Important Safety Information about AZASAN
WARNING: Chronic immunosuppression with this purine antimetabolite increases risk of neoplasia in humans. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. See WARNINGS section in complete Prescribing Information.
AZASAN®
(azathioprine tablets) 75/100 mg is indicated as an adjunct for the prevention of rejection in renal homotransplantations, and also for the management of active rheumatoid arthritis to reduce signs and symptoms.The most commonly reported side effects associated with AZASAN therapy are leukopenia and/or thrombocytopenia, secondary infections, neoplasia, nausea, vomiting, diarrhea, fever, myalgias, skin rashes, and hepatotoxicity. AZASAN therapy should be given cautiously when used concomitantly with allopurinol, ACE inhibitors, and other agents affecting myelopoiesis. AZASAN is contraindicated in pregnant and lactating women and in patients who have shown hypersensitivity to this product.
Consult with your physician to see if this product is right for you.
Complete Prescribing Information for AZASAN, including BOXED WARNING
Important Safety Information about OSMOPREP
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 nonsteroidal anti–inflammatory drugs [NSAIDs]).
It is important to use the dose and dosing regimen as recommended (PM/AM split dose).
OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing
of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OSMOPREP is used in
patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, severe chronic constipation,
bowel perforation, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal
function, patients with a history of seizures or at higher risk of seizure, patients with higher risk of cardiac arrhythmias, known or suspected electrolyte
disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as
hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OSMOPREP.
OSMOPREP is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients, and in patients with
biopsy–proven acute phosphate nephropathy. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were
abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving OSMOPREP be advised to adequately hydrate before,
during, and after the use of OsmoPrep.
For complete Prescribing Information for OSMOPREP including BOXED WARNING.
Important Safety Information about VISICOL
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 nonsteroidal anti-inflammatory drugs [NSAIDs]).
It is important to use the dose and dosing regimen as recommended (PM/AM split dose).
VISICOL®
(sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for
cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.
VISICOL is not to be used in patients with congestive heart failure, ascites, unstable angina pectoris, gastric retention,
ileus or acute obstruction or pseudo-obstruction, severe chronic constipation, bowel perforation, acute colitis, toxic
megacolon, or hypomotility syndrome. Use with caution in patients with impaired renal function, pre-existing electrolyte
disturbances, or people taking drugs that affect electrolyte levels. VISICOL is contraindicated in patients with a known
allergy or hypersensitivity to sodium phosphate salts or any of its ingredients. In clinical trials, the most commonly
observed (≥1%) adverse reactions occurring with use of VISICOL were generally transient and self-limited and included
nausea, vomiting, abdominal bloating, abdominal pain, dizziness and headache.
Consult with your physician to see if this product is right for you.
Complete Prescribing Information for VISICOL, including BOXED WARNING
Important Safety Information about METOZOLV® ODT
WARNING: TARDIVE DYSKINESIA
See full prescribing information for complete boxed warning.
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often
irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total
cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive
dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve
after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where
therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
METOZOLV® ODT
(metoclopramide HCl) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented
gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms
associated with acute and recurrent diabetic gastroparesis (diabetic gastric stasis) in adults. Therapy should not exceed
12 weeks in duration. Take on an empty stomach up to four times daily, at least 30 minutes before eating and at bedtime.
METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation;
pheochromocytoma; known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications
with extrapyramidal reactions.
Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500
patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first
24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than
30 years of age and are even more frequent at higher doses.
Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after
beginning treatment, but also after longer periods. Patients with a history of Parkinson’s disease should be given
metoclopramide cautiously, if at all, since such patients can experience exacerbation of Parkinsonian symptoms when taking
metoclopramide.
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic
Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle
rigidity, altered consciousness, and evidence of autonomic instability. The management of NMS should include immediate
discontinuation of metoclopramide and other drugs not essential to concurrent therapy.
Depression associated with metoclopramide use has occurred in patients with and without a history of depression. For
those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh
the potential risks.
In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines;
hence, caution should be exercised when metoclopramide is used in patients with hypertension. Any rapid rise in blood
pressure associated with METOZOLV ODT use should result in immediate cessation of metoclopramide use in those patients.
Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart
failure may be at risk of developing fluid retention and volume overload. If these side effects occur at any time in any
patients during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (≥2% occurrence) were headache, nausea, fatigue,
somnolence, and vomiting.
Complete Prescribing Information for METOZOLV ODT, including BOXED WARNING