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Introduction About NITROSUN 10MG TABLET
NITROSUN 10MG TABLET contains Nitrazepam which belongs to the group of medicines called Hypnotic agents. It is used for the short-term management of insomnia (difficulty in falling asleep). It can also be used in management of a type of epilepsy called myoclonic seizures (sudden, jerky muscle movements).
NITROSUN 10MG TABLET shortens the time required to fall asleep and lengthens the duration of the sleep. Take NITROSUN 10MG TABLET only for the duration recommended by your doctor. Avoid consuming alcohol while taking NITROSUN 10MG TABLET as it could make you feel dizzier and drowsier.
Before taking NITROSUN 10MG TABLET inform your doctor if you have any lung, liver, kidney or heart problems. You must also inform your doctor if you have any muscle problems, depression, anxiety, any psychiatric disorders, epilepsy or a history of alcoholism or drug abuse as a precaution.
NITROSUN 10MG TABLET is not recommended for use in patients with breathing difficulties. It is also not suitable for use in pregnant or breastfeeding women and in children aged below 18 years.
NITROSUN 10MG TABLET may reduce alertness and induce excessive drowsiness in patients. Therefore, it should not be overdosed or misused by the patients. Patients must also avoid driving or handling any heavy tools while taking NITROSUN 10MG TABLET as a precaution.
The most common side effects of taking NITROSUN 10MG TABLET are dizziness, drowsiness, muscle weakness, feeling unsteady, lack of coordination, reduced alertness, tiredness and headache. Contact your doctor if any of these side effect worsens.
You must also inform your doctor immediately if you experience any suicidal thoughts after taking NITROSUN 10MG TABLET.
Uses Of NITROSUN 10MG TABLET
It is used to manage:
- Insomnia (difficulty in falling asleep)
- Myoclonic seizures (fits causing sudden jerky muscle movements)
How NITROSUN 10MG TABLET Works
NITROSUN 10MG TABLET is a hypnotic medicine. It works by increasing the activity of certain brain chemicals (GABA) that reduces anxiety, relaxes body muscle and induces sleep. This produces a calming effect on the brain and shortens the time required for falling asleep. Additionally, it can also suppress the abnormal electrical signals in the brain which helps in reducing the onset of seizures.
How to use NITROSUN 10MG TABLET
Take NITROSUN 10MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not chew or crush the medicine.
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.
Do not stop taking NITROSUN 10MG TABLET without consulting your doctor as it may lead to recurrence of sleep problems or can cause withdrawal symptoms such as anxiety, nervousness, restlessness, mood changes, confusion, irritability, sweating, diarrhoea, headaches, muscle weakness, changes in behaviour, numbness and tingling of the extremities, fits, over-sensitivity to light, noise and touch and hallucination.
Side Effects Of NITROSUN 10MG TABLET
Common
- dizziness, drowsiness
- feeling unsteady, loss of co-ordination
- lack of emotions
- reduced alertness
- tiredness, double vision
- confusion
- headache
- muscle weakness
Rare
- changes in blood count
- changes in sex drive
- spinning sensation (vertigo)
- breathing problems
- nausea, upset stomach
- difficulty in passing urine
Stop taking NITROSUN 10MG TABLET and consult your doctor immediately if you experience any of the following side effects such as:
- signs of severe allergic reactions (such as skin rash, itching, swelling of the face, lips, throat or tongue causing difficulty in breathing or swallowing)
- severe skin reactions (such as skin rash with itching and redness, blistering and peeling of skin, skin swelling and inflammation of mucous membrane, skin lesions with a pink/red ring and a pale center which may be itchy, scaly or filled with fluid accompanied with fever and tiredness)
- worsening of depression, suicidal thoughts or behavior
- yellowing of skin and whites of the eye (signs of liver problems)
- behavioural changes (such as aggression, excitement, confusion, restlessness, agitation, irritability, rages, hallucinations, nightmares and depression)
How To Manage Side Effects
Nausea:
Take NITROSUN 10MG TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
Headache:
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
Warning & Precautions
Pregnancy
NITROSUN 10MG TABLET is not recommended for use in pregnant women as it may harm the growing baby. Therefore, inform your doctor before taking NITROSUN 10MG TABLET if you are pregnant or think you may be pregnant.
Breastfeeding
NITROSUN 10MG TABLET is not recommended for use in breastfeeding women. Therefore, consult your doctor before taking it.
Driving and Using Machines
Do not drive and use heavy machinery while taking NITROSUN 10MG TABLET as it could reduce alertness and induce drowsiness with poor muscle coordination.
Alcohol
Avoid consumption of alcohol while taking NITROSUN 10MG TABLET as it may make you feel dizzier.
Kidney
NITROSUN 10MG TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
Liver
NITROSUN 10MG TABLET is not recommended for use in patients having severe liver problems. It should be used with caution in patients with other liver problems. Therefore, consult your doctor before taking it.
Allergy
Do not take NITROSUN 10MG TABLET if you are allergic to Nitrazepam or to any other benzodiazepines (such as clonazepam, diazepam).
Lungs
NITROSUN 10MG TABLET is not recommended for use in patients with severe lung diseases (such as COPD). It should be used with caution in patients with mild lung problems. Therefore, consult your doctor before taking it.
Heart Disease
NITROSUN 10MG TABLET should be used with caution in patients with heart problems. Therefore, consult your doctor before taking it.
Others
NITROSUN 10MG TABLET is not recommended for use if you:
- have any breathing difficulties
- have sleep apnea (breathing difficulties during sleep)
- have myasthenia gravis (severe muscle weakness and tenderness)
- have any psychiatric disorders (such as schizophrenia)
- have porphyria (an inherited blood disorder)
Before taking NITROSUN 10MG TABLET, inform your doctor if you:
- are in depression or have a history of depression
- have anxiety or any other mental illnesses
- are alcoholic
- have low albumin levels in blood
- have poor blood supply to the brain
- have epilepsy
- have an history of alcoholism or drug abuse
Use in Pediatrics
NITROSUN 10MG TABLET is not recommended for use in children and adolescents (aged below 18 years). However, consult your doctor for advice.
Use in Geriatrics
NITROSUN 10MG TABLET should be used with caution in elderly patients as it could relax the muscles and increase the risk of fall or injuries in such patients. Therefore, consult your doctor before taking it. Proper dose adjustments and careful monitoring are required in such patients.
Interactions
A. Drug-Drug Interactions
Before taking NITROSUN 10MG TABLET, inform your doctor if you are taking any of the following medicines such as:
- other medicines used to manage depress brain such as antidepressants (Ex. fluoxetine, sertraline), hypnotics (Ex. alprazolam, midazolam), neuroleptics (Ex. haloperidol)
- anaesthetics (used to cause numbness of body parts or loss of consciousness) Ex. lignocaine, sevoflurane
- antihistamines (used to manage allergic symptoms) Ex. cetirizine
- lofexidine (a medicine used to manage withdrawal symptoms of opioids)
- nabilone (a medicine used to manage nausea and vomiting)
- opioid analgesics (used for pain relief) such as morphine, fentanyl, pethidine
- medicines used to manage epilepsy (Ex. phenytoin and phenobarbital)
- rifampicin (a medicine used to manage tuberculosis)
- moxonidine (a medicine used to reduce high blood pressure)
- muscle relaxants (used to reduce muscle spasms) Ex. baclofen, tizanidine
- erythromycin (a medicine used to manage bacterial infections)
- cimetidine (a medicine used to manage stomach ulcers)
Overdosage:
If you or anyone else accidentally took more NITROSUN 10MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include drowsiness, confusion, muscle relaxation, lack of coordination, decreased blood pressure, and extremely slow and/or shallow breathing and pulse.
Synopsis
| Drug | : | Nitrazepam |
| Pharmacological Category | : | Benzodiazepines |
| Therapeutic Indication | : | Insomnia, Seizure |
| Dosage Forms | : | Tablet, Capsule |
More Information
- Keep NITROSUN 10MG TABLET out of reach of children
- Store NITROSUN 10MG TABLET at room temperature
FAQs About NITROSUN 10MG TABLET
Can NITROSUN 10MG TABLET cause dependency?
NITROSUN 10MG TABLET can also elicit a withdrawl response. Recurrence of sleep problems, psychological disturbances such as depression, nervousness, tension and anxiety may also occur, along with mood changes such as irritabiliuty, restlessness and confusion may also occur. Various physical manifestations of withdrawal include frequent loose stools (diarrhea), headache and muscle weakness. Hence, it is recommended to take only the prescribed dosage for the specific amount of time and not to suddenly stop taking NITROSUN 10MG TABLET, without doctor’s consultation.
Can I drive after taking NITROSUN 10MG TABLET?
No, it is not recommended to drive after taking NITROSUN 10MG TABLET due to increased tiredness and dizziness, reduced alertness, poor muscular co-ordination and double vision. Hence NITROSUN 10MG TABLET compromises the ability to drive, hence should be avoided after taking NITROSUN 10MG TABLET to manage the hazards.
Is NITROSUN 10MG TABLET addictive?
Yes. NITROSUN 10MG TABLET is addictive in nature. Patients may feel addicted to this medicine even after using it for a short span of time. Therefore, take NITROSUN 10MG TABLET only as instructed by your doctor. Avoid overusing or misusing the medicine.
What is the use of NITROSUN 10MG TABLET?
NITROSUN 10MG TABLET is used in to manage insomnia (sleeplessness) and a type of epilepsy called myoclonic seizure.
How NITROSUN 10MG TABLET works?
NITROSUN 10MG TABLET is a hypnotic medicine. It works by increasing the activity of certain brain chemicals (GABA) that reduces anxiety, relaxes body muscle and induces sleep. This produces a calming effect on the brain and shortens the time required for falling asleep. Additionally, it can also suppress the abnormal electrical signals in the brain which helps in reducing the onset of seizures.
How to take NITROSUN 10MG TABLET?
Take NITROSUN 10MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not chew or crush the medicine.
Can I stop taking NITROSUN 10MG TABLET once I started feeling better?
No. Do not stop taking NITROSUN 10MG TABLET without consulting your doctor as it may make your symptoms re-appear once again or can cause withdrawal symptoms such as anxiety, nervousness, restlessness, mood changes, confusion, irritability, sweating, diarrhoea, headaches, muscle weakness, changes in behaviour, numbness and tingling of the extremities, fits, over-sensitivity to light, noise and touch and hallucination.
Can I take NITROSUN 10MG TABLET daily?
Take NITROSUN 10MG TABLET as advised by your physician. Your doctor will evaluate your health condition and suggests whether can you take NITROSUN 10MG TABLET every day or not.
Will taking a higher dose of NITROSUN 10MG TABLET be more effective?
No. Taking a higher dose of NITROSUN 10MG TABLET will not be effective rather it would be making you drowsier. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.
What to do if I forgot to take a dose of NITROSUN 10MG TABLET?
If you forgot to take a dose of NITROSUN 10MG TABLET, take it as soon as you remember. However, if it is time for the next dose of NITROSUN 10MG TABLET, skip the missed dose and take the next one regularly. Do not take a double dose of NITROSUN 10MG TABLET to compensate the missed ones. Consult your doctor for advice.
What are the side effects of NITROSUN 10MG TABLET?
The most common side effects of taking NITROSUN 10MG TABLET are dizziness, drowsiness, muscle weakness, feeling unsteady, lack of coordination, reduced alertness, tiredness and headache. Contact your doctor if any of these side effect worsens.
Is NITROSUN 10MG TABLET safe to use in children?
NITROSUN 10MG TABLET is generally not recommended for use in children and adolescents (aged below 18 years). However, consult your doctor before taking it.
Is NITROSUN 10MG TABLET safe?
NITROSUN 10MG TABLET is safe at doses prescribed by the doctor. Do not alter the dosage of NITROSUN 10MG TABLET without consulting your doctor.
References
1. KD. Tripathi. Sedative-Hypnotics. Essentials of medical pharmacology. Seventh edition. 2013. Page- 405.
2. J. E. Jan, J. A. Riegl, J. U. Crichton and H. G. Dunn. Nitrazepam in the Treatment of Epilepsy in Childhood. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed central. April 1971. [Accessed on 9th November 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1930975/
3. Accord. Electronic Medicines Compendium (EMC). [Revised in February 2020] [Accessed on 9th November 2022]. https://www.medicines.org.uk/emc/files/pil.5893.pdf
4. Central Drugs Standard Control Organization. Nitrazepam. September 1973. [Accessed on 9th November 2022]. https://cdscoonline.gov.in/CDSCO/Drugs
5. Sandoz Canada Inc. SANDOZ NITRAZEPAM Nitrazepam BP, 5 mg and 10 mg Tablets. [Revised in August 2011] [Accessed on 9th November 2022]. https://pdf.hres.ca/dpd_pm/00013815.PDF
6. Alphapharm Pty Ltd. Australia. [Revised in December 2020] [Accessed on 9th November 2022]. https://apps.medicines.org.au/files/afpalodo.pdf
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