CATAPRES Ampoules (2012)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Boehringer Ingelheim Limited
Διεύθυνση	Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS

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Name of the medicinal product

Catapres Ampoules 150 micrograms in 1 ml Solution for Injection.

Qualitative and quantitative composition

Each 1 ml ampoule contains clonidine hydrochloride 150 micrograms. For excipients, see 6.1.

Pharmaceutical form

Solution for injection. Clear, colourless solution.

Therapeutic indications

Catapres is indicated for the treatment of hypertensive crises.

Posology and method of administration

Adults, including the elderly In hypertensive crises 150 to 300 micrograms (1 to 2 ampoules) should be given by slow intravenous injection. This dose may be repeated up to a maximum of 750 micrograms (5 ...

Contraindications

Catapres should not be used in children (please refer to section 4.4 Special Warnings and Precautions for Use) or in patients with known hypersensitivity to the active ingredient or other components of ...

Special warnings and precautions for use

Clonidine should only be used with caution in patients with depression or a history thereof, with Raynauds disease or other peripheral vascular occlusive disease. The product should only be used with caution ...

Interaction with other medicinal products and other forms of interaction

The reduction in blood pressure induced by clonidine can be further potentiated by concurrent administration of other hypotensive agents. This can be of therapeutic use in the case of other antihypertensive ...

Fertility, pregnancy and lactation

Pregnancy There are limited amount of data from the use of clonidine in pregnant women. This product should only be used in pregnancy if considered essential by the physician. Careful monitoring of mother ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, sedation and ...

Undesirable effects

Most adverse effects are mild and tend to diminish with continued therapy. Adverse events have been ranked under headings of frequency using the following convention: Very common (>1/10), Common (>1/100, ...

Overdose

Symptoms Manifestations of intoxication are due to a generalised sympathetic depression and include pupillary constriction, lethargy, bradycardia, hypotension, hypothermia, somnolence including coma and ...

Pharmacodynamic properties

Clonidine acts primarily on the central nervous system, resulting in reduced sympathetic outflow and a decrease in peripheral resistance, renal vascular resistance, heart rate and blood pressure. Renal ...

Pharmacokinetic properties

The pharmacokinetics of clonidine is dose proportional in the range of 100-600 micrograms. Clonidine, the active ingredient of Catapres, is well absorbed and no first pass effect exists. It is rapidly ...

Preclinical safety data

Not applicable.

List of excipients

Sodium chloride 1N hydrochloric acid Water for injections

Incompatibilities

None known.

Shelf life

Unopened: 5 years. Once opened, use immediately and discard any unused contents.

Special precautions for storage

Do not store above 30°C. Keep the ampoules in the outer carton.

Nature and contents of container

1 ml colourless glass (Ph. Eur. Type I) ampoules, marketed in packs of 5.

Special precautions for disposal and other handling

For single use only. Discard any unused contents.

Marketing authorization holder

Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom

Marketing authorization number(s)

PL 00015/5008R

Date of first authorization / renewal of the authorization

10/05/2006

Date of revision of the text

July 2012