Nitrazepam Tablets 5mg Technical Specification:
Product Name: | Nitrazepam Tablets 5mg |
Brand Name: | Generic |
Strength: | (5mg), (10mg) |
Dosage Form: | Tablets (Un-coated) |
Route of Administration: | Via Oral Route |
Packing: | 10s, 30s, 100s, 500s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Sedative-hypnotics |
Indication: | Nitrazepam Tablets should be used for short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress, where daytime sedation is acceptable. |
Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Nitrazepam Tablets 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Nitrazepam Tablets 5mg
Each Un-coated tablet contains:
Nitrazepam……….……5mg
Excipients………………..q.s
Colour: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
Nitrazepam Tablets should be used for short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress, where daytime sedation is acceptable.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.
Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Why Taj pharmaceuticals?
Taj Pharmaceuticals is a trusted provider of Nitrazepam Tablets, a medication known for its effectiveness in treating insomnia and anxiety disorders. With a rich history of pharmaceutical excellence, our commitment to stringent quality control processes ensures that you receive medication that prioritizes your well-being and health. Our dedication to patient care makes us a reliable partner in healthcare solutions. Nitrazepam Tablets are a valuable tool in managing sleep disturbances and anxiety-related conditions. These tablets are part of a comprehensive approach to improving sleep quality and reducing anxiety symptoms. At Taj Pharmaceuticals, we understand the importance of quality medication in enhancing the overall quality of life. Our focus on pharmaceutical quality, safety, and efficacy is evident in our manufacturing processes and product standards. We adhere to international pharmaceutical guidelines to ensure that every Nitrazepam Tablet you receive meets the highest standards of quality and reliability. Sleep is essential for physical and mental well-being, and anxiety can significantly impact one’s daily life. Taj Pharmaceuticals recognizes these challenges and strives to provide accessible and effective solutions. When you choose Taj Pharmaceuticals for your medication needs, you choose a partner dedicated to your health and improved quality of life. Experience the difference in pharmaceutical quality and patient care with Taj Pharmaceuticals. Trust us as your pharmaceutical partner, and let us contribute to your well-being by providing reliable and effective Nitrazepam Tablets.
What is Nitrazepam Tablets and its uses?
Nitrazepam Tablets are a medication primarily used to treat sleep disorders, particularly insomnia. Nitrazepam belongs to the class of drugs known as benzodiazepines, which are central nervous system depressants. These tablets contain the active ingredient nitrazepam, which has sedative, hypnotic, and anxiolytic (anxiety-reducing) properties. Here are the main uses of Nitrazepam Tablets:
- Insomnia: Nitrazepam is prescribed to individuals who have difficulty falling asleep or staying asleep, a condition commonly known as insomnia. It helps induce and prolong the duration of sleep, allowing individuals to get a full night’s rest.
- Anxiety Disorders: In some cases, Nitrazepam may be used to manage symptoms of anxiety disorders, particularly when anxiety is causing sleep disturbances. It can help reduce anxiety and promote relaxation.
- Muscle Relaxation: Nitrazepam has muscle relaxant properties, and it may be prescribed in some cases to alleviate muscle spasms or tension associated with certain medical conditions.
- Seizure Disorders: Although less commonly prescribed for this purpose today, nitrazepam was historically used to treat certain types of seizure disorders, such as petit mal seizures.
- Preoperative Sedation: In some medical procedures, Nitrazepam may be used as a preoperative sedative to reduce anxiety and induce calmness in patients before surgery.
- Alcohol Withdrawal: In cases of alcohol withdrawal syndrome, Nitrazepam may be used to manage symptoms such as anxiety, agitation, and insomnia.
It’s important to note that Nitrazepam is typically prescribed for short-term use due to the risk of developing tolerance and dependence with prolonged use. Long-term use can lead to reduced effectiveness and withdrawal symptoms upon discontinuation. Healthcare providers generally recommend the lowest effective dose for the shortest duration necessary to address the specific condition The use of Nitrazepam should be closely monitored by a healthcare provider, and patients should follow their prescribed dosage and treatment duration carefully. Abruptly stopping the medication can lead to withdrawal symptoms, and it should only be discontinued under medical supervision. As with all medications, potential benefits should be weighed against the risks, and patients should be informed about the potential for side effects and dependence.
How does Nitrazepam Tablets work?
Nitrazepam Tablets work by enhancing the activity of a neurotransmitter in the brain called gamma-aminobutyric acid (GABA). GABA is an inhibitory neurotransmitter, which means it has a calming and inhibitory effect on brain activity. Nitrazepam belongs to the benzodiazepine class of medications, and its mechanism of action is centered on GABA receptors. Here’s how Nitrazepam works:
- Enhancing GABA Activity: Nitrazepam binds to specific GABA-A receptors in the brain. When it binds to these receptors, it enhances the inhibitory effects of GABA. GABA’s normal function is to reduce the activity of neurons in the brain, essentially calming down excessive electrical activity.
- Reducing Brain Excitability: By enhancing GABA activity, Nitrazepam reduces the overall excitability of the brain. This results in a calming effect on the central nervous system, leading to relaxation, sedation, and a decrease in anxiety.
- Inducing Sleep: In the case of insomnia, Nitrazepam’s ability to increase GABA activity helps induce and maintain sleep. It shortens the time it takes to fall asleep (sleep onset latency) and prolongs the total duration of sleep, improving sleep quality.
- Muscle Relaxation: Nitrazepam also has muscle relaxant properties. It can reduce muscle spasms and tension by acting on the central nervous system.
- Anticonvulsant Effect: While it is not a first-line treatment for epilepsy, Nitrazepam has been used as an anticonvulsant in certain types of seizures, particularly petit mal seizures. Its calming effect on brain activity can help prevent seizures.
It’s important to note that Nitrazepam is typically prescribed for short-term use due to the risk of developing tolerance (requiring higher doses for the same effect) and physical dependence with prolonged use. Abruptly stopping Nitrazepam can lead to withdrawal symptoms, so it should be gradually tapered under medical supervision when discontinuing treatment. The dosage and duration of Nitrazepam treatment should be determined by a healthcare provider based on the specific condition being treated, and it should only be used under their guidance. Additionally, because Nitrazepam can cause drowsiness and impair cognitive function, individuals taking this medication should avoid activities that require mental alertness, such as driving, until they are aware of how the medication affects them.
Benefits of Nitrazepam Tablets:
- Treatment of Insomnia: Nitrazepam is an effective medication for the short-term treatment of insomnia, helping individuals fall asleep faster and stay asleep throughout the night.
- Anxiety Reduction: Nitrazepam can help alleviate symptoms of anxiety disorders, offering relief from excessive worry and restlessness.
- Muscle Relaxation: It has muscle relaxant properties, which can be beneficial for individuals experiencing muscle spasms, tension, or stiffness.
- Seizure Management: While less commonly used for this purpose today, Nitrazepam was historically used to manage certain types of seizures, such as petit mal seizures.
- Preoperative Sedation: Nitrazepam may be administered before surgical procedures to reduce anxiety and promote relaxation in patients.
Side Effects of Nitrazepam Tablets:
- Drowsiness: One of the most common side effects of Nitrazepam is drowsiness. Individuals taking this medication should avoid activities that require mental alertness, such as driving, until they are aware of how the medication affects them.
- Dizziness: Some individuals may experience dizziness while taking Nitrazepam, especially when getting up from a sitting or lying position.
- Cognitive Impairment: Nitrazepam can impair cognitive function and memory, which may affect a person’s ability to concentrate and think clearly.
- Tolerance and Dependence: Prolonged use of Nitrazepam can lead to tolerance, meaning that over time, higher doses may be required to achieve the same effect. Additionally, abrupt discontinuation of Nitrazepam can lead to withdrawal symptoms, including rebound insomnia and anxiety.
- Drug Interactions: Nitrazepam can interact with other medications, potentially increasing the risk of side effects or reducing its effectiveness. It should not be combined with alcohol or other central nervous system depressants.
- Paradoxical Reactions: In some cases, Nitrazepam can lead to paradoxical reactions, where individuals may experience increased agitation, aggression, or excitement instead of sedation.
- Respiratory Depression: While respiratory depression (slowed breathing) is less common with Nitrazepam than with some other sedative medications, it can occur, particularly when taken in high doses or with other depressant substances.
- Memory Impairment: Nitrazepam can cause short-term memory impairment, leading to difficulty recalling events or activities that occurred while taking the medication.
It’s important to use Nitrazepam Tablets only as prescribed by a healthcare provider and for the duration recommended. This medication is generally intended for short-term use to avoid the development of tolerance and dependence. Patients should be aware of the potential side effects and discuss any concerns with their healthcare provider. Sudden discontinuation of Nitrazepam should be avoided, and a gradual tapering of the medication may be necessary under medical supervision when discontinuing treatment.
Frequently Asked Questions About Nitrazepam Tablets:
Certainly, here are some frequently asked questions (FAQs) about Nitrazepam Tablets:
- What is Nitrazepam used for?
Nitrazepam is primarily used to treat insomnia (sleep disorders) and anxiety disorders. It can help individuals fall asleep faster and stay asleep throughout the night.
- How does Nitrazepam work for insomnia?
Nitrazepam works by enhancing the activity of a neurotransmitter called gamma aminobutyric acid (GABA), which has a calming effect on the brain. This helps induce and maintain sleep.
- Is Nitrazepam addictive?
Nitrazepam has the potential for dependence and should be used only as prescribed by a healthcare provider. Prolonged or excessive use can lead to physical and psychological dependence.
- What is the typical dosage of Nitrazepam for insomnia?
The dosage of Nitrazepam varies depending on individual needs and the severity of the sleep disorder. Healthcare providers usually prescribe the lowest effective dose for the shortest duration necessary.
- How long can I take Nitrazepam for insomnia?
Nitrazepam is typically prescribed for shortterm use, usually for a few weeks. Longterm use can lead to tolerance and dependence, and discontinuation should be done gradually under medical supervision.
- Are there any alternatives to Nitrazepam for insomnia treatment?
Yes, there are other medications and non-pharmacological approaches to treat insomnia. Lifestyle changes, cognitive-behavioral therapy for insomnia (CBTI), and other medications may be considered based on individual circumstances.
- Can Nitrazepam be used to treat anxiety?
Yes, Nitrazepam may be prescribed to manage symptoms of anxiety disorders, particularly when anxiety is associated with sleep disturbances. However, it is generally not recommended for long-term anxiety treatment.
- What are the common side effects of Nitrazepam?
Common side effects may include drowsiness, dizziness, memory impairment, and cognitive dysfunction. These side effects can affect a person’s ability to perform tasks that require mental alertness.
- Can I drink alcohol while taking Nitrazepam?
It is generally not recommended to consume alcohol while taking Nitrazepam, as alcohol can enhance the sedative effects and increase the risk of adverse reactions.
- Is Nitrazepam safe for elderly individuals?
Elderly individuals may be more sensitive to the effects of Nitrazepam, including an increased risk of falls and cognitive impairment. Lower doses are often prescribed for older adults.
Always follow the specific instructions provided by your healthcare provider when taking Nitrazepam Tablets, and discuss any concerns or questions you may have about its use and potential side effects.
As Nitrazepam Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Nitrazepam Tablets product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Nitrazepam Tablets Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Nitrazepam Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Nitrazepam Tablets 5mg
2. Nitrazepam Tablets 10mg
2. Nitrazepam Tablets 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Nitrazepam Tablets 5mg
Each Un-coated tablet contains:
Nitrazepam……….……5mg
Excipients………………..q.s
Colour: Sunset yellow FCF
2. Nitrazepam Tablets 10mg
Each Un-coated tablet contains:
Nitrazepam……….……10mg
Excipients………………..q.s
Colour: Sunset yellow
Each Un-coated tablet contains:
Nitrazepam……….……5mg
Excipients………………..q.s
Colour: Sunset yellow FCF
2. Nitrazepam Tablets 10mg
Each Un-coated tablet contains:
Nitrazepam……….……10mg
Excipients………………..q.s
Colour: Sunset yellow
THERAPEUTIC INDICATIONS:
Nitrazepam Tablets should be used for short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress, where daytime sedation is acceptable.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.