Priora

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PRIORA (PRIORA)

Composition:

Active ingredient: docosanol;

1 g of cream contains docosanol 100 mg;

Excipients: sucrose (stearate and distearate), light mineral oil, propylene glycol, benzyl alcohol, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: cream of almost white color.

Pharmacotherapeutic group. Chemotherapeutic agents for topical use. Antiviral agents. Docosanol. ATC code D06B B11.

Pharmacological properties.

Pharmacodynamics.

The exact mechanism of antiviral activity of docosanol is not fully understood.

In vitro studies have shown that docosanol affects the fusion of the viral envelope with the host cell membrane, thereby inhibiting intracellular penetration and viral replication. In vitro studies have demonstrated that cells exposed to docosanol become resistant to infection by enveloped viruses such as HSV-1 (herpes simplex virus type 1). Docosanol has no effect on viruses lacking such an envelope.

Pharmacokinetics.

Under normal clinical use, docosanol is not detectable (limit of quantification, LOQ = 10 ng/mL) in the plasma of patients. Docosanol is metabolized to docosanoic acid, its primary metabolite. Both docosanol and docosanoic acid are endogenous components of human cell membranes, particularly in erythrocytes, brain, nerve myelin sheaths, lungs, and kidneys.

Clinical characteristics.

Indications.

Early stages (prodromal or erythematous stage) of recurrent herpes labialis in adults and children aged 12 years and older with normal immunity.

Contraindications.

Hypersensitivity to docosanol or to any other component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted; therefore, the medicinal product should not be applied simultaneously with other topical medicinal products, cosmetics, or creams to the same area.

Special precautions for use

Avoid contact of the cream with the eyes or the skin around the eyes. The medicinal product contains propylene glycol, which may cause skin irritation. The cream should not be used in patients with suppressed immunity. Treatment with docosanol should not be initiated at the stage of established vesicles or ulcers, as efficacy has not been demonstrated at this stage.

Use during pregnancy or breastfeeding.

Pregnancy.

There are no data on the use of docosanol in pregnant women. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonic/fetal development, parturition or postnatal development. Since systemic exposure to docosanol is negligible, docosanol may be used during pregnancy.

Breastfeeding period.

There are no data on the use of docosanol in women who are breastfeeding.

A lack of systemic exposure to docosanol in women who are breastfeeding suggests that docosanol is unlikely to affect breastfed infants.
Docosanol may be used during breastfeeding.

Fertility.

There are insufficient data on the effect of docosanol on human fertility.

Ability to affect reaction speed when driving or operating machinery.

Due to negligible absorption, docosanol does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

Adults and children aged 12 years and older: apply carefully as a thin layer to the entire affected skin surface with herpes virus 5 times daily (approximately every 3 hours, excluding sleep periods). Treatment should be started as early as possible upon the first signs and symptoms of herpes (pain, burning, tingling, itching, or redness), since efficacy has not been demonstrated at the stage of fully developed vesicles or ulcers.

Treatment should continue until recovery occurs, usually 4 to 6 days, or up to a maximum of 10 days.

Elderly patients: no specific dosage recommendations.

Dosing in renal impairment: dose adjustment is not required due to negligible systemic absorption following topical application.

For topical use only.

Children.

There is no experience with the use of the medicinal product in children under 12 years of age; therefore, the drug is indicated for use in children aged 12 years and older.

Overdose.

Adverse reactions related to overdose following topical application are unlikely due to minimal skin absorption. In case of accidental ingestion of docosanol, adverse reactions are unlikely due to its low oral bioavailability.

Side effects

Very common (≥1/10).
Common (≥1/100 to <1/10).
Uncommon (≥1/1,000 to <1/100).
Rare (≥1/10,000 to <1/1,000).
Very rare (<1/10,000), not known (cannot be estimated from available data).

Results of clinical studies on the treatment of recurrent herpes labialis confirm no difference in the frequency or type of adverse reactions in patients treated with Priora compared to placebo.

Nervous system disorders: very common – headache (10.4% of patients treated with docosanol and 10.7% of patients treated with placebo).

General disorders and administration site reactions: common – application site reactions including skin dryness, rash, and skin irritation (2.9% of patients treated with docosanol and 2.3% of patients treated with placebo). Facial swelling has been reported, but this application site reaction on the face is a normal response associated with herpes.

Safety studies provided no evidence of contact sensitization or photoallergy.

Shelf life.
3 years.
After first opening of the tube, shelf life: 6 months.

Storage conditions.
Store at a temperature not exceeding 25 °C.
Keep out of the reach of children!

Packaging.
2 g or 5 g in a tube; 1 tube per cardboard box.

Prescription category.
Over-the-counter (without prescription).

Manufacturer: Dendron Brands Limited.

Manufacturer's address and location of operations.
94 Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ, United Kingdom.

Marketing authorization holder: Delta Medical Promotions AG.

Address of the marketing authorization holder.
26 Oetenbachstrasse, Zurich CH-8001, Switzerland.