Diazepam (Page 5 of 5)
DOSAGE AND ADMINISTRATION
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.
ADULTS: | 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 |
PEDIATRIC PATIENTS: | |
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 |
Discontinuation or Dosage Reduction of Diazepam Tablets
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence).
HOW SUPPLIED
NDC: 71335-1584-1: 12 Tablets in a BOTTLE
NDC: 71335-1584-2: 15 Tablets in a BOTTLE
NDC: 71335-1584-3: 20 Tablets in a BOTTLE
NDC: 71335-1584-4: 30 Tablets in a BOTTLE
NDC: 71335-1584-5: 60 Tablets in a BOTTLE
NDC: 71335-1584-6: 90 Tablets in a BOTTLE
NDC: 71335-1584-7: 10 Tablets in a BOTTLE
NDC: 71335-1584-8: 2 Tablets in a BOTTLE
NDC: 71335-1584-9: 1 Tablets in a BOTTLE
NDC: 71335-1584-0: 120 Tablets in a BOTTLE
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Diazepam (dye az’ e pam) Tablets, C-IV | |||
What is the most important information I should know about diazepam tablets?
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What are diazepam tablets?
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Do not take diazepam tablets if you:
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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?
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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 Teva at 1-888-838-2872. | |||
How should I store diazepam tablets?
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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 they were not prescribed. Do not give diazepam tablets to other people, even if they have the same symptoms that you have. They 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: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate Manufactured In Czech Republic By: Teva Czech Industries, s.r.o., Opava-Komarov, Czech Republic For more information call 1-888-838-2872. |
This Medication Guide has been approved by the U.S. Food and Drug Administration.Rev. A 7/2021
Diazepam 5mg (CIV) Tablet
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Labeler — Bryant Ranch Prepack (171714327) |
Registrant — Bryant Ranch Prepack (171714327) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Bryant Ranch Prepack | 171714327 | REPACK (71335-1584), RELABEL (71335-1584) |
Revised: 02/2022 Bryant Ranch Prepack
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