Safety labeling changes approved by CDER--May 2007.Desoxyn (methamphetamine hydrochloride meth·am·phet·a·mine hydrochloride n. A crystalline amine used as a central nervous system stimulant and in the treatment of obesity. tablets, USP USP - unique sales point ) BOXED WARNING ... Misuse of methamphetamine may cause sudden death and serious cardiovascular adverse events.
WARNINGS
The following five subsections have been added:
Serious Cardiovascular Events
Sudden Death and Pre-existing Structural Cardiac
Abnormalities or other Serious Heart Problems
Children and Adolescents
Adults
Hypertension and other Cardiovascular Conditions
Assessing Cardiovascular Status in Patients being
Treated with Stimulant Medications
Psychiatric Adverse Events
Pre-existing Psychosis
Bipolar Illness
Emergence of New Psychotic or Manic Symptoms
Aggression
Long-Term Suppression of Growth
Seizures
Visual Disturbance
PRECAUTIONS
Information for Patients
Medication Guide
Usage in Nursing Mothers
Amphetamines are excreted in human milk.
Mothers taking amphetamines should be advised to refrain from
nursing.
MEDICATION GUIDE (new) See highlighted prescribing information for new text.. Tindamax (tinidazole) Tablets for Oral Use BOXED WARNING: Warning/Potential Risk for Carcinogenicity carcinogenicity /car·ci·no·ge·nic·i·ty/ (kahr?si-no-je-nis´i-te) the ability or tendency to produce cancer. carcinogenicity the ability or tendency to produce cancer. Carcinogenicity has been seen in mice and rats treated chronically with metronidazole metronidazole /met·ro·ni·da·zole/ (-ni´dah-zol) an antiprotozoal and antibacterial effective against obligate anaerobes; used as the base or the hydrochloride salt. It is also used as a topical treatment for rosacea. , another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects ... CONTRAINDICATIONS Potential Effects of Other Drugs on Tinidazole CYP CYP In currencies, this is the abbreviation for the Cyprus Pound. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 3A4 Inducers and Inhibitors The use of tinidazole is contraindicated: In patients with a previous history of hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria urticaria /ur·ti·ca·ria/ (ur?ti-kar´e-ah) hives; a vascular reaction of the upper dermis marked by transient appearance of slightly elevated patches (wheals) which are redder or paler than the surrounding skin and often attended by to Stevens Johnson syndrome ... In nursing mothers: Interruption of breast-feeding breast-feeding /breast-feed·ing/ (brest´fed?ing) nursing; the feeding of an infant at the mother's breast. is recommended during tinidazole therapy and for 3 days following the last dose ... WARNINGS & PRECAUTIONS Vaginal Candidiasis--The use of tinidazole may result in Candida vaginitis vaginitis Inflammation of the vagina. The chief symptom is a whitish or yellowish vaginal discharge. Treatment depends on the cause: appropriate drugs for sexually transmitted diseases (often from Gardnerella bacteria or trichomonads) or yeast infections; estrogen cream for . In a clinical study of 235 women who received tinidazole for bacterial vaginosis Bacterial Vaginosis Definition Bacterial vaginosis (BV) is a type of vaginal infection in which the normal balance of bacteria in the vagina is disrupted, allowing the overgrowth of harmful anaerobic bacteria at the expense of protective bacteria. , a vaginal fungal infection fungal infection, infection caused by a fungus (see Fungi), some affecting animals, others plants. Fungal Infections of Human and Animals developed in 11 (4.7%) of all study subjects ... Drug Resistance--Prescribing Tindamax in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS Bacterial Vaginosis Postmarketing Experience USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C Pediatric Use Pediatric Administration Renal Impairment Hepatic Impairment Truvada (emtricitabine and tenofovir disoproxil fumarate emtricitabine and tenofovir disoproxil fumarate Truvada Pharmacologic class: Nucleoside/nucleotide reverse-transcriptase inhibitor combination Therapeutic class: Antiretroviral Pregnancy risk category B ) Tablets BOXED WARNING ... Truvada is not approved for the treament of chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis B virus (HBV HBV hepatitis B virus. HBV abbr. hepatitis B virus ) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. . Severe acute exacerbations of hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic have been reported in patients who have discontinued Emtriva or Viread, the components of Truvada. Hepatic function hepatic function (h  ·paˑ·tik funkˑ·sh should be monitored closely with both clinical and laboratory
follow-up for at least several months in patients who are coinfected
with HIV and HBV and discontinue Truvada. If appropriate, initiation of
anti-hepatitis B therapy may be warranted.
WARNINGS: Patients Coinfected with HIV and Hepatitis B Virus See highlighted labeling for revised text. WARNINGS: Renal Impairment Emtricitabine and tenofovir are principally eliminated by the kidney. Renal impairment, including cases of acute renal failure acute renal failure Acute kidney failure Nephrology An abrupt decline in renal function, triggered by various processes–eg, sepsis, shock, trauma, kidney stones, drug toxicity-aspirin, lithium, substances of abuse, toxins, iodinated radiocontrast. and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of Viread. It is recommended that creatinine clearance creatinine clearance n. The volume of serum or plasma that would be cleared of creatinine by one minute's excretion of urine. creatinine clearance be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with Truvada. Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients at risk for renal impairment ... WARNINGS: Other Truvada is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate. Truvada should not be coadministered with Atripla, Emitriva, or Viread. Due to similarities between emtricitabine and lamivudine, Truvada should not be coadministered with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).
PRECAUTIONS
Drug Interactions
Tenofovir Disoproxil Fumarate
Bone Effects
Cases of osteomalacia ...
Information for Patients
f
ADVERSE REACTIONS
Clinical Trials
Study 934--Treatment Emergent Adverse Events
Postmarketing Experience
Viread
Skin and Subcutaneous Tissue Disorders
Rash
Musculoskeletal and Connective Tissue Disorders
Myopathy
Osteomalacia ...
Renal and Urinary Disorders
Interstitial Nephritis (including acute cases)
General Disorders and Administration Site Conditions
Asthenia
PATIENT PACKAGE INSERT package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific What is the most important information I should know about Truvada? Who should not take Truvada? What should I tell my healthcare provider before taking Truvada? What should I avoid while taking Truvada? What are the possible side effects Side effects Effects of a proposed project on other parts of the firm. of Truvada? Viread (tenofovir disoproxil fumarate tenofovir disoproxil fumarate Viread Pharmacologic class: Nucleoside analog reverse transcriptase inhibitor Therapeutic class: Antiretroviral Pregnancy risk category B ) TabletsBOXED WARNING ... Viread is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Viread have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV and have discontinued Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV and HBV and discontinue Viread. If appropriate, initiation of anti-hepatitis B therapy may be warranted. WARNINGS: Patients Coinfected with HIV and Hepatitis B Virus See highlighted prescribing information for revised text. WARNINGS: Renal Impairment Tenofovir is principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of Viread ... It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with Viread. Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients at risk for renal impairment ... WARNINGS: Other Viread should not be used in combination with the fixed-dose combination products Truvada or Atripla since it is a component of these products.
PRECAUTIONS
Drug Interactions
Bone Effects
Cases of osteomalacia ...
ADVERSE REACTIONS
Postmarketing Experience
Skin and Subcutaneous Tissue Disorders
Rash
Musculoskeletal and Connective Tissue Disorders
Myopathy
Osteomalcia ...
Renal and Urinary Disorders
Interstitial Nephritis (including acute cases)
General Disorders and Administration Site Conditions
Asthenia
PATIENT PACKAGE INSERT Who should not take Viread? What should I tell my healthcare provider before taking Viread? What are the possible side effects of Viread? Lovenox (enoxaparin sodium enoxaparin sodium Warning - High-alert drug! Clexane (UK), Lovenox 3. Pharmacologic class: Low-molecular-weight heparin Therapeutic class: Anticoagulant injection) for Subcutaneous and Intravenous Use CONTRAINDICATIONS ... Known hypersensitivity to enoxaparin sodium (e.g., pruritus pruritus /pru·ri·tus/ (proo-ri´tus) itching.prurit´ic pruritus a´ni intense chronic itching in the anal region. pruritus hiema´lis xerotic eczema. , urticaria, anaphylactoid anaphylactoid /ana·phy·lac·toid/ (-fi-lak´toid) resembling anaphylaxis. an·a·phy·lac·toid adj. Of or resembling anaphylaxis. reactions) ... WARNINGS & PRECAUTIONS: Percutaneous Coronary Revascularization Procedures To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina un·sta·ble angina n. Angina pectoris characterized by pain of coronary origin that occurs in response to less exercise or other stimuli than usually required to produce pain. , non-Q-wave myocardial infarction myocardial infarction: see under infarction. and acute ST-segment elevation myocardial infarction, adhere precisely to the intervals recommended between Lovenox doses. It is important to achieve hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis) 1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means. 2. at the puncture site after PCI (1) (Payment Card Industry) See PCI DSS. (2) (Peripheral Component Interconnect) The most widely used I/O bus (peripheral bus). . In case a closure device is used, the sheath can be removed immediately. If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC Lovenox. If the treatment with enoxaparin sodium is to be continued This article is about the Elton John box set. For the plot device commonly featuring the phrase "To be continued", see Cliffhanger. To Be Continued , the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. The site of the procedure should be observed for signs of bleeding or hematoma hematoma /he·ma·to·ma/ (he?mah-to´mah) a localized collection of extravasated blood, usually clotted, in an organ, space, or tissue. formation.
ADVERSE REACTIONS
Clinical Trials Experience
Adverse Reactions in Lovenox-Treated Patients
with Acute ST-Segment Elevation
Myocardial Infarction
USE IN SPECIFIC POPULATIONS
Geriatric Use
Prevention of DVT in hip, knee and abdominal
surgery; treatment of DVT, Prevention of
ischemic complications of unstable angina and
non-Q-Wave myocardial infarction
Lovenox should be used with care in
geriatric patients who may show delayed
elimination of enoxaprin.
Treatment of acute ST-segment Elevation Myocardial
Infarction (STEMI)
Hepatic Impairment
Norditropin Cartridges [somatropin (rDNA origin) injection] for Subcutaneous Use CONTRAINDICATIONS: Acute Critical Illness Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness ... CONTRAINDICATIONS: Prader-Willi Syndrome Prader-Willi Syndrome Definition Prader-Willi syndrome (PWS) is a genetic condition caused by the absence of chromosomal material from chromosome 15. The genetic basis of PWS is complex. in Children Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway up·per airway n. The portion of the respiratory tract that extends from the nostrils or mouth through the larynx. obstruction or sleep apnea sleep apnea, episodes of interrupted breathing during sleep. Obstructive sleep apnea is a common disorder in which relaxation of muscles in the throat repeatedly close off the airway during sleep; the person wakes just enough to take a gasping breath. , or have severe respiratory impairment ... CONTRAINDICATIONS: Hypersensitivity ... Localized reactions are the most common hypersensitivity reactions hypersensitivity reactions, n.pl any of several forms of overly responsive actions of the immune system to normally encountered, antigens. Also called allergic reactions. ... WARNINGS & PRECAUTIONS: Acute Critical Illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure Respiratory Failure Definition Respiratory failure is nearly any condition that affects breathing function or the lungs themselves and can result in failure of the lungs to function properly. has been reported after treatment with pharmacologic amounts of somatropin ... WARNINGS & PRECAUTIONS: Neoplasms ... Patients should be monitored carefully for potential malignant transformation malignant transformation Oncology The constellation of changes in the growth properties of cells in culture evoked by various agents–eg, radiation, toxins, and viruses that result in development of tumors of skin lesions Skin Lesions Definition A skin lesion is a superficial growth or patch of the skin that does not resemble the area surrounding it. Description Skin lesions can be grouped into two categories: primary and secondary. , i.e. increased growth of preexisting pre·ex·ist or pre-ex·ist v. pre·ex·ist·ed, pre·ex·ist·ing, pre·ex·ists v.tr. To exist before (something); precede: Dinosaurs preexisted humans. v.intr. nevi Nevus (plural, nevi) The medical term for any anomaly of the skin that is present at birth, including moles and birthmarks. Mentioned in: Malignant Melanoma, Moles nevi plural form of nevus. . WARNINGS & PRECAUTIONS: Fluid Retention Fluid retention during somatropin replacement therapy in adults may frequently occur ... WARNINGS & PRECAUTIONS: Progression of Preexisting Scoliosis Scoliosis Definition Scoliosis is a side-to-side curvature of the spine. Description When viewed from the rear, the spine usually appears perfectly straight. in Pediatric Patients ... Skeletal abnormalities including scoliosis are commonly seen in untreated patients with Turner syndrome Turner syndrome Chromosomal disorder (from the presence of only one sex chromosome, X, in all or some of the body's cells) that causes abnormal sexual development in females. and Noonan syndrome Noonan syndrome Turner-like syndrome Neonatology A group of specific abnormalities affecting both males and females, both sporadic in appearance but also reflecting a hereditary component, possibly AD Clinical Webbing of neck, pectus excavatum, facial ...
ADVERSE REACTIONS
Clinical Trials Experience
Clinical Trials in Children with Noonan Syndrome
Postmarketing Surveillance
... It is uncertain whether these cases of leukemia
are related to GH therapy, the pathology of
GHD itself, or other associated treatments such
as radiation therapy ...
The following additional adverse reactions ...
Headaches (children & adults)
Gynecomastia (children)
Pancreatitis (children)
Rocephin (ceftriaxone sodium ceftriaxone sodium Rocephin Pharmacologic class: Third-generation cephalosporin Therapeutic class: Anti-infective Pregnancy risk category B Action) for InjectionSee MedWatch Safety Alert posted 7/5/07 regarding Rocephin (ceftriaxone sodium) for Injection and recent labeling changes. CONTRAINDICATIONS Hyperbilirubinemic neonates, especially prematures, should not be treated with[] Rocephin. In vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. studies have shown that ceftriaxone ceftriaxone /cef·tri·ax·one/ (cef?tri-ak´son) a semisynthetic, ß–resistant, third-generation cephalosporin effective against a wide range of gram-positive and gram-negative bacteria, used as the sodium salt. can displace bilirubin Bilirubin The predominant orange pigment of bile. It is the major metabolic breakdown product of heme, the prosthetic group of hemoglobin in red blood cells, and other chromoproteins such as myoglobin, cytochrome, and catalase. from its[] binding to serum albumin serum albumin n. See seralbumin. and bilimbin encephalopathy encephalopathy /en·ceph·a·lop·a·thy/ (en-sef?ah-lop´ah-the) any degenerative brain disease. AIDS encephalopathy HIV e. anoxic encephalopathy hypoxic e. can possibly develop in these patients. Rocephin should not be administered concurrently with calcium-containing solutions or products in newborns because of the risk of precipitation of ceftriaxone-calcium salt (see WARNINGS). WARNINGS Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Calcium-containing solutions or products must not be administered within 48 hours of last administration of ceftriaxone. Cases of fatal reactions with calcium-ceftriaxone precipitates in lung and kidneys in both term and premature neonates have been described. In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed (see CONTRAINDICATIONS and ADVERSE REACTIONS adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. ). ADVERSE REACTIONS Cases of fatal reactions with calcium-ceftriaxone precipitates in lung and kidneys in both term and premature neonates have been described. In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed. Aptivus (tipranvir) Capsules WARNINGS: Effects on Platelet Aggregation Platelet aggregation The clumping together of blood cells, possibly forming a clot. Mentioned in: Herbalism, Traditional Chinese and Coagulation coagulation (kōăg'y  lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or
Aptivus/ritonavir should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other medical conditions, or who are receiving medications known to increase the risk of bleeding such as antiplatelet agents and anticoagulants Anticoagulants Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms. Mentioned in: Embolism, Heart Valve Replacement , or who are taking supplemental high doses of vitamin E vitamin E or tocopherol Fat-soluble organic compound found principally in certain plant oils and leaves of green vegetables. Vitamin E acts as an antioxidant in body tissues and may prolong life by slowing oxidative destruction of membranes. . In in vitro experiments, tipranavir was observed to inhibit human platelet aggregation at levels consistent with exposures observed in patients receiving Aptivus/Ritonavir. In rats, co-administration with vitamin E increased the bleeding effects of tipranavir (see ANIMAL PHARMACOLOGY AND TOXICOLOGY). Avelox (moxifloxacin hydrochloride moxifloxacin hydrochloride Avelox, Vigamox Pharmacologic class: Fluoroquinolone Therapeutic class: Anti-infective Pregnancy risk category C Action) TabletsAvelox I.V. (moxifloxacin hydrochloride in sodium chloride sodium chloride, NaCl, common salt. Properties Sodium chloride is readily soluble in water and insoluble or only slightly soluble in most other liquids. It forms small, transparent, colorless to white cubic crystals. injection) WARNINGS: Hypersensitivity Reactions ... Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including Avelox. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following ... The drug should be discontinued immediately at the first appearance of a skin rash, jaundice jaundice (jôn`dĭs, jän`–), abnormal condition in which the body fluids and tissues, particularly the skin and eyes, take on a yellowish color as a result of an excess of bilirubin. , or any other sign of hypersensitivity and supportive measures instituted ... WARNINGS: Clostridium difficile Clostridium difficile A common cause of bacterial colitis; it is the causative agent in 99% of pseudomembranous colitis, and 20-30% of antibiotic-associated diarrhea associated diarrhea (CDAD CDAD Clostridium Difficile-Associated Diarrhea CDAD Component Data Administrator ) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Avelox, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora Normal flora The mixture of bacteria normally found at specific body sites. Mentioned in: Sputum Culture, Wound Culture of the colon leading to overgrowth overgrowth Rapid growth in the sales of a mutual fund's shares to the extent that the fund has difficulty finding promising new investments or it must take such large positions in individual investments that its trading flexibility is reduced. of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality Morbidity and Mortality can refer to:
co·lec·to·my n. Surgical removal of part or all of the colon. . CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
PRECAUTIONS
Information for Patients
... The risk of serious tendon disorders
with quinolones is higher in those over
65 years of age, especially those on corticosteroids.
... diarrhea is a common problem caused
by antibiotics which usually ends when
the antibiotic is discontinued. Sometimes
after starting treatment with antibiotics,
patients can develop watery and
bloody stools (with or without stomach
cramps and fever) even as late as two or
more months after having taken the last
dose of the antibiotic. If this occurs, patients
should contact their physician as
soon as possible.
Geriatric Use
... The clinical trial data demonstrate that
the safety of intravenous moxifloxacin
in patients aged 65 or older was similar
to that of comparator-treated patients.
... In general, elderly patients may be
more susceptible to drug-associated effects
of the QT interval. Therefore,
Avelox should be avoided in patients
taking drugs that can result in prolongation
of the QT interval (e.g. class IA or
class III antiarrhythmics) or in patients
with risk factors for torsade de pointes
(e.g., known QT prolongation, uncorrected
hypokalemia).
... Tendon rupture usually involves the
Achilles, hand or shoulder tendons and
can occur during therapy or up to a few
months post completion of therapy ...
Postmarketing Adverse Event Reports
Hepatic Failure, including fatal cases
Toxic Epidermal Necrolysis
PATIENT PACKAGE INSERT
What are possible side effects of Avelox?
ChloraPrep (2% chlorhexidine gluconate
(w/v) topical solution) 3-mL applicator
with tint applicator containing FD&C
Green #3 dye
WARNINGS
Solution contains alcohol and gives off flammable vapors
Doxil (doxorubicin HCl liposome injection)
WARNINGS & PRECAUTIONS: Cardiac Toxicity
In the randomized multiple myeloma study, the incidence
of heart failure events (ventricular dysfunction,
cardiac failure, right ventricular failure, congestive cardiac
failure, chronic cardiac failure, acute pulmonary
edema and pulmonary edema) was similar in the Doxil +
bortezomib group and the bortezomib monotherapy
group, 3% in each group. LVEF decrease was defined as
an absolute decrease of [greater than or equal to] 15% over
baseline or a [greater than or equal to] 5%
decrease below the institutional lower limit of normal.
Based on this definition, 25 patients in the bortezomib
arm (8%) and 42 patients in the Doxil + bortezomib
arm (13%) experienced a reduction in LVEF.
ADVERSE REACTIONS
Overall Adverse Reactions Profile
Cardiac Toxicity
Infusion Reactions
Myelosuppression
Hand-Foot Syndrome
Adverse Reactions in Clinical Trials
Initial Paragraph
Patients With Multiple Myeloma
Table 10
Postmarketing Experience
Use in Specific Populations
Geriatric Use
Factive Fac´tive a. 1. Making; having power to make. (gemifloxacin mesylate gemifloxacin mesylate Factive Pharmacologic class: Quinolone Therapeutic class: Broad-spectrum anti-infective Pregnancy risk category C Action) Tablets WARNINGSWARNINGS: QT Effects ... No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Factive treatment in over 8119 patients, including 707 patients concurrently receiving drugs known to prolong the QTc interval and 7 patients with hypokalemia Hypokalemia Definition Hypokalemia is a condition of below normal levels of potassium in the blood serum. Potassium, a necessary electrolyte, facilitates nerve impulse conduction and the contraction of skeletal and smooth muscles, including the heart. ... WARNINGS: Hypersensitivity Reactions Serious hypersensitivity and/or anaphylactic anaphylactic /ana·phy·lac·tic/ (an?ah-fi-lak´tik) pertaining to anaphylaxis. anaphylactic (an´ reactions have been reported in patients receiving fluoroquinolone fluoroquinolone /flu·o·ro·quin·o·lone/ (-kwin´o-lon) any of a subgroup of fluorine-substituted quinolones, having a broader spectrum of activity than nalidixic acid. fluor·o·quin·o·lone n. therapy, including Factive. Hypersensitivity reactions reported in patients receiving fluroquinolone therapy have occasionally been fatal ... ... Clinical manifestations may include one or more of the following, fever [added to list] ... The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted ... WARNINGS: Clostridium difficile associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Factive, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. MAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since MAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS Rash Table 2 Information for Patients ... Rash occurs more commonly in those under 40, especially women and in women on hormone replacement therapy. The incidence of rash increases with duration more than 5 days and particularly longer than 7 days. ... diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible ... other central nervous system problems such as tremors, restlessness, lightheadedness, confusion and hallucinations may occur rarely Geriatric Use ADVERSE REACTIONS Initial Section Adverse Events with a Frequency of Less than 1% Table 3 Laboratory Changes Postmarketing Adverse Reactions PATIENT PACKAGE INSERT What are possible side effects of Factive? What are the ingredients in Factive? Floxin Tablets (ofloxacin tablets) WARNINGS: Clostridium difficile associated diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Floxin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hyper toxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS Information for Patients ... diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Fragmin (dalteparin sodium injection) for Subcutaneous Use Only WARNINGS: Thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. In Fragmin clinical trials supporting non-cancer indications, platelet counts of < 100,000/[mm.sup.3] and < 50,000/[mm.sup.3] occurred in < 1% and < 1% of patients, respectively. In the clinical trial of patients with cancer and acute symptomatic venous thromboembolism thromboembolism /throm·bo·em·bo·lism/ (-em´bo-lizm) obstruction of a blood vessel with thrombotic material carried by the blood from the site of origin to plug another vessel. throm·bo·em·bo·lism n. treated for up to 6 months in the Fragmin treatment arm, platelet counts of < 100,000/[mm.sup.3] occurred in 13.6% of patients, including 6.5% who also had platelet counts less than 50,000/[mm.sup.3]. In the same clinical trial, thrombocytopenia was reported as an adverse event in 10.9% of patients in the Fragmin arm and 8.1% of patients in the OAC OAC On Approved Credit OAC Online Archive of California (California Digital Library) OAC Ohio Athletic Conference OAC Ontario Arts Council (Canada) OAC Ontario Agricultural College arm ...
PRECAUTIONS
Drug/Laboratory Test Interactions
Elevations of Serum Transaminases
ADVERSE REACTIONS
Postmarketing Experience
Geodon (ziprasidone HCl) Capsules Geodon (ziprasidone mesylate) for Injection for IM Use Only WARNINGS: QT Prolongation and Risk of Sudden Death ... Although torsade de pointes tor·sade de pointes n. Paroxysms of ventricular tachycardia in which the electrocardiogram shows a steady undulation in the QRS axis in runs of 5 to 20 beats and with progressive changes in direction. has not been observed in association with the use of ziprasidone at recommended doses in premarketing studies and experience is too limited to rule out an increased risk, there have been rare post-marketing reports (in the presence of multiple confounding factors) ...
ADVERSE REACTIONS
Other Events Observed During Postmarketing Use
Reproductive System and Breast Disorders
Priapism
Nervous System Disorders
Mania/Hypomania
Serotonin Syndrome (alone or in combination with serotonergic
medicinal products)
Syncope
Skin and Subcutaneous Tissue Disorders
Allergic Reaction (such as allergic dermatitis, angioedema,
orofacial edema, urticaria)
Haldol Decanoate (haloperidol haloperidol /hal·o·peri·dol/ (hal?o-per´i-dol) an antipsychotic agent of the butyrophenone group with antiemetic, hypotensive, and hypothermic actions; used especially in the management of psychoses and to control vocal utterances and ) for IM Injection Only WARNINGS: Cardiovascular Effects Cases of sudden death have been reported in psychiatric patients receiving antipsychotic drugs, including Haldol Decanoate. Since QT-prolongation has been observed during Haldol Decanoate treatment, it is advised to be cautious in patients with QT-prolonging conditions (long QT-syndromes, hypokalaemia, electrolyte imbalance, drugs known to prolong QT, cardiovascular diseases, family history of QT prolongation). HALDOL DECANOATE MUST NOT BE ADMINISTERED INTRAVENOUSLY. ADVERSE REATIONS Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients ... Cases of sudden and unexpected death have been reported in association with the administration of Haldol ... Haldol (haloperidol) Injection for Immediate Release WARNINGS: Cardiovascular Effects Cases of sudden death have been reported in psychiatric patients receiving antipsychotic drugs, including Haldol. Since QT-prolongation has been observed during Haldol treatment, it is advised to be cautious in patients with QT-prolonging conditions (long QT-syndromes, hypokalaemia, electrolyte imbalance, drugs known to prolong QT, cardiovascular diseases, family history of QT prolongation). HALDOL INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION. ADVERSE REATIONS Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients ... Cases of sudden and unexpected death have been reported in association with the administration of Haldol ... Levaquin (levofloxacin) Tablets and Oral Solution Levaquin (levofloxacin) Injection Levaquin (levofloxacin in 5% dextrose dextrose: see glucose. ) Injection WARNINGS WARNINGS: Clostridium difficile associated diarrhea (CDAD) Clostridium difficile ssociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Levaquin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS Information for Patients ... diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. ADVERSE REACTIONS Postmarketing Adverse Reactions PATIENT PACKAGE INSERT What are the possible side effects of Levaquin? NegGram Caplets (nalidixic acid, USP) WARNINGS: Clostridium difficile associated diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including NegGram, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS Information for Patients ... diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Norvir (ritonavir ritonavir /ri·to·na·vir/ (ri-to´nah-vir) an HIV protease inhibitor used in treatment of HIV infection and AIDS. ri·ton·a·vir n. capsules) Soft Gelatin gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid. (ritonavir oral solution) WARNINGS: Drug Interactions Tipranavir co-administered with 200 mg of ritonavir has been associated with reports of clinical hepatitis and hepatic decompensation decompensation /de·com·pen·sa·tion/ (de?kom-pen-sa´shun) 1. inability of the heart to maintain adequate circulation, marked by dyspnea, venous engorgement, and edema. 2. including some fatalities. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity hepatotoxicity (hepˑ· ·tō·t .
PRECAUTIONS
Drug Interactions
Table 6
HIV Protease Inhibitor
Atazanavir
Daunavir
Fosamprenavir
Saquinavir
Tipranavir
PegIntron (peginterferon alfa-2b) Powder for Injection WARNINGS: Neuropsychiatric neu·ro·psy·chi·a·try n. The medical study of disorders with both neurological and psychiatric features. neu Events Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal hom·i·cid·al adj. 1. Of or relating to homicide. 2. Capable of or conducive to homicide: a homicidal rage. ideation ideation /ide·a·tion/ (i?de-a´shun) the formation of ideas or images.idea´tional i·de·a·tion n. The formation of ideas or mental images. , depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PegIntron treatment and follow-up ... ADVERSE REACTIONS Postmarketing Experience Pure Red Cell Aplasia pure red cell aplasia Hematology A type of anemia caused by selective depletion of erythroid cells Pure red cell aplasia types Acute MEDICATION GUIDE What is the most important information I should know about PegIntron and PegIntron/Rebetol combination therapy? Plavix (clopidogrel bisulfate tablets) WARNINGS: Thrombotic Thrombocytopenic Purpura thrombotic thrombocytopenic purpura n. A disease of unknown origin, characterized by abnormally low levels of platelets in the blood, the formation of blood clots in the arterioles and capillaries of many organs, and neurological damage. (TTP TTP (thymidine triphosphate): see thymine. ) TTP has been reported rarely following use of Plavix, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis plasmapheresis, see apheresis. (plasma exchange). It is characterized by thrombocytopenia, microangiopathic hemolytic anemia mic·ro·an·gi·o·path·ic hemolytic anemia n. The fragmentation of red blood cells because of narrowing or obstruction of small blood vessels. (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever. PRECAUTIONS Information for Patients Patients should be told that it may take them longer than usual to stop bleeding, that they may bruise and/or bleed more easily when they take Plavix or Plavix combined with aspirin, and that they should report any unusual bleeding to their physician. Patients should inform physicians and dentists that they are taking Plavix and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken. Rapamune (sirolimus) Oral Solution and Tablets WARNINGS Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis, have been associated with the administration of sirolimus ... Exfoliative Dermatitis (term added) PRECAUTIONS Renal Function ... In patients with delayed graft function, Rapamune may delay recovery of renal function. Proteinuria ... The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant population has not been established. ADVERSE REACTIONS Other Clinical Experience Exfoliative Dermatitis Nephrotic Syndrome ... In patients with delayed graft function, Rapamune may delay recovery of renal function. WARNINGS WARNINGS: Clostridium difficile associated diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Tygacil, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS Information for Patients ... Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Adderall XR (mixed salts of a single entity amphetamine amphetamine (ămfĕt`əmēn), any one of a group of drugs that are powerful central nervous system stimulants. Amphetamines have stimulating effects opposite to the effects of depressants such as alcohol, narcotics, and barbiturates. product) Extended-Release Capsules PRECAUTIONS Information for Patients Medication Guide MEDICATION GUIDE (new) Anzemet Injection (dolasetron mesylate injection) PRECAUTIONS Pediatric Use Dolasetron should be administered with caution in pediatric patients who have or may develop prolongation of cardiac conduction intervals, particularly QTc. Rare cases of sustained supraventricular and ventricular arrhythmias, cardiac arrest leading to death, and myocardial infarction have been reported in children and adolescents ... Anzemet Tablets (dolasetron mesylate) PRECAUTIONS Pediatric Use Dolasetron should be administered with caution in pediatric patients who have or may develop prolongation of cardiac conduction intervals, particularly QTc. Rare cases of sustained supraventricular and ventricular arrhythmias, cardiac arrest leading to death, and myocardial infarction have been reported in children and adolescents ... BenzaClin Topical Gel (clindamycin--benzoyl peroxide gel) PRECAUTIONS Carcinogenesis car·ci·no·gen·e·sis n. The production of cancer. carcinogenesis production of cancer. biological carcinogenesis viruses and some parasites are capable of initiating neoplasia. , Mutagenesis mutagenesis /mu·ta·gen·e·sis/ (mu?tah-jen´e-sis) 1. the production of change. 2. the induction of genetic mutation. mu·ta·gen·e·sis n. pl. , Impairment of Fertility In a 2-year dermal carcinogenicity study in rats, treatment with BenzaClin Topical Gel at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats. The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g BenzaClin Topical Gel, based on mg/m2) was statistically significantly higher than that in the sham- and vehicle-controls. Concerta (methylphenidate HCl) Extended-Release Tablets
PRECAUTIONS
Information for Patients
Medication Guide
MEDICATION GUIDE (new)
Daytrana (methylphenidate transdermal
system)
PRECAUTIONS
Information for Patients
Medication Guide
MEDICATION GUIDE (new)
Dexedrine (dextroamphetamine sulfate)
Spansule Sustained-Release Capsules
and Tablets
PRECAUTIONS
Information for Patients
Medication Guide
MEDICATION GUIDE (new)
Metadate CD (methylphenidate HCl,
USP) Extended-Release Capsules
PRECAUTIONS
Information for Patients
Medication Guide
MEDICATION GUIDE (new)
MS Contin (morphine sulfate controlled-release)
Tablets
PRECAUTIONS
General
Initial Sentence
Morphine may aggravate convulsions in patients
with convulsive disorders, and all
opioids may induce or aggravate seizures in
some clinical settings
Use in Pancreatic/Biliary Tract Disorders Tolerance
Physical Dependence
Pregnancy: Teratogenic Effects: Category C
MS Contin should be used in pregnant
women only if the need for strong opioid an
algesia clearly outweighs the potential risk to
the fetus ...
Neonatal Withdrawal Syndrome
ADVERSE REACTIONS
Less Frequently Observed Reactions
Gastrointestinal
Dyspepsia
Genitourinary
Amenorrhea
Other
Bronchospasm
Ortho Tri-Cyclen Tablets Ortho-Cyclen Tablets (norgestimate/ethinyl estradiol) PRECAUTIONS Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. Use ... There was no significant difference between Ortho Tri-Cyclen Tablets and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population ... Prevpac (lansoprazole 30-mg capsules, amoxicillin amoxicillin /amox·i·cil·lin/ (ah-mok?si-sil´in) a semisynthetic derivative of ampicillin effective against a broad spectrum of gram-positive and gram-negative bacteria. a·mox·i·cil·lin n. 500-mg capsules, USP, and clarithromycin 500-mg tablets, USP) PRECAUTIONS Drug Interactions Prevacid
... Prevacid substantially decreases the
systemic concentrations of the HIV
protease inhibitor atazanavir, which is
dependent upon the presence of gastric
acid for absorption, and may result in a
loss of therapeutic effect of atazanavir
and the development of HIV resistance ...
... It is theoretically possible that Prevacid
may also interfere with the absorption
of other drugs where gastric
pH is an important determinant of
bioavailability (e.g., ketoconazole, ampicillin
esters, iron salts, digoxin).
ADVERSE REACTIONS
Postmarketing
Musculoskeletal System
Myositis
Urogenital System
Interstitial Nephritis
Primacor (milrinone lactate injection) Primacor Flexible Containers (200 mcg/mL in 5% Dextrose Injection)
PRECAUTIONS
General
There is no experience in controlled trials
with infusions of milrinone for periods exceeding
48 hours. Cases of infusion site reaction
have been reported with intravenous milrinone
therapy. Consequently, careful monitoring
of the infusion site should be maintained
to avoid possible extravasation.
ADVERSE REACTIONS
Postmarketing Adverse Event Reports
Isolated spontaneous reports of Bronchospasm and Anaphylactic Shock
Liver Function Test Abnormalities
Skin Reactions such as Rash
Administration Site Conditions
Infusion Site Reaction
Verelan PM (verapamil hydrochloride) Extended-Release Capsules Controlled Onset PRECAUTIONS Drug-Drug Interactions Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent telithromycin, an antibiotic in the ketolide class of antibiotics. Dyazide (hydrochlorothiazide/triamterene) Capsules
ADVERSE REACTIONS
Hypersensitivity
Subacute Cutaneous Lupus Erythematosus-like Reactions
Metabolic
Hypokalemia
Hyponatremia
Acidosis
Hypercalcemia
Intron Intron In split genes, a portion that is included in ribonucleic acid (RNA) transcripts but is removed from within a transcript during RNA processing and is rapidly degraded. A (interferon alfa-2b, recombinant) for Injection ADVERSE REACTIONS Postmarketing Experience Prevacid I.V. (lansoprazole) for Injection
ADVERSE REACTIONS
Postmarketing
Musculoskeletal System
Myositis
Urogenital System
Interstitial Nephritis
Levemir FlexPen (insulin detemir [rDNA origin] injection) in a 3 mL Pre-filled Syringe PATIENT PACKAGE INSERT What is Levemir? Levemir (insulin detemir [rDNA origin] injection) 3 mL PenFill Disposable Cartridge PATIENT PACKAGE INSERT What is Levemir? Naprelan (naproxen sodium) Controlled Release Tablets NSAID MEDICATION GUIDE Table: NSAID medicines that need a prescription Vicoprofen Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. (included as footer) |
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