For the treatment of a wide range of gastrointestinal disorders, including such conditions as peptic ulcer, gastritis, hyperchlorhydria, functional diarrhea, irritable or spastic colon, pyloroduodenal irritability, pylorospasm, acute nonspecific gastroenteritis, biliary dyskinesia and chronic cholelithiasis, duodenitis, gastrointestinal spasm; it may also be used to treat genitourinary spasm.
Cold, Muscular spasm, Peptic ulcer, Rhinitis.
Isopropamide (Spascol) iodide is a long-acting quaternary anticholinergic drug. It is used in the treatment of peptic ulcer and other gastrointestinal disorders marked by hyperacidity and hypermotility.
Trifluoperazine (Spascol) is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.
Trifluoperazine (Spascol) is used to treat anxiety or psychotic disorders such as schizophrenia.
Trifluoperazine (Spascol) may also be used for purposes not listed in this medication guide.
For the management of schizophrenia.
Trifluoperazine (Spascol) (Trifluoperazine (Spascol) HCl) is effective for the short-term treatment of generalized non-psychotic anxiety. However, Trifluoperazine (Spascol) (Trifluoperazine (Spascol)) is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines).
When used in the treatment of non-psychotic anxiety, Trifluoperazine (Spascol) (Trifluoperazine (Spascol)) should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of Trifluoperazine (Spascol) (Trifluoperazine (Spascol)) at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible.
The effectiveness of Trifluoperazine (Spascol) (Trifluoperazine (Spascol)) as a treatment for non-psychotic anxiety was established in a 4-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that Trifluoperazine (Spascol) (Trifluoperazine (Spascol)) will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (i.e., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).
Trifluoperazine (Spascol) (Trifluoperazine (Spascol) HC1) has not been shown effective in the management of behavioral complications in patients with mental retardation.
Use Trifluoperazine (Spascol) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Trifluoperazine (Spascol).
Trifluoperazine (Spascol) is used for the short-term treatment of anxiety or depression and also for the treatment of nausea and vomiting. Trifluoperazine (Spascol) may also be used to prevent relapse of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
A sympathomimetic drug used primarily as an appetite depressant. Its actions and mechanisms are similar to dextroamphetamine.
Dosage should be adjusted to the needs of the individual. The lowest effective dosage should always be used. Dosage should be increased more gradually in debilitated or emaciated patients. When maximum response is achieved, dosage may be reduced gradually to a maintenance level. Because of the inherent long action of the drug, patients may be controlled on convenient b.i.d. administration; some patients may be maintained on once-a-day administration.
When Trifluoperazine (Spascol) (Trifluoperazine (Spascol) HCl) is administered by intramuscular injection, equivalent oral dosage may be substituted once symptoms have been controlled.
Note: Although there is little likelihood of contact dermatitis due to the drug, persons with known sensitivity to phenothiazine drugs should avoid direct contact.
Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.
Usual dosage is 1 or 2 mg twice daily. Do not administer at doses of more than 6 mg per day or for longer than 12 weeks.
Oral: Usual starting dosage is 2 mg to 5 mg b.i.d. (Small or emaciated patients should always be started on the lower dosage.)
Most patients will show optimum response on 15 mg or 20 mg daily, although a few may require 40 mg a day or more. Optimum therapeutic dosage levels should be reached within 2 or 3 weeks.
When the Concentrate dosage form is to be used, it should be added to 60 mL (2 fl oz) or more of diluent just prior to administration to insure palatability and stability. Vehicles suggested for dilution are: tomato or fruit juice, milk, simple syrup, orange syrup, carbonated beverages, coffee, tea or water. Semisolid foods (soup, puddings, etc.) may also be used.
Intramuscular (for prompt control of severe symptoms): Usual dosage is 1 mg to 2 mg (V2 to 1 mL) by deep intramuscular injection q4 to 6h, p.r.n. More than 6 mg within 24 hours is rarely necessary.
Only in very exceptional cases should intramuscular dosage exceed 10 mg within 24 hours. Injections should not be given at intervals of less than 4 hours because of a possible cumulative effect.
Note: Trifluoperazine (Spascol) (Trifluoperazine (Spascol) HCl) Injection has been usually well tolerated and there is little, if any, pain and irritation at the site of injection.
This solution should be protected from light. This is a clear, colorless to pale yellow solution; a slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded.
Dosage should be adjusted to the weight of the child and severity of the symptoms. These dosages are for children, ages 6 to 12, who are hospitalized or under close supervision.
Oral: The starting dosage is 1 mg administered once a day or b.i.d. Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome.
While it is usually not necessary to exceed dosages of 15 mg daily, some older children with severe symptoms may require higher dosages.
Intramuscular: There has been little experience with the use of Trifluoperazine (Spascol) (Trifluoperazine (Spascol) HCl) Injection in children. However, if it is necessary to achieve rapid control of severe symptoms, 1 mg (V2 mL) of the drug may be administered intramuscularly once or twice a day.
Tablets, 1 mg, 2 mg, 5 mg and 10 mg in bottles of 100.
1 mg 100's: NDC 0108-4903-20
2 mg 100's: NDC 0108-4904-20
5 mg 100's: NDC 0108-4906-20
10 mg 100's: NDC 0108-4907-20
Multi-Dose Vials, 10 mL (2 mg/mL), in 1's: NDC 0108-4902-01
Concentrate (for institutional use), 10 mg/mL, in 2 fl oz bottles and in cartons of 12 bottles.
The Concentrate form is light-sensitive. For this reason, it should be protected from light and dispensed in amber bottles. Refrigeration is not required.
10 mg/mL 2 fl oz (carton of 12): NDC 0108-4901-42
Store all Trifluoperazine (Spascol) (Trifluoperazine (Spascol) HCl) formulations between 15° and 30°C (59° and 86°F).
Date Of Issuance Mar.. 2002. GlaxoSmithKline., Research Triangle Park, NC 27709
What other drugs will affect Trifluoperazine (Spascol)?
Phenothiazines may diminish the effect of oral anticoagulants.
Concomitant administration of propranolol with phenothiazines results in increased plasma levels of both drugs.
Phenothiazines may lower the convulsive threshold; dosage adjustment of anticonvulsants may be necessary. Potentiation of anticonvulsant effects does not occur. However, it has been reported that phenothiazines may interfere with the metabolism of phenytoin and thus precipitate phenytoin toxicity.
Drugs which lower the seizure threshold, including phenothiazine derivatives, should not be used with metrizamide. As with other phenothiazine derivatives, Trifluoperazine (Spascol) should be discontinued at least 48 hours before myelography, should not be resumed for at least 24 hours post procedure, and should not be used for the control of nausea and vomiting occurring either prior to myelography or post procedure
What are the possible side effects of Trifluoperazine (Spascol)?
Drowsiness, dizziness, skin reactions, rash, dry mouth, insomnia, amenorrhea, fatigue, muscular weakness, anorexia, lactation, blurred vision and neuromuscular (extrapyramidal) reactions.
These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism.
Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases barbiturates by suitable route of administration will suffice. (Or, injectable Benadryl®" may be useful.) In more severe cases, the administration of an anti-parkinsonism agent, except levodopa, usually produces rapid reversal of symptoms. Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed.
Motor Restlessness: Symptoms may include agitation or jitteriness and sometimes insomnia. These symptoms often disappear spontaneously. At times these symptoms may be similar to the original neurotic or psychotic symptoms. Dosage should not be increased until these side effects have subsided.
If this phase becomes too troublesome, the symptoms can usually be controlled by a reduction of dosage or change of drug. Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful.
Dystonias: Symptoms may include: spasm of the neck muscles, sometimes progressing to torticollis; extensor rigidity of back muscles, sometimes progressing to opisthotonos; carpopedal spasm, trismus, swallowing difficulty, oculogyric crisis and protrusion of the tongue.
These usually subside within a few hours, and almost always within 24 to 48 hours, after the drug has been discontinued.
In mild cases, reassurance or a barbiturate is often sufficient. In moderate cases, barbiturates will usually bring rapid relief. In more severe adult cases, the administration of an anti-parkinsonism agent, except levodopa, usually produces rapid reversal of symptoms. Also, intravenous caffeine with sodium benzoate seems to be effective. In children, reassurance and barbiturates will usually control symptoms. (Or, injectable Benadryl may be useful.) Note: See Benadryl prescribing information for appropriate children's dosage. If appropriate treatment with anti-parkinsonism agents or Benadryl fails to reverse the signs and symptoms, the diagnosis should be reevaluated.
Pseudo-parkinsonism: Symptoms may include: mask-like facies; drooling; tremors; pill-rolling motion; cogwheel rigidity; and shuffling gait. Reassurance and sedation are important. In most cases these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly. Anti-parkinsonism agents should be used only when required. Generally, therapy of a few weeks to 2 to 3 months will suffice. After this time patients should be evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in pseudo-parkinsonism.) Occasionally it is necessary to lower the dosage of Trifluoperazine (Spascol) (Trifluoperazine (Spascol) HCl) or to discontinue the drug.
Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The syndrome can also develop, although much less frequently, after relatively brief treatment periods at low doses. This syndrome appears in all age groups. Although its prevalence appears to be highest among elderly patients, especially elderly women, it is impossible to rely upon prevalence estimates to predict at the inception of antipsychotic treatment which patients are likely to develop the syndrome. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia, has also been described.
There is no known effective treatment for tardive dyskinesia; anti-parkinsonism agents do not alleviate the symptoms of this syndrome. If clinically feasible, it is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked.
It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time the syndrome may not develop.
Adverse Reactions Reported with Trifluoperazine (Spascol) (Trifluoperazine (Spascol) HCl) or Other Phenothiazine Derivatives: Adverse effects with different phenothiazines vary in type, frequency, and mechanism of occurrence, i.e., some are dose-related, while others involve individual patient sensitivity. Some adverse effects may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses of certain phenothiazines.
Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.
Not all of the following adverse reactions have been observed with every phenothiazine derivative, but they have been reported with one or more and should be borne in mind when drugs of this class are administered: extrapyramidal symptoms (opisthotonos, oculogyric crisis, hyperreflexia, dystonia, akathisia, dyskinesia, parkinsonism) some of which have lasted months and even years-particularly in elderly patients with previous brain damage; grand mal and petit mal convulsions, particularly in patients with EEG abnormalities or history of such disorders; altered cerebrospinal fluid proteins; cerebral edema; intensification and prolongation of the action of central nervous system depressants (opiates, analgesics, antihistamines, barbiturates, alcohol), atropine, heat, organophosphorus insecticides; autonomic reactions (dryness of mouth, nasal congestion, headache, nausea, constipation, obstipation, adynamic ileus, ejaculatory disorders/impotence, priapism, atonic colon, urinary retention, miosis and mydriasis); reactivation of psychotic processes, catatonic-like states; hypotension (sometimes fatal); cardiac arrest; blood dyscrasias (pancytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, eosinophilia, hemolytic anemia, aplastic anemia); liver damage (jaundice, biliary stasis); endocrine disturbances (hyperglycemia, hypoglycemia, glycosuria, lactation, galactorrhea, gynecomastia, menstrual irregularities, false-positive pregnancy tests); skin disorders (photosensitivity, itching, erythema, urticaria, eczema up to exfoliative dermatitis); other allergic reactions (asthma, laryngeal edema, angioneurotic edema, anaphylactoid reactions); peripheral edema; reversed epinephrine effect; hyperpyrexia; mild fever after large I.M. doses; increased appetite; increased weight; a systemic lupus erythematosus-like syndrome; pigmentary retinopathy; with prolonged administration of substantial doses, skin pigmentation, epithelial keratopathy, and lenticular and corneal deposits.
EKG changes-particularly nonspecific, usually reversible Q and T wave distortions-have been observed in some patients receiving phenothiazine antipsychotics. Although phenothiazines cause neither psychic nor physical dependence, sudden discontinuance in long-term psychiatric patients may cause temporary symptoms, e.g., nausea and vomiting, dizziness, tremulousness.
Note: There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex.
What is the most important information I should know about Trifluoperazine (Spascol)?
Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.
Trifluoperazine (Spascol) is not for use in psychotic conditions related to dementia. Trifluoperazine (Spascol) may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.
Do not use Trifluoperazine (Spascol) if you have liver disease, brain damage, bone marrow depression, a blood cell disorder (such as low platelets or low red or white blood cell counts), or if you are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to Trifluoperazine (Spascol) or other phenothiazines.
Before you take Trifluoperazine (Spascol), tell your doctor about all of your medical conditions, and if you have ever had a serious side effect while using Trifluoperazine (Spascol) or similar medicines. Also, tell your doctor about all other medications you use.
|Unit description / dosage (Manufacturer)||Price, USD|
|SPASCOL 5MG/1MG TABLET 1 strip / 10 tablets each (Vilco Laboratories Pvt Ltd)||$ 0.35|
|Spascol 5 mg/1 mg Tablet (Vilco Laboratories Pvt Ltd)||$ 0.03|
List of Spascol substitutes (brand and generic names):
|GASTOBID TABLET 1 strip / 10 tablets each (Thrift Pharmaceuticals)||$ 0.33|
|Tablet; Oral; Isopropamide Iodide 7.5 mg; Trifluoperazine Hydrochloride 2 mg|
|Stelabid No 1|
|Tablet; Oral; Isopropamide Iodide 5 mg; Trifluoperazine Hydrochloride 1 mg|
|Stelabid No 2|
|Tablet; Oral; Isopropamide Iodide 5 mg; Trifluoperazine Hydrochloride 2 mg|
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Information checked by Dr. Sachin Kumar, MD Pharmacology