Quazepam

Quazepam Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

QUAZEPAM® (quazepam) is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of QUAZEPAM has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of QUAZEPAM has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of QUAZEPAM Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.

History

There is currently no drug history available for this drug.

Other Information

QUAZEPAM contains quazepam, a trifluoroethyl benzodiazepine hypnotic agent, having the chemical name 7-chloro-5- (o-fluoro-phenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-2H-1,4-benzodiazepine-2-thione and the following structural formula:

Quazepam has the empirical formula C17H11CIF4N2S, and a molecular weight of 386.8. It is a white crystalline compound, soluble in ethanol and insoluble in water. Each QUAZEPAM Tablet contains 15 mg of quazepam. The inactive ingredients for QUAZEPAM Tablets include cellulose, corn starch, FD&C Yellow No. 6 Al Lake, lactose, magnesium stearate, silicon dioxide, and sodium lauryl sulfate.

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Quazepam Manufacturers

Lake Erie Medical Dba Quality Care Products Llc
No Recall
Quazepam | Lake Erie Medical Dba Quality Care Products Llc
Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.

The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.

The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
2.1 Special Populations
Elderly and debilitated patients may be more sensitive to benzodiazepines.
A-s Medication Solutions Llc
No Recall
Quazepam | A-s Medication Solutions Llc
Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.

The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.

The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
2.1 Special Populations
Elderly and debilitated patients may be more sensitive to benzodiazepines.
A-s Medication Solutions Llc
No Recall
Quazepam | A-s Medication Solutions Llc
Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.

The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.

The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
2.1 Special Populations
Elderly and debilitated patients may be more sensitive to benzodiazepines.
Kle 2, Inc.
No Recall
Quazepam | Kle 2, Inc.
Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.

The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.

The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
2.1 Special Populations
Elderly and debilitated patients may be more sensitive to benzodiazepines.
Preferred Pharmaceuticals, Inc.
No Recall
Quazepam | Preferred Pharmaceuticals, Inc.
Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.

The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.

The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
2.1 Special Populations
Elderly and debilitated patients may be more sensitive to benzodiazepines.
Unit Dose Services
No Recall
Quazepam | Unit Dose Services
Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.

The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.

The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
2.1 Special Populations
Elderly and debilitated patients may be more sensitive to benzodiazepines.
Bryant Ranch Prepack
No Recall
Quazepam | Bryant Ranch Prepack
Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.

The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.

The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
2.1 Special Populations
Elderly and debilitated patients may be more sensitive to benzodiazepines.

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