Chloropyramine (Tablets, Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

R06AC03 (Chloropyramine)

Active Substance

Chloropyramine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Histamine H₁-receptor blocker, an ethylenediamine derivative. It has an antiallergic and antipruritic effect. It causes a sedative effect. It has peripheral anticholinergic activity and moderate antispasmodic properties.

Pharmacokinetics

After oral administration, chloropyramine hydrochloride is rapidly and completely absorbed from the gastrointestinal tract. The C_max in blood plasma is reached within the first 1-2 hours, and the therapeutic concentration level is maintained for 3-6 hours.

Regardless of the route of administration, it is well distributed in the body, including the CNS.

The binding of chloropyramine to plasma proteins is 7.9%. The binding peak is noted at pH 7.4.

It is metabolized in the liver.

It is excreted mainly by the kidneys in the form of metabolites. In children, excretion occurs faster than in adults.

Indications

Allergic diseases, including urticaria, serum sickness, angioneurotic edema, pollinosis (hay fever), allergic rhinopathies, allergic conjunctivitis.

Skin diseases, including contact dermatitis, acute and chronic eczema, drug rashes, pruritic dermatoses.

Itching from insect bites.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
H10.1	Acute atopic (allergic) conjunctivitis
J30.1	Allergic rhinitis due to pollen
J30.3	Other allergic rhinitis (perennial allergic rhinitis)
L20.8	Other atopic dermatitis (neurodermatitis, eczema)
L23	Allergic contact dermatitis
L24	Irritant contact dermatitis
L28.0	Lichen simplex chronicus (circumscribed neurodermatitis)
L29	Pruritus
L30.0	Nummular eczema
L50	Urticaria
T14.0	Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T78.3	Angioneurotic edema (Quincke's edema)
T80.6	Other serum reactions
T88.7	Unspecified adverse effect of drug or medicament

ICD-11 code	Indication
9A06.70	Atopic eczema of the eyelids
9A60.01	Acute atopic conjunctivitis
9A60.02	Allergic conjunctivitis
9A60.0Y	Other specified papillary conjunctivitis
9A60.0Z	Papillary conjunctivitis, unspecified
CA08.00	Allergic rhinitis due to pollen
CA08.03	Other allergic rhinitis
EA80.0	Infantile atopic eczema
EA80.1	Childhood atopic eczema
EA80.2	Adult atopic eczema
EA80.Z	Atopic eczema, unspecified
EA82	Nummular dermatitis
EA83.00	Lichen simplex of vulva
EA83.01	Lichen simplex of male genital organs
EA83.02	Lichen simplex of perianal area
EA83.0Z	Lichen simplex of unspecified location
EA85.20	Atopic hand eczema
EB04	Idiopathic angioedema
EC90.Z	Itching, unspecified
EH92	Dermatoses provoked by friction or mechanical impact
EH92.1	Blister due to friction
EK00.Z	Allergic contact dermatitis, unspecified
EK02.Z	Irritant contact dermatitis, unspecified
ND56.0	Superficial injury of unspecified body region
NE60	Poisoning by drugs, medicaments or biological substances, not elsewhere classified
NE80.3	Other serum reactions

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer tablets or oral solution with a full glass of water.

For adults, the typical oral dose is 25 mg three to four times daily.

The maximum daily dose for adults is 150 mg; do not exceed this limit.

For children, base the oral dose on age: administer 6.25 mg to 12.5 mg two to three times daily.

For intramuscular or intravenous administration to adults, use a single dose of 20 mg to 40 mg.

Adjust the dosing frequency based on the clinical response and severity of symptoms.

Initiate therapy at the lower end of the dosage range for elderly patients or those with hepatic impairment.

Monitor patients for excessive sedation or other adverse effects, particularly at the beginning of treatment.

Discontinue treatment if severe adverse reactions occur.

Adverse Reactions

From the CNS, lethargy, drowsiness, weakness, mild tremor, dizziness are possible. In children, some stimulating effect on the CNS is possible, manifested by anxiety, increased irritability, insomnia.

From the digestive system, dry mouth, nausea, vomiting, diarrhea or constipation are possible.

From the cardiovascular system, rarely – decreased blood pressure (more often in elderly patients), tachycardia, arrhythmia.

Allergic reactions: skin rash, itching are possible.

Other: rarely – difficult urination.

Contraindications

Glaucoma (for parenteral administration), benign prostatic hyperplasia, urinary retention (for parenteral administration), simultaneous use of MAO inhibitors (for parenteral administration), gastric ulcer in the acute phase (for parenteral administration), acute attack of bronchial asthma, pregnancy, lactation period, early childhood up to 1 month, hypersensitivity to chloropyramine or other ethylenediamine derivatives.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Should be used with caution in cases of liver function insufficiency.

Pediatric Use

Contraindicated in early childhood under 1 month.

Use with caution in children due to the increased sensitivity of this category of patients to antihistamines.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Should be used with caution in elderly patients, in cases of liver function insufficiency and/or heart disease.

Use with caution in children due to the increased sensitivity of this category of patients to antihistamines.

Oral administration should be used with particular caution in patients with angle-closure glaucoma, urinary retention, and prostatic hypertrophy.

When taken at night, Chloropyramine may exacerbate the symptoms of reflux esophagitis.

Alcohol consumption should be avoided during treatment.

Effect on the ability to drive vehicles and operate machinery

During the initial, individually determined period of chloropyramine use, driving vehicles and engaging in other potentially hazardous activities requiring speed of psychomotor reactions are not permitted. During further treatment, the degree of restrictions is determined depending on treatment tolerance.

Drug Interactions

With simultaneous use, Chloropyramine potentiates the effects of anesthetics, hypnotics, tranquilizers, analgesics, MAO inhibitors, tricyclic antidepressants, atropine, and sympatholytics (such a combination requires caution).

With simultaneous use of chloropyramine and caffeine or phenamine, a decrease or elimination of the inhibitory effect of chloropyramine on the CNS is noted.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Chloropyramine [Armavir Biopharmaceutical Plant, FSE (Russia)]
Solution for intravenous and intramuscular administration 20 mg/ml: amp. 5 or 10 pcs.

Marketing Authorization Holder

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Chloropyramine

Solution for intravenous and intramuscular administration 20 mg/ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless or slightly colored liquid.

	1 ml
Chloropyramine hydrochloride	20 mg

Excipients: water for injections – up to 1 ml.

1 ml – ampoules (5) – cardboard pack.
1 ml – ampoules (10) – cardboard pack.

Chloropyramine [Atoll LLC (Russia)]
Tablets 25 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120, or 200 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Chloropyramine

Tablets 25 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat, odorless or almost odorless, with a cross-shaped score on one side and bevels on both sides.

	1 tab.
Chloropyramine hydrochloride	25 mg

Excipients: lactose monohydrate (milk sugar) – 130 mg, microcrystalline cellulose (MCC-101 Premium) – 32 mg, povidone K25 – 6 mg, sodium carboxymethyl starch type A – 5 mg, magnesium stearate – 2 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Chloropyramine [Atoll LLC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/ml: amp. 5 or 10 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Chloropyramine

Solution for intravenous and intramuscular administration 20 mg/ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless or slightly yellowish liquid, with a weak characteristic odor.

	1 ml
Chloropyramine hydrochloride	20 mg

Excipients: water for injections – up to 1 ml.

1 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.

Chloropyramine [Biosintez, PJSC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/ml: amp. 5 or 10 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Chloropyramine

Solution for intravenous and intramuscular administration 20 mg/ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless or slightly yellowish liquid, with a weak characteristic odor.

	1 ml
Chloropyramine hydrochloride	20 mg

Excipients: water for injections – up to 1 ml.

1 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Chloropyramine [Valenta Pharm, JSC (Russia)]
Tablets 25 mg: 20 pcs.

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

Dosage Form

Chloropyramine

Tablets 25 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, flat-cylindrical in shape with a bevel.

	1 tab.
Chloropyramine hydrochloride	25 mg

Excipients: lactose (milk sugar), potato starch, talc, magnesium stearate.

10 pcs. – contour cell packs (2) – cardboard packs.

Chloropyramine [Grotex, LLC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/1 ml: amp. 5, 10, or 20 pcs.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Chloropyramine

Solution for intravenous and intramuscular administration 20 mg/1 ml: amp. 5, 10, or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless or slightly colored liquid, with a characteristic odor.

	1 ml
Chloropyramine hydrochloride	20 mg

Excipients: water for injections – up to 1 ml.

1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.
1 ml – ampoules (20) – cardboard packs.

Chloropyramine [Novosibkhimpharm, JSC (Russia)]
Solution for intravenous and intramuscular injection 20 mg/1 ml: amp. 1 ml or 2 ml 5, 10, or 20 pcs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Chloropyramine

Solution for intravenous and intramuscular injection 20 mg/1 ml: amp. 1 ml or 2 ml 5, 10, or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular injection in the form of a transparent, colorless or slightly yellowish liquid with a weak characteristic odor.

	1 ml
Chloropyramine hydrochloride	20 mg

Excipients: water for injections – up to 1 ml.

1 ml – glass ampoules (10) – cardboard boxes.
1 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml – glass ampoules (10) – contour cell packs (1) – cardboard packs.
1 ml – glass ampoules (10) – contour cell packs (2) – cardboard packs.
2 ml – glass ampoules (10) – cardboard boxes.
2 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – glass ampoules (10) – contour cell packs (1) – cardboard packs.
2 ml – glass ampoules (10) – contour cell packs (2) – cardboard packs.

Chloropyramine [Promomed Rus LLC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/ml: amp. 5 or 10 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Chloropyramine

Solution for intravenous and intramuscular administration 20 mg/ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless or yellowish liquid, with a weak characteristic odor.

	1 amp. (1 ml)
Chloropyramine hydrochloride*	20 mg

Excipients: water for injections – up to 1 ml.
* calculated as 100% substance.

1 ml – Ampoules with a capacity of 2 ml (5) – contour cell packs made of polyvinyl chloride film (1) – cardboard packs.
1 ml – Ampoules with a capacity of 2 ml (5) – contour cell packs made of polyvinyl chloride film (2) – cardboard packs.
1 ml – Ampoules with a capacity of 2 ml (10) – cardboard boxes – inserts.

Chloropyramine [Promomed Rus LLC (Russia)]
Tablets 25 mg: 10, 20, or 40 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Chloropyramine

Tablets 25 mg: 10, 20, or 40 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel.

	1 tab.
Chloropyramine hydrochloride	25 mg

Excipients: lactose monohydrate (milk sugar) – 130 mg, microcrystalline cellulose (type 12) – 32 mg, sodium carboxymethyl starch – 5 mg, povidone K30 – 6 mg, magnesium stearate – 2 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – glass jars (1) – cardboard packs.

Chloropyramine [Pharmfirma Sotex, CJSC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/1 ml: amp. 1 ml 5 or 10 pcs.

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Dosage Form

Chloropyramine

Solution for intravenous and intramuscular administration 20 mg/1 ml: amp. 1 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a colorless or slightly yellowish, or slightly greenish, transparent liquid with a characteristic odor.

	1 amp. (1 ml)
Chloropyramine (as hydrochloride)	20 mg

Excipients: water for injections – up to 1 ml.

1 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.

Chloropyramine [Ellara, LLC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/1 ml: amp. 1 ml 5 or 10 pcs.

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Chloropyramine

Solution for intravenous and intramuscular administration 20 mg/1 ml: amp. 1 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, colorless or slightly yellowish, or slightly greenish, with a characteristic odor.

	1 ml
Chloropyramine hydrochloride (calculated as 100% substance)	20 mg

Excipients: water for injections – up to 1 ml.

1 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Chloropyramine [YUGPHARM, LLC (Russia)]
Tablets 25 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Chloropyramine

Tablets 25 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a score on one side and a bevel, odorless or almost odorless.

	1 tab.
Chloropyramine hydrochloride	25 mg

Excipients: lactose monohydrate – 130 mg, microcrystalline cellulose MCC-101 – 32 mg, povidone K-17 – 6 mg, sodium carboxymethyl starch (type A) – 5 mg, magnesium stearate – 2 mg.

Chloropyramine-BV [Bright Way, LLC (Russia)]
Tablets 25 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, or 180 pcs.

Marketing Authorization Holder

Bright Way, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Dosage Form

Chloropyramine-BV

Tablets 25 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, or 180 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, odorless or almost odorless, with a cross score and bevels.

	1 tab.
Chloropyramine hydrochloride	25 mg

Excipients: lactose monohydrate, microcrystalline cellulose type 101, sodium carboxymethyl starch type A, povidone K25 (kollidon K25), magnesium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (7) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (9) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
70 pcs. – jars – cardboard packs.
80 pcs. – jars – cardboard packs.
90 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.

Chloropyramine-Ferein [Bryntsalov-A, JSC (Russia)]
Tablets 25 mg: 10, 20, 30, 40, or 50 pcs.

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Form

Chloropyramine-Ferein

Tablets 25 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Chloropyramine hydrochloride	25 mg

20 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.

Medixlife (Author)

View all posts Profile link