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Montelukast (Tablets) Instructions for Use

ATC Code

R03DC03 (Montelukast)

Active Substance

Montelukast (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Leukotriene receptor antagonist. Drug for the treatment of bronchial asthma and allergic rhinitis

Pharmacotherapeutic Group

Drugs for the treatment of obstructive airway diseases; other systemic agents for the treatment of obstructive airway diseases; leukotriene receptor antagonists

Pharmacological Action

Leukotriene receptor antagonist. Montelukast binds with high selectivity and affinity to CysLT1 receptors (instead of other pharmacologically important airway receptors, such as prostanoid, cholinergic, or β-adrenergic receptors).

Montelukast inhibits the physiological actions of the cysteinyl leukotrienes LTC4, LTD4, and LTE4 by binding to CysLT1 receptors without exerting any agonist activity on these receptors. Montelukast inhibits CysLT1 receptors in the airway epithelium, thereby possessing the ability to inhibit bronchospasm induced by inhaled LTD4 in patients with bronchial asthma.

A dose of 5 mg is sufficient to block LTD4-induced bronchospasm.

Montelukast causes bronchodilation within 2 hours after oral administration and may add to the bronchodilation induced by beta2-adrenergic agonists.

Pharmacokinetics

After oral administration, Montelukast is rapidly and almost completely absorbed from the gastrointestinal tract. In adults receiving doses of 5-10 mg, the Cmax in plasma is achieved within 2-3 hours. Oral bioavailability is 64-73%.

The plasma protein binding of montelukast is more than 99%. The mean Vd is 8-11 L.

Moderate accumulation (approximately 14%) of the active substance in plasma is observed after once-daily administration of a 10 mg dose.

Montelukast is extensively metabolized in the liver. At therapeutic doses, the concentrations of montelukast metabolites in plasma at steady state are undetectable in adults and children.

It is presumed that the isoenzymes CYP3A4 and CYP2C9 are involved in the metabolism of montelukast; at therapeutic concentrations, Montelukast does not inhibit the CYP3A4, 2C9, 1A2, 2A6, 2C19, and 2D6 isoenzymes.

The T1/2 of montelukast in young healthy adults ranges from 2.7 to 5.5 hours. The clearance of montelukast in healthy adults averages 45 ml/min. After oral administration of montelukast, 86% is excreted in the feces over 5 days and less than 0.2% is excreted in the urine, confirming that Montelukast and its metabolites are excreted almost exclusively via the bile.

The pharmacokinetics of montelukast remain nearly linear following oral administration of doses greater than 50 mg.

Indications

Prophylaxis and long-term treatment of bronchial asthma, including: prevention of daytime and nighttime symptoms of the disease; treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid; prevention of exercise-induced bronchoconstriction.

Relief of daytime and nighttime symptoms of seasonal allergic rhinitis.

ICD codes

ICD-10 code Indication
J30.1 Allergic rhinitis due to pollen
J45 Asthma
ICD-11 code Indication
CA08.00 Allergic rhinitis due to pollen
CA23 Asthma

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.

Take orally once daily in the evening.

For asthma prophylaxis and allergic rhinitis, adhere strictly to the once-daily schedule.

For exercise-induced bronchoconstriction, take at least 2 hours before physical activity; do not take more than one dose in a 24-hour period.

The dose is determined by the patient’s age: administer 10 mg for adults and adolescents 15 years and older.

Administer 5 mg for pediatric patients 6 to 14 years old; a 4 mg chewable tablet is available for children 2 to 5 years old.

Montelukast can be added to existing therapy with bronchodilators and inhaled corticosteroids.

Do not use for the treatment of an acute asthma attack; ensure patients have access to a short-acting inhaled beta2-agonist for rescue therapy.

Do not abruptly substitute montelukast for inhaled or oral corticosteroids; any dose reduction of corticosteroids must be gradual and supervised by a physician.

Tablets may be taken with or without food.

Adverse Reactions

Infections and infestations: very common – upper respiratory tract infections.

Blood and lymphatic system disorders: uncommon – increased bleeding tendency; frequency unknown – thrombocytopenia.

Immune system disorders: uncommon – hypersensitivity reactions, including anaphylaxis; very rare – eosinophilic infiltration of the liver.

Psychiatric disorders: uncommon – agitation, including aggressive behavior or hostility, anxiety, depression, disorientation, dream abnormalities, insomnia, psychomotor hyperactivity (including irritability, restlessness, and tremor), somnambulism, tic; rare – attention disturbance, memory impairment; very rare – hallucinations, suicidal thoughts and behavior (suicidality).

Nervous system disorders: uncommon – headache, dizziness, drowsiness, paresthesia/hypoesthesia, seizures.

Cardiac disorders: rare – palpitations.

Respiratory, thoracic and mediastinal disorders: uncommon – epistaxis; very rare – pulmonary eosinophilia.

Gastrointestinal disorders: common – diarrhea, nausea, vomiting; uncommon – dyspepsia, dry mouth; frequency unknown – abdominal pain, pancreatitis.

Hepatobiliary disorders: common – increased ALT and AST activity; very rare – hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).

Skin and subcutaneous tissue disorders: common – rash; uncommon – pruritus, urticaria, increased tendency to bruising; rare – angioedema; very rare – erythema nodosum, erythema multiforme.

Musculoskeletal and connective tissue disorders: uncommon – arthralgia, myalgia including muscle cramps.

Renal and urinary disorders: frequency unknown – enuresis in children.

General disorders and administration site conditions: common – pyrexia; uncommon – asthenia (weakness)/fatigue, edema, thirst; in patients with bronchial asthma, rare – development of Churg-Strauss syndrome.

Contraindications

Hypersensitivity to montelukast; pediatric age – depending on the dosage form.

Use in Pregnancy and Lactation

During pregnancy, Montelukast should be used only if the potential benefit to the mother outweighs the possible risk to the fetus, only under medical supervision, and only at the lowest effective doses.

Cases of congenital limb defects in newborns have been reported in mothers who took Montelukast during pregnancy. Most of these women also took other medications for asthma during pregnancy. A causal relationship between montelukast use and the development of congenital limb defects has not been established.

It is not known whether Montelukast is excreted in human milk. Montelukast should not be used during lactation (breastfeeding).

Pediatric Use

Can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the montelukast drug labeling regarding contraindications for the use of specific montelukast dosage forms in children of different ages.

Geriatric Use

Can be used in elderly patients according to indications in recommended doses and regimens.

Special Precautions

The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established. Therefore, oral Montelukast is not recommended for the treatment of acute asthma attacks. Patients should be instructed to always have emergency medication for the relief of asthma attacks (short-acting inhaled beta2-agonists) with them.

Do not discontinue montelukast during an asthma exacerbation or when the use of emergency medication (short-acting inhaled beta2-agonists) is required to relieve attacks.

Patients with confirmed allergy to acetylsalicylic acid and other NSAIDs should not take these drugs during treatment with montelukast, since Montelukast, while improving respiratory function in patients with allergic bronchial asthma, cannot completely prevent NSAID-induced bronchoconstriction in them.

The dose of inhaled corticosteroids used concomitantly with montelukast can be gradually reduced under medical supervision; however, montelukast should not be abruptly substituted for inhaled or oral corticosteroids.

Effect on ability to drive and operate machinery

Some patients experienced drowsiness and dizziness while taking montelukast. If these symptoms occur, patients are advised not to drive vehicles or engage in other activities requiring concentration and speed of psychomotor reactions.

Drug Interactions

With concomitant use with phenobarbital, the AUC of montelukast decreased by approximately 40% (no adjustment of the montelukast regimen is required).

In vitro studies have shown that Montelukast inhibits the CYP2C8 isoenzyme; however, an in vivo drug interaction study of montelukast and rosiglitazone (metabolized by the CYP2C8 isoenzyme) did not confirm inhibition of the CYP2C8 isoenzyme by montelukast. Therefore, in clinical practice, no effect of montelukast on the CYP2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, and repaglinide, is expected.

In vitro studies have shown that Montelukast is a substrate of the CYP2C8, 2C9, and 3A4 isoenzymes. Data from a clinical drug interaction study regarding montelukast and gemfibrozil (an inhibitor of both the CYP2C8 and 2C9 isoenzymes) demonstrate that gemfibrozil increases the systemic exposure of montelukast by 4.4-fold.

Co-administration of itraconazole, a potent inhibitor of the CYP3A4 isoenzyme, together with gemfibrozil and montelukast did not lead to an additional increase in the systemic exposure of montelukast.

Montelukast is a rational addition to monotherapy with bronchodilators if the latter do not provide adequate control of bronchial asthma. After achieving a therapeutic effect from treatment with montelukast, a gradual reduction in the dose of bronchodilators can be initiated.

The use of montelukast provides an additional therapeutic effect in patients receiving inhaled corticosteroids. After stabilization is achieved, a gradual reduction in the dose of corticosteroids can be initiated under medical supervision. In some cases, complete withdrawal of inhaled corticosteroids may be permissible; however, abrupt replacement of inhaled corticosteroids with Montelukast is not recommended.

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

Rx Only

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

Marketing Authorization Holder

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Manufactured By

Repliek Farm Ltd. Skopje (Republic of North Macedonia)

Primary Packaging

REPLEK FARM Ltd. Skopje (Republic of North Macedonia)

Secondary Packaging

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Quality Control Release

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Dosage Form

Bottle Rx Icon Montelukast Film-coated tablets, 10 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brownish with a pinkish tint, round, biconvex; the cross-section shows two layers: a white or almost white core and a brownish with a pinkish tint coating.

1 tab.
Montelukast sodium 10.4 mg,
   Equivalent to Montelukast 10 mg

Excipients: pregelatinized starch – 30 mg, lactose monohydrate – 129.4 mg, hypromellose (hydroxypropylcellulose) low-substituted – 10 mg, sodium carboxymethyl starch (sodium starch glycolate) – 16 mg, colloidal anhydrous silicon dioxide – 1.6 mg, magnesium stearate – 2.6 mg.

Coating composition Opadry white 03F28342 (talc – 3.442 mg, hypromellose – 3.123 mg, titanium dioxide – 0.765 mg, macrogol – 0.637 mg) – 7.967 mg, iron oxide yellow dye (E172) – 0.027 mg, iron oxide red dye (E172) – 0.006 mg.

10 pcs. – blister packs (1) – cardboard cartons.
10 pcs. – blister packs (2) – cardboard cartons.
10 pcs. – blister packs (3) – cardboard cartons.

Marketing Authorization Holder

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Manufactured By

Repliek Farm Ltd. Skopje (Republic of North Macedonia)

Primary Packaging

REPLEK FARM Ltd. Skopje (Republic of North Macedonia)

Secondary Packaging

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Quality Control Release

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Dosage Forms

Bottle Rx Icon Montelukast Chewable tablets 4 mg: 10, 20, or 30 pcs.
Chewable tablets 5 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets pale pink in color, with inclusions of darker and white color, round, biconvex.

1 tab.
Montelukast sodium 4.16 mg,
   Equivalent to Montelukast 4 mg

Excipients: mannitol – 49.36 mg, sorbitol – 108 mg, hypromellose (hydroxypropylcellulose) low-substituted – 4.8 mg, iron oxide red dye E172 – 1.2 mg, croscarmellose sodium – 19.2 mg, sodium cyclamate – 1.2 mg, microcrystalline cellulose – 48.24 mg, cherry flavor – 1.44 mg, magnesium stearate – 2.4 mg.

10 pcs. – blister packs (1) – cardboard cartons.
10 pcs. – blister packs (2) – cardboard cartons.
10 pcs. – blister packs (3) – cardboard cartons.

Chewable tablets pale pink in color, with inclusions of darker and white color, round, biconvex.

1 tab.
Montelukast sodium 5.2 mg,
   Equivalent to Montelukast 5 mg

Excipients: mannitol – 61.7 mg, sorbitol – 135 mg, hypromellose (hydroxypropylcellulose) low-substituted – 6 mg, iron oxide red dye E172 – 1.5 mg, croscarmellose sodium – 24 mg, sodium cyclamate – 1.5 mg, microcrystalline cellulose – 60.3 mg, cherry flavor – 1.8 mg, magnesium stearate – 3 mg.

10 pcs. – blister packs (1) – cardboard cartons.
10 pcs. – blister packs (2) – cardboard cartons.
10 pcs. – blister packs (3) – cardboard cartons.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Manufactured By

YUGPHARM, LLC (Russia)

Dosage Form

Bottle Rx Icon Montelukast Chewable tablets 5 mg: 14, 20, 28, 30, 40, 56, 80, 90, 98, or 140 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets pink in color, round, biconvex, with numerous light pink inclusions and a fruity (cherry) odor, engraved with "M9UT" and "5" on one side.

1 tab.
Montelukast sodium 5.2 mg,
   Equivalent to montelukast content 5 mg

Excipients: microcrystalline cellulose – 66 mg, mannitol – 201.35 mg, croscarmellose sodium – 9 mg, hypromellose – 9 mg, cherry flavor – 4.5 mg, aspartame – 1.5 mg, iron oxide red dye – 0.45 mg, magnesium stearate – 3 mg.

7 pcs. – blister packs (2) – cardboard cartons.
7 pcs. – blister packs (4) – cardboard cartons.
7 pcs. – blister packs (8) – cardboard cartons.
7 pcs. – blister packs (14) – cardboard cartons.
10 pcs. – blister packs (2) – cardboard cartons.
10 pcs. – blister packs (3) – cardboard cartons.
10 pcs. – blister packs (4) – cardboard cartons.
10 pcs. – blister packs (8) – cardboard cartons.
10 pcs. – blister packs (9) – cardboard cartons.
10 pcs. – blister packs (14) – cardboard cartons.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Manufactured By

YUGPHARM, LLC (Russia)

Dosage Form

Bottle Rx Icon Montelukast Film-coated tablets 10 mg: 14, 20, 28, 30, 40, 90, 98, or 140 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light yellow to brownish-yellow in color, round, biconvex, with an engraving “M9UT” and “10” on one side.

1 tab.
Montelukast sodium 10.4 mg,
   Equivalent to montelukast content 10 mg

Excipients: microcrystalline cellulose – 89.3 mg, lactose monohydrate – 89.3 mg, croscarmellose sodium – 6 mg, hypromellose – 4 mg, magnesium stearate – 1 mg.

Film coating composition: hypromellose – 1.73 mg, hydroxypropylcellulose – 1.73 mg, titanium dioxide – 1.5 mg, iron oxide yellow – 0.036 mg, iron oxide red – 0.004 mg.

7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
7 pcs. – contour cell blisters (14) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (14) – cardboard packs.

Marketing Authorization Holder

Rapharma, JSC (Russia)

Manufactured By

Synthon Hispania, S.L. (Spain)

Dosage Form

Bottle Rx Icon Montelukast Film-coated tablets, 10 mg: 14 or 28 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light yellow to light brown in color, round, biconvex, with an engraving “M9UT” and “10” on one side.

1 tab.
Montelukast sodium 10.4 mg,
   Equivalent to montelukast content 10 mg

Excipients: microcrystalline cellulose (MCC 102), lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose (low-substituted hydroxypropylcellulose), magnesium stearate.

Coating composition Opadry I yellow 20A23676: hydroxypropylcellulose, hypromellose (HPMC 2910), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).

14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

Synthon B.V. (Spain)

Packaging and Quality Control Release

PharmFirma Sotex, CJSC (Russia)

Dosage Forms

Bottle Rx Icon Montelukast Chewable tablets 4 mg: 7, 14, or 28 pcs.
Chewable tablets 5 mg: 7, 14, or 28 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets pink in color with dark specks, oval, biconvex, with an engraving “M9UT 4” on one side.

1 tab.
Montelukast sodium 4.16 mg,
   Equivalent to montelukast content 4 mg

Excipients: mannitol, microcrystalline cellulose (MCC-102), croscarmellose sodium, hydroxypropylcellulose (low-substituted hydroxypropylcellulose), cherry flavor, magnesium stearate, aspartame, iron oxide red (E172).

7 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.

Chewable tablets pink in color with dark specks, round, biconvex, with an engraving “M9UT” and “5” on one side.

1 tab.
Montelukast sodium 5.2 mg,
   Equivalent to montelukast content 5 mg

Excipients: mannitol, microcrystalline cellulose (MCC-102), croscarmellose sodium, hydroxypropylcellulose (low-substituted hydroxypropylcellulose), cherry flavor, magnesium stearate, aspartame, iron oxide red (E172).

7 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.

Marketing Authorization Holder

HLS Pharma, LLC (Russia)

Manufactured By

Shreya Life Sciences, Pvt.Ltd. (India)

Dosage Form

Bottle Rx Icon Montelukast Film-coated tablets, 10 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow in color, round, biconvex; on cross-section, the core is white or almost white.

1 tab.
Montelukast sodium 10.4 mg,
   Equivalent to montelukast content 10 mg

Excipients: lactose monohydrate – 115 mg, microcrystalline cellulose 102 – 65 mg, croscarmellose sodium – 8 mg, magnesium stearate – 1.6 mg.

Film coating: hypromellose – 3 mg, hydroxypropylcellulose – 1.164 mg, talc – 1.1556 mg, titanium dioxide – 0.6522 mg, iron oxide yellow – 0.0282 mg.

10 pcs. – blisters – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
30 pcs. – jars – cardboard packs.

Marketing Authorization Holder

HLS Pharma, LLC (Russia)

Manufactured By

Shreya Life Sciences, Pvt.Ltd. (India)

Dosage Form

Bottle Rx Icon Montelukast Chewable tablets 5 mg: 10, 20, 28, or 30 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets white or almost white, round, biconvex, with a cherry odor.

1 tab.
Montelukast sodium 5.2 mg,
   Equivalent to montelukast content 5 mg

Excipients: mannitol – 203.3 mg, microcrystalline cellulose (112) – 81 mg, hydroxypropylcellulose – 3 mg, magnesium stearate – 3 mg, cherry flavor – 3 mg, aspartame – 1.5 mg.

10 pcs. – blisters – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
28 pcs. – jars – cardboard packs.

Marketing Authorization Holder

Pharmtekhnologiya LLC (Republic of Belarus)

Dosage Forms

Bottle Rx Icon Montelukast PhT Chewable tablets 4 mg: 14, 28 or 30 pcs.
Chewable tablets 5 mg: 14, 28 or 30 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets flat-cylindrical, with a bevel on both sides, pink in color with possible specks and marbling.

1 tab.
Montelukast sodium 4.16 mg,
   Equivalent to montelukast content 4 mg

Excipients: mannitol (E421), povidone (K30), croscarmellose sodium, Cherry flavor, magnesium stearate, aspartame (E951), iron oxide red, microcrystalline cellulose (MCC101).

7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.

Chewable tablets flat-cylindrical, with a bevel on both sides, pink in color with possible specks and marbling.

1 tab.
Montelukast sodium 5.2 mg,
   Equivalent to montelukast content 5 mg

Excipients: mannitol (E421), povidone (K30), croscarmellose sodium, Cherry flavor, magnesium stearate, aspartame (E951), iron oxide red, microcrystalline cellulose (MCC101).

7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.

Marketing Authorization Holder

Sanofi Russia JSC (Russia)

Manufactured By

Zentiva Saglik Urunleri Sanayi Ve Ticaret, A.S. (Turkey)

Dosage Forms

Bottle Rx Icon Montelukast Sanofi Chewable tablets 4 mg: 28 or 84 pcs.
Chewable tablets 5 mg: 28 or 84 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets pink in color with light pink specks, oval, biconvex.

1 tab.
Montelukast (as montelukast sodium) 4 mg (4.16 mg)

Excipients: mannitol (Pearlitol® 300DC – 75%, Parteck® 100M – 25%) – 192.38 mg, Avicel CE-15 (microcrystalline cellulose – 85%, guar gum – 15%) – 21.38 mg, croscarmellose sodium – 9.6 mg, hydroxypropylcellulose (low-substituted) – 7.2 mg, cherry flavor – 0.24 mg, iron oxide red – 0.24 mg, magnesium stearate – 4.8 mg.

14 pcs. – Al/Al blisters (2) – cardboard packs.
14 pcs. – Al/Al blisters (6) – cardboard packs.

Chewable tablets pink in color with light pink specks, round, biconvex.

1 tab.
Montelukast (as montelukast sodium) 5 mg (5.2 mg)

Excipients: mannitol (Pearlitol® 300DC – 75%, Parteck® 100M – 25%) – 240.475 mg, Avicel CE-15 (microcrystalline cellulose – 85%, guar gum – 15%) – 26.725 mg, croscarmellose sodium – 12 mg, hydroxypropylcellulose (low-substituted) – 9 mg, cherry flavor – 0.3 mg, iron oxide red – 0.3 mg, magnesium stearate – 6 mg.

14 pcs. – Al/Al blisters (2) – cardboard packs.
14 pcs. – Al/Al blisters (6) – cardboard packs.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Bottle Rx Icon Montelukast solopharm Film-coated tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 63, 70, 80, 84, 90, 98, 100, 112, 120, 126, 140 or 150 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

1 tab.
Montelukast sodium 10.4 mg
   Equivalent to montelukast content 10 mg

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate, film coating: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol (macrogol) 3350, talc.

7 pcs. – contour cell blisters (from 1 to 10 pcs) – cardboard packs.
10 pcs. – contour cell blisters (from 1 to 10 pcs) – cardboard packs.
14 pcs. – contour cell blisters (from 1 to 10 pcs) – cardboard packs.
20 pcs. – bottle (1) – cardboard packs.
30 pcs. – bottle (1) – cardboard packs.
40 pcs. – bottle (1) – cardboard packs.
50 pcs. – bottle (1) – cardboard packs.
60 pcs. – bottle (1) – cardboard packs.
90 pcs. – bottle (1) – cardboard packs.
120 pcs. – bottle (1) – cardboard packs.
150 pcs. – bottle (1) – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Or

Velpharm-M, LLC (Russia)

Dosage Form

Bottle Rx Icon Montelukast Velpharm Chewable tablets 5 mg: 7, 10, 14, 15, 20, 21, 28, 30, 35, 40, 42, 45, 49, 50, 56, 60, 63, 70, 75, 80, 84, 90, 98, 100, 105, 112, 120, 126, 135, 140 or 150 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets white or almost white, round, biconvex, with a cherry odor.

1 tab.
Montelukast sodium 5.2 mg,
   In terms of Montelukast 5 mg

Excipients: mannitol (mannite), microcrystalline cellulose (type 101), hydroxypropylcellulose, magnesium stearate, aspartame, “Cherry” flavor.

7 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (3) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
7 pcs. – contour cell blisters (5) – cardboard packs.
7 pcs. – contour cell blisters (6) – cardboard packs.
7 pcs. – contour cell blisters (7) – cardboard packs.
7 pcs. – contour cell blisters (8) – cardboard packs.
7 pcs. – contour cell blisters (9) – cardboard packs.
7 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (7) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (3) – cardboard packs.
14 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – contour cell blisters (5) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – contour cell blisters (7) – cardboard packs.
14 pcs. – contour cell blisters (8) – cardboard packs.
14 pcs. – contour cell blisters (9) – cardboard packs.
14 pcs. – contour cell blisters (10) – cardboard packs.
15 pcs. – contour cell blisters (1) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (3) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (5) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (7) – cardboard packs.
15 pcs. – contour cell blisters (8) – cardboard packs.
15 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
15 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
21 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
35 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
42 pcs. – jars (1) – cardboard packs.
45 pcs. – jars (1) – cardboard packs.
49 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
56 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
63 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
75 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
84 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
98 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
105 pcs. – jars (1) – cardboard packs.
112 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
126 pcs. – jars (1) – cardboard packs.
135 pcs. – jars (1) – cardboard packs.
140 pcs. – jars (1) – cardboard packs.
150 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Bottle Rx Icon Montelukast-Alium Film-coated tablets, 10 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the tablet cross-section is white or almost white.

1 tab.
Montelukast sodium 10.4 mg,
   Equivalent to montelukast content 10 mg

Excipients: lactose monohydrate, microcrystalline cellulose-102, croscarmellose sodium, hypromellose (hydroxypropylcellulose), magnesium stearate.

Film coating composition Opadry II 32F280008 [hypromellose (hydroxypropyl methylcellulose), lactose monohydrate, titanium dioxide, macrogol].

10 pcs. – blister packs (3) – cardboard packs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Bottle Rx Icon Montelukast-Alium Chewable tablets 5 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets white or almost white, round, flat-cylindrical, odorless or with a faint characteristic cherry odor, with a score and a bevel; the cross-section is white or almost white.

1 tab.
Montelukast sodium 5.2 mg,
   Equivalent to montelukast content 5 mg

Excipients: mannitol, microcrystalline cellulose-102, croscarmellose sodium, hydroxypropylcellulose, cherry flavor, magnesium stearate.

10 pcs. – blister packs (3) – cardboard packs.

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Montelukast-Edvansd Film-coated tablets, 10 mg: 7, 10, 14, 20, 28 or 40 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light yellow to yellow-brown, round, biconvex; the core on the cross-section is white or almost white.

1 tab.
Montelukast sodium 10.4 mg,
   In terms of Montelukast 10 mg

Excipients: lactose monohydrate – 106.7 mg, mannitol – 62.2 mg, croscarmellose sodium – 7.5 mg, hypromellose – 0.8 mg, microcrystalline cellulose (type 102) – 9 mg, magnesium stearate – 3.4 mg.

Film coating composition ready yellow coating ((Wincoat WT-4014 yellow) (hypromellose, macrogol 3350, titanium dioxide, talc, aluminum lake based on quinoline yellow dye – 5 mg.

7 pcs. – blisters (1) – cardboard packs.
7 pcs. – blisters (2) – cardboard packs.
7 pcs. – blisters (4) – cardboard packs.
7 pcs. – strips (1)- cardboard packs.
7 pcs. – strips (2) – cardboard packs.
7 pcs. – strips (4) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – strips (1) – cardboard packs.
10 pcs. – strips (2) – cardboard packs.
10 pcs. – strips (4) – cardboard packs.
7 pcs. – plastic jars (1) – cardboard packs.
10 pcs. – plastic jars (1) – cardboard packs.
14 pcs. – plastic jars (1) – cardboard packs.
20 pcs. – plastic jars (1) – cardboard packs.
28 pcs. – plastic jars (1) – cardboard packs.
40 pcs. – plastic jars (1) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle Rx Icon Montelukast-Vertex Film-coated tablets, 10 mg: 10, 14, 15, 28, 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex; the core on the cross-section is white or almost white.

1 tab.
Montelukast sodium 10.4 mg,
   Equivalent to montelukast content 10 mg

Excipients: lactose monohydrate – 115 mg, microcrystalline cellulose 102 – 65 mg, croscarmellose sodium – 8 mg, magnesium stearate – 1.6 mg.

Film coating composition: hypromellose – 3 mg, hypromellose (hydroxypropylcellulose) – 1.164 mg, talc – 1.1556 mg, titanium dioxide – 0.6522 mg, iron oxide yellow dye – 0.0282 mg or a dry mixture for film coating containing hypromellose – 50%, hypromellose (hydroxypropylcellulose) – 19.4%, talc – 19.26%, titanium dioxide – 10.87%, iron oxide yellow dye – 0.47% – 6 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (1) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
20 pcs. – blister packs (3) – cardboard packs.
28 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.

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