 mg once daily. For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
Side effectsView
The most common side effects of Eltrombopag in adults when used to treat chronic ITP are: In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia and urinary tract infection. In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis.

In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia and peripheral edema. In patients with severe aplastic anemia, the most common adverse reactions (greater than or equal to 20%) were: nausea, fatigue, cough, diarrhea and headache.
ContraindicationsView
There are no contraindications for Eltrombopag
PrecautionsView
Hepatotoxicity: Monitor liver function before and during therapy.

Thrombotic or Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag. Monitor platelet counts regularly.
InteractionsView
Take Eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods and mineral supplements.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies of Eltrombopag usein pregnancy. In animal reproduction and developmental toxicity studies, there was evidence ofembryolethality and reduced fetal weights at maternally toxic doses. Eltrombopag should beused in pregnancy only if the potential benefit to the mother justifies the potential risk to thefetus.

Nursing Mothers: It is not known whether Eltrombopag is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Eltrombopag, a decision should be made whether to discontinue nursing or to discontinue Eltrombopag taking into account the importance of Eltrombopag to the mother.
Pediatric usageView
Pediatric Use:The safety and efficacy of Eltrombopag in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled. The pharmacokinetics of Eltrombopag has been evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily for dosing recommendations for pediatric patients 1 year and older. The safety and efficacy ofEltrombopag in pediatric patients younger than 1 year with ITP have not yet been established. The safety and efficacy of Eltrombopag in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established.

Geriatric Use: Of the 106 patients in two randomized clinical trials of Eltrombopag 50 mg in chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. In the two randomized clinical trials of Eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while fewer than 1% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: Hepatic impairment influences the exposure of Eltrombopag. Reduce the initial dose of Eltrombopag in patients with chronic ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C). No dosage adjustment is necessary for patients with chronic hepatitis C and hepatic impairment.

Renal Impairment: No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.
Overdose effectsView
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.

In one report, a subject who ingested 5,000 mg of Eltrombopag had a platelet count increase to a maximum of 929 x 109/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue. The patient was treated with gastric lavage, oral Lactulose, Intravenous fluids, Omeprazole, Atropine, Furosemide, Calcium, Dexamethasone, andPlasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months follow-up, all events had resolved without sequelae.

In case of an overdose, consider oral administration of a metal cation-containing preparation, such as Calcium, Aluminum, or Magnesium preparations to chelate Eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with Eltrombopag in accordance with dosing and administration recommendations.
StorageView
Store in a cool and dry place, away from light and moisture. Keep out of the reach of children.

Eltrom

Eltrombopag Olamine
Tablet 25 mg Allopathic Haemostatic drugs

Indications

Idiopathic thrombocytopenic purpura

Indication detailsView
Eltrombopag Olamine is indicated in Chronic Immune (Idiopathic) Thrombocytopenia, Chronic Hepatitis C-associated Thrombocytopenia, Severe Aplastic Anemia.
Therapeutic classView
Haemostatic drugs
PharmacologyView
Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. Eltrombopag is a stimulator of STAT and JAK phosphorylation. Unlike recombinant TPO or romiplostim, Eltrombopag does not activate the AKT pathway in any way. It should be noted that when given to patients with aplastic anemia, other lineages besides platelet count were increased, suggesting that either eltrombopag enhanced the effect of TPO in vivo; or there is a yet uncovered mechanism of action at work.
DosageView
Chronic Immune (Idiopathic) Thrombocytopenia-
  • Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C). For patients of East Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
  • For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A,B,C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.

Chronic Hepatitis C-associated Thrombocytopenia-
  • Initiate Eltrombopag at a dose of 25 mg once daily. Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy. During antiviral therapy, adjust the dose of Eltrombopag to avoid dose reductions of Peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag.

Severe Aplastic Anemia-
  • Initiate Eltrombopag at a dose of 50 mg once daily. For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
Side effectsView
The most common side effects of Eltrombopag in adults when used to treat chronic ITP are: In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia and urinary tract infection. In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis.

In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia and peripheral edema. In patients with severe aplastic anemia, the most common adverse reactions (greater than or equal to 20%) were: nausea, fatigue, cough, diarrhea and headache.
ContraindicationsView
There are no contraindications for Eltrombopag
PrecautionsView
Hepatotoxicity: Monitor liver function before and during therapy.

Thrombotic or Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag. Monitor platelet counts regularly.
InteractionsView
Take Eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods and mineral supplements.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies of Eltrombopag usein pregnancy. In animal reproduction and developmental toxicity studies, there was evidence ofembryolethality and reduced fetal weights at maternally toxic doses. Eltrombopag should beused in pregnancy only if the potential benefit to the mother justifies the potential risk to thefetus.

Nursing Mothers: It is not known whether Eltrombopag is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Eltrombopag, a decision should be made whether to discontinue nursing or to discontinue Eltrombopag taking into account the importance of Eltrombopag to the mother.
Pediatric usageView
Pediatric Use:The safety and efficacy of Eltrombopag in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled. The pharmacokinetics of Eltrombopag has been evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily for dosing recommendations for pediatric patients 1 year and older. The safety and efficacy ofEltrombopag in pediatric patients younger than 1 year with ITP have not yet been established. The safety and efficacy of Eltrombopag in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established.

Geriatric Use: Of the 106 patients in two randomized clinical trials of Eltrombopag 50 mg in chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. In the two randomized clinical trials of Eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while fewer than 1% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: Hepatic impairment influences the exposure of Eltrombopag. Reduce the initial dose of Eltrombopag in patients with chronic ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C). No dosage adjustment is necessary for patients with chronic hepatitis C and hepatic impairment.

Renal Impairment: No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.
Overdose effectsView
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.

In one report, a subject who ingested 5,000 mg of Eltrombopag had a platelet count increase to a maximum of 929 x 109/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue. The patient was treated with gastric lavage, oral Lactulose, Intravenous fluids, Omeprazole, Atropine, Furosemide, Calcium, Dexamethasone, andPlasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months follow-up, all events had resolved without sequelae.

In case of an overdose, consider oral administration of a metal cation-containing preparation, such as Calcium, Aluminum, or Magnesium preparations to chelate Eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with Eltrombopag in accordance with dosing and administration recommendations.
StorageView
Store in a cool and dry place, away from light and moisture. Keep out of the reach of children.

Eltropag

Eltrombopag Olamine
Tablet 25 mg Allopathic Haemostatic drugs

Indications

Idiopathic thrombocytopenic purpura

Indication detailsView
Eltrombopag Olamine is indicated in Chronic Immune (Idiopathic) Thrombocytopenia, Chronic Hepatitis C-associated Thrombocytopenia, Severe Aplastic Anemia.
Therapeutic classView
Haemostatic drugs
PharmacologyView
Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. Eltrombopag is a stimulator of STAT and JAK phosphorylation. Unlike recombinant TPO or romiplostim, Eltrombopag does not activate the AKT pathway in any way. It should be noted that when given to patients with aplastic anemia, other lineages besides platelet count were increased, suggesting that either eltrombopag enhanced the effect of TPO in vivo; or there is a yet uncovered mechanism of action at work.
DosageView
Chronic Immune (Idiopathic) Thrombocytopenia-
  • Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C). For patients of East Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
  • For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A,B,C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.

Chronic Hepatitis C-associated Thrombocytopenia-
  • Initiate Eltrombopag at a dose of 25 mg once daily. Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy. During antiviral therapy, adjust the dose of Eltrombopag to avoid dose reductions of Peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag.

Severe Aplastic Anemia-
  • Initiate Eltrombopag at a dose of 50 mg once daily. For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
Side effectsView
The most common side effects of Eltrombopag in adults when used to treat chronic ITP are: In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia and urinary tract infection. In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis.

In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia and peripheral edema. In patients with severe aplastic anemia, the most common adverse reactions (greater than or equal to 20%) were: nausea, fatigue, cough, diarrhea and headache.
ContraindicationsView
There are no contraindications for Eltrombopag
PrecautionsView
Hepatotoxicity: Monitor liver function before and during therapy.

Thrombotic or Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag. Monitor platelet counts regularly.
InteractionsView
Take Eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods and mineral supplements.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies of Eltrombopag usein pregnancy. In animal reproduction and developmental toxicity studies, there was evidence ofembryolethality and reduced fetal weights at maternally toxic doses. Eltrombopag should beused in pregnancy only if the potential benefit to the mother justifies the potential risk to thefetus.

Nursing Mothers: It is not known whether Eltrombopag is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Eltrombopag, a decision should be made whether to discontinue nursing or to discontinue Eltrombopag taking into account the importance of Eltrombopag to the mother.
Pediatric usageView
Pediatric Use:The safety and efficacy of Eltrombopag in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled. The pharmacokinetics of Eltrombopag has been evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily for dosing recommendations for pediatric patients 1 year and older. The safety and efficacy ofEltrombopag in pediatric patients younger than 1 year with ITP have not yet been established. The safety and efficacy of Eltrombopag in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established.

Geriatric Use: Of the 106 patients in two randomized clinical trials of Eltrombopag 50 mg in chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. In the two randomized clinical trials of Eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while fewer than 1% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: Hepatic impairment influences the exposure of Eltrombopag. Reduce the initial dose of Eltrombopag in patients with chronic ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C). No dosage adjustment is necessary for patients with chronic hepatitis C and hepatic impairment.

Renal Impairment: No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.
Overdose effectsView
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.

In one report, a subject who ingested 5,000 mg of Eltrombopag had a platelet count increase to a maximum of 929 x 109/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue. The patient was treated with gastric lavage, oral Lactulose, Intravenous fluids, Omeprazole, Atropine, Furosemide, Calcium, Dexamethasone, andPlasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months follow-up, all events had resolved without sequelae.

In case of an overdose, consider oral administration of a metal cation-containing preparation, such as Calcium, Aluminum, or Magnesium preparations to chelate Eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with Eltrombopag in accordance with dosing and administration recommendations.
StorageView
Store in a cool and dry place, away from light and moisture. Keep out of the reach of children.

Eltroxin

Levothyroxine Sodium
Tablet 50 mcg Allopathic Thyroid drugs & hormone

Indications

Hypothyroidism

Indication detailsView
  • As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
  • For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
  • For the suppression of the goitrogenic effects of other drugs such as Lithium.
  • As a diagnostic aid in suppression tests.
Therapeutic classView
Thyroid drugs & hormone
PharmacologyView
This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.
DosageView
Adult dose:
  • Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
  • In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
  • In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium dose should be titrated until the patient is clinically euthyroid and the serum free - T4 level is restored to the upper half of the normal range.
  • For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.
Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.

Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.
  • 0-3 months: 10-15 mcg/kg/day
  • 3-6 months: 8-10 mcg/kg/day
  • 6-12 months: 6-8 mcg/kg/day
  • 1-5 years: 5-6 mcg/kg/day
  • 6-12 years: 4-5 mcg/kg/day
  • >12 years but growth and puberty incomplete: 2-3 mcg/kg/day
  • Growth and puberty complete: 1.7 mcg/kg/day.
The dose should be adjusted based on clinical response and laboratory parameters.
Side effectsView
Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:
  • General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
  • Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
  • Musculoskeletal: Tremors, muscle weakness.
  • Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
  • Respiratory: Dyspnea.
  • Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
  • Dermatologic: Hair loss, flushing.
ContraindicationsView
  • Untreated subclinical or overt Thyrotoxicosis of any etiology
  • Acute Myocardial Infarction
  • Uncorrected Adrenal failure.
PrecautionsView
  • In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
  • The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
  • Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
  • When monitoring blood levels of T3 and T4, it should be borne in mind that a "high" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.
InteractionsView
Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.
Pregnancy & lactationView
Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.
Overdose effectsView
The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.
StorageView
Store below 30°C and dry place, protect from light. Keep out of the reach of children.

Eluxan

Eluxadoline
Tablet 100 mg Allopathic Prokinetic drugs

Indications

Reduce peristalsis

Indication detailsView
Eluxadoline is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
Therapeutic classView
Carboxylic acids and derivatives, Prokinetic drugs
PharmacologyView
Eluxadoline is a mu-opioid receptor agonist, kappa opioid receptor agonist & delta opioid receptor antagonist. Eluxadoline works directly in intestine to reduce peristalsis, also makes the nerves in intestine less sensitive to stimulation.
DosageView
The recommended dosage in adults is 100 mg twice daily taken with food.

The recommended dosage is 75 mg twice daily taken with food in patients who:
  • are unable to tolerate the 100 mg dose.
  • are receiving concomitant OATP1B1 inhibitors.
  • have mild or moderate hepatic impairment.
Discontinue Eluxadoline in patients who develop severeconstipation.

If a dose is missed, take the next dose at the regular time; do not take 2 doses at once
Side effectsView
Most common adverse reactions are constipation, nausea and
abdominal pain.
ContraindicationsView
Known or suspected biliary duct obstruction, sphincter of oddi disease or dysfunction & pancreatitis.
PrecautionsView
Sphincter of Oddi spasm and Pancreatitis.
Patients who should be monitored closely-
  • without a gallbladder
  • with new or worsening abdominal pain
  • with nausea and vomiting
  • with acute biliary pain
  • with liver or pancreatic enzyme elevation
InteractionsView
Oral Contraceptive, Cyclosporine, Probenecid, Rosuvastatin.
Pregnancy & lactationView
Pregnancy: Not established.
Lactation: Not established.
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Hepatic Impairment: It is contraindicated in patients with severe hepatic impairment.
StorageView
Store in a cool & dry place, protect from light. Keep out of the reach of children.

Eluxan

Eluxadoline
Tablet 75 mg Allopathic Prokinetic drugs

Indications

Reduce peristalsis

Indication detailsView
Eluxadoline is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
Therapeutic classView
Carboxylic acids and derivatives, Prokinetic drugs
PharmacologyView
Eluxadoline is a mu-opioid receptor agonist, kappa opioid receptor agonist & delta opioid receptor antagonist. Eluxadoline works directly in intestine to reduce peristalsis, also makes the nerves in intestine less sensitive to stimulation.
DosageView
The recommended dosage in adults is 100 mg twice daily taken with food.

The recommended dosage is 75 mg twice daily taken with food in patients who:
  • are unable to tolerate the 100 mg dose.
  • are receiving concomitant OATP1B1 inhibitors.
  • have mild or moderate hepatic impairment.
Discontinue Eluxadoline in patients who develop severeconstipation.

If a dose is missed, take the next dose at the regular time; do not take 2 doses at once
Side effectsView
Most common adverse reactions are constipation, nausea and
abdominal pain.
ContraindicationsView
Known or suspected biliary duct obstruction, sphincter of oddi disease or dysfunction & pancreatitis.
PrecautionsView
Sphincter of Oddi spasm and Pancreatitis.
Patients who should be monitored closely-
  • without a gallbladder
  • with new or worsening abdominal pain
  • with nausea and vomiting
  • with acute biliary pain
  • with liver or pancreatic enzyme elevation
InteractionsView
Oral Contraceptive, Cyclosporine, Probenecid, Rosuvastatin.
Pregnancy & lactationView
Pregnancy: Not established.
Lactation: Not established.
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Hepatic Impairment: It is contraindicated in patients with severe hepatic impairment.
StorageView
Store in a cool & dry place, protect from light. Keep out of the reach of children.

Elvina

Terbinafine Hydrochloride
Tablet 250 mg Allopathic Other Antifungal preparations
Indication detailsView
Terbinafine 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.
Therapeutic classView
Other Antifungal preparations, Topical Antifungal preparations
PharmacologyView
Terbinafine, 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.
DosageView
Terbinafine 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: <25 kg: 125 mg/day up to 6 weeks
  • Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
  • 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.
Side effectsView
The 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.
ContraindicationsView
Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.
PrecautionsView
Warnings-
  • 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.
InteractionsView
In 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.
Pregnancy & lactationView
Terbinafine 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 usageView
Pediatric 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.
Overdose effectsView
Clinical 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.
StorageView
Store in a cool and dry place, below 30°C, protect from light.

Elvina

Terbinafine Hydrochloride
Cream 1% Allopathic Other Antifungal preparations
Indication detailsView
Terbinafine 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.
Therapeutic classView
Other Antifungal preparations, Topical Antifungal preparations
PharmacologyView
Terbinafine, 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.
DosageView
Terbinafine 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: <25 kg: 125 mg/day up to 6 weeks
  • Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
  • 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.
Side effectsView
The 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.
ContraindicationsView
Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.
PrecautionsView
Warnings-
  • 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.
InteractionsView
In 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.
Pregnancy & lactationView
Terbinafine 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 usageView
Pediatric 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.
Overdose effectsView
Clinical 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.
StorageView
Store in a cool and dry place, below 30°C, protect from light.

Elygyl

Metronidazole
Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
  • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
  • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
  • In the treatment of urogenital trichomoniasis.
  • Bacterial vaginosis (also known as non-specific vaginitis).
  • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
  • Giardiasis.
  • Acute ulcerative gingivitis.
  • Anaerobically infected leg ulcers and pressure sores.
  • Acute dental infections due to anaerobic organisms.
  • Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-
  • 200 mg tid or 400 mg bid for 7 days
  • 800 mg in the morning and 1-2 gm at night for 2 days
  • 2 gm as a single dose for 1 days
Trichomoniasis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Intestinal amoebiasis (Adults & Children over 10 yrs)- 
  • 800 mg tid for 5 days
Intestinal amoebiasis (Children)-
  • Children 7-10 yrs: 400 mg tid
  • Children 3-7 yrs: 200 mg qid
  • Children 1-3 yrs: 200 mg tid
Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
  • 400-800 mg tid for 5-10 days
Extra-intestinal & Asymptomatic amoebiasis (Children)-
  • Children 7-10 yrs: 200-400 mg tid
  • Children 3-7 yrs: 100-200 mg qid
  • Children 1-3 yrs: 100-200 mg tid
Giardiasis (Adults & Children over 10 yrs)-
  • 2 gm once daily for 3 days
Giardiasis (Children)-
  • Children 7-10 yrs: 1 gm once daily
  • Children 3-7 yrs: 600-800 mg once daily
  • Children 1-3 yrs: 500 mg once daily
Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
  • 200 mg tid for 3 days
Acute ulcerative  gingivitis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Acute dental infections (Adults & Children over 10 yrs)-
  • 200 mg tid for 3-7 days
Bacterial Vaginosis (Adults & Children over 10 yrs)-
  • 400 mg bid for 7 days
  • 2 gm as a single dose for 1 days
Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
  • 400 mg tid for 7 days
Anaerobic infections (Adults & Children over 10 yrs)-
  • 800 mg initially and then 400 mg tid for 7 days
Anaerobic infections (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid
Surgical prophylaxis (Adults & Children over 10 yrs)-
  • 400 mg tid started 24  hours before  surgery for 1 days
Surgical prophylaxis (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.


Suppository:

Anaerobic Infections-
  • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
  • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
Surgical Prophylaxis-
  • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
  • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
  • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
  • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
  • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
  • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
  • Patients should be warned that metronidazole may darken urine.
InteractionsView
  • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
  • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
  • Lithium: Plasma levels of lithium may be increased by metronidazole.
  • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
  • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
  • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
  • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There 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. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Elygyl

Metronidazole
Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
  • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
  • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
  • In the treatment of urogenital trichomoniasis.
  • Bacterial vaginosis (also known as non-specific vaginitis).
  • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
  • Giardiasis.
  • Acute ulcerative gingivitis.
  • Anaerobically infected leg ulcers and pressure sores.
  • Acute dental infections due to anaerobic organisms.
  • Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-
  • 200 mg tid or 400 mg bid for 7 days
  • 800 mg in the morning and 1-2 gm at night for 2 days
  • 2 gm as a single dose for 1 days
Trichomoniasis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Intestinal amoebiasis (Adults & Children over 10 yrs)- 
  • 800 mg tid for 5 days
Intestinal amoebiasis (Children)-
  • Children 7-10 yrs: 400 mg tid
  • Children 3-7 yrs: 200 mg qid
  • Children 1-3 yrs: 200 mg tid
Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
  • 400-800 mg tid for 5-10 days
Extra-intestinal & Asymptomatic amoebiasis (Children)-
  • Children 7-10 yrs: 200-400 mg tid
  • Children 3-7 yrs: 100-200 mg qid
  • Children 1-3 yrs: 100-200 mg tid
Giardiasis (Adults & Children over 10 yrs)-
  • 2 gm once daily for 3 days
Giardiasis (Children)-
  • Children 7-10 yrs: 1 gm once daily
  • Children 3-7 yrs: 600-800 mg once daily
  • Children 1-3 yrs: 500 mg once daily
Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
  • 200 mg tid for 3 days
Acute ulcerative  gingivitis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Acute dental infections (Adults & Children over 10 yrs)-
  • 200 mg tid for 3-7 days
Bacterial Vaginosis (Adults & Children over 10 yrs)-
  • 400 mg bid for 7 days
  • 2 gm as a single dose for 1 days
Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
  • 400 mg tid for 7 days
Anaerobic infections (Adults & Children over 10 yrs)-
  • 800 mg initially and then 400 mg tid for 7 days
Anaerobic infections (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid
Surgical prophylaxis (Adults & Children over 10 yrs)-
  • 400 mg tid started 24  hours before  surgery for 1 days
Surgical prophylaxis (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.


Suppository:

Anaerobic Infections-
  • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
  • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
Surgical Prophylaxis-
  • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
  • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
  • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
  • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
  • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
  • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
  • Patients should be warned that metronidazole may darken urine.
InteractionsView
  • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
  • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
  • Lithium: Plasma levels of lithium may be increased by metronidazole.
  • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
  • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
  • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
  • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There 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. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Ema

Esomeprazole
Capsule (Delayed Release) 20 mg Allopathic
Indication detailsView
Esomeprazole is indicated:
  • To relieve from chronic heartburn symptoms and other symptoms associated with GERD
  • For the healing of erosive esophagitis
  • For maintenance of healing of erosive esophagitis
  • In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
  • Zollinger-Ellison Syndrome
  • Acid related Dyspepsia
  • Duodenal & Gastric ulcer
PharmacologyView
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.

Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (Cmax) occur at approximately 1.5 hours (Tmax). The Cmax increases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.

Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.

Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.

Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.

Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.
DosageView

Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive

Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).

Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.

Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.

Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.

Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.

Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.

AdministrationView
Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.

Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.
Side effectsView
The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
ContraindicationsView
Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.
PrecautionsView
General: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.

Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.
InteractionsView
Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.

Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.
Pediatric usageView
Paediatric Use: Safety and effectiveness in paediatric patients have not been established.

Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out

Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.

Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.
Overdose effectsView
A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.
ReconstitutionView
Infusion: Reconstitute one sterile single-dose vial of Esomeprazole IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immediately. Any unused portion should be discarded.
StorageView
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.