Ar Scientific, Inc.

Ar Scientific, Inc. Drugs

• Colcrys
  

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  Colcrys

  

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  The long term use of colchicine is established for FMF and the prophylaxis of gout flares but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for COLCRYS are different for each indication and must be individualized.

  The recommended dosage of COLCRYS depends on the patient's age, renal function, hepatic function, and use of co-administered drugs [see Dose Modification for Co-administration of Interacting Drugs (2.4)].

  COLCRYS tablets are administered orally, without regard to meals.

  COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.

  2.1 Gout Flares

  Prophylaxis of Gout Flares:

  The recommended dosage of COLCRYS for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 mg/day.

  Treatment of Gout Flares:

  The recommended dose of COLCRYS for treatment of a gout flare is 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.8 mg over a 1 hour period. COLCRYS may be administered for treatment of a gout flare during prophylaxis at doses not to exceed 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Wait 12 hours and then resume the prophylactic dose.

  2.2 FMF

  The recommended dosage of COLCRYS for FMF in adults is 1.2 mg to 2.4 mg daily.

  COLCRYS should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day. The total daily COLCRYS dose may be administered in one to two divided doses.

  2.3 Recommended Pediatric Dosage

  Prophylaxis and Treatment of Gout Flares:

  COLCRYS is not recommended for pediatric use in prophylaxis or treatment of gout flares.

  FMF:

  The recommended dosage of COLCRYS for FMF in pediatric patients 4 years of age and older is based on age. The following daily doses may be given as a single or divided dose twice daily:

  Children 4 – 6 years: 0.3 mg to 1.8 mg daily Children 6 – 12 years: 0.9 mg to 1.8 mg daily Adolescents older than 12 years: 1.2 mg to 2.4 mg daily

  2.4 Dose Modification for Co-administration of Interacting Drugs

  Concomitant Therapy:

  Co-administration of COLCRYS with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1). If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown on the table below [see DRUG INTERACTIONS (7)].

  Table 1 COLCRYS Dose Adjustment for Co-administration with Interacting Drugs if no Alternative Available* Strong CYP3A4 Inhibitors† * For magnitude of effect on colchicine plasma concentrations [ see Pharmacokinetics (12.3)] † Patients with renal or hepatic impairment should not be given COLCRYS in conjunction with strong CYP3A4 or P-gp inhibitors [ see CONTRAINDICATIONS (4)]. ‡ When used in combination with Ritonavir, see dosing recommendations for strong CYP3A4 inhibitors [ see CONTRAINDICATIONS (4)]. Drug Noted or Anticipated Outcome Gout Flares FMF Prophylaxis of Gout Flares Treatment of Gout Flares Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose AtazanavirClarithromycinDarunavir/Ritonavir‡ IndinavirItraconazole KetoconazoleLopinavir/Ritonavir‡ NefazodoneNelfinavirRitonavirSaquinavir TelithromycinTipranavir/Ritonavir‡ Significant increase in colchicine plasma levels*; fatal colchicine toxicity has been reported with clarithromycin, a strong CYP3A4 inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other strong CYP3A4 inhibitors. 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day 1.2 mg(2 tablets) followed by 0.6 mg(1 tablet)1 hour later. Dose to be repeated no earlier than3 days. 0.6 mg(1 tablet) ×1 dose, followed by 0.3 mg(1/2 tablet)1 hour later. Dose to be repeated no earlier than3 days. Maximum daily dose of 1.2 – 2.4 mg Maximum daily dose of 0.6 mg (may be given as0.3 mg twice a day) Moderate CYP3A4 Inhibitors Drug Noted or Anticipated Outcome Gout Flares FMF Prophylaxis of Gout Flares Treatment of Gout Flares Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Amprenavir‡ AprepitantDiltiazem Erythromycin Fluconazole Fosamprenavir‡ (pro-drug ofAmprenavir)Grapefruit Juice Verapamil Significant increase in colchicine plasma concentration is anticipated. Neuromuscular toxicity has been reported with diltiazem and verapamil interactions. 0.6 mg twice a day0.6 mg once a day 0.3 mg twice a day or 0.6 mg once a day0.3 mg once a day 1.2 mg(2 tablets) followed by 0.6 mg(1 tablet)1 hour later. Dose to be repeated no earlier than3 days. 1.2 mg(2 tablets) ×1 dose. Dose to be repeated no earlier than3 days. Maximum daily dose of 1.2 – 2.4 mg. Maximum daily dose of 1.2 mg (may be given as0.6 mg twice a day) P-gp Inhibitors† Drug Noted or Anticipated Outcome Gout Flares FMF Prophylaxis of Gout Flares Treatment of Gout Flares Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Cyclosporine Ranolazine Significant increase in colchicine plasma levels*; fatal colchicine toxicity has been reported with cyclosporine, aP-gp inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other P-gp inhibitors. 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day 1.2 mg(2 tablets) followed by 0.6 mg(1 tablet)1 hour later. Dose to be repeated no earlier than3 days. 0.6 mg(1 tablet) ×1 dose. Dose to be repeated no earlier than3 days. Maximum daily dose of 1.2 – 2.4 mg Maximum daily dose of 0.6 mg (may be given as0.3 mg twice a day) Table 2 COLCRYS Dose Adjustment for Co-administration with Protease Inhibitors Protease Inhibitor Clinical Comment w/Colchicine – Prophylaxis of Gout Flares w/Colchicine –Treatment of Gout Flares w/Colchicine – Treatment of FMF Atazanavir sulfate(Reyataz) Patients with renal or hepatic impairment should not be given colchicine with Reyataz. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day Darunavir (Prezista) Patients with renal or hepatic impairment should not be given colchicine with Prezista/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day Fosamprenavir (Lexiva) with Ritonavir Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day Fosamprenavir (Lexiva) Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. Original dose Adjusted dose 1.2 mg (2 tablets) × 1 dose. Dose to be repeated no earlier than 3 days. Maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day) 0.6 mg twice a day 0.3 mg twice a day or 0.6 mg once a day 0.6 mg once a day 0.3 mg once a day Indinavir (Crixivan) Patients with renal or hepatic impairment should not be given colchicine with Crixivan. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day Lopinavir/Ritonavir (Kaletra) Patients with renal or hepatic impairment should not be given colchicine with Kaletra. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day Nelfinavir mesylate (Viracept) Patients with renal or hepatic impairment should not be given colchicine with Viracept. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day Ritonavir (Norvir) Patients with renal or hepatic impairment should not be given colchicine with Norvir. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day Saquinavir mesylate (Invirase) Patients with renal or hepatic impairment should not be given colchicine with Invirase/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day Tipranavir (Aptivus) Patients with renal or hepatic impairment should not be given colchicine with Aptivus/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day0.6 mg once a day 0.3 mg once a day0.3 mg once every other day

  Treatment of gout flares with COLCRYS is not recommended in patients receiving prophylactic dose of COLCRYS and CYP3A4 inhibitors.

  2.5 Dose Modification in Renal Impairment

  Colchicine dosing must be individualized according to the patient's renal function [see Renal Impairment (8.6)].

  Clcr in mL/minute may be estimated from serum creatinine (mg/dL) determination using the following formula:

  Clcr = [140-age (years) × weight (kg)]   × 0.85 for female patients 72 × serum creatinine (mg/dL)

  Gout Flares:

  Prophylaxis of Gout Flares:

  For prophylaxis of gout flares in patients with mild (estimated creatinine clearance Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].

  Treatment of Gout Flares:

  For treatment of gout flares in patients with mild (Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every 2 weeks. For patients with gout flares requiring repeated courses consideration should be given to alternate therapy. For patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (1 tablet). For these patients, the treatment course should not be repeated more than once every 2 weeks [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].

  Treatment of gout flares with COLCRYS is not recommended in patients with renal impairment who are receiving COLCRYS for prophylaxis.

  FMF:

  Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing dialysis. For these patients, the dosage should be reduced [see Clinical Pharmacology (12.3)]. Patients with mild (Clcr 50 – 80 mL/min) and moderate (Clcr 30 – 50 mL/min) renal impairment should be monitored closely for adverse effects of COLCRYS. Dose reduction may be necessary. For patients with severe renal failure (Clcr less than 30 mL/minute), start with 0.3 mg/day; any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Renal Impairment (8.6)]. For patients undergoing dialysis, the total recommended starting dose should be 0.3 mg (half tablet) per day. Dosing can be increased with close monitoring. Any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].

  2.6 Dose Modification in Hepatic Impairment

  Gout Flares

  Prophylaxis of Gout Flares:

  For prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. Dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see Hepatic Impairment (8.7)].

  Treatment of Gout Flares:

  For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, for the treatment of gout flares in patients with severe impairment while the dose does not need to be adjusted, but a treatment course should be repeated no more than once every 2 weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Hepatic Impairment (8.7)].

  Treatment of gout flares with COLCRYS is not recommended in patients with hepatic impairment who are receiving COLCRYS for prophylaxis.

  FMF:

  Patients with mild to moderate hepatic impairment should be monitored closely for adverse effects of colchicine. Dose reduction should be considered in patients with severe hepatic impairment [see Hepatic Impairment (8.7)].

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• Fibricor
  

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  Fibricor

  

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  2.1 General Considerations

  FIBRICOR can be given without regard to meals.

  Patients should be advised to swallow FIBRICOR tablets whole. Do not crush, dissolve or chew tablets.

  Patients should be placed on an appropriate lipid-lowering diet before receiving FIBRICOR and should continue this diet during treatment with fenofibric acid.

  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.

  Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of FIBRICOR. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 105 mg per day.

  Consideration should be given to reducing the dosage of FIBRICOR if lipid levels fall significantly below the targeted range.

  2.2 Severe Hypertriglyceridemia

  The initial dose is 35 to 105 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 105 mg once daily.

  2.3 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The dose of FIBRICOR is 105 mg per day.

  2.4 Impaired Renal Function

  In patients with mild-to-moderate renal impairment, treatment with FIBRICOR should be initiated at a dose of 35 mg once daily, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of FIBRICOR 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 (8.5) and Clinical Pharmacology (12.3)].

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• Qualaquin
  

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  Qualaquin

  

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  2.1 Treatment of Uncomplicated P. falciparum Malaria

  For treatment of uncomplicated P. falciparum malaria in adults: Orally, 648 mg (two capsules) every 8 hours for 7 days [see Clinical Studies (14)].

  QUALAQUIN should be taken with food to minimize gastric upset [see Clinical Pharmacology (12.3)].

  2.2 Renal Impairment

  In patients with acute uncomplicated malaria and severe chronic renal impairment, the following dosage regimen is recommended: one loading dose of 648 mg QUALAQUIN followed 12 hours later by maintenance doses of 324 mg every 12 hours.

  The effects of mild and moderate renal impairment on the safety and pharmacokinetics of quinine sulfate are not known [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

  2.3 Hepatic Impairment

  Adjustment of the recommended dose is not required in mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, but patients should be monitored closely for adverse effects of quinine. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

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• Bactrim Ds
  

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  Bactrim Ds

  

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  BACTRIM is contraindicated in pediatric patients less than 2 months of age.

  Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children:

  Adults: The usual adult dosage in the treatment of urinary tract infections is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.

  Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:

  Children 2 months of age or older: Weight Dose–every 12 hours lb kg Tablets 22 10 – 44 20 1 66 30 1½ 88 40 2 or 1 DS tablet

  For Patients with Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table:

  CreatinineClearance (mL/min) RecommendedDosage Regimen Above 30 Usual standard regimen 15–30 ½ the usual regimen Below 15 Use not recommended

  Acute Exacerbations of Chronic Bronchitis in Adults:

  The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 14 days.

  Pneumocystis Jiroveci Pneumonia:

  Treatment: Adults and Children:

  The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage:

  Weight Dose–every 6 hours lb kg Tablets 18 8 – 35 16 1 53 24 1½ 70 32 2 or 1 DS tablet 88 40 2½ 106 48 3 or 1½ DS tablets 141 64 4 or 2 DS tablets 176 80 5 or 2½ DS tablets

  For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.

  Prophylaxis:

  Adults:

  The recommended dosage for prophylaxis in adults is 1 BACTRIM DS (double strength) tablet daily.12

  Children:

  For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.13 The following table is a guideline for the attainment of this dosage in children:

  Body Surface Area Dose–every 12 hours (m2) Tablets 0.26 – 0.53 ½ 1.06 1

  Traveler's Diarrhea in Adults:

  For the treatment of traveler's diarrhea, the usual adult dosage is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 5 days.

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