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Nitrazepam belongs to the class of medications called benzodiazepines. It is used for short-term treatment of sleeping problems (Insomnia), such as difficulty falling asleep, frequent awakenings during the night, and early-morning awakening.
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Nitrazepam belongs to the class of medications called benzodiazepines. It is used for short-term treatment of sleeping problems (Insomnia), such as difficulty falling asleep, frequent awakenings during the night, and early-morning awakening. It is also used to manage myoclonic seizures. It works by slowing down the nerves in the brain (the central nervous system).
Apo Nitrazepam may be available under multiple brand names and/or in several different forms. Any specific brand name of Apo Nitrazepam may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Apo Nitrazepam may not be used for all of the conditions discussed here.
Your doctor may have suggested Apo Nitrazepam for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Apo Nitrazepam, speak to your doctor. Do not stop taking Apo Nitrazepam without consulting your doctor.
Do not give Apo Nitrazepam to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Apo Nitrazepam if their doctor has not prescribed it.
The recommended adult dose of nitrazepam when taken for insomnia is 5 mg to 10 mg taken at bedtime.
Seniors may be more likely to experience unwanted effects of Apo Nitrazepam and should start with 2.5 mg taken at bedtime.
The lowest effective dose should be used. It is important that the dose be individualized to your specific needs to avoid excessive drowsiness during the day time or motor impairment.
Apo Nitrazepam is normally used for a short period of time or as an "as required" medication. As it may be habit-forming, the treatment period should be as short as possible and not usually longer than 7 to 10 consecutive days. If you need Apo Nitrazepam for more than 2 to 3 weeks, consult your doctor for a re-evaluation of Apo Nitrazepam.
When taken for treatment of myoclonic seizures, the dose is based primarily on body weight. The dose for children (up to 30 kg of body weight) ranges from 0.3 mg per kilogram of body weight to 1 mg per kilogram of body weight daily in 3 divided doses. Your doctor will calculate an appropriate dose.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
Nitrazepam may be habit-forming when taken for long periods of time. It may not be appropriate for people who have a history of alcohol or substance abuse.
If you have been taking Apo Nitrazepam regularly for a long period of time (more than one month), do not stop taking the medication without speaking with your doctor. A gradual reduction in dose is recommended when stopping Apo Nitrazepam to avoid withdrawal effects.
It is important to take Apo Nitrazepam exactly as prescribed by your doctor. Do not take Apo Nitrazepam in a larger amount or for a longer period of time than prescribed by your doctor. If you miss a scheduled dose, take it as soon as possible and continue with your regular schedule. If you are taking nitrazepam for sleeping, do not take it if you will not be able to get a full night's sleep (approximately 8 hours or more). Apo Nitrazepam tends to make people disoriented, uncoordinated and unable to concentrate clearly until it has worn off. If you remember the missed dose during the daytime, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store Apo Nitrazepam at room temperature, protect it from light and moisture, and keep it out of reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Apo Nitrazepam. If you are concerned about side effects, discuss the risks and benefits of Apo Nitrazepam with your doctor.
The following side effects have been reported by at least 1% of people taking Apo Nitrazepam. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Apo Nitrazepam.
Each round, white, biplane, bevelled-edged tablet, engraved "APO" on one side, scored and engraved "NIT" over "5" on the other side, contains nitrazepam 5 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
Each round, white, biplane, bevelled-edged tablet, engraved "APO" on one side, scored and engraved "NIT" over "10" on the other side, contains nitrazepam 10 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
Do not take nitrazepam if you:
There may be an interaction between nitrazepam and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with Apo Nitrazepam. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Apo Nitrazepam.
HEALTH CANADA ADVISORY
October 30, 2020
Health Canada has issued new restrictions concerning the use of benzodiazepines and benzodiazepine-like prescription drugs. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Alcohol and other medications that cause drowsiness: People taking Apo Nitrazepam should not combine it with alcohol and avoid combining it with other medications, such as narcotic pain relievers, or other sedatives that cause drowsiness. Doing so can cause additional drowsiness and reduced breathing as well as other side effects, which can be dangerous.
Asthma and other respiratory conditions: Nitrazepam may cause increased breathing difficulty for people having an acute asthma attack, or those with COPD (Chronic Obstructive Pulmonary Disease) (chronic Bronchitis, emphysema) or other conditions that affect breathing. If you have asthma or any other breathing disorder, discuss with your doctor how Apo Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Nitrazepam, and whether any special monitoring is needed.
Behavioural and mood changes: Apo Nitrazepam may cause mood and psychiatric changes, including aggressiveness, confusion, anxiety, restlessness, and memory lapses. Tell your doctor as soon as possible if you notice any unusual changes in your behaviour.
Complex sleep-related behaviours: There have been reports of complex sleep-related behaviours that have occurred while using nitrazepam and other similar medications to treat difficulty sleeping. People taking nitrazepam have been reported to talk, walk, cook, eat, and drive while they were not fully awake, and did not remember doing these things afterwards. If you experience similar events, or notice them in a family member who is taking Apo Nitrazepam, contact your doctor as soon as possible.
Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with benzodiazepines such as nitrazepam. Severe withdrawal symptoms may be experienced if the dose is significantly reduced or suddenly discontinued. These symptoms include seizures, irritability, nervousness, sleep problems, agitation, tremors, Diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.
A temporary condition called rebound insomnia, where the symptoms that led to treatment with nitrazepam come back worse than before, may occur on withdrawal of the medication. It may be accompanied by other reactions including mood changes or anxiety.
Depression: Apo Nitrazepam can make some symptoms of depression worse. If you have depression or a history of depression, discuss with your doctor how Apo Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Nitrazepam, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, contact your doctor as soon as possible. If you experience feelings of wanting to harm yourself, or notice this in a family member who is taking Apo Nitrazepam, seek medical help immediately.
Drowsiness/reduced alertness: Nitrazepam causes drowsiness and sedation. Avoid activities requiring mental alertness, judgment, and physical coordination such as driving or operating machinery until you have determined how Apo Nitrazepam affects you. Drinking alcohol can increase the drowsiness effects and should be avoided.
Kidney function: If you have reduced kidney function or Kidney Disease, discuss with your doctor how Apo Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Nitrazepam, and whether any special monitoring is needed.
Liver function: People with reduced liver function or liver disease may experience a stronger effect from the medication than would normally occur. If you have reduced liver function or liver disease, discuss with your doctor how Apo Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Nitrazepam, and whether any special monitoring is needed.
Pregnancy: Nitrazepam, like other benzodiazepines, can cause harm to an unborn baby if the mother takes it while pregnant. Apo Nitrazepam should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Apo Nitrazepam, contact your doctor immediately.
Breast-feeding: Apo Nitrazepam passes into breast milk. If you are a breast-feeding mother and are taking nitrazepam, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of nitrazepam for sleep difficulties have not been established for children and adolescents less than 18 years of age.
Seniors: Seniors are more likely to experience sedation and decreased coordination when taking nitrazepam. The lowest effective dose of Apo Nitrazepam should be used for the shortest possible length of time.
All material © 1996-2021 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health providers with any questions you may have regarding a medical condition.
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