The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The prescribing information may be accessed by clicking on the drug name.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Sonata (zaleplon) Capsules

(click product name to read prescribing information)

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

• General 
  • Use in Patients with Concomitant Illness
• Drug Interactions
  • CNS Active Drugs
    • Venlafaxine
    • Promethazine
  • Drugs That Inhibit CYP3A4

Zaleplon is contraindicated in patients with a history of hypersensitivity to zaleplon or any excipients in the formulation.

Sonata, as well as other hypnotics, may produce additive CNS-depressant effects when coadministered with other psychotropic medications, anticonvulsants, antihistamines, narcotic analgesics, anesthetics, ethanol, and other drugs that themselves produce CNS depression.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Please contact Wyeth Pharmaceuticals at 1-800-395-9938 for prescribing information.

WARNINGS

• Hypotension

PRECAUTIONS

• Pulmonary Disorders
  • Early-onset pulmonary toxicity
  • ARDS
• Drug Interactions
  • HMG-CoA Reductase Inhibitors
• Pediatric Use

ADVERSE REACTIONS

• Postmarketing Reports

There have been postmarketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with Cordarone I.V. Findings have included pulmonary infiltrates on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Some cases have progressed to respiratory failure and/or death.

There have been postmarketing reports of ARDS in Cordarone I.V. patients. Cordarone I.V. may play a role in causing or exacerbating pulmonary disorders in those patients.

Simvastatin (CYP3A4 substrate) in combination with amiodarone has been associated with reports of myopathy/rhabdomyolysis.

(click product name to read prescribing information)

• Misuse, Abuse and Diversion of Opioids
• Interactions with Alcohol and Drugs of Abuse

PRECAUTIONS

• General
• Interactions with other CNS Depressants
• Interactions with Mixed Agonist/Antagonist Opioid Analgesics
• Tolerance and Physical Dependence
• Use in Drug and Alcohol Addition
• Information for Patients/Caregivers
• Drug Interactions
  • Acyclovir
  • Cimetidine
  • Phenytoin
  • Ritonavir
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Pregnancy
  • Teratogenic Effects - Pregnancy  Category C
• Pediatric Use
• Geriatric Use

Excedrin Migraine (acetaminophen, aspirin, and caffeine) Tablets

(click product name to read prescribing information)

Several warning statements added regarding concomitant use of the product with other products containing acetaminophen.

(click product name to read prescribing information)

PRECAUTIONS

• Drug Interactions
  • Vecuronium
• Pediatric Use
• Geriatric Use

ADVERSE REACTIONS

• Gastrointestinal

Additions to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the package insert concerning pseudomembranous colitis and the potential interaction of piperacillin and vecuronium in the perioperative period.

(click product name to read prescribing information)

PRECAUTIONS

• Pediatric Use

ADVERSE REACTIONS

• Pediatric patients

Tylenol Arthritis Pain (acetaminophen) Extended Release Caplets

(click product name to read prescribing information)

WARNINGS 

Do not use with other medicines containing acetaminophen.

Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets

(click product name to read prescribing information)

• Cardiac Events and Fatalities
  • Postmarketing Experience with Zolmitriptan
• Other Vasospasm-Related Events
• Increase in Blood Pressure

PRECAUTIONS

• Geriatric Use

ADVERSE REACTIONS

• Postmarketing Experience with Zomig Tablets
  • Digestive
  • Neurological
  • General

PATIENT PACKAGE INSERT

Serious cardiovascular events have been reported in association with the use of Zomig Tablets and in very rare cases, these events have occurred in the absence of known cardiovascular disease.

5-HT₁ agonists may cause vasospastic reactions other than coronary artery vasospasm such as peripheral and gastrointestional vascular ischemia. 

As with other 5-HT₁ agonists significant elevations in systemic blood pressure have been reported on rare occasions with Zomig Tablet use, in patients with and without a history of hypertension.

(click product name to read prescribing information)

PRECAUTIONS

• General
• Drug Interactions
  • Methotrexate
  • Pregnancy
    • Teratogenic effects- Pregnancy Category B
    • Piperacillin/tazobactam

ADVERSE REACTIONS

• Postmarketing Experience
  • Hematologic
  • Immune
  • Infections
  • Renal
  • Skin and Appendages
• Adverse Laboratory Events (Seen During Clinical Trials)

Alkeran (melphalan) Tablets

(click product name to read prescribing information)

• Geriatric Use

Allegra-D (fexofenadine/pseudoephedrine) ER Tablets

(click product name to read prescribing information)

• Pediatric Use

Please contact Abbott Laboratories at 1-800-633-9110 for prescribing information.

• Geriatric Use

Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets

(click product name to read prescribing information)

• Labor and Delivery

ADVERSE REACTIONS

• Hypersensitivity Reactions
• Miscellaneous

Bacteriostatic Sodium Chloride 0.9% Injection

Please contact Abbott Laboratories at 1-800-633-9110 for prescribing information.

• Pediatric Use

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. However, due to potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol are contraindicated in this patient population.

Please contact Alcon Laboratories at 1-800-757-9195 for prescribing information.

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

Cleocin T (clindamycin phosphate) Gel

Cleocin T (clindamycin phosphate) Topical Lotion

(click product name to read prescribing information)

• Geriatric Use

Corzide (nadolol and bendroflumethiazide) Tablets

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• General 
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Labor and Delivery

Demser (metyrosine) Capsules

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

Doxorubicin Hydrochloride Injection

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Pediatric Use

(click product name to read prescribing information)

• Geriatric Use

Please contact Women First HealthCare at 1-858-509-1171 for prescribing information.

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Pediatric Use

(click product name to read prescribing information)

• Pediatric Use

(click product name to read prescribing information)

• Geriatric Use

Idamycin PFS (idarubicin hydrochloride injection)

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

Megace (megestrol acetate) Oral Suspension

Please contact Bristol-Myers Squibb at 1-212-546-4000 for prescribing information

• Geriatric Use

Monopril (fosinopril) Tablets

(click product name to read prescribing information)

• Pediatric Use

ADVERSE REACTIONS

• Pediatric Patients

Please contact Pfizer at 1-800-879-3477 for prescribing information.

PRECAUTIONS

• Information for Patients
• Drug Interaction

Hepatic microsomal enzyme inducing agents, such as carbamazepine, were found to significantly increase the clearance of thiothixene. Patients receiving these drugs should be observed for signs of reduced thiothixene effectiveness. 

Due to a possible additive effect with hypotensive agents, patients receiving these drugs should be observed closely for signs of excessive hypotension when thiothixene is added to their drug regime.

ADVERSE REACTIONS

• Endocrine/Reproductive

Please contact Organon at 1-800-241-8812 for prescribing information.

• Drug Interactions
  • Thiopental

  Reconstituted Norcuron, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions such as thiopental) in the same syringe or administered simultaneously during intravenous infusion through the same needle or through the same intravenous line (see DOSAGE AND ADMINISTRATION - Compatibility).

• Geriatric Use

Please contact Sanofi-Synthelabo at 1-800-446-6267 for prescribing information.

• Geriatric Use

(click product name to read prescribing information)

• Pediatric Use

(click product name to read prescribing information)

• Drug Interactions

(click product name to read prescribing information)

• Carcinogenesis, Mutagenesis, Impairment of Fertility

Amoxil (amoxicillin) Tablets

Amoxil (amoxicillin) for Oral Suspension

(click product name to read prescribing information)

• Hypersensitivity
• Miscellaneous

(click product name to read prescribing information)

• Allergic-type Reactions

Please contact Wyeth Pharmaceuticals at 1-800-395-9938 for prescribing information.

• Postmarketing Reports

Syndrome of inappropriate antidiuretic hormone secretion (SIADH) added.

(click product name to read prescribing information)

• Gastrointestinal
• Renal
• Other

(click on product name to read prescribing information)

• Gastrointestinal

Lescol XL (fluvastatin sodium) Extended-Release Tablets

(click product name to read prescribing information)

• Table 5: "Clinically relevant adverse experiences occurring in >2% patients in Lescol and Lescol XL controlled studies"

Vioxx (rofecoxib) Tablets and Oral Solution

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 ADVERSE REACTIONS

• Eyes, Ears, Nose, and Throat
• Nervous System
• Cardiovascular

FDA/CDER/Office of Drug Safety
Web page last revised by jlw Sept 04, 2003