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Pirafene

Tablets, Syrup, Ampoule


Composition:
Chlorpheniramine maleate:
Each tablet contains
4 mg
Each 5 ml contains
2 mg
Each 1 ml ampoule contains
5 mg

 

 

Pharmacological properties:
Pirafene is an antihistamine, with anticholinergic effect. It competitively antagonize the pharmacological effects of histamine.
Histamine-related allergic reactions and tissue injury are blocked.
Pirafene antagonize the vasodilator effect of endogenously released histamine. As a consequence of these actions, antihistamines antagonize the physiological manifestations of histamine release in the nose such as congestion related to vascular engorgement, mucosal edema and irritation as well as sneezing effect.

Pharmacokinetics:
Pirafene is readily absorbed from the gastrointestinal tract and from the site of injection. It is excreted in urine, and it is bound (about 70% ) to plasma proteins.

Indications:
Pirafene is indicated for symptomatic relief of allergic reactions due to hay fever, urticaria and anaphylactoid reactions due to pollen grains, dust, food, drugs and allergic rhinitis.

Contraindications:
Pirafene is contraindicated in patients who are hypersensitive to Chlorpheniramine maleate or to any antihistamines of similar chemical structure.

Side effects:
Drowsiness is a significant side effect and it may diminish after a few days of treatment.
- Other side effects: hypersensitivity reactions (including: bronchospasm, angiooedema and anaphylaxis, rashes and photosensitivity reactions).
Extrapyramidal effects, confusion, depression, dryness of mouth and throat, tachycardia, nausea, vomiting, headache, fatigue, blurred vision, anorexia, difficult urination, sleep disturbances, tremor, blood disorders and liver dysfunction.
- Also reported: exfoliative dermatitis and tinnitus.
In case of injections: may cause transient hypotension or CNS stimulation and may be irritant.

Drug interactions:
- Increased sedative effect when Pirafene given with anxiolytics, hypnotics and alcohol.
- Increased antimuscarinic and sedative effects when Pirafene is given with tricyclic antidepressants, MAOIs and possible increase in antimuscarinic and sedative effects when given with tricyclic related antidepressants.
- Increased risk of antimuscarinic side effects when Pirafene is given with antimuscarinics.

Warnings & Precautions:
- Pirafene should be used with caution in patients with narrow angle glaucoma & peptic ulcer, as well as elderly patients and C.V. diseases.
- Patients taking Pirafene should not engage in activities requiring mental alertness such as driving a car.
- Use in children: in infants & children, especially, antihistamines in overdo sage may cause hallucinations, convulsions, or death.
- As in adults, Pirafene may diminish mental alertness in children. In the young child, particularly, antihistamines may produce excitation.
- Pirafene should be used with caution in prostatic hypertrophy, hepatic disease, urinary retention, pyloroduodenal obstruction, epilepsy and dose reduction may be necessary in renal impairment.
- Pirafene should be used with caution in patients with history of bronchial asthma, hyperthyroidism, hypertension & increased intraocular pressure.
- Pirafene may be used in children in appropriate doses. Excessive doses lead to unconsciousness, hypotension and occasionally convulsions.
- In case of injection, Pirafene should not be administered to children less than 12 years of age.

Pregnancy:
Pirafene should be used during pregnancy only if clearly needed except in the third trimester.

Lactation:
Discontinue nursing or the administration of drug, taking into account the importance of the drug to the mother.

Overdosage & antidote:
Manifestations of overdosage may vary from CNS depression (sedation, apnea, diminished mental alertness) to stimulation (insomnia, tremors or convulsions).

Treatment:
Induce vomiting (by the administration of Ipecac syrup) or gastric lavage.

Dosage and administration:
Ampoule: SC or IM injection, 10-20 mg repeated if required.
IV injection, 10-20 mg slowly.
Orally: Adults: 4 mg every 4 -6 hours daily
           Children: 6-12 years, 2 mg every 4-6 hours.

Therapeutic category: Antihistamine

Legal category: Tablet: OTC & POM
                           Syrup: OTC
                           Injection: POM

Package:
Tablets: Boxes of 20 tablets & boxes of 1000 tablets.
Syrup: bottles of 120 ml.
Ampoules: Boxes of 100 ampoules.
Boxes of 6 ampoules.

Storage:
Ampoule, Syrup: protect from light, at a temperature below 30° C.
Tablet: protect from light, in a dry place, 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.