Ketoconazole 2%w/w ointment,
|2% w/w||186.00||15g ointment|
List of Related Indications:
- Skin infection
List Of Drugs:
- Ketoconazole ( *** ) - @ Imidazoles- Antifungal- (FDC- List )- (Feb 2009)
Indication Type Description:
Dosages/ Overdosage Etc
Interaction with Food
Pregnancy and lactation
Systemic fungal infections- candiasis
Azole anti-fungals include- Fluconazole, Itraconazole, Ketoconazole, Miconazole, Econazole, Terconazole
Most reactions are mild, transcient and rarely require discontinuation. The rare occurance of hepatic dysfunction require special attention.
GI- nausea, vomiting, abdominal pain, diarrhea, hepatotoxicity
CNS- headache, dizziness, somnolence, photophobia.
Psychiatric- suicdaltendencies, severe depression (rare)
Miscellaneous- pruritis, chills, impotence, gynaecomastia, thrmbocytopenia, leukopenia, hemolytic anemia, bulging fontaelles, hypersensitivity including urticaria.
Oligopspermiahas occured at dosages above those approved upto 400mg/day,sperm counts were obtained infrequently at these dosages
Pregnancy. Hypersens, lactation.
Monitor hepatic function in long term treatment. Stop treatment if hepatitis occurs.
Hormone levels- ketoconazole lowers serum testosterone. Testosterone are inpaired with doses of 800mg/day and abolished by 1600mg/day. Closely follow the recommended dose of 200 to 400mg/day
Gastric acidity- ketoconazole requires acidity for dissolution and absorption. If antacids, antichlinergics or H2 blockers are needed, give atleast 2 hours after administration.
Hepatotoxicity- primarily of the hepatocellular type has been associated with ketoconazole including rare fatalities. Prompt recognition of liver injury is essential. Measure liver function tests eg AST,ALT, alkaline phosphatase, bilirubin, before starting treatment and frequently, during treatment.
Monitor patients receiving ketoconazole concurrently with other potentially hepatotoxic drugs, particularly those requiring prolonged therapy or those with a history of liver disease Transcient minor elevations in liver enzymes have occurred.
Discontinue drug if these persist or worsen, or are accompanied by symptoms of liver injury.
Prostatic cancer- in clinical trials involving 350 patients with metastatic prostatic cancer, 11 deaths were reported within 2 weeks of starting high dose ketoconazole therapy. High ketoconazole doses are known to supress adrenal coticosteroid secretion.
Hypersensitivity- anaphylaxis rarely occur after the first dose. Hypersensitivity reactions including urticaria, have been reported. Have ephinephrine 1: 1000 immediately available.
Pregnancy- There are no adequate and well controlled studies in pregnant women. Use only if the potential benefits outweigh the risks.
Lactation- ketoconazole is probably excreted in breast milk, mothers who are under treatment should not nurse.
Children- safety for use in children < 2 years has not been established. Do not use in pediatric patients unless the potential benefits outweigh the risks.
Dosages/ Overdosage Etc:
Systemic fungal infections- candiasis
Adults - 200mg once daily. In very serious conditions increase it to 400mg once daily. ONS,
Children - more than 2 years- 3.3 to 6.6mg/kg/day as a single daily dose. Children less than 2 years - not recommended.
1. Institute supportive measures , including gastric lavage with sodium bicarbonate
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Eczema - ( 241 ) Eczematous derematitis is not a specific disease entity but a characterstic inflammatory response of the skin due to both endogenous and exogenous agents that cause a delayed hypersensitivity reaction.
Drugs causing adverse reactions- ( 385 )
1. Topical antimicrobials
2. Topical local anesthetics
3. Topical antihistamines
4. Cream and lotion preparations
Azole anti-fungals include- Fluconazole, Itraconazole, Ketoconazole, Miconazole
1. Do not take with antacids.If antacids are required delay administration by 2 hours.
2. Take with food to alleviate GI disturbance
3. May produce headache, dizziness and drowsiness; observe caution while driving or performing tasks requiring alertness, coordination or physical dexterity.
4. Notify physician, of any signs or symptoms suggesting liver dysfunction (eg. unusual fatigue, anorexia, nausea, vomiting, jaundice, dark urine, pale stools) or if abdominal pain, fever, or diarrhoea become pronounced.
5. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to the azole fungals Tell your doctor if you are allergic to any substances such as foods, preservatives or dyes.
6. Pregnancy- Studies have shown that if azole fungals are taken in large doses, may cause harm to the mother and the fetus. Before taking this medicine make sure that your doctor knows if you are pregnant or if you become pregnant.
7. Breast feeding- Mothers who are taking these medicines and who wish to breast feed should discuss with the doctor.
8. Children- Discus with your childs doctor, the use of these medicines in children.
9. Elderly- There is no specific information comparing the use of azole antifungals in the elderly compared to use in other age groups.
10. Other medicines- It is important that your doctor knows if you ae taking any of the following medicines- Acetoaminiphen or Amiodarone or Anabolic steroids or Androgens or Antithyroid agents or Carmustine or Chloroquine or Dantrolene or Daunorubicin or Disulfram or Divalproex or Estrogens or Etretinate or Gold salts or Hydroxychloroquine Mercaptopurine or Methotrexate or Merthyldopa or Naltrexone or Oral contraceptives containg estrogens or Phenothiazines or Plicamycin or Valproic acid - use of these medicines with azole antifungals may increase the change of side effects affecting the liver
Amanatdine or Antacids or Anticholinergic medicines or Antidepressants or Antidyskinetics or Antihistamines or Antipsychotics or Buclizine or Cimetidine or Cyclizine , Cyclobenzaprine or Disopyramide or Famotidine or Flavoxate or Ipratropium or Meclizine or Methylphenedine or Nizatidine or Omeprazole or Orphenadrine or Oxybutin or Procainamide or Promethazine or Quinidine or Ranitidine or Sicralfate or Trimeprazine - use of these medicines may decrease the effect of itraconazole and ketoconazole . These medicines should be taken at least 2 hours after itraconazole or ketoconazole
Antidiabetic agents oral or Cyclosporine or Digoxin or Warfarin or - fluconazole may increase the chance of side effects Astemazole or Terfendadine - these medicines should not be taken with itraconazole or ketoconazole.
These azole antifungals may increase the chance of serious side effects of astemizole or terfenadine Carbamazepine or Isoniazid or Rifampicin - these medicines may decrease the effects of azole antifungals Ciaspride - should not be taken with oral itraconazole , oral ketoconazole or miconazole inj. These medicines may increase the chance of serious side effects of cisapride
Didanosine - use of didanoisine with itraconazole or ketoconazole may decrease the effects of both itraconazole and ketoconazole as well as didanosine. Itraconazole and ketoconazole should be taken at least 2 hours before or after didanosine is given
Phenytoin- use ofphenytoin with azole antifungals, increase the chance of phenytoin side effects.
11. Other medical problems- Tell your doctor if you have any other medical problems- Achlorhydria- absence of stomach acid or Hypochlorhydria -decreased amount ofstomach acid.
Itraconazole or Ketoconazole may not be absorbed from the stomach as well in patients who have low levels of or no stomach acid Alcohol abuse or Liver disease -alcohol abuse or liver disease may increase the chance of side efects caused by azole antifungals Kidney disease - effects of fluconazle may be increased in patients with kidney disease
12. Missed dose- if you miss a dose of this medicine take it as soon as possible However if it is almost time for your next dose skip the next dose and go back to your regular dosing schedule Do not double doses.
Interaction with Food:
Pregnancy and lactation:
Use only if potential benefit justifies the potential risks.
Ketaconazole is excreted in breast milk; mothers under treatment should not nurse. Children: Safety for use on children below 2 years not established.