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Drug Details

BARATOL

• Drug Class Description
  Selective a1 -blockers (alpha- blockers / alpha-adrenoceptor blocking drugs).
• Generic Name
  Indoramin
• Presentation
  Blue film coated tablets with shallow convex faces. “MPL 020” imprinted on one face, “25” on the other face.
• Description
  Each tablet contains Indoramin Hydrochloride 27.63 mg HSE equivalent to 25 mg of indoramin base.
• Indications
  

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

• Adult Dosage
  

  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.

• Child Dosage
  

  Baratol is not recommended for children.

• Elderly Dosage
  

  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.

• Contra Indications
  

  Baratol is contraindicated in patients:

  - Who are currently receiving monoamine oxidase inhibitors.

  - With established heart failure.

• Special Precautions
  

  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.

• Interactions
  

  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.

• Adverse Drug Reactions
  

  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