Sodium Oxybate 500mg/ml oral solution

COMPOSITION

Each 5 ml contains: 

• Diphenhydramine hydrochloride 10 mg
• Ammonium chloride 100 mg
• Sodium Citrate 40 mg
• Menthol 1 mg

PHARMACOLOGICAL CLASSIFICATION

Antitussives and expectorants.

PHARMACOLOGICAL ACTION

Diphenhydramine hydrochloride is an antihistaminic and, by its atropine-like action, relieves cough.

INDICATIONS

Letalin is indicated for the relief of cough in children above 6 years and adults.

CONTRA-INDICATIONS

Known hypersensitivity to any of the ingredients. Diphenhydramine hydrochloride should not be used with monoamine oxidase inhibitors or within 14 days of stopping monoamine oxidase inhibitor treatment.

Contra-indicated during acute asthmatic attacks, and in patients with impaired hepatic or renal function.

Safety in pregnancy and lactation has not been established.

Should not be used in children under the of 6 age years.

WARNING

This medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.

Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights as impaired decision making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE

A maximum of four doses per day should not be exceeded. 

• Children (above 6 years): 2.5 ml - 5 ml every 4 hours 
• Adults: One to two 5 ml medicine measures every 3 - 4 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

Diphenhydramine hydrochloride: The most common side-effect of diphenhydramine hydrochloride is sedation which can vary from slight drowsiness to deep sleep, and includes lassitude, dizziness and in coordination. Other side- effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhea or constipation, anorexia or increased appetite, and epigastric pain. Antimuscarinic effects include blurred vision, dryness of the mouth and tightness of the chest. Other central effects include hypotension, muscular weakness, tinnitus, euphoria, and headache. In infants and children, it may act as a cerebral stimulant. Symptoms of stimulation include insomnia, nervousness, tachycardia, tremors and convulsions.

Large doses may precipitate fits in epileptics. Deepening coma, extra pyramidal effects and photosensitization of the skin may occur.

Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects.

Allergic reactions and anaphylaxis may occur. Blood dyscrasias including agranulocytosis, leucopenia and hemolytic anemia may occur. Diphenhydramine has been reported to cause thrombocytopenia. The positive results of skin tests may be suppressed.

Diphenhydramine hydrochloride has anticholinergic properties and should be used with care in conditions such as glaucoma, urinary retention and prostatic hypertrophy. Diphenhydramine hydrochloride should be used with caution in patients with liver impairment or cardiovascular disease.

The anticholinergic effects of atropine and tricyclic antidepressants may be enhanced by diphenhydramine hydrochloride. MAO inhibitors may enhance the anticholinergic effects. Diphenhydramine hydrochloride may mask the warning symptoms of damage caused by ototoxic medicines such as amino glycoside antibiotics and may affect the metabolism of other medicines in the liver. It may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillizers.

Ammonium chloride: Large doses of ammonium chloride may cause nausea, vomiting, drowsiness, thirst, headache, hyperventilation, profound acidosis and hypokalemia. Excessive doses may give rise to hepatic encephalopathy.

KNOWN SYMPTOMS OF OVER DOSAGE AND PARTICULARS OF ITS TREATMENT

Diphenhydramine hydrochloride: Over dosage may be fatal especially in infants and children.

In infants and children CNS stimulation predominates over CNS depression causing ataxia, excitement, tremors, psychoses, hallucinations and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. In adults: CNS depression with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardiovascular collapse. Treatment is symptomatic and supportive.

PREGNANCY AND LACTATION

Ask your doctor or pharmacist for advice before taking this medicine.

INTERACTION WITH FOOD AND/OR DRUGS

Letalin syrup may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and antipsychotics.

PRESENTATION: 125ml amber bottle.

STORAGE INSTRUCTIONS: Store in a cool place below 30°C.

KEEP OUT OF REACH OF CHILDREN.

Inactive ingredients: Sugar, Sodium Citrate, Citric Acid, Sodium Benzoate, Amaranth color and flavor, Ethyl Alcohol, Raspberry Flavor Liquid, Sunset Yellow.

Date of Publication: January 2014

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

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