Betazol Cream is used as topical anti-inflammation and anti-fungal cream.
Betamethasone Dipropionate in combination with Miconazole Nitrate is indicated for infections of
skin with fungi along with inflammation.

Betazol Cream is indicated for topical use applied once or twice a day.

Betamethasone dipropionate
Local and systemic toxicity is common especially following long continued use on large areas of
damaged skin and in flexures. If used on the face, courses should be limited to 5 days.

BETAMETHASONE DIPROPIONATE CREAM SHOULD NOT BE USED WITH OCCLUSIVE
DRESSING.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound
relapses following the development of tolerance, risk of generalised pustular psoriasis and local and
systemic toxicity due to impaired barrier function of the skin.

Any of the side effects that are reported following systemic use of corticosteroids, including adrenal
suppression, manifestation of Cushing's syndrome, hyperglycemia, and glycosuria may also occur
with topical steroids, especially in infants and children.

Betamethasone dipropionate Cream is not intended for ophthalmic use.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and
intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other
visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation
of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such

as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and
topical corticosteroids.
Paediatric population
• Long term continuous therapy should be avoided in all children irrespective of age.
• Betamethasone dipropionate cream should not be used with adhesive dressing.
• The safety and effectiveness of Betamethasone dipropionate cream has not been established in
children below the age of 12.
• If used on children, courses should be limited to 5 days.
Hypothalamic-pituitary adrenal axis suppression, Cushing's syndrome and intracranial hypertension
have been reported in children receiving topical corticosteroids. Manifestation of adrenal suppression
in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and
absence of response to ACTH stimulation. Manifestation of intracranial hypertension include bulging
fontanelles, headaches, and bilateral papilloedema.

Miconazole Nitrate
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during
treatment with miconazole nitrate Cream and with other miconazole topical formulations. If a reaction
suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Must not
come into contact with the mucosa of the eyes.

Betamethasone dipropionate
There are no known interactions.
Miconazole Nitrate
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic
availability after topical application, clinically relevant interactions are rare. However, in patients on
oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be
monitored.

Betamethasone dipropionate
There are no adequate and well controlled studies of the teratogenic potential of topically applied
corticosteroids in pregnant women. Therefore topical steroids should be used during pregnancy only
if the potential benefit justifies the potential risk to the foetus.
It is not known whether topical administration of corticosteroids would result in sufficient systemic
absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids 

are secreted into breast milk in quantities not likely to have a deleterious effect on the infant.
Nevertheless, a decision should be made whether to discontinue the drug, taking into account the
importance of the drug to the mother.

Miconazole Nitrate

Pregnancy
In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses.
Only small amounts of miconazole nitrate are absorbed following topical administration. However,
as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.

Lactation
Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known
whether miconazole is excreted in human breast milk. Caution should be exercised when using
topically applied miconazole products during lactation.

Not applicable.

Betamethasone dipropionate:
Betamethasone dipropionate skin preparations are generally well tolerated and side-effects are rare.
The systemic absorption of betamethasone dipropionate may be increased if extensive body surface
areas or skin folds are treated for prolonged periods or with excessive amounts of steroids. Suitable
precautions should be taken in these circumstances, particularly with infants and children.

The following local adverse reactions that have been reported with the use of Betamethasone include:
burning, itching, and irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions,
hypopigmentation, perioral dermatitis, and allergic contact dermatitis, maceration of the skin,
secondary infection, striae and miliaria.

Continuous application without interruption may result in local atrophy of the skin, striae and
superficial vascular dilation, particularly on the face.
Vision blurred has been reported with corticosteroid use (frequency not known).

Miconazole Nitrate
Adverse reactions reported among 426 patients who received miconazole 2% cream base in 21
double-blind clinical trials are presented in Table A below.
Based on pooled safety data from these clinical trials, the most commonly reported adverse reaction
was Application site irritation (0.7%).

Including the above-mentioned adverse reaction, Table A displays adverse reactions that have been
reported with the use of topical, non-gynaecological, miconazole nitrate/miconazole from either
clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention: very common (≥1/10); common
(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<
1/10,000, including isolated reports) and Not Known (cannot be estimated from the available data).

Table A: Adverse Reactions Reported in Clinical Trials and Post-marketing Experience

To report any side effect(s):
• Saudi Arabia:
- The National Pharmacovigilance and
Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
• Other GCC States:
− Please contact the relevant competent authority.

Betamethasone dipropionate
Acute overdosage with topical application of Betamethasone cream is unlikely and would not be
expected to lead to a life-threatening situation; however topically applied corticosteroids can be
absorbed in sufficient amounts to produce systemic effects.
Toxic effects are unlikely to occur following accidental ingestion of Betamethasone cream. Signs of
toxicology appearing after such accidental ingestion should be treated symptomatically

Miconazole Nitrate

Symptoms
Cutaneous use: Excessive use can result in skin irritation, which usually disappears after
discontinuation of therapy.

Accidental ingestion: Stomach irritation may occur.
Treatment
Miconazole cream is intended for cutaneous use, not for oral use. If accidental ingestion of large
quantities of the product occurs, use appropriate supportive care.

ATC code: D01AC52, D07BC01
Betamethasone dipropionate
Betazole preparations contain the dipropionate ester of betamethasone which is a glucocorticoid
exhibiting the general properties of corticosteroids.

In pharmacological doses, corticosteroids are used primarily for their anti-inflammatory and/or
immune suppressive effects.
Topical corticosteroids such as betamethasone dipropionate are effective in the treatment of a range
of dermatoses because of their anti-inflammatory, anti-pruritic and vasoconstrictive actions. However,
while the physiologic, pharmacologic and clinical effects of the corticosteroids are well known, the
exact mechanisms of their action in each disease are uncertain.

Miconazole Nitrate
Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative)
Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability
of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial
activity.

Betamethasone Dipropionate

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including
vehicle, integrity of the epidermal barrier and the use of occlusive dressings.

Topical corticosteroids can be absorbed through intact, normal skin. Inflammation and/or other disease
processes in the skin may increase percutaneous absorption.

Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to
systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying
degrees, are metabolised primarily in the liver and excreted by the kidneys. Some of the topical
corticosteroids and their metabolites are also excreted in the bile.

Miconazole Nitrate

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is
applied topically.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).
Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated
predominantly in faeces as both unchanged drug and metabolites.

Betamethasone dipropionate
There are no pre-clinical data of relevance to the prescriber which are additional to that already included
in other sections of this SmPC.

Miconazole Nitrate
Preclinical data reveal no special hazard for humans based on conventional studies of local irritation,
single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

Cetomacrogol-1000
Cetostearyl Alcohol
Chlorocresol
Petroleum Jelly White
Propylene Glycol
Liquid Paraffin
Sodium Hydroxide 1 N
Purified water

None known

Do not store above 30°C.
Discard the tube after 3 months from opening.

Aluminum collapsible tube containing 30 g of cream

No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.