Limovan may be available in the countries listed below.
Ingredient matches for Limovan
Eszopiclone
Zopiclone is reported as an ingredient of Limovan in the following countries:
- Spain
International Drug Name Search
Sunday 25 April 2010
Osteo Bi-Flex Triple Strength
Generic Name: chondroitin and glucosamine (kon DROI tin and gloo KOE sa meen)
Brand Names: Cosamin DS, Osteo Bi-Flex, Osteo Bi-Flex Double Strength, Osteo Bi-Flex Triple Strength, Pryflex, Relamine, Schiff Move Free, Schiff Move Free Caplets
What is Osteo Bi-Flex Triple Strength (chondroitin and glucosamine)?
Chondroitin is a naturally occurring substance formed of sugar chains. Chondroitin is believed to help the body maintain fluid and flexibility in the joints.
Glucosamine is sugar protein that is believed to help develop and renew cartilage (the hard connective tissue mainly located on bones near joints in the body), and keep it lubricated for better joint movement and flexibility.
The combination of chondroitin and glucosamine is widely used to aid in maintaining healthy joints. It is also used as a nutritional supplement in people with osteoarthritis or other inflammatory joint disorders.
Not all uses for chondroitin and glucosamine have been approved by the FDA. Chondroitin and glucosamine should not be substituted for medications prescribed for you by your doctor.
Chondroitin and glucosamine is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Chondroitin and glucosamine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Osteo Bi-Flex Triple Strength (chondroitin and glucosamine)?
Not all uses for chondroitin and glucosamine have been approved by the FDA. Chondroitin and glucosamine should not be substituted for medications prescribed for you by your doctor.
Chondroitin and glucosamine is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Before using chondroitin and glucosamine, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use chondroitin and glucosamine if you have diabetes, a bleeding or blood clotting disorder such as hemophilia, if you have allergies to certain drugs, if you are overweight, or if you are on a low-salt diet.
Use chondroitin and glucosamine as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.
Do not take chondroitin and glucosamine without the advice of a healthcare provider if you are using insulin, or a blood thinner such as warfarin (Coumadin). Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin and glucosamine. Chitosan can make it harder for your body to absorb chondroitin.
What should I tell my healthcare provider before taking Osteo Bi-Flex Triple Strength (chondroitin and glucosamine)?
Before using chondroitin and glucosamine, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use chondroitin and glucosamine if you have:
diabetes;
a bleeding or blood clotting disorder such as hemophilia;
if you have allergies to certain drugs;
if you are overweight; or
if you are on a low-salt diet.
Chondroitin and glucosamine may or may not be harmful to an unborn baby. Do not use this product without talking to a healthcare provider if you are pregnant or plan to become pregnant during treatment. It is not known whether chondroitin and glucosamine can pass into breast milk or if it could harm a nursing baby. Ask your healthcare provider before using chondroitin and glucosamine if you are breast-feeding a baby.
How should I take Osteo Bi-Flex Triple Strength (chondroitin and glucosamine)?
When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.
If you choose to take chondroitin and glucosamine, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of chondroitin and glucosamine than is recommended on the label.
Chondroitin and glucosamine is usually taken 1 or 2 times per day. You may need to take the medication 3 times per day for the first couple of months of treatment. Follow your doctor's instructions.
Glucosamine may increase the glucose (sugar) levels in your blood. If you have diabetes, you may need to check your blood sugar more often while taking this medication. You may also need to adjust your insulin dosage. Do not change your dose or medication schedule without advice from your doctor.
Chondroitin and glucosamine may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
Store this medication at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Osteo Bi-Flex Triple Strength (chondroitin and glucosamine)?
Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin and glucosamine. Chitosan can make it harder for your body to absorb chondroitin.
Osteo Bi-Flex Triple Strength (chondroitin and glucosamine) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects may include:
mild nausea, upset stomach;
heartburn; or
diarrhea.
This is not a complete list of side effects and others may occur. Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Osteo Bi-Flex Triple Strength (chondroitin and glucosamine)?
Do not take chondroitin and glucosamine without the advice of a healthcare provider if you are using any of the following medications:
insulin; or
a blood thinner such as warfarin (Coumadin).
This list is not complete and other drugs may interact with chondroitin and glucosamine. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Osteo Bi-Flex Triple Strength resources
- Osteo Bi-Flex Triple Strength Use in Pregnancy & Breastfeeding
- Osteo Bi-Flex Triple Strength Drug Interactions
- 0 Reviews for Osteo Bi-Flex Triple Strength - Add your own review/rating
- Osteo Bi-Flex Triple Strength caplets
- Relamine MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Osteo Bi-Flex Triple Strength with other medications
- Dietary Supplementation
- Osteoarthritis
Where can I get more information?
- Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.
Tuesday 20 April 2010
Trandate
Trandate is a brand name of labetalol, approved by the FDA in the following formulation(s):
TRANDATE (labetalol hydrochloride - tablet; oral)
Manufacturer: PROMETHEUS LABS
Approval date: August 1, 1984
Strength(s): 200MG [RLD][AB]
Manufacturer: PROMETHEUS LABS
Approval date: May 24, 1985
Strength(s): 100MG [AB]
Has a generic version of Trandate been approved?
Yes. The following products are equivalent to Trandate:
labetalol hydrochloride tablet; oral
Manufacturer: IVAX SUB TEVA PHARMS
Approval date: August 3, 1998
Strength(s): 100MG [AB], 200MG [AB]
Manufacturer: SANDOZ
Approval date: August 4, 1998
Strength(s): 100MG [AB], 200MG [AB]
Manufacturer: WATSON LABS
Approval date: August 3, 1998
Strength(s): 100MG [AB], 200MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Trandate. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
There are no current U.S. patents associated with Trandate.
See also...
- Trandate Consumer Information (Wolters Kluwer)
- Trandate Tablets Consumer Information (Wolters Kluwer)
- Trandate Consumer Information (Cerner Multum)
- Trandate Advanced Consumer Information (Micromedex)
- Trandate Intravenous Advanced Consumer Information (Micromedex)
- Labetalol Consumer Information (Wolters Kluwer)
- Labetalol Tablets Consumer Information (Wolters Kluwer)
- Labetalol Consumer Information (Cerner Multum)
- Labetalol Advanced Consumer Information (Micromedex)
- Labetalol Intravenous Advanced Consumer Information (Micromedex)
- Labetalol Hydrochloride AHFS DI Monographs (ASHP)
Saturday 17 April 2010
Bimectin Paste
Generic Name: ivermectin paste
Dosage Form: FOR ANIMAL USE ONLY
INDICATIONS: Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. Bimectin (ivermectin) Paste provides effective treatment and control of the following parasites in horses. Large Strongyles (adults)- Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus and Craterostomum acuticaudatum; Small Strongyles(adults, including those resistant to some benzimidazole class compounds)- Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus and Petrovinema poculatum; Small Strongyles - Fourth-stage larvae; Pinworms (adults and fourth-stage larvae)- Oxyuris equi, Ascarids (adults, third-stage and fourth-stage larvae)- Parascaris equorum; Hairworms (adults)- Trichostrogylus acei, Large-mouth Stomach Worms (adults)- Habronema muscae, Bots (oral and gastric stages)- Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults ad fourth-stage larvae)- Dictyocaulus arnfieldi, Intestinal Threadworms(adults)- Strongyloids westeri, Summer Sorescaused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
DOSAGE AND ADMINISTRATION: This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91mcg invermectin per lb (200 mcg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight.
(1) While holding plunger, turn knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking. (2) Lock the ring in place by making a 1/4 turn to the right. (3) Make sure that the horse's mouth contains no feed. (4) Remove the cover from the tip of the syringe. (5) Insert the syringe tip into the horse's mouth at the space between the teeth. (6) Depress the plunger as far as it will go, depositing paste on the back of the tongue. (7) Immediately raise the horse's head for a few seconds after dosing.
PARASITE CONTROL PROGRAM: All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. Bimectin (ivermectin) Paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.
PRODUCT ADVANTAGES: Broad-spectrum Control - Bimectin (ivermectin) Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a singe dose. Bimectin (ivermectin) Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.
ANIMAL SAFETY: Bimectin (ivermectin) Paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.
WARNING: Do not use in horses intended for human consumption.
Not for use in humans. Keep this and all drugs out of reach of children. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information or to obtain MSDS, contact Bimeda, Inc. at 1-888-524-6332.
Bimectin (ivermectin) Paste hs been formulated specifically for use in horses only. This product should not be used in other animal species adverse reactions, including fatalities in dogs, may result.
Environmental Safety: Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.
INFORMATION FOR HORSE OWNERS: Swelling and itching reactions after treatment with Bimectin (ivermectin) Paste have occurred in horses carrying heavy infections of neck threadworms (Onchocerca sp. microfilariae). These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment ma be advisable. Consult our veterinarian should an such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Bimectin (ivermectin) Paste. Reinfection, and measures for its prevention, should also be considered. Consult our veterinarian if the condition does not improve.
STORAGE INFORMATION: Store at 68deg.F-77deg. F (20deg.-25deg.C). Excursions between 59deg.F-86deg.F (15deg.C-30deg.C) are permitted.
TAKE TIME
OBSERVE LABEL DIRECTIONS
For Oral Use In Horses Only
Bimectin
(ivermectin)
Paste
1.87%
Anthelmintic and Boticide
Net Wt. 0.21 oz (6.08 g)
Removes worms and bots with a single dose.
Contents will treat up to 1250 lb body weight
ANADA# 200-326, Approved by FDA
Bimeda
Apple Flavored
| BIMECTIN ivermectin paste | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANADA | ANADA200326 | 01/19/2005 | |
| Labeler - Bimeda, Inc. Division of CrossVetpharm Group (043653216) |
| Registrant - Bimeda, Inc. Division of CrossVetpharm Group (043653216) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bimeda-MTC Animal Health, Division of Cross Vetpharm Group | 256232216 | manufacture | |
Wednesday 14 April 2010
Nicoxatin
Nicoxatin may be available in the countries listed below.
Ingredient matches for Nicoxatin
Inositol Nicotinate
Inositol Nicotinate is reported as an ingredient of Nicoxatin in the following countries:
- Japan
International Drug Name Search
Tuesday 13 April 2010
Riabroxol
Riabroxol may be available in the countries listed below.
Ingredient matches for Riabroxol
Ambroxol
Ambroxol is reported as an ingredient of Riabroxol in the following countries:
- Oman
International Drug Name Search
Laxodad
Laxodad may be available in the countries listed below.
Ingredient matches for Laxodad
Lactulose
Lactulose is reported as an ingredient of Laxodad in the following countries:
- Bahrain
- Iraq
- Lebanon
- Libya
- Nigeria
- Oman
- Saudi Arabia
- Somalia
- Sudan
- United Arab Emirates
- Yemen
International Drug Name Search
Thursday 1 April 2010
OsmoPrep
sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic
Dosage Form: tablet
WARNINGS
There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteriodal anti-inflammatory drugs [NSAIDs]).
See WARNINGS.
It is important to use the dose and dosing regimen as recommended (pm/am split dose).
See DOSAGE and ADMINISTRATION.
OsmoPrep Description
OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) is a purgative used to clean the colon prior to colonoscopy. OsmoPrep is manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). OsmoPrep Tablets are oval, white to off-white compressed tablets, debossed with “SLX” on one side of the bisect and “102” on the other side of the bisect. Each OsmoPrep tablet contains 1.102 grams of sodium phosphate monobasic monohydrate, USP and 0.398 grams of sodium phosphate dibasic anhydrous, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF. OsmoPrep is gluten-free.
The structural and molecular formulae and molecular weights of the active ingredients are shown below:
- Sodium phosphate monobasic monohydrate, USP
Molecular Formula: NaH2PO4 • H2O
Molecular Weight: 137.99 - Sodium phosphate dibasic anhydrous, USP
Molecular Formula: Na2HPO4
Molecular Weight: 141.96
OsmoPrep Tablets are for oral administration only.
OsmoPrep - Clinical Pharmacology
OsmoPrep Tablets, a dosing regimen containing 48 grams of sodium phosphate (32 tablets), induces diarrhea, which effectively cleanses the entire colon. Each administration has a purgative effect for approximately 1 to 3 hours. The primary mode of action is thought to be through the osmotic effect of sodium, causing large amounts of water to be drawn into the colon, promoting evacuation.
Pharmacokinetics
Pharmacokinetic studies with OsmoPrep have not been conducted. However, the following pharmacokinetic study was conducted with Visicol® tablets which contain the same active ingredients (sodium phosphate) as OsmoPrep. In addition, Visicol is administered at a dose that is 25% greater than the OsmoPrep dose.
An open-label pharmacokinetic study of Visicol in healthy volunteers was performed to determine the concentration-time profile of serum inorganic phosphorus levels after Visicol administration. All subjects received the approved Visicol dosing regimen (60 grams of sodium phosphate with a total liquid volume of 3.6 quarts) for colon cleansing. A 30 gram dose (20 tablets given as 3 tablets every 15 minutes with 8 ounces of clear liquids) was given beginning at 6 PM in the evening. The 30 gram dose (20 tablets given as 3 tablets every 15 minutes with 8 ounces of clear liquids) was repeated the following morning beginning at 6 AM.
Twenty-three healthy subjects (mean age 57 years old; 57% male and 43% female; and 65% Hispanic, 30% Caucasian, and 4% African-American) participated in this pharmacokinetic study. The serum phosphorus level rose from a mean (± standard deviation) baseline of 4.0 (± 0.7) mg/dL to 7.7 (± 1.6 mg/dL), at a median of 3 hours after the administration of the first 30-gram dose of sodium phosphate tablets (see Figure 1). The serum phosphorus level rose to a mean of 8.4 (± 1.9) mg/dL, at a median of 4 hours after the administration of the second 30-gram dose of sodium phosphate tablets. The serum phosphorus level remained above baseline for a median of 24 hours after the administration of the initial dose of sodium phosphate tablets (range 16 to 48 hours).
Figure 1. Mean (± standard deviation) serum phosphorus concentrations
The upper (4.5 mg/dL) and lower (2.6 mg/dL) reference limits for serum phosphate are represented by solid bars.
Special Populations
Renal Insufficiency: The effect of renal dysfunction on the pharmacokinetics of OsmoPrep Tablets has not been studied. Since the inorganic form of phosphate in the circulating plasma is excreted almost entirely by the kidneys, patients with renal disease may have difficulty excreting a large phosphate load. Thus, OsmoPrep Tablets should be used with caution in patients with impaired renal function (see WARNINGS).
Hepatic Insufficiency: OsmoPrep Tablets have not been investigated in patients with hepatic failure.
Geriatric: In a single pharmacokinetic study of sodium phosphate tablets, which included 6 elderly volunteers, plasma half-life increased two-fold in subjects > 70 years of age compared to subjects < 50 years of age (3 subjects and 5 subjects, respectively).
Gender: No difference in serum phosphate AUC values were observed in the single pharmacokinetic study conducted with sodium phosphate tablets in 13 male and 10 female healthy volunteers.
Clinical Studies
The colon cleansing efficacy and safety of OsmoPrep was evaluated in 2 randomized, investigator-blinded, actively controlled, multicenter, U.S. trials in patients scheduled to have an elective colonoscopy. The trials consisted of a dose ranging and a confirmatory phase 3 study.
In the phase 3 trial, patients were randomized into one of the following three sodium phosphate treatment groups: 1) Visicol containing 60 grams of sodium phosphate given in split doses (30 grams in the evening before the colonoscopy and 30 grams on the next day) with at least 3.6 quarts of clear liquids; 2) OsmoPrep containing 60 grams of sodium phosphate given in split doses (30 grams in the evening before the colonoscopy and 30 grams on the next day) with 2.5 quarts of clear liquids; and 3) OsmoPrep containing 48 grams of sodium phosphate (30 grams in the evening before the colonoscopy and 18 grams on the next day) with 2 quarts of clear liquids. Patients were instructed to eat a light breakfast before noon on the day prior to the colonoscopy and then were told to drink only clear liquids after noon on the day prior to the colonoscopy.
The primary efficacy endpoint was the overall colon cleansing response rate in the 4-point Colonic Contents Scale. Response was defined as a rating of “excellent” or “good” on the 4-point scale as determined by the blinded colonoscopist. This phase 3 study was planned to assess the non-inferiority of the two OsmoPrep groups compared to the Visicol group.
The efficacy analysis included 704 adult patients who had an elective colonoscopy. Patients ranged in age from 21 to 89 years old (mean age 56 years old) with 55% female and 45% male patients. Race was distributed as follows: 87% Caucasian, 10% African American, and 3% other race. The OsmoPrep 60 gram and 48 gram treatment groups demonstrated non-inferiority compared to Visicol. See Table 1 for the results.
| Table 1: Phase 3 Study – Overall Colon Content Cleansing Response Rates1 | ||||||||
| Treatment Arm (grams of sodium phosphate) | No. of tablets taken at 6 PM on the day prior to colonoscopy | No. of tablets taken the next day2 | Excellent | Good | Fair | Inadequate | Overall Response Rate (Excellent or Good) | |
|---|---|---|---|---|---|---|---|---|
| 1Colon-cleansing efficacy was based on response rate to treatment. A patient was considered to be a responder if overall colon cleansing was rated as “excellent” or “good” on a 4-point scale based on the amount of retained “colonic contents.” Excellent was defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good was defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization. Fair was defined as >90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed. Inadequate was defined as <90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed. 2 On the day of the colonoscopy, study medication was taken 3 to 5 hours before the start of the colonoscopy. | ||||||||
| OsmoPrep 32 tabs (48 g) n=236 | 20 | 12 | 76% | 19% | 3% | 2% | 95% | |
| OsmoPrep 40 tabs (60 g) n=233 | 20 | 20 | 73% | 24% | 2% | 1% | 97% | |
| Visicol 40 tabs (60 g) n=235 | 20 | 20 | 51% | 43% | 6% | 0% | 94% | |
Electrolyte Changes
In the OsmoPrep clinical studies, expected serum electrolyte changes (including phosphate, calcium, potassium, and sodium levels) have been observed in patients taking OsmoPrep. In the overwhelming majority of patients, electrolyte abnormalities were not associated with any adverse events.
In the OsmoPrep phase 3 study, 96%, 96%, and 93% of patients who took 60 grams of Visicol, 60 grams of OsmoPrep, and 48 grams of OsmoPrep, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy. In this study, patients who took 60 grams of Visicol, 60 grams of OsmoPrep, and 48 grams of OsmoPrep had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy.
In the OsmoPrep phase 3 study, 20%, 22%, and 18% of patients who took 60 grams of Visicol, 60 grams of OsmoPrep, and 48 grams of OsmoPrep, respectively, developed hypokalemia (defined as a potassium level < 3.4 mEq/L) on the day of the colonoscopy. In this study, patients who took 60 grams of Visicol, 60 grams of OsmoPrep, and 48 grams of OsmoPrep all had baseline potassium levels of about 4.3 mEq/L and then developed a mean potassium level of 3.7 mEq/L on the day of the colonoscopy.
In the OsmoPrep phase 3 trial, several patients on all three sodium phosphate regimens developed hypocalcemia and hypernatremia that did not require treatment.
Indications and Usage for OsmoPrep
OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.
Contraindications
OsmoPrep Tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy.
OsmoPrep Tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients.
Warnings
Administration of sodium phosphate products prior to colonoscopy for colon cleansing has resulted in fatalities due to significant fluid shifts, severe electrolyte abnormalities, and cardiac arrhythmias. These fatalities have been observed in patients with renal insufficiency, in patients with bowel perforation, and in patients who misused or overdosed sodium phosphate products. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.
Considerable caution should be advised before OsmoPrep Tablets are used in patients with the following illnesses: severe renal insufficiency (creatinine clearance less than 30 mL/minute), congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute bowel obstruction, pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome.
Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in patients who may be at increased risk for serious adverse events, including those with history of renal insufficiency, history of-or at greater risk of-acute phosphate nephropathy, known or suspected electrolyte disorders, seizures, arrhythmias, cardiomyopathy, prolonged QT, recent history of a MI and those with known or suspected hyperphosphatemia, hypocalcemia, hypokalemia, and hypernatremia. Also if patients develop vomiting and/or signs of dehydration then measure post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN).
Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders
There have been rare, but serious, reports of renal failure, acute phosphate nephropathy, and nephrocalcinosis in patients who received oral sodium phosphate products (including oral sodium phosphate solutions and tablets) for colon cleansing prior to colonoscopy. These cases often resulted in permanent impairment of renal function and several patients required long-term dialysis. The time to onset is typically within days; however, in some cases, the diagnosis of these events has been delayed up to several months after the ingestion of these products. Patients at increased risk of acute phosphate nephropathy may include patients with the following: hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal perfusion or function [such as diuretics, angiotensin converting enzyme (ACE)inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs).
Use OsmoPrep with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OsmoPrep Tablets.
Seizures
There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of sodium phosphate products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. OsmoPrep should be used with caution in patients with a history of seizures and in patients at higher risk of seizure [patients using concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].
Cardiac Arrhythmias
There have been rare, but serious, reports of arrhythmias associated with the use of sodium phosphate products. OsmoPrep should be used with caution in patients with higher risk of arrhythmias (patients with a history of cardiomyopathy, patients with prolonged QT, patients with a history of uncontrolled arrhythmias, and patients with a recent history of a myocardial infarction). Pre-dose and post-colonoscopy ECGs should be considered in patients with high risk of serious, cardiac arrhythmias.
Precautions
General
Patients should be instructed to drink 8 ounces of clear liquids with each 4-tablet dose of OsmoPrep Tablets. Patients should take a total of 2 quarts of clear liquids with OsmoPrep. Inadequate fluid intake, as with any effective purgative, may lead to excessive fluid loss, hypovolemia, and dehydration. Dehydration from purgation may be exacerbated by inadequate oral fluid intake, vomiting, and/or use of diuretics.
Patients should be instructed not to administer additional laxative or purgative agents, particularly additional sodium phosphate-based purgative or enema products.
Prolongation of the QT interval has been observed in some patients who were dosed with sodium phosphate colon preparations. QT prolongation with sodium phosphate tablets has been associated with electrolyte imbalances, such as hypokalemia and hypocalcemia. OsmoPrep Tablets should be used with caution in patients who are taking medications known to prolong the QT interval, since serious complications may occur. Pre-dose and post-colonoscopy ECGs should be considered in patients with known prolonged QT.
Administration of OsmoPrep Tablets may induce colonic mucosal aphthous ulcerations, since this endoscopic finding was observed with other sodium phosphate cathartic preparations. In the OsmoPrep clinical program, aphthous ulcers were observed in 3% of patients who took the 48 gram OsmoPrep dosing regimen. This colonoscopic finding should be considered in patients with known or suspected inflammatory bowel disease.
Because published data suggest that sodium phosphate absorption may be enhanced in patients experiencing an acute exacerbation of chronic inflammatory bowel disease, OsmoPrep Tablets should be used with caution in such patients.
Drug Interactions
Medications administered in close proximity to OsmoPrep Tablets may not be absorbed from the gastrointestinal tract due to the rapid intestinal peristalsis and watery diarrhea induced by the purgative agent.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of OsmoPrep. Studies to evaluate the effect of OsmoPrep on fertility or its mutagenic potential have not been performed.
Pregnancy. Teratogenic Effects: Pregnancy Category C
Animal reproduction studies have not been conducted with OsmoPrep. It is not known whether OsmoPrep can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. OsmoPrep Tablets should be given to a pregnant woman only if clearly needed.
Pediatric Use
The safety and efficacy of OsmoPrep Tablets have not been demonstrated in patients less than 18 years of age.
Geriatric Use
In controlled colon preparation trials of OsmoPrep, 228 (24%) of 931 patients were 65 years of age or older. In addition, 49 (5%) of the 931 patients were 75 years of age or older.
Of the 228 geriatric patients in the trials, 134 patients (59%) received at least 48 grams of OsmoPrep. Of the 49 patients 75 years old or older in the trials, 27 (55%) patients received at least 48 grams of OsmoPrep. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. However, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after OsmoPrep administration. The mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received 48 grams of OsmoPrep in the phase 3 study were 7.0, 7.3, and 8.0 mg/dL, respectively. In addition, in all three sodium phosphate treatment groups, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old in the phase 3 study were 7.4, 7.9, and 8.0 mg/dL, respectively, after sodium phosphate administration. Greater sensitivity of some older individuals cannot be ruled out; therefore, OsmoPrep Tablets should be used with caution in geriatric patients.
Sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. Since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients (see WARNINGS). It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.
Adverse Reactions
Abdominal bloating, abdominal pain, nausea, and vomiting were the most common adverse events reported with the use of OsmoPrep Tablets. Dizziness and headache were reported less frequently. Since diarrhea was considered as a part of the efficacy of OsmoPrep, diarrhea was not defined as an adverse event in the clinical studies. Table 2 shows the most common adverse events associated with the use of 48 grams of OsmoPrep, 60 grams of OsmoPrep, and 60 grams of Visicol in the colon preparation trials (n=931).
| Table 2: Frequency of Adverse Events of Any Severity Occurring in Greater Than 3% of Patients in the OsmoPrep Trials | |||
| OsmoPrep 32 tabs (48 g) N=272 | OsmoPrep 40 tabs (60 g) N=265 | Visicol 40 tabs (60 g) N=268 | |
|---|---|---|---|
| Bloating | 31% | 39% | 41% |
| Nausea | 26% | 37% | 30% |
| Abdominal Pain | 23% | 24% | 25% |
| Vomiting | 4% | 10% | 9% |
Postmarketing Experience
In addition to adverse events reported from clinical trials, the following adverse events have been identified during post-approval use of OsmoPrep. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to OsmoPrep, or a combination of these factors.
General: Hypersensitivity reactions including anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, paresthesia and swelling of the lips and tongue, and facial swelling.
Cardiovascular: Arrhythmias
Nervous system: Seizures
Renal: Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.
Drug Abuse and Dependence
Laxatives and purgatives (including OsmoPrep) have the potential for abuse by bulimia nervosa patients who frequently have binge eating and vomiting.
Overdosage
There have been no reported cases of overdosage with OsmoPrep Tablets. Purposeful or accidental ingestion of more than the recommended dosage of OsmoPrep Tablets might be expected to lead to severe electrolyte disturbances, including hyperphosphatemia, hypocalcemia, hypernatremia, or hypokalemia, as well as dehydration and hypovolemia, with attendant signs and symptoms of these disturbances. Certain severe electrolyte disturbances resulting from overdose may lead to cardiac arrhythmias, seizure, renal failure, and death. The patient who has taken an overdosage should be monitored carefully, and treated symptomatically for complications until stable.
OsmoPrep Dosage and Administration
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 procedure: 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 procedure: 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.
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.
How is OsmoPrep Supplied
OsmoPrep Tablets are supplied in child-resistant bottles containing 100 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.
Each bottle contains two silica desiccant packets, which should not be ingested.
NDC 65649-701-41 (100 tablet bottle)
Rx only.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.
Manufactured by:
WellSpring Pharmaceutical Canada Corp.
Oakville, Ontario Canada L6H 1M5
for:
Salix Pharmaceuticals, Inc.
Morrisville, NC 27560
Made in Canada
VENART-30-4/Mar. 2009
Product protected by US Patent No. 5,616,346 and other pending applications.
Medication Guide
OsmoPrep® (AhZ-MŌ-prěp) (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets
Read the Medication Guide that comes with OsmoPrep before you take it and each time you take it. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about OsmoPrep, ask your doctor or pharmacist.
What is the most important information I should know about OsmoPrep?
OsmoPrep can cause serious side effects, including:
Serious kidney problems. Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including OsmoPrep, to clean your colon before colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis for a long time. These problems often happen within a few days, but sometimes may happen several months after taking OsmoPrep.
Conditions that can make you more at risk for having serious kidney problems with OsmoPrep include if you:
- lose too much body fluid (dehydration)
- have slow moving bowels
- have bowels blocked with stool (constipation)
- have severe stomach pain or bloating
- have any disease that causes bowel irritation (colitis)
- have kidney disease
- have heart failure
- take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)
Your age may also affect your risk for having kidney problems with OsmoPrep.
Before you start taking OsmoPrep tell your doctor if you:
- have kidney problems.
- take any medicines for blood pressure, heart disease, or kidney disease.
Severe fluid loss. People who take medicines that contain sodium phosphate can have severe loss of body fluid, with severe changes in body salts in the blood, and abnormal heart rhythms. These problems can lead to death.
Tell your doctor if you have any of these symptoms of loss of too much body fluid (dehydration) while taking OsmoPrep:
- vomiting
- dizziness
- urinating less often than normal
- headache
See “What are the possible side effects of OsmoPrep?” for more information about side effects.
What is OsmoPrep?
OsmoPrep is a prescription medicine used in adults 18 years and older, to clean your colon before a colonoscopy. OsmoPrep cleans your colon by causing you to have diarrhea. Cleaning your colon helps your doctor see the inside of your colon more clearly during the colonoscopy.
It is not known if OsmoPrep is safe and works in children under age 18.
Who should not take OsmoPrep?
Do not take OsmoPrep if:
- you have had a kidney biopsy that shows you have kidney problems because of too much phosphate
- you are allergic to sodium phosphate salts or any of the ingredients in OsmoPrep. See the end of this Medication Guide for a list of ingredients in OsmoPrep.
What should I tell my doctor before taking OsmoPrep?
Before taking OsmoPrep, tell your doctor about all of your medical conditions, including if you have:
- any of the medical conditions listed in the section “What is the most important information I should know about OsmoPrep?"
- irritation of the bowel (colitis). OsmoPrep can cause symptoms of irritable bowel disease to flare-up.
- damage to your bowels
- problems with abnormal heart beat
- had a recent heart attack or have other heart problems
- symptoms of too much body fluid loss (dehydration) including vomiting, dizziness, urinating less often than normal, or headache)
- had stomach surgery
- a history of seizures
- if you drink alcohol
- are on a low salt diet
- are pregnant. It is not known if OsmoPrep will harm your unborn baby.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Any medicine that you take close to the time that you take OsmoPrep may not work as well. Especially tell your doctor if you take:
- water pills (diuretics)
- medicines for blood pressure or heart problems
- medicines for kidney damage
- medicines for pain, such as aspirin or a non-steroidal anti-inflammatory drug (NSAID)
- a medicine for seizures
- a laxative for constipation in the last 7 days. You should not take another medicine that contains sodium phosphate while you take OsmoPrep.
Ask your doctor if you are not sure if your medicine is listed above.
Know the medicines you take. Keep a list of your medicines to show your doctor or pharmacist when you get a new prescription.
How should I take OsmoPrep?
- Take OsmoPrep exactly as prescribed by your doctor.
- It is important for you to drink clear liquids before, during, and after taking OsmoPrep. This may help prevent kidney damage. 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.
You must read, understand, and follow these instructions to take OsmoPrep the right way:
On the evening before your colonoscopy you will take a total of 20 OsmoPrep tablets, as follows:
- Take 4 OsmoPrep tablets with 8 ounces of clear liquids.
- Wait 15 minutes.
- Take 4 more OsmoPrep tablets with 8 ounces of clear liquids.
- Repeat steps 2 and 3 above, three more times. Make sure you wait 15 minutes after each time.
On the day of your colonoscopy you will take a total of 12 OsmoPrep tablets, starting about 3 to 5 hours before your colonoscopy, as follows:
- Take 4 OsmoPrep tablets with 8 ounces of clear liquids.
- Wait 15 minutes.
- Take 4 more OsmoPrep tablets with 8 ounces of clear liquids.
- Repeat steps 2 and 3 one more time.
Tell your doctor if you have any of these symptoms while taking OsmoPrep:
- vomiting, dizziness, or if you urinate less often than normal. These may be signs that you have lost too much fluid while taking OsmoPrep.
- trouble drinking clear fluids
- severe stomach cramping, bloating, nausea, or headache.
If you take too much OsmoPrep, call your doctor or get medical help right away.
What should I avoid while taking OsmoPrep?
- You should not take other laxatives or enemas made with sodium phosphate, while taking OsmoPrep.
- You should not use OsmoPrep if you have already used it in the last 7 days.
What are the possible side effects of OsmoPrep?
OsmoPrep can cause serious side effects, including:
- See “What is the most important information I should know about OsmoPrep?”
- Seizures or fainting (black-outs). People who take a medicine that contains sodium phosphate, such as OsmoPrep, can have seizures or faint (become unconscious) even if they have not had seizures before. Tell your doctor right away if you have a seizure or faint while taking OsmoPrep
- Abnormal heart beat (arrhythmias)
- changes in your blood levels of calcium, phosphate, potassium, sodium
The most common side effects of OsmoPrep are:
- bloating
- stomach area (abdominal) pain
- nausea
- vomiting
These are not all the possible side effects of OsmoPrep. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How do I store OsmoPrep?
- Store OsmoPrep at room temperature, between 59° F to 86° F (15° C to 30° C).
- Throw away any OsmoPrep that is not needed.
- Keep OsmoPrep and all medicines out of the reach of children.
General information about OsmoPrep
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OsmoPrep for a condition for which it was not prescribed. Do not give OsmoPrep to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about OsmoPrep. If you would like more information about OsmoPrep, talk with your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for healthcare professionals. For more information, call 1-866-669-7597 (toll-free) or go to www.Salix.com.
What are the ingredients in OsmoPrep?
Active ingredients: sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous
Inactive ingredients: polyethylene glycol 8000 and magnesium stearate
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised March 2009
Salix Pharmaceuticals, Inc.
Morrisville, NC 27560, USA
This Medication Guide has been approved by the U.S. Food and Drug Administration.
VENART-30-4/Mar 2009
PACKAGE LABEL – PRINCIPAL DISPLAY – OsmoPrep 100 Tablet Bottle Label
NDC 65649-701-41
Rx Only
OsmoPrep®
(sodium phosphate monobasic monohydrate, USP
and sodium phosphate dibasic anhydrous, USP) Tablets
100 Tablets
Dispense the accompanying Medication Guide to each patient.
| OsmoPrep sodium phosphate, monobasic, monohydrate, sodium phosphate, dibasic anhydrous tablet | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021892 | 05/15/2006 | |
| Labeler - Salix Pharmaceuticals, Inc (793108036) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| WellSpring Pharmaceutical Canada Corp. | 251086799 | MANUFACTURE | |
More OsmoPrep resources
- OsmoPrep Side Effects (in more detail)
- OsmoPrep Dosage
- OsmoPrep Use in Pregnancy & Breastfeeding
- OsmoPrep Drug Interactions
- OsmoPrep Support Group
- 3 Reviews for OsmoPrep - Add your own review/rating
- OsmoPrep Advanced Consumer (Micromedex) - Includes Dosage Information
- OsmoPrep MedFacts Consumer Leaflet (Wolters Kluwer)
- OsmoPrep Consumer Overview
Compare OsmoPrep with other medications
- Bowel Preparation
- Constipation
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