Pheniramine Maleate: Uses,Dosage,Side Effects

Generic Name

Pheniramine Maleate
Therapeutic Class: Sedating Anti-histamine

Indications:
In different allergic conditions (hypersensitivity reactions) such as:

• Seasonal and perennial rhinitis;
• Hay fever (pollinosis) with attacks of sneezing, itching, running of the nose;
• Conjunctivitis;
• Different skin allergies like; dermatitis, eczema, urticaria, angioedema;
• Pruritus of various etiology;
• Vasomotor rhinitis;
• Vertigo.

Presentation:
Pheniramine Maleate Syrup: Each 5 ml syrup contains Pheniramine Maleate BP 15 mg.

Description:
Pheniramine Maleate is suitable for the treatment of hypersensitivity reactions and pruritus of varying origin.

Dosage & Administration:
Unless otherwise prescribed by the doctor, the following dosages are recommended for the different dosage forms:

Pheniramine Maleate Injection Solution: Except in life-threatening conditions, the initial dose should be kept as low as possible: particularly in small children, a daily dose of 3 mg active substance per kg body weight should not be exceeded.

The following doses are administered once or twice daily:

• Adults and Young people aged 12 years or over: 1.0-2.0 ml IV/IM.
• Children aged 1-2 years (about 11-14 kg body weight): 0.5-0.7 ml IM only
• Children aged 3-5 years (about 20 kg body weight): 0.8-1.3 ml IM only
• Children aged 6-11 years (up to about 25 kg body weight): 1.0-1.5 ml IM only 

Pheniramine Maleate Injection (45.5 mg/2 ml): This is administered to adults and young people aged 12 years or over either slowly by intravenous route (1 ml per minute) or intramuscularly. To infants and children up to 12 years old the injection must only be given intramuscularly. The recommended dose may be repeated at 12 hourly intervals until acute symptoms have subsided. Pheniramine Maleate can be combined with commercial calcium preparations but the compatibility should be tested in individual cases.

Pheniramine Maleate Tablet (22.7 mg): In adults and young people over 12 years of age it is advisable to begin treatment with 1 tablet 2-3 times daily after meals. If necessary, the daily dose may be increased to 2 tablets 3 times daily from the second day of treatment onwards.

Pheniramine Maleate Syrup (15 mg/5 ml): is particularly suitable for children. Children aged 1-3 years should receive half a measuring spoonful two or three times daily; children aged 4-12 years, 1 measuring spoonful 2 or 3 times daily; adults and young people 1-2 measuring spoonful of syrup twice or three times a day after meals. A daily dose of 3 mg/kg body weight must not be exceeded. Diabetics must bear in mind that Pheniramine Maleate Syrup contains carbohydrates which are equivalent to 1.75 gm glucose per measuring spoonful (5 ml)

Pheniramine Maleate Retard Tablet (75 mg): The coated tablets have a prolonged action. In most adults and adolescents over 12 years of age 1 coated tablet taken after supper is sufficient to produce an antihistaminic effect that for up to 24 hours. Only in very resistant cases will it be necessary to give an additional coated tablet in the morning after breakfast. The tablets are swallowed whole with a little liquid.

Side Effects:
Occasionally there may be drowsiness, gastrointestinal complaints, dryness of mouth, palpitation, urinary retention, or hypersensitivity reactions. In isolated cases, higher doses may produce hallucinations, restlessness, or confusion; in small children, agitation. In patients with narrow-angle glaucoma, a rise in intraocular pressure is possible, which makes ophthalmologic control necessary. Even if used according to prescription, these preparations may reduce alertness to such an extent that the ability to cope with street traffic or operate machinery is impaired.

Precautions:
During pregnancy and lactation, pheniramine should be used only if strictly indicated,
and after considering the benefit/risk ratio for mother and child.

Interaction:
The effect of drugs that act on the central nervous system (e.g. tranquilizers, sedatives, neuroleptic agents, and MAO inhibitors) and of alcohol may be potentiated.

Pregnancy & Lactation:
Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Overdose:
Symptoms: Agitation and convulsions (especially in children), and restlessness, disorientation, and hallucinations in adults. Accidental ingestion in small children has resulted in convulsions and in some cases fatal.

Treatment: No specific antidote; symptomatic and supportive. Gastric lavage may be useful for some time after ingestion. Do not use stimulants. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used for hypotension.

Storage:
Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician. Do not use later than the date of expiry.