Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)
Mylan Pharmaceuticals Inc.
HALOPERIDOL
HALOPERIDOL 0.5 mg
ORAL
PRESCRIPTION DRUG
Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any caus
Haloperidol Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP. The 0.5 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 351 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0351-01 bottles of 100 tablets NDC 0378-0351-10 bottles of 1000 tablets The 1 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 257 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0257-01 bottles of 100 tablets NDC 0378-0257-10 bottles of 1000 tablets The 2 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 214 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0214-01 bottles of 100 tablets NDC 0378-0214-10 bottles of 1000 tablets The 5 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 327 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0327-01 bottles of 100 tablets NDC 0378-0327-10 bottles of 1000 tablets The 10 mg tablets are light green, round, flat-faced, scored tablets debossed with MYLAN over 334 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0334-01 bottles of 100 tablets The 20 mg tablets are light blue, round, flat-faced, scored tablets debossed with MYLAN over 335 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0335-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75076829 Revised: 7/2020 MXI:HALO:R1
Abbreviated New Drug Application
HALOPERIDOL- HALOPERIDOL TABLET MYLAN PHARMACEUTICALS INC. ---------- 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 IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (SEE WARNINGS). DESCRIPTION Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following structural formula: C H CLFNO 375.87 Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. In addition, the 10 mg and 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake. 21 23 2 CLINICAL PHARMACOLOGY The precise mechani Les hele dokumentet