THEMIBUTOL
Manufacturer Details
THEMIS CHEMICALS
Compositions:
Ethambutol hcl 200mg/400mg/600mg/800mg /1g tablets,
Strength
|
Rate
|
Packing Style
|
200mg
|
10.83
|
10s tablets
|
400mg
|
24.00
|
10s tablets
|
600mg
|
35.17
|
10s tablets
|
800mg
|
41.75
|
10s tablets
|
1g
|
73.30
|
10s tablets
|
List of Related Indications:
List Of Drugs:
- Ethambutol - Plain @ - Antitubercular Agents
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Interacting drugs- summary
Aluminium hydroxide Absorption delayed or reduced by aluminium hydroxide.
Indication:
Preliminary treatment of pulmonary or extrapulmonary tuberculosis
Adverse Reaction:
Retrobulbar neuritis with reduction in visual acuity,
Constriction of visual field, central or peripheral scotoma and green-red colour blindness.
Retinal haemorrhage (rare).
Reduced renal clearance of urates(gout).
GI disturbances,rash, headache, dizziness, anorexia.
False positive screening test for pheochromocytoma.
Contra-Indications:
Optic neuritis, impaired renal function, susceptibility to epilepsy,neonates.Hypersens.
Special precautions::
Test visual functions before treatment.
Pregnancy and children.
Reduce dosage for patients with impaired kidney function.
Serum concentration of ethambutol should not exceed 5mcg per ml.
Elderly.
Dosages/ Overdosage Etc:
Preliminary treatment of pulmonary or extrapulmonary tuberculosis
Dosage:
Do not use ethambutol alone. Administer once in 24 hours only. Absorption not significantly
altered with food.
Initial - administer 15mg/kg as a single dose every 24 hours. Concurrently administer at least
one other anti-tubercular drug to which the organism is susceptible.
Other Information:
Classification: Anti-tubercular
Patent position:
Major brands:
AKT-4 LUPIN
COMBUNEX LUPIN
COMBUTOL LUPIN MARKET LEADER
INABUTOL THEMIS CHEM
LY-BUTOL LYKA
MYAMBUTOL CYANAMID
MYCOBUTOL CADILA PHARMA
MYCONEX CADILA PHARMA
RIFACOM INDOCO
THEMIBUTOL THEMIS CHEM
TIBITOL PCI
WOKEX TRIDOSS
Domestic production 93/94 570.8T
Demand projection 94/95 531T
Raw materials:
1.dl 2 aminobutanol
2.Mono sodium glutamate
3.Glutamic acid
4.Tartaric acid
5.d 2 aminobutanol
6.d 2 amino butanol tartarate
7.1,2 dichloro ethane
8.1,2 dibromo methane
9.Glyoxal
10.Lithium aluminium hydride
Manufacturers:
1.Cadila Labs- 40T
2.Plasma Labs,Mangalore- 70T- 7/92
Patient Information:
1. May cause stomach upset; take with food.
2. Notify if changes in vision( eg blurring, red-green colour blindness) or skin rash occurs.
3. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to ethambutol or other related medicines. Also tell your doctor if your are allergic to any other substances such as foods, preservatives or dyes.
4.Pregnancy- pregnant women with tuberculosis should be treated with TB medicines,including ethambutol. However, studies in animals have shown that ethambutol causes cleft palate, skull and spine defects absence of one eye and hare lip.
5. Breast feeding- ethambutol has not been shown to cause problems in nursing babies
6. Children- not normally used in children younger than 6 years of age becau it may be hard to tell if they are having side effects affecting their eyes.
7. Elderly- this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
8. Other medicines- tell your doctor if you are taking any of the following-
if you are taking any other non prescription medicines or OTC medicines
9. Other medical problems-
Make sure if you have any other medical problems-
Gouty arthiritis - ethambutol may cause or worsen attacks of gout
Kidney disease- patients with kidney disease may be more likely to have side effects
Optic neuritits - ethambutol may cause or worsen eye disease
10.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 go back to your regular dosing schedule.
Do not double doses.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Ethambutol diffuse into actively growing mycobacterium cells such as tubercle bacilli. It
arrests synthesis of one or more metabolites, thus causing impairment of cell metabolism,
arrest of multiplication and cell death.
Pharmacokinetics:
Following a single oral dose of 15/25mg/kg, ethambutol attains a peak of 2 to 5mcg/ml in
serum 2 to 4 hours after administration. During the 24 hours following oral administration, about 20% of ethambutol is metabolised by the liver. About 50% of unchanged drug is excreted in the urine.
Interaction with Food:
Absorption is not significantly altered by administration of food.
Pregnancy and lactation:
Pregnancy:
The effects of combinations of ethambutol with other antituberculous drugs on the fetus
are not known. Use only when needed, when the potential benefits outweigh the potential
hazards.
Children:
Not recommended for use in childrern below 13 years.