Dimetindene + Phenylephrine

Dosage form

Nasal drops

Composition per 1 ml:

Active ingredients:

dimethindene maleate – 0.25 mg; phenylephrine hydrochloride (corresponds to 2.5 mg phenylephrine) – 3.045 mg.

Excipients:

anhydrous sodium hydrogen phosphate – 4.4 mg, citric acid monohydrate – 2.6 mg, sorbitol – 35.0 mg, benzalkonium chloride – 0.1 mg, lavender oil – 0.2 mg, purified water – up to 1 ml.

Description

A transparent, colorless to slightly yellow solution with a faint specific odor of lavender.

Pharmacotherapeutic group

Combined antiallergic agent (H1-histamine receptor blocker + alpha-adrenergic agonist).

ATX code:

R01AB01.

Pharmacological properties

Pharmacodynamics

Dimetindene + Phenylephrine is a combination drug containing phenylephrine and dimethindene.

Phenylephrine is a sympathomimetic agent; when applied topically, it has a moderate vasoconstrictor effect (due to stimulation of alpha1-adrenergic receptors located in the venous vessels of the nasal mucosa), eliminates swelling of the nasal mucosa and its paranasal sinuses.
Dimetindene is an antiallergic drug - an antagonist of histamine H1 receptors, does not reduce the activity of the ciliated epithelium of the nasal mucosa.

Pharmacokinetics

Dimetindene + Phenylephrine is intended for topical use, and its activity does not depend on the concentration of active substances in the blood plasma.

Indications for use

Acute rhinitis (including runny nose due to colds), allergic rhinitis (including hay fever), vasomotor rhinitis, chronic rhinitis, acute and chronic sinusitis, acute otitis media (as an auxiliary treatment method). Preparation for surgical interventions in the nasal area and elimination of swelling of the nasal mucosa and paranasal sinuses after surgical interventions in this area.

Contraindications

Hypersensitivity to phenylephrine, dimethindene maleate or other components of the drug.

Atrophic rhinitis (including with foul-smelling discharge - ozena). Taking MAO inhibitors (simultaneously or in the previous 14 days).

Angle-closure glaucoma. Children's age up to 1 year.

Carefully

Cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), hyperthyroidism, prostate adenoma, diabetes mellitus, bladder neck obstruction (for example, due to prostatic hypertrophy), epilepsy.

As with any local vasoconstrictor, caution should be exercised when prescribing Dimetindene + Phenylephrine to patients with severe reactions to sympathomimetics, manifested by insomnia, dizziness, tremor, cardiac arrhythmia or increased blood pressure.

Use during pregnancy and breastfeeding

Given the possible systemic vasoconstrictor effect of phenylephrine, Dimetindene + Phenylephrine is not recommended for use during pregnancy and lactation.

Directions for use and doses

Intranasally.

Children under 1 year of age: contraindicated.

Children aged 1 to 6 years (under adult supervision): 1-2 drops in each nasal passage 3-4 times a day.

Children aged 6 to 12 years (under adult supervision) 3-4 drops in each nasal passage 3-4 times a day.

Adolescents over 12 years of age and adults: 3-4 drops in each nasal passage 3-4 times a day.

Before use, it is recommended to thoroughly clean the nasal passages; instilled into the nose with the head thrown back. This head position is maintained for several minutes.

The drug should not be used continuously for more than 7 days. If symptoms persist, you should consult your doctor.

Side effect

Classification of the incidence of side effects according to the recommendations of the World Health Organization (WHO):

Very often > 1/10;
Often >1/100 to <1/10;
Uncommon > 1/1000 to < 1/100;
Rarely > 1/10000 to < 1/1000;
Very rare <1/10000, including isolated reports;

From the respiratory system :

Rarely: discomfort in the nose, dry nose, nosebleeds.

Local reactions:

Rarely: burning in the area of application.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

An overdose of Dimetindene + Phenylephrine can cause sympathomimetic effects, for example, rapid heartbeat, premature contraction of the ventricles of the heart, headache in the back of the head, tremor, fatigue, increased blood pressure, emotional agitation, insomnia, pale skin.

The drug may also cause mild sedation, dizziness, stomach pain, nausea, and vomiting.

Treatment:

the use of activated carbon, laxatives in young children; in adults and children over 6 years old, take large amounts of fluid. There is no specific antidote.

High blood pressure caused by phenylephrine can be treated with alpha-blockers.

Interaction with other drugs

Phenylephrine (as well as other vasoconstrictors) is contraindicated in patients currently receiving MAO inhibitors or who have received them within the previous 2 weeks.

The drug should not be prescribed simultaneously with tri- and tetracyclic antidepressants, beta-blockers.

special instructions

Dimetindene + Phenylephrine should not be used continuously for more than 7 days without consulting a doctor. Prolonged or excessive use of the drug can cause tachyphylaxis and the “ricochet” effect associated with the re-development of nasal congestion (rhinitis medicamentosa), leading to the development of a systemic vasoconstrictor effect.

Do not exceed the recommended doses of Dimetindene + Phenylephrine! Otherwise, manifestations of the systemic effect of the drug may develop, especially in children and elderly patients.

For children under 6 years of age, only nasal drops are used.

Dimetindene + Phenylephrine does not have a sedative effect (does not affect the speed of psychomotor reactions).

The effect of the drug on the ability to drive vehicles and machinery

Does not affect.

Release form

Nasal drops (0.25 mg + 2.5 mg)/ml.

10, 15, 20, 30, 40 or 50 ml of the drug in a dark glass bottle or in a polymer bottle made of high-density polyethylene or in a polyethylene terephthalate bottle with a polyethylene dropper and a screw cap made of polypropylene with or without first opening control or sealed with a stopper - dropper and a plastic screw cap or with a dropper plug (a dropper in the form of a plastic divider), with/without a plastic screw cap and a first opening ring or equipped with a plastic divider, sealed with a plastic cap with/without a first opening ring

A label made of writing or label paper, or a self-adhesive label, is attached to each bottle.

Each bottle, together with instructions for medical use, is placed in a pack of boxed cardboard for consumer packaging or chrome-ersatz cardboard.

Storage conditions

At a temperature not exceeding 30 °C.

Keep out of the reach of children.

Best before date

3 years.

Do not use after expiration date.

Vacation conditions

Available without a prescription.

Dimetindene drops 1 mg/ml 20 ml bottle (Tula Pharmaceutical Factory)

Registration Certificate Holder

TULA PHARMACEUTICAL FACTORY (Russia)

Dosage form

Medicine - Fenicitol

Description

Drops for oral administration

in the form of a clear, colorless liquid with virtually no odor.

1 ml

dimethindene maleate 1 mg

Excipients

: sodium hydrogen phosphate dodecahydrate - 16 mg, citric acid monohydrate - 5 mg, benzoic acid - 1 mg, disodium edetate - 1 mg, sodium saccharinate - 0.5 mg, propylene glycol - 100 mg, purified water - up to 1 ml.

10 ml - dark glass bottles with a dropper (1) - cardboard packs. 20 ml - dark glass bottles with a dropper (1) - cardboard packs. 30 ml - dark glass bottles with a dropper (1) - cardboard packs. 40 ml - dark glass bottles with a dropper (1) - cardboard packs. 50 ml - dark glass bottles with a dropper (1) - cardboard packs. 60 ml - dark glass bottles with a dropper (1) - cardboard packs. 70 ml - dark glass bottles with a dropper (1) - cardboard packs. 80 ml - dark glass bottles with a dropper (1) - cardboard packs. 90 ml - dark glass bottles with a dropper (1) - cardboard packs. 100 ml - dark glass bottles with a dropper (1) - cardboard packs.

Indications

For oral administration: urticaria, hay fever, vasomotor rhinitis, food and drug allergies, angioedema; as an adjuvant in the treatment of anaphylactic reactions and serum sickness; itching due to insect bites, eczema, dermatoses of allergic and non-allergic origin, measles, rubella, chicken pox. Preventive hyposensitizing therapy in patients prone to allergic reactions.

For external use: itchy skin lesions with dermatoses, urticaria, insect bites, as well as minor burns.

Contraindications for use

Hypersensitivity to dimethindene; angle-closure glaucoma, urinary disorders (including with prostate hypertrophy), children under 1 month of age (especially in the case of premature birth).

For oral administration: bronchial asthma; I trimester of pregnancy; breastfeeding period.

pharmachologic effect

Histamine H1 receptor blocker, alkylamine derivative. It has antiallergic, antipruritic and slight anticholinergic effects. It also has a pronounced local anesthetic effect. Causes a mild sedative effect of central origin.

Drug interactions

When used simultaneously with drugs that have a depressant effect on the myocardium, the effect of the latter may be enhanced.

When used simultaneously with tricyclic antidepressants or anticholinergics, the risk of increased intraocular pressure increases.

MAO inhibitors may enhance the anticholinergic and sedative effects of dimethindene.

With simultaneous use, dimethindene enhances the effect of anxiolytics and hypnotics.

With the simultaneous use of ethanol, a slowdown in the reaction rate is observed.

Dosage regimen

Inside. For adults and children over 12 years of age, the recommended daily dose is 3-6 mg, divided into 3 doses. Children aged 1 month to 12 years are prescribed a daily dose of 0.1 mg/kg body weight. The daily dose must be divided into 3 doses.

Externally. Apply to the affected area of skin 2-4 times a day.

In cases of severe itching or widespread skin lesions, simultaneous use of oral forms is recommended.

Side effect

From the immune system: when taken orally, very rarely - anaphylactoid reactions, including swelling of the face, swelling of the pharynx, rash, muscle spasms and shortness of breath.

From the nervous system: when taken orally - fatigue, drowsiness (especially at the beginning of treatment), nervousness, state of excitement, muscle spasm; rarely - headache, dizziness, anxiety.

From the digestive system: when taken orally, nausea, dry mouth or throat may occur.

Other: when taken orally - swelling; rarely - skin rash; in isolated cases - disorders of the respiratory system.

For external use: rarely - dryness and burning sensation at the site of application, allergic skin reactions.

special instructions

Ingestion. In children aged 1 month to 1 year, the drug should be used only as prescribed by a doctor and if there are indications for the use of H1-histamine receptor blockers, and the recommended doses should not be exceeded.

Impact on the ability to drive vehicles and machinery

During the treatment period, you should not engage in activities that require increased attention or rapid psychomotor reactions.

External use. In children from 1 month to 2 years, dimethindene is used only after consultation with a doctor. In infants and young children, the product should not be used on large areas of skin (especially if it is wet or inflamed). In case of severe itching or if large areas of skin are affected, dimethindene can be used only after consultation with a doctor. When applying dimethindene externally to large areas of skin, avoid exposure to sunlight. Ineffective for itching associated with cholestasis.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - Contraindicated.

Ingestion. Dimetindene is contraindicated for oral use in the first trimester of pregnancy. Use in the II-III trimesters of pregnancy is possible under medical supervision, only if the expected benefit to the mother outweighs the potential risk to the fetus. Use during breastfeeding is contraindicated.

External use. Use in the first trimester of pregnancy is possible only after consultation with a doctor. In the second and third trimesters of pregnancy, as well as during breastfeeding, it should not be used on large areas of the skin, especially in the presence of inflammation or bleeding. Nursing mothers should not apply the product to the nipples of the mammary glands.

Use in elderly patients

Restrictions for elderly patients - No restrictions. Use in elderly patients is allowed according to indications in recommended doses.

Use in children

Restrictions for children - With caution.

Ingestion. Contraindicated for use in children under 1 month of age (especially in the case of premature birth). Children aged 1 month to 1 year should use the drug only as prescribed by a doctor and if there are indications for the use of H1-histamine receptor blockers, and the recommended doses should not be exceeded.

Dimetindene Phenicitol gel external 0.1% 25 g x1

Dimetinden gel external 0.1% 25 g x1 Registration numberLP-005383 Trade name

Dimetinden

International nonproprietary name

Dimetinden

Dosage form

Gel for external use

Composition per 100 g:

Active ingredient: dimethindene maleate – 0.1 g. Excipients: disodium edetate – 0.05 g, carbomer – 0.9 g, sodium hydroxide – 0.3 g, benzalkonium chloride – 0.005 g, propylene glycol – 15.0 g, purified water – up to 100 g.

Description

Homogeneous colorless gel, transparent or slightly opalescent, practically odorless.

Pharmacotherapeutic group

Antiallergic agent – H1-histamine receptor blocker.

ATX Code:

D04AA13.

Pharmacological properties

Pharmacodynamics Antihistamine, antiallergic and antipruritic agent. H1-histamine receptor blocker, is a competitive histamine antagonist. The drug reduces increased capillary permeability associated with allergic reactions. When applied to the skin, the drug reduces itching and irritation caused by allergic skin reactions. The drug also has a pronounced local anesthetic effect. It also has antikinin and weak anticholinergic effects. When used externally, thanks to the gel base, it has a quick onset of action (within a few minutes) and a slight cooling effect. The maximum effect is after 1-4 hours. Pharmacokinetics When used externally, it penetrates well into the skin, systemic bioavailability is 10%.

Indications for use

Skin itching of various origins (except those associated with cholestasis), for example: itchy dermatoses, eczema, urticaria, insect bites. Sunburn, household and industrial burns (mild).

Contraindications

Hypersensitivity to dimethindene and other components included in the drug, angle-closure glaucoma, prostatic hyperplasia, children under 1 month of age, especially premature infants.

Carefully

Pregnancy 1st trimester, breastfeeding period.

Use during pregnancy and breastfeeding

Before using Dimetindene, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor. The use of the drug in the first trimester of pregnancy is possible only after consultation with a doctor. In the second and third trimesters, as well as during breastfeeding, the drug should not be used on large areas of the skin, especially in the presence of inflammation or bleeding. Nursing mothers should not apply the drug to the nipples of the mammary glands.

Directions for use and doses

Externally. The gel is applied to the affected area of the skin 2-4 times a day. In cases of severe itching or widespread skin lesions, simultaneous use of oral forms of dimetindene is recommended.

Side effect

The frequency of adverse reactions that may occur during therapy is given in the following gradation: very often (≥1/10), often (≥1/100 to <.1/10), infrequently (≥1/1000 to <.1 /100), rare (≥1/10000 to <.1/1000), very rare (<.1/10000), including isolated reports and reactions with unknown frequency (cannot be calculated from available data). Skin and subcutaneous tissue disorders: Uncommon: dry, burning skin. Very rare: allergic dermatitis, including skin rash, itching. If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

If a large amount of the drug is accidentally ingested, symptoms characteristic of an overdose of H1-histamine receptor blocker drugs may occur, including depression of central nervous system (CNS) functions, drowsiness (mainly in adults), stimulation of CNS functions, antimuscarinic effects (especially in children ), including increased excitability, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, flushing, urinary retention and fever. This may be followed by a drop in blood pressure. Treatment: No specific antidote is known. The usual emergency measures should be taken: if taken orally, take activated charcoal, saline laxatives, and, if necessary, take measures to maintain the functions of the cardiovascular and respiratory systems. Vasoconstrictors can be used to treat arterial hypotension. Do not exceed the recommended dose of the drug. In case of accidental overdose, tell your doctor immediately.

Interaction with other drugs

There are no known drug interactions for the drug.

special instructions

In children from 1 month to 2 years, the drug is used after consultation with a doctor. In infants and young children, the drug should not be used on large areas of the skin, especially if there is inflammation or bleeding. In case of severe itching or if large areas of skin are affected, the drug can be used only after consultation with a doctor. When using the drug on large areas of the skin, avoid exposure to sunlight. If during the period of use of the drug the severity of the symptoms of the disease does not decrease or, on the contrary, intensifies, you should consult a doctor. Ineffective for itching associated with cholestasis. The drug contains propylene glycol and benzalkonium chloride, which can cause local allergic reactions.

The effect of the drug on the ability to drive vehicles and machinery

Does not affect.

Release form

Gel for external use 0.1%. 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100 g in orange glass jars with a triangular rim and a lid that is tensioned with a sealing element. 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100 g in polymer jars complete with lids or in polyethylene terephthalate jars with closures. 20, 25, 30, 35, 40, 50, 60, 70, 80, 100 g in aluminum tubes, coated with BF-2 varnish, with caps made of high-density polyethylene or in polymer tubes with polyethylene screw caps. Each jar and tube, along with instructions for use, is placed in a cardboard pack.

Storage conditions

At a temperature not higher than 25 °C. Keep out of the reach of children.

Best before date

3 years. Do not use after expiration date.

Vacation conditions

Available without a prescription.

Manufacturer/Organization receiving complaints:

LLC "Tula Pharmaceutical Factory" Russia, 300004, Tula, Torkhovsky proezd, 10