Isotretinoin Soft Capsules
exported to South Africa, Thailand, Peru, Singapore, and etc.
GMP certificates
CP/USP/BP

Isotretinoin Soft Capsules

[DRUG Name]

Generic name: Isotretinoin Soft Capsules

[Active ingredient]

Chemical Name: Retinoic acid,13-cis-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)2-cis-

4-trans-6-trans-8-trans-nonatetraenoic acid [4759-48-2].

Chemical Structural formula:

Molecular formula: C20H28O2

Molecular Weight: 300.44

[Description]

Dark brown soft capsules. The content is orange yellow oil suspension.

[Indication] 

Severe forms of acne, special for nodulo-cystic acne, and also for pityriasis rubra pilaris etc.

[SPECIFICATION] 10mg

[Dosage and Administration]

The oral dosage for different patient is not the same, from 0.1~1 (mg/kg)/ day. It is commonly recommended to take 0.5 (mg/kg)/ day, divided by 2 times, at the beginning. Since this drug is fat-soluble, taking it when having meal will promote its absorption. After treatment for 2~4 weeks, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects. 6~8 weeks is one period of treatment. During period of treatment, the patient can stop taking the drug for 8 weeks, and its effectiveness may remain in a short period after withdrawal.

[SIDE EFFECT]

1. Dryness, erosion of mucosa. Monitor for keratitis with dry eye. Alopecia.

2. Rise in liver enzymes and serum triglycerides (risk of fatal pancreatitis).

3. Nausea, headache, drowsiness, sweating, mood changes, neurological disorders, psychiatric reactions, seizers, menstrual irregularities, myalgia, arthralgia.

4. Reversible heamaturia and proteinuria.

5. Occasionally, hearing loss, allergic vasculities, thrombocytopenia, visual disturbances (warn patient as can be sudden; refer patients for ophthalmological examination and consider withdrawal).

6. Rarely, facial hyperpigmentation, hirsutism, acne fulminans, lymphadenopathy.

[Contraindications]

Renal or hepatic impairment, hyperlipidaemia. Pregnancy, lactation, Hypervitaminosis A.

[Warnings and Precautions]

Prescription must be written by a named dermatologist. Exclude pregnancy before starting treatment; effective contraceptive measures must be taken by women of child-bearing potential for 1 month before, during and for least 4 weeks after therapy. Monitor liver function before starting treatment, 1 month later and then at 3 month intervals; reduce dose or discontinue if transaminase levels exceed normal. Monitor fasting serum lipids before starting treatment, 1 month later and then at end of treatment; discontinue if hypertriglyceridaemia is uncontrolled or symptoms of pancreatitis occur. History of depression; monitor all patients for signs of depression and suicidal ideation. Avoid dermabrasion for 5-6 months, or wax epilation for min. 6 months, after treatment. History of intestinal disorders; discontinue if severe diarrhea.

[Pregnancy and Lactation]

Women of childbearing potential and men must use effective contraception during treatment and during the 3 months before and after treatment has concluded.

[Pediatric Use]

The safety of the drug for children has not yet been established. Meanwhile, pay more attention to the dosage to avoid changing bone structure, including Premature Epiphyseal Closure.

[Geriatric Use]

Generally, as for old people, pay more attention to the dosage due to their physiological functions decrescence.

[drug interaction]

1. Concomitant treatment with Isotretinoin and tetracyclines should be avoided because Isotretinoin use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.

2. Because of the relationship of Isotretinoin to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.

3. Treatment with Isotretinoin and Carbamazepine should be avoided because it can decrease blood concentration of Carbamazepine.; Taking with Warfarin can increase treatment effect of Warfarin; And treatment with Osotretinoin and MTX should be avoided because it will make liver damage.

[OVerdose]

Still indeterminate

[storage]

It should be stored in a light-protected, sealed, dark and dry condition (not exceeding 20oC).

[package]

Oral solid preparation is packed in PVC/Aluminium foil package, 10 grains per blister strip, 2 strips per box.

[Shelf-life] 24 months

[Manufacturer]

Company Name: Shanghai Sine Yanan Pharmaceutical Co., Ltd.

Production Address: 298 Xinggong Road, Tinglin Town, Jinshan District, Shanghai

Post Code: 201505

Tel: +86-21-57234239

Fax: +86-21-57233447