Salix Pharmaceuticals, Inc.

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Salix Pharmaceuticals, Inc. Drugs

Anusol Hc

Anusol Hc

Anusol-HC® 2.5% (Hydrocortisone Cream, USP) should be applied to the affected area two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Visicol

Visicol

The recommended dose of Visicol Tablets for colon cleansing for adult patients is 40 tablets (60 grams of sodium phosphate) taken orally with a total of 3.6 quarts of clear liquids in the following manner:

The evening before the colonoscopy procedure: Take 3 Visicol Tablets (the last dose will be 2 Visicol Tablets) with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets. On the day of the colonoscopy procedure: Starting 3-5 hours before the procedure, take 3 Visicol Tablets (the last dose will be 2 Visicol Tablets) with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets.

It is recommended that patients receiving Visicol be advised to adequately hydrate before, during, and after the use of Visicol.

Patients should not use Visicol within seven days of previous administration. No additional enema or laxative is required, and patients should be advised NOT to take additional agents, particularly those containing sodium phosphate.
Proctocort

Proctocort

For rectal administration. Detach one suppository from strip of suppositories. Remove the foil wrapper. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with gentle pressure, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.
Proctocort

Proctocort

Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Anusol Hc

Anusol Hc

Usual dosage: One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
Azasan

Azasan

TPMT TESTING CANNOT SUBSTITUTE FOR COMPLETE BLOOD COUNT (CBC) MONITORING IN PATIENTS RECEIVING AZASAN. TPMT genotyping or phenotyping can be used to identify patients with absent or reduced TPMT activity. Patients with low or absent TPMT activity are at an increased risk of developing severe, life-threatening myelotoxicity from AZASAN if conventional doses are given. Physicians may consider alternative therapies for patients who have low or absent TPMT activity (homozygous for non-functional alleles). AZASAN should be administered with caution to patients having one non-functional allele (heterozygous) who are at risk for reduced TPMT activity that may lead to toxicity if conventional doses are given. Dosage reduction is recommended in patients with reduced TPMT activity. Early drug discontinuation may be considered in patients with abnormal CBC results that do not respond to dose reduction.

Renal Homotransplantation: The dose of AZASAN required to prevent rejection and minimize toxicity will vary with individual patients; this necessitates careful management. The initial dose is usually 3 to 5 mg/kg daily, beginning at the time of transplant. AZASAN is usually given as a single daily dose on the day of, and in a minority of cases 1 to 3 days before, transplantation. Dose reduction to maintenance levels of 1 to 3 mg/kg daily is usually possible. The dose of AZASAN should not be increased to toxic levels because of threatened rejection. Discontinuation may be necessary for severe hematologic or other toxicity, even if rejection of the homograft may be a consequence of drug withdrawal.

Rheumatoid Arthritis: AZASAN is usually given on a daily basis. The initial dose should be approximately 1.0 mg/kg (50 to 100 mg) given as a single dose or on a twice-daily schedule. The dose may be increased, beginning at 6 to 8 weeks and thereafter by steps at 4-week intervals, if there are no serious toxicities and if initial response is unsatisfactory. Dose increments should be 0.5 mg/kg daily, up to a maximum dose of 2.5 mg/kg per day. Therapeutic response occurs after several weeks of treatment, usually 6 to 8; an adequate trial should be a minimum of 12 weeks. Patients not improved after 12 weeks can be considered refractory. AZASAN may be continued long-term in patients with clinical response, but patients should be monitored carefully, and gradual dosage reduction should be attempted to reduce risk of toxicities.

Maintenance therapy should be at the lowest effective dose, and the dose given can be lowered decrementally with changes of 0.5 mg/kg or approximately 25 mg daily every 4 weeks while other therapy is kept constant. The optimum duration of maintenance AZASAN has not been determined. AZASAN can be discontinued abruptly, but delayed effects are possible.

Use in Renal Dysfunction: Relatively oliguric patients, especially those with tubular necrosis in the immediate post-cadaveric transplant period, may have delayed clearance of AZASAN or its metabolites, may be particularly sensitive to this drug, and are usually given lower doses.

Procedures for proper handling and disposal of this immunosuppressive antimetabolite drug should be considered. Several guidelines on this subject have been published.25-31 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Metozolv Odt

Metozolv Odt

2.1 Important Instructions for Use

Take on an empty stomach at least 30 minutes before eating since food can decrease the peak concentrations of drug in the bloodstream and/or the time it takes to achieve the maximum drug level in the bloodstream [see Clinical Pharmacology (12.3)]. Do not repeat dose if inadvertently taken with food.

Since the tablet absorbs moisture rapidly, only remove each dose from the packaging just prior to taking. Handle the tablet with dry hands and place on the tongue. If the tablet should break or crumble while handling, discard and remove a new tablet.

METOZOLV ODT disintegrates on the tongue in approximately one minute (with a range of 10 seconds to 14 minutes). METOZOLV ODT is designed to be taken without liquid; however, the effect on the pharmacokinetics of METOZOLV ODT taken with liquid is unknown.

2.2 Symptomatic Gastroesophageal Reflux Disease

For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks in duration.

Take 10 mg to 15 mg dose of METOZOLV ODT up to four times daily (e.g., at least 30 minutes before each meal and at bedtime). Doses may vary depending upon the symptoms being treated and the clinical response. If symptoms only occur intermittently or at specific times of the day, metoclopramide may be used in single doses up to 20 mg prior to the symptoms rather than continuous treatment.

Since there is a poor correlation between symptomatic relief and healing of esophageal lesions, any therapy directed at esophageal lesions is best confirmed by endoscopic evaluation. Although experience with the effects of metoclopramide on esophageal erosions and ulcerations is limited, healing was documented in a controlled trial using four times daily therapy at 15 mg/dose. Prolonged treatment (>12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia. [see Warnings and Precautions (5.1)]

2.3 Diabetic Gastroparesis (Diabetic Gastric Stasis)

For the relief of symptoms associated with diabetic gastroparesis (diabetic gastric stasis), therapy of two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.

Take a 10 mg dose of METOZOLV ODT up to four times a day (e.g., at least 30 minutes before each meal and at bedtime).

The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of METOZOLV ODT may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection.

Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, METOZOLV ODT therapy should be reinstituted at the earliest manifestation.

2.4 Renal Impairment

Some patients, such as the elderly or those with impaired kidney function (creatinine clearance below 40 mL/min) may be more sensitive to the therapeutic dose or the adverse effects of metoclopramide. Therefore, these patients should start therapy at a lower dose (approximately half the recommended dosage) and the dose should be titrated according to their overall clinical response and/or adverse event profile. Dialysis is not likely to be an effective method of drug removal in overdose situations.
Colazal

Colazal

2.1 Adult Dose

For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg COLAZAL capsules to be taken 3 times a day (6.75 g per day) for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks.

2.2 Pediatric Dose

For treatment of active ulcerative colitis in pediatric patients, aged 5 to 17 years, the usual dose is EITHER:
• three 750 mg COLAZAL capsules 3 times a day (6.75 g per day) for up to 8 weeks; OR: • one 750 mg COLAZAL capsule 3 times a day (2.25 g per day) for up to 8 weeks.
Use of COLAZAL in the pediatric population for more than 8 weeks has not been evaluated in clinical trials. [See Clinical Studies Section (14)]

2.3 Administration Alternatives

COLAZAL capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on applesauce. The entire drug/applesauce mixture should be swallowed immediately; the contents may be chewed, if necessary, since contents of COLAZAL are NOT coated beads/granules. Patients should be instructed not to store any drug/applesauce mixture for future use.

If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.

Teeth and/or tongue staining may occur in some patients who use COLAZAL in sprinkle form with food.
Apriso

Apriso

The recommended dose for maintenance of remission of ulcerative colitis in adult patients is 1.5 g (four APRISO capsules) orally once daily in the morning. APRISO may be taken without regard to meals. APRISO should not be co-administered with antacids. An evaluation of renal function is recommended before initiating therapy with APRISO.
Fulyzaq

Fulyzaq

The recommended dose of FULYZAQ is one 125 mg delayed-release tablet taken orally two times a day, with or without food. FULYZAQ tablets should not be crushed or chewed. Tablets should be swallowed whole.
Osmoprep

Osmoprep

The recommended dose of OsmoPrep Tablets for colon cleansing for adult patients is 32 tablets (48 grams of sodium phosphate) taken orally with a total of 2 quarts of clear liquids in the following manner:

The evening before the colonoscopy: Take 4 OsmoPrep Tablets with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets.

On the day of the colonoscopy: Starting 3-5 hours before the procedure, take 4 OsmoPrep Tablets with 8 ounces of clear liquids every 15 minutes for a total of 12 tablets.

Examples of clear liquids are water, flavored water, lemonade (no pulp), ginger ale or apple juice. Do not drink any liquids colored purple or red.

Patients should be advised of the importance of taking the recommended fluid regimen. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.

Patients should not use OsmoPrep for colon cleansing within seven days of previous administration. No additional enema or laxative is required, and patients should be advised NOT to take additional agents, particularly those containing sodium phosphate.
Giazo

Giazo

The dose is three 1.1 g GIAZO tablets to be taken 2 times a day with or without food (6.6 g per day) for up to 8 weeks.
Cetirizine Hydrochlorid...

Cetirizine Hydrochloride

2.1 Dosage

The recommended dosage regimen is 1 metered dose administered rectally twice daily for 2 weeks followed by 1 metered dose administered rectally once daily for 4 weeks.

2.2 Administration Instructions

Advise patients:
UCERIS rectal foam is only to be applied rectally. It is not for oral use. Before using UCERIS rectal foam, use the bathroom to empty your bowels. Each applicator is coated with a lubricant. If additional lubrication is needed, petrolatum or petroleum jelly can also be used. Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use. UCERIS rectal foam can be used in a standing, lying or sitting position (e.g., while using the toilet). Apply UCERIS rectal foam in the morning and the evening for the first 2 weeks of treatment; then once daily in the evening for the next 4 weeks. When applied in the evening, use immediately prior to bedtime. Try not to empty your bowels again until the next morning. Avoid concomitant use of CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice) during treatment with UCERIS rectal foam.
Diuril

Diuril

Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.

Adults

For Edema

The usual adult dosage is 500 mg to 1000 mg (10 mL to 20 mL) once or twice a day. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.

For Control of Hypertension

The usual adult starting dosage is 500 mg to 1000 mg (10 mL to 20 mL) a day as a single or divided dose. Dosage is increased or decreased according to blood pressure response. Rarely some patients may require up to 2000 mg (40 mL) a day in divided doses.

Infants and Children

For Diuresis and For Control of Hypertension

The usual pediatric dosage is 5 mg to 10 mg per pound (10 mg/kg to 20 mg/kg) per day in single or two divided doses, not to exceed 375 mg per day (2.5 mL to 7.5 mL or ½ to 1½ teaspoonfuls of the oral suspension daily) in infants up to 2 years of age or 1000 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 15 mg per pound (30 mg/kg) per day in two divided doses may be required. (See PRECAUTIONS, Pediatric Use.)
Pepcid

Pepcid

Duodenal Ulcer

Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use PEPCID at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

Benign Gastric Ulcer

Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

Gastroesophageal Reflux Disease (GERD)

The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

Dosage for Pediatric Patients <1year of age Gastroesophageal Reflux Disease (GERD)

See PRECAUTIONS, Pediatric Patients < 1 year of age.

The studies described in PRECAUTIONS, Pediatric Patients < 1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

Dosage for Pediatric Patients 1‑16 years of age

See PRECAUTIONS, Pediatric Patients 1‑16 years of age.

The studies described in PRECAUTIONS, Pediatric Patients1‑16 years of age suggest the following starting doses in pediatric patients 1‑16 years of age:

Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1‑16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

The dosage of PEPCID in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Oral Suspension

PEPCID for Oral Suspension may be substituted for PEPCID Tablets in any of the above indications. Each five mL contains 40 mg of famotidine after constitution of the powder with 46 mL of Purified Water as directed.

Directions for Preparing PEPCID for Oral Suspension

Prepare suspension at time of dispensing. Slowly add 46 mL of Purified Water. Shake vigorously for 5‑10 seconds immediately after adding the water and immediately before use.

Stability of PEPCID for Oral Suspension

Unused constituted oral suspension should be discarded after 30 days.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of PEPCID is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of PEPCID may be reduced to half the dose or the dosing interval may be prolonged to 36‑48 hours as indicated by the patient's clinical response.

Based on the comparison of pharmacokinetic parameters for PEPCID in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
Relistor

Relistor

2.1 Important Administration Information
RELISTOR is for subcutaneous use only. Inject RELISTOR subcutaneously in the upper arm, abdomen or thigh.Do not inject at the same spot each time (rotate injection sites). Be within close proximity to toilet facilities once RELISTOR is administered. Discontinue RELISTOR if treatment with the opioid pain medication is also discontinued. In patients with chronic non-cancer pain and opioid-induced constipation: RELISTOR has been shown to be efficacious in patients who have taken opioids for at least 4 weeks. Sustained exposure to opioids prior to starting RELISTOR may increase the patient’s sensitivity to the effects of RELISTOR [see Clinical Studies (14.1)]. Discontinue all maintenance laxative therapy prior to initiation of RELISTOR. Laxative(s) can be used as needed if there is a suboptimal response to RELISTOR after three days. Inject one dose every day. Re-evaluate the continued need for RELISTOR when the opioid regimen is changed to avoid adverse reactions. In patients with advanced illness and opioid-induced constipation: Inject one dose every other day, as needed, but no more frequently than one dose in a 24-hour period.
2.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain

The recommended dosage of RELISTOR is 12 mg subcutaneously once daily [see Clinical Studies (14.1)].

2.3 Opioid-Induced Constipation in Adult Patients with Advanced Illness

The recommended dose of RELISTOR administered subcutaneously is 8 mg for adult patients weighing 38 kg to less than 62 kg and 12 mg for patients weighing 62 kg to 114 kg. Adult patients whose weight falls outside of these ranges should be dosed at 0.15 mg/kg. The recommended dosage regimen is one dose every other day, as needed [see Clinical Studies (14.2)].

See Table 1 to determine the correct dose by patient weight and injection volume to be administered. The pre-filled syringe is designed to deliver a fixed dose; therefore, adult patients requiring dosing calculated on a mg/kg basis should not be prescribed pre-filled syringes.

Table 1: Weight-Based Dosing of RELISTOR and Corresponding Injection Volume for Adult Patients with Opioid-Induced Constipation and Advanced Illness
Weight of Adults Patient
Subcutaneous Dose

Injection Volume

Less than 38 kg

0.15 mg/kg

See below*

38 kg to less than 62 kg

8 mg

0.4 mL

62 kg to 114 kg

12 mg

0.6 mL

More than 114 kg

0.15 mg/kg

See below*

*The injection volume for these patients should be calculated using the following method:

Multiply the patient weight in kilograms by 0.0075 and round up the volume to the nearest 0.1mL.

2.4 Use in Patients with Severe Renal Impairment

In adult patients with severe renal impairment (creatinine clearance less than 30 mL/min as estimated by Cockcroft-Gault), dose reduction of RELISTOR by one-half is recommended [see Use in Specific Populations (8.6)]. No dosage adjustment is recommended for adult patients with mild to moderate renal impairment.

The pre-filled syringe is designed to deliver a fixed dose; therefore, adult patients with severe renal impairment should only be prescribed single-use vials to ensure correct dosing.

2.5 Administration and Storage

RELISTOR is a sterile, clear, and colorless to pale yellow aqueous solution. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the vial if any of these are present.

Single-use Vials

Once drawn into the 1 mL syringe with a 27-gauge x ½-inch needle, if immediate administration is not possible, store at ambient room temperature and administer within 24 hours. Discard any unused portion that remains in the vial. Advise patients concerning proper training in subcutaneous technique.

Single-use Pre-filled Syringes

Only adult patients requiring an 8 mg or 12 mg dose should be prescribed pre-filled syringes. Do not remove the pre-filled syringe from the tray until ready to administer.

2.1 Important Administration Information
RELISTOR is for subcutaneous use only. Inject RELISTOR subcutaneously in the upper arm, abdomen or thigh.Do not inject at the same spot each time (rotate injection sites). Be within close proximity to toilet facilities once RELISTOR is administered. Discontinue RELISTOR if treatment with the opioid pain medication is also discontinued. In patients with chronic non-cancer pain and opioid-induced constipation: RELISTOR has been shown to be efficacious in patients who have taken opioids for at least 4 weeks. Sustained exposure to opioids prior to starting RELISTOR may increase the patient’s sensitivity to the effects of RELISTOR [see Clinical Studies (14.1)]. Discontinue all maintenance laxative therapy prior to initiation of RELISTOR. Laxative(s) can be used as needed if there is a suboptimal response to RELISTOR after three days. Inject one dose every day. Re-evaluate the continued need for RELISTOR when the opioid regimen is changed to avoid adverse reactions. In patients with advanced illness and opioid-induced constipation: Inject one dose every other day, as needed, but no more frequently than one dose in a 24-hour period.
2.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain

The recommended dosage of RELISTOR is 12 mg subcutaneously once daily [see Clinical Studies (14.1)].

2.3 Opioid-Induced Constipation in Adult Patients with Advanced Illness

The recommended dose of RELISTOR administered subcutaneously is 8 mg for adult patients weighing 38 kg to less than 62 kg and 12 mg for patients weighing 62 kg to 114 kg. Adult patients whose weight falls outside of these ranges should be dosed at 0.15 mg/kg. The recommended dosage regimen is one dose every other day, as needed [see Clinical Studies (14.2)].

See Table 1 to determine the correct dose by patient weight and injection volume to be administered. The pre-filled syringe is designed to deliver a fixed dose; therefore, adult patients requiring dosing calculated on a mg/kg basis should not be prescribed pre-filled syringes.

Table 1: Weight-Based Dosing of RELISTOR and Corresponding Injection Volume for Adult Patients with Opioid-Induced Constipation and Advanced Illness
Weight of Adults Patient
Subcutaneous Dose

Injection Volume

Less than 38 kg

0.15 mg/kg

See below*

38 kg to less than 62 kg

8 mg

0.4 mL

62 kg to 114 kg

12 mg

0.6 mL

More than 114 kg

0.15 mg/kg

See below*

*The injection volume for these patients should be calculated using the following method:

Multiply the patient weight in kilograms by 0.0075 and round up the volume to the nearest 0.1mL.

2.4 Use in Patients with Severe Renal Impairment

In adult patients with severe renal impairment (creatinine clearance less than 30 mL/min as estimated by Cockcroft-Gault), dose reduction of RELISTOR by one-half is recommended [see Use in Specific Populations (8.6)]. No dosage adjustment is recommended for adult patients with mild to moderate renal impairment.

The pre-filled syringe is designed to deliver a fixed dose; therefore, adult patients with severe renal impairment should only be prescribed single-use vials to ensure correct dosing.
Moviprep

Moviprep

2.1. Dosing Overview

There are two possible dosing regimens. Each regimen requires different dosing times:
Split-dose (2-Day) [see Dosage and Administration (2.2)] Evening only (1-Day) [see Dosage and Administration (2.3)]
Both MoviPrep dosing regimens require administration of MoviPrep using the mixing container provided to dilute powder for oral solution (contents of Pouch A and B) with water to the Fill line. Preparation of MoviPrep solution (the contents of one Pouch A and one Pouch B) occurs twice in each dosing regimen. Additional fluids must be consumed in both dosing regimens [see Dosage and Administration (2.2, 2.3)]. Instruct patients to consume only clear liquids (no solid food) from the start of MoviPrep treatment until after the colonoscopy [see Warnings and Precautions (5.1)]. Additionally, instruct patients to not consume any clear liquids at least 2 hours before the colonoscopy.

2.2. Split-dose (2-Day) Regimen (Preferred Method)

The Split-Dose regimen is the preferred dosing method. Instruct patients to take two separate doses in conjunction with fluids, as follows:

Dose 1 – Take this dose the evening before the colonoscopy (10 to 12 hours before Dose 2)

1. Empty the contents of 1 pouch A and 1 pouch B into the container that comes with MoviPrep.

2. Add lukewarm water to the Fill line on the container.

3. Mix to completely dissolve the contents of pouch A and B into the lukewarm water.

4. Drink one 8 oz. (ounce) glass (240 mL) every 15 minutes. Be sure to drink all of the solution. This should take about 1 hour.

5. Fill the container with 16 oz. (two 8 oz. glasses) of clear liquid and drink all of this liquid before going to bed.

Dose 2 – Take this dose the next morning, on the day of the colonoscopy (start at least 3 ½ hours prior to colonoscopy)

1. Repeat steps 1 through 4 from Dose 1 of the Split-dose (2-Day) instructions.

2. Fill the container with 16 oz. (two 8 oz. glasses) of clear liquid and drink all of this liquid at least 2 hours before the colonoscopy.

3. Drink only clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy.

2.3. Evening only (1-Day) Regimen (Alternative Method)

The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing regimen is inappropriate. Instruct patients to take two separate doses in conjunction with fluids as follows:

Dose 1 – Take this dose at least 3 ½ hours before bedtime the evening before the colonoscopy:

1. Empty the contents of 1 pouch A and 1 pouch B into the container that comes with MoviPrep.

2. Add lukewarm water to the Fill Line on the container.

3. Mix to completely dissolve the contents of pouch A and B into the lukewarm water.

4. Drink one 8 oz. (ounce) glass (240 mL) every 15 minutes. Be sure to drink all of the solution. This should take about 1 hour.

Dose 2 – Take Dose 2 about 1 ½ hours after starting Dose 1 on the evening before the colonoscopy:

1. Repeat Steps 1 through 4 from Dose 1 of the Evening only (1-Day) instructions.

2. After you complete step 1 through 4, fill the container again to the Fill Line with clear liquid and drink all of this liquid before going to bed.

3. Drink only clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy.

Additional Information:

MoviPrep solution may be refrigerated before drinking. Keep the mixed solution in an upright position and store in the refrigerator. MoviPrep should be taken within 24 hours after it is mixed in water. Do not add other ingredients to the MoviPrep solution.
Xifaxan

Xifaxan

2.1 Dosage for Travelers’ Diarrhea

The recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days.

2.2 Dosage for Hepatic Encephalopathy

The recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day.

2.3 Dosage for Irritable Bowel Syndrome with Diarrhea

The recommended dose of XIFAXAN is one 550 mg tablet taken orally three times a day for 14 days. Patients who experience a recurrence of symptoms can be retreated up to two times with the same dosage regimen.

2.4 Administration

XIFAXAN can be taken with or without food [see Clinical Pharmacology (12.3)].

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Salix Pharmaceuticals, Inc. Drugs