Phenothiazine (oral route, parenteral route, rectal route)

Brand Name

US Brand Name

Compazine

Compro

Mellaril

Permitil

Phenadoz

Prolixin

Serentil

Sparine

Thorazine

Torecan

Trilafon

Canadian Brand Name

Largactil

Moditen Hydrochloride

Phenergan

Pms-Perphenazine

Pms-Prochlorperazine

Pms-Promethazine

Pms-Thioridazine

Stemetil

Trilafon Concentrate

Description

Phenothiazines 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.

These medicines are available only with your doctor's prescription.

Levoprome(R) (methotrimeprazine) is no longer available in the United States. At the end of May 1998, Immunex Corporation stopped marketing it.

This product is available in the following dosage forms:

Suppository
Tablet
Solution
Elixir
Syrup

Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

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.

Breastfeeding

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.

Drug Interactions

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 any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Alfuzosin
Amiodarone
Amisulpride
Amitriptyline
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asenapine
Astemizole
Atazanavir
Azithromycin
Bedaquiline
Bepridil
Bromopride
Buprenorphine
Buserelin
Calcium Oxybate
Ceritinib
Chloroquine
Chlorpromazine
Ciprofloxacin
Cisapride
Citalopram
Clarithromycin
Clobazam
Clofazimine
Clomipramine
Clorgyline
Clothiapine
Clozapine
Crizotinib
Cyclobenzaprine
Dabrafenib
Dasatinib
Degarelix
Delamanid
Desipramine

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone Acetate
Abiraterone Acetate, Micronized
Acecainide
Acepromazine
Aclidinium
Adagrasib
Alfentanil
Alfuzosin
Alprazolam
Amantadine
Amifampridine
Amiodarone
Amisulpride
Amitriptyline
Amobarbital
Amoxapine
Anagrelide
Anileridine
Apomorphine
Aprindine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asenapine
Astemizole
Atazanavir
Atropine
Avacopan
Azimilide
Azithromycin
Baclofen
Bedaquiline
Benperidol
Benzhydrocodone
Benztropine
Berotralstat
Biperiden
Bretylium
Bromazepam

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use

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 medicines in this class 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take 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 using the medicine.

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 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.
- For nausea and vomiting:
  - Adults and teenagers—10 to 25 mg every four to six hours as needed.
  - 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.
- For nausea and vomiting:
  - Adults and teenagers—10 to 25 mg every four to six hours as needed.
  - 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.
- 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 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.
- 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 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.
- 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 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.
- For sedation before surgery:
  - Adults—12.5 to 25 mg, injected into a muscle one to two hours before surgery.
  - 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.
- 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 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.
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 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.
  - Children up to 6 months of age—Dose must be determined by your doctor.

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 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.
  - 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.
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 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 5 years of age and older—2.5 to 10 mg taken in the morning, and 5 to 30 mg taken in the evening.
  - Children up to 5 years of age—Dose must be determined by your doctor.
  - 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 dosage form (solution):
- 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 dosage form (tablet):
- 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 in hospitalized patients:
  - 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 long-acting oral dosage form (extended-release capsules):
- 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 forms (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 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.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- 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 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.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- 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 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.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- 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 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.
  - Children up to 2 years of age—Dose must be determined by your doctor.

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 12 years of age and older—10 to 25 mg, injected into a muscle, every four to six hours.
  - Children up to 12 years of age—Dose must be determined by your doctor.

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 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.
  - Children 3 through 10 years of age—Dose must be determined by your doctor.

For thioridazine

For oral dosage forms (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 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.
  - Children up to 2 years of age—Dose must be determined by your doctor.

For trifluoperazine

For oral dosage forms (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 6 to 12 years of age—At first, 1 mg one or two times a day. Your doctor may increase your dose if needed.
  - Children up to 6 years of age—Dose must be determined by your doctor.
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 6 to 12 years of age—1 mg injected into a muscle one or two times a day.
  - Children up to 6 years of age—Dose must be determined by your doctor.

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 2½ 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.
  - Children up to 2½ years of age—Dose must be determined by your doctor.
- 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 2½ 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.
  - Children up to 2½ years of age—Dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions

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 phenylketonuria, 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.
If you have a severe reaction from the sun, check with your doctor.

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

Confusion (severe) or coma
difficult or fast breathing
drooling
fast heartbeat
high or low (irregular) blood pressure
increased sweating
loss of bladder control
muscle stiffness (severe)
trembling or shaking
trouble in speaking or swallowing

Check with your doctor immediately if any of the following side effects occur:

More common

Inability to move eyes
increased blinking or spasms of eyelid
lip smacking or puckering
muscle spasms of face, neck, body, arms, or legs causing unusual postures 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 movements of arms or legs
uncontrolled twisting movements of neck, trunk, arms, or leg

Rare

Irregular or slow heart rate
recurrent fainting

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Blurred vision, change in color vision, or difficulty in seeing at night
fainting
loss of balance control
mask-like face
restlessness or need to keep moving
shuffling walk
stiffness of arms or legs
trembling and shaking of hands and fingers

Less common

Difficulty in urinating
skin rash
sunburn (severe)

Rare

Abdominal or stomach pains
aching muscles and joints
agitation, bizarre dreams, excitement, or trouble in sleeping
bleeding or bruising (unusual
chest pain
clumsiness
confusion (mild)
constipation (severe)
convulsions (seizures)
dark urine
fever and chills
hair loss
headaches
hot, dry skin or lack of sweating
itchy skin (severe)
muscle weakness
nausea, vomiting, or diarrhea
pain in joints
prolonged, painful, inappropriate erection of the penis
redness of hands
shivering
skin discoloration (tan or blue-gray)
sore throat and fever
sores in mouth
unusual bleeding or bruising
unusual tiredness or weakness
yellow eyes or skin

Phenothiazines may cause your urine to be dark. In most cases, this is not a sign of a serious problem. However, if your urine does become dark, discuss it with your doctor.

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation (mild)
decreased sweating
dizziness
drowsiness
dryness of mouth
nasal congestion

Less common

Changes in menstrual period
decreased sexual ability
increased sensitivity of eyes to light
rough or “fuzzy” tongue
secretion of milk (unusual)
swelling or pain in breasts
watering of mouth
weight gain (unusual)

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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