OPTIMAL 0.05% Cream
Tretinoin
0.5mg/g
Pharma International Co.
| Pack size | 30g Collapsible Tube |
|---|---|
| Dispensing mode | POM |
| Source | JORDAN |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 15.00 AED |
Available as:
Indications
OPTIMAL 0.05% Cream is used for:
Acute promyelocytic leukaemia
Adult Dose
Oral
Acute promyelocytic leukaemia
Adult: Remission induction: 45 mg/m2 daily in 2 divided doses. Treatment is continued until 30 days after complete remission or up to 90 days, whichever occurs first.
Hepatic impairment: Reduce dose to 25 mg/m2 daily.
Child Dose
Oral
Acute promyelocytic leukaemia
Child: Remission induction: 1-16 yr 45 mg/m2 daily in 2 divided doses. Treatment is continued until 30 days after complete remission or up to 90 days, whichever occurs first.
Hepatic impairment: Reduce dose to 25 mg/m2 daily.
Renal Dose
Renal impairment: Reduce dose to 25 mg/m2 daily.
Administration
Should be taken with food.
Contra Indications
Hypersensitivity to retinoids. Application to eczematous, sunburnt or abraded skin. Pregnancy, lactation.
Precautions
Children, hepatic or renal impairment. Reduce dose if intractable headache occurs. Discontinue temporarily if LFT exceed 5 times upper limit of normal. Monitor closely for leukocytosis or respiratory compromise. Monitor haematologic profile, coagulation parameters, LFT, serum triglyceride and cholesterol concentrations regularly.
Lactation: Unknown if excreted in breast milk; do not breast-feed, because of potential for serious adverse reactions in infant
Pregnancy-Lactation
Pregnancy category: D (systemic)
Lactation: Unknown if excreted in breast milk; do not breast-feed, because of potential for serious adverse reactions in infant
Interactions
Enhances percutaneous absorption of minoxidil. Increased risk of fatal thrombotic complications with antifibrinolytic. Increased tretinoin concentrations with azole antifungals. Enhances peeling action of sulphur, resorcinol, benzoyl peroxide, salicylic acid. Increased photosensitivity with photosensitising medications eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines and sulfonamides.
Potentially Fatal: Increased risk of intracranial pressure with tetracyclines.
Adverse Effects
Side effects of Tretinoin :
>10%
Headache (86%), Fever (83%), Bone pain (77%), Dry mucous membranes (77%), Malaise (67%), URI (63%), Shivering (60%), Dyspnea (60%), Hemorrhage (60%), Elevated liver function tests (50-60%), Hyperlipidemia (60%).Infections (58%), Nausea and vomiting (57%), Rash (54%), Peripheral edema (52%), Leukocytosis (40%), Pain (37%), Abdominal pain (31%), DIC (26%), Respiratory insufficiency (26%), Mucositis (26%), GI disorder (26%), Retinoic acid-APL syndrome (25%), Ear ache (23%), Diarrhea (23%), Pleural effusion (20%), Dizziness (20%), Pruritus (20%), Sweating (20%), Anxiety (17%), Paresthesia (17%), Constipation (17%), Vision changes (17%), Dyspepsia (14%), Depression(14%), Insomnia (14%), Alopecia (14%), Skin changes (14%), Confusion (11%), Abdominal distention (11%), Renal insufficiency (11%)
1-10% (selected)
Cardiac failure, Pseudotumor cerebri, Ulcer
Potentially Fatal: Retinoic acid syndrome, cardiac arrthythmia, disseminated intravascular coagulation, blood dyscrasias, cardiac arrest, cerebral haemorrhage.
Mechanism of Action
Tretinoin is a trans-retinoic acid form of vitimin A. It stimulates mitosis and turnover of follicular epithelial cells and reduce their cohesiveness. This facilitates extrusion of existing comedones and prevents formation of new comedone. It also exhibits thinning effect on the stratum corneum. In acute promyelocytic leukaemia, it induces cellular differentiation and decreases proliferations.
Note
OPTIMAL 0.05% 0.5mg/g Cream manufactured by Pharma International Co.. Its generic name is Tretinoin. OPTIMAL 0.05% is availble in United Arab Emirates.
Farmaco UAE drug index information on OPTIMAL 0.05% Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.