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.
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
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).
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
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?
- Physical dependence and withdrawal reactions. Diazepam tablets can cause physical dependence and withdrawal reactions.
- Do not suddenly stop taking diazepam tablets. Stopping diazepam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
- Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
- Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
- Do not take more diazepam tablets than prescribed or take diazepam tablets for longer than prescribed.
What are diazepam tablets?
- Diazepam tablets are a prescription medicine used:
- to treat anxiety disorders
- for the short-term relief of the symptoms of anxiety
- to relieve the symptoms of alcohol withdrawal including agitation, shakiness (tremor), sudden and severe mental or nervous system changes (delirium tremens) and seeing or hearing things that others do not see or hear (hallucinations)
- along with other medicines for the relief of muscle spasms
- along with other medicines to treat seizure disorders
- Diazepam tablets are a federal controlled substance (C-IV) because it contains diazepam that can be abused or lead to dependence. Keep diazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away diazepam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
- It is not known if diazepam tablets are safe and effective in children under 6 months of age.
- It is not known if diazepam tablets are safe and effective for use longer than 4 months.
Do not take diazepam tablets if you:
- are allergic to diazepam or any of the ingredients in diazepam tablets. See the end of this Medication Guide for a complete list of ingredients in diazepam tablets.
- have a disease that can cause muscle weakness called myasthenia gravis
- have severe breathing problems (severe respiratory insufficiency)
- have severe liver problems
- have a sleep problem called sleep apnea syndrome
Before you take diazepam tablets, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had depression, mood problems, or suicidal thoughts or behavior
- have lung disease or breathing problems
- have liver or kidney problems
- are pregnant or plan to become pregnant. Diazepam tablets may harm your unborn baby. You and your healthcare provider should decide if you should take diazepam tablets while you are pregnant.
- are breastfeeding or plan to breastfeed. Diazepam passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take diazepam tablets. Do not breastfeed while taking diazepam tablets.
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?
- Take diazepam tablets exactly as your healthcare provider tells you to take them. Your healthcare provider will tell you how many diazepam tablets to take and when to take them.
- Talk to your healthcare provider about slowly stopping diazepam tablets to avoid withdrawal symptoms.
- If you take too many diazepam tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of diazepam tablets?
Diazepam tablets may cause serious side effects, including:
- See “What is the most important information I should know about diazepam tablets?”
- Seizures. Taking diazepam tablets with other medicines used to treat epilepsy can cause an increase in the number or severity of grand mal seizures.
- Diazepam tablets can make you sleepy or dizzy, and can slow your thinking and motor skills.
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how diazepam tablets affect you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking diazepam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, diazepam tablets may make your sleepiness or dizziness much worse.
- Like other antiepileptic drugs, diazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- new or worse depression
- feeling agitated or restless
- trouble sleeping (insomnia)
- acting aggressive, being angry or violent
- other unusual changes in behavior or mood
- attempts to commit suicide
- new or worse anxiety or irritability
- an extreme increase in activity and talking (mania)
- new or worse panic attacks
- acting on dangerous impulses
| How can I watch for early symptoms of suicidal thoughts and actions? |
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
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:
- muscle weakness
- loss of control of body movements (ataxia)
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? |
- Store diazepam tablets in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C) and out of the light.
- Keep diazepam tablets and all medicines out of the reach of children.
| 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
Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054
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
| DIAZEPAM |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:71335-1584(NDC:63629-1523) |
|Route of Administration ||ORAL ||DEA Schedule ||CIV
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|DIAZEPAM (DIAZEPAM) ||DIAZEPAM ||5 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| ANHYDROUS LACTOSE || |
| SILICON DIOXIDE || |
| D&C YELLOW NO. 10 ALUMINUM LAKE || |
| FD&C YELLOW NO. 6 || |
| MAGNESIUM STEARATE || |
| MICROCRYSTALLINE CELLULOSE || |
| STARCH, CORN || |
| SODIUM STARCH GLYCOLATE TYPE A POTATO || |
|Product Characteristics |
|Color ||yellow ||Score ||2 pieces |
|Shape ||ROUND ||Size ||8mm |
|Flavor || ||Imprint Code ||3926;TEVA |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:71335-1584-1 ||12 TABLET in 1 BOTTLE ||None |
| 2 ||NDC:71335-1584-2 ||15 TABLET in 1 BOTTLE ||None |
| 3 ||NDC:71335-1584-3 ||20 TABLET in 1 BOTTLE ||None |
| 4 ||NDC:71335-1584-4 ||30 TABLET in 1 BOTTLE ||None |
| 5 ||NDC:71335-1584-5 ||60 TABLET in 1 BOTTLE ||None |
| 6 ||NDC:71335-1584-6 ||90 TABLET in 1 BOTTLE ||None |
| 7 ||NDC:71335-1584-7 ||10 TABLET in 1 BOTTLE ||None |
| 8 ||NDC:71335-1584-8 ||2 TABLET in 1 BOTTLE ||None |
| 9 ||NDC:71335-1584-9 ||1 TABLET in 1 BOTTLE ||None |
| 10 ||NDC:71335-1584-0 ||120 TABLET in 1 BOTTLE ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|ANDA ||ANDA071321 ||12/10/1986 || |
|Labeler — Bryant Ranch Prepack
|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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