GENERIC NAME OF MEDICINAL PRODUCT:

(A) Haloperidol Injection BP 5mg/mL
(B) Haloperidol Injection BP 50mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Haloperidol Injection BP 5mg/mL
Each ml contains:
Haloperidol BP
Equivalent to Haloperidol……….5mg
Lactic acid BP………………………q. s
Water for Injection BP……………. q. s

B. Haloperidol Injection BP 50mg/mL
Each ml contains:
Haloperidol BP
Equivalent to Haloperidol……….50mg
Lactic acid BP………………………q. s
Water for Injection BP……………. q. s

THERAPEUTIC INDICATION:

It is used for Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate

CAUTION & WARNING:

CAUTION: Do not use if solution is not clear or has suspended matter.
KEEP OUT OF REACH OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store Protected from Light at a temperature between 15°C and 25°C.
Dosage: As directed by Physician.

Haloperidol Injection BP 5mg/ml Technical Specification:

Product Name:Haloperidol Injection BP
Brand Name:Generic
Strength:5mg/ml, 50mg/ml
Dosage Form:Liquid Injection (Sterile)
Packing:1ml (ampoule)
Route of Administration:For I.M./I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antipsychotics
Indication: For Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate
Storage:Store Protected from moisture at a temperature Between 15°C and 25°C.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Haloperidol Injection BP 5mg/mL

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Haloperidol Injection BP 5mg/mL
    Each ml contains:
    Haloperidol BP
    Equivalent to Haloperidol……….5mg
    Lactic acid BP………………………q. s
    Water for Injection BP……………. q. s

THERAPEUTIC INDICATION:

It is used for Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate

CAUTION & WARNING:

CAUTION: Do not use it if the solution is not clear or has suspended matter.

WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store Protected from Light at a temperature between 15°C and 25°C.

KEEP OUT OF REACH OF CHILDREN.

Dosage: As directed by the Physician.

Why Choose Taj Pharmaceuticals for Haloperidol Injection?

Taj Pharma stands as your reliable provider for Haloperidol Injection. With a rich history of pharmaceutical excellence, rigorous quality control measures, and an unwavering commitment to patient well-being, Taj Pharma offers dependable solutions for mental health and behavioral disorders. Selecting Taj Pharma for your Haloperidol Injection needs ensures access to pharmaceutical expertise that prioritizes your health.

Opt for Taj Pharma’s Haloperidol Injection to benefit from our extensive experience in producing high-quality medications, particularly in the realm of mental health and behavioral disorders. Our commitment to stringent quality control is evident in the formulation of Haloperidol Injection BP, guaranteeing the safety and efficacy of treatments for patients. Taj Pharma is dedicated to delivering innovative solutions and elevating the standard of patient care, making it a trusted name in the healthcare industry.

By choosing Taj Pharma, you are opting for pharmaceutical excellence that significantly impacts the lives of those relying on our medications. Taj Pharma’s unwavering dedication to quality, patient care, and innovation establishes it as the preferred choice for Haloperidol Injection BP and a range of other pharmaceutical products. Experience the difference in healthcare excellence with Taj Pharma.

What is Haloperidol Injection BP 5mg/ml and its use?

Haloperidol Injection BP 5mg/ml is a pharmaceutical product containing the active ingredient haloperidol, which belongs to the class of antipsychotic medications. Haloperidol is commonly used to manage various mental health conditions, particularly psychotic disorders.

Its primary uses include:

  1. Psychotic Disorders: Haloperidol is often prescribed to individuals experiencing psychotic disorders, such as schizophrenia. It helps alleviate symptoms like delusions, hallucinations, and disorganized thinking.
  2. Severe Agitation: In some cases, Haloperidol Injection may be administered to manage severe agitation or aggressive behavior associated with psychiatric conditions.
  3. Tourette’s Syndrome: Haloperidol may be used to treat symptoms of Tourette’s syndrome, a neurological disorder characterized by repetitive, involuntary movements and vocalizations (tics).

It’s important to note that the use of Haloperidol Injection should be under the guidance and prescription of a qualified healthcare professional. The dosage and duration of treatment will vary based on the specific condition being addressed, the patient’s medical history, and individual response to the medication.

As with any medication, there may be potential side effects, and patients should be monitored closely during the course of treatment. It’s crucial to communicate any concerns or unusual reactions to the prescribing healthcare provider. Additionally, Haloperidol Injection is typically administered by healthcare professionals in a controlled medical setting.

How does Haloperidol Injection BP 5mg/ml work?

Haloperidol Injection BP 5mg/ml works by affecting the activity of certain neurotransmitters in the brain, specifically dopamine. Dopamine is a neurotransmitter that plays a key role in regulating mood, behavior, and cognition. Haloperidol is classified as a first-generation or typical antipsychotic medication, and its mechanism of action involves blocking dopamine receptors.

Here’s how Haloperidol works:

  1. Dopamine Receptor Blockade: Haloperidol binds to dopamine receptors in the brain, particularly those of the D2 subtype. By doing so, it inhibits the binding of dopamine to these receptors.
  2. Normalization of Dopamine Activity: In conditions like schizophrenia, there is often an imbalance in dopamine activity, leading to symptoms such as hallucinations, delusions, and disorganized thinking. By blocking dopamine receptors, Haloperidol helps normalize the activity of this neurotransmitter.
  3. Reduction of Psychotic Symptoms: The normalization of dopamine activity contributes to a reduction in the severity of psychotic symptoms. This includes a decrease in hallucinations, improved thought processes, and a reduction in agitation.

It’s important to note that while Haloperidol is effective in managing psychotic symptoms, its use may be associated with side effects. These can include extrapyramidal symptoms (movement disorders), sedation, and changes in blood pressure. The choice to prescribe Haloperidol and the determination of the appropriate dosage are made by healthcare professionals based on the individual’s specific condition, medical history, and response to the medication. Regular monitoring and communication with the healthcare provider are essential to ensure the medication’s effectiveness and manage any potential side effects.

Benefits of Haloperidol Injection:

Haloperidol Injection can provide several benefits in the management of certain mental health conditions. Here are some of the key benefits:

  1. Psychotic Symptom Relief: Haloperidol is effective in alleviating symptoms associated with psychotic disorders, such as schizophrenia. It helps reduce or eliminate hallucinations, delusions, and disorganized thinking, contributing to an improved overall mental state.
  2. Agitation and Aggression Control: The medication can be beneficial in managing severe agitation and aggressive behavior related to various psychiatric conditions. By exerting its antipsychotic effects, Haloperidol helps stabilize mood and behavior.
  3. Tourette’s Syndrome Management: Haloperidol is sometimes used to manage symptoms of Tourette’s syndrome, including repetitive movements and vocalizations (tics). It can help reduce the frequency and severity of these involuntary actions.
  4. Rapid Onset of Action: Haloperidol Injection, when administered intramuscularly, can have a relatively rapid onset of action compared to oral formulations. This can be advantageous in situations where prompt symptom relief is necessary, such as acute agitation.
  5. Clinical Versatility: Haloperidol is a versatile antipsychotic that has been used for decades. Its long history of clinical use and effectiveness in various psychiatric conditions make it a valuable option in certain therapeutic contexts.

It’s important to note that while Haloperidol can be beneficial, its use should be carefully monitored by healthcare professionals. The decision to prescribe Haloperidol, the appropriate dosage, and the duration of treatment depend on the specific diagnosis, individual patient factors, and the assessment of potential risks and benefits. Patients and their healthcare providers should maintain open communication to ensure the medication’s effectiveness while managing any potential side effects.

Side Effects of Haloperidol Injection:

Haloperidol Injection, like any medication, may be associated with certain side effects. It’s important for patients and healthcare providers to be aware of these potential effects. Here are some common side effects of Haloperidol Injection:

  1. Extrapyramidal Symptoms (EPS): These are movement disorders that can include muscle stiffness, tremors, restlessness, and difficulty in initiating or controlling movements. Parkinsonism, a condition resembling Parkinson’s disease, can also occur.
  2. Sedation: Haloperidol may cause drowsiness or sedation, affecting the alertness and concentration of individuals. It is advisable for patients to avoid activities requiring mental alertness, such as driving or operating machinery, until they understand how the medication affects them.
  3. Orthostatic Hypotension: Some individuals may experience a drop in blood pressure upon standing, leading to dizziness or fainting. This effect is more common when going from a sitting or lying position to standing.
  4. Anticholinergic Effects: Haloperidol can produce side effects associated with the blockade of acetylcholine, a neurotransmitter. These effects may include dry mouth, blurred vision, constipation, and urinary retention.
  5. Hyperprolactinemia: Haloperidol may increase levels of the hormone prolactin, potentially causing side effects such as menstrual irregularities, breast enlargement (gynecomastia), and, in some cases, lactation.
  6. Neuroleptic Malignant Syndrome (NMS): While rare, NMS is a serious and potentially life-threatening condition associated with antipsychotic medications. Symptoms may include hyperthermia (elevated body temperature), muscle rigidity, altered mental status, and autonomic dysfunction.

It’s crucial for individuals prescribed Haloperidol Injection to be aware of these potential side effects and promptly report any unusual or severe reactions to their healthcare provider. The choice to use Haloperidol, the dosage, and the management of side effects should be carefully monitored and adjusted by a qualified healthcare professional based on the individual’s response to the medication. Regular communication between the patient and healthcare provider is essential for optimizing the benefits of treatment while minimizing potential risks.

Frequently asked questions (FAQs) about Haloperidol Injection BP 5mg/ml:

1. What is Haloperidol Injection BP 5mg/ml used for?

Haloperidol Injection BP 5mg/ml is primarily used to manage psychotic disorders such as schizophrenia, severe agitation associated with psychiatric conditions, and symptoms of Tourette’s syndrome.

2. How does Haloperidol Injection BP 5mg/ml work?

Haloperidol works by blocking dopamine receptors in the brain, helping to normalize dopamine activity. This action contributes to the reduction of psychotic symptoms and the management of conditions like schizophrenia.

3. What are the potential side effects of Haloperidol Injection BP 5mg/ml?

Common side effects may include extrapyramidal symptoms (movement disorders), sedation, orthostatic hypotension, anticholinergic effects (dry mouth, blurred vision), and hyperprolactinemia. In rare cases, neuroleptic malignant syndrome (NMS) may occur.

4. How quickly does Haloperidol Injection BP 5mg/ml take effect?

When administered intramuscularly, Haloperidol Injection BP 5mg/ml can have a relatively rapid onset of action, making it suitable for situations requiring prompt symptom relief, such as acute agitation.

5. How is Haloperidol Injection BP 5mg/ml administered?

Haloperidol Injection is typically administered by healthcare professionals through intramuscular injection. The dosage and frequency of administration depend on the specific condition being treated.

6. Can Haloperidol Injection BP 5mg/ml be used in children?

Haloperidol may be prescribed to children in certain situations, but the dosage and appropriateness of use should be determined by a qualified healthcare professional based on the child’s specific needs and condition.

7. What precautions should be taken with Haloperidol Injection BP 5mg/ml?

Patients should be cautious about activities requiring mental alertness, as Haloperidol can cause sedation. It’s important to avoid alcohol and inform the healthcare provider about any existing medical conditions or medications.

8. How long does the effect of Haloperidol Injection BP 5mg/ml last?

The duration of the medication’s effect varies among individuals and depends on factors such as the specific condition being treated and the individual’s response to the medication.

9. Can Haloperidol Injection BP 5mg/ml be stopped abruptly?

Discontinuing Haloperidol should be done under the guidance of a healthcare professional to avoid potential withdrawal effects. Abruptly stopping the medication may lead to a recurrence of symptoms.

10. What should I do if I experience side effects from Haloperidol Injection BP 5mg/ml?

Any unusual or severe side effects should be promptly reported to your healthcare provider. They can assess the situation and make necessary adjustments to the treatment plan if needed. Regular communication with the healthcare provider is crucial for optimal care.