Pirafene 5mg/1ml ampoules COMPANY NAME: Memphis company for pharmaceutical & chemical Industries. TRADE NAME: Pirafene GENERIC NAME: chlorpheniramine maleate COMPOSITION: Each 1 ml ampoule contains : Active ingredient: Chlorpheniramine maleate 5 mg Excipients : sodium chloride , sodium acid phosphate, sterile water for injection. PHARMACEUTICAL FORM: Solution in ampoule for subcutaneous, intramuscular or intravenous infusion. PHARMACOLOGICAL ACTION: PHARMACODYNAMICS: Pharmacotherapeutic group: Antihistamines for systemic use, substituted alkylamines. Antihistamines, including Chlorpheniramine, used in the treatment of allergy act by competing with histamine for H1- receptor sites on cells and tissues. Chlorpheniramine also has anticholinergic activity. The mechanism by which Chlorpheniramine exerts its anti-emetic, anti-motion sickness and anti-vertigo effects is not precisely known but may be related to its central actions. Further, most antihistamines, including Chlorpheniramine, cross the blood-brain barrier and probably produce sedation largely by occupying H1-receptors in the brain. PHARMACOKINETICS: Following IV administration, the apparent steady-state volume of distribution of Chlorpheniramine is approximately 3L/kg in adults and 3.8L/kg in children. Chlorpheniramine is approximately 70% bound to plasma proteins. In adults with normal renal and hepatic function, the terminal elimination half-life of Chlorpheniramine reportedly ranges from 12 to 43 hours. The systemic exposure per mg dose is lower in children than adults and the elimination half-life may be shorter. INDICATIONS: Chlorpheniramine is indicated in adults, and children (aged 2 years to 18 years) for: • acute urticaria • control of allergic reactions to insect bites and stings • angioneurotic oedema • drug and serum reactions • desensitisation reactions • hayfever • vasomotor rhinitis • severe pruritus of non-specific origin. DOSAGE AND ADMINISTRATION: Posology Adults The usual dose of Chlorpheniramine injection for adults is 10 mg to 20 mg, but not more than 40 mg should be given within a 24-hour period. The injection should be given immediately after opening the ampoule. Once opened, any unused portion should be discarded. When a rapid effect is desired, as in anaphylactic reactions, the intravenous route is recommended in addition to emergency therapy with adrenaline (epinephrine), corticosteroids, oxygen and supportive therapy as required. In this case Chlorpheniramine injection should be injected slowly over a period of one minute, using the smallest adequate syringe. Any drowsiness, giddiness or hypotension which may follow is usually transitory. In the event of a blood transfusion reaction, a dose of 10 mg to 20 mg of Chlorpheniramine injection should be given by the subcutaneous route. This can be repeated to a total of 40 mg within a 24-hour period, or oral forms of Chlorpheniramine may be given until the symptoms subside. Chlorpheniramine injection may be helpful in the prevention of delayed reactions to penicillin and other drugs when given separately by intramuscular injection immediately prior to administration of the other drug. The usual dose is 10 mg. Chlorpheniramine injection cannot, however, be relied on to prevent anaphylactic reactions in patients known to be allergic to a particular drug. Paediatric population The dose for children should be calculated, based on either the child's age or their body weight, using the following table: Age Dose 2 to 5 years 2.5 mg to 5 mg OR 0.20 mg/kg 6 to 12 years 5 mg to 10 mg OR 0.20 mg/kg 12 to 18 years 10 mg to 20 mg OR 0.20 mg/kg - Pirafene ampoule should not be used for children less than two years old and used for children less than 6 years old under medical supervision. - Extra care should be taken when preparing the injection for children from 2 years due to the small volumes that are required. Dilution of Chlorpheniramine injection with sodium chloride intravenous infusion (0.9% w/v) should facilitate preparation. For example, diluting 0.2 ml Chlorpheniramine injection to 2 ml with sodium chloride 0.9% injection produces a solution containing Chlorpheniramine 1 mg/ml. The diluted product should be used immediately. The diluted solution should be inspected visually for particulate matter and discoloration prior to administration. In the event of either being observed, discard the medicinal product. Only clear solution should be used. Method of administration Intramuscular Subcutaneous Intravenous When administered intravenously the injection should be given slowly over a period of one minute in order to avoid hypotension or central nervous system
