Calcium Dobesilate + Lidocaine + Dexamethasone Acetate

Indications

Calcium Dobesilate, Lidocaine HCl & Dexamethasone Acetate Ointment is indicated for the treatment of internal and external hemorrhoids, anal pruritus, anal eczema, anitis, perianitis, cryptitis, papillitis, acute hemorrhoidal thrombosis and anal fissures. It is also indicated for the treatment of pre-and postoperative hemorrhoidectomy.

Therapeutic Class

Drugs used in Ano-rectal region

Dosage

Calcium Dobesilate, Lidocaine & 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 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’s must be informed if, after 1 to 2 weeks of treatment the symptomatology has not improved or has worsened.

Administration

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 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 a 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 finger
  • Wash the hands thoroughly with warm water and soap after each application
  • Reattach the cap to tube

Interaction

No interaction is known up to now.Side effects: Very rare cases have been reported like modification of the intestinal transit, temporary burning sensation, local pain. Hypersensitivity reactions together with skin reactions and/or fever can occur. These reactions can be of allergic origin and, if it is the case, the treatment must be discontinued.

Contraindications

Calcium Dobesilate, Lidocaine HCl and Dexamethasone Acetate ointment is contraindicated in patients with hypersensitivity to Calcium Dobesilate, Lidocaine HCl and Dexamethasone Acetate. Precautions: In case of renal insufficiency the use of this ointment should be limited to a few days. Long-lasting treatment should be avoided.

Pregnancy & Lactation

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, these drug 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 either the treatment or the breast-feeding should be stopped.

Overdose Effects

The clinical signs of a possible over dosage are not known.

Storage Conditions

Store in a cool and dry place, protected from light.