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Composition

Each gram rectal ointment contains-
  • Calcium Dobesilate BP 40 mg
  • Lidocaine Hydrochloride USP 20 mg
  • Dexamethasone Acetate BP 0.25 mg.

Indications

This rectal ointment is indicated in-
  • Internal and external hemorrhoids,
  • Anal pruritus
  • Anal eczema
  • Anitis
  • Perianitis
  • Acute hemorrhoidal thrombosis 
  • Anal fissure
  • Pre and postoperative treatment in cases of hemorrhoidectomy
A long-lasting treatment is not indicated.

Pharmacology

Calcium Dobesilate acts on the capillary walls by regulating their impaired physiological functions- i.e. increased permeability and decreased resistance and on different signs of inflammation. It also has an antithrombotic activity. Lidocaine hydrochloride, a local anesthetic, contributes to relieve pain. Dexamethasone Acetate, a Corticosteroid for topical use, possesses anti-inflammatory and antipruritic actions.

Dosage & Administration

2-3 times daily. Apply in the morning and bedtime and if possible after defecation. If the ointment is preferred, use the applicator by screwing it to the tube. Insert the applicator as deep as possible in the anus then press the tube gently while withdrawing it. In this case, the tube is sufficient for 8 applications. In case of external hemorrhoids or anal pruritus, apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The doctor must be informed if, after 1 to 2 weeks of treatment, the symptomatology has not improved or has worsened.

Calcium Dobesilate, Lidocaine HCI & Dexamethasone Acetate Ointment should be applied 2-3 times daily preferably in the morning and at bedtime, if possible apply after defecation. In the case of internal hemorrhoids apply the ointment by the applicator. In cases of external hemorrhoids and anal pruritus, apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The physician must be informed if, after 1 to 2 weeks of treatment the symptomatology has not improved or has worsened.

Method of use of this ointment:
For internal use-
  • Before use remove the cap from the tube.
  • Pierce the tube membrane by inverting the cap.
  • Attach the applicator (supplied) to the tube.
  • Squeeze the tube to fill the applicator and lubricate the tip with ointment for smooth insertion.
  • Insert the applicator gently and to full extend into the anus and squeeze once again from the end of the tube to force the required amount of ointment into the anal canal.
  • Remove the applicator after application and discard it.
  • Try not to have defecation for a couple of hours after an internal application.
For external use-
  • Squeeze the tube of ointment and apply a small amount to the finger.
  • Apply the ointment around the outside of the anus with a finger.
  • Wash the hands thoroughly with warm water and soap after each application.
  • Reattach the cap to tube.

Contraindications

Hypersensitivity towards the components of this preparation.

Side Effects

Very rare cases have been reported: Modifications of the intestinal transit, temporary burning sensation and local pain. Hypersensitivity reactions together with skin reactions and/or fever can occur. These reactions can be of allergic origin and in this case, the treatment must be discontinued.

Pregnancy & Lactation

Pregnancy category C. Studies in pregnant women or animals are not available and in humans, it is not known whether Calcium Dobesilate crosses the placental barrier. On the other hand, after topical administration, Lidocaine Hydrochloride and Dexamethasone Acetate are resorbed in variable quantities and can have systemic effects. Moreover, both substances cross the placental barrier. In these conditions, this rectal ointment should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. After oral administration, Calcium Dobesilate is excreted in the maternal milk in low amounts but it is not known whether this is the case with local use. After topical administration, Lidocaine Hydrochloride and Dexamethasone Acetate are excreted in the maternal milk. As a precaution, it should be decided between discontinuating the treatment or the breast-feeding.

Precautions & Warnings

In case of renal insufficiency, this rectal ointment should not be used during longer periods. Avoid long-lasting treatments.

Overdose Effects

No overdosage information found yet.

Therapeutic Class

Drugs used in Ano-rectal region

Storage Conditions

The ointment must be stored protected from heat. Store it below 30°C.