• Pheniramine Maleate is indicated for the treatment of various allergic conditions, including hay fever, drug-induced rashes, angioneurotic edema, serum sickness, allergic conjunctivitis, and food allergies.
• It is also used in respiratory conditions associated with increased secretions, such as vasomotor rhinitis and acute rhinitis.
• Additionally, it is effective in managing a wide range of pruritic (itching) skin disorders, including neurodermatitis, eczema of any origin, lichen planus, acute and chronic urticaria, itching of the anus or genital area, and pruritus associated with jaundice or diabetes, as well as radiation sickness.
• Pheniramine Maleate is further indicated for the prevention and treatment of motion sickness, as well as for nausea, vomiting, and vertigo associated with Meniere’s disease and other labyrinthine disorders.

Pheniramine is a competitive H1 histamine receptor antagonist. Like other alkylamine antihistamines, it can also block muscarinic cholinergic receptors and has local anesthetic properties. However, the concentration needed for local anesthesia is likely not reached at normal therapeutic doses.

Pheniramine acts by competing with histamine at H1 receptors and functions as an inverse agonist after binding. This reduces H1 receptor activity, leading to decreased itching, as well as reduced vasodilation and capillary permeability, which in turn lowers redness and swelling. These effects are evident in the suppression of histamine-induced wheal (swelling) and flare (vasodilation) responses. Its action on H1 receptors in the central nervous system also contributes to the sedative effects commonly seen with first-generation antihistamines such as pheniramine. Additionally, pheniramine may bind to H4 receptors and exert inverse agonist activity, further helping to reduce itching by modulating inflammatory responses.

Doses must be individually determined in all cases and should be taken with or soon after food. Treatment should be commenced at the lowest possible dose because experience has shown that antihistamines are often effective at low doses. The maximum dose of 3 mg/kg per day should not be exceeded. Elderly patients should use the adult dose with caution.

To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.

Pheniramine Maleate tablets:

• In adults and children over 10 years of age: Treatment is commenced with half a tablet taken up to three times daily. This dose may be increased to one tablet taken up to three times daily if required.
• Children 5-10 years of age: Half a tablet up to three times daily. Pheniramine Maleate tablets are not recommended in children under 5 years of age.

• MAO inhibitors may prolong and strengthen the anticholinergic effects of Pheniramine (see Contraindications).
• Alcohol and other CNS depressants (such as hypnotics, sedatives, and tranquilizers) may increase the sedative effects of Pheniramine.
• Atropine and related drugs can enhance the anticholinergic activity of Pheniramine.

• Allergy or hypersensitivity to Pheniramine or any other ingredient (e.g., methyl hydroxybenzoate or propyl hydroxybenzoate in the syrup)
• Symptomatic prostatic hypertrophy (enlarged prostate with symptoms)
• Patients currently taking MAO inhibitors
• Newborns and premature infants

• Most common: Sedation, which often decreases after a few days as tolerance develops.
• Hypersensitivity: Allergic reactions have been reported.
• Central Nervous System: Lassitude (fatigue), dizziness, tinnitus (ringing in the ears), difficulty concentrating, incoordination, irritability, insomnia, and tremors. Overdose may cause agitation, convulsions (especially in children), and restlessness, disorientation, or hallucinations in adults.
• Gastrointestinal: Nausea, vomiting, diarrhea, colic, epigastric pain, loss of appetite (anorexia), dry mouth, and constipation.
• Genitourinary: Urinary retention.
• Cardiovascular: Palpitations, headache.
• Ocular: Blurred vision, increased intraocular pressure.
• Musculoskeletal: Muscle weakness.
• Hematological: Rare cases of blood disorders, including agranulocytosis and hemolytic anemia, have been reported.

Pregnancy Category A: Use only when clearly necessary.

• Drowsiness: Pheniramine may cause drowsiness. Dosage and timing should be carefully considered for patients performing activities that require alertness, such as driving or operating machinery.
• Alcohol and CNS depressants: Patients should avoid alcohol and other central nervous system depressants while taking Pheniramine.
• Overdose risk: At toxic doses, Pheniramine may cause hallucinations. It has potential for abuse due to its CNS-stimulating effects.
• Anticholinergic effects: Caution and close monitoring are needed in patients with prostatic hypertrophy, narrow-angle glaucoma, asthma, or severe cardiovascular disease.
• Masking other conditions: The anti-emetic effect may hide symptoms of other illnesses.
• Administration: Pheniramine should not be taken on an empty stomach.

Symptoms: In toxic doses, antihistamines can produce a combination of central nervous system (CNS) stimulation and depression. Accidental ingestion, particularly in young children, may lead to convulsions and can occasionally be fatal.

Management: There is no specific antidote, so treatment is mainly symptomatic and supportive. Inducing vomiting should only be considered immediately after ingestion, as the sedative effects of absorbed antihistamines increase the risk of life-threatening aspiration. Gastric lavage using a cuffed endotracheal tube may be beneficial, since the anticholinergic effects of antihistamines delay gastric emptying. Stimulants should be avoided as they may trigger convulsions. Seizures can be managed with diazepam or short-acting barbiturates. Hypotension may be treated with vasopressors. In cases of severe respiratory depression, mechanical ventilation may be necessary. Continuous ECG monitoring is advised if cardiac toxicity occurs, and centrally acting anticholinesterases such as physostigmine may be used when appropriate.

Sedating Anti-histamine

Keep in a cool, dry place protected from light. Do not use after the expiry date. Keep out of reach of children. Use only with a prescription from a registered physician.