Valid Ghana · FDA Ghana

DEBRIDACE TOPICAL GEL (Each gram contains Papun/ Urea

Papun/ Urea

FDA/SD.265-020146 Papun/ Urea INN generic

What it does

Papun is a medication that may be used to treat various health conditions. It helps manage symptoms and improve overall health.

Commonly used for: general health support

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.265-020146
Registration date
2026-02-12
Expiry date
2031-09-01
Status
Valid
Active ingredient
Papun/ Urea
Dosage form
Papun/ Urea
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Vishen Biotech
Applicant / LTR
GOKALS LTD
Country of origin
INDIA
Manufacturer location
B-104, 1st Floor, City Vista, Kolte Patil Downtown, Fountain Road, Ashoka Nagar, Kharadi, Pune, Maharashtra 411014, India

Source: Food and Drugs Authority · fetched 2026-05-22 02:34:25 · updated 2026-10-20 04:00:03

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About papun

Papun is a medication that may be used to treat various health conditions. It helps manage symptoms and improve overall health.

What it treats

  • general health support

How it works

Papun works by supporting the body's natural processes to promote wellness.

Who it's for

Papun is generally suitable for adults and children, but users should consult with a healthcare professional before use.

Cautions

  • • Always consult a doctor before starting any new medication.
  • • Inform your doctor about any other medications you are taking.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About urea

Urea is a substance that helps keep the skin moist and can help treat dry skin conditions.

What it treats

  • dry skin
  • eczema
  • psoriasis

How it works

Urea works by attracting moisture to the skin and helping to soften and break down dry, flaky skin.

Who it's for

Urea is suitable for anyone experiencing dry skin, including people with skin conditions like eczema and psoriasis.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: papun

Papun, also known as Papaverine, is a non-selective phosphodiesterase inhibitor derived from opium. It is primarily used as a vasodilator to treat conditions associated with smooth muscle spasms, including gastrointestinal and vascular disorders. Papaverine works by relaxing the smooth muscles and increasing blood flow to various tissues.

Indications

  • Smooth muscle spasms
  • Vasospastic disorders
  • Angina pectoris
  • Cerebral vasospasm
  • Peripheral vascular disease

Dosage

Children: Refer to the BNF for Children for appropriate pediatric dosing.

Adults: Refer to clinical guidelines or prescribing information for specific dosing recommendations.

Mechanism of action

Papun inhibits phosphodiesterase enzymes, which results in increased levels of cyclic adenosine monophosphate (cAMP) within cells. Elevated cAMP leads to smooth muscle relaxation and vasodilation by inhibiting calcium influx and promoting the relaxation of the muscle fibers. This mechanism is critical in reducing spasms in various smooth muscle tissues, including those in the gastrointestinal tract and blood vessels.

Pharmacodynamics

Papun exhibits vasodilatory effects, primarily through the relaxation of vascular smooth muscle. The increase in cAMP levels leads to reduced intracellular calcium concentrations, which is essential for muscle contraction. This action helps alleviate symptoms associated with conditions such as angina, cerebral vasospasm, and other vascular disorders.

Pharmacokinetics

Papun is absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1 to 2 hours after oral administration. It has a bioavailability of approximately 25-50%, which can be affected by first-pass metabolism. The drug is extensively metabolized in the liver, and its metabolites are primarily excreted in urine. The elimination half-life of papaverine is approximately 1-2 hours, but this may vary based on the route of administration and individual patient factors.

Pregnancy

The safety of papun during pregnancy has not been established. Use only if potential benefits justify potential risks to the fetus.

Breast-feeding

It is unknown whether papun is excreted in human milk. Caution is advised when administering to nursing women.

Storage

Store at room temperature, away from direct light and moisture. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: urea

BNF-referenced

Urea is a nitrogenous compound that plays a crucial role in the body's nitrogen metabolism. It is primarily used as a keratolytic emollient, treating conditions characterized by dry, rough, scaly, and itchy skin. Urea functions by softening and hydrating the skin, thus providing relief from various dermatological conditions.

Indications

  • Dry skin
  • Ichthyosis
  • Eczema
  • Psoriasis
  • Dermatitis

Dosage

Children: Refer to the BNF for Children for appropriate dosing recommendations for paediatric patients.

Adults: Refer to the specific product information for dosing instructions, as doses may vary based on formulation and intended use.

Mechanism of action

The primary mechanism of ammonia toxicosis appears to be inhibition of the citric acid cycle. There is an increase in anaerobic glycolysis, blood glucose, and blood lactate. Acidosis is manifested. The exact means by which ammonia blocks the citric acid cycle is not known. It is postulated that ammonia saturation of the glutamine-synthesizing system causes a backing-up in the citrate cycle, a decrease in its intermediates, and a decrease in energy production and cellular respiration, which leads to convulsions. The decrease of citrate cycle intermediates is postulated to result from reamination of pyruvic, ketoglutaric, and oxaloacetic acids.

Pharmacodynamics

Urea is a keratolytic emollient that works to treat or prevent dry, rough, scaly, itchy skin. Its emollient properties help to maintain skin hydration and improve the overall condition of the skin.

Pharmacokinetics

Urea is absorbed through the skin and metabolized in the body. It does not have significant systemic effects when used topically, as it primarily acts locally to alter the moisture content of the stratum corneum, thereby enhancing the skin's barrier function and improving hydration.

Adverse effects

  • Skin irritation
  • Burning sensation
  • Dryness
  • Redness

Precautions

  • Use with caution in individuals with renal impairment
  • Avoid contact with eyes
  • Discontinue use if severe irritation occurs

Pregnancy

Consult healthcare provider before use, safety in pregnancy not established.

Breast-feeding

Consult healthcare provider before use, safety in breastfeeding not established.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Topical cream
  • Topical ointment
  • Topical lotion

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: urea

PubChem CID 1176

Molecular formula: CH4N2O

Mechanism of action

... The primary mechanism of ammonia toxicosis appears to be inhibition of the citric acid cycle. There is an increase in anaerobic glycolysis, blood glucose, and blood lactate ... . Acidosis is manifested. The exact means by which ammonia blocks the citric acid cycle is not known. It is postulated that ammonia saturation of the glutamine-synthesizing system causes a backing-up in the citrate cycle, a decrease in its intermediates, and a decrease in energy production and cellular respiration, which leads to convulsions ... . The decrease of citrate cycle intermediates is postulated to result from reamination of pyruvic, ketoglutaric, and oxaloacetic acids.

Pharmacodynamics

Urea is a keratolytic emollient that works to treat or prevent dry, rough, scaly, itchy skin.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.