GNH USA

Europe — EMA

Nitrazepam Aurobindo

GNH USA supplies Nitrazepam Aurobindo (Nitrazepam), a benzodiazepine hypnotic for insomnia, anxiety and seizures. Request a quote for global supply.

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What is Nitrazepam?

Nitrazepam, the active ingredient in Nitrazepam Aurobindo, is a benzodiazepine presented as an oral dosage form for systemic use. It acts as a hypnotic and anxiolytic, helping to manage insomnia, anxiety disorders, and certain seizure types in adult patients under medical supervision and are typically prescribed when non‑pharmacologic measures have proven insufficient.

GNH USA supplies Nitrazepam Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide with a focus on quality assurance and regulatory compliance globally.

What is Nitrazepam used for?

Nitrazepam is a benzodiazepine that modulates central nervous system activity and is indicated for several sleep‑related and neurological conditions. - Insomnia: Improves sleep onset and maintenance in patients with difficulty falling or staying asleep. - Anxiety disorders: Reduces excessive tension and worry in generalized anxiety or acute stress situations. - Seizure disorders: Controls certain types of epileptic seizures, particularly those responsive to benzodiazepine therapy.

What are the side effects of Nitrazepam?

Nitrazepam may cause a range of adverse reactions, varying from mild to serious. Common Side Effects: - Drowsiness: Excessive sleepiness during daytime. - Fatigue: General feeling of low energy. - Dizziness: Light‑headed sensation, especially when standing quickly. - Impaired coordination: Reduced motor control and balance. - Memory disturbances: Short‑term recall difficulties. - Headache: Mild to moderate cranial pain. - Blurred vision: Temporary visual disturbances. - Nausea: Stomach upset or queasiness. Serious or Rare Side Effects: - Respiratory depression: Slowed breathing that may require medical attention. - Severe allergic reaction: Rash, swelling, or anaphylaxis. - Depression or suicidal thoughts: Mood changes requiring urgent evaluation. - Paradoxical agitation: Increased anxiety or aggression instead of calming. - Dependence and withdrawal: Physical reliance with symptoms on abrupt cessation. - Liver function abnormalities: Elevated enzymes indicating hepatic stress. - Psychomotor impairment: Slowed reaction time affecting tasks like driving. - Seizure worsening: Rare increase in seizure frequency.

What precautions apply to Nitrazepam?

When prescribing Nitrazepam, clinicians should consider several precautionary measures to minimize risks. - Assess renal and hepatic function: Adjust use if significant impairment is present. - Review concomitant CNS depressants: Avoid additive sedation with alcohol, opioids or antihistamines. - Evaluate dependence risk: Limit duration and monitor for signs of tolerance. - Pregnancy and lactation: Contraindicated in pregnancy (Category D) and not recommended while breastfeeding. - Elderly patients: Use lower doses and monitor for falls or confusion. - Store at ambient temperature: Keep below 25 °C in the original container, protect from moisture and light.

What does Nitrazepam interact with?

Nitrazepam can interact with other medicines, altering its efficacy or safety profile. Major Interactions (Avoid): - Opioids: Combined CNS depression may cause profound respiratory depression. - Barbiturates: Counteract sedative effect and increase seizure risk. - Antifungal azoles (e.g., ketoconazole): Inhibit metabolism, raising nitrazepam plasma levels. Moderate Interactions (Monitor Closely): - Antidepressants (SSRIs, SNRIs): May enhance sedation or serotonergic effects. - Antihistamines: Additive drowsiness. - Oral contraceptives: May reduce contraceptive efficacy. - Antiepileptic drugs (phenytoin, carbamazepine): May lower nitrazepam concentrations.

Frequently asked questions

What is Nitrazepam Aurobindo used for?+
Nitrazepam Aurobindo is a prescription benzodiazepine indicated for the short‑term management of insomnia, for the relief of anxiety symptoms, and as an adjunct in the control of certain seizure types. It is prescribed by qualified healthcare professionals based on individual patient needs.
How does nitrazepam work?+
Nitrazepam binds to the benzodiazepine site on the GABA‑A receptor complex, increasing the receptor’s affinity for the inhibitory neurotransmitter GABA. This enhances chloride ion influx, hyperpolarising neurons and reducing neuronal excitability, which produces sedative, anxiolytic, muscle‑relaxant and anticonvulsant effects.
What is the usual dose of nitrazepam?+
The appropriate dose of nitrazepam is determined by the prescribing clinician based on the specific indication, patient age, renal and hepatic function, and other individual factors. Dosage regimens are not standardized in public literature and must follow the prescriber’s instructions.
Is nitrazepam safe in pregnancy or breastfeeding?+
Nitrazepam is classified as Pregnancy Category D, indicating evidence of risk to the fetus, and it is generally contraindicated during pregnancy. It is also not recommended for breastfeeding mothers because it can be excreted in breast milk and may affect the infant.
How do I order Nitrazepam Aurobindo from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does nitrazepam compare with other hypnotic drugs?+
Compared with non‑benzodiazepine hypnotics (e.g., zolpidem or zaleplon), nitrazepam has a longer half‑life and a higher potential for next‑day sedation, dependence and withdrawal. It may be preferred when a clinician needs a longer‑acting agent, but the risk‑benefit profile must be evaluated for each patient.
How should nitrazepam be stored and handled?+
Nitrazepam tablets should be stored at ambient temperature, preferably below 25 °C, in the original packaging to protect from moisture and light. Keep the product out of reach of children and do not use if the packaging is damaged.
How is nitrazepam administered?+
Nitrazepam is taken orally, usually with a glass of water. The tablet should be swallowed whole and not crushed or chewed unless specifically directed by a healthcare professional. Administration timing (e.g., before bedtime) follows the prescriber’s guidance.
What are the most serious risks associated with nitrazepam?+
Serious risks include respiratory depression, especially when combined with other central nervous system depressants, severe allergic reactions, profound sedation leading to falls or accidents, dependence with withdrawal symptoms on abrupt discontinuation, and rare psychiatric effects such as paradoxical agitation or worsening depression.
Who should not use nitrazepam?+
Nitrazepam should be avoided in patients with known hypersensitivity to benzodiazepines, severe hepatic impairment, acute narrow‑angle glaucoma, and in pregnant or breastfeeding women. Caution is also advised for the elderly, individuals with a history of substance dependence, and those taking interacting CNS depressants.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Nitrazepam
Route
Oral Use
Manufacturer
Aurobindo Pharma B.V.
Origin
EU

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