Prochlorperazine Maleate Tablets

DRUG DESCRIPTION

Prochlorperazine Maleate is classified as an antiemetic and antipsychotic tranquilizer. Prochlorperazine is a phenothiazine derivative, present in the tablets as the maleate. Its chemical name is 2-chloro-10- [3-(4-methyl-1-piperazinyl)propyl]-10 H-phenothiazine (Z)-2-butenedioate (1:2). Empirical formulas (and molecular weight) are: prochlorperazine maleate-C20H24CIN3S2C4H4O4 (606.10) and prochlorperazine base- C20H24CIN3S (373.95).

Prochlorperazine Maleate Structural Formula Illustration

Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.

What are the precautions when taking prochlorperazine maleate tablets (Prochlorperazine Maleate Tablets)?

Before taking prochlorperazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., chlorpromazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used to treat patients who are unconscious or taking large amounts of any drug that causes drowsiness and slow/shallow breathing (e.g., alcohol, barbiturates, narcotics).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow depression), ongoing breathing problems (e.g., asthma, emphysema), certain heart rhythm problems (e.g., prolonged QTc interval,...

Read All Potential Precautions of Prochlorperazine Maleate Tablets


Prochlorperazine Maleate Tablets Consumer (continued)

SIDE EFFECTS: Constipation, drowsiness, dizziness, blurred vision, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: agitation/restlessness, face/muscle twitching, uncontrolled movements, drooling, trouble swallowing, difficulty talking, enlarged/tender breasts, unusual breast milk production, shaking (tremors), trouble urinating.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), severe abdominal pain, unusual bleeding/bruising, weakness, yellowing eyes/skin.

This drug may infrequently cause a very serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). If you notice any of the following unlikely but very serious side effects, stop taking this medication and seek immediate medical attention: severe muscle stiffness, mental/mood changes (e.g., confusion, extreme drowsiness), very high fever, seizures, irregular/fast heartbeat, increased sweating.

In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking prochlorperazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., chlorpromazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used to treat patients who are unconscious or taking large amounts of any drug that causes drowsiness and slow/shallow breathing (e.g., alcohol, barbiturates, narcotics).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow depression), ongoing breathing problems (e.g., asthma, emphysema), certain heart rhythm problems (e.g., prolonged QTc interval, irregular heartbeat), low blood pressure, glaucoma, liver problems (e.g., cirrhosis), Reye's syndrome, seizures, urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and light-headedness, get up slowly when rising from a sitting or lying position.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication may decrease your body's ability to adjust to either very hot or very cold temperatures. Due to the risk of fainting, avoid being alone if exposed to temperature extremes (e.g., swimming in cold water). In hot weather, fever and heatstroke may occur due to decreased sweating. Avoid strenuous work/exercise, drink plenty of fluids, and dress lightly while in hot weather.

The elderly may be more sensitive to the effects of this drug, especially low blood pressure, constipation, urinary problems, and nerve/muscle problems.

Children may be at greater risk for nerve/muscle side effects while using this drug. Therefore, this medication is not recommended for use in children who are in surgery or have a short-term illness (e.g., chickenpox, flu) or in children under 2 years old.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this medication during pregnancy may rarely have liver problems with symptoms including yellowing eyes/skin or dark urine. When this drug is used during the last 3 months of pregnancy, babies born to these mothers may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

Based on information from related drugs, this medication may pass into breast milk. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.



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