Diphenhydramine HCL 50mg | 10mL Injectable MDV

Product Overview:

Diphenhydramine HCL 50mg in a 10mL Multi-Dose Vial (MDV) is a sterile, injectable solution of diphenhydramine hydrochloride, a first-generation antihistamine. This formulation is intended for intravenous (IV) or intramuscular (IM) administration and is used primarily in healthcare settings to provide rapid relief from allergic reactions, motion sickness, and other conditions requiring antihistamine therapy.

Key Features:

1. Concentration and Volume:

• Each vial contains 10mL of solution, with a concentration of 50mg of diphenhydramine per milliliter. This dosage form allows for precise administration tailored to the patient’s needs.

• The injectable formulation offers a quick onset of action, which is particularly useful in emergencies such as severe allergic reactions, including anaphylaxis, where prompt treatment is critical.

• Diphenhydramine is effective in treating a range of conditions, including:
• Allergic reactions (e.g., urticaria, angioedema, anaphylaxis)
• Motion sickness and nausea
• Insomnia
• Parkinsonian syndromes and extrapyramidal symptoms

• The multi-dose vial design allows for multiple administrations from a single vial, making it economical and efficient for use in clinical settings.

• The solution is sterile, pyrogen-free, and ready for immediate use, reducing preparation time and minimizing the risk of contamination.

Intended Use: Diphenhydramine HCL 50mg Injectable MDV is indicated for:

• The management of acute allergic reactions and anaphylaxis when administered with epinephrine.
• The prevention and treatment of motion sickness.
• Symptomatic relief of extrapyramidal symptoms caused by certain medications.
• Use as a sedative or hypnotic for short-term management of insomnia.

Administration:

• Dosage: The dosage should be determined by a healthcare professional, based on the patient’s condition and response to treatment.
• Route of Administration: Can be administered intravenously (IV) or intramuscularly (IM) depending on the urgency and clinical scenario.

Contraindications and Precautions:

• Contraindications: Patients with known hypersensitivity to diphenhydramine or any component of the formulation, neonates, or premature infants.
• Precautions: Use with caution in patients with conditions such as glaucoma, prostatic hypertrophy, peptic ulcer, or bladder neck obstruction. Caution is also advised in elderly patients and those with underlying cardiovascular conditions.

Possible Side Effects:

• Common side effects may include drowsiness, dizziness, dry mouth, blurred vision, and constipation.
• Serious side effects can include hypotension, confusion, respiratory depression, and hypersensitivity reactions.

Storage and Handling:

• Store at controlled room temperature, protected from light.
• Once opened, the multi-dose vial can be used multiple times according to the institution's policy, but it should be used within a designated period to maintain sterility.