Generic Fusiderm B ( Betamethasone and Fusidic Acid )

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Fusiderm B is a combination topical medication used to treat inflamed skin conditions like eczema or dermatitis when a bacterial infection is present or likely to occur. It contains fusidic acid, an antibiotic that stops bacterial growth, and betamethasone, a potent corticosteroid that reduces redness, swelling, and itching.
The usual treatment is to apply a thin layer to the affected area twice daily, for a maximum of 2 weeks.
The administration form is a topical cream, supplied in 15 g and 30 g tubes.
The steroid component starts reducing inflammation within hours, while the antibiotic effect on the skin bacteria builds over the first few days of use.
Alcohol consumption is not a concern with this topical product, as systemic absorption through intact skin is minimal.
The most common side effects are local skin reactions such as itching, burning, or irritation at the application site.
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Common Use Fusiderm B

This cream is designed for a specific problem: inflamed skin that has also become infected. The betamethasone valerate in Fusiderm B is a potent corticosteroid. It works inside skin cells to block the release of inflammatory substances, which is why it calms redness, swelling, and itch so effectively. The fusidic acid is a naturally derived antibiotic. It gets into bacterial cells and stops them from making the proteins they need to multiply. It is mainly active against Staphylococcus aureus and Streptococcus species, the bacteria that most often complicate eczema and dermatitis. In Canada, this combination is indicated for eczematous dermatoses, including atopic eczema, when a secondary bacterial infection is confirmed or suspected. It is not meant for skin infections that are purely fungal (like athlete's foot) or purely viral (like cold sores).

Basic Fusiderm B Information

• INN (International Nonproprietary Name): Betamethasone (as valerate) and fusidic acid
• Brand names available in Canada: Fucibet® is the brand name available in Canada for this exact combination. Fusiderm B is the brand name used in other markets. There is no generic version currently marketed in Canada.
• ATC Code: D07CC01 (Betamethasone and antibiotics)
• Forms and dosages: Cream – fusidic acid 2% w/w (20 mg/g) and betamethasone valerate 0.1% w/w (equivalent to betamethasone 0.1% w/w). Supplied in 15 g and 30 g tubes.
• Manufacturers in Canada: LEO Pharma Inc. holds the DIN for Fucibet cream in Canada.
• Registration status in Canada: Approved by Health Canada. Fucibet cream (DIN 02474883) is currently marketed. The product was authorized based on a submission that relied on the long-standing European marketing of a similar product, Fucicort Lipid.
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Wash your hands and clean the affected area gently. Pat the skin dry. Apply a small quantity of Fusiderm B to the affected area twice daily. Rub it in lightly. Wash your hands afterwards unless your hands are the area being treated. The treatment course should not normally exceed 2 weeks. If your skin has not improved after that, stop using the cream and see your doctor. Do not cover the area with an airtight dressing or bandage unless your doctor specifically tells you to. Occlusion increases how much steroid gets absorbed into your body and raises the risk of side effects. This cream is for external use only. Do not use it on open wounds, on large areas of skin, or in skin folds like under the breasts or in the groin, unless your doctor has told you to. Do not use it on your face, as the skin there is thinner and more prone to steroid side effects.

Precautions

Because Fusiderm B contains a potent steroid, it needs to be used carefully. Prolonged use, application to large areas, or use under dressings can allow enough betamethasone to be absorbed into the bloodstream to cause systemic effects. These include reversible suppression of the adrenal glands, which can affect how your body responds to stress, and Cushing's syndrome, with symptoms like a rounded face, weight gain around the middle, and easy bruising. Children are more susceptible to these effects because their skin surface area to body weight ratio is larger. If you use this cream near the eyes, be extremely careful not to get it in them. Steroids applied around the eye can increase the risk of glaucoma and cataracts. Blurred vision or other visual disturbances during treatment should be evaluated by an ophthalmologist. Bacterial resistance to fusidic acid can develop if the cream is used for longer than necessary or repeatedly. This is why the 2-week limit matters. If you have a skin infection that is not improving or is getting worse, the bacteria may be resistant. Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The safety of this combination during pregnancy has not been firmly established. It should only be used if the potential benefit justifies the potential risk. If you are breastfeeding, do not apply the cream to your breasts. Do not use this product on children under 2 years of age without specific medical advice.

Contraindications

Do not use Fusiderm B if you are allergic to fusidic acid, sodium fusidate, betamethasone valerate, or any of the inactive ingredients in the cream. Because it contains a corticosteroid, it is contraindicated for several skin conditions. Do not use it on untreated fungal infections (like athlete's foot or ringworm), viral infections (like cold sores or chickenpox), or on skin conditions caused by tuberculosis. It should not be used on skin that is infected only by bacteria, such as impetigo, boils, or isolated spots, because the steroid component is not needed and could mask or worsen the infection. It is also contraindicated for perioral dermatitis (a red, bumpy rash around the mouth) and rosacea (redness and inflammation on the nose and cheeks). Do not apply it to skin ulcers, acne, or thinning skin. If you have a widespread fungal infection, do not use this product.

Possible Side Effects

Most side effects from Fusiderm B are local and affect the skin where you apply it. Itching is the most commonly reported effect. You may also notice a burning or stinging sensation, dryness, redness, or general irritation at the application site. These reactions are usually mild and tend to settle as treatment continues or once the cream is stopped. If the irritation becomes severe or worsens, stop using the cream and speak to your doctor. Less common but more serious local effects can occur with prolonged use of potent topical steroids. These include thinning of the skin (atrophy), stretch marks (striae), visible small blood vessels (telangiectasia), and changes in skin pigmentation. Contact dermatitis, an allergic reaction to the cream itself, can also develop. If you experience a severe skin reaction, or if you develop signs of a systemic reaction like unusual weight gain, a rounded face, or easy bruising, contact your doctor. Allergic reactions that require immediate medical attention include rash, hives, swelling of the face, lips, tongue, or throat, and difficulty breathing.

Drug Interaction

Because Fusiderm B is applied to the skin, it is not expected to interact significantly with medications you take by mouth. The amount of betamethasone and fusidic acid that reaches your bloodstream from topical use is usually very small. However, if you use the cream on large areas of skin, under an airtight dressing, or for a prolonged period, enough steroid could be absorbed to affect other conditions or medications. For example, it could affect blood sugar control in people with diabetes. There are no formal studies of interactions between this specific combination and other drugs. Still, it is wise to tell your doctor or pharmacist about every medication you take, including over-the-counter products and supplements, especially if you have diabetes or take any medication that affects your immune system. Do not use other topical products on the same area of skin without checking with your doctor first.

Missed Dose

If you forget to apply Fusiderm B, put it on as soon as you remember. If it is almost time for your next dose, skip the missed application and continue with your regular schedule. Do not apply extra cream to make up for a missed one. Consistency is important for the antibiotic to work properly and for the steroid to keep inflammation under control.

Overdose

Overdose with topical Fusiderm B is unlikely to cause serious harm from a single application of too much cream. You may notice increased local irritation. The bigger concern is chronic overuse: using it for longer than 2 weeks, on large areas, or under occlusion. This can lead to the systemic steroid effects described in the precautions section, such as adrenal suppression or Cushing's syndrome. If you have been using the cream excessively and experience unusual weight gain, a rounded face, or easy bruising, contact your doctor. If someone swallows the cream, contact a poison control centre or go to an emergency department. Do not induce vomiting unless a healthcare professional tells you to.

Storage

Store Fusiderm B cream below 25 degrees Celsius (77 degrees Fahrenheit). Do not refrigerate. Do not freeze. Keep the tube tightly closed when not in use. Store it in the original packaging to protect it from light and moisture. Do not store it in the bathroom or near a sink. Keep out of reach of children and pets. Do not use the cream after the expiry date on the tube. Dispose of unused cream according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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