Vesanoid Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tretinoin

Indications/Uses

Newly diagnosed, relapsed or refractory to chemotherapy acute promyelocytic leukemia (APL) in combination w/ arsenic trioxide or chemotherapy.

Click to view Vesanoid detailed prescribing information

Dosage/Direction for Use

Adult & elderly APL 45 mg/m² daily in 2 equally divided doses (approx 8 cap daily). Patient w/ hepatic &/or renal impairment 25 mg/m². Induction therapy should be continued until complete remission has been achieved or up to max 90 days.

Click to view Vesanoid detailed prescribing information

Overdosage

View Vesanoid overdosage for action to be taken in the event of an overdose.

Administration

Should be taken with food.

Contraindications

Hypersensitivity to tretinoin, other retinoids, soya, peanut. Use in combination w/ vit A, tetracyclines & retinoids. Pregnancy & lactation.

Click to view Vesanoid detailed prescribing information

Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Vesanoid detailed prescribing information

Special Precautions

May cause intracranial HTN/pseudotumour cerebri; consider dose reduction in childn; torsade de pointes arrhythmias; increased hepatotoxicity; depression aggravated depression, anxiety & mood alterations; Sweet's syndrome or acute febrile neutrophilic dermatitis; risk of venous & arterial thrombosis; monitor Ca levels due to risk of hypercalcemia. Patients w/ rare hereditary problems of fructose intolerance. May impair ability to drive or operate machinery. Pregnant women & women who might become pregnant during 1 mth of the cessation of treatment. Discontinue in during lactation if therapy is initiated. Childn.

Click to view Vesanoid detailed prescribing information

Use In Pregnancy & Lactation

Click to view Vesanoid detailed prescribing information

Adverse Reactions

Decreased appetite; confusional state, anxiety, depression, insomnia; headache, increased ICP, pseudotumour cerebri, dizziness, paraesthesia; visual disturbances, conjunctival disorders; hearing impaired; arrhythmia; flushing; resp failure, nasal dryness, asthma; dry mouth, nausea, vomiting, abdominal pain, diarrhoea, constipation, pancreatitis, cheilitis; erythema, rash, pruritus, alopecia, hyperhidrosis; bone pain; chest pain, chills, malaise; increased blood triglyceride, blood creatinine, cholesterol, transaminases.

Click to view Vesanoid detailed prescribing information

Drug Interactions

May potentially alter pharmacokinetics parameters w/ P450 inducers (including rifampicin, glucocorticoids, phenobarb, pentobarbital & P450 inhibitors (including ketoconazole, cimetidine, erythromycin, verapamil, diltiazem & ciclosporin). Increased toxicity w/ azole antifungals (eg, fluconazole, voriconazole, posaconazole). Combination w/ other strong CYP3A4 inhibitors (PI or macrolides, eg, clarithromycin) may trigger tretinoin toxicity. Cases of fatal thrombotic complications when concomitantly used w/ antifibrinolytics eg, tranexamic acid, aminocaproic acid & aprotinin. Concomitant use of agents known to cause intracranial HTN/pseudotumour cerebri eg, tetracyclines increased risk of this condition. Symptoms of hypervitaminosis A could be aggravated w/ vit A.

Click to view Vesanoid detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Vesanoid detailed prescribing information

Storage

View Vesanoid storage conditions for details to ensure optimal shelf-life.

Description

View Vesanoid description for details of the chemical structure and excipients (inactive components).

Action

View Vesanoid mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01XF01 - tretinoin ; Belongs to the class of retinoids for cancer treatment. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Vesanoid cap 10 mg

Packing/Price

100's

Vesanoid

tretinoin

Manufacturer:

Cheplapharm Arzneimittel

Distributor:

Zuellig