Pentoxifylline
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Uses
Pentoxifylline extended-release tablet is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablet can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
History
There is currently no drug history available for this drug.
Other Information
Pentoxifylline extended-release tablets for oral administration, contains 400 mg of the active drug and the following inactive ingredients: hydroxyethyl cellulose, isopropyl alcohol, magnesium stearate, povidone, and talc in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3,7-dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene.
The chemical structure is:
Molecular weight: 278.31
Molecular formula: C13H18N4O3
Sources
Pentoxifylline Manufacturers
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Lake Erie Medical Dba Quality Care Products Llc
![Pentoxifylline Tablet, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pentoxifylline | Lake Erie Medical Dba Quality Care Products Llc
The usual dosage of Pentoxifylline extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of Pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Pentoxifylline extended-release tablet should be discontinued.
In patients with severe renal impairment (creatinine clearance below 30 ml/min) reduce dose to 400 mg once a day. Dosing information cannot be provided for patients with hepatic impairment.
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Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Pentoxifylline | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline extended-release tablets may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline extended-release tablets should be discontinued.
In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day.
Dosing information cannot be provided for patients with hepatic impairment.
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State Of Florida Doh Central Pharmacy
Pentoxifylline | State Of Florida Doh Central Pharmacy
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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State Of Florida Doh Central Pharmacy
Pentoxifylline | State Of Florida Doh Central Pharmacy
The usual dosage of Pentoxifylline extended-release Tablet form is one tablet (400 mg) three times a day with meals.
While the effect of Pentoxifylline extended-release Tablet may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Pentoxifylline extended-release Tablet should be discontinued.
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State Of Florida Doh Central Pharmacy
Pentoxifylline | State Of Florida Doh Central Pharmacy
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Udl Laboratories, Inc.
Pentoxifylline | Mylan Institutional Inc.
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Stat Rx Usa Llc
Pentoxifylline | Stat Rx Usa Llc
The usual dosage of Pentoxifylline Extended-release Tablet form is one tablet (400 mg) three times a day with meals.
While the effect of Pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Pentoxifylline Extended-release Tablet should be discontinued.
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Cardinal Health
Pentoxifylline | Cardinal Health
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Cardinal Health
Pentoxifylline | Cardinal Health
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Cardinal Health
Pentoxifylline | Cardinal Health
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Pd-rx Pharmaceuticals, Inc.
Pentoxifylline | Pd-rx Pharmaceuticals, Inc.
The usual dosage of Pentoxifylline Extended-release Tablet form is one tablet (400 mg) three times a day with meals.
While the effect of Pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Pentoxifylline Extended-release Tablet should be discontinued.
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Golden State Medical Supply, Inc.
Pentoxifylline | Golden State Medical Supply, Inc.
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Mckesson Contract Packaging
Pentoxifylline | Mckesson Contract Packaging
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Major Pharmaceuticals
Pentoxifylline | Major Pharmaceuticals
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Preferred Pharmaceuticals, Inc.
Pentoxifylline | Preferred Pharmaceuticals, Inc.
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Physicians Total Care, Inc.
Pentoxifylline | Physicians Total Care, Inc.
The usual dosage of Pentoxifylline Extended-release Tablet form is one tablet (400 mg) three times a day with meals.
While the effect of Pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Pentoxifylline Extended-release Tablet should be discontinued.
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Bryant Ranch Prepack
Pentoxifylline | Bryant Ranch Prepack
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Remedyrepack Inc.
Pentoxifylline | Remedyrepack Inc.
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Cardinal Health
Pentoxifylline | Cardinal Health
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Avkare, Inc.
Pentoxifylline | Avkare, Inc.
The usual dosage of Pentoxifylline Extended-release Tablet form is one tablet (400 mg) three times a day with meals.
While the effect of Pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Pentoxifylline Extended-release Tablet should be discontinued.
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Aidarex Pharmaceuticals Llc
Pentoxifylline | Aidarex Pharmaceuticals Llc
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Aphena Pharma Solutions – Tennessee, Llc
Pentoxifylline | Aphena Pharma Solutions - Tennessee, Llc
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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Teva Pharmaceuticals Usa Inc
Pentoxifylline | Teva Pharmaceuticals Usa Inc
The usual dosage of Pentoxifylline extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of Pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of Pentoxifylline extended-release tablet should be discontinued.
In patients with severe renal impairment (creatinine clearance below 30 ml/min) reduce dose to 400 mg once a day. Dosing information cannot be provided for patients with hepatic impairment.
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Mylan Pharmaceuticals Inc.
Pentoxifylline | Baxter Healthcare Corporation
Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of NEXTERONE is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:
Table 1: NEXTERONE PREMIXED INJECTION DOSE RECOMMENDATIONS: FIRST 24 HOURSLoading infusions
First Rapid:
150 mg over the FIRST 10 minutes (15 mg/min).
Directly infuse NEXTERONE Premixed Injection (150 mg/100 mL; 1.5mg/mL) at a rate of 10mL/min.
Followed by
Slow:360 mg over the NEXT 6 hours (1 mg/min).
Directly infuse NEXTERONE Premixed Injection (360 mg/200 mL; 1.8 mg/mL) at a rate of 0.556 mL/min.
Maintenance infusion
540 mg over the REMAINING 18 hours (0.5 mg/min). Decrease the rate of the slow loading infusion to 0.5 mg/min. Directly infuse NEXTERONE Premixed Injection (360 mg/200 mL; 1.8 mg/mL) at a rate of 0.278 mL/min.
After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) by directly infusing NEXTERONE Premixed Injection (360 mg/200 mL; 1.8 mg/mL) at a rate of 0.278 mL/min. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression.
In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of NEXTERONE (infused over 10 minutes to minimize the potential for hypotension).
The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.
Based on the experience from clinical studies of intravenous amiodarone, a maintenance infusion of up to 0.5 mg/min can be continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks.
Administer NEXTERONE, whenever possible, through a central venous catheter dedicated to that purpose. Use an in-line filter during administration.
Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)].
Intravenous amiodarone concentrations greater than 3 mg/mL have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, do not exceed NEXTERONE concentrations of 2 mg/mL, unless a central venous catheter is used [see Adverse Reactions (6.2)].
NEXTERONE Premixed Injection is available in GALAXY containers as a single-use, ready-to-use, iso-osmotic solution in dextrose for intravenous administration. No further dilution is required. NEXTERONE Premixed Injection should not be combined with any product in the same intravenous line or premixed container. Do not add supplemental medication. Protect from light until ready to use.
NEXTERONE does not need to be protected from light during administration.
Since the premixed container is for single-use only, any unused portion should be discarded.
NOTE: Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit, solution should be clear. Visually inspect the container. If the administration port protector is damaged, detached or not present, discard the container as the solution path sterility may be compromised. Check for minute leaks prior to use by squeezing the bag firmly. If leaks are detected, discard solution as sterility may be impaired.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.
Preparation of NEXTERONE Premixed Injection for administration:
1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.Admixture Incompatibility
Table 2: Y-SITE INJECTION INCOMPATIBILITY D5W = Dextrose 5% in Sterile Water, NS = Normal Saline
Amiodarone in D5W Injection forms precipitates with the drugs shown in Table 2. If co-administration of the following drugs is necessary, use separate intravenous administration lines.
Drug
VehicleAmiodarone
ConcentrationAminophylline
D5W; NS
4 mg/mL
Amoxicillin Sodium-Clavulanic Acid
unknown
12.5 mg/mL
Ampicillin Sodium-Sulbactam Sodium
NS
6 mg/mL
Argatroban
D5W
1.8 mg/mL
Bivalirudin
D5W
4 mg/mL
Cefamandole Nafate
D5W
4 mg/mL
Cefazolin Sodium
D5W
4 mg/mL
Ceftazidime
D5W
6 mg/mL
Digoxin
D5W
6 mg/mL
Furosemide
(10 mg/mL)D5W
6 mg/mL
Mezlocillin Sodium
D5W
4 mg/mL
Heparin Sodium
D5W
--
Imipenem-Cilastin Sodium
D5W
6 mg/mL
Magnesium Sulfate (500 mg/mL)
D5W
6 mg/mL
Micafungin
NS
4 mg/mL
Piperacillin Sodium –Tazobactam Sodium
D5W
6 mg/mL
Potassium Phosphates
D5W
6 mg/mL
Sodium Bicarbonate
D5W
3 mg/mL
Sodium Nitroprusside
D5W
1.5, 6 and 15 mg/mL
Sodium Phosphates
D5W
6 mg/mL
Intravenous to Oral Transition
Patients whose arrhythmias have been suppressed by NEXTERONE may be switched to oral amiodarone. The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of NEXTERONE already administered, as well as the bioavailability of oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. See package insert for oral amiodarone.Since grapefruit juice is known to inhibit CYP3A-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone [see Drug Interactions (7)].
Table 3 provides suggested doses of oral amiodarone to be initiated after varying durations of NEXTERONE administration. These recommendations are made on the basis of a similar total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.
Table 3: RECOMMENDATIONS FOR ORAL DOSAGE AFTER INTRAVENOUS INFUSION * Assuming a 720 mg/day infusion (0.5 mg/min). † NEXTERONE is not intended for maintenance treatment.Duration of NEXTERONE Infusion*
Initial Daily Dose of
Oral Amiodarone< 1 week
800-1600 mg
1-3 weeks
600-800 mg
> 3 weeks†
400 mg
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Oceanside Pharmaceuticals
Pentoxifylline | Pack Pharmaceuticals, Llc
Dosage and Administration in Adults: Single DoseVaginal candidiasis: The recommended dosage of Fluconazole for vaginal candidiasis is 150 mg as a single oral dose.
Multiple DoseSINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.
The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Oropharyngeal candidiasis:The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis:The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
Systemic Candida infections:For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.
Urinary tract infections and peritonitis:For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50-200 mg have been used in open, noncomparative studies of small numbers of patients.
Cryptococcal meningitis:The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.
Prophylaxis in patients undergoing bone marrow transplantation:The recommended fluconazole daily dosage for the prevention of candidiasis of patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
Dosage and Administration in Children:The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
* Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended. Pediatric Patients Adults 3 mg/kg 100 mg 6 mg/kg 200 mg 12* mg/kg 400 mgExperience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns. (See CLINICAL PHARMACOLOGY.) Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding fluconazole pharmacokinetics in full-term newborns is available.
Oropharyngeal candidiasis:The recommended dosage of fluconazole for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis:For the treatment of esophageal candidiasis, the recommended dosage of fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms.
Systemic Candida infections:For the treatment of candidemia and disseminated Candida infections, daily doses of 6-12 mg/kg/day have been used in an open, noncomparative study of a small number of children.
Cryptococcal meningitis:For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of fluconazole is 6 mg/kg once daily.
Dosage In Patients With Impaired Renal Function:Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
Creatinine Clearance
(mL/min) Percent of
Recommended Dose >50 100% ≤50 (no dialysis) 50% Regular dialysis 100% after each dialysisThese are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:
Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:
Administration:Fluconazole tablets are administered orally. Fluconazole Tablets can be taken with or without food.
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Apotex Corp.
Pentoxifylline | Apotex Corp.
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day.
Dosing information cannot be provided for patients with hepatic impairment.
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