Trade Name: HALOPERIDOL DECANOATE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 50 mg/mL

Storage and handling

HALOPERIDOL DECANOATE Typical Antipsychotic [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • WARNING
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Haloperidol Decanoate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
  • Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol, USP. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, USP, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:
  • Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents.
  • Each mL of haloperidol decanoate, USP 50 mg (base)/mL for intramuscular injection contains 50 mg haloperidol, USP (present as haloperidol decanoate, USP 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.
  • Each mL of haloperidol decanoate, USP 100 mg (base)/mL for intramuscular injection contains 100 mg haloperidol, USP (present as haloperidol decanoate, USP 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.
  • Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are the long-acting forms of haloperidol. The basic effects of haloperidol decanoate are no different from those of haloperidol with the exception of duration of action. Haloperidol blocks the effects of dopamine and increases its turnover rate; however, the precise mechanism of action is unknown.
  • Administration of haloperidol decanoate in sesame oil results in slow and sustained release of haloperidol. The plasma concentrations of haloperidol gradually rise, reaching a peak at about 6 days after the injection, and falling thereafter, with an apparent half-life of about 3 weeks. Steady state plasma concentrations are achieved after the third or fourth dose. The relationship between dose of haloperidol decanoate and plasma haloperidol concentration is roughly linear for doses below 450 mg. It should be noted, however, that the pharmacokinetics of haloperidol decanoate following intramuscular injections can be quite variable between subjects.
  • Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy.
  • Since the pharmacologic and clinical actions of haloperidol decanoate injection, 50 mg /mL and haloperidol decanoate injection, 100 mg/mL are attributed to haloperidol, USP as the active medication, Contraindications, Warnings, and additional information are those of haloperidol, USP, modified only to reflect the prolonged action.u00a0u00a0
  • Haloperidol is contraindicated in patients with:
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol Decanoate Injection is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
  • No data
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • While overdosage is less likely to occur with a parenteral than with an oral medication, information pertaining to haloperidol is presented, modified only to reflect the extended duration of action of haloperidol decanoate.
  • Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL should be administered by deep intramuscular injection. A 21 gauge needle is recommended. The maximum volume per injection site should not exceed 3 mL. DO NOT ADMINISTER INTRAVENOUSLY.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are intended for use in schizophrenic patients who require prolonged parenteral antipsychotic therapy. These patients should be previously stabilized on antipsychotic medication before considering a conversion to haloperidol decanoate, USP. Furthermore, it is recommended that patients being considered for haloperidol decanoate, USP therapy have been treated with, and tolerate well, short-acting haloperidol, USP in order to reduce the possibility of an unexpected adverse sensitivity to haloperidol, USP. Close clinical supervision is required during the initial period of dose adjustment in order to minimize the risk of overdosage or reappearance of psychotic symptoms before the next injection. During dose adjustment or episodes of exacerbation of symptoms of schizophrenia, haloperidol decanoate, USP therapy can be supplemented with short-acting forms of haloperidol, USP.
  • The dose of haloperidol decanoate injection, 50 mg (base)/mL or haloperidol decanoate injection, 100 mg (base)/mL should be expressed in terms of its haloperidol, USP content. The starting dose of haloperidol decanoate, USP should be based on the patient's age, clinical history, physical condition, and response to previous antipsychotic therapy. The preferred approach to determining the minimum effective dose is to begin with lower initial doses and to adjust the dose upward as needed. For patients previously maintained on low doses of antipsychotics (e.g. up to the equivalent of 10 mg/day oral haloperidol), it is recommended that the initial dose of haloperidol decanoate, USP be 10-15 times the previous daily dose in oral haloperidol equivalents; limited clinical experience suggests that lower initial doses may be adequate.
  • Haloperidol Decanoate Injection is clear, slightly viscous, colorless to pink or amber solution supplied as follows:
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect from Light.
  • Keep out of reach of children.
  • For Product Inquiry call 1-800-417-9175.
  • Manufactured for:
  • Somerset Therapeutics, LLC
  • Hollywood, FL 33024
  • Made in India
  • Code No.: KR/DRUGS/KTK/28/289/97
  • ST-HAD/P/03
  • Revised: January, 2020
  • Container Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 1 mL Ampule
  • Carton Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 Pack of 3's
  • Carton Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 Pack of 5's
  • Container Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 1 mL Ampule
  • Carton Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 Pack of 5's
  • Container Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 1 mL Single-Dose Vial
  • Carton Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 1 x 1 mL Single-Dose Vial
  • Carton Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 10 x 1 mL Single-Dose Vials
  • Container Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 5 mL Multiple-Dose Vial
  • Carton Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 1 x 5 mL Multiple-Dose Vial
  • Carton Label (Haloperidol Decanoate Injection, 50 mg (base)/mL) u2013 5 x 5 mL Multiple-Dose Vials
  • Container Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 1 mL Single-Dose Vial
  • Carton Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 1 x 1 mL Single-Dose Vial
  • Carton Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 5 x 1 mL Single-Dose Vials
  • Carton Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 10 x 1 mL Single-Dose Vials
  • Container Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 5 mL Multiple-Dose Vial
  • Carton Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 1 x 5 mL Multiple-Dose Vial
  • Carton Label (Haloperidol Decanoate Injection, 100 mg (base)/mL) u2013 5 x 5 mL Multiple-Dose Vials

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE) which is also known as HALOPERIDOL DECANOATE and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 50 mg/mL.

HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE) 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.

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