Drugs List

Therapeutic Indications

Uses

Treatment of conditions for which alpha blockade is indicated.

Management of urinary outflow obstruction due to benign prostatic hyperplasia.

Treatment of essential hypertension (all grades).

Not all brands are licensed for all indications.

Contraindications

Uncontrolled cardiac failure
Postural hypotension and micturition syncope
Galactosaemia
Children under 18 years

Precautions and Warnings

Not all available brands are licensed fir all indications.

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during the cataract surgery of patients who were currently taking alpha-1 receptor blockers or who had previously alpha-1 receptor blockers. A class-effect may exist. It is therefore important that ophthalmic surgeons are informed if a patient has ever been treated with indoramin, as IFIS may lead to increased procedural complications.

Elderly patients may require a reduced dosage. A reduced dose and/or frequency of dosing may be sufficient for effective control of blood pressure. (see Dosage - Elderly ).

Patients with incipient cardiac failure should be controlled with diuretics and digitalis before treatment with indoramin.

Use with caution in patients with renal impairment.

Use with caution in patients with hepatic impairment.

Use with caution in patients with cardiac failure.

Use with caution in patients with Parkinson's disease (indoramin therapy has been associated with a few cases of extrapyramidal disorders).

Use with caution in patients with epilepsy as convulsions have occurred according to animal studies and one case of overdose in humans.

Use indoramin with caution in patients with a history of depression.

Pregnancy (see Pregnancy ).

Breastfeeding (see Lactation ).

Alcohol should be kept to a minimum as this enhances the rate and extent of absorption.

There is no data available on the effect of indoramin on driving and machinery operation. One of the side effects is drowsiness and patients should not drive if they feel this side effect.

This preparation contains lactose and should used with caution in patients with rare hereditary problems of lactose intolerance or glucose-galactose malabsorption syndrome.

Pregnancy and Lactation

Pregnancy

Indoramin should not be used during pregnancy unless considered essential by a physician.

Schaefer (2007) concludes that inadvertent use use of indoramin, is no reason for termination of pregnancy or for invasive diagnostic procedures in the absence of severe maternal toxicity.

Animal studies indicate no teratogenic effects.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Indoramin should not be used during breastfeeding unless considered clinically necessary by a physician.

Schaefer (2007) concludes that if treatment has begun with indoramin then weaning is not necessary, but the therapy should be changed.

There is no data available on the excretion of indoramin in human breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Drowsiness
Sedation
Somnolence
Tachycardia
Palpitations
Dry mouth
Gastro-intestinal disturbances
Rash
Pruritus
Angioedema
Decreased energy
Fatigue
Weakness
Weight gain
Dizziness
Extrapyramidal effects
Headache
Asthenia
Depression
Urinary frequency
Urinary incontinence
Failure of ejaculation
Erectile disturbance
Priapism
Nasal congestion
Hypotension
Postural hypotension
Syncope
Worsening of Parkinson's disease
Oedema
Blurred vision
Rhinitis
Intraoperative floppy iris syndrome
Diarrhoea
Nausea
Hypersensitivity reactions

Presentation

Tablets containing 25mg indoramin (as hydrochloride).

Tablets containing 20mg indoramin (as hydrochloride).

Drugs List

Therapeutic Indications

Uses

Treatment of conditions for which alpha blockade is indicated.

Management of urinary outflow obstruction due to benign prostatic hyperplasia.

Treatment of essential hypertension (all grades).

Not all brands are licensed for all indications.

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Contraindications

Uncontrolled cardiac failure
Postural hypotension and micturition syncope
Galactosaemia
Children under 18 years

Precautions and Warnings

Not all available brands are licensed fir all indications.

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during the cataract surgery of patients who were currently taking alpha-1 receptor blockers or who had previously alpha-1 receptor blockers. A class-effect may exist. It is therefore important that ophthalmic surgeons are informed if a patient has ever been treated with indoramin, as IFIS may lead to increased procedural complications.

Elderly patients may require a reduced dosage. A reduced dose and/or frequency of dosing may be sufficient for effective control of blood pressure. (see Dosage - Elderly ).

Patients with incipient cardiac failure should be controlled with diuretics and digitalis before treatment with indoramin.

Use with caution in patients with renal impairment.

Use with caution in patients with hepatic impairment.

Use with caution in patients with cardiac failure.

Use with caution in patients with Parkinson's disease (indoramin therapy has been associated with a few cases of extrapyramidal disorders).

Use with caution in patients with epilepsy as convulsions have occurred according to animal studies and one case of overdose in humans.

Use indoramin with caution in patients with a history of depression.

Pregnancy (see Pregnancy ).

Breastfeeding (see Lactation ).

Alcohol should be kept to a minimum as this enhances the rate and extent of absorption.

There is no data available on the effect of indoramin on driving and machinery operation. One of the side effects is drowsiness and patients should not drive if they feel this side effect.

This preparation contains lactose and should used with caution in patients with rare hereditary problems of lactose intolerance or glucose-galactose malabsorption syndrome.

Pregnancy and Lactation

Pregnancy

Indoramin should not be used during pregnancy unless considered essential by a physician.

Schaefer (2007) concludes that inadvertent use use of indoramin, is no reason for termination of pregnancy or for invasive diagnostic procedures in the absence of severe maternal toxicity.

Animal studies indicate no teratogenic effects.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Indoramin should not be used during breastfeeding unless considered clinically necessary by a physician.

Schaefer (2007) concludes that if treatment has begun with indoramin then weaning is not necessary, but the therapy should be changed.

There is no data available on the excretion of indoramin in human breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Drowsiness
Sedation
Somnolence
Tachycardia
Palpitations
Dry mouth
Gastro-intestinal disturbances
Rash
Pruritus
Angioedema
Decreased energy
Fatigue
Weakness
Weight gain
Dizziness
Extrapyramidal effects
Headache
Asthenia
Depression
Urinary frequency
Urinary incontinence
Failure of ejaculation
Erectile disturbance
Priapism
Nasal congestion
Hypotension
Postural hypotension
Syncope
Worsening of Parkinson's disease
Oedema
Blurred vision
Rhinitis
Intraoperative floppy iris syndrome
Diarrhoea
Nausea
Hypersensitivity reactions

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Store below 25 degrees C.
Store in the original container.

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Baratol Tablets. Amdipharm Plc. Revised August 2009.
Summary of Product Characteristics: Doralese Tiltab 20mg Tablets. Chemidex Pharma Ltd. Revised January 2011.