Chloropyramine (Tablets, Solution) Instructions for Use
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 Cmax 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
| 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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
![Chloropyramine [Tablets, Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Chloropyramine [Tablets, Solution] 2")