Dermazol Tablets
Dermazol Tablets

Philippines Product

Dermazol Tablets

Dermazole Tablets

Dermazole Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Treatment of dermatophytosis and Malassezia (previously called Pityrosporum) folliculitis that cannot be treated topically because of the site, extent of the lesion or deep infection of the skin, in patients resistant to, or intolerant of, fluconazole, terbinafine and itraconazole.

Treatment of chronic mucocutaneous candidosis, cutaneous candidosis, and oropharyngeal candidosis that cannot be treated topically because of the site, extent of the lesion or deep infection of the skin, in patients resistant to or intolerant of both fluconazole and itraconazole.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

In a multinational multi-centre, open label study in patients with various superficial and deep mycoses, adverse events during Ketoconazole treatment were evaluable in 1361 cases, 149 (11%) reported adverse events. The adverse events were summarized regardless of the causality assessment of the investigator.

The most frequently reported adverse events were of gastrointestinal origin, i.e. nausea and vomiting.

Adverse events that were reported with an incidence of > 0.5% are presented in the table below:


System Organ Class

 

Superficial Mycosis

Deep Mycosis

Total

Adverse Event

 

 

 

 

 

% (N=1,026)

% (N=335)

% (N=1,361)

Preferred Term

 

 

 

 

 

Nervous system disorder

 

 

 

 

 

 

 

Headache

 

0.7

0.9

0.7

 

 

 

 

 

Dizziness

 

0.5

1.2

0.7

 

 

 

 

 

Somnolence

 

0.5

1.2

0.7

 

 

 

 

Gastrointestinal disorders

 

 

 

 

 

 

Nausea/Vomiting

 

1.8

6.9

3.0

 

 

 

 

 

Abdominal pain

 

1.2

1.2

1.2

 

 

 

 

 

Diarrhoea

 

0.7

0.6

0.7

 

 

 

 

Skin and subcutaneous tissue disorders

 

 

 

 

 

 

Pruritus

 

0.8

3.3

1.4

 

 

 

 

 

Rash

 

0.6

0.6

0.6


Post-marketing Experience
Including the above mentioned Adverse Drug Reactions (ADRs), the following ADRs have been observed from post-marketing experiences reported with the use of Ketoconazole 200 mg tablets.
Unlike for clinical trials, precise frequencies cannot be provided for spontaneous reports. The frequency for these reports is therefore classified as 'not known'.

Blood and the lymphatic system disorders

Not Known

thrombocytopenia

 

 

Immune system disorders

 

 

Not Known

allergic conditions including anaphylactic shock, anaphylactoid and

 

anaphylactic reactions and angioneurotic oedema

 

 

Endocrine disorders

 

 

Not Known

adrenocortical insufficiency

 

 

Nervous system disorders

 

 

Not Known

Reversible increased intracranial pressure (e.g. papilloedema, fontanelle

 

bulging in infants), paraesthesia

 

 

Eye disorders

 

 

 

Not Known

photophobia

 

 

Gastrointestinal disorders

 

 

Not Known

dyspepsia

 

 

Hepato-biliary disorders

 

 

Not Known

Serious hepatotoxicity, including jaundice, hepatitis, biopsy-confirmed

 

hepatic necrosis, cirrhosis, hepatic failure including cases resulting in

 

transplantation or death, abnormal liver function test results

 

 

Skin and subcutaneous tissue disorders

 

 

Not Known

urticaria, alopecia, photosensitivity

 

 

Reproductive system and breast disorders

 

 

Not Known

Erectile dysfunction, gynaecomastia, menstrual disorder; with doses higher

 

than the recommended therapeutic dose of 200 or 400mg daily, azoospermia


What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

What to do if you accidentally take too much (overdose) of the medicine?

Oral
Ketoconazole 200 mg tablets should be taken during meals for maximal absorption.
Dosage Adults
One tablet (= 200 mg) once daily with a meal. If no adequate response is obtained with this dose, the dose should be increased to 2 tablets (= 400 mg) once daily. Children

- Children weighing from 15 to 30 kg: half a tablet (=100 mg) once daily with a meal.
- Children weighing more than 30 kg: same as for adults.
Duration of Treatment
For all indications, treatment should be continued without interruption until clinical parameters or laboratory tests indicate that the fungal infection has resolved. An inadequate treatment period may lead to recurrence of the active infection. However, the risk of serious hepatic toxicity increases with longer duration of treatment; courses greater than 10 days should only be given after full consideration of the extent of treatment response and the risk-benefit of continuing treatment, and liver function should be closely monitored.
For the treatment of Malassezia infections, treatment should not normally exceed 4 weeks.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Storage Condition:
Store at temperatures not exceeding 30 °C.
Caution:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Availability:
Aluminium foil strip of 10 tablets (box of 10's and 30's).

Manufactured By:
Kusum Healthcare Pvt. Ltd.
SP-289 (A), RIICO Indl. Area, Chopanki (Bhiwadi), Distt- Alwar (Rajasthan), INDIA
Imported and Distributed By:

Kusum Healthcare Private Limited.
Branch Office:
Unit 401, 4th Flr.
Peninsula Court Bldg
8735 Paseo de Roxas
Makati City.