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Logo BARATOL® 25 mg tablets
BARATOL® 50 mg tablets
SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

BARATOL® 25 mg tablets
BARATOL® 50 mg tablets

COMPOSITION:
Each 25 mg BARATOL tablet contains:
  Indoramin hydrochloride 27,625 mg
  equivalent to Indoramin 25,000 mg
Each 50 mg BARATOL tablet contains:
  Indoramin hydrochloride 55,250 mg
  equivalent to Indoramin 50,000 mg
PHARMACOLOGICAL CLASSIFICATION:
Category A, 7.1.3 Hypotensive agents

PHARMACOLOGICAL ACTION:
The anti-hypertensive effect is due to alpha adrenergic blockade. BARATOL (indoramin) lowers blood pressure by producing peripheral vasodilatation. There is no concomitant elevation of heart rate or increased cardiac output. Indoramin is devoid of beta-adrenoceptor blocking properties. Indoramin has direct negative chronotropic and inotropic effects on the heart. The heart rate is slowed in some patients.
BARATOL (indoramin) has no angiotensin blocking properties.
BARATOL (indoramin) possesses antihistaminic activity and a membrane stabilising effect. Central nervous sedation occurs in some patients.
The anti-hypertensive action of BARATOL (indoramin) persists for a variable time after discontinuation of prolonged therapy. This may be due to a change in baroreceptor activity. Rebound hypertension does not occur.
The effect of indoramin on blood pressure is not reversed by concomitant administration of the tricyclic antidepressant desipramine.
Postural hypotension is uncommon.
Headache, dyspnoea and insomnia decrease in some patients.

INDICATIONS:
BARATOL (indoramin) is indicated for the treatment of all grades of hypertension (mild, moderate and severe).

CONTRA-INDICATIONS:
There are no known contra-indications to the use of BARATOL (indoramin).

DOSAGE AND DIRECTIONS FOR USE:
BARATOL tablets are available in two strengths for oral use, containing 25 mg and 50 mg of indoramin.
The recommended starting dose is 25 mg twice daily.
The daily dosage of BARATOL (indoramin) may be adjusted by 25 mg, preferably at weekly intervals.

It is recommended that a thiazide diuretic be added if effective control of the blood pressure cannot be maintained at a daily intake of 150 mg indoramin.

The dosage of indoramin should be limited to a maximum of 200 mg daily.

USE WITH OTHER MEDICINES: Indoramin may be administered with thiazide diuretics, digoxin and alphamethyldopa.
BARATOL (indoramin) treatment need not be discontinued in patients undergoing general anaesthesia. The effect of halothane on the blood pressure may be enhanced by indoramin.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sedation is a common side-effect: there is a particular risk of this becoming severe at doses exceeding 150 mg daily and intolerable at doses exceeding 200 mg daily. Dizziness, dry mouth, failure of ejaculation or loss of libido may also occur. Mass gain and oedema have been reported in some studies. The concomitant use of a thiazide diuretic is recommended in these cases.

Less common side-effects which have been reported in some studies are headaches, depression, gastro-intestinal disturbances, chest pain, irritability, numbness in hands and skin rash.

Usage in pregnancy:
The use of indoramin has not been studied in pregnant patients, accordingly, indoramin is not recommended for usage in pregnant patients. Therefore, the use of this drug in pregnancy or suspected pregnancy requires that the benefits be weighed against the possible hazards to the foetus.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Sedation, dizziness, dry mouth and nasal congestion occur. Massive overdosage with BARATOL (indoramin) in man has not been reported, but profound cardiovascular effects are to be expected. Treatment should be aimed at adequate circulatory function, use of an appropriate plasma-volume expander and a sympathomimetic such as isoprenaline is recommended.

CONDITIONS OF REGISTRATION:
May be advertised to the professions only.

IDENTIFICATION:
The 25 mg BARATOL tablet is white, round bevel edged and 8 mm in diameter. It is deep-scored with “25”impressed on the one side.
The 50 mg BARATOL tablet is white round bevel edged and 9,5 mm in diameter. It is deep-scored with “50”impressed on the one side.

PRESENTATION:
BARATOL 25 mg tablets are available in packs of 30, 100, 200, and sample packs of 6 tablets.
BARATOL 50 mg tablets are available in packs of 30, 100 and 200.

STORAGE DIRECTIONS:
Store in a cool (below 25°C), dry place.
Keep out of reach of children.

REGISTRATION NUMBERS:
BARATOL 25 mg K/7.1.3/176
BARATOL 50 mg K/7.1.3/223

NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS
Electron Avenue ISANDO 1600
Trademark and product,
under licence from
WYETH-AYERST LABORATORIES, U.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1979
        24220 GR401

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