Dobesil LD

Indications

This rectal ointment is effective for treating:

• Internal and external hemorrhoids
• Anal pruritus (itching)
• Anal eczema
• Anitis
• Perianitis
• Acute hemorrhoidal thrombosis
• Anal fissures
• Preoperative and postoperative care for hemorrhoidectomy

Note: Prolonged treatment is not recommended. Always consult a registered healthcare professional before use.

Composition

Each gram of this rectal ointment contains:

• Calcium Dobesilate BP: 40 mg
• Lidocaine Hydrochloride USP: 20 mg
• Dexamethasone Acetate BP: 0.25 mg

Pharmacology

Calcium Dobesilate works by stabilizing capillary walls and regulating their physiological functions, such as reducing permeability and increasing resistance, while also exhibiting anti-inflammatory and antithrombotic properties. Lidocaine hydrochloride serves as a local anesthetic, providing pain relief, while Dexamethasone Acetate, a topical corticosteroid, offers anti-inflammatory and antipruritic benefits.

Dosage & Administration

Apply the ointment 2-3 times daily, ideally in the morning and at bedtime, and preferably after bowel movements. For internal hemorrhoids, use the provided applicator by screwing it onto the tube. Insert the applicator as deeply as possible into the anus, gently squeeze the tube while withdrawing it. This method allows for approximately 8 applications from one tube. For external hemorrhoids or anal pruritus, apply a thin layer of ointment multiple times a day. Treatment duration typically lasts for a few days. Consult a doctor if symptoms do not improve or worsen after 1 to 2 weeks of treatment.

Method of Application

For Internal Use:

1. Remove the cap from the tube before use.
2. Pierce the tube membrane by inverting the cap.
3. Attach the supplied applicator to the tube.
4. Squeeze the tube to fill the applicator, lubricating the tip with the ointment for easier insertion.
5. Gently insert the applicator fully into the anus and squeeze the tube again to release the ointment into the anal canal.
6. Remove and discard the applicator after use.
7. Refrain from having a bowel movement for a few hours after internal application.

For External Use:

1. Squeeze a small amount of ointment onto your finger.
2. Apply the ointment around the external area of the anus using your finger.
3. Wash your hands thoroughly with warm water and soap after each application.
4. Reattach the cap to the tube.

Note: Consult a registered healthcare professional before use.

Contraindications

This product is contraindicated in individuals with hypersensitivity to any of its components.

Side Effects

Rare side effects may include changes in bowel transit, temporary burning sensations, and localized pain. Allergic reactions, skin irritations, and fever may occur; if so, discontinue use immediately.

Pregnancy & Lactation

Pregnancy Category C: There are no available studies in pregnant women or animals. It is unknown whether Calcium Dobesilate crosses the placenta. Both Lidocaine Hydrochloride and Dexamethasone Acetate can have systemic effects post-topical application and also cross the placental barrier. This ointment should only be used during pregnancy if the benefits outweigh the risks to the fetus. Calcium Dobesilate is excreted in low amounts in maternal milk post-oral administration, but it is unclear if the same occurs with local use. As both Lidocaine Hydrochloride and Dexamethasone Acetate are present in breast milk, a decision must be made between continuing treatment or breastfeeding.

Precautions & Warnings

Avoid prolonged use of this ointment, especially in cases of renal insufficiency.

Overdose Effects

Currently, there is no available information regarding overdose effects.

Therapeutic Class

Medications used in the ano-rectal region.

Storage Conditions

Store the ointment in a cool place, away from heat, at temperatures below 30°C.