RECTOGESIC Rectal ointment (2016)
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Περιεχόμενα
Name of the medicinal product
Rectogesic 4 mg/g Rectal Ointment.
Qualitative and quantitative composition
Glyceryl trinitrate: 4 mg/g. One gram of rectal ointment contains 4 mg Glyceryl trinitrate (GTN). The delivered dose from 375 mg of this formulation is approximately 1.5 mg GTN. Excipient(s) with known ...
Pharmaceutical form
Rectal ointment. Off-white smooth opaque ointment formulation.
Therapeutic indications
Rectogesic 4 mg/g Rectal Ointment is indicated in adults for relief of pain associated with chronic anal fissure. In the clinical development of the drug, a modest effect has been shown on improvements ...
Posology and method of administration
Route of administration Rectal use. Adults A finger covering, such as cling film or a finger cot, may be placed on the finger to be used to apply the ointment. (Finger cots to be obtained separately from ...
Contraindications
Hypersensitivity to the active substance glyceryl trinitrate or to any of the excipients listed in section 6.1 or to other organic nitrates. Concomitant treatment with phosphodiesterase type 5 (PDE5) inhibitors ...
Special warnings and precautions for use
The risk/benefit ratio of Rectogesic has to be established on an individual basis. In some patients, following treatment with Rectogesic, severe headache can occur. In some cases re-evaluation of the correct ...
Interaction with other medicinal products and other forms of interaction
Concomitant treatment with other vasodilators, calcium channel blockers, ACE inhibitors, beta blockers, diuretics, anti-hypertensives, tricyclic anti-depressants and major tranquillisers, as well as the ...
Fertility, pregnancy and lactation
Fertility There are no data available on the effect of Rectogesic on fertility in humans. Studies in rats suggest no particular hazard under recommended conditions of use (see Section 5.3). Pregnancy ...
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed with Rectogesic. Rectogesic may cause dizziness, light-headedness, blurred vision, headache or tiredness in some patients, ...
Undesirable effects
In patients treated with Rectogesic 4 mg/g Rectal Ointment, the most common treatment related adverse reaction was dose-related headache which occurred with an incidence of 57%. Adverse reactions from ...
Overdose
Accidental overdose of Rectogesic may result in hypotension and reflex tachycardia. No specific antagonist of the vasodilator effects of glyceryl trinitrate is known, and no intervention has been subjected ...
Pharmacodynamic properties
Pharmacotherapeutic group: Muscle relaxants ATC Code: C05AE01 The principal pharmacologic action of glyceryl trinitrate is relaxation of vascular smooth muscle mediated via the release of nitric oxide. ...
Pharmacokinetic properties
The volume of distribution of glyceryl trinitrate is about 3 L/kg and is cleared from this volume at extremely rapid rates, with a resulting serum half-life of about 3 minutes. The observed clearance rates ...
Preclinical safety data
Repeat Dose Toxicity No systemic toxicity studies have been conducted with Rectogesic. Published data suggest that high oral doses of glyceryl trinitrate may have toxic effects (methaemoglobinaemia, testicular ...
List of excipients
Propylene glycol Lanolin Sorbitan sesquioleate Hard paraffin White soft paraffin
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months. After first opening: 8 weeks.
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the tube tightly closed.
Nature and contents of container
30 g. Aluminium tubes with white polyethylene non-piercing screw caps.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, UK
Marketing authorization number(s)
PL 16508/0037
Date of first authorization / renewal of the authorization
28/08/2009
Date of revision of the text
05/2016
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