Baratol Tablets 25 mg

¹Indoramin Hydrochloride 25 mg Tablets

¹ PL 20072-0044-0004; 26/08/2009

Each tablet contains Indoramin Hydrochloride 27.63 mg HSE equivalent to 25 mg of indoramin base.

Blue film coated tablets with shallow convex faces. “MPL 020” imprinted on one face, “25” on the other face.

Treatment of all grades of essential hypertension and conditions for which alpha blockade is indicated.

Route of administration

The tablet is taken orally.

Adults

Elderly

Clearance of indoramin may be affected in the elderly. A reduced dose and/or frequency of dosing may be sufficient for effective control of blood pressure in some elderly patients.

Children

Baratol is not recommended for children.

Combination with other anti-hypertensive agents:

The anti-hypertensive effect of Baratol is enhanced by concomitant administration of a thiazide diuretic or a β-adrenoceptor blocking drug.

When Baratol is used in combination with other anti-hypertensive agents, the dose of Baratol should be titrated in the same way as when it is used alone.

Baratol is contraindicated in patients:

- Who are currently receiving monoamine oxidase inhibitors.

- With established heart failure.

Drowsiness is sometimes seen in the initial stages of treatment with Baratol or when dosage is increased too rapidly. Patients should be warned not to drive or operate machinery until it is established that they do not become drowsy while taking Baratol.

Incipent cardiac failure should be controlled with diuretics and digitalis before treatment with Baratol.

Caution should be observed in prescribing Baratol for patients with hepatic or renal insufficiency.

A few cases of extrapyramidal disorders have been reported in patients treated with Baratol. Caution should be observed in prescribing Baratol in patients with Parkinson's Disease.

In animals and in the one reported overdose in humans, convulsions have occurred. Due consideration should be given and great caution exercised in the use of Baratol in patients with Epilepsy.

Caution should be observed in prescribing Baratol for patients with a history of depression.

Clearance of indoramin may be affected in the elderly. A reduced dose and/or frequency of dosing may be sufficient for effective control of blood pressure.

The following, when administered at the same time as Baratol, result in an enhanced hypotensive effect:

• Anaesthetics

• Antidepressants, especially MAOIs

• Antihypertensives

• Beta-blockers

• Calcium-channel blockers

• Diuretics, especially thiazide diuretics

Moxisylyte, when administered at the same time as Baratol, may cause possible severe postural hypotension.

The ingestion of ethanol has been shown to increase both the rate and the extent of absorption of Baratol, and patients should be cautioned to avoid the ingestion of alcohol.

Animal experiments indicate no teratogenic effects but Baratol Tablets should not be prescribed for pregnant women unless considered essential by the physician.

There are no data available on the excretion of Baratol in human milk but the drug should not be administered during lactation unless in the judgement of the physician such administration is clinically justifiable.

Baratol may cause drowsiness. See " Special warnings and precautions for use".

The most commonly reported adverse drug reactions are drowsiness, sedation or somnolence occurring in >10% of patients. This effect is often seen in the initial stages of treatment or when the dose is increased too rapidly.

The information available at present of the effects of acute overdosage in humans with Baratol is limited to one case. Effects seen in this case included deep sedation leading to coma, hypotension and fits. Results of animal work suggest that hypothermia may occur.

The suggested therapy is along the following lines:

- Recent ingestion of large numbers of tablets would require gastric lavage or a dose of Ipecacuanha to remove any of the product still in the stomach of the conscious patient.

- Ventilation should be monitored and assisted if necessary.

- Circulatory support and control of hypotension should be maintained.

- If convulsions occur, diazepam may be tried.

- Temperature should be closely monitored. If hypothermia occurs, rewarming should be carried out very slowly to avoid possible convulsions.

Baratol is an α-adrenoceptor blocking agent, which acts selectively and competitively on post-synaptic α₁-adrenoceptors, causing a decrease in peripheral resistance.

Baratol tablets are rapidly absorbed and have a half-life of about 5 hours. There is little accumulation during long-term treatment. When three volunteers and four hypertensive patients were treated with radiolabelled indoramin at doses of 40 - 60mg daily for up to 3 days, plasma concentrations reached a peak 1-2 hours after administration of single doses. Over 90% of plasma indoramin was protein bound. After 2 or 3 days, 35% of the radioactivity was excreted in the urine and 46% in the faeces. Extensive first pass metabolism was suggested.

None applicable.

Amberlite IRP 88

Avicel PH 101

Lactose

Magnesium Stearate

Coating:

Hydroxypropylmethyl Cellulose 2010

Polyethylene Glycol 400

Opaspray M-1-20972

Not applicable.

36 months.

Do not store above 25ºC. Store in the original container.

Pack sizes of 10, 28, 56, 84 100 and 112 in amber glass bottles with suitable closures, aluminium/polyethylene foil strip and securitainers.

Not all pack sizes may be marketed.

None.

Amdipharm PLC

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

United Kingdom

PL 20072/0044

23 April 1993

August 2009