Dimedrol-BP (inj)

Diphenhydraminum

One ampoule (1 ml) contains diphenhydramine hydrochloride 10 mg.

Indication: Antihistamine and anti-allergic agent: adjunctive treatment of anaphylactic or anaphylactoid shock; symptomatic treatment of immediate histamine-mediated allergic reactions (urticaria, pruritus of various etiologies, dermatitis, angioedema, allergic rhinitis, allergy to pollen, food and medicines). Hypnotic agent: short-term treatment of occasional insomnia. Motion sickness: active treatment when oral therapy is not possible. Antiemetic: postoperative vomiting.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
− Pregnancy and breast-feeding
− Newborn or premature infants
− Acute exacerbation of bronchial asthma
− Phaeochromocytoma
− Angle-closure glaucoma
− Convulsive disorders (eclampsia, epilepsy)
− Myasthenia gravis
− Congenital long QT interval syndrome or prolonged administration of medicinal products that may prolong the QT interval
− Prostatic hypertrophy
− Stenosing gastric and duodenal ulcers
− Pyloroduodenal obstruction
− Bladder-neck stenosis
− Bradycardia, arrhythmias
− Porphyria
− Use as a local anaesthetic (risk of local necrosis)
− Concomitant administration with other medicinal products containing diphenhydramine, including oral and topical forms.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Dimedrol-BP solution for injection should be used with caution in the following cases: − chronic respiratory disorders − cardiac disorders − hypertension − hyperthyroidism − renal and hepatic impairment. Diphenhydramine may worsen the course of obstructive pulmonary disease, severe cardiovascular disease, intestinal obstruction and biliary obstruction. Diphenhydramine may cause adynamia and may also cause agitation (particularly in children), hallucinations and convulsions, especially in case of overdose. Because of the existing risk of toxicity, Dimedrol-BP should not be used more often than indicated, under any circumstances; more than one preparation containing diphenhydramine should not be used concomitantly (for example, concomitant use of oral and topical medicinal products containing […]