Roche Valium (Diazepam) is an antianxiety agent (benzodiazepine), used primarily for short-term relief of mild to moderate anxiety. It may also be used to treat symptoms of acute alcohol withdrawals, to help control epilepsy, or to relieve muscle spasms.
Diazepam / ValiumTM, ValreleaseTM, DizacTM
Description: Diazepam is a long-acting oral and parenteral benzodiazepine. Diazepam is similar to chlordiazepoxide and clorazepate in that all three generate the same active metabolite. Diazepam is used orally for the short-term management of anxiety disorders and acute alcohol withdrawal, and as a skeletal muscle relaxant. Parenterally, it is indicated as an antianxiety agent, sedative, amnestic, anticonvulsant, skeletal muscle relaxant, anesthetic adjunct, and as a treatment for alcohol withdrawal. In addition to treating status epilepticus, diazepam has recently been shown effective in preventing recurrence of febrile seizures.I Although diazepam has been the benzodiazepine of choice for status epilepticus, recent evidence indicates that lorazepam may be more beneficial because it provides longer control of seizures and produces less cardiorespiratory depression. Diazepam was approved by the FDA in November 1963. Phase III data for a rectal formulation of diazepam in the treatment of acute repetitive seizures was completed April 1995. The NDA for the rectal formulation (Diastat) is expected to be filed in 1995. Diazepam is a schedule IV controlled substance.
Mechanism of Action: Benzodiazepines act at the level of the limbic, thalamic, and hypothalamic regions of the CNS, and can produce any level of CNS depression required including sedation, hypnosis, skeletal muscle relaxation, anticonvulsant activity, and coma. The action of these drugs is mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Central benzodiazepine receptors interact allosterically with GABA receptors, potentiating the effects of GABA and increasing the inhibition of the ascending reticular activating system.
Evidence suggests that GABA receptors are heterogeneous with many different subtypes, which may account for the various effects of GABA receptor agonists and benzodiazepines. Midazolam, for example, has twice the affinity for benzodiazepine receptors than diazepam. The antianxiety action of benzodiazepines may be a result of their ability to block cortical and limbic arousal following stimulation of the reticular pathways while muscle relaxation properties are mediated by inhibiting both mono-and polysynaptic pathways. Benzodiazepine can also depress muscle and motor nerve function directly. Animal studies of the anticonvulsant actions suggest that benzodiazepines augment presynaptic inhibition of neurons, thereby limiting the spread of electrical activity, although they do not actually inhibit the abnormally discharging focus.
Benzodiazepines may also have other actions. For example, diazepam has been shown to counteract the cardiovascular toxicity of chloroquine. It is thought that diazepam increases the urinary clearance of chloroquine by improving electrocardiographic and hemodynamic function.
Pharmacokinetics: Diazepam is administered orally and parenterally. A viscous solution intended for rectal administration in undergoing investigation. Diazepam is the most rapidly absorbed benzodiazepine following an oral dose; however, absorption following an IM injection is slow and erratic. Anticonvulsant, skeletal muscle relaxant, and anxiolytic effects are usually evident after the first dose. The onset of action after an IV dose is 1-5 minutes. The duration for some clinical effects (e.g., sedation, anticonvulsant activity) is much shorter than would be expected considering the very long half-life for both diazepam and its metabolite, desmethyldiazepam.
Diazepam is widely distributed, with CSF levels similar to plasma levels. This benzodiazepine crosses the placenta and distributes into breast milk (see Contraindications). The disparity between elimination half-life and duration of action for some conditiona may be partially explained by rapid shifts in distribution of diazepam out of the CNS. Although diazepam is 99% protein-bound, interactions based on protein binding are not clinically significant. The half-life of diazepam is 30-60 hours. Oxidation in the liver produces the active metabolites desmethyldiazepam, temazepam, and oxazepam, with half-lives of 30-100 hours, 9.5-12 hours, and 5-15 hours, respectively. These metabolites are subsequently glucuronidated and excreted in the urine.
CONTRAINDICATIONS/PRECAUTIONS: Diazepam can cause physical and psychological dependence, and should be used with extreme caution in patients with known, suspected, or a history of substance abuse.
Abrupt discontinuation of diazepam after prolonged use can cause seizures in susceptible patients. Benzodiazepine withdrawal causes irritability, nervousness, and insomnia. Benzodiazepine withdrawal is more likely to occur following abrupt cessation after excessive or prolonged doses, but it can occur following the discontinuance of therapeutic doses administered for as few as 1-2 weeks. Benzodiazepine withdrawal is also more severe if the agent involved has a relative shorter duration of action. Abdominal cramps, confusion, depression, perceptual disturbances, sweating, nausea, vomiting, parasthesias, photophobia, hyperacusis, tachycardia, and trembling also occur during benzodiazepine withdrawal, but their incidence is less frequent. Convulsions, hallucinations, delirium, and paranoia also can occur. Benzodiazepines should be withdrawn cautiously and gradually, using a very gradual dosage-tapering schedule. Diazepam is usually chosen as the agent for controlled tapering in all cases of benzodiazepine withdrawal.
Diazepam should not be administered parenterally to patients with acute ethanol intoxication, shock, or coma because the drug can worsen CNS depression.
Diazepam should be used with extreme caution in patients with respiratory depression, pulmonary disease such as severe COPD (chronic obstructive pulmonary disease), or sleep apnea because the drug can exacerbate ventilatory failure.
Diazepam should be used with extreme caution in patients with myasthenia gravis because the drug can exacerbate this condition.
Diazepam is occasionally beneficial for patients with major depression or psychosis. It can, however, induce paradoxical effects in these patients and in those with suicidal ideation. The drug should be administered to such patients with careful monitoring.
Diazepam is classified as pregnancy category D because it can cause harm to the fetus when administered to pregnant women. Positive evidence of human fetal risk exists based on investigational, marketing, or human studies, but the potential benefit to the mother may outweigh the potential risks to the fetus. Diazepam is distributed into breast milk and can cause sedation, feeding difficulties, and weight loss in the nursing infant. The use of diazepam during breast-feeding is generally not recommended.
Diazepam should be administered cautiously to patients with severe hepatic disease because its elimination half-life can be prolonged, possibly resulting in toxicity. Diazepam is metabolized to an active metabolite, and patients with hepatic disease are more likely to experience adverse CNS reactions and should receive reduced initial dosages.
Patients with renal impairment should be carefully monitored during prolonged treatment with benzodiazepines to avoid the adverse reactions that occur from accumulation.
The clearance and/or elimination of many drugs are reduced in the elderly. Delayed elimination can either intensify or prolong the actions of adverse reactions of the drug. Benzodiazepines have been associated with falls in the elderly and the consumer advocate group, Public Citizen, has recommended these drugs not be used in the elderly.
DRUG INTERACTIONS: Diazepam is metabolized by oxidative metabolism and is susceptible to drugn interactions with drugs that inhibit this hepatic enzyme system. Cimetidine, disulfiram, erythromycin, or fluvoxamine can decrease the hepatic metabolism of diazepam if administered concomitantly. Patients should be monitored for signs of altered benzodiazepine response when cimetidine, disulfiram, erythromycin, or fluvoxamine are initiated or discontinued.
Patients receiving levodopa for Parkinson's disease experienced an exacerbation of parkinsonian symptoms when benzodiazepines were added to their regimen. Benzodiazepines should be administered cautiously to such patients.
Concomitant administration of diazepam with CNS-depressant drugs, including opiate agonists, phenothiazines, barbiturates, ethanol, HA-blockers, general anesthetics, or tricyclic antidepressants, can potentiate the CNS effects (e.g., increased sedation or respiratory depression) of either agent.
Omeprazole can increase the plasma concentrations and the elimination half-life of diazepam, presumably due to inhibition of the hepatic metabolism of diazepam. Although the pharmacodynamics of this interaction are not clear, it is recommended that patients receiving omeprazole and diazepam concomitantly should be monitored for enhanced diazepam response.
Long-term treatment with lansoprazole in conjunction with diazepam therapy has been studied. Plasma elimination half-life, clearance, and volume of distribution of diazepam were not affected by concurrent use of lansoprazole.D
Concurrent use of isoniazid, INH and diazepam can increase serum concentrations of diazepam due to alterations in the half-life and clearance of diazepam. Although patient response to diazepam has not been reported, patients should be observed for signs of altered diazepam effects if isoniazid therapy is initiated or discontinued.
Diazepam has reportedly decreased the elimination of digoxin in some patients. Digoxin toxicity has occurred in a patient receiving alprazolam and digoxin. The interaction between benzodiazepines and digoxin may be the result of increased protein binding of digoxin and/or an effect of benzodiazepines at the renal tubules, which decreases the elimination of digoxin. Pending further clarification of this interaction, patients receiving a benzodiazepine and digoxin concurrently should be monitored for increased serum digoxin levels.
Oral contraceptives can increase the effects of diazepam because they inhibit oxidative metabolism, thereby increasing serum concentrations of concomitantly administered benzodiazepines that undergo oxidation. Patients receiving oral contraceptive therapy should be observed for evidence of increased response to diazepam.
The administration of valproic acid to patients receiving diazepam can cause an increase in diazepam serum concentrations and a concurrent increase in absence seizures. This interaction appears to be the result of inhibited metabolism of diazepam during concurrent use. If absence seizures increase in patients receiving these medications, an alternative anticonvulsant should be instituted.
Rifampin is a potent hepatic enzyme inducer and can accelerate the hepatic metabolism of diazepam. Patients should be monitored closely for signs of reduced diazepam effects if given rifampin concomitantly.
Diazepam 2 mg/kg IV, in combination with epinephrine and mechanical ventilation, was used successfully in treating severe chloroquine poisoning. Ten patients receiving diazepam and epinephrine survived compared to one patient in a retrospective control group. Diazepam is reported to antagonize the toxic effects of chloroquine, although the mechanism is unclear. Further study is needed to confirm the usefulness of diazepam in chloroquine poisoning.
Flumazenil and benzodiazepines are pharmacological opposites. Flumazenil is specifically used to reverse the actions of benzodiazepines. Clinicians should note that the duration of action for some benzodiazepines may be much longer than that of flumazenil and repeat doses of flumazenil may be necessary.
ADVERSE REACTIONS: Most of the adverse effects associated with diazepam therapy are dose-dependent and CNS-related including headache, drowsiness, ataxia, dizziness, confusion, depression, syncope, fatigue, tremor, and vertigo. CNS stimulation occurs in as many as 10% of patients and is of particular significance in psychiatric patients and hyperactive children. This paradoxical effect is possibly due to release of previously inhibited responses. Symptoms of CNS stimulation include nightmares, talkativeness, excitement, mania, tremor, insomnia, anxiety, restlessness, euphoria, acute rage reactions, and hyperactivity. Benzodiazepine therapy usually should be discontinued if signs of CNS stimulation occur.
Apnea, hypotension, and cardiac arrest have been reported following parenteral administration of benzodiazepines to the elderly, severely ill patients, or patients with compromised respiratory function. Respiratory depression also has occurred in these patients during benzodiazepine therapy, occasionally resulting in death.
Abrupt discontinuation of diazepam after prolonged use can cause seizures in susceptible patients. Benzodiazepine withdrawal causes irritability, nervousness, and insomnia. Benzodiazepine withdrawal is more likely to occur following abrupt cessation after excessive or prolonged doses, but it can occur following the discontinuance of therapeutic doses administered for as few as 1-2 weeks. Benzodiazepine withdrawal is also more severe if the agent involved has a relative shorter duration of action. Abdominal cramps, confusion, depression, perceptual disturbances, sweating, nausea, vomiting, parasthesias, photophobia, hyperacusis, tachycardia, and trembling also occur during benzodiazepine withdrawal, but the incidence is less frequent. Convulsions, hallucinations, delirium, and paranoia can occur as well. Benzodiazepines should be withdrawn cautiously and gradually, using a very gradual dosage-tapering schedule. Diazepam is usually chosen as the agent for controlled tapering in all cases of benzodiazepine withdrawal.
Sexual dysfunction has been reported with diazepam. Libido decrease, impotence, ejaculation dysfunction (delayed ejaculation), and orgasm dysfunction (retarded or no orgasm).
A number of reports have documented diazepam causing interstitial nephritis, although this is considered a rare adverse effect.
What do diazepam tablets do?
Diazepam (ValiumTM ) is a benzodiazepine. Benzodiazepines belong to a group of medicines that slow down the central nervous system. Diazepam relieves anxiety and nervousness. It also can help patients cope with alcohol withdrawal, relax muscles, and treat certain types of seizures (convulsions). Federal law prohibits the transfer of diazepam to any person other than the patient for whom it was prescribed. Do not share this medicine with anyone else. Generic diazepam tablets are available.
What should my doctor or pharmacist know before I take diazepam?
They need to know if you have any of these conditions:
- an alcohol or drug abuse problem
- kidney or liver disease
- lung disease or breathing difficulties
- myasthenia gravis
- shock, or coma
- sleep disturbance or shortness of breath
- suicidal thoughts
- an unusual or allergic reaction to diazepam, other benzodiazepines, foods, dyes, or preservatives
- pregnant or trying to get pregnant
How should I take this medicine?
Take diazepam tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If diazepam upsets your stomach, take it with food or milk. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
Special precautions for use in children:
This medicine is not for children under 6 months old.
Elderly patients over 65 years old may have a stronger reaction to this medicine and need smaller doses.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What other medicines can interact with diazepam?
- barbiturate medicines for inducing sleep or treating seizures (convulsions)
- female hormones, including contraceptive or birth control pills
- medicines for hay fever and other allergies
- medicines for mental depression
- medicines for mental problems and psychotic disturbances
- medicines for pain
- valproic acid
Tell your doctor or pharmacist: about all other medicines you are taking, including non-prescription medicines; if you are a frequent user of drinks with caffeine or alcohol; if you smoke; or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medicines.
What side effects may I notice from taking diazepam?
Serious side effects with diazepam include:
lightheadedness or fainting spells
mood changes, excitability or aggressive behavior
movement difficulty, staggering or jerky movements
problems passing urine
weakness or tiredness
Call your doctor as soon as you can if you get any of these side effects.
Minor side effects with diazepam include:
- difficulty sleeping, nightmares
- dizziness, drowsiness, clumsiness, or unsteadiness; a "hangover" effect
- nausea, vomiting
Let your doctor know about these side effects if they do not go away or if they annoy you.
What do I need to watch for while I take diazepam?
Visit your doctor for regular checks on your progress. Your body can become dependent on diazepam, ask your doctor if you still need to take it. However, if you have been taking diazepam regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get severe side effects. Ask your doctor for advice. Even after you stop taking diazepam it can still affect your body for several days.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how diazepam affects you. To reduce the risk of dizzy and fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.
Do not treat yourself for coughs, colds or allergies without asking your doctor or pharmacist for advice. Some ingredients can increase possible side effects.
If you are going to have surgery, tell your doctor or dentist that you are taking diazepam.
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at room temperature between 15 and 30C (59 and 86F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.
White Roche Valium (Diazepam) Tablets 10mg
10mg Roche Valiums are WHITE Manufactured by Roche India.
- Please read this leaflet carefully before you start to take your medicine.
- It gives you important information about your medicine.
- If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.
- Keep the leaflet until you have finished the medicine.
WHAT IS IN YOUR MEDICINE?
Each tablet 10mg of the active ingredient diazepam.
The tablets also contain: lactose, magnesium stearate, maize starch, pregelatinised maize starch, purified water and stearic acid. The 5mg tablets also contain quinoline yellow (E104) and the 10mg tablets also contain HT Lake (E132).
ABOUT YOUR MEDICINE
Diazepam is one of a group of medicines called benzodiazepine tranquilizers. These medicines act on brain transmitters and help in the treatment of anxiety and muscle spasms.
Diazepam tablets may be used in adults:
- for the short term (2-4 weeks) relief of anxiety, which is severe, disabling, distressing, occurring alone or associated with sleeplessness or with other illnesses.
- to relieve muscle spasms in cerebral palsy or other causes of muscular spasm.
- to help in the treatment of certain forms of epilepsy (usually epilepsy associated with muscular spasms).
- to relieve the symptoms of acute alcohol withdrawal.
- as an oral pre-medication for nervous dental patients or before surgery.
- to control tension and irritability in cerebral palsy and muscle spasms caused by tetanus.
- as an oral pre-medication before surgery.
BEFORE TAKING YOUR MEDICINE
Do not take Diazepam tablets if you:
- have ever had an allergic reaction to diazepam, any of the ingredients in the tablet or other similar benzodiazepine medicines (eg nitrazepam or temazepam). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue)
- suffer from any mental illness such as obsessions, phobias (irrational fears) or schizophrenia
- suffer from depression or anxiety associated with depression
- have severe liver disease
- suffer from porphyria (a hereditary disease affecting the liver or bone marrow)
- suffer from glaucoma (increased pressure in the eye)
- suffer from muscle weakness (myasthenia gravis)
- suffer from a condition where you stop breathing whilst asleep (sleep apnoea)
- do you have any diseases of the lung
Check with your doctor or pharmacist before taking Diazepam tablets if you:
- have severe kidney problems
- suffer from memory loss (amnesia)
- suffer from low blood levels of the water-soluble blood protein called albumin (detected via a blood test)
- have a personality disorder
- have a history of alcoholism or drug abuse
- are elderly
- have suffered a loss or bereavement (diazepam can affect the way you react to this).
Other precautions you should take:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains lactose.
Taking Diazepam tablets with al cohol:
Alcohol will increase the sedative effects of diazepam and should therefore be avoided.
Check with your doctor or pharmacist if you are taking any of the following:
- other medicines which act on the brain causing sedation including strong painkiller medicines to make you sleep, anaesthetics, antihistamines, lofexidine and nabilone.
- medicines to treat depression- (e.g. fluoxetine, fluvoxamine, amitriptyline or mirtazipine).
- muscle relaxants such as baclofen or tizanidine.
- oestrogen-containing contraceptives (breakthrough bleeding may occur).
- medicines to treat epilepsy (e.g. phenytoin, carbamazepine, zotepine, sodium valproate or barbiturates).
- medicines which lower high blood pressure (in particular alpha blockers, diuretics (water tablets), moxonidine).
- disulfiram, used as an adjunct to treat alcohol dependence
- medicines used to treat Parkinsonism.
- ulcer healing drugs such as omeprazole, or cimetidine.
- antibiotics (isoniazid, erythomycin and rifampicin).
- digoxin or nitrates for heart conditions.
- metoclopramide injection
- antivirals (ampenavir and ritonavir).
Driving and using machines:
Diazepam tablets may make you sleepy or affect your concentration or vision. This may affect your performance at skilled tasks eg driving and operating machinery. This effect may occur the following morning, make sure you are not affected before you drive or operate machinery.
Pregnancy and Breast-feeding:
If you are pregnant, may be pregnant, or are breast-feeding DO NOT take this medicine. If your doctor has decided that you should have this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness, and breathing and feeding difficulties. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
If you see another doctor or go into hospital, especially if you need an operation, let them know what medicines you are taking.
TAKING YOUR MEDICINE
Follow your doctors instructions. Check the pharmacy label to see how many tablets to take and how often to take them. If you are not sure how to take them, ask your pharmacist or doctor.
The usual dosage(s) are described below.
- Indication and Dosage:
- Anxiety, obsession and psychiatric disturbances: 5-30mg daily in divided doses.
- Anxiety associated with sleeplessness: 5-15mg before going to bed.
- Cerebral palsy and other forms of spacitiy: 5-60mg daily in divided doses.
- Other causes of muscle spasms: 5-15mg daily in divided doses.
- Epilepsy: 2-60mg daily in divided doses.
- Alcohol withdrawal: 5-20mg, repeated if necessary in 2-4 hours.
- Pre-medication in dental patients: 5mg the night before treatment, 5mg on waking and 5mg two hours before the appointment.
- Pre-medication before surgery: 5-20mg given 1-2 hours before surgery.
- Elderly and debilitated patients: dose should be half the recommended adult doses.
- Kidney or liver impairment: a reduced dose will be given.
- Children: Alternative presentations of diazepam are preferred for use in children in order to obtain suitable doses of less than 5mg.
- Cerebral spasticity with a little amount of brain damage: 5-40mg daily in divided doses.
- Pre-medication before surgery: 2-10mg given 1-2 hours before surgery.
Swallow these tablets with water. This medicine should be taken for as long as your doctor tells you to, it may be dangerous to stop without their advice. Treatment should not usually exceed 4 weeks and should be gradually withdrawn as side effects, such as difficulty sleeping, irritability, anxiety, loss of concentration, headache, dizziness, tremor, feeling or being sick, stomach cramps, muscle pain, tension, restlessness, heart disturbances, nervousness, sweating, diarrhoea and depression, have been observed on abrupt withdrawal.
If you forget to take a dose, take one as soon as you remember. Then go on as before. DO NOT take two doses at the same time. If you are worried ask your pharmacist or doctor for advice.
Do not take more tablets than your doctor tells you to. If you ever take too many, go to the nearest hospital casualty department or tell your doctor, immediately. Take the container and any remaining tablets with you to show to the doctor.
AFTER TAKING YOUR MEDICINE
This medicine sometimes causes unwanted effects in some people. These effects may include
- drowsiness, sedation, muscle weakness, unsteadiness and shaky movements (particularly when you first start taking Diazepam tablets or if the dosage is high). The elderly may also experience confusion.
- Other rare effects include allergic reaction (skin rash or itching), headaches, ’spinning’ sensation, low blood pressure, stomach upsets, dystonic effects (muscle spasm in the shoulders, neck and trunk), visual disturbances, difficulty passing water, changes in desire for sex, aggression, excitement, confusion, depression with suicidal tendencies and lack of co-ordination at high doses. You should consult your doctor if these are troublesome or continue. Changes in the number and types of blood cells can occur and if you develop sore throats, infections, bruising or nose bleeds tell your doctor who may wish to give you a blood test. Also contact your doctor if you develop jaundice (yellowing of the eyes or skin).
- Diazepam treatment can be associated with withdrawal symptoms. Talk to your doctor before stopping taking the tablets and follow their advice. If you stop taking the tablets too quickly you may develop depression, nervousness, sleeplessness, irritability, sweating and diarrhoea. If you have been taking a large dose and stop taking the tablets abruptly you may become confused or suffer from delusions, hallucinations or fits. These symptoms can occur for up to three weeks after withdrawal; broken sleep and vivid dreams may persist for several weeks.
If you are concerned about any of these effects or get any other unusual effects, tell your doctor or pharmacist immediately. Please do not be worried. Most people taking this medicine will not experience any problems.
STORING YOUR MEDICINE
Do not use the tablets after the expiry (use by) date shown on the product packaging. Keep the tablets stored in the orginal packaging and do not store above 25°C. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.
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