Haloperidol Lactate (Haloperidol)

Trade Name : Haloperidol

Hikma Pharmaceuticals USA Inc.

INJECTION

Strength 5 mg/mL

HALOPERIDOL LACTATE Typical Antipsychotic [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Haloperidol Lactate (Haloperidol) which is also known as Haloperidol and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 5 mg/mL per ml. Read more

Haloperidol Lactate (Haloperidol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx only
  • Haloperidol is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(-Chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula:
  • M.F. =CHClFNOn
  • M.W.=375.86
  • Haloperidol Injection, USP is available as a sterile parenteral form for intramuscular injection. Each mL of Haloperidol Injection, USP contains 5 mg haloperidol (as the lactate) with 1.8 mg methylparaben and 0.2 mg propylparaben per mL, and lactic acid for pH adjustment between 3.0 to 3.8.
  • The precise mechanism of action has not been clearly established.
  • Haloperidol Injection, USPu00a0is indicated for use in the treatment of schizophrenia.
  • Haloperidol Injection, USPu00a0is indicated for the control of tics and vocal utterances of Tourette's Disorder.
  • Haloperidol Injection is contraindicated in patients with:
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis u2014 Elderly patients with dementia-related psychosis treated withantipsychotic drugs are at an increased risk of death. Haloperidol Injection is not approved for the treatment of patients with dementia-related psychosis (see BOXED ).
  • No data
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • No data
  • There is considerable variation from patient to patient in the amount of medication required for treatment. As with all drugs used to treat schizophrenia, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control.
  • To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels.
  • Parenteral medication, administered intramuscularIy in doses of 2 to 5 mg, is utilized for prompt control of the acutely agitated schizophrenic patient with moderately severe to very severe symptoms. Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4 to 8 hour intervals may be satisfactory. The maximum dose is 20 mg/day.
  • Controlled trials to establish the safety and effectiveness of intramuscular administration in children have not been conducted.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • An oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient's clinical status, the first oral dose should be given within 12 to 24 hours following the last parenteral dose.
  • Haloperidol Injection, USP, equivalent to 5 mg/mL haloperidol (as the lactate), is supplied as follows:
  • NDC 0143-9501-25
  • NDC 0143-9502-01
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. . .
  • Keep out of reach of children.
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .
  • For Product Inquiry call 1-877-845-0689.
  • Manufactured by:
  • HIKMA FARMACu00caUTICA (PORTUGAL), S.A.
  • Estrada do Rio da Mu00f3, 8, 8A e 8B u2013 Fervenu00e7a u2013 2705-906 Terrugem SNT, PORTUGAL
  • Distributed by:
  • West-Ward Pharmaceuticals
  • Eatontown, NJ 07724 USA
  • Revised May 2019
  • PIN425-WES/8
  • NDC 0143-9501-01u00a0Rx onlyn
  • Haloperidol Injection, USP
  • (For Immediate Release)
  • 5 mg/mL
  • FOR INTRAMUSCULAR
  • USE ONLY
  • NDC 0143-9502-01u00a0Rx only
  • Haloperidol Injection, USP
  • (For Immediate Release)
  • 50 mg/10 mL
  • (5 mg/mL)
  • FOR INTRAMUSCULAR
  • USE ONLY
  • NDC 0143-9501-25
  • Haloperidol Injection, USP
  • (For Immediate Release)
  • 5 mg/mL
  • For Intramuscular Use Only
  • 25 x 1 mL Single-Dose Vials
  • NDC 0143-9502-01u00a0Rx only
  • Haloperidol Injection, USP
  • (For Immediate Release)
  • 50 mg/10 mL
  • (5 mg/mL)
  • For Intramuscular Use Only
  • No data

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