Compazine

(Generic versions may still be available.)

DRUG DESCRIPTION

Compazine (prochlorperazine) is a phenothiazine derivative, present in Compazine (prochlorperazine) tablets and Spansule sustained release capsules as the maleate. Its chemical name is 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl]-10H-phenothiazine (Z)-2-butenedioate (1:2).

COMPAZINE® (prochlorperazine) Structural Formula Illustration

Compazine vials and syrup contain prochlorperazine as the edisylate salt and Compazine suppositories contain prochlorperazine base. Empirical formulas (and molecular weights) are: prochlorperazine maleate—C20H24CIN3S•2C4H4O4 (606.10); prochlorperazine edisylate --C20H24CIN3S•C2H6O6S2 (564.14); and prochlorperazine base—C20H24CIN3S (373.95).

Tablets - Each round, yellow-green, coated tablet contains prochlorperazine maleate equivalent to prochlorperazine as follows: 5 mg imprinted SKF and C66; 10 mg imprinted SKF and C67.

5 mg and 10 mg Tablets - Inactive ingredients consist of cellulose, lactose, magnesium stearate, polyethylene glycol, sodium croscarmellose, titanium dioxide, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Yellow No. 6, FD&C Red No. 40, iron oxide, starch, stearic acid and trace amounts of other inactive ingredients, including aluminum lake dyes.

Spansule® sustained release capsules - Each Compazine® (prochlorperazine) Spansule capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Food slows absorption of prochlorperazine and decreases Cmax by 23% and AUC by 13%.

Each capsule, with black cap and natural body, contains prochlorperazine maleate equivalent to prochlorperazine. The 10 mg capsule is imprinted 10 mg and 3344 on the black cap and is imprinted 10 mg and SB on the natural body. The 15 mg capsule is imprinted 15 mg and 3346 on the black cap and is imprinted 15 mg and SB on the natural body. Inactive ingredients consist of ammonio methacrylate co-polymer, D&C Green No. 5, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hydroxypropyl methylcellulose, propylene glycol, silicon dioxide, simethicone emulsion, sodium lauryl sulfate, sorbic acid, sugar spheres, talc, triethyl citrate, and trace amounts of other inactive ingredients.

Vials, 2 mL (5 mg/mL) and 10 mL (5 mg/mL)–Each mL contains, in aqueous solution, 5 mg prochlorperazine as the edisylate, 5 mg sodium biphosphate, 12 mg sodium tartrate, 0.9 mg sodium saccharin and 0.75% benzyl alcohol as preservative.

Suppositories - Each suppository contains 2? mg, 5 mg or 25 mg of prochlorperazine; with glycerin, glyceryl monopalmitate, glyceryl monostearate, hydrogenated cocoanut oil fatty acids and hydrogenated palm kernel oil fatty acids.

Syrup - Each 5 mL (1 teaspoonful) of clear, yellow-orange, fruit-flavored liquid contains 5 mg of prochlorperazine as the edisylate. Inactive ingredients consist of FD&C Yellow No. 6, flavors, polyoxyethylene polyoxypropylene glycol, sodium benzoate, sodium citrate, sucrose and water.

What are the possible side effects of oral prochlorperazine (Compazine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using prochlorperazine and call your doctor at once if you have a serious side effect such as:

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • ...

Read All Potential Side Effects and See Pictures of Compazine »


Compazine Patient Information Including Side Effects

Brand Names: Compazine

Generic Name: prochlorperazine (oral) (Pronunciation: pro klor PER a zeen)

  • What is oral prochlorperazine (Compazine)?
  • What are the possible side effects of oral prochlorperazine (Compazine)?
  • What is the most important information I should know about oral prochlorperazine (Compazine)?
  • What should I discuss with my healthcare provider before taking oral prochlorperazine (Compazine)?
  • How should I take oral prochlorperazine (Compazine)?
  • What happens if I miss a dose (Compazine)?
  • What happens if I overdose (Compazine)?
  • What should I avoid while taking oral prochlorperazine (Compazine)?
  • What other drugs will affect oral prochlorperazine (Compazine)?
  • Where can I get more information?

What is oral prochlorperazine (Compazine)?

Prochlorperazine 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.

Prochlorperazine is used to treat psychotic disorders such as schizophrenia. It is also used to treat anxiety, and to control severe nausea and vomiting.

Prochlorperazine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of oral prochlorperazine (Compazine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using prochlorperazine and call your doctor at once if you have a serious side effect such as:

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
  • feeling like you might pass out;
  • seizure (black-out or convulsions);
  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
  • nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
  • pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
  • urinating less than usual or not at all;
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • dizziness, drowsiness, anxiety;
  • sleep problems (insomnia), strange dreams;
  • dry mouth, stuffy nose;
  • blurred vision;
  • constipation;
  • breast swelling or discharge;
  • a missed menstrual period;
  • weight gain, swelling in your hands or feet;
  • impotence, trouble having an orgasm;
  • mild itching or skin rash; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about oral prochlorperazine (Compazine)?

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.

Prochlorperazine is not for use in psychotic conditions related to dementia. Prochlorperazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not use prochlorperazine if you have brain damage, bone marrow depression, or are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to prochlorperazine or other phenothiazines.

Before you take prochlorperazine, tell your doctor if you have glaucoma, heart disease or high blood pressure, liver or kidney disease, severe asthma or breathing problems, a history of seizures, adrenal gland tumor, Parkinson's disease, enlarged prostate or urination problems, an infectious disease (such as chickenpox, measles, flu, or central nervous system infection), past or present breast cancer, low levels of calcium in your blood, or if you have ever had a serious side effect while using prochlorperazine or similar medicines.

Before taking prochlorperazine, tell your doctor about all other medications you use.

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