INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PASRIN-10 Tablets

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

PASRIN-10 Tablets

COMPOSITION:
Each tablet contains 10 mg
buspirone hydrochloride respectively.

PHARMACOLOGICAL CLASSIFICATION:
A 2.6.5. Tranquillizers, miscellaneous structures.

PHARMACOLOGICAL ACTION:
Buspirone hydrochloride is an anxiolytic agent. The exact mechanism of buspirone's anxiolytic action in humans is not fully understood. Buspirone does not act through a benzodiazepine - receptor mechanism. Buspirone has been shown to have a high affinity for serotonin 5 - HT
1A) receptors in the dorsal rophe neurons and a moderate affinity for brain D2 - dopamine receptors. Buspirone hydrochloride is rapidabsorbed from the gastro-intestinal tract reaching peak plasma concentrations 60 to 90 minutes after administration. Systemic bioavailis low due to extensive first-pass metabolism but may be further increased by concurrent administration of food. Buspirone is about 95% bound to plasma proteins. Buspirone clearance is reduced in the presence of renal and hepatic function impairments. The elimination half-life of Buspirone has varied between 2 and 11 hours.

INDICATIONS:
Pasrin
is indicated for the management of anxiety disorders with or without accompanying depression.

CONTRA-INDICATIONS:
Patients with known hypersensitivity to buspirone hydrochloride. Pregnancy and lactation. Patients with severe renal or hepatic impairment. Patients with a history of seizure disorders. Safety and efficacy of Pasrin in children under 18 years have not been established.

WARNINGS:
Pasrin
may lower convulsion threshold. Pasrin should not be used concomitantly with a monoamine oxidase inhibitor. Reports have described the occurrence of elevated blood pressure in patients receiving both buspirone and monoamine oxidase inhibitors.

DOSAGE AND DIRECTIONS FOR USE:
It is usually given in initial doses of 5 mg two or three times per day in the short term management of anxiety disorders. The dose may be increased in increments of 5 mg at 2- to 3 day intervals if required. The usual effective daily dose is 20 to 30 mg daily up to a maximum recdaily dose of 60 mg in divided doses. In view of Buspirone's low propensity to sedate and induce muscle relaxation patients may not immediately notice the effect of the medication. Clinical experience has also indicated that 1-2 weeks treatment maybe required before the full anxiolytic action is evident. Safety and effectiveness of buspirone for prolonged use have not been established

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Reported side effects include dizziness, nausea, headache, nervousness, light-headedness, excitement, paraesthesia, sleep disturbances, chest pain, tinnitus and nasal congestion. Hypersensitivity reactions including skin rash and, pruritus may occur. Pasrin should be used with caution in patients with moderate hepatic or renal impairment, adjust dosage accordingly. Pasrin has a low incidence of sedation. However, its Central Nervous System (CNS) effects in individual patients may not be predictable. Patients operating machinery or a motor vehicle should do so with caution until the effect the medicine has on them is known. Interactions between buspirone and benzodiazepines, haloperidol, and chlordiazepoxide have been reported. Buspirone does not exhibit cross-tolerance with benzodiazepines and other sedative/hypnotic medicines. Therefore it will not block possible withdrawal symptoms seen with cessation of therapy with these medicines. Patients who have been using benzodiazepines and other sedative/hypnotic medicines chronically, must be withdrawn gradually from treatment, prior to treatment with buspirone. Concomitant use of alcohol must be avoided.

KNOWN SYMPTOMS OF OVERDOSAGE AND TREATMENT:
Nausea, vomiting, dizziness, CNS depression, drowsiness, miosis and gastric distress are the most commonly observed symptoms of overdose.
General symptomatic and supportive measures should be administered along with immediate gastric lavage. There is no known antidote to buspirone and it is not dialysable.

IDENTIFICATION:
Pasrin 10 mg tablets:
        A round, white tablet 8 mm in diameter, with bevelled edges, bisected, imprinted with "B1" on one side, and with mortar and pestle on the other.

PRESENTATION:
Pasrin 10 mg tablets:
        Securitainer packs of 60.

STORAGE INSTRUCTIONS:
Store in tightly closed containers in a cool place under 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Pasrin 10 mg tablets:
        30/2.6.5/0168.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited,
7 Fairclough Road,
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19/01/1996
.        G977
        A & S PRINTERS
Updated on this site: November 2000

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2000