Diphenhydramine, Naphazoline
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2019-09-19
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Clinical Pharmacology
Pharmacodynamics
Combined drug with antihistamine (diphenhydramine) and vasoconstrictor (naphazoline) action.
Diphenhydramine is an antagonist of histamine H1 receptors. By competitively blocking histamine H1 receptors, it reduces allergic symptoms, especially those associated with histamine release, such as increased permeability and vascular dilation.
Naphazoline stimulates vascular alpha-adrenergic receptors, its local application leads to a narrowing of the dilated vessels and a decrease in the symptoms of the inflammatory state.
Pharmacokinetics
The full local effect of naphazoline appears already after 5 minutes from the moment of use. The action lasts 6-8 hours.
Naphazoline can be absorbed from the mucous membranes, causing systemic effects, although such an effect is unlikely in adults after administration of the drug in the conjunctival sac. Systemic reactions occur mainly in elderly patients and in young children.
The manifestation of the systemic action of diphenhydramine is unlikely.
Indications
exacerbation of seasonal or year-round allergic conjunctivitis;
inflammatory conditions associated with conjunctival irritation as a result of the use of contact lenses, exposure to sunlight, cigarette smoke, contact with water in a swimming pool, etc.
Composition
1 ml of the preparation contains:
Active ingredients:
Diphenhydramine hydrochloride
Naphazoline nitrate (naphthyzine)
1.0 mg
0.33 mg
Excipients:
Boric acid 16.0 mg
Macrogol 300 1.125 mg
Sodium hyaluronate 1.0 mg
Disodium edetate dihydrate (Trilon B) 0.5 mg
1 M sodium hydroxide solution
or nitric acid 0.1 M solution
up to pH 4.0 - 7.0
Water for injection up to 1 ml
Diphenhydramine, Naphazoline is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| Sigida duo | eye drops | ||
| Polynadim | Synthesis AKOMP | Russia | eye drops |
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Dosage and Administration
Locally, in the conjunctival sac.
Adults and children over 6 years: 1-2 drops in the conjunctival sac with
need every 6-8 hours.
The drug should not be used for longer than 3-5 days.
The procedure for working with a drip tube:
1. Open the package, separate one tube-dropper, put the rest in
package.
2. Open the dropper tube (making sure the solution is in the bottom
tube-dropper, rotate the rotation and separate the valve).
3. Instill the required amount of the drug in the eye.
The dose contained in the tube-dropper is sufficient for one instillation in both eyes.
After a single use, the dropper tube should be discarded, even if
content left.
Adverse reactions
Burning, itching, hyperemia, irritation of the conjunctiva, eye pain, visual disturbances, dryness of the nasal mucosa, mydriasis, increased intraocular pressure.
A single case of corneal opacification is described (when used for 7 days at least 10 times a day), which disappeared after cessation of treatment.
Prolonged use may lead to local epithelial changes associated with hypoxia (worsening prognosis).
Contraindications
hypersensitivity to any component of the drug (including
sympathomimetic amines);
pregnancy;
breast-feeding;
angle-closure glaucoma;
children's age (up to 2 years).
Drug interactions
The use of the drug containing naphazoline, while taking tricyclic antidepressants can potentiate the vasoconstrictor effect of naphazoline.
Simultaneous use of naphazoline with monoamine oxidase inhibitors may lead to the development of a hypertensive crisis.
Pregnancy and Lactation
During pregnancy, the use of the drug is not recommended. If necessary
use of the drug during lactation breastfeeding is recommended
stop
Special instructions
The drug is intended for topical use only: instillation in the conjunctival sac.
Overdosage
Symptoms: prolonged or too frequent use in children under 6 years of age may
lead to inhibition of the central nervous system, hypothermia (decrease in body temperature), prolonged
mydriasis, increased blood pressure, tachycardia, coma.
Treatment: symptomatic.
- Brand name: Psilo balm
- Active ingredient: Diphenhydramine
- Dosage form: Gel for external use 1%. On 20 g or 50 g in aluminum tubes. Each tube, along with instructions for medical use of the drug is placed in a stack of cardboard.
- Manufacturer: Nizhpharm
- Country of Origin: Russia
Studies and clinical trials of Diphenhydramine, Naphazoline (Click to expand)
- Simultaneous determination of naphazoline, diphenhydramine and phenylephrine in nasal solutions by capillary electrophoresis
- Analysis of Diphenhydramine Hydrochloride and Naphazoline Hydrochloride in Presence of Methylene Blue in Eye Drops by Second Derivative Spectrophotometry
- Effects of Diphenhydramine, Naphazoline and m-Amino-α(1-Aminoethyl)Benzyl Alcohol Dihydrochloride on the Nasal Mucosa Determined by Impedance Method: a Simple Method for Evaluation of Nasal Decongestant
- Diphenhydramine/naphazoline
- Sub-Minute Method for Determination of Naphazoline in the Presence of Diphenhydramine, Pheniramine or Chlorpheniramine by Capillary Electrophoresis
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