20 Nov 2012

BritLofex Tablets (lofexidine hydrochloride) - United Kingdom

Updated: 20 Nov 2012

BritLofex Tablets 0.2mg

To relieve symptoms in patients undergoing opiate detoxification.

BritLofex Tablets Description, Presentation and Dosage

BritLofex Tablets Description

BritLofex Tablets Drug Class Description

Drugs used in opioid dependence - ATC Classification: N07BC04

BritLofex Tablets Drug Description

Lofexidine hydrochloride 0.2mg

BritLofex Tablets Generic Name

lofexidine hydrochloride

BritLofex Tablets Presentation

BritLofex Tablets Presentation

Film-coated tablet.

Peach coloured, round tablet.

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BritLofex Tablets Dosage

BritLofex Tablets Adult Dosage

The recommended route of administration is by mouth.

ADULTS

The dosage of lofexidine should be titrated according to the patient's response. Initial dosage should be 0.8mg per day in divided doses. The dosage may be increased by increments of 0.4 to 0.8mg per day up to a maximum of 2.4mg daily. Maximum single dose should not exceed 4 x 0.2mg tablets (0.8mg). Each patient should be assessed on an individual basis; those undergoing acute detoxification will usually require the highest recommended dose and dosage increments to provide optimum relief at the time of expected peak withdrawal symptoms.

In cases where no opiate use occurs during detoxification, a duration of treatment of 7-10 days is recommended. In some cases the physician may consider longer treatment is warranted.

CHILDREN:

Safety and effectiveness in children has not been established.

ELDERLY:

There is no experience of dosing in the elderly from clinical studies. Should use in the elderly be necessary it is advised that special caution is observed in the presence of heart disease or anti-hypertensive therapy.

BritLofex Tablets Precautions, Reactions and Contraindications

BritLofex Tablets Special Precautions

BritLofex Tablets Special Precautions

As with other hypotensive agents, therapy with lofexidine should not be discontinued abruptly. Dosage should be reduced gradually over a period of 2-4 days or longer, to minimise blood pressure elevation and associated signs and symptoms. Lofexidine should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease or chronic renal failure and in patients with bradycardia or hypotension. Blood pressure and pulse rate should be assessed frequently. Patients with a history of depression should be carefully observed during long-term therapy with lofexidine.

There have been reports of QT prolongation during lofexidine treatment. Whilst the nature of the relationship between lofexidine and these ECG changes is not yet clear, it would be prudent to avoid the use of lofexidine in patients at risk of QT prolongation i.e. those with known QT problems, metabolic disturbances, pre-existing cardiovascular disease, relevant family history or those taking other drugs known to prolong the QT interval.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Allergic reactions may occur due to the presence of E110 (Sunset Yellow).

BritLofex Tablets Adverse Reactions

BritLofex Tablets Adverse Reactions

The adverse effects of the drug are primarily related to its central alpha-adrenergic agonist effects:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Immune system disorders:

Not known:

Allergic reactions may occur due to the presence of E110 (Sunset Yellow).

Nervous system disorders:

Very common:

Dizziness has been reported following treatment with lofexidine.

Drowsiness and related symptoms including sedation and somnolence have been reported.

Cardiac disorders:

Very common:

Bradycardia has been reported.

Not known:

There have been reports of QT prolongation during lofexidine treatment.

Vascular disorders:

Very common:

Hypotension has been reported

General disorders and administration site conditions:

Very common:

Dryness of mucous membranes especially the mouth, throat and nose has been reported.

BritLofex Tablets Contraindications

BritLofex Tablets Contraindications

BritLofex tablets are contraindicated in patients who are allergic to lofexidine or to other imidazoline derivatives or to any excipients of BritLofex.

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