This rectal ointment is indicated for the relief of symptoms of:

• Relief of itching
• Relief of irritation
• Relief of discomfort or pain associated with local, non-infective anal or peri-anal conditions, such as external hemorrhoids

The composition of this rectal ointment is given below:

• Betamethasone (as 17-valerate) 0.05%
• Phenylephrine hydrochloride 0.1%
• Lignocaine hydrochloride 2.5%

Betamethasone is a corticosteroid with predominantly glucocorticoid activity. It stimulates the production of phospholipase A2 inhibitory proteins, known as lipocortins, which inhibit the release of arachidonic acid and subsequently reduce the formation and activity of prostaglandins, leukotrienes, and other inflammatory mediators.

Phenylephrine is a sympathomimetic agent that acts primarily on alpha-adrenergic receptors, with weak activity on beta-adrenergic receptors. It produces vasoconstriction of arterioles, thereby reducing local swelling and congestion.

Lidocaine exerts its effect by blocking fast voltage-gated sodium (Na+) channels in neuronal cell membranes, thereby inhibiting nerve impulse conduction. When this blockade is sufficient, depolarization of the postsynaptic neuron is prevented, resulting in failure of action potential transmission.

Treatment should be limited to a maximum of 7 days. Apply a small amount of ointment two to three times daily initially, using the applicator if internal application is required. As the inflammation subsides, once-daily application is usually sufficient. Use as directed by the physician.

This ointment is contraindicated in patients with primary cutaneous viral infections, such as herpes simplex or chickenpox, and in those with known hypersensitivity to any of its components. It is also not indicated for the treatment of primarily infected skin lesions caused by fungal infections, such as candidiasis or tinea, or bacterial infections, such as impetigo.

Signs of hypersensitivity may occur. Prolonged or intensive use of highly potent corticosteroid preparations may lead to local atrophic changes in the skin.

There is insufficient evidence regarding the safety of this product during human pregnancy.

Long-term continuous use should be avoided whenever possible, particularly in infants and children, as adrenal suppression may occur.

4-Quinolone preparations; phlebotonic and vascular protective preparations.

Store below 30°C, protected from light and moisture. Keep out of reach of children.