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 Stela (Stela 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: Stela (Stela 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 Stela (Stela 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 Stela (Stela HCl) formulations between 15° and 30°C (59° and 86°F).
Date Of Issuance Mar.. 2002. GlaxoSmithKline., Research Triangle Park, NC 27709
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with Stela and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines, or any other anti-psychotic medications.
Also tell your doctor if you are taking any of the following medicines:
This list is not complete and there are many other drugs that can interact with Stela. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
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, Stela 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
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Information checked by Dr. Sachin Kumar, MD Pharmacology