International reference: 3 US FDA recalls for this ingredient

Lack of Assurance of Sterility (emollient)

Lack of Assurance of Sterility (emollient)

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study. (emollient)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Rwanda.

Registered Rwanda · Rwanda FDA

PEITEL 0.25% CREAM

1 g of cream contains: 2.5 mg of prednicarbate (INN) in an oil-in-water emollient (O/A)

Rwanda FDA-HMP-MA-0331 CREAM 2.5 mg INN generic

What it does

This medicine contains a variety of active ingredients that work together to help treat certain health conditions.

Read more in plain English ↓

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

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-0331
Registration date
26/06/2023
Expiry date
25/06/2028
Status
Registered
Active ingredient
1 g of cream contains: 2.5 mg of prednicarbate (INN) in an oil-in-water emollient (O/A)
Dosage form
CREAM
Strength
2.5 mg
Pack size
30 g tubes
Therapeutic class
-
Manufacturer / MAH
Ferrer Internacional
Applicant / LTR
FERRER INTERNACIONAL, S.A.
Country of origin
SPAIN
Manufacturer location
Av. Diagonal, 549, 5°, Les Corts, 08029 Barcelona, Spain

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:33 · updated 2026-09-21 02:30:20

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

About contains

This medicine contains a variety of active ingredients that work together to help treat certain health conditions.

How it works

The active ingredients in this medicine perform specific functions to help your body in various ways, depending on the condition being treated.

Who it's for

This medicine is meant for individuals with specific health issues as determined by a healthcare provider.

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

About emollient

Emollients are moisturizing treatments used to soothe and hydrate the skin.

What it treats

  • dry skin
  • eczema
  • psoriasis

How it works

Emollients work by forming a protective barrier on the skin, preventing moisture loss and helping to keep the skin soft and smooth.

Who it's for

Emollients are suitable for anyone with dry or irritated skin, including children and adults.

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

About prednicarbate

Prednicarbate is a topical corticosteroid used to reduce inflammation and relieve itching on the skin.

What it treats

  • skin inflammation (dermatitis)
  • eczema
  • psoriasis

How it works

It works by decreasing the immune response in the skin, which helps to reduce redness, swelling, and itching.

Who it's for

It is for adults and children who have certain skin conditions that require anti-inflammatory treatment.

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

Clinical monograph: contains

Contains is a term generally used to refer to formulations that include one or more active pharmaceutical ingredients. The specific effects, uses, and formulations depend on the particular drug in question. It is often used in the context of drug labels to inform about the components of a medication.

Dosage

Children: Refer to specific drug information for detailed dosage recommendations.

Adults: Refer to specific drug information for detailed dosage recommendations.

Mechanism of action

The mechanism of action varies depending on the specific drug that 'contains' certain active ingredients. Each compound will have its own unique pharmacological pathway and target within the body, which can include receptor modulation, enzyme inhibition, or other biochemical interactions.

Pharmacodynamics

Pharmacodynamics will depend on the active ingredients in the formulation. It generally encompasses the biochemical and physiological effects of the drug and its mechanisms of action, including the relationship between drug concentration and effect.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of the specific active ingredients within the formulation. This can vary significantly based on the drug's chemical properties, route of administration, and individual patient factors.

Pregnancy

Consult with a healthcare provider before use, as safety during pregnancy has not been established.

Breast-feeding

Consult with a healthcare provider before use, as it is not known if this drug is excreted in human milk.

Storage

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

Emollients are moisturizing treatments used to soothe and hydrate the skin, particularly in conditions characterized by dryness, itching, and irritation. They work by forming a barrier on the skin surface that helps to retain moisture and protect against irritants, making them essential in managing skin disorders like eczema, psoriasis, and xerosis.

Indications

  • Dry skin
  • Eczema
  • Psoriasis
  • Xerosis
  • Atopic dermatitis
  • Irritated skin
  • Sensitive skin

Dosage

Children: Apply liberally to affected areas as needed, typically several times daily; specific pediatric formulations may be available.

Adults: Apply liberally to affected areas as needed, typically several times daily.

Mechanism of action

Emollients act by forming an occlusive film on the skin, which reduces transepidermal water loss (TEWL) and increases skin hydration. They may contain various substances such as oils, fats, and humectants that soften the stratum corneum and improve the skin's barrier function.

Pharmacodynamics

Emollients improve skin hydration and elasticity, decrease skin roughness, and reduce the symptoms of dryness and irritation. By enhancing the skin barrier, they also help to prevent the entry of allergens and irritants, thereby alleviating inflammation and discomfort associated with various dermatological conditions.

Pharmacokinetics

Emollients are primarily applied topically and do not undergo significant systemic absorption. Their effects are localized to the skin surface, where they exert their moisturizing effects. The onset of action is immediate, with sustained benefits observed with regular use.

Adverse effects

  • Skin irritation
  • Allergic reactions
  • Contact dermatitis

Precautions

  • Use with caution in patients with sensitive skin
  • Perform a patch test prior to extensive use in patients with a history of allergies

Pregnancy

Generally considered safe for use during pregnancy, but it is advisable to consult a healthcare provider before use.

Breast-feeding

Typically safe for use while breastfeeding, but it is recommended to consult a healthcare provider.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Creams
  • Lotions
  • Ointments
  • Gels

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: prednicarbate

BNF-referenced

Prednicarbate is a topical corticosteroid used primarily for its anti-inflammatory, antipruritic, and vasoconstrictive properties. It is indicated for the management of various inflammatory skin conditions due to its ability to reduce inflammation and alleviate itching.

Indications

  • Atopic dermatitis
  • Contact dermatitis
  • Psoriasis
  • Seborrheic dermatitis
  • Eczematous dermatitis

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidance based on age and condition.

Adults: Apply a thin layer to the affected area once or twice daily, depending on the severity of the condition. Refer to the BNF for further details.

Mechanism of action

Prednicarbate acts by inducing phospholipase A2 inhibitory proteins, collectively known as lipocortins. These proteins inhibit the release of arachidonic acid from membrane phospholipids, thereby controlling the biosynthesis of potent inflammatory mediators such as prostaglandins and leukotrienes. The anti-inflammatory effect is achieved through the suppression of the inflammatory response at the cellular level.

Pharmacodynamics

Corticosteroids like prednicarbate diffuse across cell membranes and bind to specific cytoplasmic receptors. The resulting complexes translocate to the nucleus, where they bind to DNA and stimulate the transcription of mRNA. This leads to the synthesis of various inhibitory proteins that mediate the anti-inflammatory effects. These effects include the inhibition of edema, fibrin deposition, capillary dilation, and the movement and activity of phagocytes, as well as suppression of later inflammatory processes such as capillary production and collagen deposition.

Pharmacokinetics

The pharmacokinetics of prednicarbate when applied topically involves absorption through the skin, where its systemic bioavailability is generally low. The onset of action can vary based on the condition being treated and the formulation used. Prednicarbate's effects are localized primarily to the area of application, minimizing systemic exposure and potential side effects.

Adverse effects

  • Skin atrophy
  • Striae
  • Telangiectasia
  • Folliculitis
  • Allergic contact dermatitis
  • Systemic absorption leading to adrenal suppression

Precautions

  • Use with caution in patients with a history of skin infections.
  • Avoid prolonged use to minimize risk of skin atrophy.
  • Monitor for signs of systemic absorption, especially in children.

Pregnancy

Prednicarbate should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data is available on its use during pregnancy.

Breast-feeding

Prednicarbate is excreted in breast milk but is unlikely to pose a risk to a breastfeeding infant when applied topically. Consult with a healthcare provider for specific guidance.

Storage

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

Formulations

  • Topical cream
  • Topical ointment

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: prednicarbate

PubChem CID 6714002

Molecular formula: C27H36O8

Mechanism of action

In common with other topical corticosteroids, prednicarbate has anti-inflammatory, antipruritic, and vasoconstrictive properties. In general, the mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacodynamics

Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin), and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various inhibitory enzymes responsible for the anti-inflammatory effects of topical corticosteroids. These anti-inflammatory effects include inhibition of early processes such as edema, fibrin deposition, capillary dilatation, movement of phagocytes into the area, and phagocytic activities. Later processes, such as capillary production, collagen deposition, and keloid formation also are inhibited by corticosteroids.

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.

Tanzania 1 product