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|Prolixin Concentrate

PHENOTHIAZINES (Systemic)

Some commonly used brand names are:

In the U.S.—

• Chlorpromazine Hydrochloride Intensol ¹
• Compazine ⁸
• Compazine Spansule ⁸
• Mellaril ¹¹
• Mellaril Concentrate ¹¹
• Mellaril-S ¹¹
• Permitil ²
• Permitil Concentrate ²
• Prolixin ²
• Prolixin Concentrate ²
• Prolixin Decanoate ²
• Prolixin Enanthate ²
• Serentil ³
• Serentil Concentrate ³
• Stelazine ¹²
• Stelazine Concentrate ¹²
• Thorazine ¹
• Thorazine Spansule ¹
• Trilafon ⁶
• Trilafon Concentrate ⁶
• Vesprin ¹³

In Canada—

• Apo-Fluphenazine ²
• Apo-Perphenazine ⁶
• Apo-Thioridazine ¹¹
• Apo-Trifluoperazine ¹²
• Chlorpromanyl-20 ¹
• Chlorpromanyl-40 ¹
• Largactil ¹
• Largactil Liquid ¹
• Largactil Oral Drops ¹
• Majeptil ¹⁰
• Mellaril ¹¹
• Modecate ²
• Modecate Concentrate ²
• Moditen Enanthate ²
• Moditen HCl ²
• Neuleptil ⁵
• Novo-Chlorpromazine ¹
• Novo-Trifluzine ¹²
• Novo-Ridazine ¹¹
• Nozinan ⁴
• Nozinan Liquid ⁴
• Nozinan Oral Drops ⁴
• Nu-Prochlor ⁸
• Piportil L ₄ ⁷
• PMS Fluphenazine ²
• PMS Perphenazine ⁶
• PMS Prochlorperazine ⁸
• PMS Thioridazine ¹¹
• PMS Trifluoperazine ¹²
• Serentil ³
• Stelazine ¹²
• Stemetil ⁸
• Stemetil Liquid ⁸

Category

• Analgesic—Methotrimeprazine
• Anesthetic adjunct—Chlorpromazine; Methotrimeprazine, intravenous
• Antidyskinetic, Huntington"s chorea—Chlorpromazine; Thioridazine
• Antiemetic—Chlorpromazine; Methotrimeprazine; Perphenazine; Prochlorperazine; Trifluoperazine; Triflupromazine
• Antineuralgia adjunct—Fluphenazine
• Antipsychotic—Chlorpromazine; Fluphenazine; Mesoridazine; Methotrimeprazine; Perphenazine; Pipotiazine; Prochlorperazine; Promazine; Thioproperazine; Thioridazine; Trifluoperazine; Triflupromazine
• Antipsychotic adjunct—Pericyazine
• Sedative—Chlorpromazine; Methotrimeprazine; Thioridazine

Description

Phenothiazines (FEE-noe-THYE-a-zeens) are used to treat serious mental and emotional disorders, including schizophrenia and other psychotic disorders. Some are used also to control agitation in certain patients, severe nausea and vomiting, severe hiccups, and moderate to severe pain in some hospitalized patients. Chlorpromazine is used also in the treatment of certain types of porphyria, and with other medicines in the treatment of tetanus. Phenothiazines may also be used for other conditions as determined by your doctor.

Phenothiazines may cause unwanted, unattractive, and uncontrolled face or body movements that may not go away when you stop taking the medicine. They may also cause other serious unwanted effects. You and your doctor should talk about the good this medicine will do as well as the risks of using it. Also, your doctor should look for early signs of these effects at regular visits. Your doctor may be able to stop or decrease some unwanted effects, if they do occur, by changing your dose or by making other changes in your treatment.

Phenothiazines are available only with your doctor"s prescription in the following dosage forms:

• Oral
• Chlorpromazine
  • Extended-release capsules (U.S.)
  • Oral concentrate (U.S. and Canada)
  • Syrup (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Fluphenazine
  • Elixir (U.S. and Canada)
  • Oral solution (U.S.)
  • Tablets (U.S. and Canada)
• Mesoridazine
  • Oral solution (U.S.)
  • Tablets (U.S. and Canada)
• Methotrimeprazine
  • Oral solution (Canada)
  • Tablets (Canada)
• Pericyazine
  • Capsules (Canada)
  • Oral solution (Canada)
• Perphenazine
  • Oral solution (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Prochlorperazine
  • Extended-release capsules (U.S.)
  • Oral solution (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Thioproperazine
  • Tablets (Canada)
• Thioridazine
  • Oral solution (U.S. and Canada)
  • Oral suspension (U.S. and Canada)
  • Tablets (U.S. and Canada)
• Trifluoperazine
  • Syrup (U.S. and Canada)
  • Tablets (U.S. and Canada)

• Parenteral
• Chlorpromazine
  • Injection (U.S. and Canada)
• Fluphenazine
  • Injection (U.S. and Canada)
• Mesoridazine
  • Injection (U.S.)
• Methotrimeprazine
  • Injection (Canada)
• Perphenazine
  • Injection (U.S.)
• Pipotiazine
  • Injection (Canada)
• Prochlorperazine
  • Injection (U.S. and Canada)
• Promazine
  • Injection (Canada)
• Trifluoperazine
  • Injection (U.S.)
• Triflupromazine
  • Injection (U.S.)

• Rectal
• Chlorpromazine
  • Suppositories (U.S. and Canada)
• Prochlorperazine
  • Suppositories (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For phenothiazines, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to phenothiazines. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Some of the phenothiazine dosage forms contain parabens, sulfites, or tartrazine.

Pregnancy—Although studies have not been done in pregnant women, some side effects, such as jaundice and movement disorders, have occurred in a few newborns whose mothers received phenothiazines during pregnancy. Studies in animals have shown that, when given to the mother during pregnancy, these medicines can decrease the number of successful pregnancies and cause problems with bone development in the offspring. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Phenothiazines pass into breast milk and may cause drowsiness or unusual muscle movements in the nursing baby. It may be necessary for you to take a different medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, especially those with severe illness or dehydration. Children are usually more sensitive than adults to the effects of phenothiazines.

Older adults—Constipation, trouble urinating, dryness of mouth, confusion, problems with memory, dizziness or fainting, drowsiness, trembling of the hands and fingers, and problems with muscle movement, such as decreased or unusual movements, are especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of phenothiazines.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking phenothiazines, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Antihypertensives (high blood pressure medicine) or
• Bromocriptine (e.g., Parlodel) or
• Deferoxamine (e.g., Desferal) or
• Diuretics (water pills) or
• Levobunolol (e.g., Betagan) or
• Medicine for heart disease or
• Metipranolol (e.g., OptiPranolol) or
• Nabilone (e.g., Cesamet) (with high doses) or
• Narcotic pain medicine or
• Pentamidine (e.g., Pentam)—Severe low blood pressure may occur

• Antidepressants (medicine for depression)—The risk of developing serious side effects, including severe constipation, low blood pressure, severe drowsiness, unusual body or facial movements, and changes in heart rhythm, may be increased

• Antipsychotics, other (medicine for mental illness) or
• Promethazine (e.g., Phenergan) or
• Trimeprazine (e.g., Temaril)—Severe low blood pressure or unusual body or facial movements may occur

• Antithyroid agents (medicine for overactive thyroid)—The risk of developing serious blood problems may be increased

• Astemizole (e.g., Hismanal) or
• Cisapride (e.g., Propulsid) or
• Disopyramide (e.g., Norpace) or
• Erythromycin (e.g., E.E.S., EryPed) or
• Probucol (e.g., Lorelco) or
• Procainamide (e.g., Procan SR) or
• Quinidine (e.g., Duraquin)—Serious changes in heart rhythm may occur

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—Severe drowsiness and trouble in breathing may occur

• Epinephrine (e.g., Adrenalin)—Severe low blood pressure and fast heartbeat may occur

• Levodopa (e.g., Dopar)—Phenothiazines may prevent levodopa from working properly in the treatment of Parkinson"s disease

• Lithium (e.g., Lithane, Lithizine, Lithobid)—Some unwanted effects, such as decreased or unusual body or facial movements, may be increased. The blood levels of the phenothiazine and/or lithium may be changed, so the medicines may not work properly. Your doctor may need to change your dose of either or both medicines

• Metoclopramide (e.g., Reglan) or
• Metyrosine (e.g., Demser) or
• Pemoline (e.g., Cylert) or
• Rauwolfia alkaloids (deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil])—Taking these medicines with phenothiazines may increase the chance of having decreased or unusual body or facial movements or may make the movement problems worse

• Pimozide (e.g., Orap)—Serious changes in heart rhythm, severe low blood pressure, or unusual body or facial movements may occur

Other medical problems—The presence of other medical problems may affect the use of phenothiazines. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—Certain unwanted effects, such as heatstroke and liver disease, may be more likely to occur

• Blood disease or
• Breast cancer or
• Difficult urination or
• Glaucoma or
• Heart or blood vessel disease or
• Parkinson"s disease or
• Seizure disorders, or history of or
• Stomach ulcers—Phenothiazines may make the condition worse

• Brain damage or
• Blood vessel disease in the brain—Serious increase in body temperature may occur

• Enlarged prostate—Difficulty in urinating may occur or may become more severe

• Liver disease—Phenothiazines may make the condition worse. Higher blood levels of phenothiazines may occur, increasing the chance of having unwanted effects

• Lung disease—Difficulty in breathing may become more severe. Decrease in cough reflex caused by phenothiazines may increase the risk of developing complications, such as pneumonia

• Pheochromocytoma or
• Kidney disease—Severe low blood pressure may occur

• Reye"s syndrome—The risk that the phenothiazine will have unwanted effects on the liver may be increased

Proper Use of This Medicine

For patients taking this medicine by mouth :

• This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.
• If your medicine comes in a dropper bottle , measure each dose with the special dropper provided with your prescription and dilute it in a small glass (4 ounces) of orange or grapefruit juice or water just before taking it.
• If you are taking the extended-release capsule form of this medicine, each dose should be swallowed whole. Do not break, crush, or chew before swallowing .

For patients using the suppository form of this medicine:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
• To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

Do not take more or less of this medicine and do not take it more or less often than your doctor ordered . Not taking more than your doctor ordered is particularly important for children or elderly patients, since they may react very strongly to this medicine.

This medicine must be taken for several weeks before its full effect is reached when it is used to treat mental and emotional conditions .

Dosing—The dose of phenothiazines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of phenothiazines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules, tablets, or teaspoonfuls of elixir, solution, suspension, or syrup that you take, or the number of injections you receive or suppositories that you use, depends on the strength of the medicine. Also, the number of doses you use each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking phenothiazines .

• For chlorpromazine
• For oral extended-release capsule dosage form:
  • For mental or emotional disorders:
    • Adults—30 to 300 milligrams (mg) one to three times a day. Your doctor may increase your dose if needed.
    • Children—This dosage form is not recommended for use in children.
• For oral concentrate, syrup, or tablet dosage forms:
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 10 to 25 mg two to four times a day. Your doctor may increase your dose if needed.
    • Children up to 6 months of age—Dose must be determined by your doctor.
    • Children 6 months to 12 years of age—Dose is based on body weight or size, and must be determined by your doctor. The usual dose is 0.55 mg per kilogram (kg) (0.25 mg per pound) of body weight, every four to six hours.
  • For nausea and vomiting:
    • Adults and teenagers—10 to 25 mg every four to six hours as needed.
    • Children up to 6 months of age—Dose must be determined by your doctor.
    • Children 6 months to 12 years of age—Dose is based on body weight or size, and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, every four to six hours.
  • For sedation before surgery:
    • Adults and teenagers—25 to 50 mg two to three hours before surgery.
    • Children—Dose is based on body weight or size, and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, two to three hours before surgery.
  • For treatment of hiccups:
    • Adults and teenagers—25 to 50 mg three or four times a day. If hiccups remain after two to three days of oral treatment, treatment by injection may be needed.
    • Children—Dose must be determined by your doctor.
  • For porphyria:
    • Adults and teenagers—25 to 50 mg three or four times a day.
    • Children—Dose must be determined by your doctor.
• For injection dosage form:
  • For severe mental or emotional disorders:
    • Adults—At first, 25 to 50 mg, injected into a muscle. The dose may be repeated in one hour, and every three to twelve hours thereafter. Your doctor may increase your dose if needed.
    • Children up to 6 months of age—Dose must be determined by your doctor.
    • Children 6 months to 12 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, injected into a muscle every six to eight hours as needed.
  • For nausea and vomiting:
    • Adults—At first, 25 mg injected into a muscle. If needed, doses of 25 to 50 mg may be given every three to four hours.
    • Children up to 6 months of age—Dose must be determined by your doctor.
    • Children 6 months to 12 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, injected into a muscle every six to eight hours as needed.
  • For nausea and vomiting during surgery:
    • Adults—At first, 12.5 mg injected into a muscle. The dose may be repeated if needed. Or up to 25 mg may be diluted and injected slowly into a vein.
    • Children up to 6 months of age—Dose must be determined by your doctor.
    • Children 6 months to 12 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 0.275 mg per kg (0.125 mg per pound) of body weight injected into a muscle or diluted and injected slowly into a vein.
  • For sedation before surgery:
    • Adults—12.5 to 25 mg, injected into a muscle one to two hours before surgery.
    • Children up to 6 months of age—Dose must be determined by your doctor.
    • Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, injected into a muscle one to two hours before surgery.
  • For treatment of hiccups:
    • Adults—25 to 50 mg, injected into a muscle three or four times a day. If hiccups remain after treatment by injection into muscle, 25 to 50 mg may be diluted and injected slowly into a vein.
    • Children—Dose must be determined by your doctor.
  • For porphyria:
    • Adults—25 mg injected into a muscle every six to eight hours.
    • Children—Dose must be determined by your doctor.
  • For tetanus:
    • Adults—25 to 50 mg, injected into a muscle three or four times a day. Or 25 to 50 mg, diluted and injected slowly into a vein. Your doctor may increase your dose if needed.
    • Children up to 6 months of age—Dose must be determined by your doctor.
    • Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, injected into a muscle every six to eight hours or diluted and injected slowly into a vein.
• For rectal dosage form (suppositories):
  • For nausea and vomiting:
    • Adults and teenagers—50 to 100 mg, inserted into the rectum every six to eight hours as needed.
    • Children up to 6 months of age—Dose must be determined by your doctor.
    • Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 mg per kg (0.45 mg per pound) of body weight, inserted into the rectum every six to eight hours as needed.

• For fluphenazine
• For oral dosage form (elixir, solution, or tablets):
  • For mental or emotional disorders:
    • Adults—At first, a total of 2.5 to 10 milligrams (mg) a day, taken in smaller doses every six to eight hours during the day. Your doctor may increase your dose if needed. However, the dose usually is not more than 20 mg a day.
    • Children—0.25 to 0.75 mg one to four times a day.
    • Older adults—1 to 2.5 mg a day. Your doctor may increase your dose if needed.
• For long-acting decanoate injection dosage form:
  • For mental or emotional disorders:
    • Adults—At first, 12.5 to 25 mg, injected into a muscle or under the skin every one to three weeks. Your doctor may increase your dose if needed. However, the dose usually is not more than 100 mg.
    • Children 5 to 12 years of age—3.125 to 12.5 mg, injected into a muscle or under the skin every one to three weeks.
    • Children 12 years of age and older—At first, 6.25 to 18.75 mg, injected into a muscle or under the skin once a week. Your doctor may increase your dose if needed. However, the dose usually is not more than 25 mg every one to three weeks.
• For long-acting enanthate injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 25 mg, injected into a muscle or under the skin every two weeks. Your doctor may adjust your dose if needed. However, the dose usually is not more than 100 mg.
    • Children up to 12 years of age—Dose must be determined by your doctor.
• For short-acting hydrochloride injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 1.25 mg, injected into a muscle. Your doctor may repeat and increase your dose if needed. However, the dose usually is not more than 10 mg a day.
    • Children up to 12 years of age—Dose must be determined by your doctor.
    • Older adults—1 to 2.5 mg a day, injected into a muscle. Your doctor may increase your dose if needed.

• For mesoridazine
• For oral dosage form (solution or tablets):
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 50 milligrams (mg) three times a day. Your doctor may adjust your dose if needed.
    • Children up to 12 years of age—Dose must be determined by your doctor.
• For injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—25 mg injected into a muscle. The dose may be repeated in thirty to sixty minutes if needed.
    • Children up to 12 years of age—Dose must be determined by your doctor.

• For methotrimeprazine
• For oral dosage form (solution or tablets):
  • For mental or emotional disorders:
    • Adults and teenagers—At first, a total of 50 to 75 milligrams (mg) a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is a total of 0.25 mg per kilogram (kg) (0.11 mg per pound) of body weight a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed.
  • For pain:
    • Adults and teenagers—For moderate pain, at first a total of 6 to 25 mg a day, taken in smaller doses three times a day with meals. For severe pain, at first a total of 50 to 75 mg a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is a total of 0.25 mg per kg (0.11 mg per pound) of body weight a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For sedation:
    • Adults and teenagers—At first, a total of 6 to 25 mg a day, taken in smaller doses three times a day with meals. Your doctor may increase your dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is a total of 0.25 mg per kg (0.11 mg per pound) of body weight a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
• For injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 10 to 20 mg, injected into a muscle every four to six hours. Your doctor may increase your dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is a total of 0.062 to 0.125 mg per kg (0.028 to 0.057 mg per pound) of body weight a day, injected into a muscle in one dose or in a few smaller doses.
  • For pain:
    • Adults and teenagers—At first, 2.5 to 20 mg, injected into a muscle. Your doctor may repeat or increase your dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is a total of 0.062 to 0.125 mg per kg (0.028 to 0.057 mg per pound) of body weight a day, injected into a muscle in one dose or in a few smaller doses.
    • Older adults—At first, 5 to 10 mg injected into a muscle every four to six hours. Your doctor may increase your dose if needed.
  • For sedation before surgery:
    • Adults and teenagers—2 to 20 mg, injected into a muscle forty-five minutes to three hours before surgery.
    • Children—Dose must be determined by your doctor.

• For pericyazine
• For oral dosage form (capsules or solution):
  • For mental or emotional disorders:
    • Adults—At first, 5 milligrams (mg) taken in the morning, and 10 mg taken in the evening. Your doctor may change your dose if needed. However, the dose usually is not more than 20 mg taken in the morning and 40 mg taken in the evening.
    • Children up to 5 years of age—Dose must be determined by your doctor.
    • Children 5 years of age and older—2.5 to 10 mg taken in the morning, and 5 to 30 mg taken in the evening.
    • Older adults—At first, 5 mg a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 30 mg a day.

• For perphenazine
• For oral solution dosage form:
  • For mental or emotional disorders in hospitalized patients:
    • Adults and teenagers—8 to 16 milligrams (mg) two to four times a day.
    • Children up to 12 years of age—Dose must be determined by your doctor.
• For oral tablet dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—4 to 16 mg two to four times a day.
    • Children up to 12 years of age—Dose must be determined by your doctor.
  • For nausea and vomiting:
    • Adults and teenagers—A total of 8 to 16 mg a day, taken in smaller doses during the day. Your doctor will lower your dose as soon as possible.
    • Children up to 12 years of age—Dose must be determined by your doctor.
• For injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—5 to 10 mg injected into a muscle every six hours.
    • Children up to 12 years of age—Dose must be determined by your doctor.
  • For nausea and vomiting:
    • Adults and teenagers—At first, 5 to 10 mg injected into a muscle, or 5 mg diluted and injected slowly into a vein. Your doctor may adjust your dose if needed.
    • Children up to 12 years of age—Dose must be determined by your doctor.

• For pipotiazine
• For injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 50 to 100 milligrams (mg) injected into a muscle every two to three weeks. Your doctor may increase your dose if needed. However, the dose usually is not more than 150 mg every four weeks.
    • Children up to 12 years of age—Dose must be determined by your doctor.

• For prochlorperazine
• For oral extended-release capsule dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—Dose must be determined by your doctor.
    • Children—This dosage form is not recommended for use in children.
  • For nausea and vomiting:
    • Adults and teenagers—At first, 15 mg taken once a day in the morning, or 10 mg taken every twelve hours. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
    • Children—This dosage form is not recommended for use in children.
• For oral dosage form (solution or tablets):
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 5 to 10 milligrams (mg) three or four times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 150 mg a day.
    • Children up to 2 years of age—Dose must be determined by your doctor.
    • Children 2 to 12 years of age—2.5 mg two or three times a day. Your doctor may increase your dose if needed. However, for children 2 through 5 years of age, the dose usually is not more than 20 mg a day. For children 6 to 12 years of age, the dose usually is not more than 25 mg a day.
  • For nausea and vomiting:
    • Adults and teenagers—5 to 10 mg three or four times a day.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2.5 mg taken one to three times a day.
• For injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 10 to 20 mg injected into a muscle. The dose may be repeated if needed. Later, the dose is usually 10 to 20 mg every four to six hours. However, the dose usually is not more than 200 mg a day.
    • Children up to 2 years of age—Dose must be determined by your doctor.
    • Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.132 mg per kilogram (kg) (0.06 mg per pound) of body weight, injected into a muscle. However, the dose for children 2 through 5 years of age usually is not more than 20 mg a day. The dose for children 6 to 12 years of age usually is not more than 25 mg a day.
  • For nausea and vomiting:
    • Adults and teenagers—5 to 10 mg, injected into a muscle every three to four hours as needed. Or 2.5 to 10 mg injected slowly into a vein. The dose usually is not more than 40 mg a day.
    • Children up to 2 years of age—Dose must be determined by your doctor.
    • Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.132 mg per kg (0.06 mg per pound) of body weight, injected into a muscle. However, the dose for children 2 through 5 years of age usually is not more than 20 mg a day. The dose for children 6 to 12 years of age usually is not more than 25 mg a day.
  • For nausea and vomiting in surgery:
    • Adults and teenagers—5 to 10 mg, injected into a muscle or injected slowly into a vein. The dose may be repeated if needed. However, the total dose usually is not more than 40 mg a day.
    • Children—Dose must be determined by your doctor.
• For rectal dosage form (suppositories):
  • For mental or emotional disorders:
    • Adults and teenagers—10 mg inserted into the rectum three or four times a day. Your doctor may increase your dose if needed.
    • Children 2 to 12 years of age—2.5 mg inserted into the rectum two or three times a day. Your doctor may increase your dose if needed. However, for children 2 through 5 years of age, the dose usually is not more than 20 mg a day. For children 6 to 12 years of age, the dose usually is not more than 25 mg a day.
  • For nausea and vomiting:
    • Adults and teenagers—25 mg inserted into the rectum two times a day.
    • Children up to 2 years of age—Dose must be determined by your doctor.
    • Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 2.5 mg inserted into the rectum one to three times a day.

• For promazine
• For injection dosage form:
  • For mental or emotional disorders:
    • Adults—At first, 50 to 150 mg, injected into a muscle or, in hospitalized patients, diluted and injected into a vein. Later, 10 to 200 mg, injected into a muscle every four to six hours.
    • Children up to 12 years of age—Dose must be determined by your doctor.
    • Children 12 years of age and older—10 to 25 mg, injected into a muscle, every four to six hours.

• For thioproperazine
• For oral dosage form (tablets):
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 5 milligrams (mg) a day. Your doctor may increase your dose if needed.
    • Children 3 through 10 years of age—Dose must be determined by your doctor.
    • Children 11 years of age and older—At first, a total of 1 to 3 mg a day taken all at one time in a single dose each day or divided and taken in smaller doses several times during the day. Your doctor may increase your dose if needed.

• For thioridazine
• For oral dosage form (suspension, solution, or tablets):
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 50 to 100 milligrams (mg) one to three times a day. Your doctor may adjust your dose if needed. However, the dose usually is not more than 800 mg a day.
    • Children up to 2 years of age—Dose must be determined by your doctor.
    • Children 2 to 12 years of age—At first, 10 to 25 mg two or three times a day. Your doctor may adjust your dose, if needed, based on body weight or size.

• For trifluoperazine
• For oral dosage form (syrup or tablets):
  • For mental or emotional disorders:
    • Adults and teenagers—At first, 2 to 5 milligrams (mg) one or two times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
    • Children up to 6 years of age—Dose must be determined by your doctor.
    • Children 6 to 12 years of age—At first, 1 mg one or two times a day. Your doctor may increase your dose if needed.
• For injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—1 to 2 mg, injected into a muscle every four to six hours as needed. However, the dose usually is not more than 10 mg a day.
    • Children up to 6 years of age—Dose must be determined by your doctor.
    • Children 6 to 12 years of age—1 mg injected into a muscle one or two times a day.

• For triflupromazine
• For injection dosage form:
  • For mental or emotional disorders:
    • Adults and teenagers—60 milligrams (mg) injected into a muscle as needed. However, the dose usually is not more than 150 mg a day.
    • Children up to 21/2 years of age—Dose must be determined by your doctor.
    • Children 21/2 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.2 to 0.25 mg per kilogram (kg) (0.09 to 0.11 mg per pound) of body weight, injected into a muscle. However, the dose usually is not more than 10 mg a day.
  • For nausea and vomiting:
    • Adults and teenagers—5 to 15 mg injected into a muscle every four hours, as needed. However, the dose usually is not more than 60 mg a day injected into a muscle. Or 1 mg injected into a vein, the dose being repeated as needed. However, the dose usually is not more than 3 mg a day injected into a vein.
    • Children up to 21/2 years of age—Dose must be determined by your doctor.
    • Children 21/2 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.2 to 0.25 mg per kg (0.09 to 0.11 mg per pound) of body weight, injected into a muscle. However, the dose usually is not more than 10 mg a day.

Missed dose—If you miss a dose of this medicine and your dosing schedule is:

• One dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if you do not remember the missed dose until the next day, skip it and go back to your regular dosing schedule. Do not double doses.
• More than one dose a day—If you remember within an hour or so of the missed dose, take it right away. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow your dosage to be changed if necessary to meet your needs.

Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to prevent side effects and to keep your condition from becoming worse.

Do not take this medicine within 2 hours of taking antacids or medicine for diarrhea. Taking these products too close together may make this medicine less effective.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

Before using any prescription or over-the-counter (OTC) medicine for colds or allergies, check with your doctor. These medicines may increase the chance of developing heatstroke or other unwanted effects, such as dizziness, dry mouth, blurred vision, and constipation, while you are taking a phenothiazine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (such as electrocardiogram [ECG or EKG] readings, the gonadorelin test, the metyrapone test, tests for phenylketonurea, and urine bilirubin tests) may be affected by this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine . Taking phenothiazines together with medicines that are used during surgery, dental treatments, or emergency treatments may increase CNS depression or cause low blood pressure.

This medicine may cause some people to become drowsy or less alert than they are normally. Even if this medicine is taken only at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

Phenothiazines may cause blurred vision, difficulty in reading, or other changes in vision, especially during the first few weeks of treatment. Do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If the problem continues or gets worse, check with your doctor .

Dizziness, lightheadedness, or fainting may occur , especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine , since overheating may result in heatstroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

This medicine also may make you more sensitive to cold temperatures. Dress warmly during cold weather. Be careful during prolonged exposure to cold, such as in winter sports or swimming in cold water.

Phenothiazines may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute . However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Phenothiazines may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a skin protection factor (SPF) of at least 15. You may require a product with a higher SPF number, especially if you have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

Phenothiazines may cause your eyes to be more sensitive to sunlight than they are normally . Exposure to sunlight over a period of time (several months to years) may cause blurred vision, change in color vision, or difficulty in seeing at night. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your medical doctor or eye doctor.

If you are taking a liquid form of this medicine , avoid getting it on your skin or clothing because it may cause a skin rash or other irritation.

If you are receiving this medicine by injection:

• The effects of the long-acting injection form of this medicine may last for 6 to 12 weeks. The precautions and side effects information for this medicine applies during this time .

Side Effects of This Medicine

Along with their needed effects, phenothiazines can sometimes cause serious unwanted effects. Tardive dyskinesia or tardive dystonia (muscle movement disorders) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia or tardive dystonia include worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, body, arms, or legs. Another possible serious unwanted effect is the neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS include severe muscle stiffness, fever, fast heartbeat, difficult breathing, increased sweating, and loss of bladder control. You and your doctor should discuss the good this medicine will do as well as the risks of taking it .

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time, check with your doctor if you notice dizziness, nausea and vomiting, stomach pain, trembling of the fingers and hands, or any of the following signs of tardive dyskinesia or tardive dystonia:

Inability to move eyes; lip smacking or puckering; muscle spasms of face, neck, body, arms, or legs, causing unusual body positions or unusual expressions on face; puffing of cheeks; rapid or worm-like movements of tongue; sticking out of tongue; tic-like or twitching movements; trouble in breathing, speaking, or swallowing; uncontrolled chewing movements; uncontrolled twisting or other movements of neck, trunk, arms, or legs

Although not all of the side effects listed above have been reported for all of the phenothiazines, they have been reported for at least one of them. However, since all of the phenothiazines are very similar, any of the above side effects may occur with any of these medicines.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it also is useful for other medical problems. Although these uses are not included in product labeling, phenothiazines are used in certain patients with the following medical conditions:

• Chronic neurogenic pain (certain continuing pain conditions)
• Huntington"s chorea (hereditary movement disorder)
• Migraine headaches

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 12/18/2003

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