PROCHLORPERAZINE- prochlorperazine maleate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROCHLORPERAZINE MALEATE (UNII: I1T8O1JTL6) (PROCHLORPERAZINE - UNII:YHP6YLT61T)

Available from:

STAT RX USA LLC

INN (International Name):

PROCHLORPERAZINE MALEATE

Composition:

PROCHLORPERAZINE MALEATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4 week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic cond

Product summary:

Prochlorperazine maleate tablets USP are supplied as: 5 mg (as free base) tablets - yellow, round, film-coated; unscored on both sides, debossed “93” on one side and debossed “9643” on the other side, in bottles of 100. 10 mg (as free base) tablets - yellow, round, film-coated; unscored on both sides, debossed “93” on one side and debossed “9652” on the other side, in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. * Levophed® is a registered trademark of Abbott Laboratories. † Neo-Synephrine® is a registered trademark of Abbott Laboratories. ‡ Dilantin® is a registered trademark of Parke-Davis. § Amipaque® is a registered trademark of Sanofi Pharmaceuticals. # Benadryl® is a registered trademark of Parke-Davis. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. G 5/2009

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROCHLORPERAZINE - PROCHLORPERAZINE MALEATE TABLET
STAT RX USA LLC
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DESCRIPTION
Prochlorperazine is a phenothiazine derivative, present in
prochlorperazine tablets as the maleate.
Prochlorperazine maleate is designated chemically as
2-chloro-10-[3-(4-methyl-1- piperazinyl)propyl]
phenothiazine maleate and has the following structural formula:
C
H ClN S•2C H O M.W. 606.10
Prochlorperazine maleate is classified as an anti-emetic and
antipsychotic agent. Prochlorperazine
maleate is white or pale yellow, practically odorless, crystalline
powder. It is practically insoluble in
water and in alcohol; slightly soluble in warm chloroform.
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: microcrystalline
cellulose, hypromellose, lactose monohydrate, magnesium stearate,
polydextrose, polyethylene glycol,
pregelatinized starch, stearic acid, titanium dioxide, triacetin, and
yellow iron oxide
INDICATIONS AND USAGE
For control of severe nausea and vomiting.
For the treatment of schizophrenia.
Prochlorperazine is effective for the short-term treatment of
generalized non-psychotic anxiety.
However, prochlorperazine is not the first drug to be used in therapy
for most patients with non-
psychotic anxiety, because certain risks associated with its use are
not shared by common alternative
treatments (e.g., benzodiazepines).
When used in the treatment of non-psychotic anxiety, prochlorperazine
should not be administered at
doses of more than 20 mg per day or for longer than 12 weeks, because
the use of prochlorperazine at
higher doses or for longer intervals may cause persistent tardive
dyskinesia that may prove irreversible
(see WARNINGS).
The effectiveness of prochlorperazine as treatment for non-psychotic
anxiety was established in 4 week
clinical studies of outpatients with generalized anxiety disorder.
This evidence does not predict that
prochlorperazine will be useful in patie