Sivotheotamol Theophylline and Salbutamol Tablet

SIVOTHEOTAMOL TABLET

 

DESCRIPTION

Sivotheotamol contains an active ingredient Theophylline and salbutamol. Theophylline chemical name is 1,3-Dimethyl-3,7- dihydro-1H-purine-2,6-dione. Salbutamol chemical name is (1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxy- 3(hydroxymethyl)phenyl]ethanol.

 

LABEL CLAIM

Each uncoated tablet contains:
Theophylline (Anhydrous) BP 100mg
Salbutamol Sulphate BP
equivalent to salbutamol 2mg
Colour: Erythrosine

 

MECHANISM OF ACTION

PHARMACODYNAMICS

Salbutamol is a seIective β2- agonist. It causes bronchial smooth muscle relaxation via the cyclic adenyl cyclase (CAMP) system. Theophylline is a phosphodiesterase inhibitor. It enhances intracellular cAMP conc thereby contributing to bronchial smooth muscle relaxation.

 

PHARMACOKINETICS

Theophylline is well absorbed from uniphyllin continus tablets and at least 60% may be bound to plasma proteins. The main urinary metabolites are 1,3-dimethyl uric acid and 3-methylxanthine. Salbutanol is readily absorbed from the gastrointestinal tract. Its effects occur within 15 minutes and last for about 14 hours.

 

INDICATIONS

For the relief of bronchospasm in bronchial asthmas of all types. Chronic bronchitis, Emphysema, inhibition of premature labour in selected patients where a definite benefit is likely to occur.

 

DOSAGE

Oral, 1 or 2 tab 3-4 times daily.

 

CONTRAINDICATION

Hypersensitivity, thyrotoxicosis.

 

DRUG INTERACTION

Increased theophylline toxicity with propranolol, cimetidine, erythromycin (7-5 days), quinolone antibiotics.

 

SIDE EFFECTS

Seizures, tremor, muscle cramps, palpitation, hypokalaemia, headache; anorexia, nausea, anxiety, irritability, insomnia, rarely rash and angioedema.

 

OVER DOSAGE

If overdose is suspected, contact the hospital nearest to you immediately. Symptoms of overdose may include: seizures, increase in blood pressure, increase in heart rate, nervousness, headache, dry mouth, palpitation, nausea, dizziness and sleep deprivation.

 

KEEP OUT OF THE REACH OF CHILDREN.

 

PACKING

10 x 10 Tablets packed in Strip along with pack insert.

 

NAFDAC Regn. No. : A4-8866

 

Manufactured in India by

Rhydburg Pharmdceuticals Ltd.

C-2 & 3, S.I.E.L., Selaqui, Dehradun

Uttarakhand, INDIA

 

Manufactured for

Adpharm Pharmaceuticals Ltd.

60 Ajao Road, Surulere,

Lagos State, Nigeria

Salbutamol Sulphate Tablets

SALBUTAMOL TABLETS BP 2mg/4mg

 

Composition

Each uncoated tablets contains

Salbutamol Sulphate BP

Equivalent to Salbutamol 2mg/4mg

Excipient q.s.

Approved colour used

 

Pharmacological Action

Salbutamol is a beta-adrenergic stimulant which has a selective action on bronchia; beta-adreno-receptors.

 

Indication

Salbutamol Tablets is indicated for the relief of bronchospasm in patients 6 years of age or older with reversible obstructive airways disease.

 

Contraindications

Salbutamol Tablets is contraindicated to cardiac arrhythmia along with tachycardia, narrow angle glaucoma, shock, hypersensitivity, halongenated GA agents.

 

Drug Interactions

The adverse effects of high doses of Salbutamol amy be exacerbated by concomitant administration of high doses of corticosteroids. The effects of Salbutamol are antagonized by propranolol and other Beta-adrenoceptor blocking agents and enhanced by aminophyline or other xanthenes. An increased risk of arrhythmias may occur if patients are receiving cardiac glycosides, quinidine or tricyclic antidepressants. Interaction with alpha-and beta-blocking agents may occur.

 

Side Effects

Tremor, Nervousness, Hypokinesia, Nausea, Vomiting, Headache, Muscle cramp, Hypokalaemia, Palpitions, Tachycardia Arrhythmias, Throat irritation.

 

Precautions

Diabetes mellitus may aggravate any pre-existing D.M. and D.K.A. may require an increased dose of OHA/insulin, BHP Hypertension, Renal or hepatic disease.

 

Presentation

1000 tablets in one jar along with its packaging insert.

 

Storage

Store in a cool, dry and dark place.

 

Manufactured by

Medico Remedies Pvt. Ltd.

Palghar, Maharashtra-401 404

India.

 

Marketed by

Manfes Pharmaceuticals Ltd.

3, Belawa Street, Fegge, Onitsha,

Anambra State, Nigeria.