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Glucolynamine ampoules

Composition:

Each 10 ml ampoule contains:
Khellin   0.03 gm
Dihydroxypropyl theophylline (diprophylline)     0.15 gm
Theophylline anhydrous 0.075 gm
Dextrose 2 gm

Properties:
Theophylline directly relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels, thus acting mainly as a bronchodilator and smooth muscle relaxant.
Khellin intensifies coronary and myocardial circulation, acting as a mild positive inotrope. It has an antispasmodic effect on smooth muscles.

Indications:
Glucolynamine is indicated for relief and/or prevention of symptoms from asthma and reversible bronchospasm associated with chronic bronchitis and emphysema.

Contraindications:-
• Glucolynamine is contraindicated in:
- Individuals who have hypersensitivity to its components or with underling seizure disorders.
- Patients with active peptic ulcer disease.

• Intravenous solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Side effects:
The most frequent side effects are usually due to overdosage:
Nausea, vomiting, headaches, irritability, reflex hyperexcitability, tachycardia, insomnia, extrasystole, palpitation, albuminuria, tachypnea, hypotension, circulatory failure.

Treatment:
In case of severe reactions, discontinue use of the drug if the patient presents with a seizure:
- Establishment of airway & administeration of oxygen.

Drug interactions:
- Toxic synergism with ephedrine and with some other sympathetic bronchodilators.
- Halothane anesthesia in the presence of Glucolynamine ampoules may produce sinus tachycardia or ventricular arrhythmias.
- Glucolynamine ampoule administered concurrently with allopurinol (high dose), cimetidine, ciprofloxacin, clindamycin, erythromycin, norfloxacin and oral contraceptives will increase serum theophylline levels. While when administered with carbamazepine, Phenobarbital, phenytion will decrease serum theophylline levels.

Warnings & precautions:
- Excessive doses of Glucolynamine may be associated with toxicity. The determination of serum theophylline levels is recommended to assure maximal benefit without excessive risk.

- Ventricular arrhythmias or convulsions may appear as the first sign of toxicity without any previous warning.

- The intravenous administeration of solutions containing dextrose without electrolytes may cause fluid overloading resulting in congested states or pulmonary edema.

- Glucolynamine must be used with caution in patients with hypoxema, hypertension, severe cardiac disease, hyperthyroidism, congestive heart failure, liver disease, in the elderly and neonates.

- Clinical evaluations and periodic determinations are necessary to monitor changes in fluid balance and electrolyte concentrations during prolonged intravenous therapy.

Pregnancy:
Glucolynamine ampoules should be used during pregnancy only if the potential benefit justifies the potential risk to fetus.

Lactation:
A decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to mother.
One ampoule once or twice daily by slow I. V. injection.

Therapeutic category: Smooth muscle relaxant and antispasmodic.

Legal category: Prescription only medicine (POM).

Package:
Boxes of 6 ampoules each of 10 ml.

Storage:
Store at a temperature below 30° C.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.