Consumer medicine information

Klarvanta Foam spray

Calcipotriol + Betamethasone dipropionate

BRAND INFORMATION

Brand name

Klarvanta

Active ingredient

Calcipotriol + Betamethasone dipropionate

Schedule

S4

1. Why am I using Klarvanta®?


Klarvanta® is a combination product that contains the active ingredients calcipotriol and betamethasone dipropionate. Klarvanta® is a topical treatment for a skin condition called psoriasis.
For more information, see Section 1. Why am I using Klarvanta®? in the full CMI.

2. What should I know before I use Klarvanta®?


Do not use if you have ever had an allergic reaction to Klarvanta® 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 Klarvanta®? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Klarvanta® 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 Klarvanta®?

  • Klarvanta® is designed for direct application (spray on) to your skin where it is affected by psoriasis
  • Klarvanta® should be applied to dry skin on the affected areas of the body or scalp
  • Your doctor will decide how much Klarvanta® you need to use and for how long

More instructions can be found in Section 4. How do I use Klarvanta®? in the full CMI.

5. What should I know while using Klarvanta®?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Klarvanta®
  • Protect the treated skin areas from sunlight and ultraviolet (UV) rays
  • Inform your doctor and pharmacist that you are using Klarvanta® if you are starting any new medicine
  • Tell your doctor immediately if you become pregnant while using Klarvanta®
Things you should not do
  • Do not give your medicine to anyone else, even if they have the same condition as you
  • Do not use more than the recommended daily or weekly dose
  • Do not use other topical corticosteroids on areas treated with Klarvanta®
Driving or using machines
  • Klarvanta® is not expected to affect your ability to drive or operate machinery
Looking after your medicine
  • Keep Klarvanta® in a cool dry place. Store below 25°C
  • Klarvanta® comes in a pressurised container and is extremely flammable. It may burst if heated. Protect from sunlight and do not expose to temperatures above 50°C

For more information, see Section 5. What should I know while using Klarvanta®? in the full CMI.

6. Are there any side effects?


Klarvanta® may cause local skin reactions or irritation to the eyes and mucous membrane. Some common side effects include skin irritation, skin pain, rash, change in skin colour, increased skin sensitivity to light, change in control of diabetes.
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.

BRAND INFORMATION

Brand name

Klarvanta

Active ingredient

Calcipotriol + Betamethasone dipropionate

Schedule

S4

1 Name of Medicine

Calcipotriol monohydrate.
Betamethasone dipropionate.

2 Qualitative and Quantitative Composition

Klarvanta contains 50 microgram of calcipotriol (as monohydrate) and 500 microgram of betamethasone (as dipropionate) per gram.
Excipients with known effect. Butylated hydroxytoluene.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The foam spray in the can is a white to off-white opalescent liquid.
After spraying, a white to off white foam is formed. The foam has the appearance of non-expanding that gradually collapses after spraying.

4 Clinical Particulars

4.9 Overdose

Usage above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcaemia include polyuria, constipation, muscle weakness, confusion and coma.
Excessive prolonged use of topical corticosteroids may result in adrenocortical suppression which is usually reversible. Symptomatic treatment may be indicated.
In case of chronic toxicity the corticosteroid treatment must be discontinued gradually.
For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Calcipotriol was not genotoxic in assays for gene mutations (Ames test and mouse lymphoma TK locus assay) or chromosomal damage (human lymphocyte chromosomal aberration or mouse micronucleus test). Betamethasone dipropionate was not genotoxic in the Ames mutagenicity assay, the mouse lymphoma TK locus assay or in the rat micronucleus test.
Carcinogenicity. A dermal 2-year carcinogenicity study with calcipotriol in mice showed no indications of an increase in tumours at doses up to 30 microgram/kg/day (below the clinical dose on a body surface area basis).
In a 40 week study in which albino hairless mice were exposed to both ultraviolet radiation (UVR) and topically applied calcipotriol, a reduction in the time required for UVR to induce the formation of skin tumours was observed (statistically significant in males only), suggesting that calcipotriol may enhance the effect of UVR to induce skin tumours.
A 2 year oral carcinogenicity study was conducted with calcipotriol in rats at doses up to 15 microgram/kg/day. A treatment-related increase in benign c-cell adenomas was observed in the thyroid of males at 15 microgram/kg/day and females that received ≥ 5 microgram/kg/day. A treatment related increase in benign pheochromocytomas was observed in the adrenal glands of males receiving 15 microgram/kg/day. The relevance of these findings to patients is unknown.
When betamethasone dipropionate was applied topically to mice for up to 24 months at doses up to 8.5 microgram/kg/day in females, and 12.9 microgram/kg/day in males or administered given orally to rats for up to 24 months at doses up to 200 microgram/kg/day (estimated exposures based on AUC of the metabolite betamethasone 17-propionate at least 70 times that expected in patients), no significant changes in tumour incidence were observed when compared to control.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Calcipotriol monohydrate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCALMON.gif Calcipotriol monohydrate is (5Z, 7E, 22E, 24S) -24-Cyclopropyl-9,10-secochola- 5,7,10(19),22-tetraene-1α,3β,24-triol monohydrate. The molecular weight of calcipotriol monohydrate is 430.6.
Calcipotriol is a white or almost white crystalline substance. It is freely soluble in ethanol, soluble in chloroform and propylene glycol, particularly insoluble in liquid paraffin. Solubility in water is 0.6 microgram/mL and the melting point is 166 to 168°C. Calcipotriol is a vitamin D derivative and behaves in a similar manner to vitamin D, forming a reversible temperature-dependent equilibrium between calcipotriol and pre-calcipotriol.
Betamethasone dipropionate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBETDIP.gif Betamethasone dipropionate is 9-fluoro-11 β, 17, 21-trihydroxy-16 β-methylpregna-1,4- diene-3,20-dione 17,21-dipropionate. The empirical formula is C28H37FO7. The molecular weight of betamethasone dipropionate is 504.6.
Betamethasone dipropionate is a white or almost white, crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol.
CAS number. Calcipotriol monohydrate. 147657-22-5.
Betamethasone dipropionate. 5593-20-4.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

Summary Table of Changes

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