Important Safety Information about AZASAN
WARNING: Chronic immunosuppression with this purine antimetabolite increases risk of
malignancy in humans. Reports of malignancy include post-transplant lymphoma and
hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. 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. Physicians should inform patients
of the risk of malignancy with AZASAN. See WARNINGS.
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. Patients are at increased risk of developing lymphoma and other malignancies,
particularly of the skin. Exposure to sunlight and ultraviolet light should be limited by wearing protective
clothing and a high SPF sunscreen. Patients should have complete blood count (CBC), including platelet
counts periodically during treatment. TPMT testing should be conducted to identify with absent or
reduced TPMT activity. 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. Patients with
rheumatoid arthritis previously treated with alkylating agents (cyclophosphamide, chlorambucil,
melphalan, or others) may have a prohibitive risk of malignancy if treated with AZASAN. 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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com
Please see complete Prescribing Information for AZASAN, including BOXED WARNING.
Indication for METOZOLV ODT
METOZOLV® ODT is indicated for short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease that fails to respond to conventional therapy (refractory GERD) and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults.
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) orally disintegrating tablet therapy should not exceed 12 weeks in duration and is recommended for adults only (the safety and effectiveness in pediatric patients have not been established).
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.
Patients may experience withdrawal symptoms after stopping METOZOLV ODT that could include
dizziness, nervousness, and/or headaches.
METOZOLV ODT interacts with anticholinergics, narcotic analgesics, monoamine oxidase inhibitors,
insulin, antidepressants, antipsychotics, and neuroleptics. METOZOLV ODT may alter drug absorption.
Elderly patients may be more sensitive to adverse reactions such as sedation and drug-induced movement disorders. In patients with impaired renal function, initial dosing may need to be reduced and titrated.
In clinical studies, the most frequently reported adverse events (≥2% occurrence) for METOZOLV ODT were headache, nausea, fatigue, somnolence, and vomiting.
Please see complete Prescribing Information for METOZOLV ODT, including BOXED WARNING.
Indication for OSMOPREP
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.
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 contraindicated in patients with a biopsy-proven acute phosphate
nephropathy, gastrointestinal (GI) obstruction, gastric bypass or stapling surgery, bowel perforation,
toxic colitis, toxic megacolon, and known allergy or hypersensitivity to sodium phosphate salts or any
component of OSMOPREP.
Renal impairment may occur with OSMOPREP. Assess renal function before treatment and during
therapy. Use OSMOPREP with caution in patients with impaired renal function (creatinine clearance less
than 30mL/minute), 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 due to electrolyte abnormalities can occur. OSMOPREP should be used with caution in patients
with a history of seizures or at higher risk of seizure [e.g. 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].
Use caution in patients with higher risk of arrhythmias (e.g., patients with a history of cardiomyopathy,
prolonged QT, uncontrolled arrhythmias, or recent myocardial infarction).
Advise patients to hydrate adequately before, during, and after the use of OSMOPREP.
Use OSMOPREP with caution in patients with history of Inflammatory Bowel Disease. In patients with
suspected GI obstruction or perforation, rule out the diagnosis before administration of OSMOPREP.
Animal reproduction studies have not been performed. OSMOPREP should only be given to a pregnant
woman if clearly needed.
In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were
abdominal bloating, abdominal pain, nausea, and vomiting.
Please see complete Prescribing Information for OSMOPREP, including BOXED WARNING.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.