Sodium Oxybate 500mg/ml oral solution

Each 5ml contains:

Cyproheptadine Hydrochloride B. P. Equivalent to 

Anhydrous Cyproheptadine hydrochloride 2mg

L-Lysine Hydrochloride U. S. P. 150mg

Proteolyzed Liver Extract 25mg

PHARMACOLOGICAL CLASSIFICATION:

Dynewell Syrup, an orally administered syrup, is a rational combination of a powerful antihistamine ant serotonin agent. Cyproheptadine an essential amino acid, lysine, near complete formulation of Proteolyzed Liver Extract.

PHARMACOLOGICAL ACTION

The pharmacology effect of Dynewell Syrup is based on its peripheral and central action. In experimental animals, it has been investigated that Cyproheptadine, an ingredient of Dynewell Syrup, antagonised serotonim and histamine, with Broch constrictive, spasmogenic, vasopressive and gastro-secretory properties. The central action of Dynewell Syrup is manifested by its sedative and Anti tremorgenic properties. Lysine and the Proteolised Liver Extract provide a favorable condition for tissue growth and repair.

PHARMACOKINETICS

After absorption from the gastrointestinal tract, cyproheptadine hydrochloride undergoes almost complete metabolism. Metabolites are excreted principally in the urine as conjugates, and also in the faeces.

INDICATIONS

Dynewell Syrup is indicated as an appetite stimulant and also includes L-lysine and Liver Extract as dietary supplements.

CONTRAINDICATIONS

As with other drugs possessing anticholinergic activity, Dynewell Syrup is contraindicated in patients with glaucoma and urinary retention.

ADVERSE REACTIONS

The most important side effect of Dynewell Syrup is drowsiness in some individuals. Other side effects such as dry mouth, dizziness and nausea have been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

Signs and symptoms of cyproheptadine overdosage may vary from hallucinations and central nervous system depression or stimulation to convulsions and death, especially in infants and children. Atropine-like effects (dry mouth, fixed dilated pupils, flushing, etc.), as well as gastro- intestinal symptoms may occur. If overdosage occurs, the patient should be monitored, and standard supportive treatment applied as required. If vomiting has not occurred spontaneously, vomiting should be induced if the patient is conscious, or the patient should be subjected to gastric lavage.

Stimulants should not be used.

SPECIAL PRECAUTIONS

Dizziness, sedation and hypotension is more likely to occur in elderly patients. Prolonged therapy with cyproheptadine may cause blood dyscrasias. Due to the atropine-like action of cyproheptadine, it should be used with caution in patients with a history of bronchial asthma, hyperthyroidism, increased intra-ocular pressure, cardiovascular disease and hypertension.

DOSAGE

Unless otherwise prescribed by the Physician.

Adults & Children of age Six (6) years and above: 10 ml 2 to 3 times a day

PREGNANCY AND LACTATION

Safety in pregnancy and lactation has not been established.

Ask your doctor or pharmacist before using this medicine.

INTERACTION WITH FOOD AND/OR DRUGS

Monoamine oxidase (MAO) inhibitors may prolong and intensify the anticholinergic effects of cyproheptadine. Cyproheptadine may have additive effects when combined with alcohol and other CNS depressants, e.g. hypnotics, sedatives, tranquillizers and anxiolytic agents.

STORAGE INSTRUCTIONS

Keep tightly closed and store in a cool (below 30°C) place.

Keep out of reach of children.

Presentation: 200ml Amber Bottle.

Inactive ingredient: Sugar, Sorbitol, Sorbic Acid, Potassium sorbate, Glycerin, Sodium Saccharin, Citric Acid, Ethyl, Alcohol, Sunset Yellow Color, Lemon oil, Flavors.

Date of Publication: January 2014.

Letap Pharmaceuticals Limited.

P.O. Box 3346, Plot 107, Graphic Road, Accra, Ghana.