Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
USUAL DAILY DOSE:
Management of Anxiety Disorders and Relief of Symptoms of Anxiety.
Depending upon severity of symptoms—2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal.
10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm.
2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders.
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease.
2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months.
1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated
Diazepam Tablets, USP are available containing 2 mg, 5 mg or 10 mg of diazepam, USP.
The 2 mg tablets are white, round, scored tablets debossed with MYLAN over 271 on one side and the other side being scored. They are available as follows:
NDC 51079-284-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
The 5 mg tablets are orange, round, scored tablets debossed with MYLAN over 345 on one side and the other side being scored. They are available as follows:
NDC 51079-285-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
The 10 mg tablets are green, round, scored tablets debossed with MYLAN over 477 on one side and the other side being scored. They are available as follows:
NDC 51079-286-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
PHARMACIST: Dispense a Medication Guide with each prescription.
Diazepam Tablets, USP (dye az’ e pam)
What is the most important information I should know about diazepam tablets?
What are diazepam tablets?
Do not take diazepam tablets if you:
Before you take diazepam tablets, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking diazepam tablets with certain other medicines can cause side effects or affect how well diazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take diazepam tablets?
What should I avoid while taking diazepam tablets?
What are the possible side effects of diazepam tablets?
Diazepam tablets may cause serious side effects, including:
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
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How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
The most common side effects of diazepam tablets include:
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These are not all the possible side effects of diazepam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
How should I store diazepam tablets?
General information about the safe and effective use of diazepam tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use diazepam tablets for a condition for which it was not prescribed. Do not give diazepam tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about diazepam tablets that is written for health professionals.
What are the ingredients in diazepam tablets?
Active ingredient: diazepam
Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake. The 10 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.
Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
This Medication Guide has been approved by the U.S. Food and Drug Administration
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.
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