Contraindications and warnings--March 2007.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. listed the following drugs and drug products as having had modifications to the Contraindications and/or Warnings/Boxed Warnings sections. For additional information or to read the full labeling of the drug products, visit: http://www.fda.gov/medwatch/ Aggrenox (aspirin/extended-release dipyridamole dipyridamole /di·py·rid·a·mole/ (di?pi-rid´ah-mol) a platelet inhibitor and coronary vasodilator used to prevent thromboembolism associated with mechanical heart valves, to treat transient ischemic attacks, and as an adjunct in ) Capsules ADVERSE REACTIONS Headache was most notable in the first month of treatment. Aldara (imiquimod) Cream, 5% for Topical Use Only USE IN SPECIFIC POPULATIONS 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 PATIENT COUNSELING INFORMATION Important: Not for mouth, eye, or vaginal use How do I store Aldara Cream? Ambien (zolpidem tartrate) Tablets WARNINGS & PRECAUTIONS Special Populations--Pediatric Patients USE IN SPECIFIC POPULATIONS Pediatric Use.... Ten patients on zolpidem zolpidem /zol·pi·dem/ (zol-pi´dem) a non-benzodiazepine sedative-hypnotic; used as the tartrate salt in the short term treatment of insomnia. (7.4%) discontinued treatment due to an adverse event. PATIENT COUNSELING INFORMATION Special Concerns--Children WARNINGS & PRECAUTIONS: Special Populations/Pediatric Patients.... Hallucinations Hallucinations Definition Hallucinations are false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even were reported in 7.4% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations. Aristospan (triamcinolone hexacetonide injectable suspension, USP USP - unique sales point ) 5 mg/mL WARNINGS--General PRECAUTIONS--General.... Atrophy at the site of injection has been reported. Pediatric Use--This product contains benzyl alcohol as a preservative. Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients.... The "gasping syndrome".... WARNINGS: General.... Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol.... Avandaryl (rosiglitazone maleate and glimepiride) Tablets PATIENT PACKAGE INSERT What should I tell my doctor before starting Avandaryl? How should I take Avandaryl? What are the ingredients in Avanadryl? Baraclude (entecavir) Tablets and Oral Solution PATIENT PACKAGE INSERT What should I tell my healthcare provider before I take Baraclude? How should I take Baraclude? Carnitor (levocarnitine) Tablets/ Oral Solution Carnitor SF (levocarnitine) Sugar-Free Oral Solution PRECAUTIONS--General ADVERSE REACTIONS--Initial Paragraph Cordarone (amiodarone HCl) Tablets WARNINGS Pulmonary Toxicity--Pulmonary Alveolar Hemorrhage ADVERSE REACTIONS--Post-marketing Reports--Pulmonary Alveolar Hemorrhage WARNINGS: Pulmonary Toxicity There have been postmarketing reports of acuteonset (days to weeks) pulmonary injury in patients treated with oral Cordarone with or without initial I.V. therapy. Findings have included pulmonary infiltrates and/or mass on X-ray, pulmonary alveolar hemorrhage, bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma. bron·cho·spasm n. , wheezing, fever, dyspnea, cough, hemoptysis Hemoptysis Definition Hemoptysis is the coughing up of blood or bloody sputum from the lungs or airway. It may be either self-limiting or recurrent. Massive hemoptysis is defined as 200-600 mL of blood coughed up within a period of 24 hours or less. , and hypoxia. Some cases have progressed to respiratory failure and/or death.... Cyclessa (desogestrel/ethinyl estradiol) Tablets CONTRAINDICATIONS/WARNINGS Initial Overview Thromboembolic thromboembolic pertaining to or emanating from thromboembolism. thromboembolic meningoencephalitis see hemophilosis. thromboembolic parasitism see thromboembolic colic. Disorders and Other Vascular Problems--Cerebrovascular Diseases Estimates of Mortality from Contraceptive Use Carcinoma of the Reproductive Organs and Breasts Oral Contraceptive Use Before Or During Early Pregnancy Elevated Blood Pressure Bleeding Irregularities PRECAUTIONS Sexually Transmitted Diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely Lipid Disorders Emotional Disorders Drug Interactions--Anti-HIV Protease Inhibitors; Herbal Products Nursing Mothers ADVERSE REACTIONS The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related.... The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted.... PACKAGE INSERT Brief Summary Instructions to Patients--How to Take Cyclessa Detailed Patient Package Insert--Who Should Not Take Oral Contraceptives?; Other Considerations Before Taking Oral Contraceptives; Risks of Taking Oral Contraceptives CONTRAINDICATIONS Oral contraceptives should not be used in women who currently have the following conditions: * Hepatic tumors (benign or malignant) or active liver disease * Heavy smoking ([greater than or equal to] 15 cigarettes per day) and over age 35 WARNINGS See highlighted labeling for revised text. Delatestryl (testosterone enanthate injection, USP) PRECAUTIONS--Geriatric Use Detrol LA (tolterodine tartrate tartrate /tar·trate/ (tahr´trat) a salt of tartaric acid. tar·trate n. A salt or ester of tartaric acid. tartrate a salt of tartaric acid. extended release capsules) PRECAUTIONS--Information for Patients Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities.... ADVERSE REACTIONS--Post-marketing Surveillance: Gastrointestinal--Diarrhea; Central/ Peripheral Nervous--Confusion, Disorientation, Memory Impairment, Hallucinations Reports of aggravation of symptoms of dementia.... Detrol (tolterodine tartrate tablets) ADVERSE REACTIONS--Post-marketing Surveillance: Central/Peripheral Nervous--Confusion, Disorientation, Memory Impairment, Hallucinations Reports of aggravation of symptoms of dementia.... Dolobid (diflunisal) Tablets MEDICATION GUIDE (new) Fentora (fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and buccal tablet) MEDICATION GUIDE--Revised to provide for the addition of a 300-mcg strength dose. Flumadine (rimantadine hydrochloride tablets and syrup) PRECAUTIONS Drug Interactions: Influenza Virus Vaccine influenza virus vaccine n. A vaccine containing influenza virus, usually several strains of the virus, prepared in chick embryos and used to immunize against influenza. Live, Intranasal (FluMist) Focalin (dexmethylphenidate hydrochloride) Tablets PRECAUTIONS--Drug Interactions.... In common with other antibiotics, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption reabsorption /re·ab·sorp·tion/ (re?ab-sorp´shun) 1. the act or process of absorbing again, as the absorption by the kidneys of substances (glucose, proteins, sodium, etc.) already secreted into the renal tubules. 2. and reduced efficacy of combined oral estrogen/ progesterone contraceptives. Genotropin (somatropin [rDNA origin] for injection) CONTRAINDICATIONS PRECAUTIONS General Pediatric Patients Adult Patients Information for Patients Laboratory Tests Drug Interactions Geriatric Use CONTRAINDICATIONS Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses. Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.... In general, somatropin is contraindicated in the presence of active malignancy. Any 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. malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency growth hormone deficiency Hypopituitarism Endocrinology A condition which affects 1:4000 children; ♂:♀, 3-4:1 Etiology 70% of GHD is idiopathic and attributed to a prenatal insult, possibly due to hypothalamic dysfunction, given that GHD children may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.... Extensive labeling revisions. See highlighted prescribing information for revised text. Geodon (ziprasidone HCl) Capsules PATIENT PACKAGE INSERT--What is Geodon? Who Should Take Geodon? Symptoms of manic or mixed episodes of bipolar depression may include.... What is the most important safety information I should know about Geodon? How to Take Geodon Kaletra (lopinavir/ritonavir) Tablets and Oral Solution PATIENT PACKAGE INSERT--How Do I Store Kaletra? Kaletra tablets should be stored at room temperature. Exposure of Kaletra tablets to high humidity outside the pharmacy container for longer than 2 weeks is not recommended. Keppra (levetiracetam) Tablets/Oral Solution WARNINGS Primary Generalized Tonic-Clonic Seizures (new) PRECAUTIONS Information for Patients--Patients should be advised that Keppra may cause changes in behavior.... ADVERSE REACTIONS Primary Generalized Tonic-Clonic Seizures--Table 10 Discontinuation or Dose Reduction in Well-Controlled Clinical Studies Primary Generalized Tonic-Clonic Seizures--Post-marketing Experience Hepatic Failure PATIENT PACKAGE INSERT Keppra may cause the following serious problems in adults. Call your healthcare provider right away if you get any of the following symptoms.... WARNINGS: Primary Generalized Tonic-Clonic Seizures.... In patients 6 years of age and older experiencing primary generalized tonic-clonic seizures, Keppra is associated with behavioral abnormalities.... In the double-blind, controlled trial in patients with idiopathic generalized epilepsy Idiopathic generalized epilepsy (IGE) is a group of epileptic disorders that are believed to have a strong underlying genetic basis. Patients with an IGE subtype are typically otherwise normal and have no anatomical brain abnormalities. experiencing primary generalized tonic-clonic seizures, irritability was the most frequently reported psychiatric adverse event occurring in 6.3% of Keppra-treated patients compared to 2.4% of placebo patients. Additionally, non-psychotic behavioral disorders (reported as abnormal behavior, aggression, conduct disorder, and irritability) occurred in 11.4% of the Keppra-treated patients compared to 3.6% of placebo patients. Of the Keppra-treated patients experiencing nonpsychotic behavioral disorders, one patient discontinued treatment due to aggression. Non-psychotic mood disorders (reported as anger, apathy, depression, mood altered, mood swings, negativism negativism /neg·a·tiv·ism/ (neg´ah-ti-vizm?) opposition to suggestion or advice; behavior opposite to that appropriate to a specific situation or against the wishes of others, including direct resistance to efforts to be moved. , suicidal ideation, and tearfulness) occurred in 12.7% of Keppra-treated patients compared to 8.3% of placebo patients.... Lipitor (atorvastatin calcium) Tablets ADVERSE REACTIONS--Clinical Adverse Experiences: Treating to New Targets Study (TNT TNT: see trinitrotoluene. TNT in full trinitrotoluene Pale yellow, solid organic compound made by adding nitrate (−NO2) groups to toluene. ) Incremental Decrease in Endpoints Through Aggressive Lipid Lowering Study (IDEAL) Nexavar (sorafenib) Tablets PRECAUTIONS--General: Gastroinestinal Information for Patients.... Patients should be advised that cases of gastroinestinal perforation have been reported in patients taking Nexavar. ADVERSE REACTIONS Additional Data from Multiple Clinical Trials: Cardiovascular--Congestive Heart Failure; Digestive--Gastrointestinal Perforation; General Disorders--Hemorrhage (including gastrointestinal and respiratory tract and uncommon cases of cerebral hemorrhage; Pain (including mouth, bone, and tumor pain); Nervous System and Psychiatric--Reversible Posterior Leukoencephalopathy Transient Ischemia Attack & Arrhythmia PATIENT PACKAGE INSERT What are possible side effects of Nexavar? Noroxin (norfloxacin) Tablets WARNINGS Clostridium Difficile-Associated Diarrhea PRECAUTIONS Information for Patients: Patients should be advised: that diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting the 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. WARNINGS: Clostridium Difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Noroxin 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.... ... 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. Orencia (abatacept) PRECAUTIONS--Blood Glucose Testing PATIENT PACKAGE INSERT--Who should not receive Orencia? What should I tell my doctor before treatment with Orencia? Can I receive Orencia if I am taking other medicines for my RA or other conditions? Prilosec OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). (omeprazole magnesium delayed-release tablet) Over-the-Counter Drug Product WARNINGS Ask a doctor or pharmacist before use if you are taking: warfarin warfarin (wôr`fərĭn), anticoagulant used to treat blood clots. In large doses it causes bleeding. Warfarin, mixed with bait, is used in rodent control. warfarin Anticoagulant drug, marketed as Coumadin. (blood-thinning medicine); prescription antifungal or anti-yeast medicines; diazepam diazepam /di·az·e·pam/ (di-az´e-pam) a benzodiazepine used as an antianxiety agent, sedative, antipanic agent, antitremor agent, skeletal muscle relaxant, anticonvulsant, and in the management of alcohol withdrawal symptoms. (anxiety medicine); digoxin digoxin: see digitalis. (heart medicine); tacrolimus (immune system medicine); atazanavir (medicine for 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. infection) Primaxin I.M. (imipenem and cilastatin injectable suspension) WARNINGS ADVERSE REACTIONS Systemic Adverse Reactions--CNS--Seizures WARNINGS Seizures and other CNS See Continuous net settlement. CNS See continuous net settlement (CNS). adverse experiences, such as myoclonic myoclonic pertaining to myoclonus. myoclonic epilepsy see glycoproteinosis. myoclonic jerk a generalized seizure consisting of a jerk of most muscles in the body. activity, have been reported during treatment with Primaxin I.M.... Prozac (fluoxetine fluoxetine /flu·ox·e·tine/ (floo-ok´se-ten) a selective serotonin reuptake inhibitor used as the hydrochloride salt in the treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder. capsules and oral solution, USP) Prozac Weekly (fluoxetine delayed-relase capsules, USP) PRECAUTIONS--Drug Interactions: Drugs metabolized by 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. 2D6--Propafenone Pregnancy--Nonteratogenic Effects.... Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN PPHN Persistent pulmonary hypertension of the newborn ). PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality Morbidity and Mortality can refer to:
... Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression.... Reyataz (atazanavir sulfate) Capsules PRECAUTIONS--General: Nephrolithiasis ADVERSE REACTIONS--Post-marketing Experience: Renal System--Nephrolithiasis PATIENT PACKAGE INSERT What are the possible side effects of Reyataz? Risperdal Consta (risperidone) Long-Acting Injection PRECAUTIONS--General; Administration; Hyperprolactinemia Use in Patients with Concomitant Illness--Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis--Oral ADVERSE REACTIONS--Postintroduction Reports: Pituitary Adenomas; QT Prolongation; Retinal Artery Occlusion Retinal Artery Occlusion Definition Retinal artery occlusion refers to the closure of the central retinal artery and usually results in complete loss of vision in one eye. .... Saizen (somatropin [rDNA origin] for injection) for Subcutaneous or Intramuscular Injection CONTRAINDICATIONS WARNINGS PRECAUTIONS General Pediatric Patients Adult Patients Information for Patients Laboratory Tests Drug Interactions Geriatric Use CONTRAINDICATIONS Saizen reconstituted with Bacteriostatic bacteriostatic /bac·te·rio·stat·ic/ (bak-ter?e-o-stat´ik) inhibiting growth or multiplication of bacteria; an agent that so acts. Water for Injection, USP (0.9% Benzyl Alcohol) should not be administered to patients with a known sensitivity to Benzyl Alcohol. Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. In general, somatropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin.... See highlighted prescribing information for revised text. Soliris (eculizumab) MEDICATION GUIDE (new) Symmetrel (amantadine hydrochloride, USP) Tablets and Syrup PRECAUTIONS--Drug Interactions: The concurrent use of Symmetrel with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated.... ADVERSE REACTIONS--Other Adverse Reactions Reported During Post-marketing Experience.... Hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. ; Agranulocytosis agranulocytosis (əgrăn'yəlōsītō`sis), disease in which the production of granulated white blood cells by the bone marrow is impaired. Timentin (ticarcillin disodium and clavulanate potassium ticarcillin disodium and clavulanate potassium Timentin Pharmacologic class: Penicillin (extended-spectrum) Therapeutic class: Anti-infective Pregnancy risk category B Action) InjectionPRECAUTIONS--Geriatric Use Timentin (sterile ticarcillin disodium and clavulanate potassium) for Intravenous Administration PRECAUTIONS--Geriatric Use Toprol-XL (metoprolol succinate) Extended-Release Tablets PRECAUTIONS--Drug Interactions: Both digitalis digitalis (dĭj'ĭtăl`ĭs), any of several chemically similar drugs used primarily to increase the force and rate of heart contractions, especially in damaged heart muscle. The effects of the drug were known as early as 1500 B.C. glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia bradycardia: see arrhythmia. . ADVERSE REACTIONS--Post-marketing Experience--Cardiovascular: Cardiogenic shock in patients with acute myocardial infarction acute myocardial infarction (  ·kyōōtˑ mī·ō·karˑ·dē·
Uroxatral (alfuzosin HCl extended-release tablets) PRECAUTIONS--General: Patients with Congenital or Acquired QT Prolongation--A post-marketing study evaluating the effect of combining Uroxatral with another drug of comparable QT effect showed an increased effect when compared to either drug alone.... |
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