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

Logo COSALDON RETARD Tablets
SCHEDULING STATUS
S1

PROPRIETARY NAME
(and dosage form)

COSALDON RETARD Tablets

COMPOSITION
Per tablet:
Pentifylline         400 mg
Nicotinic acid         100 mg

PHARMACOLOGICAL CLASSIFICATION
A 7.1.5 Vasodilators - peripheral

PHARMACOLOGICAL ACTION
Pentifylline is an active vasodilating substance which does not affect blood sugar levels.
Nicotinic acid belongs to the well-known class of drugs producing dilation of blood vessels in the head, neck and upper extremities of the body.
COSALDON RETARD is well tolerated in therapeutic dosages.
While quantitative confirmation of the effect of COSALDON RETARD on the blood-brain barrier in humans cannot be obtained without risk in the present state of medical technology, tests on experimental animals show that COSALDON RETARD increases the permeability of the blood-brain barrier to glucose by 28% and phosphates by 22%. These tests also show enhanced transport of glucose into cerebral tissue by 10% when pentifylline and nicotinic acid are administered together (in contradistinction to the use of nicotinic acid alone). The pharmacological action of COSALDON RETARD in this context is, therefore, superior to that of nicotinic acid alone.
COSALDON RETARD has a beneficial influence on cerebral metabolism as demonstrated in the drug’s ability to help prevent certain side-effects of ECT therapy in animals and in humans. It thus improves the supply of oxygen to the cerebral tissue.
Tests in aged patients by subjective and objective methods have shown that COSALDON RETARD can improve the elderly patients ability to orientate, and improve his memory and thinking functions.

INDICATIONS
Cerebral circulatory disorders:
The relief of the symptoms accompanying cerebral sclerosis and certain cerebral circulatory disturbances, such as forgetfulness, inability to concentrate, loss of energy and drive, accompanied in some cases by irritability and moodiness. COSALDON RETARD may also be of use in postapoplectic and traumatic brain-function disturbances, providing there is no extensive organic damage.
It is recommended for accelerating recovery from ECT therapy. Administered with ECT treatment, COSALDON RETARD will shorten the patient’s recovery time.
Circulatory disorders of the eye:
Exchanges between blood and the retina are restricted in a manner similar to that between the blood and brain, and COSALDON RETARD has been found to be of value in certain conditions accompanied by acute, subacute or chronic ischaemia of the retina and choroidea.
In certain studies, COSALDON RETARD has been shown to be of value in Raynaud’s syndrome, varicose ulcers and certain other peripheral disorders of blood supply.

CONTRA-INDICATIONS
During severe (non-compensated) weakness of the heart, recent heart infarct or severe haemorrhage, COSALDON RETARD should only be taken on the advice of a doctor.
Give cautiously to patients with a history of peptic ulcer.
Do not take during pregnancy, especially the first three months, without consulting your doctor.

DOSAGE AND DIRECTIONS FOR USE
Disorders of cerebral blood flow and nutrition are generally due to organic changes of a progressive nature. Any possible successful outcome will depend on long-term treatment.

Cerebral and peripheral circulatory disorders:
Initial and normal dose        :        one tablet twice daily
Maintenance dose         : one tablet daily for as long as necessary
Circulatory disorders of the eye:
Initial and normal dose :        one tablet two or three times daily
Maintenance dose :        one tablet once or twice daily for as long as necessary
The tablets should be swallowed whole with water or other liquid after meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
COSALDON RETARD coated tablets are particularly well tolerated.
Nicotinic acid flushes and transient dizziness, as occasionally encountered with the short-acting form, seldom occur. There is no reason to expect a fall in blood pressure beyond the range of physiological fluctuation with normal therapeutic doses of COSALDON RETARD. It is therefore not contra-indicated, even in the presence of hypotension.
Regular blood pressure checks are advised, however, during high dosage therapy, as may be necessary in certain ophthalmic conditions.
No evidence of any effect on carbohydrate metabolism has so far been observed in diabetic patients taking COSALDON RETARD.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
NO cases of acute poisoning with COSALDON RETARD have yet been reported, but likely clinical signs would be flush-like reddening of the skin, particularly of the face; complaints of warm, burning feeling in the stomach; a sensation of fullness and distension; a marked drop in blood pressure and tiredness.
Any overdose of COSALDON RETARD could be aggravated by alcohol consumption.
It is recommended that blood pressure be monitored and if there is a severe drop in blood pressure, a drip infusion of plasma expander be administered. Coagulation states should also be closely watched.
Treatment is symptomatic and supportive.

IDENTIFICATION
Bright yellow, oblong, sugar coated tablet

PRESENTATION
Coated tablets: 30’and 100’

STORAGE INSTRUCTIONS
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
C/7.1.5/12

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hoechst Marion Roussel Limited
16th Road, Midrand

DATE OF PUBLICATION OF THIS PACKAGE INSERT
4 April 1973

        D 171/15

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