Jane S. Ricciuti, RPh, MS

Disclosures

April 22, 2003

In This Article

Anti-infective Agents

Avelox
(moxifloxacin hydrochloride) Tablets and Avelox (moxifloxacin hydrochloride in NaCL) Injection

Manufacturer: Bayer Corporation

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 2/28/03)

New Indication: Avelox (moxifloxacin hydrochloride) is now indicated for the treatment of community-acquired pneumonia (CAP) caused by penicillin-resistant strains of Streptococcus pneumoniae (MIC penicillin ≥ 2 mcg/mL).

Clinical Summary: Nine clinical studies evaluated the efficacy of moxifloxacin in the treatment of CAP due to penicillin-resistant S pneumoniae. The primary end point was clinical cure at the test-of-cure visit. Efficacy results are summarized in Table 1 .

Adverse Effects: Adverse events observed in recent postmarketing reports include hepatitis (predominantly cholestatic), psychotic reaction, Stevens-Johnson syndrome, and syncope.

Avelox (moxifloxacin hydrochloride) Labeling

Avelox (moxifloxacin hydrochloride)

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 03/28/03)

Warnings: The product labeling of lotion and shampoo products containing lindane have been revised to include a boxed warning and the addition of a Medication Guide to be distributed directly to patients.

The boxed warning states:

  • Lindane Shampoo should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of lice.

  • Neurologic Toxicity

    • Seizures and deaths have been reported following Lindane Shampoo use with repeat or prolonged application, but also in rare cases following a single application according to directions. Lindane Shampoo should be used with caution in infants, children, the elderly, and individuals with other skin conditions, and those who weigh < 110 lbs (50 kg) as they may be at risk of serious neurotoxicity.

  • Contraindications

    • Lindane Shampoo is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.

  • Proper Use

    • Instruct patients on proper use of Lindane Shampoo, the amount to apply, how long to leave it on, and avoiding re-treatment. Inform patients that itching occurs after the successful killing of lice and is not necessarily an indication for retreatment with Lindane Shampoo.

Clinical Summary: Data from the FDA's voluntary Adverse Event Reporting System (AERS) indicate that serious adverse events reported were attributed to misuse of lindane products. Seventeen deaths have been associated with lindane use; 3 of these have been confirmed as being due to lindane.

Neurologic side effects (ranging from dizziness to seizures) have been reported. Patients at greatest risk are neonates, children, people weighing less than 110 pounds, and the elderly.

Lindane Lotion and Shampoo Labeling

Lindane Lotion and Shampoo

Terazol 7 & 3
(terconazole) Vaginal Cream & Suppositories

Manufacturer: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 03/11/03)

Precautions: A "Geriatric Use" section has been added to the labeling for Terazol (terconazole):

  • Clinical studies of Terazol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Terazol (terconazole) Labeling

Terazol (terconazole)

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