Lupin Pharma

Lupin Pharma Drugs

• Irenka
  

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  Irenka

  

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  Swallow Irenka whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Irenka can be given without regard to meals. If a dose of Irenka is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Irenka at the same time.

  2.1 Dosage for Treatment of Major Depressive Disorder

  Administer duloxetine at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.1)].

  2.2 Dosage for Treatment of Generalized Anxiety Disorder

  Adults

  For most patients, initiate duloxetine 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].

  Elderly

  Initiate duloxetine at a dose of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg. Thereafter, patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. Safety of doses above 120 mg once daily has not been adequately evaluated [see CLINICAL STUDIES (14.2)].  

  Children and Adolescents (7 to 17 years of age)

  Initiate duloxetine at a dose of 30 mg once daily for 2 weeks before considering an increase to 60 mg. The recommended dose range is 30 to 60 mg once daily. Some patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. The safety of doses above 120 mg once daily has not been evaluated [see CLINICAL STUDIES (14.2)].

  2.3 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain

  Administer duloxetine 60 mg once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see CLINICAL STUDIES (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.

  Since diabetes is frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment [see DOSAGE AND ADMINISTRATION (2.6), USE IN SPECIFIC POPULATIONS (8.10), and CLINICAL PHARMACOLOGY (12.3)].

  2.5 Dosage for Treatment of Chronic Musculoskeletal Pain

  Administer duloxetine 60 mg once daily. Begin treatment at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see CLINICAL STUDIES (14.5)].

  2.6 Dosing in Special Populations

  Hepatic Impairment

  Avoid use in patients with chronic liver disease or cirrhosis [see WARNINGS AND PRECAUTIONS (5.14) and USE IN SPECIFIC POPULATIONS (8.9)].

  Severe Renal Impairment

  Avoid use in patients with severe renal impairment, GFR <30 mL/min [see WARNINGS AND PRECAUTIONS (5.14) and USE IN SPECIFIC POPULATIONS (8.10)].

  2.7 Discontinuing Irenka

  Adverse reactions after discontinuation of Irenka, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see WARNINGS AND PRECAUTIONS (5.7)].

  2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Irenka. Conversely, at least 5 days should be allowed after stopping Irenka before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS (4)].

  2.9 Use of Irenka with Other MAOIs such as Linezolid or Methylene Blue

  Do not start Irenka in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS (4)].

  In some cases, a patient already receiving Irenka therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Irenka should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Irenka may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS (5.4)].

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Irenka is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS (5.4)].

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• Suprax
  

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  Suprax

  

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  ALL RECOMMENDED DOSAGE FOR CEFIXIME SUSPENSION ARE INCLUDED IN THIS SECTION FOR INFORMATIONAL PURPOSE ONLY. SUPRAX (CEFIXIME) CHEWABLE TABLETS  100 MG ARE APPROPRIATE FOR A 100 MG DOSE, SUPRAX (CEFIXIME) CHEWABLE TABLETS  150 MG ARE APPROPRIATE FOR A 150 MG DOSE AND SUPRAX (CEFIXIME) CHEWABLE TABLETS 200 MG ARE APPROPRIATE FOR A 200 MG DOSE.

  SUPRAX (CEFIXIME) CHEWABLE TABLETS MUST BE CHEWED OR CRUSHED BEFORE SWALLOWING.

  Adults: The recommended dose is 400 mg daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.

  Children: The recommended dose is 8 mg/kg/day of the cefixime. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.

  PEDIATRIC DOSAGE CHART 100 mg/5 mL 200 mg/5 mL Suprax (cefixime) Chewable Tablet Patient Weight (kg) Dose/Day mg Dose/Day mL Dose/Day tsp of Suspension Dose/Day mL Dose/Day tsp of Suspension Dose 6.25 50 2.5 ½ 1.25 ¼ --- 12.5 100 5 1 2.5 ½ 1 tablet of 100 mg 18.75 150 7.5 1½ 3.75 ¾ 1 tablet of 150 mg 25 200 10 2 5 1 1 tablet of 200 mg 31.25 250 12.5 2½ 6.25 1¼  1 tablet of 100 mg and 1 tablet of 150 mg 37.5 300 15 3 7.5 1½ 2 tablets of  150 mg

  Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.

  Otitis media should be treated with Suprax (cefixime) chewable tablets or suspension. Clinical studies of otitis media were conducted with Suprax (cefixime) chewable tablets or suspension, and the Suprax (cefixime) chewable tablets or suspension results in higher peak blood levels than the immediate-release tablets when administered at the same dose. Therefore, the immediate-release tablets should not be substituted for Suprax (cefixime) chewable tablets or suspension in the treatment of otitis media. (See CLINICAL PHARMACOLOGY.)

  Efficacy and safety in infants aged less than six months have not been established.

  In the treatment of infections due to S. pyogenes, a therapeutic dosage of Suprax (cefixime) chewable tablets should be administered for at least 10 days.

  Renal Impairment

  Suprax (cefixime) chewable tablets may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval (i.e., 300 mg daily). Patients whose clearance is < 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (i.e., 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.

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• Alinia
  

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  Alinia

  

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  * Alinia Tablets and Alinia for Oral Suspension have not been studied for the treatment of Giardia lamblia in HIV-infected or immunodeficient patients. Alinia Tablets and Alinia for Oral Suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients (see CLINICAL STUDIES).

  Indication Age Dosage Duration Treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum* 1-3 years 5 mL of Alinia for Oral Suspension(100 mg nitazoxanide) every 12 hours with food 3 days 4-11 years 10 mL of Alinia for Oral Suspension(200 mg nitazoxanide) every 12 hours with food ≥12 years 1 Alinia Tablet (500 mg nitazoxanide) every 12 hours with food or 25 mL of Alinia for Oral Suspension (500 mg nitazoxanide) every 12 hours with food

  A single Alinia tablet contains a greater amount of nitazoxanide than is recommended for pediatric dosing and should therefore not be used in pediatric patients 11 years or younger.

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• Suprax
  

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  Suprax

  

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  2.1 Adults

  The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule and tablet may be administered without regard to food.

  In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

  2.2 Pediatric Patients (6 months or older)

  The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.

  Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because Suprax for oral suspension is available in three different concentrations (100 mg/5 mL, 200 mg/5 mL, and 500 mg/5 mL).

  Table 1. Suggested doses for pediatric patients * The preferred concentrations of oral suspension to use are 100 mg/5 mL or 200 mg/5 mL for pediatric patients in these weight ranges. PEDIATRIC DOSAGE CHART Doses are suggested for each weight range and rounded for ease of administration Suprax (cefixime) for Oral Suspension Suprax (cefixime) Chewable Tablet 100 mg/5 mL 200 mg/5 mL 500 mg/5 mL Patient Weight (kg) Dose/Day  (mg) Dose/Day  (mL) Dose/Day  (mL) Dose/Day  (mL) Dose 5 to 7.5* 50 2.5 -- -- -- 7.6 to 10* 80 4 2 -- -- 10.1 to 12.5 100 5 2.5 1 1 tablet of 100 mg 12.6 to 20.5 150 7.5 4 1.5 1 tablet of 150 mg 20.6 to 28 200 10 5 2 1 tablet of 200 mg 28.1 to 33 250 12.5 6 2.5 1 tablet of 100 mg and 1 tablet of 150 mg 33.1 to 40 300 15 7.5 3 2 tablets of 150 mg 40.1to 45 350 17.5 9 3.5 1 tablet of 150 mg and 1 tablet of 200 mg 45.1 or greater 400 20 10 4 2 tablets of 200 mg

  Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Suprax (cefixime) Chewable Tablets must be chewed or crushed before swallowing.

  Otitis media should be treated with the chewable tablets or suspension. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose.

  Therefore, the tablet or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media. [See CLINICAL PHARMACOLOGY (12.3)]

  In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

  2.3 Renal Impairment

  Suprax may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.

  Table 2. Doses for Adults with Renal Impairment * The preferred concentrations of oral suspension to use are 200 mg/5 mL or 500 mg/5 mL for patients with this renal dysfunction Renal Dysfunction  Suprax (cefixime) for Oral Suspension Tablet Chewable Tablet Creatinine Clearance (mL/min) 100 mg/5 mL 200 mg/5 mL 500 mg/5 mL 400 mg 200 mg Dose/Day (mL) Dose/Day (mL) Dose/Day (mL) Dose/Day Dose/Day 60 or greater Normal dose Normal dose Normal dose Normal dose Normal dose 21 to 59* OR renal hemodialysis* 13 6.5 2.6 Not Appropriate Not Appropriate 20 or less OR continuous peritoneal dialysis  8.6 4.4 1.8 0.5 tablet 1 tablet

  2.4 Reconstitution Directions for Oral Suspension

  Strength Bottle Size Reconstitution Directions 100 mg/5 mL and 200 mg/5 mL 100 mL To reconstitute, suspend with 68 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 100 mg/5 mL and 200 mg/5 mL 75 mL To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 100 mg/5 mL and 200 mg/5 mL 50 mL To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 200 mg/5 mL 37.5 mL To reconstitute, suspend with 26 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 200 mg/5 mL 25 mL To reconstitute, suspend with 17 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 500 mg/5 mL 20 mL To reconstitute, suspend with 14 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 500 mg/5 mL 10 mL To reconstitute, suspend with 8 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.

  After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.

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• Antara
  

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  Antara

  

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  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving Antara, and should continue this diet during treatment with Antara. Antara capsules can be given without regard to meals.

  Patients should be advised to swallow Antara capsules whole. Do not open, crush, dissolve or chew capsules.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Antara if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 90 mg once daily.

  2.2 Primary Hypercholesterolemia and Mixed Dyslipidemia

  The initial dose of Antara is 90 mg per day.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 30 to 90 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 90 mg per day.

  2.4 Impaired Renal Function

  Treatment with Antara should be initiated at a dose of 30 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Antara should be avoided in patients with severe renal impairment [see Use In Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

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• Antara
  

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  Antara

  

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  2.1 General Consideration

  Patients should be placed on an appropriate lipid-lowering diet before receiving Antara, and should continue this diet during treatment with Antara. Antara tablets can be given without regard to meals.

  Patients should be advised to swallow Antara capsules whole. Do not open, crush, dissolve or chew capsules.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Antara if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 130 mg once daily.

  2.2 Primary Hypercholesterolemia and Mixed Dyslipidemia

  The initial dose of Antara is 130 mg per day.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 43 to 130 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 130 mg per day.

  2.4 Impaired Renal Function

  Treatment with Antara should be initiated at a dose of 43 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Antara should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]

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