Quazepam

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Quazepam Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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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.

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History

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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.

Sources

Quazepam Manufacturers

Lake Erie Medical Dba Quality Care Products Llc

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.

No Recall
A-s Medication Solutions Llc

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.

No Recall
A-s Medication Solutions Llc

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.

No Recall
Kle 2, Inc.

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.

No Recall
Preferred Pharmaceuticals, Inc.

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.

No Recall
Unit Dose Services

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.

No Recall
Bryant Ranch Prepack

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.

No Recall