Isotretinoin

Drug #399

Isotretinoin is the 13-cis-retinoic acid, a vitamin A derivative, used systematically for treatment of severecystic and conglobulate acne acne not responsive to antibiotic therapy. Thought to act directly on sebaceous glands in the skin to reduce sebum production and alters the lipid composition of the skin surface.

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Primary Characteristics

It is of Synthetic origin and belongs to Retinoid.

It is classified in Retinoic Acid Derivative pharmacological group. It is also classified under Dermatological Products .

Molecular Weight: 300.4 · Solubility in Water: Insoluble · Solubility in Alcohol: slightly soluble · Non-proprietary name: Isotretinoin.

Pharmacokinetics

Absorption: Isotretinoin has an oral bioavailability is 94% (±4%), pre-systemic (first-pass) metabolism accounts for 2.5% (±2.5%).

Distribution: Isotretinoin has a volume of distribution is 1.5 l/kg. plasma protein binding is 99.9%.

Elimination: it is metabolised via Hepatic, plasma half-life is 10-20 hr.

Indications

Isotretinoin is primarily indicated in conditions like Gram negative folliculitis, Keratiniztion disorders, Mild acne in patients with dysmorphohobia, Rosacea, Severe acne.

Contraindications

Isotretinoin is contraindicated in conditions like Hypersensitivity.

Dosage

Isotretinoin's dosage details are as follows:

Dose	Single Dose	Frequency	Route	Instructions
Adult Dosage
500 ug	500 ug	Every 24h	PO	Initial oral dose for acne with food amdatjust up to 1 mg/kg according to response.
0.05 %	0.05 %	Every 12h	Topical,gel	For 8 Weeks
Paediatric Dosage (20kg)
0 – 0	—	—		Doses not established for this age group
Neonatal Dosage (3kg)
0 – 0	—	—		Not recommended in this age group

Drug Interactions

Unknown4 interactions

1 interaction

Moderate1 interaction

Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Side Effects

Isotretinoin in overdosage may give rise to further complications which include Thrombocytopenia , Hepatitis , Myalgia , Hypercholesterolemia, Hypercholesterolemia.

Isotretinoin produces potentially life-threatening effects which include Depression. Careful monitoring is needed with proper medical management.

Isotretinoin is known to cause more or less tolerable side effects which are usually transient. These include Abdominal pain, Alopecia, Arthralgia, Blepharoconjunctivitis, Blurred vision, Cheilitis, Conjunctivitis, Desquamation , Epistaxis, Erythematous rash, Facial dermatitis, Headache, Hearing impairment, Impaired night vision, Nasal bleeding, Paronychia, Photophobia , Pruritis, Skin fragility, Skin sepsis.

Warnings / Precautions

Isotretinoin should be used with caution in patients with medical history, including diabetes, family history of high blood fats (triglycerides), depression or any allergy (including drugs e.g. Tetracyclines). Do not donate blood while taking isotretinoin and for at least one month after stop taking it. Avoid exposure to the sun and sunlamps use a sunscreen and wear protective clothing when exposed to direct sunlight. Isotretinoin can affect night vision. Be cautious when driving or operating any machinery after dark. Avoid the use of alcohol while taking this. It should not be used during pregnancy or lactation. Do not apply isotretinoin gel to your lips, mouth and mucous membrane or in the angle of your nose.

Interference in Pathology

Isotretinoin may interfere in the diagnosis of Liver Function Test (LFT) , Raised creatine phosphokinase.

Available Brands

Click on a strength to view available brands.

Single Ingredient

Caps

10 mg 20 mg

Cream

0.05 %w/w 0.5 mg

Gel

0.05 %0.05 % w/w 0.05 %w/w 0.05 %w/w.0.5 %

Tabs

10 mg 20 mg

Multi-Ingredient Combinations

Gel

0.05 %0.05 %w/w 0.5 mg

Storage Conditions

Isotretinoin should be stored Caps.

Drug Classification

1.13.5.1 — Antiacne preparations

Manufacturers

Manufacturers of Isotretinoin in Pakistan: