Consumer medicine information

1. Why am I using ISOTRETINOIN-WGR?

ISOTRETINOIN-WGR contains the active ingredient isotretinoin. ISOTRETINOIN-WGR is used to treat severe acne, where other treatments have not worked.
For more information, see Section 1. Why am I using ISOTRETINOIN-WGR? in the full CMI.

2. What should I know before I use this medicine?

Do not use if you have ever had an allergic reaction to Isotretinoin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use this medicine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ISOTRETINOIN-WGR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ISOTRETINOIN-WGR?

• Your doctor will tell you how many ISOTRETINOIN-WGR capsules to take each day,

• Take them exactly as your doctor has prescribed.

• ISOTRETINOIN-WGR capsules should be swallowed whole with a glass of water or milk and must always be taken with food. Do not open the capsules or take any capsules that are damaged.

5. What should I know while using this medicine?

6. Are there any side effects?

Common side effects include nosebleeds, mild headache, weight loss, abnormal periods, bony growths, change in hair growth, feeling sick (nausea), mild headache.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Notes

Distributed by Wagner Pharmaceuticals Pty Ltd

1 Name of Medicine

Isotretinoin.

2 Qualitative and Quantitative Composition

Each capsule contains 10 mg or 20 mg of isotretinoin as the active ingredient.
Excipients with known effect. Sulfites, phenylalanine, and soy bean products.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Isotretinoin-WGR 10 mg capsule. Red-orange, size 3, oval, soft gelatin capsules marked P10.
Isotretinoin-WGR 20 mg capsule. Red-orange, size 6, oval, soft gelatin capsules marked P20.

4 Clinical Particulars

4.9 Overdose

Isotretinoin is a derivative of vitamin A. Although acute toxicity of isotretinoin is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Clinically, overdose has been associated with transient headache, (severe), nausea or vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, drowsiness, irritability, pruritus and ataxia. All symptoms quickly resolved without apparent residual effects.
The oral LD₅₀ of isotretinoin is greater than 4000 mg/kg in rats and mice and approximately 1960 mg/kg in rabbits.
Treatment.Treatment of overdose should consist of general supportive measures.
Isotretinoin causes serious birth defects at any dosage (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use). Female patients of childbearing potential who present with isotretinoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counselling about the risks to the foetus. Non-pregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counselling. Because an overdose would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for 1 month after the overdose.
All patients with isotretinoin overdose should not donate blood for at least one month.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Isotretinoin was negative in tests for gene mutation (histidine reversion in S. typhimurium), chromosomal damage in vitro (Chinese hamster lung cell and S. cerevisiae D7 assays) and in vivo (mouse micronucleus test), and unscheduled DNA synthesis in vitro (rat hepatocytes).
Carcinogenicity. In Fischer, 344 rats given isotretinoin at dosages of 32 or 8 mg/kg/day for greater than 18 months, there was dose related increased incidence of phaeochromocytoma. The incidence of adrenal medullary hyperplasia was also increased at the higher dosage. There is doubt as to the validity of this animal model as a predictor of tumorigenicity in humans, as the Fischer rat is genetically predisposed to the multiple endocrine neoplasia syndrome which includes spontaneous occurrence of phaeochromocytoma. In these studies there was also a dose related decrease in the incidence of liver adenomata, liver angiomata and leukaemia.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Isotretinoin is a yellow-orange to orange crystalline powder that is practically insoluble in water, soluble in methylene chloride, sparingly soluble in ether and slightly soluble in alcohol. It is sensitive to air, heat and light, especially in solution. It is related to both retinoic acid and retinol (vitamin A).
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSISOTRM.gif Chemical name: (2Z, 4E, 6E, 8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetraenoic acid (also known as 13-cis-retinoic acid).
Molecular formula: C₂₀H₂₈O₂.
Molecular weight: 300.44.
CAS number. 4759-48-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ISTWGRST.gif