Selective a1 -blockers (alpha- blockers / alpha-adrenoceptor blocking drugs).

Indoramin

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.

Dose Range: 50 mg - 200 mg daily.

Initial Dose: 25 mg twice daily for all patients.

Dose Titration: The dose of Baratol should be titrated as necessary to control blood pressure to a maximum of 200 mg daily in two or three divided doses. The daily dose may be increased by the progressive addition of 25 mg or 50 mg. This may be done at intervals of two weeks. Many patients may be stabilised with doses up to 100 mg daily, especially those already being treated with diuretics. When unequal doses are used, the largest dose should be given at night in order to avoid day time sedation.

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 not recommended for children.

Initial Dose: 25mg twice daily.

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.

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.

Incipient 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.

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.

Cardiac disorders
Palpitations

Gastrointestinal disorders
Diarrhoea
Dry mouth
Nausea

General disorders and administration site conditions
Hypersensitivity reactions such as rash and pruritus
Lack of energy
Weakness

Investigations
Weight increased

Nervous system disorders
Dizziness
Drowsiness
Extrapyramidal disorder
Headache
Sedation
Somnolence

Psychiatric disorders
Depression

Renal and urinary disorders
Urinary frequency
Urinary incontinence

Reproductive system and breast disorders
Ejaculation failure
Priapism

Respiratory, thoracic and mediastinal disorders
Nasal congestion

Vascular disorders
Hypotension
Postural hypotension

Amdipharm

(POM)