Drug Interaction:
Other beta agonists.
Digoxin, corticosteroids, xanthines
MAOIs diuretics, sympathomimetics,
Anti-cholinergics, beta-blockers, tricyclic or within 2 weeks
Halogenated hydrocarbon anesthestics
Indication:
LIST OF DRUGS DURING 2004
Sr.No- 215
Name of the Drug- Levosalbutamol Tablet 1mg/2mg &
Syrup 1mg/5ml
Pharmacological Classification- For Obstructive airway disease
Date of Approval- 16-07-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
LIST OF DRUGS DURING 2004
Sr.No- 250
Name of the Drug- Levosalbutamol rotacaps (100mcg/capsule) &
Inhaler (50mcg/actuation)
Pharmacological Classification- For Obstructive airway disease
Date of Approval- 20-10-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
LIST OF DRUGS DURING 2007
Sr.No- 37
Name of the Drug- Levosalbutamol MDI
(50mcg/actuation & Dry Powder Inhaler
(100mcg /capsule )
New dosage form
Pharmacological Classification- As approved
Date of Approval- 16-03-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007) Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Levosalbutamol MDI 50mcg/ actuation 16-03-2007
& Dry powder inhaler (100mcg/capsule)
(New dosage form)
As approved
2.Levosalbutamol Rotacaps (100mcg/capsule) 20-10-2004
& Inhaler 50mcg/actuation)
For obstructive airway disease
Bronchial spasm
Adverse Reaction:
Tremor, nervousness, headache, tachycardia, dizziness,
Hypokalemia, dry mouth, throat irritation, GI upset,
Brochospasm, urinary retention, arrhythmias, ocular effects
Pruritus, dental carries
Contra-Indications:
Hypersensitivity to atropine, soya lecithin,
or related foods eg soya bean, peanuts
Hypertrophic obstructive cardiopathy, tachyarrhythmias,
Special precautions/warnings-
Diabetes (poorly controlled ) recent MI
arrhythmias, ischemic heart disease, severe heart or vascular disorders
Hyperthyroidism, risk of narrow angle glaucoma,
Prosaic hypertrophy, bladder neck obstruction,
Cystic fibrosis, prolonged use. High dose. Deteriorating condition
Pregnancy, Lactation
Dosages/ Overdosage Etc:
Indication-
Bronchial spasm
Dosage-
2 puffs 4 times daily
Not recommended for children-
Pregnancy and lactation:
Oberve caution. Use only if needed.
Manufacturer Details